Archive for October, 2017

$DYNT Announces Strategic Alliance Partnership with Zimmer MedizinSysteme

COTTONWOOD HEIGHTS, Utah, Oct. 23, 2017  — Dynatronics Corporation (NASDAQ:DYNT) today announced that it has signed an exclusive distribution agreement (“Strategic Alliance”) for the United States with Zimmer MedizinSysteme GmbH (Zimmer) for select therapy equipment.

Under the terms of the agreement, Dynatronics will be the exclusive U.S. distributor for Zimmer’s ThermoProTM (Shortwave Diathermy), enPulsTM (Radial Pulse Therapy), and OptonProTM (Class IV Laser) products.  Combining Dynatronics’ existing modalities with these Zimmer products will provide Dynatronics customers in the U.S. with a complete range of modality products.  Principally operating outside the U.S., Zimmer is the leading manufacturer of physical rehabilitation modalities in Germany, and one of the top three manufacturers of therapeutic modalities in Europe.  Dynatronics has been operating as a distributor for Zimmer for the last nine months on a non-exclusive basis, building its base of experience and confidence in the products during that period.

Jeff Gephart, Senior VP of Sales at Dynatronics, stated, “Dynatronics is pleased to provide such a high quality product line to our customers.  We are always seeking to improve outcomes for our customers, and this new partnership highlights that commitment.  We look forward to building this segment of our business more rapidly.”  Mr. Gephart continued, “Zimmer’s choice of Dynatronics underscores the value of the distribution presence that Dynatronics continues to build in the U.S.  Over the last two years we have made significant investment in our sales force through increased training, and marketing support to better reach our customers.”  The Zimmer product line will be sold through both the Dynatronics direct sales force and dealer channel.

According to Armin Zimmer, Zimmer’s CEO, “We are excited to have Dynatronics as our exclusive distribution partner in the U.S.  Dynatronics has developed a great reputation in the market as a leading manufacturer of physical therapy modalities.  We are committed to expanding our North American footprint and are confident in Dynatronics’ ability to lead that effort through this Strategic Alliance. We were also quite excited to participate in Dynatronics’ recent equity placement. Our $500,000 investment in Dynatronics will support additional investment in the Company’s distribution footprint, and is a vote of confidence in the Company’s acquisition strategy and very bright future in physical medicine.”

Previously, Dynatronics acted as a non-exclusive distributor of these types of products for several other manufacturers.  Currently, Dynatronics sales account for less than 2% of the relevant U.S. market opportunity for these products, which is estimated to be over $100 million.  With this new proprietary product line, Dynatronics is better positioned to capture market share and improve gross margin.

About Dynatronics

Dynatronics designs, manufactures, markets, and distributes advanced-technology medical devices, therapeutic and medical treatment tables, rehabilitation equipment, custom athletic training treatment tables and equipment, institutional cabinetry, as well as other rehabilitation and therapy products and supplies.  Through its various distribution channels, the company markets and sells its products to physical therapists, chiropractors, athletic trainers, sports medicine practitioners, and other medical professionals and institutions.  More information is available at www.dynatronics.com.

About Zimmer MedizinSysteme

Zimmer MedizinSysteme GmbH manufactures, markets and distributes, medical devices and aesthetics products for the physical therapy, athletic training, sports medicine, and related physical medicine markets.  More information is available at https://zimmer.de/en/.

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$BYSI Receives Two Grants in China to Further Develop Innovative Drug Pipeline

NEW YORK, Oct. 23, 2017 – BeyondSpring Inc. (NASDAQ:BYSI), a global clinical stage biopharmaceutical company focused on the development of innovative immuno-oncology cancer therapies, today announced that the Company has received two China non-equity diluting grants, which will be used to further develop BeyondSpring’s innovative drug pipeline. BeyondSpring received one in August 2017 from the city government of Dalian, China, and received the other on Sept. 30, 2017, from the Dalian Economic Development Park.

“The awarding of these two grants underscores the Chinese government’s support for BeyondSpring,” said Richard Brand, Chief Financial Officer, BeyondSpring. “Part of the proceeds will be particularly helpful in advancing our de novo drug discovery effort for BeyondSpring’s ubiquitination platform, which has the promise to target up to 70 percent of undruggable targets.”

In addition to the government’s grant support, BeyondSpring greatly benefits from the new game-changing regulatory steps that the State Council of China announced on Oct. 8, 2017.

“These new changes in regulatory policy allow for conditional drug approval based on a trend in clinical benefits to patients with unmet medical needs,” added Dr. Lan Huang, CEO, co-founder and chairman, BeyondSpring. “Given BeyondSpring’s Phase 3 China CTA status for Plinabulin for both indications of non-small cell lung cancer and the prevention of chemotherapy-induced neutropenia (CIN), we are well-positioned to obtain earlier-than-expected regulatory approval (conditional) based on Phase 3 interim analysis results. A Phase 3 interim analysis is planned for both indications in the first half of 2018, and we also expect to receive earlier-than-expected market authorization for China.”

“China is the second largest cancer market in the world, with four million new cancer patients per year and up to 65 percent of patients using chemotherapy,” concluded Dr. Huang. “BeyondSpring and Plinabulin are uniquely positioned to benefit from the new regulations, and the grants further reduce drug development costs, as well. All in all, BeyondSpring’s unique business model, which integrates both U.S. and Chinese clinical resources, ultimately provides time- and cost-efficiency – a powerful combination when it comes to bringing our drug candidates to market in the near future.”

About BeyondSpring
BeyondSpring is a global clinical stage biopharmaceutical company developing innovative immuno-oncology cancer therapies with a robust pipeline from internal development and from collaboration with Fred Hutchinson Cancer Research Center and University of Washington. BeyondSpring’s lead asset, Plinabulin, is in a Phase 3 clinical trial as a direct anticancer agent in non-small cell lung cancer and a Phase 2/3 clinical program in the prevention of chemotherapy-induced neutropenia. BeyondSpring has a seasoned management team with many years of experience bringing drugs to market.

About Plinabulin
Studies on Plinabulin’s method of action indicate that Plinabulin activates GEF-H1, a guanine nucleotide exchange factor. GEF-H1 activates downstream transduction pathways leading to the activation of the protein c-Jun. Activated c-Jun enters the nucleus of dendritic cells to upregulate immune-related genes, which contributes to the up-regulation of a series of genes leading to dendritic cell maturation, T-cell activation and other effects that prevent neutropenia.

Cautionary Note Regarding Forward-Looking Statements
This press release includes forward-looking statements that are not historical facts. Words such as “will,” “expect,” “anticipate,” “plan,” “believe,” “design,” “may,” “future,” “estimate,” “predict,” “objective,” “goal,” or variations thereof and variations of such words and similar expressions are intended to identify such forward-looking statements. Forward-looking statements are based on BeyondSpring’s current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions. Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of several factors including, but not limited to, the anticipated amount needed to finance the company’s future operations, unexpected results of clinical trials, delays or denial in regulatory approval process, our expectations regarding the potential safety, efficacy or clinical utility of our product candidates, or additional competition in the market. The forward-looking statements made herein speak only as of the date of this release and BeyondSpring undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law.

CONTACT INFO:
Caitlin Kasunich / Amy Singh
KCSA Strategic Communications
212.896.1241 / 212.896.1207
ckasunich@kcsa.com / asingh@kcsa.com

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$EXAC Enters Definitive Agreement with TPG Capital to Go Private

GAINESVILLE, Fla.

  • Leading Healthcare Investor Provides Company with Strategic Growth Capital
  • Exactech Shareholders To Receive $42.00 Per Share In Cash
  • Transaction Values Exactech at $625 Million
  • Represents a Premium of Approximately 31% to the Prior Closing and a 37% Premium to the 90-day Volume Weighted Average Price

Exactech (Nasdaq: EXAC), a leading developer and producer of orthopaedic implant devices and surgical instrumentation for extremities and large joints, today announced that it has entered into a definitive merger agreement under which TPG Capital, the global private equity platform of alternative asset firm TPG, will acquire all of the outstanding shares of Exactech common stock. Exactech’s board of directors approved the agreement which provides for the payment of $42.00 per share in cash to all holders of Exactech common stock other than certain management stockholders who have agreed to exchange a portion of their shares for new equity securities in the transaction. Exactech founders Dr. Bill Petty and Betty Petty and CEO David Petty have agreed with TPG to vote all of their shares in favor of the merger and to exchange a significant portion of their shares for new shares in the parent entity immediately following the merger. Such share exchange will be made at the same $42.00 value being paid in cash to Exactech’s shareholders. The transaction values Exactech at $625 million and the cash purchase price represents a premium of approximately 31% over Exactech’s closing stock price on October 20, 2017.

Upon completion of the transaction, Exactech will be a privately-held company headquartered in Gainesville, Florida, and Exactech’s common shares will no longer be listed on the NASDAQ stock exchange. The transaction is expected to close in the first quarter of 2018, subject to customary closing conditions, including approval by Exactech’s shareholders and termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976.

“We believe that this agreement offers Exactech shareholders an opportunity to realize the company’s tremendous growth and capture the value that’s been created since going public 21 years ago, at a significant premium to the current share price,” said Jim Binch, Exactech’s lead independent director.

Exactech CEO David Petty added, “This agreement provides maximum value for our shareholders, who have shared our vision and supported our growth over the past two decades.”

Exactech was founded in 1985 by orthopaedic surgeon Dr. Bill Petty, his wife Betty and biomedical engineer Gary Miller, PhD, with the purpose of improving the quality of care for patients suffering from joint injury or disease, such as arthritis. The company employs more than 700 individuals including engineers, researchers, manufacturing professionals, and sales representatives, and distributes its products to more than 35 countries around the world.

“As long-term healthcare investors, we aim to identify and partner with strong companies that are in growing, attractive sectors,” said Todd Sisitsky, Managing Partner at TPG Capital. “With their strong commitment to patients and surgeons and a comprehensive product portfolio, Exactech has strategically built a platform poised for significant growth. We are thrilled to partner with CEO David Petty, the company founders, the Exactech management team and TPG Capital advisors Jeff Binder and Dan Hann to further realize Exactech’s exciting potential.”

“The basis of our investment thesis is that there are outstanding opportunities for nimble, innovative and responsive companies to invest in growth and compete with the larger competitors in the orthopaedic industry,” said Jeff Binder, Senior Advisor to TPG Capital. “I look forward to working with management to fully realize the potential of a company for which I have always had great respect.”

Over the past 10 years, TPG Capital has invested more than $8 billion in healthcare. Taking a growth-oriented approach to its partnerships, the platform has invested in companies across the entire healthcare continuum, including medical devices companies such as Biomet, Fenwal, Beaver-Visitec International and Immucor; global healthcare providers such as Surgical Care Affiliates, Healthscope and Parkway; pharmaceutical companies such as Par Pharmaceutical and Adare; and healthcare IT companies such as QuintilesIMS and Mediware.

Advisors

J.P. Morgan Securities LLC is acting as the financial advisor to Exactech. Greenberg Traurig, P.A. (Miami) and Greenberg Traurig, LLP (NYC) are serving as Exactech’s legal advisor. Ropes & Gray is acting as legal advisor to TPG Capital.

About Exactech

Based in Gainesville, Fla., Exactech develops and markets orthopaedic implant devices, related surgical instruments and biologic materials and services to hospitals and physicians. The company manufactures many of its orthopaedic devices at its Gainesville facility. Exactech’s orthopaedic products are used in the restoration of bones and joints that have deteriorated as a result of injury or diseases such as arthritis. Exactech markets its products in the United States, in addition to more than 30 markets in Europe, Latin America, Asia and the Pacific. Additional information about Exactech can be found at http://www.exac.com.

About TPG

TPG is a leading global alternative asset firm founded in 1992 with more than $73 billion of assets under management and offices in Austin, Beijing, Boston, Dallas, Fort Worth, Hong Kong, Houston, London, Luxembourg, Melbourne, Moscow, Mumbai, New York, San Francisco, Seoul, and Singapore. TPG’s investment platforms are across a wide range of asset classes, including private equity, growth venture, real estate, credit, and public equity. TPG aims to build dynamic products and options for its investors while also instituting discipline and operational excellence across the investment strategy and performance of its portfolio. For more information, visit www.tpg.com.

Forward-Looking Statements

This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements include, but are not limited to, statements regarding Exactech’s proposed business combination transaction with TPG Capital, all statements regarding Exactech’s expected future financial position, results of operations, cash flows, dividends, financing plans, business strategy, budgets, capital expenditures, competitive positions, growth opportunities, plans and objectives of management, and statements containing the words such as “anticipate,” “approximate,” “believe,” “plan,” “estimate,” “expect,” “project,” “could,” “would,” “should,” “will,” “intend,” “may,” “potential,” “upside,” and other similar expressions. All Statements in this press release that are not historical facts, are forward-looking statements that reflect the best judgment of Exactech based upon currently available information.

Such forward-looking statements are inherently uncertain, and shareholders and other potential investors must recognize that actual results may differ materially from Exactech’s expectations as a result of a variety of factors, including, without limitation, those discussed below. Such forward-looking statements are based upon management’s current expectations and include known and unknown risks, uncertainties and other factors, many of which Exactech is unable to predict or control, that may cause its actual results, performance or plans to differ materially from any future results, performance or plans expressed or implied by such forward-looking statements. These statements involve risks, uncertainties and other factors discussed below and detailed from time to time in Exactech’s filings with the Securities and Exchange Commission (the “SEC”).

Risks and uncertainties related to the proposed merger include, but are not limited to, the risk that Exactech’s shareholders do not approve the merger, potential adverse reactions or changes to business relationships resulting from the announcement or completion of the merger, uncertainties as to the timing of the merger, adverse effects on Exactech’s stock price resulting from the announcement of the merger or the failure of the merger to be completed, competitive responses to the announcement of the merger, the risk that regulatory, licensure or other approvals required for the consummation of the merger are not obtained or are obtained subject to terms and conditions that are not anticipated, litigation relating to the merger, the inability to retain key personnel, and any changes in general economic and/or industry-specific conditions.

In addition to the factors set forth above, other factors that may affect Exactech’s plans, results or stock price are set forth in its most recent Annual Report on Form 10-K and in its subsequently filed reports on Forms 10-Q and 8-K.

Many of these factors are beyond Exactech’s control. Exactech cautions investors that any forward-looking statements made by it are not guarantees of future performance. Exactech disclaims any obligation to update any such factors or to announce publicly the results of any revisions to any of the forward-looking statements to reflect future events or developments.

Additional Information and Where to Find It

The Company will furnish to the SEC a report on Form 8-K regarding the proposed transaction described in this announcement, which will include the merger agreement. All parties desiring details regarding the merger are urged to review these documents, which will be available at the SEC’s website (http://www.sec.gov).

This press release does not constitute an offer to sell or the solicitation of an offer to buy any securities or a solicitation of any vote or approval. This communication may be deemed to be solicitation material in respect of the proposed merger. In connection with the merger, the Company will prepare and mail a proxy statement to its shareholders. In addition, certain participants in the merger will prepare and file with the SEC a Schedule 13E-3 transaction statement. These documents will be filed with or furnished to the SEC. Investors and shareholders are urged to read carefully and in their entirety these materials and other materials filed with or furnished to the SEC when they become available, as they will contain important information about the Company, the merger and related matters. In addition to receiving the proxy statement by mail, shareholders also will be able to obtain these documents, as well as other filings containing information about the Company, the merger and related matters, without charge, from the SEC’s website (http://www.sec.gov). In addition, these documents can be obtained, without charge, by sending an e-mail to investors@exac.com, along with complete contact details and a mailing address.

Participants in Solicitation

The Company and certain of its directors, executive officers and other members of management and employees may, under SEC rules, be deemed to be “participants” in the solicitation of proxies from shareholders with respect to the merger. Information regarding the persons or entities who may be considered “participants” in the solicitation of proxies will be set forth in the proxy statement and Schedule 13E-3 transaction statement relating to the merger when it is filed with the SEC. Information regarding the directors and executive officers of the Company is set forth in the proxy statement for the Company’s 2017 Annual Meeting of Shareholders, which was filed with the SEC on March 24, 2017. Additional information regarding the interests of such potential participants will be included in the proxy statement and Schedule 13E-3 transaction statement and the other relevant documents filed with the SEC when they become available.

 

Exactech
Investor Contact:
Jody Phillips, 352-377-1140
Executive Vice President of Finance & Chief Financial Officer
or
Media Contact:
TPG
Luke Barrett, 415-743-1550
media@tpg.com
or
Exactech
Priscilla Bennett, 352-377-1140
Priscilla@exac.com

Monday, October 23rd, 2017 Uncategorized Comments Off on $EXAC Enters Definitive Agreement with TPG Capital to Go Private

$SNES Signs a Distribution Agreement with Univar for ContraPest®

FLAGSTAFF, Ariz., Oct. 23, 2017 — SenesTech, Inc. (NASDAQ: SNES), a developer of proprietary technologies for managing animal pest populations through fertility control, today announced a national distribution agreement with Univar for ContraPest®.  In addition to distribution, Univar will be marketing and selling ContraPest throughout its network.

“Univar is an excellent sales and distribution partner for SenesTech, with their extensive breadth and depth of coverage, their direct connection with the pest control operators, and their commitment to sustainability. They will immediately provide us with nationwide sales coverage and nine dedicated sales representatives,” said Dr. Loretta P. Mayer, Chair, CEO and co-founder of SenesTech. “As they have assured us, as our distributor, Univar sees their role as an active partner in creating and building a market for ContraPest.”

About SenesTech 

SenesTech has developed an innovative technology for managing animal pest populations through fertility control as opposed to a lethal approach.

The Company’s first ContraPest’s novel technology and approach targets the reproductive capabilities of both sexes, inducing egg loss in female rodents and impairing sperm development in males. Using a proprietary bait delivery method, ContraPest is dispensed in a highly palatable liquid formulation that promotes sustained consumption by rat communities. ContraPest is designed, formulated and dispensed to be safe for handlers and non-target species such as wildlife, livestock and pets, where the active ingredients break down rapidly, unlike rodenticides. In contrast, the historical approach to managing rodent pest populations, rodenticides, carries a high risk of environmental contamination and the poisoning of non-target animals, pets and children. ContraPest is a Restricted Use product.

We believe our non-lethal approach, targeting reproduction, is more humane, less harmful to the environment, and more effective in providing a sustainable solution to pest infestations than traditional lethal pest management methods. There is currently no other non-lethal fertility control product approved by the Food and Drug Administration (FDA), or the Environmental Protection Agency (EPA), for the management of rodent populations.  We believe ContraPest® will establish a new paradigm in rodent control, resulting in improved performance in rodent control over rodenticides, without the negative environmental effects of rodenticides.  For more information visit the SenesTech website at www.senestech.com.

About Univar

Founded in 1924, Univar (NYSE: UNVR) is a global chemical and ingredient distributor and provider of value-added services, working with leading suppliers worldwide. Supported by a comprehensive team of sales and technical professionals with deep specialty and market expertise, Univar operates hundreds of distribution facilities throughout North America, Western Europe, Asia-Pacific and Latin America. Univar delivers tailored customer solutions through a broad product and services portfolio sustained by one of the most extensive industry distribution networks in the world.

Univar USA is the leading chemical distributor in the United States, providing more chemical products and related services than any other company in the marketplace. Their wide distribution network, with locations coast-to-coast, helps guarantee fast, reliable service to Univar’s customers.

Safe Harbor Statement
This release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. “Forward-looking statements” describe future expectations, plans, results, or strategies and are generally preceded by words such as “may,” “future,” “plan” or “planned,” “will” or “should,” “expected,” “anticipates,” “draft,” “eventually” or “projected.” You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements, including the risks that actual results may differ materially from those projected in the forward-looking statements as a result of various factors and other risks identified in our filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. We do not undertake any obligation to publicly update any forward-looking statements, whether as a result of the receipt of new information, the occurrence of future events or otherwise.

CONTACT: 

Investor: Robert Blum, Joe Dorame, Joe Diaz, Lytham Partners, LLC, 602-889-9700, senestech@lythampartners.com

Company: Tom Chesterman, Chief Financial Officer, SenesTech, Inc., 928-779-4143

Monday, October 23rd, 2017 Uncategorized Comments Off on $SNES Signs a Distribution Agreement with Univar for ContraPest®

$PBIO Engages NetworkNewsWire for Corporate Communications Solutions

NEW YORK, NY–(Oct 23, 2017) – Pressure BioSciences, Inc. (OTCQB: PBIO), a leader in the development and sale of proprietary laboratory instrumentation and associated consumables to the estimated $6 billion life sciences sample preparation market, announces that it has engaged the corporate communications expertise of NetworkNewsWire (“NNW”).

“Our award-winning proprietary technology is being installed in some of the top research laboratories around the world, we have just gone from one to six sales personnel, we will finish the development and release four new instruments to the market over the next 18 months, and our revenue continues to grow year-over-year. We believe that we now have the right resources, tools, and people to accelerate our growth plan and capture an even greater share of this large and expanding biopharma market,” said Richard T. Schumacher, President and CEO of Pressure BioSciences. “We look forward to integrating NetworkNewsWire’s strategies into our own as we focus on delivering an equitable return to our shareholders by increasing the exposure of our company and its potentially remarkable impact on the life sciences industry.”

NNW is a multifaceted financial news and publishing company that delivers a new generation of social communication solutions, news aggregation and syndication, and enhanced news release services. NNW’s strategies help public and private organizations find their voice and build market visibility. As part of the Client-Partner relationship with Pressure BioSciences, NNW will leverage its investor-based distribution network of over 5,000 key syndication outlets, various newsletters, social media channels, blogs, and other outreach tools to generate greater brand awareness for the Company.

“Pressure BioSciences has developed a cutting-edge technology that has the potential to play a significant role in a number of commercially important areas,” states Sherri Franklin, director of Content Marketing for NNW. “We look forward to assisting the company with a corporate communications campaign that effectively keeps shareholders and the investment community up-to-date on its operations, growth, and unique technology acceptance.”

About Pressure BioSciences, Inc.

Pressure BioSciences, Inc. (“PBI”) (OTCQB: PBIO) develops, markets, and sells proprietary laboratory instrumentation and associated consumables to the estimated $6 billion life sciences sample preparation market. Our products are based on the unique properties of both constant (i.e., static) and alternating (i.e., pressure cycling technology, or “PCT”) hydrostatic pressure. PCT is a patented enabling technology platform that uses alternating cycles of hydrostatic pressure between ambient and ultra-high levels to safely and reproducibly control bio-molecular interactions. Our primary focus is in the development of PCT-based products for biomarker and target discovery, drug development and design, bio-therapeutics characterization, soil & plant biology, forensics, and counter-bioterror applications. Major new focal market opportunities are emerging in the use of our patented, scalable, high-efficiency Ultra Shear Technology (“UST”) to create stable nanoemulsions of otherwise immiscible fluids (such as oils and water), and to prepare higher quality, homogenized, extended shelf-life or room temperature stable, low-acid liquid foods that cannot be effectively prepared using existing technologies.

For more information, visit www.PressureBioSciences.com

About NetworkNewsWire
NetworkNewsWire (NNW) is an information service that provides (1) access to our news aggregation and syndication servers, (2) NetworkNewsBreaks that summarize corporate news and information, (3) enhanced press release services, (4) social media distribution and optimization services, and (5) a full array of corporate communication solutions. As a multifaceted financial news and content distribution company with an extensive team of contributing journalists and writers, NNW is uniquely positioned to best serve private and public companies that desire to reach a wide audience of investors, consumers, journalists and the general public. NNW has an ever-growing distribution network of more than 5,000 key syndication outlets across the country. By cutting through the overload of information in today’s market, NNW brings its clients unparalleled visibility, recognition and brand awareness. NNW is where news, content and information converge.

For more information please visit https://www.NetworkNewsWire.com

Please see full terms of use and disclaimers on the NetworkNewsWire website applicable to all content provided by NNW, wherever published or re-published: http://NNW.fm/Disclaimer

Forward-Looking Statements

This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. All forward-looking statements are inherently uncertain as they are based on current expectations and assumptions concerning future events or future performance of the company. Readers are cautioned not to place undue reliance on these forward-looking statements, which are only predictions and speak only as of the date hereof. In evaluating such statements, prospective investors should review carefully various risks and uncertainties identified in this release and matters set in the company’s SEC filings. These risks and uncertainties could cause the company’s actual results to differ materially from those indicated in the forward-looking statements.

NNW Contact:

NetworkNewsWire (NNW)
New York, New York
www.NetworkNewsWire.com
212.418.1217 Office
Email Contact

Monday, October 23rd, 2017 Uncategorized Comments Off on $PBIO Engages NetworkNewsWire for Corporate Communications Solutions

$GALT to Present Clinical Data at The Liver Meeting® 2017

Research to be presented demonstrates VCTE liver stiffness measurement is a surrogate for identifying portal hypertension in patients with compensated NASH cirrhosis

NORCROSS, Ga., Oct. 20, 2017 — Galectin Therapeutics Inc. (NASDAQ:GALT), the leading developer of therapeutics that target galectin proteins, announced today that Dr. Raj Vuppalanchi of Indiana University will present a poster demonstrating the use of vibration-controlled transient elastography (VCTE) for non-invasively measuring liver stiffness (LSM) as a proven surrogate for identifying the progression of cirrhosis in patients with nonalcoholic steatohepatitis (NASH).  These data were collected from a 137 patient baseline subset of Galectin Therapeutics’ Phase 2b NASH-CX trial of its antifibrotic agent, GR-MD-02, in patients with compensated NASH cirrhosis and portal hypertension.  The study will be presented at The Liver Meeting® in Washington D.C. on October 19-23, 2017 and is co-authored by investigators involved in the NASH-CX trial. Topline results from the trial will be reported in December, 2017.

Based on previous studies that showed a strong correlation between hepatic venous pressure gradient (HVPG) and liver stiffness measurement (LSM) as a valid predictor of the development of complications from cirrhosis, investigators examined the potential utility of VCTE to measure LSM in patients with NASH cirrhosis as well as the ability to detect clinically significant portal hypertension (CSPH) in this patient population.

Vibration-controlled transient elastography is a non-invasive tool that measures the liver stiffness measurement (LSM) reliably.  Several studies have reported a good correlation between LSM and HPVG and its ability to detect CPSH.

“Measuring HVPG is an invasive and expensive procedure that requires special expertise, therefore, having a non-invasive diagnostic tool that predicts HPVG is very valuable in the management of cirrhosis,” said Peter Traber, M.D., president, chief executive officer and chief medical officer of Galectin Therapeutics and co-investigator of both studies. “This research suggests that LSM by VCTE is a useful test for prognostication in patients with compensated NASH cirrhosis with low MELD scores.  It can non-invasively identify patients who are at risk for complications of cirrhosis and better target those who might need invasive diagnostics such as HVPG and liver biopsy.  Additionally, it can be used to help identify subjects in clinical trials.”

Details for poster presentation at The Liver Meeting:

Friday, October 20, 2017
Poster Session I
“Liver Stiffness Measured By Vibration Controlled Transient Elastography Is An Excellent Surrogate for Identifying Clinically Significant Portal Hypertension In Patients With Compensated NASH Cirrhosis,” R. Vuppalanchi, et al. Abstract #446.

Galectin Therapeutics anticipates to announce top-line results from their NASH-CX trial in December 2017. Further information on the NASH-CX trial is also available at www.clinicaltrials.gov

About Galectin Therapeutics
Galectin Therapeutics is dedicated to developing novel therapies to improve the lives of patients with chronic liver and skin diseases and cancer. Galectin’s lead drug (GR-MD-02) is a carbohydrate-based drug that inhibits the galectin-3 protein that is directly involved in multiple inflammatory, fibrotic, and malignant diseases. The lead development program is in non-alcoholic steatohepatitis (NASH) with cirrhosis, the most advanced form of NASH related fibrosis. This is the most common liver disease and one of the largest drug development opportunities available today. Additional development programs are for treatment of severe atopic dermatitis, moderate-to-severe plaque psoriasis, and in combination immunotherapy for advanced melanoma and other malignancies. Galectin seeks to leverage extensive scientific and development expertise as well as established relationships with external sources to achieve cost-effective and efficient development. Additional information is available at www.galectintherapeutics.com.

Contact:
Jack Callicutt, Chief Financial Officer
678-620-3186
ir@galectintherapeutics.com

Friday, October 20th, 2017 Uncategorized Comments Off on $GALT to Present Clinical Data at The Liver Meeting® 2017

$ACRX DSUVIA™ Clinical Trial Results Selected as a “Top Abstract”

DSUVIA clinical trial results was one of the top eight abstracts featured as an oral presentation at an opioid pharmacotherapy symposium at ANESTHESIOLOGY® 2017

REDWOOD CITY, Calif., Oct. 20, 2017 — AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX) (AcelRx), a specialty pharmaceutical, today announced its clinical data presentation on the safety and efficacy of DSUVIA(sufentanil sublingual tablet), 30 mcg classified by age group across four clinical trials at the American Society of Anesthesiologists'(ASA) ANESTHESIOLOGY® 2017 Annual Meeting. The information presented during the session was authored by Karen DiDonato, MSN, RN; Jacob Hutchins, MD; James Miner, MD; Harold Minkowitz, MD; and Pamela Palmer, MD, PhD.

“We are honored to be one of the top eight abstracts featured as an oral presentation at the Frontiers in Opioid Pharmacotherapy symposium at ANESTHESIOLOGY® 2017. Our inclusion in this important symposium acknowledges the potential clinical relevance of DSUVIA for the management of moderate-to-severe acute pain in medically supervised settings,” said Pamela Palmer, MD, PhD, Co-Founder and Chief Medical Officer, AcelRx.

AcelRx will also host a breakfast satellite symposium that discusses the pharmacokinetics and dynamics of sublingual sufentanil tablets. This symposium will be led by Eugene Viscusi, MD; Albert Dahan, MD, PhD; and Dennis Fisher, MD.

The ANESTHESIOLOGY® 2017 Annual Meeting is hosted by the American Society of Anesthesiologists (ASA) and is taking place on October 21-25 in Boston, Massachusetts. ANESTHESIOLOGY 2017 is expected to welcome nearly 15,000 attendees. For more information on ASA, please visit www.asahq.org.

Details of the presentations are as follows:

Title:               Safety and Efficacy of Sufentanil Sublingual Tablet 30 mcg by Age Group for the   Treatment of Acute Pain in Medically Supervised Settings
Authors:         Karen DiDonato, MSN, RN of AcelRx Pharmaceuticals; Jacob Hutchins, MD of the University of Minnesota in Minneapolis, MN; James Miner, MD of the Hennepin County Medical Center in Minneapolis, MN; Harold Minkowitz, MD of the Memorial Hermann Memorial City Medical Center in Houston, TX; Pamela Palmer, MD, PhD of AcelRx Pharmaceuticals
Time/Place:    9:00 am – 12:00 pm on October 22, 2017 at the Westin Boston Waterfront Grand Meeting Room 206 A/B
Title:               ASA® Non-Accredited Satellite Symposium: Pharmacokinetics and Dynamics of Sublingual Sufentanil
Authors:         Eugene Viscusi, MD, Professor, Jefferson University Hospitals in Philadelphia, PA; Albert Dahan, MD, PhD, Professor, Leiden University Medical Center in Leiden, Netherlands; and Dennis Fisher, MD, Professor Emeritus, University of California, San Francisco.
Time/Place:    6:30 am – 8:00 am on October 23, 2017 at the Westin Boston Waterfront Grand Ballroom B – E

About DSUVIA™ (sufentanil sublingual tablet), 30 mcg
DSUVIA (sufentanil sublingual tablet, SST, 30 microgram), known as ARX-04 outside the United States, is designed to treat moderate-to-severe acute pain and dosing errors associated with IV administration via its non-invasive single-dose applicator (SDA) in medically supervised settings. Sufentanil is an opioid analgesic currently marketed for intravenous (IV) and epidural anesthesia and analgesia. The sufentanil pharmacokinetic profile when delivered sublingually potentially avoids the high peak plasma levels and short duration of action observed with IV administration. In the EU, the European Medicines Agency (EMA) has notified the company that the ARX-04 Marketing Authorization Application (MAA) is under scientific review.

Clinical and Rehabilitative Medicine Research Program (CRMRP)
DSUVIA is funded in part by the Clinical and Rehabilitative Medicine Research Program (CRMRP) of the U.S. Army Medical Research and Materiel Command (USAMRMC) under contract No. W81XWH-15-C-0046. The CRMRP was established in 2008 to foster research and technology advances for regeneration, restoration, and rehabilitation of traumatic injuries. In accordance with USAMRMC guidelines, in the conduct of clinical research, AcelRx has adhered to the policies regarding the protection of human subjects as prescribed by Code of Federal Regulations (CFR) Title 45, Volume 1, Part 46; Title 32, Chapter 1, Part 219; and Title 21, Chapter 1, Part 50 (Protection of Human Subjects).

About AcelRx Pharmaceuticals, Inc.
AcelRx Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of moderate-to-severe acute pain. AcelRx’s proprietary, non-invasive sublingual formulation technology delivers sufentanil with a consistent pharmacokinetic profile. The company is simultaneously developing ZALVISO® (sufentanil sublingual tablet system, SST system, 15 microgram) as an innovatively designed patient-controlled analgesia (PCA) system for treatment of moderate-to-severe pain in medically supervised settings. The company recently completed a Phase 3 clinical trial, IAP312, which included input from the FDA on the study protocol. This study was designed to evaluate the effectiveness of changes made to the functionality and usability of the ZALVISO device, to evaluate the incidence of inadvertent dosing, and to take into account comments from the FDA on the study protocol. AcelRx intends to resubmit the NDA for ZALVISO to the FDA by the end of the year. AcelRx has successfully received EU Marketing Approval for ZALVISO® in the EU. Grunenthal Group holds the rights for ZALVISO® in Europe, where a commercialization across multiple countries is underway. In June 2017, ZALVISO®   was selected for a Red Dot Award in the category of Product Design – Life Sciences and Medicine.

For additional information about AcelRx’s clinical programs, please visit www.acelrx.com.

Forward-Looking Statements
This press release contains forward-looking statements, including, but not limited to, statements related to the process and timing of anticipated future development of AcelRx’s product candidates, DSUVIA™ (sufentanil sublingual tablet, 30 mcg), known as ARX-04 outside the United States, and ZALVISO® (sufentanil sublingual tablet system), including U.S. Food and Drug Administration, or FDA, review of the New Drug Application, or NDA, for DSUVIA; and evaluation of the CRL and AcelRx’s plans for resubmission of the NDA for DSUVIA with the FDA.  These forward-looking statements are based on AcelRx Pharmaceuticals’ current expectations and inherently involve significant risks and uncertainties. AcelRx Pharmaceuticals’ actual results and timing of events could differ materially from those anticipated in such forward-looking statements, and as a result of these risks and uncertainties, which include, without limitation, risks related to AcelRx Pharmaceuticals’ DSUVIA and ARX-04 development programs, including the EMA review of the ARX-04 MAA, and the possibility that EMA may dispute or interpret differently clinical results obtained from the ARX-04 Phase 2 and 3 studies; the possibility that the FDA may dispute or interpret differently the results of the ZALVISO development program, including the results from the IAP312 clinical trial; the resubmission of the ZALVISO NDA to the FDA; any delays or inability to obtain and maintain regulatory approval of its product candidates, including DSUVIA in the United States, ARX-04 in Europe and ZALVISO in the United States; the uncertain clinical development process, including adverse events; the success, cost and timing of all development activities and clinical trials; and other risks detailed in the “Risk Factors” and elsewhere in AcelRx’s U.S. Securities and Exchange Commission filings and reports, including its Quarterly Report on Form 10-Q filed with the SEC on August 2, 2017. AcelRx undertakes no duty or obligation to update any forward-looking statements contained in this release as a result of new information, future events or changes in its expectations.

Friday, October 20th, 2017 Uncategorized Comments Off on $ACRX DSUVIA™ Clinical Trial Results Selected as a “Top Abstract”

$MNI Announces Final Results Of Debt Tender Offer At Par For 2022 Notes

SACRAMENTO, Calif., Oct. 20, 2017 — The McClatchy Company (NYSE American-MNI) announced today the final results of its offer to purchase for cash up to $40 million of its 9.0% Senior Secured Notes due in 2022 (the “9.0% Notes”) pursuant to the terms and conditions of the Offer to Purchase dated September 20, 2017 (the “Offer”). Based on the results provided by the trustee of the 9.0% Notes, $0.1 million aggregate principal amount of the 9.0% Notes were tendered prior to the Offer’s expiration at 5 p.m., Eastern time on Thursday, October 19, 2017.

As previously announced, and in compliance with the terms of the indenture for the 9.0% Notes, McClatchy was required to offer to purchase for cash up to $40 million of the outstanding 9.0% Notes at par as a result of selling The Kansas City Star’s office building and land and The Sacramento Bee building and surrounding land.

Elaine Lintecum, McClatchy’s chief financial officer, said, “These 9.0% Notes continue to trade at a premium and similar to our Offer made in August of 2017, we are not surprised that a majority of holders declined our offer. Now that the tender offer has expired, we will consider the appropriate use of the remaining proceeds. We expect that we may use some of the remaining proceeds, along with cash from operations, to repurchase the company’s outstanding senior secured or unsecured notes in privately negotiated transactions, to reinvest in the company’s digital transformation, or other uses as determined by our board of directors.”

About McClatchy

McClatchy is publisher of iconic brands such as the Miami HeraldThe Kansas City Star, The Sacramento Bee, The Charlotte Observer, The (Raleigh) News & Observer, and the (Fort Worth) Star-Telegram. McClatchy operates 30 media companies in 14 states, providing each of its communities with high-quality news and advertising services in a wide array of digital and print formats. McClatchy is headquartered in Sacramento, Calif., and listed on the New York Stock Exchange American under the symbol MNI.

Additional Information

Statements in this press release regarding future financial and operating results, including our strategies for success and their effects, our real estate monetization efforts and the repurchase of outstanding notes, revenues, and management’s efforts with respect to cost reduction efforts and efficiencies, cash expenses, revenues, adjusted EBITDA, debt levels, interest costs and creation of shareholder value as well as future opportunities for the company and any other statements about management’s future expectations, beliefs, goals, plans or prospects constitute forward-looking statements  as defined in the Private Securities Litigation Reform Act of 1995. Any statements that are not statements of historical fact (including statements containing the words “believes,” “plans,” “anticipates,” “expects,” “estimates” and similar expressions) should also be considered to be forward-looking statements. There are a number of important risks and uncertainties that could cause actual results or events to differ materially from those indicated by such forward-looking statements, including: McClatchy may not generate cash from operations, or otherwise, necessary to reduce debt or meet debt covenants as expected; we may not be successful in reducing debt whether through tenders offers, open market repurchase programs or other negotiated transactions; including sales of real estate properties may not close as anticipated or result in cash distributions in the amount or timing anticipated; McClatchy may not successfully implement audience strategies designed to increase audience revenues and may experience decreased audience volumes or subscriptions; McClatchy may experience diminished revenues from advertising; McClatchy may not achieve its expense reduction targets including efforts related to legacy expense initiatives or may do harm to its operations in attempting to achieve such targets; McClatchy’s operations have been, and will likely continue to be, adversely affected by competition, including competition from internet publishing and advertising platforms; increases in the cost of newsprint; bankruptcies or financial strain of its major advertising customers; litigation or any potential litigation; geo-political uncertainties including the risk of war; changes in printing and distribution costs from anticipated levels, including changes in postal rates or agreements; changes in interest rates; changes in pension assets and liabilities; changes in factors that impact pension contribution requirements, including, without limitation, the value of the company-owned real property that McClatchy has contributed to its pension plan; increased consolidation among major retailers in our markets or other events depressing the level of advertising; our inability to negotiate and obtain favorable terms under collective bargaining agreements with unions; competitive action by other companies; an inability to fully implement and execute its share repurchase plan; and other factors, many of which are beyond our control; as well as the other risks detailed from time to time in the company’s publicly filed documents, including the company’s Annual Report on Form 10-K for the year ended Dec. 25, 2016, filed with the U.S. Securities and Exchange Commission. McClatchy disclaims any intention and assumes no obligation to update the forward-looking information contained in this release.

Friday, October 20th, 2017 Uncategorized Comments Off on $MNI Announces Final Results Of Debt Tender Offer At Par For 2022 Notes

$ONVO Presents New Preclinical Data on 3D Bioprinted Human Liver Tissues

SAN DIEGO, Oct. 20, 2017  — Organovo Holdings, Inc. (NASDAQ:ONVO) (“Organovo”) today presented new preclinical data showing extended survival and sustained functionality of its 3D bioprinted human liver tissue when implanted into diseased animal models. This data will be presented at The Liver Meeting 2017 (American Association For The Study of Liver Diseases or “AASLD”) by Vaidehi Joshi, Scientist I, Therapeutics, at Organovo.

Organovo previously implanted its 3D bioprinted human liver tissue patches onto the livers of healthy NOD/SCID mice, and is now presenting additional data from promising early studies in an established model for alpha-one-antitrypsin deficiency (“A1AT”). The tissue was composed of human hepatocytes and select non-parenchymal cells. Serum and histopathologic evaluation of the implanted therapeutic tissue showed engraftment, retention and a high degree of disease clearing through 125 days post-implantation, a significant increase in duration from the Company’s first preclinical studies, which demonstrated functionality through 28 days. These results demonstrate a significant increase in the reported duration of implanted human hepatocyte synthetic function, demonstrating sustained presence of key human liver proteins such as albumin and A1AT in the animal bloodstream. Importantly, pathologic evaluation of diseased animals receiving implanted bioprinted liver tissues suggests an approximately 75 percent reduction in the pathologic hallmarks of the disease in treated animals versus non-treated control animals in the region of implant.

“With tens of thousands of patients being treated for inborn errors of metabolism (“IEMs”) in the U.S., and an annual cost per patient that exceeds $250,000 for drug therapy alone, Organovo continues to advance a novel therapeutic solution for direct surgical implantation,” said Eric David, M.D., J.D., chief strategy officer and executive vice president of preclinical development, Organovo. “Our preclinical data continues to show robust engraftment and durability of the liver tissue and strong early evidence of successfully impacting the disease state in animal models. Taken together, these data support continued preclinical development of Organovo’s 3D bioprinted liver tissue for therapeutic use.”

“The data show that the approach of delivering a 3D bioprinted tissue patch directly to the liver offers great promise in solving the engraftment and integration issues that have held back many cell and gene therapy attempts at these diseases,” said Dr. David Brenner, vice chancellor of Health Sciences and dean of the School of Medicine at UC San Diego, who is also an advisor to Organovo. “We’re encouraged by these solid early results, and are eager to see this work advance to the next stages. UC San Diego’s ability to leverage translational research to understand and redress disease progression is one of the many reasons we’re ideally suited for this kind of collaboration.”

Focusing first on pediatric inborn errors of metabolism, Organovo intends to submit an Investigational New Drug (“IND”) application to the U.S. Food and Drug Administration (“FDA”) for its therapeutic liver tissue in calendar-year 2020. In the next 12 months, the Company expects to optimize its final liver tissue design and continue pre-GLP studies, including efficacy, safety and dosing studies in small animal disease models for IEMs. Organovo is also seeking orphan designation in the U.S. and will partner with contract research organizations (“CROs”) to define and scope IND enabling studies.

The Company’s posters are as follows:

Title: Long-Term Performance of Implanted Bioprinted Human Liver Tissue in a Mouse Model of Human Alpha-1 Antitrypsin Deficiency
Date: Saturday, October 21, 5:30 – 7:00 pm – Hall D
Poster: 805
Title: Modeling NAFLD Using 3D Bioprinted Human Liver Tissue
Date: Monday, October 23, 12:30 – 2:00 pm – Hall D
Poster: 1963

About Organovo Holdings, Inc.

Organovo designs and creates functional, three-dimensional human tissues for use in drug discovery, clinical development, and therapeutic applications. The Company develops 3D human tissue systems through internal research programs and in collaboration with pharmaceutical, academic and other partners. Organovo’s 3D human tissues have the potential to transform the drug discovery process, enabling treatments to be developed more effectively and with greater relevance to performance in human trials and commercialization. The Company’s ExViveTM Human Liver and Kidney Tissues are used in high-value drug profiling, including compound screening in disease models, toxicology, target and marker discovery/validation, and other drug testing. The Company is also advancing a preclinical program to develop liver therapeutic tissues for critical unmet medical needs, including certain life-threatening pediatric diseases. In addition to numerous scientific publications, the Company’s technology has been featured in The Wall Street Journal, Time Magazine, The Economist, Forbes, and numerous other media outlets. Organovo is changing the shape of life science research and transforming medical care. Learn more at www.organovo.com.

Forward-Looking Statements

Any statements contained in this press release that do not describe historical facts constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements contained herein are based on current expectations, but are subject to a number of risks and uncertainties. Forward-looking statements include, but are not limited to, statements regarding the potential benefits and therapeutic uses of the Company’s therapeutic liver tissue; the Company’s ability to successfully complete additional preclinical studies, development activities and clinical trials for its therapeutic liver tissue; and the Company’s development and regulatory plans and timeline. The factors that could cause the Company’s actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the Company’s ability to develop, market and sell products and services based on its technology; the expected benefits and efficacy of the Company’s products, services and technology; the Company’s ability to successfully complete studies and provide the technical information required to support market acceptance of its products, services and technology, on a timely basis or at all; the Company’s business, research, product development, regulatory approval, marketing and distribution plans and strategies, including its use of third party distributors; the Company’s ability to successfully complete the contracts and recognize the revenue represented by the contracts included in its previously reported total contract bookings and secure additional contracted collaborative relationships; the final results of the Company’s preclinical studies may be different from the Company’s studies or interim preclinical data results and may not support further clinical development of its therapeutic tissues; the Company may not successfully complete the required preclinical and clinical trials required to obtain regulatory approval for its therapeutic tissues on a timely basis or at all; the risk of further adjustments to the Company’s preliminary revenue results for the second quarter of fiscal 2018; the Company’s ability to control the costs and to achieve the expected operational benefits and long- term cost savings of its previously announced restructuring plan; and the Company’s ability to meet its fiscal year 2018 outlook. These and other factors are identified and described in more detail in the Company’s filings with the SEC, including its Annual Report on Form 10-K filed with the SEC on June 7, 2017. You should not place undue reliance on these forward-looking statements, which speak only as of the date that they were made. These cautionary statements should be considered with any written or oral forward-looking statements that the Company may issue in the future. Except as required by applicable law, including the securities laws of the United States, the Company does not intend to update any of the forward-looking statements to conform these statements to reflect actual results, later events or circumstances or to reflect the occurrence of unanticipated events.

Investor Contact:
Steve Kunszabo
Organovo Holdings, Inc.
+1 (858) 224-1092
skunszabo@organovo.com

Press Contact:
Jessica Yingling
Little Dog Communications
+1 (858) 344-8091
jessica@litldog.com
Friday, October 20th, 2017 Uncategorized Comments Off on $ONVO Presents New Preclinical Data on 3D Bioprinted Human Liver Tissues

$DGLY and VIEVU®, LLC Enter into Supply Agreement

VIEVU® to have exclusive rights to integrate Digital Ally’s patented VuLink® technology in its body-worn camera products

LENEXA, KS, Oct. 20, 2017  — Digital Ally, Inc (Nasdaq: DGLY) today announced that it has entered into an exclusive supply agreement with VIEVU®, LLC, owned by The Safariland Group (“VIEVU”), to integrate Digital Ally’s patented VuLink® automatic activation technology with VIEVU’s suite of body-worn cameras. This integration allows VIEVU’s body-worn camera to receive wireless triggers from emergency lights, speed thresholds, or even from a Digital Ally in-car video system to automatically activate a recording without requiring officers to manually start the recording.

The VuLink® product allows Digital Ally’s in-car video systems and VIEVU’s body-worn cameras to work seamlessly together, providing law enforcement with a fully integrated audio/video recording system for capturing activities and evidence collected in the field.

The supply agreement provides VIEVU with the exclusive right to integrate the VuLink system in its body camera products. The supply agreement is renewable annually as long as VIEVU® purchases at least 10,000 VuLink systems in 2018, with minimum purchases requirements increasing in 2019 for calendar year 2020. The agreement can be extended by the parties thereafter subject to mutual agreement. The engineering and integration of VIEVU body-worn cameras with the VuLink® system has been completed and the integrated system is now being actively marketed by VIEVU.  Digital Ally® will continue to market the VuLink® system with its FirstVu HD body camera and line of in-car video systems to its customers and prospective customers.

Sean McCarthy who leads VIEVU and Safariland’s wearable technology business commented, “VIEVU, with its outstanding technology platform and track record of growth is excited to now offer a complete solution that includes the integration of Digital Ally’s VuLink® connectivity system with VIEVU’s suite of body-worn cameras.  VIEVU and our customers recognize the value of automatic hands-free activation of VIEVU’s cameras.  There have been several recent positive developments in the U.S. Patent and Trademark Office relative to the VuLink® patent, which appears to confirm the validity of Digital Ally’s technology.  VIEVU recognizes the apparent validity of the VuLink® system patent which has led us entering into the supply agreement with Digital Ally.”

Stanton Ross, CEO and President of Digital Ally, commented, “We are excited to enter into this supply agreement with VIEVU and are appreciative of it acknowledging our patent and choice to enter into this agreement. This agreement will provide a clear path forward for VIEVU’s customers to realize the value of a complete solution with automatic activation and help clarify to our competitors and to the entire law enforcement community which offerings will be available exclusively with our patented technology.”

The patented VuLink® system is at the heart of Digital’s lawsuit currently being litigated against Axon Enterprises (“Axon,” formerly known as TASER International, Inc.). The lawsuit alleges that Axon is willfully infringing Digital’s patents directed to an ecosystem for automatically activating law enforcement recording devices which is embodied in the VuLink® product. Digital believes that Axon has grown its own market share on the back of Digital’s innovations because it was unable to develop its own solution. Ross stated, “Digital will continue to aggressively pursue its claims that Axon has willfully infringed its patent. We are committed to holding Axon accountable for the significant damages associated with Axon’s infringement of the VuLink® patent. With the defeat of Axon’s inter partes review (“IPR”) for the VuLink® ‘patent we will request an expedited path to trial where a jury can assess Axon’s willful infringement of the ‘452 Patent and award Digital Ally appropriate damages.” On July 6, 2017, the U.S. Patent Office (the “Patent Office”) denied Axon’s petition for IPR of Digital’s Patent No. 9,253,452 (the “’452 Patent”). And on August 3, 2017, the Patent Office denied Axon’s final petition for IPR of the ‘452 Patent. The Patent Office determined that Axon failed to demonstrate even a reasonable likelihood of invalidating the ‘452 Patent in its IPR petition, and therefore such IPR’s were dismissed. This was Axon’s final attempt to invalidate the ‘452 Patent before the Patent Office and it is now statutorily barred from filing any additional IPR’s.

About Digital Ally
Digital Ally, headquartered in Lenexa, KS, specializes in the design and manufacturing of the highest quality video recording equipment and video analytic software. Digital Ally pushes the boundaries of technology in industries such as law enforcement, emergency management, commercial fleets, and consumer use. Digital Ally’s complete product solutions include in-car and body cameras, cloud and local management software, and automatic recording technology. These products work seamlessly together and are simple to install and operate. Digital Ally products are sold by domestic direct sales representatives and international distributors worldwide.

About VIEVU

VIEVU® is a leading provider of body-worn camera and video technologies, providing secure, high-quality video cameras for law enforcement, security, emergency medical services, and first responders. VIEVU Solution™, the company’s next generation fully-hosted cloud evidence management system, is built on Microsoft® Azure Government Cloud, the first enterprise cloud compliant with the FBI’s Criminal Justice Information Services (CJIS) standards. VIEVU was the first provider of body-worn cameras with Automated Video Redaction technology, a highly advanced redaction tool built to automatically blur faces and objects recorded on body-worn cameras, without user involvement, in order to protect the privacy and identity of victims, innocent bystanders, minors and undercover police officers. Built on police experience, VIEVU technology is used by thousands of law enforcement agencies in 17 countries. For information please visit www.vievu.com.

About The Safariland Group 
The Safariland Group is a leading global provider of a broad range of safety and survivability products designed for the public safety, military, professional and outdoor markets. The Safariland Group offers a number of recognized brand names in these markets including Safariland®, Med-Eng®, Safariland® Armor, Safariland®VIEVU®®, Mustang Survival®, Bianchi®, Break Free®, PROTECH® Tactical, Defense Technology®, Hatch®, Monadnock®, Identicator® and NIK®. The Safariland Group’s mission, “Together, We Save Lives™”, is inherent in the lifesaving and protective products it delivers. The Safariland Group is headquartered in Jacksonville, Florida. The Safariland Group is a trade name of Safariland, LLC.

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Act of 1934. These forward-looking statements are based largely on the expectations or forecasts of future events, can be affected by inaccurate assumptions, and are subject to various business risks and known and unknown uncertainties, a number of which are beyond the control of management. Therefore, actual results could differ materially from the forward-looking statements contained in this press release. A wide variety of factors that may cause actual results to differ from the forward-looking statements include, but are not limited to, the following: whether the Company will achieve positive outcomes in its patent litigation with various parties, including Axon Enterprise, Inc.; whether the USPTO rulings will curtail, eliminate or otherwise have an effect on the actions of Axon and other parties respecting the Company, its products and customers; whether the Company will be able to adapt its technology to new and different uses, including being able to introduce new products; competition from larger, more established companies with far greater economic and human resources; its ability to attract and retain customers and quality employees; the effect of changing economic conditions; and changes in government regulations, tax rates and similar matters. These cautionary statements should not be construed as exhaustive or as any admission as to the adequacy of the Company’s disclosures. The Company cannot predict or determine after the fact what factors would cause actual results to differ materially from those indicated by the forward-looking statements or other statements. The reader should consider statements that include the words “believes”, “expects”, “anticipates”, “intends”, “estimates”, “plans”, “projects”, “should”, or other expressions that are predictions of or indicate future events or trends, to be uncertain and forward-looking. The Company does not undertake to publicly update or revise forward-looking statements, whether as a result of new information, future events or otherwise. Additional information respecting factors that could materially affect the Company and its operations are contained in its annual report on Form 10-K for the year ended December 31, 2016 and quarterly report on Form 10-Q for the three and six months ended June 30, 2017, filed with the Securities and Exchange Commission.

Contact Information
Stanton Ross, CEO
Tom Heckman, CFO
Digital Ally, Inc
913-814-7774

info@digitalallyinc.com
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$CNCE Announces PTAB Denies Incyte Petition Challenging CTP-543 Patent

LEXINGTON, Mass.

Concert Pharmaceuticals, Inc. (NASDAQ: CNCE) today announced that the Patent Trials and Appeal Board (PTAB) of the U.S. Patent and Trademark Office has denied Incyte’s petition to institute inter partes review (IPR) of U.S. Patent No. 9,249,149 (the ‘149 patent). The denial of Incyte’s IPR petition upholds the validity of the ‘149 patent that includes claims covering CTP-543, the Company’s investigational compound for the treatment of alopecia areata.

“We are very pleased that the PTAB did not institute the IPR, and that our composition-of-matter patent relating to CTP-543 remains valid and enforceable,” stated Roger Tung, President and Chief Executive Officer of Concert Pharmaceuticals. “This is the second case in which the PTAB has elected not to institute an IPR challenge to a deuterated compound based on a pre-existing drug and further supports Concert’s technology approach.”

In April 2017, Incyte filed a petition challenging the validity of the ‘149 patent. Documents relating to the IPR can be accessed online at: http://www.concertpharma.com/technology-overview/intellectual-property/

About Concert

Concert Pharmaceuticals is a clinical stage biopharmaceutical company focused on applying its DCE Platform® (deuterated chemical entity platform) to create novel medicines designed to address unmet patient needs. The Company’s approach starts with approved drugs in which deuterium substitution has the potential to enhance clinical safety, tolerability or efficacy. Concert has a broad pipeline of innovative medicines targeting autoimmune and inflammatory diseases and central nervous systems (CNS) disorders. For more information please visit www.concertpharma.com.

Cautionary Note on Forward Looking Statements

Any statements in this press release about our future expectations, plans and prospects, including statements about the strength of Concert’s intellectual property, and other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including factors discussed in the “Risk Factors” section of our most recent Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission and in other filings that we make with the Securities and Exchange Commission. In addition, any forward-looking statements included in this press release represent our views only as of the date of this release and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligation to update any forward-looking statements included in this press release.

Concert Pharmaceuticals Inc., the CoNCERT Pharmaceuticals Inc. logo and DCE Platform are registered trademarks of Concert Pharmaceuticals, Inc.

 

Investors
Concert Pharmaceuticals, Inc.
Justine Koenigsberg, 781-674-5284
ir@concertpharma.com
or
Media
The Yates Network
Kathryn Morris, 845-635-9828
kathryn@theyatesnetwork.com

Thursday, October 19th, 2017 Uncategorized Comments Off on $CNCE Announces PTAB Denies Incyte Petition Challenging CTP-543 Patent

$ADHD Strategic RNA Medicines Collaboration with $JNJ

Initial Focus on Hepatitis B, With Option to Expand to Additional Disease Areas

SAN DIEGO, Oct. 19, 2017 — Arcturus Therapeutics, Inc., a leading RNA medicines company, announced today that it has entered into a research collaboration and worldwide license agreement with Janssen Pharmaceuticals, Inc. (Janssen), one of the Janssen Pharmaceutical Companies of Johnson & Johnson. The two companies will work together to develop and commercialize nucleic acid-based drug products for the treatment of Hepatitis B, using Arcturus’ UNA Oligomer chemistry and LUNAR™ lipid-mediated delivery platform. The agreement also includes an option to expand into other infectious and respiratory diseases. The deal was facilitated by the Johnson & Johnson Innovation center, in California.

Under the agreement, Arcturus will receive an upfront cash payment, R&D support, and pre-clinical, development, and sales milestone payments, as well as royalty payments on any future licensed product sales. Janssen will assume responsibility for development costs and all commercialization costs associated with the program.

“This new collaboration signifies an expanded relationship between Arcturus and Janssen,” said Joseph Payne, President and CEO of Arcturus. “Arcturus’ expertise and intellectual property in the field of RNA medicines is complemented by Janssen’s broad capabilities in clinical development, regulatory affairs, and marketing. Together we aim to bring new treatments to patients who are suffering from Hepatitis B and potentially other infectious diseases.”

About Arcturus Therapeutics, Inc.
Founded in 2013 and based in San Diego, Arcturus Therapeutics, Inc. is an RNA medicines company with enabling technologies — UNA Oligomer chemistry and LUNAR™ lipid-mediated delivery. Arcturus’s versatile RNA therapeutics platforms can be applied toward multiple types of RNA medicines including small interfering RNA, messenger RNA, antisense RNA, microRNA and gene editing therapeutics. The company owns LUNAR lipid-mediated delivery and Unlocked Nucleomonomer Agent (UNA) technology including UNA Oligomers, which are covered by its patent portfolio (120 patents and patent applications, issued in the U.S., Europe, Japan, China and other countries). Arcturus’ proprietary UNA technology can be used to target individual genes in the human genome, as well as viral genes, and other species for therapeutic purposes. The company’s commitment to the development of novel RNA therapeutics has led to partnerships with Ultragenyx Pharmaceutical, Inc., Takeda Pharmaceutical Inc., and Cystic Fibrosis Foundation Therapeutics Inc. For more information, visit www.ArcturusRx.com, the content of which is not incorporated herein by reference. On September 27, 2017, Arcturus and Alcobra Ltd. (Alcobra) (NASDAQ:ADHD) entered into an agreement and plan of merger and reorganization pursuant to which a wholly-owned subsidiary of Alcobra will merge with and into Arcturus, with Arcturus becoming a wholly-owned subsidiary of Alcobra and the surviving corporation of the merger, and the holders of Arcturus outstanding capital stock immediately prior to the merger will receive ordinary shares representing approximately 60% of the outstanding shares of Alcobra.  Upon consummation of the transaction, Alcobra’s name will be changed to Arcturus Therapeutics, Ltd., and Alcobra will change its ticker symbol to ARCT on NASDAQ.

Forward-looking Statements 
This press release contains “forward-looking statements” that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release regarding strategy, future operations, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to whether the agreement will result in a successful collaboration or potential products; the structure, timing and completion of the proposed merger transaction; and the combined company’s listing on NASDAQ after closing of the proposed merger.  You should not place undue reliance on these forward-looking statements. Such statements are based on management’s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors. Except as otherwise required by law, all parties disclaim any intention or obligation to update or revise any forward-looking statements, which speak only as of the date they were made, whether as a result of new information, future events or circumstances or otherwise.

Additional Information about the Proposed Merger involving Alcobra and Arcturus and Where to Find It
In connection with the previously disclosed proposed merger involving Alcobra and Arcturus, a proxy statement and a proxy card will be furnished to the Securities and Exchange Commission (SEC) and will be mailed to Alcobra’s shareholders seeking any required shareholder approvals in connection with the proposed merger transactions. Before making any voting or investment decision, investors and shareholders are urged to read the proxy statement (including any amendments or supplements thereto) and any other relevant documents that Alcobra may furnish to or file with the SEC when they become available because they will contain important information about the proposed merger transactions.

This communication shall not constitute an offer to sell or the solicitation of an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction.

Contact
Arcturus Therapeutics
858-900-2660
info@arcturusRx.com

Andrew McDonald Ph.D.
LifeSci Advisors LLC
646-597-6979

Thursday, October 19th, 2017 Uncategorized Comments Off on $ADHD Strategic RNA Medicines Collaboration with $JNJ

$IMMY to Offer Compounded Cyclosporine Alternative to Restasis®

Initial prescriptions will be 99 cents for a one month supply with refills starting at $79 per month, including shipping

SAN DIEGO, Oct. 19, 2017 — Imprimis Pharmaceuticals, Inc. (NASDAQ: IMMY), an ophthalmology-focused pharmaceutical company, today announced it is making compounded Cyclosporine-based formulations available for physicians to consider prescribing as customizable and potentially lower-cost alternatives to Restasis®.  Imprimis’ Cyclosporine-based compounded formulations, which will be packaged in a multi-use preservative-free bottle, are patent-pending and include “Klarity Drops™,” a patented formulation developed by renowned ophthalmologist Richard L. Lindstrom, MD.

Dry Eye Disease is estimated to affect up to 30 million Americans and is commonly characterized by irritated, gritty, scratchy or burning eyes, blurred vision, and feeling particles in the eye when there are none. Advanced Dry Eye Disease may damage the front surface of the eye and ultimately impair vision. The Imprimis Cyclosporine-based formulations, which are made from FDA-approved drug components and compounded in FDA-inspected facilities, require a patient specific prescription and may be customized according to patients’ individual needs.

Mark L. Baum, CEO of Imprimis stated, “We believe Dry Eye Disease patients can benefit from unique customized medications that are not commercially available.  While physicians who use compounded Cyclosporine formulations have anecdotally known this for many years, there is now published data that demonstrates the clinical value of topical Cyclosporine formulations at  concentrations greater than those currently available in commercially available medications.  We are pleased to be able to offer affordable customized Cyclosporine formulations that are designed for patients’ individual needs.”

Baum added, “Imprimis has long championed issues of access, affordability and competition.  While there are an estimated 30 million Americans suffering from Dry Eye Disease, only a small fraction of these patients receive therapy.  Topical Cyclosporine, which is an off-patent and inexpensive drug, can cost more than $5,000 per year when it is purchased in the commercially available form of Restasis®.  We believe that affordability can affect access to needed medications, and it is our hope that our formulations will allow more patients to gain access to a high quality customized Cyclosporine treatment option.”

In addition to this announcement, Imprimis will soon make publicly available a presentation on Surface Pharmaceuticals, Inc.  Surface is a wholly owned subsidiary of Imprimis that is focused entirely on ocular surface disease, including Dry Eye Disease and Blepharitis.  Surface has three core drug formulations based on two issued US patents and three pending patents, and intends to seek FDA-approval through the 505(b)(2) pathway for as many as five ocular surface disease and ophthalmic indications.

ABOUT IMPRIMIS PHARMACEUTICALS

Imprimis Pharmaceuticals, Inc. (NASDAQ: IMMY) is an ophthalmology-focused pharmaceutical company that produces and dispenses high quality innovative medications in all 50 states.  Imprimis is dedicated to patient access and affordability to many critical medicines.  Headquartered in San Diego, California, Imprimis produces and dispenses from both California and New Jersey. Imprimis is the largest shareholder of Eton Pharmaceuticals, Inc. (www.etonpharma.com), a company it spun out in 2017.  For more information about Imprimis, please visit the corporate website at www.ImprimisRx.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this release that are not historical facts may be considered such “forward looking statements.” Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties which may cause results to differ materially and adversely from the statements contained herein. Some of the potential risks and uncertainties that could cause actual results to differ from those predicted include our ability to make commercially available our compounded formulations and technologies in a timely manner or at all; physician interest in prescribing our formulations; risks related to our compounding pharmacy operations; our ability to enter into other strategic alliances, including arrangements with pharmacies, physicians and healthcare organizations for the development and distribution of our formulations; our ability to obtain intellectual property protection for our assets; our ability to accurately estimate our expenses and cash burn, and raise additional funds when necessary; risks related to research and development activities; the projected size of the potential market for our technologies and formulations; unexpected new data, safety and technical issues; regulatory and market developments impacting compounding pharmacies, outsourcing facilities and the pharmaceutical industry; competition; and market conditions. These and additional risks and uncertainties are more fully described in Imprimis’ filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Such documents may be read free of charge on the SEC’s web site at www.sec.gov. Undue reliance should not be placed on forward looking statements, which speak only as of the date they are made. Except as required by law, Imprimis undertakes no obligation to update any forward-looking statements to reflect new information, events or circumstances after the date they are made, or to reflect the occurrence of unanticipated events.

Other than drugs compounded at a registered outsourcing facility, all Imprimis compounded formulations may only be prescribed pursuant to a physician prescription for an individually identified patient consistent with federal and state laws.

Restasis® and all other trademarks, service marks and trade names included or referenced in this press release, are the property of their respective owners.

CONTACTS

John Saharek
jsaharek@imprimispharma.com
858.704.4298

Investor Contact:
Jon Patton
jpatton@imprimispharma.com
858.704.4587

Thursday, October 19th, 2017 Uncategorized Comments Off on $IMMY to Offer Compounded Cyclosporine Alternative to Restasis®

$QURE Hemophilia B Gene Therapy Program to Enter Pivotal Study

~ AMT-060 with the FIX-Padua Modification (AMT-061) Demonstrates Substantial Increase in FIX Activity in Non-human Primates ~

~ Plans to Initiate Pivotal Study with Enhanced AMT-061 in 2018 ~

~ Achieves Alignment with FDA on Streamlined Clinical and Regulatory Strategy for AMT-061, Which Will be Included Under Existing Breakthrough Therapy Designation ~

~ Acquires a Patent Family Covering FIX-Padua in Hemophilia B ~

~ Conference Call Scheduled for Today at 8:30 a.m. ET ~

LEXINGTON, Mass. and AMSTERDAM, The Netherlands, Oct. 19, 2017  —  uniQure N.V. (NASDAQ:QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, today announced that following multi-disciplinary meetings with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), the company plans to expeditiously advance AMT-061, which combines an AAV5 vector with the FIX-Padua mutant, into a pivotal study in 2018 for patients with severe and moderately severe hemophilia B.

AMT-061 and AMT-060, the latter of which has been tested in 10 patients in an ongoing Phase I/II clinical trial, are identical in structure apart from two nucleotide substitutions in the coding sequence for FIX.  The gene variant, referred to as FIX-Padua, expresses a protein with a single amino acid substitution that has been reported in multiple preclinical and nonclinical studies to provide an approximate 8 to 9-fold increase in FIX activity compared to the wild-type FIX protein. All other critical quality attributes of AMT-061 are expected to be comparable to those of AMT-060, as AMT-061 utilizes the same AAV5 capsid and proprietary insect cell-based manufacturing platform.

“Our mission in hemophilia B has always been to develop the safest and most effective gene therapy with the broadest application to patients. We believe AMT-061 moves us closer to this goal, as it has the potential to provide optimized clinical and tolerability benefits to nearly all severe and moderately severe patients with hemophilia B,” stated Matthew Kapusta, chief executive officer of uniQure.  “We are delighted to have received constructive guidance from both the FDA and EMA, which we believe allows us to expeditiously advance AMT-061 into a pivotal study next year, as previously planned. In anticipation of this, we have begun GMP production of AMT-061 in our Lexington facility and preparations for the pivotal study are underway.”

“I believe AMT-061 has the potential to be an important gene therapy for patients suffering with hemophilia B,” stated Steven Pipe, M.D., professor of pediatrics and pathology and pediatric medical director of the hemophilia and coagulation disorders program at the University of Michigan. “Based on the data generated to date, AMT-061 may be the first gene therapy to provide durable, curative benefits to nearly all patients with hemophilia B, without the complications associated with capsid-related immune responses.  I very much look forward to serving as an investigator in this exciting Phase III program.”

Clinical and Regulatory Pathway for AMT-061

  • The FDA has agreed that AMT-061 will be included under the existing Breakthrough Therapy designation and Investigational New Drug (IND) for AMT-060. The EMA also has agreed that AMT-061 will be included under the current PRIME designation.
  • The Company achieved general agreement with the FDA and EMA on the proposed pivotal trial plan for AMT-061. The study is expected to be an open-label, single-dose, multi-center, multi-national trial investigating the efficacy and safety of AMT-061 administered to adult patients with severe or moderately severe hemophilia B. The primary objective of the trial is to evaluate AMT-061 for prevention of bleedings. Secondary objectives include additional efficacy and safety aspects. Patients will serve as their own control, with a baseline established during a six-month observational lead-in phase prior to treatment with AMT-061.
  • Concurrent with the start of the six-month lead-in phase of the pivotal study, a short dose-confirmation study is expected to begin in the third quarter of 2018. Three patients will receive a single intravenous (IV) dose of AMT-061 at 2 x 1013 gc/kg and will be evaluated for a period of approximately six weeks to assess FIX activity levels and confirm the dose.  Each patient will continue to be followed longer term, and no lead-in phase is required for the dose confirmation study.

AMT-061 Nonclinical Data Demonstrate Tolerability and Substantial Increases in FIX Activity

  • A Good Laboratory Practices (GLP), nonclinical study of AMT-061 has been performed in non-human primates at four different dose levels up to a dose of 9 x 1013 gc/kg. The purpose of this study was to compare AMT-061 to AMT-060 with respect to liver transduction, circulating FIX protein levels, circulating FIX activity levels and toxicity, after a single intravenous dose with 13- or 26-week observation periods.
  • Data from the study demonstrated a strong correlation between dose and human FIX (hFIX) expression levels, as well as biological activity of the expressed hFIX protein.  At equal doses, circulating vector DNA plasma levels, liver distribution, liver cell transduction and hFIX protein expression were comparable for both AMT-060 and AMT-061.  Additionally, AMT-061 demonstrated substantial increases in hFIX clotting activity compared to AMT-060, consistent with those previously reported for FIX-Padua.
  • Based on a statistical analysis of the AMT-061 and AMT-060 non-human primate data, as well as the clinical data from the Phase I/II trial of AMT-060, the Company believes that AMT-061 administered at a dose of 2 x 1013 gc/kg may lead to mean FIX activity of approximately 30 to 50 percent of normal.
  • The study also examined toxicology of AMT-061, including liver enzyme activity, coagulation biomarkers and other safety parameters.  Data from the study demonstrated that AMT-061 was well-tolerated with no evidence of any significant toxicological findings.  There was no increased thrombin generation or increased fibrin formation or degradation detected during the six months of follow-up.  No increase in immunogenicity is expected with AMT-061, as there are no changes in the AAV5 capsid.

AMT-061 Continues to Leverage AAV5’s Favorable Tolerability and Immunogenicity Results

  • AAV5-based gene therapies have been demonstrated to be generally safe and well-tolerated in a multitude of clinical trials, including three uniQure trials conducted in 22 patients in hemophilia B and other indications.
  • In contrast to data reported using other AAV capsids delivered systemically via IV infusion, no patient treated in clinical trials with the Company’s AAV5 gene therapies has experienced any confirmed, T-cell-mediated immune response to the capsid or material loss of FIX activity.
  • An independent clinical trial has demonstrated that AAV5 has the lowest prevalence of preexisting neutralizing antibodies (NAb) compared to other AAV vectors.  Data from the Phase I/II study of AMT-060 also demonstrated clinical proof-of-concept in the presence of preexisting NAb to AAV5, suggesting that all, or nearly all hemophilia B patients may be eligible for treatment with AMT-061.

Commercial-scale, GMP Manufacturing of AMT-061 Clinical Material Underway

  • uniQure has initiated production of multiple clinical-grade batches of AMT-061 in its state-of-the-art Lexington, MA manufacturing facility. Material is being produced at commercial scale and utilizing current Good Manufacturing Practices (cGMP).  uniQure expects to begin releasing product for the pivotal trial by the first quarter of 2018.  The manufacturing process, controls and methods utilized for AMT-061 are consistent to those previously used for AMT-060.
  • The Company has achieved alignment with the FDA and EMA on its plan to establish comparability between AMT-061 and AMT-060.  uniQure expects to complete its ongoing comparability analysis and plans to submit the data to the agencies for review in the first quarter of 2018. Data reviewed to date support comparability between AMT-061 and AMT-060.

Exclusive Patent Covers the Use of Padua in Gene Therapy for Hemophilia B

  • In a separate press release, uniQure today announced that it has acquired a patent family that broadly covers the FIX-Padua variant and its use in gene therapy for the treatment of coagulopathies, including hemophilia B. This family includes a patent issued in the U.S., as well as pending patent applications in Europe and Canada.  uniQure recently filed divisional patent applications that would further strengthen its intellectual property position related to the FIX-Padua variant.
  • The patent family was acquired from Professor Paolo Simioni, a renowned hemophilia expert at the University of Padua, Italy, who is widely recognized as the first to identify the mutation. Professor Simioni is serving as an advisor and consultant exclusively to uniQure for the development of gene therapy products using his invention.  He is expected to assist the Company in its discussions with regulators, investigators and key opinion leaders throughout the clinical development of AMT-061.

Conference Call Information

uniQure will host a conference call today, October 19, 2017 at 8:30 a.m. ET to discuss this announcement.  To access the live call by phone, dial (877) 280-2296 (United States) or +44 (0)20 3427 1900 (international); the conference ID is 2516119.  The call may also be accessed through the Investors section of the Company’s website at www.uniQure.com.  Following the live webcast, a replay of the call will be available at the same location through November 2, 2017.

About uniQure
uniQure is delivering on the promise of gene therapy – single treatments with potentially curative results. We are leveraging our modular and validated technology platform to rapidly advance a pipeline of proprietary and partnered gene therapies to treat patients with hemophilia, Huntington’s disease and cardiovascular diseases. www.uniQure.com

uniQure Forward-Looking Statements

This press release contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “look forward to”, “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions. Forward-looking statements are based on management’s beliefs and assumptions and on information available to management only as of the date of this press release. These forward-looking statements include, but are not limited to, the development of our gene therapy product candidates, the success of our collaborations and the risk of cessation, delay or lack of success of any of our ongoing or planned clinical studies and/or development of our product candidates, and the scope of protection provided by our patent portfolio. Our actual results could differ materially from those anticipated in these forward-looking statements for many reasons, including, without limitation, risks associated with our and our collaborators’ clinical development activities, collaboration arrangements, corporate reorganizations and strategic shifts, regulatory oversight, product commercialization and intellectual property claims, as well as the risks, uncertainties and other factors described under the heading “Risk Factors” in uniQure’s Quarterly Report on Form 10-Q filed on August 8, 2017. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and we assume no obligation to update these forward-looking statements, even if new information becomes available in the future.

uniQure Contacts

For Investors:

Maria E. Cantor
Direct: 339-970-7536
Mobile: 617-680-9452
m.cantor@uniQure.com

Eva M. Mulder
Direct: +31 20 240 6103
Mobile: +31 6 52 33 15 79
e.mulder@uniQure.com

For Media:

Tom Malone
Direct: 339-970-7558
Mobile: 339-223-8541
t.malone@uniQure.com

Thursday, October 19th, 2017 Uncategorized Comments Off on $QURE Hemophilia B Gene Therapy Program to Enter Pivotal Study

$PRKR Enters into Common Stock Purchase Agreement with Aspire Capital Fund

JACKSONVILLE, Fla., Oct. 18, 2017 — ParkerVision, Inc. (Nasdaq:PRKR) (“ParkerVision” or “Company”), a developer and marketer of semiconductor technology solutions for wireless applications today announced that it has entered into a common stock purchase agreement with Aspire Capital Fund, LLC (“Aspire Capital”) for Aspire Capital’s private placement purchase of 312,500 shares of the Company’s common stock at $1.60 per share for proceeds of $500,000.  In addition, Aspire Capital has agreed to purchase up to an aggregate of $19.5 million of additional shares of the Company’s common stock, subject to registration of such shares by the Company. The Company will file a registration statement for an aggregate of 4 million shares of Company common stock related to this transaction. Aspire Capital’s purchase of shares under this agreement are at the Company’s sole discretion, over the 30-month term of the agreement, at prices based on the market price at the time of each purchase and subject to the Company’s registration of the resale of such shares.

ParkerVision Chief Executive Officer Jeffrey Parker said, “Our relationship with Aspire Capital will enable us to support product investments for future revenue growth that we believe can be achieved from our recently introduced Milo™ Wi-Fi products.  The agreement allows us to control the timing and amount of common stock being sold, enabling us to use this resource in a manner that minimizes shareholder dilution as we grow the business.”

Erik Brown, Principal at Aspire Capital Partners, LLC, said, “ParkerVision has a long history of developing innovative technologies.  After visiting their headquarters and testing Milo™, ParkerVision’s “whole-home” Wi-Fi system, we were convinced that a highly reliable distributed Wi-Fi product at an affordable price would be a game-changer as consumers continue to embrace the Internet of Things and connected homes.”

Upon execution of the agreement, the Company issued as a commitment fee to Aspire Capital 287,500 shares of common stock which will be registered for resale under the registration statement.  Aspire Capital has agreed that neither it nor any of its agents, representatives and affiliates shall engage in any direct or indirect short-selling or hedging of ParkerVision’s common stock during pendency of the agreement. The agreement does not contain any financial covenants, restrictions on future financings, rights of first refusal, participation rights or penalties.

This news release does not and shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall it constitute an offer, solicitation or sale in any jurisdiction in which, or to any person to whom, such offer, solicitation or sale is unlawful. Details of the stock purchase agreement and registration rights agreement have been filed with the SEC on Form 8-K.

About ParkerVision, Inc.
ParkerVision, Inc. designs, develops and markets its proprietary radio-frequency (RF) technologies, which enable advanced wireless solutions for current and next generation communications networks. Currently developing several new products to enhance Wi-Fi connectivity for small businesses and consumers, ParkerVision has recently unveiled a family of products under the Milo™ brand that leverages existing Wi-Fi infrastructure to create more optimal Wi-Fi configuration and superior coverage.  For more information please visit www.parkervision.com. (PRKR-G)

About Aspire Capital Fund, LLC
Aspire Capital is an institutional investor based in Chicago, Illinois, with a fundamental investment approach.  Aspire Capital invests in a wide range of companies and industries emphasizing life sciences, energy and technology.

Safe Harbor Statement
This press release contains forward-looking information. Readers are cautioned not to place undue reliance on any such forward-looking statements, each of which speaks only as of the date made. Such statements are subject to certain risks and uncertainties which are disclosed in the Company’s SEC reports, including the Form 10-K for the year ended December 31, 2016 and the Forms 10-Q for the quarters ended March 31, 2017 and June 30, 2017. These risks and uncertainties could cause actual results to differ materially from those currently anticipated or projected.

Cindy Poehlman
Chief Financial Officer
ParkerVision, Inc.
904-732-6100
cpoehlman@parkervision.com

Laurie Little
The Piacente Group
212-481-2050
parkervision@tpg-ir.com

Wednesday, October 18th, 2017 Uncategorized Comments Off on $PRKR Enters into Common Stock Purchase Agreement with Aspire Capital Fund

$DRIO Gains CE Mark for iPhone 7 and iPhone 8 Smart Glucose Meter

DarioHealth Bringing its Lightning®-enabled Version to the UK Market

CAESAREA, Israel, Oct. 18, 2017 — DarioHealth Corp. (NASDAQ: DRIO), a leading global digital health company with mobile health and big data solutions, announced today that it received the CE Mark for its Lightning®-enabled version of the acclaimed Dario™ Blood Glucose Monitoring System. The news ensures that consumers, beginning in the UK market, will be able to receive the same quality user experience with DarioHealth on the latest Apple devices, including the brand-new iPhone 8.

The launch of Apple’s smartphones with only a Lightning connector posed a unique challenge to the entire mobile ecosystem. With today’s announcement, DarioHealth can now successfully offer its proprietary meter with either a 3.5mm headphone jack or Lightning connector.

Erez Raphael, Chairman and CEO of DarioHealth, commented, “We’ve been working tirelessly to bring forth a solution that would meet the rigorous standards required to achieve the CE Mark. We are proud that our organization worked with agility to ensure connectivity to the latest Apple devices. This significant milestone will allow us to open to a whole new market segment and reengage with former-Dario users who now have the newest Apple devices.

“The actual Lighting-enabled prototype has been ready for a long time, and the CE Mark is just the beginning. We will continue to support our users around the world and, to that end, have begun the formal process with regulatory agencies in the U.S., Canada, and Australia.”

This is a big breakthrough for the UK market because as many as 4 million people in the UK have diabetes, and now more tech-savvy consumers can use the acclaimed Dario diabetes device with their smartphones. DarioHealth continues to shine in the UK after recently being named the “First Choice” by several Clinical Commissioning Groups for people with Type 1 Diabetes.

About DarioHealth Corp.
DarioHealth Corp. is a leading global digital health company serving tens of thousands of users with dynamic mobile health solutions. We believe people deserve the best tools to manage their treatment, and harnessing big data, we have developed a unique way for our users to analyze and personalize their diabetes management. With our smart diabetes solution, users have direct access to track and monitor all facets of diabetes, without having the disease slow them down. The acclaimed Dario™ Blood Glucose Monitoring System all-in-one blood glucose meter and native smartphone app gives users an unrivaled method for self-diabetes management. DarioHealth is headquartered in Caesarea, Israel with a regional office in Burlington, Massachusetts. For more information, visit http://mydario.investorroom.com/.

Cautionary Note Regarding Forward-Looking Statements
This news release and the statements of representatives and partners of DarioHealth Corp. (the “Company”) related thereto contain or may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the generality of the foregoing, words such as “plan,” “project,” “potential,” “seek,” “may,” “will,” “expect,” “believe,” “anticipate,” “intend,” “could,” “estimate,” or “continue” are intended to identify forward-looking statements. For example, when the Company describes the benefits of CE Mark approval, it is using forward-looking statements. Readers are cautioned that certain important factors may affect the Company’s actual results and could cause such results to differ materially from any forward-looking statements that may be made in this news release. Factors that may affect the Company’s results include, but are not limited to, regulatory approvals, product demand, market acceptance, impact of competitive products and prices, product development, commercialization or technological difficulties, the success or failure of negotiations and trade, legal, social and economic risks, and the risks associated with the adequacy of existing cash resources. Additional factors that could cause or contribute to differences between the Company’s actual results and forward-looking statements include, but are not limited to, those risks discussed in the Company’s filings with the U.S. Securities and Exchange Commission. Readers are cautioned that actual results (including, without limitation, the timing for and results of the Company’s commercial and regulatory plans for Dario™) may differ significantly from those set forth in the forward-looking statements. The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.

DarioHealth Corporate Contact:
Shmuel Herschberg
Marketing Director
shmuel@mydario.com
+1-914-775-5548

DarioHealth Public Relations Contact:
Terese Kelly
Rosica PR
terese@rosica.com
+ 1-201-843-5600

DarioHealth Investor Relations Contact:
Stephen Hart
Hayden IR
DRIO@HaydenIR.com
+1-917-658-7878

Wednesday, October 18th, 2017 Uncategorized Comments Off on $DRIO Gains CE Mark for iPhone 7 and iPhone 8 Smart Glucose Meter

$CIFS Announces Changes to Its Board of Directors

BEIJING, Oct. 18, 2017 — China Internet Nationwide Financial Services Inc. (NASDAQ: CIFS) (“CIFS” or the “Company”), a leading financial advisory services company, today announced changes to its Board of Directors (the “Board”) with the appointment of Mr. Buting Yang as director of the Company, effective October 16, 2017.

On October 16, 2017, Mr. Kam Cheng Leong tendered his resignation as director of the Company, Chairman of the Nominating and Corporate Governance Committee and member of both Audit Committee and Compensation Committee of the Company. Mr. Leong’s resignation was for personal reasons and was not a result of any dispute with the Company. The Board accepted Mr. Leong’s resignation with immediate effect.

On the same day, the Board resolved to appoint Mr. Buting Yang to replace Mr. Leong in the abovementioned capacities, effective immediately.

Mr. Yang has held a number of senior leadership positions in a variety of institutions in the media industry of China. He has been a director of and technology counsel to the China Film Association since 2000. From 2000 to 2007, Mr. Yang served as president of China Film Group Corporation. From 2000 to 2017, he served as independent director of Zhejiang Talent Television & Film Co., Ltd., a Shenzhen Stock Exchange listed company. From 2007 to 2009, Mr. Yang was independent director of Beijing Galloping Horse Media Co., Ltd. From 2007 to 2015, Mr. Yang also served as chairman of China Film Promotion International Corp. and president of China Film Distribution & Screening Association. In addition, Mr. Yang has been serving as a member of the Film Committee of State Administration of Radio, Film and Television of China since 2012. Mr. Yang also has been serving as independent director of SkyOcean International Holdings Limited since 2014, which is a company listed on Hong Kong Exchange. Mr. Yang’s leadership positions also include serving as independent director of Zhejiang Times Cinema Chain Co., Ltd. since 2015 and honorary chairman of Chinese Creative Culture Organization since 2012. Mr. Yang received his Bachelor degree in Geology from Jilin University in 1969.

“I’d like to take this opportunity to thank Mr. Leong for his leadership, guidance and dedication to CIFS and wish his success in all his future endeavors,” said Jianxin Lin, Chairman and Chief Executive Officer of CIFS. “I am also delighted that Mr. Yang has joined the CIFS Board and look forward to his expertise and insights in helping us further strengthen our Board and respond to new challenges as we continue to diversify and grow our business through geographical expansion, vertical integration and selective acquisitions.”

About China Internet Nationwide Financial Services Inc.

Incorporated in 2014 and headquartered in Beijing, China Internet Nationwide Financial Services Inc. provides financial advisory services, including commercial payment advisory, intermediary bank loan advisory, and international corporate financing advisory, to meet the financing and capital needs of its clients, comprised largely of small-to-medium sized enterprises.

Forward Looking Statements

This news release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and as defined in the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates” and similar statements. All statements other than statements of historical fact in this press release are forward-looking statements and involve certain risks and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. These forward-looking statements are based on management’s current expectations, assumptions, estimates and projections about the Company and the industry in which the Company operates, but involve a number of unknown risks and uncertainties, Further information regarding these and other risks is included in the Company’s filings with the U.S. Securities and Exchange Commission. The Company undertakes no obligation to update forward-looking statements to reflect subsequent occurring events or circumstances, or changes in its expectations, except as may be required by law. Although the Company believes that the expectations expressed in these forward looking statements are reasonable, it cannot assure you that such expectations will turn out to be correct, and actual results may differ materially from the anticipated results. You are urged to consider these factors carefully in evaluating the forward-looking statements contained herein and are cautioned not to place undue reliance on such forward-looking statements, which are qualified in their entirety by these cautionary statements.

INVESTOR RELATIONS:

China Internet Nationwide Financial Services Inc.
Email: ir@cifsp.com
Phone: +86 10 8587 8166

Tony Tian, CFA
Weitian Group LLC
Email: tony.tian@weitian-ir.com
Phone: +1 732 910 9692

Wednesday, October 18th, 2017 Uncategorized Comments Off on $CIFS Announces Changes to Its Board of Directors

$IGC IGC-AD1 Targeting Alzheimer’s Disease Sees Early 2018 Commercialization

IGC-AD1 for Alzheimer’s Shows Promise by Inhibiting GSK3β and Tau hyperphosphorylation a key hallmark of AD

BETHESDA, Md., Oct. 18, 2017 – India Globalization Capital, Inc. (NYSE-MKT:IGC) provides compelling in vitro data compiled from genetically engineered cell lines within an Alzheimer’s disease model, showing that at varying concentrations of IGC-AD1 the expression of GSK3β is reduced by as much as 62%, leading in turn to a reduction in hyper phosphorylation of tau protein.

“Based on this and other previously announced compelling data, we are readying IGC-AD1, brand name Hyalolex, in a liquid formulation for commercialization in early 2018,” stated IGC’s CEO, Ram Mukunda.

We have identified Germany, Canada and certain licensed medical cannabis states in the U.S. for commercialization. The German market recently opened for imports of cannabis products that can be sold in licensed pharmacies. Our initial research indicates that there are about 7.8 million patients with AD in these combined markets.

One of the two types of legions found in the brain of AD patients is intracellular neurofibrillary tangles (NFTs) composed of tau protein. This study shows that IGC-AD1 inhibits glycogen synthase kinase-3β (GSK3β) a major kinase (catalyst) in the phosphorylation of tau protein. Curtailing abnormal hyperphosphorylation of tau, which leads to NFTs, is an accepted strategy for combating AD.

Tau proteins are Microtubule Associated Proteins (MAPs) that stabilize microtubules within a neuron. Abnormally phosphorylated tau leads to a disassociation of tau from MAP, leading to a destabilization of microtubule associated protein complexes; eventually leading to neuronal degeneration. Studies have shown that in the brains of AD patients the phosphorylation of tau is 3 to 4 times more than in normal brains.

This study result, when combined with the earlier reported data that shows IGC-AD1 reduces Aβ production and inhibits Aβ aggregation without any neuronal toxicity, represents a novel breakthrough. The summary in vitro data indicates that at varying concentrations of IGC-AD1, GSK3β levels decreased between 53% and 62%.  This in turn curtailed hyperphosphorylation of tau protein as measured by immunoblotting studies on N2aAβPPswe cells.  Dr. Chuanhai Cao, IGC’s Senior Advisor and Associate Professor of Pharmaceutical Sciences at USF’s College of Pharmacy conducted the studies.

About Alzheimer’s Disease
Alzheimer’s Disease (AD) is a form of dementia.  It is known as America’s most expensive disease, with an estimated cost to the U.S. economy of $236 billion.  AD currently affects more than 5.3 million Americans and over 65% of AD patients are women.  Over the next 20 years, the number of those afflicted with the disease is expected to double.  The forecast is staggering, considering that to date, no effective cure has been found.

About IGC
IGC is engaged in the development of cannabis based combination therapies to treat Alzheimer’s, pain, nausea, eating disorders, several end points of Parkinson’s, and epilepsy in dogs and cats.  IGC has assembled a portfolio of patent filings and four lead product candidates addressing these conditions. The company is based in Maryland, USA.

For more information please visit www.igcinc.us
Follow us on Twitter @IGCIR and Facebook.com/IGCIR/

Forward-looking Statements
Please see forward looking statements as discussed in detail in IGC’s Form 10K for fiscal year ended March 31, 2017, and in other reports filed with the U.S. Securities and Exchange Commission.

 

Contact:
Claudia Grimaldi
301-983-0998
Wednesday, October 18th, 2017 Uncategorized Comments Off on $IGC IGC-AD1 Targeting Alzheimer’s Disease Sees Early 2018 Commercialization

$PBIO and Phasex Announce Strategic Collaboration; Stable, Water-Soluble Nanoemulsions

Companies Will Combine PBI’s Recently Patented Ultra Shear Technology with Phasex’s Supercritical Fluid Processing Methods to Enable Development of Stable, Water-Soluble Nanoemulsions, Including CBD-Enriched Plant Oil

SOUTH EASTON, MA–(Oct 18, 2017) – Pressure BioSciences, Inc. (OTCQB: PBIO) (“PBI” and the “Company”), a leader in the development and sale of innovative, broadly enabling, pressure-based solutions for the worldwide life sciences industry, today announced a collaboration with Phasex Corporation, one the world’s most experienced supercritical fluid (“SCF”)-based toll processors. Since 1981, Phasex has been a leader in the development of cutting-edge, industrially-viable SCF-based separation processes for extracting, purifying, recrystallizing, and fractionating a wide range of polymers, natural extracts, specialty and fine chemicals, and nutraceutical and pharmaceutical preparations. The goal of the collaboration is to combine PBI’s recently patented Ultra Shear Technology (“UST”) with Phasex’s SCF-based processing methods to enable the development of stable, water-soluble nanoemulsions of nutraceuticals, including CBD-enriched plant oil.

Dr. Edmund Ting, Sr. Vice President of Engineering for PBI, said: “Data from scientific studies indicate that nanoemulsions of nutraceuticals and pharmaceuticals may exhibit improved absorption, higher bioavailability, greater stability, and lower levels of stabilizing additives (surfactants) compared to the larger droplet sizes resulting from current emulsion processes. Because of these significant advantages, nanoemulsions are currently the focus of many research efforts worldwide. Unfortunately, even with these increased efforts, scale-up to a cost-effective, industrial level nanoemulsion production process remains a significant challenge.”

Dr. Val Krukonis, Founder of Phasex, commented: “We are impressed with the potential of UST as a complimentary technology to SCF extraction. Several customers are currently seeking new methods to turn hydrophobic extracts into stable, water-soluble formulations. UST offers the potential to solve this problem by producing stable nanoemulsions of oil-like products in water. Such formulations could potentially have enormous success in many markets, including inks, industrial lubricants, and cosmetics, as well as in pharmaceuticals and nutraceuticals, such as medically important plant oil extracts.”

Mr. Hans Schonemann, President of Phasex, said: “Following discussions with our colleagues at PBI, we believe the UST platform can be scaled to a cost-effective, commercially-viable level. This would allow production of large quantities of stable, water-soluble nanoemulsions of compounds that were previously water-insoluble, such as CBD from cannabis. Such aqueous nanoemulsions could significantly increase the absorption and bioavailability of CBD and other previously water-insoluble compounds, which we believe would subsequently result in significant increases in their commercial demand.”

Mr. Richard T. Schumacher, President and CEO of PBI, said: “We believe the ability to subject liquids to UST following the Phasex SCF extraction and purification process would be a highly sought-after “Value-add” for Phasex customers. Rapidly expanding markets for non-psychoactive extracts of cannabis plant material, for instance, is an example of a potentially high demand application for our combined, synergistic technologies. Oral bioavailability of CBD in aqueous emulsions has been previously demonstrated in several studies. Combining the capabilities and experience of PBI and Phasex could effectuate commercial scale production of such formulations with long shelf stability, which in turn could potentially result in a highly profitable service model for the PBI and Phasex collaboration.”

About Ultra Shear Technology
UST utilizes ultra-high pressure-driven fluid dynamic shear forces, combined with controlled temperatures, resulting in a novel homogenization process. Depending on conditions, UST concomitantly disrupts particulate materials, blends immiscible fluids, and may inactivate spoilage and pathogenic organisms such as bacteria, viruses and spores. This process offers a potential pathway to create stable nanoemulsion mixtures of otherwise immiscible fluids (such as oils and water), as well as a potential pathway to homogenized products with improved sensory and other qualities (such as food nutrition). Many oil-based nutraceuticals (including CBD oil from cannabis) may be more medically desirable, and thus commercially successful, in an orally-administered nanoemulsion. Furthermore, many industrial processes (such as inks and lubricants) should benefit from the production of high quality nanoemulsions.

About Supercritical Fluids and Supercritical Fluid Processing
A supercritical fluid is any substance at a temperature and pressure above its “critical point” where distinct liquid and gas phases do not exist. SCFs offer enhanced solubility conditions and are often suitable substitutes for undesirable organic solvents in a range of industrial and laboratory processes. Phasex applies supercritical fluid technology to the development of innovative, industrially-viable separation processes for extracting, purifying, recrystallizing, and fractionating a wide range of polymers, natural extracts, and specialty and fine chemicals. Carbon dioxide and water are the most common solvents used in SCF processing.

About Phasex Corporation
Phasex Corporation, founded in 1981, exploits the attributes of supercritical fluids in the development of superior, organic, solvent-free separation processes. Phasex focuses on applications that will help customers create value-added products. As product and process requirements continue to evolve, Phasex remains committed to developing new applications for SCF technology in order to meet the changing needs of industry as well as ever-increasing regulatory constraints.

About Pressure BioSciences, Inc.
Pressure BioSciences, Inc. (“PBI”) (OTCQB: PBIO) develops, markets, and sells proprietary laboratory instrumentation and associated consumables to the estimated $6 billion life sciences sample preparation market. Our products are based on the unique properties of both constant (i.e., static) and alternating (i.e., pressure cycling technology, or “PCT”) hydrostatic pressure. PCT is a patented enabling technology platform that uses alternating cycles of hydrostatic pressure between ambient and ultra-high levels to safely and reproducibly control bio-molecular interactions. Our primary focus is in the development of PCT-based products for biomarker and target discovery, drug development and design, bio-therapeutics characterization, soil & plant biology, forensics, and counter-bioterror applications. Major new focal market opportunities are emerging in the use of our patented, scalable, high-efficiency Ultra Shear Technology (“UST”) to create stable nanoemulsions of otherwise immiscible fluids (such as oils and water), and to prepare higher quality, homogenized, extended shelf-life or room temperature stable, low-acid liquid foods that cannot be effectively prepared using existing technologies.

Forward Looking Statements
Statements contained in this press release regarding PBI’s intentions, hopes, beliefs, expectations, or predictions of the future are “forward-looking” statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are based upon the Company’s current expectations, forecasts, and assumptions that are subject to risks, uncertainties, and other factors that could cause actual outcomes and results to differ materially from those indicated by these forward-looking statements. These risks, uncertainties, and other factors include, but are not limited to, the risks and uncertainties discussed under the heading “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2016, and other reports filed by the Company from time to time with the SEC. The Company undertakes no obligation to update any of the information included in this release, except as otherwise required by law.

For more information about PBI and this press release, please click on the following website link: http://www.pressurebiosciences.com

Please visit us on Facebook, LinkedIn, and Twitter

Investor Contacts:
Pressure BioSciences, Inc.

Richard T. Schumacher
President & CEO

Nathan P. Lawrence, Ph.D.
VP of Marketing and Sales
(508) 230-1828 (T)

Wednesday, October 18th, 2017 Uncategorized Comments Off on $PBIO and Phasex Announce Strategic Collaboration; Stable, Water-Soluble Nanoemulsions

$VYGR New Data Presentations at ESGCT

New data with novel AAV gene therapy capsids demonstrate widespread gene transfer to the brain and spinal cord of non-human primates after a single intravenous administration

Additional studies at Voyager are underway in non-human primates with these novel capsids and other novel AAV vectors focusing on regions critical for the treatment of ALS, Friedreich’s ataxia, as well as brain regions and approaches for treating other areas for Parkinson’s disease and Huntington’s disease, and other severe neurological diseases

New data for Friedreich’s ataxia with a novel capsid demonstrate reversal of disease phenotype in a preclinical disease model

Voyager’s AAV gene therapy baculovirus/Sf9 system demonstrates increased yields and comparable quality compared with a mammalian-cell based manufacturing system

CAMBRIDGE, Mass., Oct. 17, 2017 — Voyager Therapeutics, Inc. (NASDAQ:VYGR), a clinical-stage gene therapy company focused on developing life-changing treatments for severe neurological diseases announced today multiple data presentations at the Congress of the European Society of Gene and Cell Therapy (ESGCT) taking place October 17-20, 2017, in Berlin, Germany. The data include an oral presentation related to recent results from Voyager’s ongoing Phase 1b trial of VY-AADC01 in advanced Parkinson’s disease, as well as six poster presentations related to Voyager’s novel adeno-associated virus (AAV) capsid optimization efforts, gene therapy manufacturing, and preclinical pipeline programs.

“A core competency of Voyager’s gene therapy platform is vector optimization and a critical component of this is optimizing and choosing the capsid, or outer shell of the gene therapy vector,” said Dinah Sah, Ph.D., Voyager’s chief scientific officer. “At this year’s ESGCT meeting, we describe exciting progress with novel AAV capsids that enhance the transfer of genes to the brain and spinal cord of non-human primates and in a preclinical model of Friedreich’s ataxia, representing unique opportunities for our current pipeline as well as for future potential programs. An additional core competency of Voyager is the production and manufacturing of AAV gene therapy vectors at scale, and at the meeting, we also describe the high yield and quality of AAV vectors produced with Voyager’s baculovirus/Sf9 manufacturing system.”

Clinical, Preclinical, and Manufacturing Posters and Presentations at ESGCT

“Translation of Intravenous Delivery of AAV Gene Therapy for the Treatment of CNS Diseases.” Poster P209.

Intravenous dosing of AAV gene therapy vectors in adult large mammals has resulted in limited transfer across the blood-brain barrier to achieve gene expression in the central nervous system (CNS). In these studies in adult non-human primates, novel AAV gene therapy capsids readily crossed the blood-brain barrier after a single, intravenous administration resulting in widespread, enhanced gene transfer to the brain and spinal cord. One month after dosing of a transgene encoding both a therapeutic protein (frataxin) and a reporter gene (HA) to facilitate molecular and immunohistochemical measurements, substantial levels of frataxin-HA were expressed in the CNS, including motor neurons throughout the length of the spinal cord, the brain stem, pyramidal neurons in the motor cortex, and neurons in the substantia nigra, thalamus and cerebellar dentate nucleus. Voyager continues to conduct additional studies in non-human primates with these and other novel AAV capsids to optimize delivery of genes to regions critical for the treatment of amyotrophic lateral sclerosis (ALS), Parkinson’s disease and Friedreich’s ataxia (FA), as well as other severe neurological diseases.

“Rescue of Central and Peripheral Neurological Phenotype in a Novel Mouse Model of Friedreich’s Ataxia by Intravenous Delivery of AAV Frataxin.” Poster P107.

Friedreich’s ataxia is a severe, inherited neurological disease caused by mutations in the frataxin gene leading to decreased expression of frataxin (FXN), which results in severe sensory impairment, progressive loss of the ability to walk, generalized weakness, loss of sensation, as well as severe and potentially fatal cardiomyopathy. In a transgenic mouse model of FA, one-time intravenous post-symptomatic dosing of an AAV vector composed of a novel AAV capsid and a frataxin transgene, together with intracerebral dosing also delivering a frataxin transgene, rapidly halted and reduced FA disease progression in multiple tests including three functional tests of motor behavior and one electrophysiological test. In addition, increasing intravenous vector doses with the same novel capsid together with a fixed dose of the intracerebral vector led to a dose-dependent rescue of the FA phenotype. This novel AAV capsid provided at least 20-fold greater delivery of the vector to sensory ganglia as measured by vector genomes, and approximately a three-fold greater expression of frataxin in the cerebellum, as compared to an AAV9 vector at a similar dose. Additional preclinical studies are underway at Voyager including steps to optimize a lead clinical candidate for the treatment of FA.

“Enabling Large-Scale Manufacturing of rAAV Vectors with the Baculovirus/Sf9 Production System.” Poster P324.

Voyager’s manufacturing platform utilizes a baculovirus/Sf9 cell production process that enables the production of AAV vectors at clinical and commercial scale, with the potential for increased yields over traditional production processes. The current study demonstrated comparability in the quality of AAV vectors produced with the baculovirus/Sf9 process compared to AAV vectors produced with a mammalian process. AAV vectors produced with baculovirus/Sf9 cells showed similar analytical characteristics, in vitro and in vivo pharmacological activity, and CNS bio-distribution when compared to AAV vectors produced using triple-transfection of human embryonic kidney (HEK293) cells. Similar, robust knock down of HTT (huntingtin) gene expression occurred in vivo for vectors produced in either baculovirus/Sf9 or HEK293 cells. These data demonstrate that the baculovirus/Sf9 production system can be used to produce AAV vectors that are indistinguishable with respect to bio-distribution, potency and expression in vivo compared to AAV vectors produced in mammalian cells.

“Translation of Intrathecal Delivery of an AAV Gene Therapy Targeting SOD1 for the Treatment of ALS.” Poster P207.

ALS is a rapidly progressive, fatal disease characterized by the degeneration of nerve cells in the spinal cord and brain resulting in severe muscle atrophy with loss of the ability to walk and speak, and premature death. Mutations in the superoxide dismutase 1 gene (SOD1), the first mutant gene discovered to be causal for the development of ALS, lead to motor neuron loss through a toxic gain of function mechanism and accounts for two to three percent of ALS cases worldwide. Intrathecal (IT) administration of AAV vectors in preclinical models of ALS has effectively transferred genes to the spinal cord, providing less exposure to peripheral tissues and reducing the impact of pre-existing immunity compared with systemic dosing. However, the efficacy of an AAV gene therapy directed against SOD1 has not been reported to date in a large animal model of ALS.

In this study, Voyager evaluated IT delivery of an AAV gene therapy vector targeting SOD1 using RNAi for the treatment of canine degenerative myelopathy, a naturally-occurring disease of companion dogs that is similar to some forms of human ALS, including the SOD1 form of disease. The results demonstrated that a single IT administration of Voyager’s AAV SOD1 RNAi vector resulted in 74% and 41% suppression, or knock down, of SOD1 mRNA in dorsal root ganglia and spinal cord, respectively, and was well-tolerated. Precise and efficient processing of the primary microRNA was also observed.

“Selection of an AAV Gene Therapy Targeting Huntingtin for the Treatment of Huntington’s Disease.” Poster P212.

Huntington’s disease is a fatal, inherited neurodegenerative disease that results in the progressive decline of motor and cognitive functions caused by an expansion mutation in the huntingtin, or HTT, gene. For the treatment of Huntington’s disease, suppression of mutant huntingtin as a therapeutic approach is supported by multiple preclinical studies. Voyager previously selected VY-HTT01 as a clinical candidate for the treatment of Huntington’s disease. VY-HTT01 is composed of an AAV capsid and proprietary transgene that harnesses the RNAi pathway to selectively knock down the production of HTT mRNA. Direct delivery of VY-HTT01 to the brain with a one-time administration could potentially slow or halt the progression of Huntington’s disease.

In the non-human primate putamen (a disease-relevant region of the brain), VY-HTT01 resulted in 54% suppression of HTT mRNA after a single administration. The extent of HTT mRNA suppression, as well as the high precision and efficiency of primary microRNA processing and tolerability in the non-human primate supported the selection of VY-HTT01 as the lead clinical candidate. Preclinical pharmacology and toxicology studies are underway with VY-HTT01 to support filing of an IND application.

“AAV Gene Delivery of an Anti-Tau Antibody using a Novel Blood Brain Barrier Penetrant Capsid in Wild Type and P301S Tauopathy Mice.” Poster P229.

In healthy individuals, tau is an abundant soluble cytoplasmic protein in neurons that binds to microtubules to promote microtubule stability and function. In Alzheimer’s disease (AD), Frontotemporal Dementia (FTD), progressive supranuclear palsy (PSP) and other tauopathies, tau aggregates and forms insoluble neurofibrillary tangles that closely correlate to the progression of neurodegeneration. The use of therapeutic antibodies targeting various forms of tau to prevent, reduce, or slow the development of tau pathology is an important potential therapeutic strategy for these diseases.

Because of the blood-brain barrier, only very low levels of antibody distribute to the brain from the systemic circulation after passive immunization, resulting in modestly reduced tau pathology in animal models. In Voyager’s study, a one-time intravenous dose of an AAV vector composed of a novel capsid and transgene encoding an anti-tau antibody penetrated the blood-brain barrier resulting in widespread and durable expression of a tau monoclonal antibody in the brain and spinal cord to levels at least 15-fold higher than those achieved following standard passive immunization.

These data suggest that intravenous dosing of vectorized anti-tau antibody with a novel AAV capsid represents a new single-dose therapeutic strategy for treating various tauopathies, including FTD and AD. Voyager is optimizing the AAV vectored delivery of monoclonal antibodies directed against tau and other misfolded proteins to potentially treat a variety of neurodegenerative disorders.

“Intraputaminal AADC gene therapy for advanced Parkinson’s disease: Interim Results of a Phase 1b Trial.” An oral presentation is scheduled for October 18, 2017, 2:40 pm CET.

Voyager’s lead program for Parkinson’s disease, VY-AADC01, is designed to deliver the AADC gene directly into neurons of the putamen where dopamine receptors are located, bypassing the degenerating dopamine neurons of the substantia nigra and enabling neurons of the putamen to express the AADC enzyme and to convert levodopa into dopamine. The approach with VY-AADC01, therefore, has the potential to durably enhance the conversion of levodopa to dopamine and provide clinically meaningful improvements in motor function in advanced Parkinson’s disease patients, improving their symptoms at lower doses of levodopa and following a single administration.

Recently reported data for VY-AADC01 from the ongoing Phase 1b data will be presented at this year’s ESGCT. The results demonstrated durable, dose-dependent and time-dependent improvements across multiple measures of patients’ motor function after a one-time administration of VY-AADC01, and with meaningfully lower doses of oral levodopa. These measures include patient-reported diaries, Parkinson’s disease rating scales, and activities of daily living. Voyager will continue to follow the patients in this Phase 1b trial. A pivotal Phase 2-3 program is scheduled to begin later this year with patient enrollment commencing the first half of 2018.

Additional information for these poster presentations can be found on the “Publications” section of Voyager Therapeutics’ website at www.voyagertherapeutics.com.

About Voyager Therapeutics

Voyager Therapeutics is a clinical-stage gene therapy company focused on developing life-changing treatments for severe neurological diseases. Voyager is committed to advancing the field of adeno-associated virus (AAV) gene therapy through innovation and investment in vector engineering and optimization, manufacturing and dosing and delivery techniques. Voyager’s pipeline focuses on severe neurological diseases in need of effective new therapies, including advanced Parkinson’s disease, a monogenic form of ALS, Huntington’s disease, Friedreich’s ataxia, frontotemporal dementia, Alzheimer’s disease and severe, chronic pain. Voyager has broad strategic collaborations with Sanofi Genzyme, the specialty care global business unit of Sanofi, and the University of Massachusetts Medical School. Founded by scientific and clinical leaders in the fields of AAV gene therapy, expressed RNA interference and neuroscience, Voyager Therapeutics is headquartered in Cambridge, Massachusetts. For more information, please visit www.voyagertherapeutics.com.

Forward-Looking Statements

This press release contains forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws. The use of words such as “may,” “might,” “will,” “should,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “undoubtedly,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expressions are intended to identify forward-looking statements. For example, all statements Voyager makes regarding the initiation, timing, progress and reporting of results of its preclinical programs and clinical trials and its research and development programs; its ability to advance its AAV-based gene therapies into, and successfully initiate, enroll, and complete, clinical trials; the potential clinical utility of its product candidates; its ability to continue to develop its product engine; its ability to add new programs to its pipeline; its ability to enter into new partnerships or collaborations; its expected cash, cash equivalents and marketable debt securities at the end of a fiscal year and anticipation for how long expected cash, cash equivalents and marketable debt securities will last; and the timing or likelihood of its regulatory filings and approvals are forward-looking. All forward-looking statements are based on estimates and assumptions by Voyager’s management that, although Voyager believes to be reasonable, are inherently uncertain. All forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those that Voyager expected. Such risks and uncertainties include, among others, those related to the initiation and conduct of preclinical studies and clinical trials, the availability of data from clinical trials and the expectations for regulatory submissions and approvals; the continued development of the product engine; Voyager’s scientific approach and general development progress; the availability or commercial potential of Voyager’s product candidates; the sufficiency of cash resources; and need for additional financing. These statements are also subject to a number of material risks and uncertainties that are described in Voyager’s most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, as updated by its subsequent filings with the Securities and Exchange Commission. Any forward-looking statement speaks only as of the date on which it was made. Voyager undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law.

Investor Relations:
Matt Osborne
Vice President of Investor Relations & Corporate Communications
857-259-5353
mosborne@vygr.com

Media: 
Katie Engleman
Pure Communications, Inc.
910-509-3977
Katie@purecommunicationsinc.com

Tuesday, October 17th, 2017 Uncategorized Comments Off on $VYGR New Data Presentations at ESGCT

$DFFN Final FDA Guidance for TSC Phase 3 Clinical in Glioblastoma

Expects to Begin Trial by Year-End

CHARLOTTESVILLE, Va., Oct. 17, 2017 — Diffusion Pharmaceuticals Inc. (NASDAQ:DFFN) (“Diffusion” or “the Company”), a clinical-stage biotechnology company focused on extending the life expectancy of cancer patients, announced that it has received final protocol guidance from the U.S. Food and Drug Administration (FDA) for a Phase 3 clinical trial with the Company’s lead compound trans sodium crocetinate (TSC) in patients newly diagnosed with inoperable glioblastoma multiforme (GBM), a type of brain cancer. The Company has responded to all outstanding points raised by the FDA and plans to begin the trial under the protocol agreed to by the FDA by the end of 2017.  The trial will compare survival at two years of patients receiving TSC concurrent with chemotherapy and radiation (standard of care, or SOC), with patients receiving SOC alone.

“Following a series of interactions with the FDA, we are gratified to have an agreed-upon protocol and to be preparing to start our TSC Phase 3 trial in patients newly diagnosed with inoperable GBM,” said David Kalergis, Chief Executive Officer of Diffusion Pharmaceuticals.  “As previously announced, we have engaged the contract research organization to oversee this trial and have completed the Phase 3 TSC drug production run to FDA standards.  On our way to opening an anticipated total of 100 sites across the U.S. and Europe, we have 17 initial sites selected in the U.S., all under one Institutional Review Board, and first patients are expected to be enrolled this year.”

Mr. Kalergis continued, “This Phase 3 study will focus on treating newly diagnosed GBM patients who have been judged by their medical team to be inoperable because of the size or location of the tumor. In Diffusion’s Phase 2 proof-of-concept trial, the inoperable GBM patients who were treated with TSC plus standard of care showed a nearly four-fold increase in survival at two years compared with standard of care patients only. Due to their poor prognoses, inoperable patients are often excluded from GBM clinical trials and have usually been treated with radiation and chemotherapy only. We are excited to bring a new treatment possibility to patients with inoperable GBM, and look forward to beginning the trial.”

About the Glioblastoma Multiforme Phase 3 Trial

The Phase 3 trial is a randomized, controlled registration trial with TSC and SOC chemotherapy and radiation, compared with SOC alone in newly diagnosed inoperable GBM patients.  The primary endpoint is overall survival, either after a predetermined number of patient deaths or following successful results of an optional interim analysis. Secondary endpoints include progression-free survival (PFS) and objective response rate (ORR; tumor response) using RANO criteria, as well as patient performance scoring (Karnofsky Performance Scale; KPS), Quality of Life (EQ-5D-5L questionnaire) and corticosteroid and anticonvulsant usage.

A total of 236 patients will be randomized 1:1 at 100 clinical sites (54 U.S., 46 EU).  TSC will be dosed three times each week for six weeks concurrent with standard radiation and chemotherapy as initial treatment. This will be followed by one month of rest and then adjuvant chemotherapy consisting of six monthly cycles of TSC and temozolomide given for the first week of each cycle.  As such, 18 doses of TSC will be administered during initial treatment and another 18 doses will be administered during adjuvant treatment to those so randomized.

About Treatment-Resistant Cancers and TSC

Oxygen deprivation at the cellular level (hypoxia) is the result of rapid tumor growth, causing the tumor to outgrow its blood supply.  Cancerous tumor cells thrive with hypoxia and the resultant changes in the tumor microenvironment cause the tumor to become resistant to radiation therapy and chemotherapy. Using a novel, proprietary mechanism of action, Diffusion’s lead drug TSC counteracts tumor hypoxia – and therefore treatment-resistance – by safely re-oxygenating tumor tissue, thus enhancing tumor kill and potentially prolonging patient life expectancy. Oxygen levels of normal tissue remain unaffected upon administration of TSC, thereby avoiding the introduction of harmful side effects.

About Diffusion Pharmaceuticals Inc.

Diffusion Pharmaceuticals Inc. is a clinical-stage biotechnology company focused on extending the life expectancy of cancer patients by improving the effectiveness of current standard-of-care treatments including radiation therapy and chemotherapy. Diffusion is developing its lead product candidate, trans sodium crocetinate, for use in the many cancers where tumor hypoxia (oxygen deprivation) is known to diminish the effectiveness of SOC treatments. TSC targets the cancer’s hypoxic micro-environment, re-oxygenating treatment-resistant tissue and making the cancer cells more vulnerable to the therapeutic effects of SOC treatments without the apparent addition of any serious side effects.

A Phase 2 clinical program was completed in the second quarter of 2015 and evaluated 59 patients with newly diagnosed glioblastoma multiforme, a type of brain cancer. This open-label, historically controlled study demonstrated a favorable safety and efficacy profile for TSC combined with SOC, including a 37% improvement in overall survival compared with the control group at two years.  A particularly strong efficacy signal was seen in the subset of inoperable patients where survival of TSC-treated patients at two years was nearly four-fold higher compared with the controls. Due to its novel mechanism of action, TSC has safely re-oxygenated a range of tumor types in preclinical and clinical studies.  Diffusion believes the therapeutic potential of TSC is not limited to specific tumors, thereby making it potentially useful to improve SOC treatments of other life-threatening cancers.  Additional planned studies include Phase 2 trials in pancreatic cancer and brain metastases, with study initiation subject to receipt of additional funding or collaborative partnering. The Company also believes that TSC has potential application in other indications involving hypoxia, such as neurodegenerative diseases and emergency medicine

Forward-Looking Statements

To the extent any statements made in this news release deal with information that is not historical, these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about the company’s plans, objectives, expectations  and intentions with respect to future operations and products, the potential of the company’s technology and product candidates, the anticipated timing of future clinical trials and protocol review, and other statements that are not historical in nature, particularly those that utilize terminology such as “would,” “will,” “plans,” “possibility,” “potential,” “future,” “expects,” “anticipates,” “believes,” “intends,” “continue,” “expects,” other words of similar meaning, derivations of such words and the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause the company’s actual results to be materially different than those expressed in or implied by such forward-looking statements. Particular uncertainties and risks include: general business and economic conditions; the company’s need for and ability to obtain additional financing; and the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance, and the various risk factors (many of which are beyond Diffusion’s control) as described under the heading “Risk Factors” in Diffusion’s filings with the United States Securities and Exchange Commission. All forward-looking statements in this news release speak only as of the date of this news release and are based on management’s current beliefs and expectations. Diffusion undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

Contacts:
David Kalergis, CEO
Diffusion Pharmaceuticals Inc.
(434) 220-0718
dkalergis@diffusionpharma.com
or
LHA Investor Relations
Kim Sutton Golodetz
(212) 838-3777
kgolodetz@lhai.com

Tuesday, October 17th, 2017 Uncategorized Comments Off on $DFFN Final FDA Guidance for TSC Phase 3 Clinical in Glioblastoma

$SSKN GPO Exclusive for Aesthetic Medical Market, Agreement MedResults Network

Agreement will enhance sales efforts of Nordlys and STRATAPEN

HORSHAM, Pa., Oct. 17, 2017 — STRATA Skin Sciences, Inc. (NASDAQ:SSKN) (“STRATA”) a medical technology company in Dermatology and Plastic Surgery dedicated to developing, commercializing and marketing innovative products for the treatment of dermatologic conditions, today announced signing an Agreement with MedResults Network (MRN). MRN is a Group Purchasing Organization that has more than 3,000 members including Dermatology Offices, Plastic Surgery Practices, Facial Plastic Practices, MediSpas and other providers. MRN researches product categories and selects advantaged products and then negotiates pricing for its membership. MRN focuses on the aesthetic market and has agreements with more than 50 vendors with only one vendor per product category.

Frank McCaney, President and Chief Executive Officer of STRATA, commented, “We are pleased to announce this relationship, which we believe has major benefits to STRATA. MRN has a loyal and long-term subscriber base and a reputation for providing value to its members. MRN provides additional value to its members by offering educational seminars and value to its vendors by active promotion of the products on agreement with them.”

“Furthermore, the products that STRATA introduced earlier this year in the Aesthetic space are outstanding, technology-advantaged products but lacked broad awareness. We believe that the reach and credibility of MRN will greatly benefit our sales efforts,” continued Mr. McCaney.

Jeff Routledge, President of MRN, added, “We are excited about the opportunity to assist STRATA in marketing their products to our membership. STRATA’s Aesthetic products, Nordlys and STRATAPEN, are excellent products that are in growing sectors of the Aesthetic market. MRN’s mission is to offer our members best-in-class products from world class companies through pricing that can only be achieved by leveraging the buying power of our 3,000 member practices and medical spas.”

The relationship between MRN and STRATA, which offers special pricing to MRN members, is being fully launched to the membership this week.

About STRATA Skin Sciences, Inc. (www.strataskinsciences.com)
STRATA Skin Sciences is a medical technology company in Dermatology and Plastic Surgery dedicated to developing, commercializing and marketing innovative products for the treatment of dermatologic conditions.  Its products include the XTRAC® laser and VTRAC® excimer lamp systems utilized in the treatment of psoriasis, vitiligo and various other skin conditions; the STRATAPEN™ MicroSystem, marketed specifically for the intended use of micropigmentation; and Nordlys, a multi-technology aesthetic laser device.

About MedResults Network  (www.medresultsnetwork.com)
MedResults Network is a free membership service that offers instant discounts and quarterly rebates at no risk or obligation. They have partnered with over 50 leading national vendors to negotiate cost savings for its members in product categories including dermal fillers, lasers, skin care, and more. Since 2008, MRN’s leadership team has worked closely with both their members and partners to ensure their continued growth and success.

Nordlys® Laser
The Nordlys Hybrid System incorporates a multitude of light-based technologies in an all-in-one compact platform – SWT (Selective Waveband Technology: the latest evolution and most efficacious utilization of Intense Pulsed Light), Nd:YAG and the FRAX 1550 non-ablative fractionated technology. The Nordlys laser uses Ellipse’s patented Dual Wave Filtration, a technology that has made the Nordlys the device of choice to over 6,000 cosmetic and dermatologic physician offices worldwide.  The Nordlys system has 16 indications cleared to date by the U.S. Food and Drug Administration (FDA).

STRATAPENTM
STRATAPEN MicroSystems is a micropigmentation device that provides advanced technology offering exceptional results. The STRATAPEN features both a patent-pending Biolock cartridge, which incorporates a seven-step safety system to prevent fluids from entering the motor, as well as a patent-pending removable nose cone.

Nordlys is a registered trademark of Ellipse A/S, Horsholm, Denmark.

Safe Harbor

This press release includes “forward-looking statements” within the meaning of the Securities Litigation Reform Act of 1995. These statements include but are not limited to the Company’s plans, objectives, expectations and intentions and may contain words such as “will,” “may,” “seeks,” and “expects,” that suggest future events or trends. These statements, including the Company’s ability to sell products to MRN members,  generate the anticipated revenue stream, the Company’s ability to generate sufficient cash flow to fund the Company’s ongoing operations beginning at any time in the future, the Company’s ability to license or acquire new products, the public’s reaction to the Company’s new advertisements and marketing campaign, access to capital markets, and the Company’s ability to build a leading franchise in dermatology and aesthetics, are based on the Company’s current expectations and are inherently subject to significant uncertainties and changes in circumstances. Actual results may differ materially from the Company’s expectations due to financial, economic, business, competitive, market, regulatory and political factors or conditions affecting the Company and the medical device industry in general, as well as more specific risks and uncertainties set forth in the Company’s SEC reports on Forms 10-Q and 10-K. Given such uncertainties, any or all of these forward-looking statements may prove to be incorrect or unreliable. The Company assumes no duty to update its forward-looking statements and urges investors to carefully review its SEC disclosures available at www.sec.gov and www.strataskinsciences.com.

Investor Contacts:

Christina L. Allgeier, Chief Financial Officer   Bob Yedid, Managing Director
STRATA Skin Sciences, Inc.   LifeSci Advisors, LLC
215-619-3267   646-597-6989
callgeier@strataskin.com   Bob@LifeSciAdvisors.com
Tuesday, October 17th, 2017 Uncategorized Comments Off on $SSKN GPO Exclusive for Aesthetic Medical Market, Agreement MedResults Network

$SRAX to Pursue Strategic Alternatives for SRAXmd Healthcare Business

LOS ANGELES, Oct. 17, 2017 — Social Reality, Inc. (NASDAQ: SRAX) an advertising technology company providing the tools to automate digital marketers and content owners’ campaigns across digital channels, announced management has engaged financial advisors to explore strategic alternatives for the SRAXmd business to maximize shareholder value.  The range of alternatives that may be considered could include spinning off the business into its own public company, strategic acquisitions or a variety of other possible transactions.

SRAXmd works with healthcare and pharmaceutical companies and their agencies to engage healthcare professionals, patients and caregivers through digital and mobile advertising.  SRAXmd has a patent-pending platform that allows for an event-triggered response for targeting to HCP facilities, to capture the attention of providers before they decide on a treatment course for patients.

“The ability to positively impact patient outcomes through real-time mobile targeting to professionals is the future of Non-Personal Promotion,” said Social Reality Co-Founder and Chief Innovations Officer Erin DeRuggiero.  “We have delivered 100% year-over-year revenue growth for SRAXmd since the rollout of MD products in 2014.  Non-Personal Promotion continues to evolve at a more rapid rate than traditional methodologies.  As a company, we need to explore all corporate options available to us to help ensure we can capture what we expect will be a continuing surge in demand for our SRAXmd technologies, based largely upon the restrictions imposed upon pharma sales reps from calling on healthcare professionals at institutions and facilities.”

Chardan Capital Markets, LLC and Noble Financial Capital Markets are serving as financial advisors in connection with these matters.

The company does not intend to disclose additional details unless and until it selects a course of action, and specifically disclaims any obligation to provide further updates to the market, except as specifically required by any applicable securities law or regulation. The company cannot predict whether or when any initiatives involving SRAXmd will occur, and there can be no assurance that any will be consummated.

About SRAXmd

SRAXmd engages healthcare professionals and patients with banner and video ad targeting through eight core products:  DOCTRAX™, DOCTRAX MATCH™, DOME™, MOSEE, ROOMrx, SOCIALrx, CAUSErx and Coupon Intenders.  Working directly with pharmaceutical companies and their media buying and planning agencies, the business  is focused on deploying ads in real time with the use of triggering event data; de-identified and HIPAA-compliant distribution or claims data that allows for the right message to the right target at the right time.

About Social Reality

Social Reality, Inc. (NASDAQ: SRAX) is an advertising technology company providing the tools to automate digital marketers and content owners’ campaigns across digital channels. SRAX’s tools amplify performance and maximize profits for brands in the healthcare, CPG, automotive, wellness and lifestyle verticals through an omnichannel approach that integrates all aspects of the marketing experience into one platform. The company’s machine-learning technology identifies brands’ core consumers and their characteristics discovering new and measurable opportunities to target, reach and monetize audiences driving online and offline sales lift. For more information on how SRAX delivers a digital competitive advantage to surpass today’s marketing challenges, visit www.srax.com.

Safe Harbor Statement

This press release contains certain forward-looking statements that are based upon current expectations and involve certain risks and uncertainties within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Words or expressions such as “anticipate,” “plan,” “will,” “intend,” “believe” or “expect'” or variations of such words and similar expressions are intended to identify such forward-looking statements. These forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties, and other factors, some of which are beyond our control and difficult to predict and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements, including, without limitation, statements made with respect to expectations of our ability to increase our revenues, satisfy our obligations as they become due, report profitable operations and other risks and uncertainties, all as set forth in our Annual Report on Form 10-K for the year ended December 31, 2016, as filed with the Securities and Exchange Commission. All forward-looking statements involve significant risks and uncertainties that could cause actual results to differ materially from those in the forward-looking statements, many of which are generally outside the control of Social Reality and are difficult to predict. Social Reality undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise.

Contact Information:
Kirsten Chapman, LHA Investor Relations, +1 415 433 3777, srax@lhai.com

Tuesday, October 17th, 2017 Uncategorized Comments Off on $SRAX to Pursue Strategic Alternatives for SRAXmd Healthcare Business

$NEOT and Evofem Biosciences Merger Agreement to Create Women’s Health Company

SAN DIEGO, Oct. 17, 2017 — Neothetics, Inc. (NASDAQ:NEOT) and Evofem Biosciences, Inc. today announced they have entered into a definitive agreement under which privately-held Evofem Biosciences will merge with a wholly-owned subsidiary of Neothetics in an all-stock transaction. The merger will position the combined company with an opportunity to become a leading women’s health company that develops and commercializes novel products. Upon closing of the transaction, Neothetics will be renamed Evofem Biosciences, Inc., and will be under the leadership of Evofem Biosciences’ Chief Executive Officer, Saundra Pelletier.

An affiliate of an existing Evofem Biosciences’ investor, Invesco Asset Management Ltd., has entered into a securities purchase agreement to acquire an additional $20 million of common stock in the combined company immediately following the completion of the merger.

“Following an extensive and thorough review of strategic alternatives, we believe the proposed merger with Evofem Biosciences provides the best opportunity to maximize value for Neothetics’ shareholders,” said Martha Demski, a member of Neothetics Strategic Transaction Committee and Board of Directors.  “We believe the strength of the leadership team, coupled with the completion of its pregnancy prevention trial, will enable Amphora® to reach significant value inflection points in the near term.”

“This merger and concurrent financing provides continued funding for Evofem Biosciences’ ongoing Phase III study of Amphora® as a vaginal contraceptive – AMPOWER.  We expect to close the study database and file for FDA review in the second quarter of 2019,” said Saundra Pelletier, Chief Executive Officer of Evofem Biosciences.  “In addition, we have expanded our Amphora® clinical development platform with potential supplemental indications which would further strengthen its position as a cornerstone therapy in hormone-free birth control and as a preventative option for certain sexually transmitted infections.”

Amphora® is an on-demand non-hormonal, woman controlled, surfactant-free investigational new drug being developed as a vaginal contraceptive and for the prevention of certain sexually transmitted infections. Amphora® is also designated as a Qualified Infectious Disease Product (QIDP) by the U.S. Food & Drug Administration for two separate indications: the prevention of urogenital gonorrhea infection in women, and for the reduction of reoccurrence of bacterial vaginosis. These two QIDP designations could potentially offer a significant advancement in Evofem Biosciences’ efforts to make this drug available to women at risk of infection.

The AMPOWER trial is a single-arm, Phase III, open-label, multicenter, study in women aged 18-35 years of the contraceptive efficacy and safety of Amphora® contraceptive vaginal gel.  The trial is expected to enroll approximately 1,350 women at risk of pregnancy at over 100 centers in the United States. The primary endpoint is the contraceptive efficacy of Amphora® over seven cycles of use.

“Evofem Biosciences is positioned to become a leading provider of women’s healthcare solutions with a much needed and truly differentiated offering,” said Mr. Thomas Lynch, Evofem Biosciences’ Chairman. “This merger with Neothetics creates an even stronger platform for the advancement of Evofem initiatives which will continue to create value for shareholders.”

Details of the Proposed Transaction

The parties determined the exchange ratio in the merger agreement by assuming $171,400,000 in value of Neothetics common stock will be issued to the Evofem Biosciences stockholders in the merger with $28,600,000 in value of common stock being retained by the Neothetics stockholders, in each case immediately prior to the Invesco financing.  On a pro forma basis after giving effect to both the number of shares of Neothetics common stock issued in the merger and the number of shares of Neothetics common stock issued to Invesco in the Invesco financing, current Neothetics stockholders will own approximately 13% of the combined company and current Evofem Biosciences stockholders, including Invesco, will own approximately 87% of the combined company. The transactions have been approved by the board of directors of both companies. The merger is expected to close in January 2018, subject to the approval of the stockholders of each company as well as other customary conditions.

Neothetics financial advisor in the transaction is Oppenheimer & Co, Inc.  RBC Capital Markets is serving as financial advisor to Evofem Biosciences.  DLA Piper LLP (US) is serving as legal counsel to Neothetics and Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. is serving as legal counsel to Evofem Biosciences.

Management and Organization

Following the merger, the company will be led by Saundra Pelletier as Chief Executive Officer. The board of directors of the combined company is anticipated to be comprised of seven representatives, one of whom will be designated by Neothetics and the remaining six of whom will be designated by Evofem Biosciences, including, Ms. Pelletier and Mr. Lynch, Evofem Biosciences’ Chairman.

About Neothetics, Inc.

Neothetics is a San Diego based clinical-stage specialty pharmaceutical company that has been focused on developing therapeutics for the aesthetic market. For more information on Neothetics, please visit www.neothetics.com. Neothetics, LIPO-202, LIPO-102 and the Neothetics logo are trademarks or registered trademarks of Neothetics. For more information on Neothetics, please visit www.neothetics.com

About Evofem Biosciences, Inc.

Evofem Biosciences develops and anticipates commercializing innovative products that support and promote women as the primary healthcare consumer. Evofem Biosciences is currently identifying and developing new and novel products that specifically address unmet needs in the areas of sexual and reproductive health, the prevention of acquisition of sexually transmitted infections and products that address or promote general health and wellbeing. For more information on Evofem Biosciences, please visit www.evofem.com.

Additional Information about the Proposed Merger and Where to Find It

In connection with the proposed merger, Neothetics intends to file relevant materials with the Securities and Exchange Commission, or the SEC, including a registration statement on Form S‑4 that will contain a prospectus and a proxy statement/information statement.  Investors and security holders of Neothetics and Evofem Biosciences are urged to read these materials when they become available because they will contain important information about Neothetics, Evofem Biosciences and the proposed merger. The proxy statement/information statement, prospectus and other relevant materials (when they become available), and any other documents filed by Neothetics with the SEC, may be obtained free of charge at the SEC web site at www.sec.gov. In addition, investors and security holders may obtain free copies of the documents filed with the SEC by Neothetics by directing a written request to: Neothetics Inc., 9171 Towne Centre Drive, Ste. 250, San Diego, CA 92122, Attn: Investor Relations. Investors and security holders are urged to read the joint proxy statement, prospectus and the other relevant materials when they become available before making any voting or investment decision with respect to the proposed merger.

This communication shall not constitute an offer to sell or the solicitation of an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities in connection with the proposed merger shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended.

Participants in the Solicitation

Neothetics and its directors and executive officers and Evofem Biosciences and its directors and executive officers may be deemed to be participants in the solicitation of proxies from the stockholders of Neothetics and Evofem Biosciences in connection with the proposed transaction. Information regarding the special interests of these directors and executive officers in the proposed merger will be included in the proxy statement/information statement/prospectus referred to above. Additional information regarding the directors and executive officers of Neothetics is also included in Neothetics Annual Report on Form 10-K for the year ended December 31, 2016 and the proxy statement for Neothetics 2017 Annual Meeting of Stockholders. These documents are available free of charge at the SEC web site (www.sec.gov) and from Investor Relations at Neothetics at the address described above.

Cautionary Note Regarding Forward-Looking Statements

Certain statements in this communication regarding the proposed merger and other contemplated transactions (including statements relating to satisfaction of the conditions to and consummation of the proposed merger, the expected ownership of the combined company, the alternatives to the proposed merger, and the ability of the combined company to raise additional capital to complete its clinical programs) constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act and are usually identified by the use of words such as “anticipates,” “believes,” “estimates,” “expects,” “intends,” “may,” “plans,” “projects,” “seeks,” “should,” “will,” and variations of such words or similar expressions. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Securities Exchange Act and are making this statement for purposes of complying with those safe harbor provisions. These forward-looking statements reflect our current views about our plans, intentions, expectations, strategies and prospects, which are based on the information currently available to us and on assumptions we have made. Although we believe that our plans, intentions, expectations, strategies and prospects as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a variety of risks and factors that are beyond our control.

Risks and uncertainties for Neothetics and Evofem Biosciences and of the combined company include, but are not limited to: inability to complete the proposed merger and other contemplated transactions in connection with the merger; liquidity and trading market for shares prior to and following the consummation of the proposed merger and proposed financing; costs and potential litigation associated with the proposed merger; the inability to raise the additional capital necessary to complete current and anticipated clinical trials; failure or delay in obtaining required approvals by the SEC or any other governmental or quasi-governmental entity necessary to consummate the proposed merger, including our ability to file an effective proxy statement/information statement/prospectus in connection with the proposed merger and other contemplated transactions in connection with the merger, which may also result in unexpected additional transaction expenses and operating cash expenditures on the parties; an inability or delay in obtaining required regulatory approvals for product candidates, which may result in unexpected cost expenditures; risks inherent in drug development in general; uncertainties in obtaining successful clinical results for product candidates and unexpected costs that may result therefrom; failure to realize any value of certain product candidates developed and being developed in light of inherent risks and difficulties involved in successfully bringing product candidates to market; inability to develop new product candidates and support existing products; the approval by the FDA and EMA and any other similar foreign regulatory authorities of other competing or superior products brought to market; risks resulting from unforeseen side effects; risk that the market for the combined company’s products may not be as large as expected; inability to obtain, maintain and enforce patents and other intellectual property rights or the unexpected costs associated with such enforcement or litigation; inability to obtain and maintain commercial manufacturing arrangements with third party manufacturers or establish commercial scale manufacturing capabilities; loss of or diminished demand from one or more key customers or distributors; unexpected cost increases and pricing pressures; failure to obtain the necessary stockholder approvals or to satisfy other conditions to the closing of the proposed merger and the other contemplated transactions; a superior proposal being submitted to either party; uncertainties of cash flows and inability to meet working capital needs; and risks associated with the possible failure to realize certain benefits of the proposed merger, including future financial, tax, accounting treatment, and operating results. Many of these factors that will determine actual results are beyond Neothetics, Evofem Biosciences, or the combined company’s ability to control or predict.

Other risks and uncertainties are more fully described in periodic filings with the Securities and Exchange Commission (the “SEC”), including the  risk factor disclosure set forth in the reports and other documents the company files with the SEC available at www.sec.gov, including without limitation, Neothetics’ Form 10-K for the year ended December 31, 2016 and subsequent Quarterly Reports on Form 10-Q and in other filings that Neothetics makes and will make with the SEC in connection with the proposed transactions, including the proxy statement described above “Important Information and Where to Find It.” Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The statements made in this press release speak only as of the date stated herein, and subsequent events and developments may cause our expectations and beliefs to change. Unless otherwise required by applicable securities laws, we do not intend, nor do we undertake any obligation, to update or revise any forward-looking statements contained in this news release to reflect subsequent information, events, results or circumstances or otherwise. While we may elect to update these forward-looking statements publicly at some point in the future, we specifically disclaim any obligation to do so, whether as a result of new information, future events or otherwise, except as required by law.

Neothetics Contact:
Susan A. Knudson
Chief Financial Officer
(858) 500-7780
sknudson@neothetics.com or ir@neothetics.com

Evofem Biosciences’ Contact:
Ellen Thomas
VP, Global Governance and Communications
(718) 490-3248
ethomas@evofem.com

Tuesday, October 17th, 2017 Uncategorized Comments Off on $NEOT and Evofem Biosciences Merger Agreement to Create Women’s Health Company

$DEST Maternity Provides Operational Update

Continues to expect $10 – $11 million in annualized savings E-commerce sales increase over 50% in the first eleven-weeks of Q3 2017, accelerating from 30.2% rise in Q2

MOORESTOWN, N.J., Oct. 16, 2017 — Destination Maternity Corporation (NASDAQ: DEST), the world’s leading maternity apparel retailer, today provided an operational update following constructive engagements with Company stockholders over the last several weeks.

Allen Weinstein, Interim Chief Executive Officer, stated: “Since assuming the role of Interim CEO just over a month ago, I have been impressed by the depth of talented employees we have at every level of the Company. I firmly believe that the infrastructure improvements implemented at Destination over the past three years have established a solid foundation on which the Company can further enhance its position as the leader in maternity and nursing apparel, and I am working diligently with the rest of the management team to ensure that we are well-positioned for the permanent CEO to make an immediate impact from day one.

The investments we have made in our ecommerce platform this year have generated significant positive momentum, as evidenced by the channel’s 30.2% rise in comparable sales for the second quarter and an over 50% rise so far in the third quarter.  Building from this strength, we will continue to maximize the connectivity between our digital and brick and mortar channels, creating a seamless, category-focused retail experience with a high level of personal service for our customer.  The next steps in this evolution include opening up ship-from-store fulfillment from all Company stores by the beginning of next month, rolling out our pick-up-from store by the end of this calendar year, as well as additional short term initiatives including reserve online/pickup in store, and online appointments for in-store visits.”

Mr. Weinstein continued, “In addition to implementing operational initiatives, management has worked closely with the Board to transform Destination into a more nimble, more efficient and more effective Company by streamlining the organizational structure and business processes, and focusing resources to more directly benefit the customer. Apart from the operational benefits which should manifest themselves in better operating results, these changes are expected to deliver $10 to $11 million in run-rate savings beginning in fiscal year 2018, with one-time costs of approximately $3 million that will mostly be incurred in fiscal year 2017. As we look to the future, we will continue to evaluate effective means of streamlining processes, such as the ongoing evaluation of our real estate portfolio, as part of our broader efforts to meaningfully improve financial results and generate shareholder value.”

Barry Erdos, Non-Executive Chairman of the Board, commented, “The Board is encouraged by what Allen and the management team have accomplished in such a brief time. We continue to search for a permanent CEO, and are gratified to have Allen leading Destination during the interim period, giving us the time needed to conduct a thorough search.”

Mr. Erdos continued, “During this critical time, the Board is working closely with all of its key advisors, including Guggenheim Securities, to assist the Board in its exploration of alternatives designed to maximize returns and value for the Company’s stockholders. Separately, the Board is evaluating its composition and is prepared to add individuals who possess additional skills and experience which will help further Destination’s growth. We look forward to making progress in that regard after the upcoming shareholders meeting.”

Forward-Looking Statements

The Company cautions that any forward-looking statements (as such term is defined in the Private Securities Litigation Reform Act of 1995) contained in this press release or made from time to time by management of the Company, including those regarding run-rate savings, earnings, net sales, comparable sales, other results of operations, liquidity and financial condition, and various business initiatives, involve risks and uncertainties, and are subject to change based on various important factors. The following factors, among others, in some cases have affected and in the future could affect the Company’s financial performance and actual results and could cause actual results to differ materially from those expressed or implied in any such forward-looking statements: the strength or weakness of the retail industry in general and of apparel purchases in particular, our ability to successfully manage our various business initiatives, the success of our international business and its expansion, our ability to successfully manage and retain our leased department and international franchise relationships and marketing partnerships, future sales trends in our various sales channels, unusual weather patterns, changes in consumer spending patterns, raw material price increases, overall economic conditions and other factors affecting consumer confidence, demographics and other macroeconomic factors that may impact the level of spending for apparel (such as fluctuations in pregnancy rates and birth rates), expense savings initiatives, our ability to anticipate and respond to fashion trends and consumer preferences, unanticipated fluctuations in our operating results, the impact of competition and fluctuations in the price, availability and quality of raw materials and contracted products, availability of suitable store locations, continued availability of capital and financing, our ability to hire, develop and retain senior management and sales associates, our ability to develop and source merchandise, our ability to receive production from foreign sources on a timely basis, our compliance with applicable financial and other covenants under our financing arrangements, potential debt prepayments, the trading liquidity of our common stock, changes in market interest rates, our compliance with certain tax incentive and abatement programs, war or acts of terrorism and other factors set forth in the Company’s periodic filings with the U.S. Securities and Exchange Commission (the “SEC”), or in materials incorporated therein by reference.

Although it is believed that the expectations reflected in such forward-looking statements are reasonable, no assurance can be given that such expectations will prove to have been correct and persons reading this announcement are therefore cautioned not to place undue reliance on these forward-looking statements which speak only as at the date of this announcement. The Company assumes no obligation to update or revise the information contained in this announcement (whether as a result of new information, future events or otherwise), except as required by applicable law.

Important Additional Information
Destination Maternity, its directors and certain of its executive officers may be deemed to be participants in the solicitation of proxies from Destination Maternity stockholders in connection with the matters to be considered at Destination Maternity’s 2017 Annual Meeting to be held on October 19, 2017. Destination Maternity filed a definitive proxy statement on September 21, 2017 and supplements thereto on October 4, 2017 and October 10, 2017 (the “Proxy Statement”) with the SEC in connection with any such solicitation of proxies from Destination Maternity stockholders. INVESTORS AND STOCKHOLDERS ARE STRONGLY ENCOURAGED TO READ THE PROXY STATEMENT AND ACCOMPANYING WHITE PROXY CARD WITH RESPECT TO THE 2017 ANNUAL MEETING, AND OTHER DOCUMENTS FILED WITH THE SEC, CAREFULLY AND IN THEIR ENTIRETY AS THEY CONTAIN IMPORTANT INFORMATION. Detailed information regarding the identity of potential participants, and their direct or indirect interests, by security holdings or otherwise, is set forth in the Proxy Statement and other materials to be filed with the SEC in connection with Destination Maternity’s 2017 Annual Meeting. Stockholders may obtain the Proxy Statement, any amendments or supplements to the Proxy Statement and other documents filed by Destination Maternity with the SEC for no charge at the SEC’s website at www.sec.gov. Copies will also be available at no charge at the Investor Relations section of our corporate website at http://investor.destinationmaternity.com.

About Destination Maternity
Destination Maternity Corporation is the world’s largest designer and retailer of maternity apparel. As of April 29, 2017 Destination Maternity operates 1,157 retail locations in the United States, Canada and Puerto Rico, including 511 stores, predominantly under the trade names Motherhood Maternity®, A Pea in the Pod® and Destination Maternity®, and 646 leased department locations. The Company also sells merchandise on the web primarily through its brand-specific websites, motherhood.com and apeainthepod.com, as well as through its destinationmaternity.com website. Destination Maternity has international store franchise and product supply relationships in the Middle East, South Korea, Mexico, Israel and India. As of April 29, 2017 Destination Maternity has 219 international franchised locations, including 19 standalone stores operated under one of the Company’s nameplates and 200 shop-in-shop locations.

Monday, October 16th, 2017 Uncategorized Comments Off on $DEST Maternity Provides Operational Update

$ETRM Announces Presentations at ObesityWeek 2017

ST. PAUL, Minn., Oct. 16, 2017 — EnteroMedics Inc. (NASDAQ:ETRM), a developer of minimally invasive medical devices to treat obesity, metabolic diseases and other gastrointestinal disorders, today announced that the Company and its products will be the subjects of two oral presentations and one poster presentation at ObesityWeek 2017, taking place in Washington, D.C. from October 29, 2017 to November 2, 2017.

The presentations will feature:

  • vBloc® Real-World Patient Data
  • ReShape®  Integrated Dual Balloon System Patient Data
  • Gastric Vest™ System Initial Clinical Results

Details of the presentations are as follows:

Tuesday, October 31, 2017: 2:13PM ET: Poster Presentation

Presentation Title: A5292 Short-Term Results for Intermittent Vagal Nerve Blocking (vBloc) in the “Real-World”, Non-Research Environment
Presenter: Scott Shikora, M.D., F.A.C.S., F.A.S.M.B.S., Professor of Surgery at Harvard Medical School; Director of the Center for Metabolic and Bariatric Surgery at Brigham and Women’s Hospital

Thursday, November 2, 2017: Podium Presentations  

Location:                   Maryland A, Ballroom Level
Session:                      ASMBS PAPER SESSION V ENDOSCOPY & EMERGING TECHNOLOGY
2:14PM ET
Presentation Title: A149 Intragastric Balloon: 342 Patients Treated at a Multicenter Bariatric Practice
Presenters: Shawn Garber, M.D., FACS FASMBS, New York Bariatric Group
2:36PM ET
Presentation Title: A151 Gastric Vest System: Initial Results of a Novel Restrictive Bariatric Procedure
Presenters: Juan Antonio Lopez-Corvala, M.D., Professor of Surgery, Medical Faculty of the Autonomous University of Baja California; Leader in Bariatric Surgery Program, Hospital Ángeles Tijuana.

For more details on ObesityWeek 2017, please visit https://obesityweek.com.

About EnteroMedics Inc.
EnteroMedics is a medical device company focused on the development and commercialization of technology to treat obesity and metabolic diseases. vBloc® Neurometabolic Therapy, delivered by an FDA-approved pacemaker-like device called the vBloc System, is designed to help patients feel full and eat less by intermittently blocking hunger signals on the vagus nerve. The Company’s ReShape® Integrated Dual Balloon System involves a non-surgical weight loss procedure that uses advanced balloon technology designed to help people with a 30-40 Body Mass Index (BMI), and at least one co-morbidity, lose weight. The ReShape Procedure was approved by the U.S. Food and Drug Administration in July of 2015 and has been available in Europe since 2011. The Gastric Vest™ System (GVS) is an investigational, minimally invasive, laparoscopically implanted medical device being studied for weight loss in obese and morbidly obese patients. The device wraps around the stomach, emulating the effect of conventional weight-loss surgery, and is intended to enable gastric volume reduction without permanently changing patient anatomy.  EnteroMedics acquired the Gastric Vest System through its acquisition of BarioSurg, Inc. in May 2017 and the ReShape Dual Intragastric Balloon through its acquisition of ReShape Medical in October 2017.

Forward-Looking Safe Harbor Statement:

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements generally can be identified by the use of words such as expect,” “plan,” “anticipate,” “could,” “may,” “intend,” “will,” “continue,” “future,” other words of similar meaning and the use of future dates. These forward-looking statements are based on the current expectations of our management and involve known and unknown risks and uncertainties that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others: our limited history of operations; our losses since inception and for the foreseeable future; our limited commercial sales experience with our vBloc® System for the treatment of obesity in the United States or in any foreign market other than Australia and the European Community; the competitive industry in which we operate; our ability to maintain compliance with the Nasdaq continued listing requirements; our ability to commercialize our vBloc System; our dependence on third parties to initiate and perform our clinical trials; the need to obtain regulatory approval for any modifications to our vBloc System; physician adoption of our vBloc System and vBloc Neurometabolic Therapy; our ability to obtain third party coding, coverage or payment levels; ongoing regulatory compliance; our dependence on third party manufacturers and suppliers; the successful development of our sales and marketing capabilities; our ability to raise additional capital when needed; international commercialization and operation; our ability to attract and retain management and other personnel and to manage our growth effectively; potential product liability claims; the cost and management time of operating a public company; potential healthcare fraud and abuse claims; healthcare legislative reform; and our ability to obtain and maintain intellectual property protection for our technology and products. These and additional risks and uncertainties are described more fully in the Company’s filings with the Securities and Exchange Commission, particularly those factors identified as “risk factors” in Exhibit 99.3 of our current report on Form 8-K filed July 26, 2017. We are providing this information as of the date of this press release and do not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.

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$EXEL Phase 3 CELESTIAL Trial of Cabozantinib Meets Primary Endpoint in Carcinoma

PARIS

Regulatory News:

Ipsen (Euronext: IPN; ADR: IPSEY) and its partner Exelixis (NASDAQ: EXEL) today announced that its global phase 3 CELESTIAL trial met its primary endpoint of overall survival (OS), with cabozantinib providing a statistically significant and clinically meaningful improvement in median OS compared to placebo in patients with advanced hepatocellular carcinoma (HCC). The independent data monitoring committee for the study recommended that the trial should be stopped for efficacy following review of the second planned interim analysis. CELESTIAL is a randomized, global phase 3 trial of cabozantinib versus placebo in patients with advanced HCC who have been previously treated with sorafenib. The safety data in the study were consistent with the established profile of cabozantinib.

In line with and in collaboration with our partner Exelixis, Ipsen expects to file in the first half of 2018 a variation of the initial application to the EMA and other relevant regulatory agencies and to evaluate potential next steps in the development strategy for cabozantinib outside the United States and Japan as a treatment for advanced HCC in patients who have been previously treated. Detailed results from CELESTIAL will be submitted for presentation at a future medical conference.

Alexandre Lebeaut, MD, Executive Vice-President, R&D, Chief Scientific Officer, Ipsen, said: “Liver cancer is one of the leading causes of cancer deaths worldwide and more effective treatment options are urgently needed. We are pleased to report that in the CELESTIAL clinical study cabozantinib has been shown to provide a survival benefit and therefore has the potential to bring a new oral systemic treatment to previously treated patients with advanced liver cancer. ”

About the CELESTIAL Study

CELESTIAL is a randomized, double-blind, placebo-controlled study of cabozantinib in patients with advanced HCC conducted at more than 100 sites globally in 19 countries. The trial was designed to enroll 760 patients with advanced HCC who previously received sorafenib and may have received up to two prior systemic cancer therapies for HCC and had adequate liver function. Enrollment of the trial was completed in September 2017, and 773 patients were ultimately randomized. Patients were randomized 2:1 to receive 60 mg of cabozantinib once daily or placebo and were stratified based on etiology of the disease (hepatitis C, hepatitis B or other), geographic region (Asia versus other regions) and presence of extrahepatic spread and/or macrovascular invasion (yes or no). No cross-over was allowed between the study arms.

The primary endpoint for the trial is OS, and secondary endpoints include objective response rate and progression-free survival. Exploratory endpoints include patient-reported outcomes, biomarkers and safety.

Based on available clinical trial data from various published trials conducted in the second-line setting of advanced HCC, the CELESTIAL trial statistics for the primary endpoint of OS assumed a median OS of 8.2 months for the placebo arm. A total of 621 events provide the study with 90 percent power to detect a 32 percent increase in median OS (HR = 0.76) at the final analysis. Two interim analyses were planned and conducted at 50 percent and 75 percent of the planned 621 events.

About HCC
Hepatocellular Carcinoma (HCC) is the most common form of liver cancer in adults.1 The disease originates in cells called hepatocytes found in the liver. With approximately 800’000 new cases diagnosed each year, HCC is the sixth most common cancer and the second-leading cause of cancer deaths worldwide.2,3 According to the GLOBOCAN data, it is estimated that across the European Union (EU-28) nearly 60’000 new patients will be diagnosed with liver cancer in 2020.4 Without treatment, patients with the disease in advanced stage usually survive between 4 and 8 months.5

About CABOMETYX® (cabozantinib)
Cabometyx® is an oral small molecule inhibitor of receptors, including VEGFR, MET, AXL and RET. In preclinical models, cabozantinib has been shown to inhibit the activity of these receptors, which are involved in normal cellular function and pathologic processes such as tumor angiogenesis, invasiveness, metastasis and drug resistance.

In February of 2016, Exelixis and Ipsen jointly announced an exclusive licensing agreement for the commercialization and further development of cabozantinib indications outside of the United States, Canada and Japan. This agreement was amended in December of 2016 to include commercialization rights for Ipsen in Canada. On April 25, 2016, the FDA approved Cabometyx® tablets for the treatment of patients with advanced RCC who have received prior anti-angiogenic therapy and on September 9, 2016, the European Commission approved Cabometyx® tablets for the treatment of advanced RCC in adults who have received prior vascular endothelial growth factor (VEGF)-targeted therapy in the European Union, Norway and Iceland. Cabometyx® is available in 20 mg, 40 mg or 60 mg doses. The recommended dose is 60 mg orally, once daily.

Ipsen also submitted to European Medicines Agency (EMA) the regulatory dossier for cabozantinib as a treatment for first-line advanced RCC in the European Union on August 28, 2017; on September 8, 2017, Ipsen announced that the EMA validated the application.

Cabozantinib is not approved for the treatment of advanced hepatocellular carcinoma.

About Ipsen

Ipsen is a global specialty-driven biopharmaceutical group focused on innovation and specialty care. The group develops and commercializes innovative medicines in three key therapeutic areas – Oncology, Neurosciences and Rare Diseases. Its commitment to oncology is exemplified through its growing portfolio of key therapies for prostate cancer, neuroendocrine tumors, renal cell carcinoma and pancreatic cancer. Ipsen also has a well-established Consumer Healthcare business. With total sales close to €1.6 billion in 2016, Ipsen sells more than 20 drugs in over 115 countries, with a direct commercial presence in more than 30 countries. Ipsen’s R&D is focused on its innovative and differentiated technological platforms, and centers located in the heart of leading biotechnological and life sciences hubs (Paris-Saclay, France; Oxford, UK; Cambridge, US). The Group has about 5,100 employees worldwide. Ipsen is listed in Paris (Euronext: IPN) and in the United States through a Sponsored Level I American Depositary Receipt program (ADR: IPSEY). For more information on Ipsen, visit www.ipsen.com.

Forward Looking Statement

The forward-looking statements, objectives and targets contained herein are based on the Group’s management strategy, current views and assumptions. Such statements involve known and unknown risks and uncertainties that may cause actual results, performance or events to differ materially from those anticipated herein. All of the above risks could affect the Group’s future ability to achieve its financial targets, which were set assuming reasonable macroeconomic conditions based on the information available today. Use of the words “believes,” “anticipates” and “expects” and similar expressions are intended to identify forward-looking statements, including the Group’s expectations regarding future events, including regulatory filings and determinations. Moreover, the targets described in this document were prepared without taking into account external growth assumptions and potential future acquisitions, which may alter these parameters. These objectives are based on data and assumptions regarded as reasonable by the Group. These targets depend on conditions or facts likely to happen in the future, and not exclusively on historical data. Actual results may depart significantly from these targets given the occurrence of certain risks and uncertainties, notably the fact that a promising product in early development phase or clinical trial may end up never being launched on the market or reaching its commercial targets, notably for regulatory or competition reasons. The Group must face or might face competition from generic products that might translate into a loss of market share. Furthermore, the Research and Development process involves several stages each of which involves the substantial risk that the Group may fail to achieve its objectives and be forced to abandon its efforts with regards to a product in which it has invested significant sums. Therefore, the Group cannot be certain that favorable results obtained during pre-clinical trials will be confirmed subsequently during clinical trials, or that the results of clinical trials will be sufficient to demonstrate the safe and effective nature of the product concerned. There can be no guarantees a product will receive the necessary regulatory approvals or that the product will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Other risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the Group’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the Group’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. The Group also depends on third parties to develop and market some of its products which could potentially generate substantial royalties; these partners could behave in such ways which could cause damage to the Group’s activities and financial results. The Group cannot be certain that its partners will fulfil their obligations. It might be unable to obtain any benefit from those agreements. A default by any of the Group’s partners could generate lower revenues than expected. Such situations could have a negative impact on the Group’s business, financial position or performance. The Group expressly disclaims any obligation or undertaking to update or revise any forward looking statements, targets or estimates contained in this press release to reflect any change in events, conditions, assumptions or circumstances on which any such statements are based, unless so required by applicable law. The Group’s business is subject to the risk factors outlined in its registration documents filed with the French Autorité des Marchés Financiers.

The risks and uncertainties set out are not exhaustive and the reader is advised to refer to the Group’s 2016 Registration Document available on its website (www.ipsen.com).

References

1. McGlynn KA, London WT. The Global Epidemiology of Hepatocellular Carcinoma, Present and Future. Clinics in liver disease. 2011;15(2):223-x. doi:10.1016/j.cld.2011.03.006.
2. Ferlay J, Soerjomataram I, Dikshit R, et al: Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012. Int J Cancer 136:E359-86, 2015
3. GLOBOCAN International Agency for Research on Cancer (IARC). Available at: http://gco.iarc.fr/today/fact-sheets-cancers?cancer=7&type=0&sex=0
4. GLOBOCAN International Agency for Research on Cancer (IARC). Available at: http://globocan.iarc.fr/Pages/burden_sel.aspx
5. Annals of Oncology 23 (Supplement 7): vii41–vii48, 2012

 

Ipsen
Media
Ian Weatherhead, Tél.: +44 (0) 7584230549
Vice-President, Corporate External communications
E-mail: ian.weatherhead@ipsen.com
or
Brigitte Le Guennec, Tel.: +33 (0)1 58 33 51 17
Corporate External Communication Manager
E-mail : brigitte.le.guennec@ipsen.com
or
Financial Community
Eugenia Litz, Tel.: +44 (0) 1753 627721
Vice-President Investor Relations
E-mail: eugenia.litz@ipsen.com
or
Côme de La Tour du Pin, Tel.: +33 (0)1 58 33 53 31
Investor Relations Manager
E-mail: come.de.la.tour.du.pin@ipsen.com

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$RCON and BOW Signed Sewage Treatment Strategic Cooperation Agreement

BEIJING, Oct. 16, 2017  — Recon Technology, Ltd. (NASDAQ: RCON), (“Recon” or the “Company”), a China-based independent solutions integrator in the oilfield service, electric power and coal chemical industries, today announced that it has signed a three-year strategic cooperation agreement (“Agreement”) with Beijing OriginWater Purification Engineering Technology Co., Ltd (“BOW Engineering”), a subsidiary of Beijing OriginWater Technology Co. Ltd. (Shenzhen Stock Exchange: 300070) (“BOW”). Pursuant to the Agreement, Recon Technology and BOW Engineering will cooperate to promote advanced sewage treatment technology in Chinese oilfield markets and to provide integrative solutions and services of superior quality and effectiveness to tackle industrial water pollution.

Recon Technology united with BOW Engineering to render effective waste water treatment solution for a PetroChina petroleum refinery earlier this year(The full text of the press release can be read here: http://recon.mediaroom.com/2017-05-30-Recon-Completes-an-Agreement-to-Provide-Wastewater-Treatment-Equipment-and-Solution-for-a-PetroChina-Petroleum-Refinery?pagetemplate=widgetpopup, and achieved superb results. Based on this prior success, both parties decided that a more comprehensive strategic relationship would be beneficial to their business development in this area.

Management Commentary

“We are excited about BOW Engineering’s unique membrane technologies and rich experiences in sewage treatment industry,” said Mr. Shenping Yin, CEO of Recon Technology. “Chinese government as well as large oil companies are dedicated to protecting the environmental during oil production and seeking more efficient techniques and equipment to realize cost-saving and meet increasingly stringent environmental protection requirement. Recon Technology has provided reliable and efficient technologies to China’s major oilfield companies, such as CNPC and Sinopec, for years. Recon Technology has made some strides in oily sewage treatment for last two years. With its abundant market experience, deep insights and visions in oilfield markets, and support of BOW’s team of specialists, we believe Recon will maintain research and technological advantages and deliver better performance.”

About Beijing OriginWater Technology Co., Ltd. (Shenzhen Stock Exchange: 300070) and Beijing OriginWater Purification Engineering Technology Co., Ltd

Founded in 2001 and listed in Shenzhen market in 2010, Beijing OriginWater Technology Co. Ltd. is a one stop solution provider that has dedicated itself to resolving China’s three main water issues: water pollution, water shortage and drinking water insecurity. BOW is one of the world biggest membrane tech R&D, manufacturing and application enterprises and is also the alpha dog of environmental protection enterprises on Growth Enterprises Exchange Market.

Beijing OriginWater Purification Engineering Technology Co., Ltd is an affiliation of Beijing OriginWater Technology Co. Ltd and focusing on render of complete resolutions of drinking water treatment to areas with fresh water supply threaten.

About Recon Technology, Ltd. (NASDAQ: RCON)

Recon Technology, Ltd. is China’s first listed non-state owned oil and gas field service company on NASDAQ. Recon supplies China’s largest oil exploration companies, Sinopec (NYSE: SNP) and CNPC, with advanced automated technologies, efficient gathering and transportation equipment and reservoir stimulation measure for increasing petroleum extraction levels, reducing impurities and lowering production costs. Through the years, RCON has taken leading positions on several segmented markets of the oil and gas filed service industry. RCON also has developed stable long-term cooperation relationship with its major clients, and its products and service are also well accepted by clients. For additional information please visit: www.recon.cn .

Company Contact

Liu Jia, CFO
Recon Technology, Ltd.
+86 (10) 8494-5799
info@recon.cn

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$CIIX a First Mover in CBD Skin Care

October 12, 2017

  • China is the second-largest global cosmetics consumer, representing $30 billion annually
  • Savvy industry veteran recruited for vast untapped CBD skin care market
  • 100% of cannabis skin care product market in China up for grabs

It comes as little surprise that cannabidiol (CBD) likely possesses skin healing properties. Found in the marijuana plant, CBD is one of over 80 natural compounds in marijuana that have been used for centuries as natural medicines and therapeutics. Cannabis is a known anti-inflammatory, containing antioxidants and anti-aging elements, while hemp seed oil contains both omega-3 and omega-6 fatty acids.

In spite of vast anecdotal evidence, science has not yet definitively settled on the positive effects of CBD skin care. However, the recent article “The Role of Cannabinoids in Dermatology,” published in the prestigious Journal of American Academy of Dermatology, suggests efficacy in CBD use for the treatment of several dermatologic conditions, including pruritus, inflammatory skin disease and skin cancer (http://nnw.fm/mXI9m). It’s likely that even more beneficial effects will be found.

Further scientific validation will be icing on the cake for ChineseInvestors.com, Inc. (OTCQB: CIIX). With the introduction of its line of cannabidiol-based skin care products, CIIX is primed and fast moving into the multi-billion dollar Chinese skin care industry. The company has already filed a record of its first line of hemp-infused skin care products with the China Food and Drug Administration and expects to launch it in the next couple months. As the company stated in a recent press release, “Although ancient Chinese recognized the medicinal properties of the cannabis plant, CBD extract appears to be largely unrecognized in China today for its benefits, including but not limited to, its potential benefits to the largest visible human organ, the skin.”

China is the second-largest consumer of skin care products in the world and generates nearly $30 billion in annual retail sales. Since no other notable manufacturers have entered the cannabis skin care product market in China, CIIX would be first to market and anticipates capturing “100% of China’s market share in this novel skin care products category.” The market potential is immense.

To facilitate and expedite market dominance, CIIX recently appointed skin care industry veteran and Shanghai beauty influencer Fannie (Chun Fang) Tang as marketing director of its wholly-owned CBD Biotechnology Co., Ltd. enterprise. Well known in China, Tang will be responsible for developing and implementing branding strategies for the company’s CBD Magic Hemp Series skin care line (http://nnw.fm/TMy1e).

Tang has proven success in the industry, bringing more than two decades of industry experience and previously serving as the CEO of L.D. Waxson, a leading skin care company with a footprint throughout China and much of Southeast Asia. Moving from CEO to director of marketing is a strong testament to the opportunity. There’s little doubt that with Tang’s experience, guidance and industry connections, CBD Biotechnology will position itself to become a leader in China’s skin care industry.

For more information, visit the company’s website at www.ChineseInvestors.com

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$MARK 3D Augmented Reality Chosen for Sina Weibo’s New Mobile App

LAS VEGAS, Oct. 13, 2017 — Remark Holdings, Inc. (NASDAQ: MARK), a global digital media technology company, announced that Sina Weibo, one of the world’s largest social media companies, is launching its first augmented-reality-enabled mobile application, named SuiShouPai (which means “take a picture anywhere, anytime”).  Remark Holdings’ KanKan subsidiary implemented SuiShouPai’s core augmented-reality feature using KanKan’s 3D facial-feature-tracking technology.

By choosing KanKan’s AI technology, Sina Weibo is using one of the world’s most advanced 3D facial-feature-tracking technologies, which makes the best mobile 3D augmented reality possible.  KanKan’s software, which was developed over the last several years using millions of globally-sourced facial feature samples, can precisely recognize and track the movements of hundreds of different facial features. The additional samples made available through SuiShouPai will enable KanKan’s facial-recognition technologies to better understand various facial expressions by improving the underlying AI’s ability to learn human emotions based on changes in facial features.

“We not only created a facial tracking system that we believe is far superior to existing technologies, but we also created 3D filters that can be used socially among friends or used to identify business opportunities in various industries, such as in the cosmetics field,” said Kai-Shing Tao, Remark Holdings’ Chairman and CEO.

“Our contract with Sina Weibo continues to demonstrate that we are able to monetize our artificial-intelligence technology, including facial and object recognition,” said Tao.  An example of how the technology functions can be found here.

Remark Holdings uses “deep learning”, a type of algorithm-based machine learning that is used to model high-level abstractions in data, to train its artificial intelligence products.  Utilizing KanKan’s extensive data sets to train its KanKan Artificial Intelligence Platform with tens of millions of supervised and unsupervised samples allows Remark Holdings to develop models that extract facial features and recognize objects, such as branded logos, animals or license plates, with a high degree of precision.

The KanKan Artificial Intelligence Platform is designed as a one-stop shop that will provide small to large enterprises and developers with the ability to customize and train their own artificial-intelligence models for their businesses, with stable and ready-to-use artificial-intelligence modeling stacks and pre-trained models.

 

About Remark Holdings, Inc.
Remark Holdings, Inc. (NASDAQ: MARK) primarily focuses on the development and deployment of artificial-intelligence-based solutions for businesses and software developers in many industries.  Additionally, the company owns and operates digital media properties that deliver relevant, dynamic content. The company is headquartered in Las Vegas, Nevada, with additional operations in Los Angeles, California and in Beijing, Shanghai, Chengdu and Hangzhou, China. For more information, please visit the company’s website at www.remarkholdings.com.

Investor Relations Contact:
Douglas Osrow
Remark Holdings, Inc.
dosrow@remarkholdings.com
702-701-9514 ext. 3025

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