(CERE) Licenses Bioinformatics Technology to KWS

– Crop development group to evaluate Persephone for its global product segments

THOUSAND OAKS, Calif., Sept. 29, 2015  — Ceres, Inc. (NASDAQ: CERE), an agricultural biotechnology company, today announced that KWS SAAT SE, a global seed developer with operations in over 70 counties, will evaluate Ceres’ Persephone bioinformatics technology under a license agreement.

Originally developed for in-house use by Ceres, the Persephone system allows researchers to organize, store, access and explore a diverse array of DNA-related information in much the same way online mapping programs allow users to explore geographic regions and locations.

“We look forward to working with researchers at KWS to demonstrate how Persephone can help deliver complex genomic information directly to its diverse product development groups,” said Tim Swaller, Ceres Vice President of Genomic Technologies.

Swaller noted that next generation sequencing technologies have substantially increased the amount and complexity of information generated in crop research and development. Despite the power of this information, it is often difficult to access and fully utilize throughout a research organization. “Persephone’s capabilities and user experience is designed to allow more eyes on information that is often inaccessible today,” said Swaller.

KWS, which develops, produces and markets seed for corn, sugarbeet, cereals, potatoes, canola and sunflower, has more than 1,000 employees involved in research, including large-scale genomic research programs across its major products lines.

Dr. Andreas Menze, Head of Bioinformatics at KWS, noted that the company’s high-throughput bioinformatics platform generates continuously increasing volumes of data which must be made available for its research teams. “We plan to evaluate how Persephone can help disseminate data for the widest audience within KWS for discussion and discovery. We believe that broad accessibility to data will be a key driver of long-term novel discovery,” said Dr. Menze.

In addition to crop research, Ceres markets Persephone to companies and institutions in the human and biomedical fields, where DNA-related information is analyzed and used in a similar manner to plants. The Persephone platform can be installed either within a customer’s own IT infrastructure or in the cloud using Amazon Web Services. Ceres also offers a demo software version utilizing Amazon’s infrastructure.

About Persephone
Persephone is a genome visualization platform marketed by Ceres, Inc. The technology platform allows researchers to store, access and explore DNA databases in much the same way online mapping programs allow users to explore geographic regions and places. Driven by dramatically lower costs, DNA sequencing is one of the most commonly used technologies in biological and medical research laboratories. Persephone has been designed to more fully utilize what has become an overload of data by enabling the rapid and easy visualization of large amounts of genomics data by experts and non-experts alike. The software features a number of optimizations to quickly fetch and render very large datasets. Persephone can display diverse datasets such as genetic maps, genomic sequences, gene models, synteny, QTLs, SNPs, RNA-Seq, and gene expression, among others. Persephone is a trademark of Ceres, Inc.

About Ceres
Ceres, Inc. is an agricultural biotechnology company that develops and markets seeds and traits to produce crops for animal feed, sugar and other markets. The company’s advanced plant breeding and biotechnology technology platforms, which can increase crop productivity, improve quality, reduce crop inputs and improve cultivation on marginal land, have broad application across multiple crops, including food, feed, fiber and fuel crops. Ceres markets its seed products under its Blade brand.

Ceres Forward-Looking Statements
This press release may contain forward-looking statements. All statements, other than statements of historical facts, including statements regarding Ceres’ efforts to develop and commercialize its products and technologies, anticipated yields and product performance, status of crop plantings, short-term and long-term business strategies, market and industry expectations, future operating metrics, and future results of operations and financial position, including anticipated cost savings from the company’s restructuring plan and projected cash expenditures, are forward-looking statements. You should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties and other factors that are, in some cases, beyond Ceres’ control. Factors that could materially affect actual results can be found in Ceres’ filings with the U.S. Securities and Exchange Commission. Ceres undertakes no obligation to update publicly, except to the extent required by law, any forward-looking statements for any reason after the date the company issues this press release to conform these statements to actual results or to changes in the company’s expectations.

(OPXA) Announces Reverse Stock Split

Opexa Therapeutics, Inc. (NASDAQ: OPXA), a biopharmaceutical company developing personalized immunotherapies for autoimmune disorders including multiple sclerosis (MS) and neuromyelitis optica (NMO), today announced that its Board of Directors approved a 1-for-8 reverse stock split of its common stock which will become effective immediately following the close of trading September 28, 2015. The consolidated common shares will begin trading on a split-adjusted basis on September 29, 2015 on the NASDAQ Capital Market.

The Company’s shareholders approved the reverse stock split at its annual meeting of shareholders on August 28, 2015, as determined by the Board of Directors in its discretion, at a ratio of not less than 1-for-4 and not more than 1-for-8. The reverse stock split is being implemented by Opexa to maintain the listing of its common stock on the NASDAQ Capital Market. Opexa received a deficiency notice from NASDAQ in December 2014 and, following a 180-day cure period, received an additional 180 days from NASDAQ in June 2015 to regain compliance with the minimum bid price requirement. To regain compliance, the closing bid price of the Company’s common stock must be at least $1.00 per share for a minimum of ten consecutive business days (or such longer period of time as the NASDAQ staff may require) before November 30, 2015. There can be no assurance that the reverse stock split will have the desired effect of raising the closing bid price of Opexa’s common stock prior to such date to meet this requirement.

The reverse split reduced the number of shares of Opexa’s outstanding common stock from approximately 54.3 million shares to approximately 6.8 million shares. Fractional shares created as a result of the stock split will be settled in cash. Informational letters will be sent to all shareholders of record by Opexa’s transfer agent, Continental Stock Transfer & Trust Company. Additional information about the reverse stock split can be found in the Company’s Form 8-K filed with the Securities and Exchange Commission.

About Opexa

Opexa is a biopharmaceutical company developing a personalized immunotherapy with the potential to treat major illnesses, including multiple sclerosis (MS) as well as other autoimmune diseases such as neuromyelitis optica (NMO). These therapies are based on Opexa’s proprietary T-cell technology. The Company’s leading therapy candidate, Tcelna®, is a personalized T-cell immunotherapy that is in a Phase IIb clinical development program (the Abili-T trial) for the treatment of secondary progressive MS. Tcelna consists of myelin-reactive T-cells, which are expanded ex vivo from the patient’s peripheral blood and reintroduced into the patient in an attenuated form via subcutaneous injections. This process triggers a potent immune response against specific subsets of autoreactive T-cells known to attack myelin for each individual patient.

For more information, visit the Opexa Therapeutics website at www.opexatherapeutics.com or follow company news on Twitter via @OpexaCEO.

Cautionary Statement Relating to Forward-Looking Information for the Purpose of “Safe Harbor” Provisions of the Private Securities Litigation Reform Act of 1995

Statements contained in this release, other than statements of historical fact, constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. The words “expects,” “believes,” “may,” “intends,” “potential” and similar expressions are intended to identify forward-looking statements. These forward-looking statements do not constitute guarantees of future performance. Investors are cautioned that forward-looking statements, including without limitation statements regarding the effect of the reverse stock split on the trading price of our common stock, the safety, efficacy and projected development timeline of drug candidates such as Tcelna® and OPX-212, constitute forward-looking statements. These forward-looking statements are based upon our current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include without limitation our ability to raise additional capital to continue our development programs, our ability to successfully develop potential products such as Tcelna and OPX-212, our ability to obtain, maintain and protect intellectual property rights (including for Tcelna and OPX-212), our ability to regain and maintain compliance with NASDAQ listing standards, as well as other risks associated with the process of discovering, developing and commercializing drug candidates that are safe and effective for use as human therapeutics. These and other risks are described in detail in our SEC filings, including our Annual Report on Form 10-K for the year ended December 31, 2014 and our Quarterly Report on Form 10-Q for the quarter ended June 30, 2015. All forward-looking statements contained in this release speak only as of the date on which they were first made by us, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after such date.

Opexa Therapeutics, Inc.
Karthik Radhakrishnan, 281-775-0600
Chief Financial Officer

(BLDP) Inks $6M Deal in China For First Global Deployment of Fuel Cell-Powered Trams

VANCOUVER, Canada and QINGDAO & FOSHAN, China, Sept. 28, 2015  – At a ceremony held at the Company’s global headquarters, Ballard Power Systems (NASDAQ: BLDP; TSX: BLD) signed a joint development agreement and a supply agreement to develop and commercialize a fuel cell engine specifically designed for integration into low floor trams manufactured by CRRC Qingdao Sifang Company, Ltd. (CRRC Sifang), a Chinese rolling stock manufacturer. The agreements include 2016 delivery of ten (10) customized FCvelocity^® modules and the agreements have an initial value expected to be approximately $6 million.

Ballard plans to develop a new prototype configuration of its FCvelocity^® fuel cell module to deliver 200 kilowatts (kW) of net power for use in powering trams in urban deployments. An initial deployment of eight (8) fuel cell-powered trams is planned by CRRC Sifang and the City of Foshan on the Gaoming Line starting in 2017.

“We are pleased with the strong relationship we are developing with CRRC Sifang, a company with a rich history of innovation in Chinese rail transit, to pursue the China market opportunity for fuel cell powered trams,” said Randy MacEwen, Ballard’s President and CEO.

CRRC Sifang, based in Qingdao, Shandong province was established more than 100-years ago, in 1900. CRRC Sifang has a yearly production capacity of 200 high-speed electric multiple units (EMUs), 1,000 mass transit vehicles and 300 high-grade passenger cars. In March 2015, a Ballard fuel cell module powered the world’s first hydrogen fuel cell powered fixed rail electric tram that was successfully demonstrated at a ceremonial event held at CRRC Sifang’s head office, production and testing facility.

Mr. Luo Bin, Deputy President of CRRC Qingdao Sifang Company stated, “Clean urban transportation is a high priority in China. Our collaboration with Ballard to develop a purpose-built engine for our low floor tram, and the initial planned deployments in Foshan, position us well for this attractive opportunity. Ballard is our chosen partner for fuel cell technology because they have leading fuel cell expertise, experience, capabilities and a focus on safety, reliability and quality.”

Mr. Xu Guo, Vice Mayor of the City of Foshan/Yunfu added, “Our planned move toward clean mass transit technology is being accelerated with this announcement of fuel cell-powered trams as well as our announcement of 300 fuel cell powered buses in Foshan/Yunfu. We have confidence that the consortium partners, including Ballard and CRRC Sifang, will effectively deliver ground-breaking solutions for the benefit of our Chinese citizens.”

Alfred Wong, Ballard’s Director – Sales for Asia Pacific said, “Our ground-breaking announcement a few days ago regarding a deal to support deployment of 300 fuel cell buses in the Cities of Foshan and Yunfu, together with today’s announcement of an initial order supporting deployment of 8 fuel cell trams in the City of Foshan provide concrete evidence that Ballard’s customer-centric China strategy is moving toward an unparalleled level of industry success.”

Further discussion of Ballard’s activities and plans in the heavy-duty mass transit market will take place during the Company’s Investor and Analyst Day, scheduled to be held on October 1, 2015 in New York City. Institutional investors wishing to attend are asked to register as soon as possible, as space is limited, by emailing Ballard at analystday@ballard.com. Ballard’s Investor and Analyst Day will also be webcast, with the live audio stream and presentation materials accessible through a link on Ballard’s homepage at www.ballard.com. Following the event, the webcast and presentation materials will be archived in the Investors section of Ballard’s website at www.ballard.com/investors.

About Ballard Power Systems

Ballard Power Systems (NASDAQ: BLDP; TSX: BLD) provides clean energy products that reduce customer costs and risks, and helps customers solve difficult technical and business challenges in their fuel cell programs. To learn more about Ballard, please visit www.ballard.com.

This release contains forward-looking statements concerning planned product development efforts, product deployments and anticipated market demand for our products. These forward-looking statements reflect Ballard’s current expectations as contemplated under section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Any such forward-looking statements are based on Ballard’s assumptions relating to its financial forecasts and expectations regarding its product development efforts, manufacturing capacity, and market demand.

These statements involve risks and uncertainties that may cause Ballard’s actual results to be materially different, including risks related to our ability to develop and commercialize our products, risk of market acceptance of our products, general economic and regulatory changes, detrimental reliance on third parties, successfully achieving our business plans and achieving and sustaining profitability. For a detailed discussion of these and other risk factors that could affect Ballard’s future performance, please refer to Ballard’s most recent Annual Information Form. Readers should not place undue reliance on Ballard’s forward-looking statements and Ballard assumes no obligation to update or release any revisions to these forward looking statements, other than as required under applicable legislation.

This press release does not constitute an offer to sell or the solicitation of an offer to buy securities.  The Ballard Common Shares have not been registered under the United States Securities Act of 1933, as amended, or the securities laws of any other jurisdiction and may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements.

(STXS) Extends Warrants Offering Subscription Period

Company CEO and CFO Fully Exercise Subscription Warrants

ST. LOUIS, Sept. 28, 2015  — Stereotaxis, Inc. (NASDAQ:STXS), a global leader in innovative technologies for the treatment of cardiac arrhythmias, today announced it is extending its registered offering of subscription warrants to the holders of common shares, as described in its prospectus supplement filed with the Securities and Exchange Commission (SEC) on September 4, 2015 (the “Prospectus”). The warrants offering was originally scheduled to expire on Wednesday, September 30, 2015 and the Company is extending the warrants offering by two days in order to better ensure that its stockholders who hold shares in brokerage accounts receive the offering materials and have time to act on them. The subscription warrants will now be exercisable until 5:00 p.m. New York City time on Friday, October 2, 2015.

As previously announced, the Company is conducting a registered offering of subscription warrants to the holders of its common shares, which functions similarly to a rights offering. The Company declared the record date for determination of stockholders eligible to participate as September 9, 2015 at 5:00 p.m. New York City time, at which time, each holder was issued, at no charge, one subscription warrant for every four common shares held, entitling the holder to purchase one share of common stock at a price of $1.10 per share. As previously reported on Form 4 filings made with the SEC on September 24, 2015, Stereotaxis CEO William Mills and CFO Martin Stammer have fully exercised their allotted subscription warrants to purchase Stereotaxis common shares.

The warrants commenced being listed on the NASDAQ Capital Market under the symbol “STXSW” on September 14, 2015 and will continue through the new expiration date of October 2, 2015. In addition to being able to purchase their pro rata portion of the shares offered, based on their ownership as of the record date of the warrants offering, Stereotaxis stockholders who exercise all of their warrants may subscribe to purchase additional common shares pursuant to an over-subscription privilege, subject to certain limitations and subject to allotment, as described in the Prospectus. No fractional subscription warrants will be distributed and no fractional shares will be issued, pursuant to the warrants offering. Any fractional warrants issuable, pursuant to the warrants offering, resulting from the number of shares owned as of the record date or fractional shares issuable, pursuant to the over-subscription, resulting from prorations or other limitations, will be eliminated by rounding down to the nearest whole warrant or whole share.

This press release does not constitute an offer to sell or the solicitation of an offer to buy the securities described herein, nor shall there be any offer, solicitation, or sale of the securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful, prior to the registration or qualification of the securities under the securities law of such state or jurisdiction. A shelf registration statement on Form S-3, pursuant to which the warrants are being issued, was filed with the SEC on November 27, 2013 and declared effective on December 11, 2013. The warrants offering is being made only by means of the Prospectus together with a base prospectus filed with the registration statement. Copies of the Prospectus and base prospectus, which contain further details regarding the warrants offering, will be provided to all stockholders, as of the record date.

Holders of Stereotaxis’ shares who hold their shares in “street name” at a brokerage firm, bank or similar organization, like the vast majority of Stereotaxis stockholders, may direct any questions about the warrants offering to the broker or bank at the number identified in the offering materials mailed to the holders. Stockholders who hold their shares directly may contact the warrants agent, Broadridge Corporate Issuer Solutions, Inc. at (855) 300-4994.

About Stereotaxis

Stereotaxis is a healthcare technology and innovation leader in the development of robotic cardiology instrument navigation systems designed to enhance the treatment of arrhythmias and coronary disease, as well as information management solutions for the interventional lab. Over 100 issued patents support the Stereotaxis platform, which helps physicians around the world provide unsurpassed patient care with robotic precision and safety, improved lab efficiency and productivity, and enhanced integration of procedural information. Stereotaxis’ core Epoch® Solution includes the Niobe® ES remote magnetic navigation system, the Odyssey® portfolio of lab optimization, networking and patient information management systems, and the Vdrive™ robotic navigation system and consumables.

The core components of Stereotaxis’ systems have received regulatory clearance in the United States, European Union, Canada, China, Japan, and elsewhere. The V-Sono™ ICE catheter manipulator, V-Loop™ variable loop catheter manipulator, and V-CAS™ catheter advancement system have received clearance in the United States, Canada, and the European Union. For more information, please visit www.stereotaxis.com.

This press release includes statements that may constitute “forward-looking” statements, usually containing the words “believe”, “estimate”, “project”, “expect”, or similar expressions. Forward-looking statements inherently involve risks and uncertainties that could cause actual results to differ materially from the forward-looking statements. Factors that would cause or contribute to such differences include, but are not limited to, the Company’s ability to raise additional capital on a timely basis and on terms that are acceptable, its ability to continue to manage expenses and cash burn rate at sustainable levels, its ability to continue to work with lenders to extend, repay or refinance indebtedness on acceptable terms, continued acceptance of the Company’s products in the marketplace, the effect of global economic conditions on the ability and willingness of customers to purchase its systems and the timing of such purchases, competitive factors, changes resulting from the recently enacted healthcare reform in the United States, including changes in government reimbursement procedures, dependence upon third-party vendors, timing of regulatory approvals, and other risks discussed in the Company’s periodic and other filings with the Securities and Exchange Commission. By making these forward-looking statements, the Company undertakes no obligation to update these statements for revisions or changes after the date of this release. There can be no assurance that the Company will recognize revenue related to its purchase orders and other commitments in any particular period, or at all, because some of these purchase orders and other commitments are subject to contingencies that are outside of the Company’s control. In addition, these orders and commitments may be revised, modified, delayed or canceled, either by their express terms, as a result of negotiations, or by overall project changes or delays.

CONTACT: STXS Company Contact:
         Martin Stammer
         Chief Financial Officer
         314-678-6155

         STXS Investor Contact:
         Todd Kehrli / Jim Byers
         MKR Group, Inc.
         323-468-2300
         stxs@mkr-group.com

(FLL) Resorts to Acquire Bronco Billy’s Casino and Hotel in Cripple Creek, Colorado

Full House Resorts (NASDAQ: FLL) has entered into a definitive agreement with privately-owned Pioneer Group, Inc. to acquire the operating assets of Bronco Billy’s Casino and Hotel in Cripple Creek, Colorado for approximately $30.0 million. The transaction is expected to be accretive to Full House.

Believed to be one of the two market leaders in Cripple Creek, Bronco Billy’s is located on the north side of Bennett Avenue, along the key city block that accounts for the bulk of the town’s gaming activity. The casino comprises a majority of that block and has certain ownership rights to portions of the rest of the block. Bronco Billy’s also controls significant land and structures that adjoin this key city block.

Bronco Billy’s has approximately 830 slot and video poker machines, 13 table games, a 24-room hotel, a steakhouse, four casual dining outlets, and an outdoor amphitheater. The casino was expanded in May 2015, adding approximately 15% more slot machines, 14 guest rooms (to the ten that the property previously operated), and 2.3 acres of additional surface parking. The expansion extended the Bronco Billy’s footprint to an important street corner, whereas previously it was confined to the center of that key block of Cripple Creek’s prime “casino strip.”

Gaming in Colorado is limited to three historic mining towns: Black Hawk and Central City, which adjoin each other, and Cripple Creek. The first two towns are located about an hour west of Denver. Cripple Creek is located approximately one hour from Colorado Springs, Colorado’s second largest city. The Colorado Springs metropolitan statistical area (MSA) has a population of approximately 668,000 and has shown steady growth in recent years. Between 2000 and 2012, the MSA’s population grew approximately 22%. It is estimated that the population has continued to grow since 2012 at approximately 3.5% per year.

Cripple Creek has offered gaming for more than 20 years. It is near the center of the state and will not easily be affected by expanded gaming in neighboring states. Additionally, there are no federally- or state-recognized Native American tribes nearby which could potentially offer gaming. Efforts over the years to legalize additional casinos in Colorado outside of these historical mining towns, including one in 2014, have been soundly defeated by voters. Through August 2015, the Cripple Creek market has grown approximately 2.7% compared to the first eight months of 2014.

“We look forward to adding Bronco Billy’s Casino and Hotel to the Full House portfolio,” said Daniel R. Lee, President and Chief Executive Officer of Full House Resorts. “In addition to diversifying our geographic presence and cash flows, we are acquiring Bronco Billy’s at an attractive EBITDA multiple and price. It is well-run and well- maintained, and a stable leader within its market. We expect that its management team will remain at the property and we look forward to welcoming them and all of the Bronco Billy’s employees to the Full House family.”

Mr. Lee continued, “We see potential for growth at Bronco Billy’s as the property benefits from a full year of its recently-completed expansion. Over the long term, there may be opportunities to develop the property’s excess surrounding acreage. Bronco Billy’s will significantly increase our Company’s EBITDA, without any significant increase in corporate overhead. In fact, there may be corporate cost savings related to economies of scale. We look forward to completing this transaction as quickly as possible, potentially in the fourth quarter of 2015 or early in 2016.”

The $30.0 million purchase price, exclusive of working capital and other adjustments, is subject to reduction to $28.5 million if Bronco Billy’s twelve-month Adjusted EBITDA, as defined, falls below $4.7 million in certain periods prior to closing. If Bronco Billy’s twelve-month Adjusted EBITDA, as defined, further falls below $4.5 million in certain periods prior to closing, Full House Resorts may terminate the purchase agreement without penalty. Strictly for purposes of the Adjusted EBITDA definition contained in the purchase agreement, Pioneer Group advised us that, for the twelve-month period ended August 31, 2015, the amount would have been $5.1 million.

The Company will make a $2.5 million deposit to secure its performance under the purchase agreement. As stated above, the deposit will be returned if Bronco Billy’s twelve-month Adjusted EBITDA, as defined, is less than $4.5 million.

Full House Resorts intends to finance the acquisition concurrent with the refinancing of its outstanding first and second lien debt, much of which comes due in 2016. Management expects to complete the refinancing of the Company’s debt simultaneous with the close of the Bronco Billy’s transaction in late 2015 or early 2016, subject to obtaining regulatory approvals and completion of other customary closing conditions.

“This transaction significantly increases the scope and diversity of Full House,” concluded Mr. Lee. “While there is no ‘financing contingency’ in the purchase agreement, we believe the Company’s credit statistics, including the cost of the acquisition, will be within the norm for regional casino companies. While nothing is certain, our bankers have expressed confidence that the Company’s debt can be refinanced, including the entire cost of the acquisition, on terms that are better than the cost of our existing debt.”

Note: The amounts in the above table were provided by Pioneer Group, Inc.

Forward-looking Statements
Some of the statements made in this release are forward-looking statements. These forward-looking statements are based upon Full House’s current expectations and projections about future events and generally relate to Full House’s plans, objectives and expectations for Full House’s business. Although Full House’s management believes that the plans and objectives expressed in these forward-looking statements are reasonable, the outcome of such plans, objectives and expectations involve risks and uncertainties including, without limitation, regulatory approvals, compliance with conditions precedent under the purchase agreement, review of negotiated financial terms in the definitive agreement, the ability to refinance indebtedness, financing sources and terms, the increase in Full House’s indebtedness if the acquisition closes, the risk that the acquisition does not close, and general macroeconomic conditions. Additional information concerning potential factors that could affect Full House’s financial condition and results of operations is included in the reports that Full House files with the Securities and Exchange Commission, including, but not limited to, its Form 10-K for the most recently ended fiscal year, Forms 10-Q and other periodic filings. The Company is under no obligation to (and expressly disclaims any such obligation to) update or revise its forward-looking statements as a result of new information, future events or otherwise.

About Full House Resorts, Inc.
Full House Resorts owns, develops and operates gaming facilities throughout the country. The Company’s properties include Rising Star Casino Resort in Rising Sun, Indiana; Silver Slipper Casino and Hotel in Hancock County, Mississippi; and Stockman’s Casino in Fallon, Nevada. The Company also operates the Grand Lodge Casino at the Hyatt Regency Lake Tahoe Resort, Spa and Casino in Incline Village, Nevada on the north shore of Lake Tahoe under a lease agreement with the Hyatt organization. The Company recently announced its intent to purchase Bronco Billy’s Casino and Hotel in Cripple Creek, Colorado and has proposed American Place, a major development in Indianapolis, Indiana. Further information about Full House Resorts can be viewed on its website at www.fullhouseresorts.com.

(GVP) $35 Million of Nuclear Operations Support for Major US Utility

GSE Systems, Inc. (NYSE MKT: GVP) (“GSE”), the global energy industry performance improvement company, today announced that its Hyperspring LLC subsidiary has been awarded a contract for the continuation of Nuclear Operations support services in the form of providing Nuclear Operations Instructors at a major nuclear utility in the southern United States. The on-call services contract allows for total payment up to $35 million to GSE over the three-year contract term. Instructor tasks include leading the development, maintenance and conduct of training and qualification activities to ensure operators and shift technical advisor qualifications meet regulatory and accreditation requirements.

For the year ended December 31, 2014 and the six-month period ended June 30, 2015, Hyperspring generated revenues from this utility of $11.1 million and $5.3 million, respectively.

Paul Abbott, President of Hyperspring LLC said, “This contract is a continuation of a long standing relationship with the utility customer and reflects their satisfaction with the quality of services we have provided. We are honored to serve this customer, are proud of the value we have provided, and are excited for the opportunity to continue the relationship, serving the customer’s needs well into the future.”

Hyperspring LLC was acquired by GSE Systems in November of 2014 and provides professional plant support services to a variety of power generation facilities throughout the United States. Services include: instruction, procedure writing, work management, corrective action, training program development and accreditation, self-assessments and equipment reliability. In addition, Hyperspring offers turn-key courses for Senior Reactor Operator (SRO) Instructor Certification, SRO Management Certifications, and NRC Generic Fundamentals exam preparation.

ABOUT GSE SYSTEMS, INC.

GSE Systems, Inc. provides performance improvement solutions to the energy and process industries. We improve human performance though turnkey training, unique visualization and simulation applications, and our staff of instructors, as well as plant improvement through our engineering expertise and use of technology to improve plant design, commissioning and operations. The Company has more than 340 employees and over four decades of experience as well as more than 1,100 installations and hundreds of customers in over 50 countries spanning the globe. GSE Systems is headquartered in Sykesville (Baltimore), Maryland, with offices in St. Marys, Georgia; Cary, North Carolina; Huntsville, Alabama; Chennai, India; Nyköping, Sweden; Stockton-on-Tees, UK; Glasgow, UK; Manama, Bahrain; and Beijing, China. Information about GSE Systems is available at www.gses.com.

Forward-Looking Statements

We make statements in this press release that are considered 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. These statements reflect our current expectations concerning future events and results. We use words such as “expect,” “intend,” “believe,” “may,” “will,” “should,” “could,” “anticipates,” and similar expressions to identify forward-looking statements, but their absence does not mean a statement is not forward-looking. These statements are not guarantees of our future performance and are subject to risks, uncertainties, and other important factors that could cause our actual performance or achievements to be materially different from those we project. For a full discussion of these risks, uncertainties, and factors, we encourage you to read our documents on file with the Securities and Exchange Commission, including those set forth in our periodic reports under the forward-looking statements and risk factors sections. We do not intend to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.

GSE Systems, Inc.
Kyle J. Loudermilk, 410-970-7950
Chief Executive Officer
or
The Equity Group Inc.
Devin Sullivan, 212-836-9608
Senior Vice President
dsullivan@equityny.com
or
Kalle Ahl, CFA, 212-836-9614
Senior Associate
kahl@equityny.com

(PSDV) Announces NDA for Medidur™

pSivida Corp. (NASDAQ:PSDV) (ASX:PVA), a leader in the development of sustained release drug delivery products for treating eye diseases, announced that the Company now plans to file a New Drug Application (NDA) for Medidur for posterior uveitis based on six-month efficacy data for both Phase III trials. The U.S. Food & Drug Administration (FDA) has advised pSivida that this data will be acceptable for review by the agency. pSivida previously planned to utilize 12-month efficacy data from the first trial and six-month efficacy data from the second trial. As six-month visits in the first trial will be completed this month, top-line results from the first Phase III trial are now anticipated to be reported in December 2015. Enrollment in the second Phase III trial continues and is expected to be completed during the first half of 2016, with an NDA anticipated in the first half of 2017.

“We are very pleased that the FDA has agreed to review an NDA for posterior uveitis based on six-month efficacy data,” said Dr. Paul Ashton, president and CEO of pSivida. “The primary end-point of the Phase III trials is recurrence of disease, which in the majority of patients occurs typically within six months. Our analysis of the masked data from our first trial is consistent with this. We believe therefore that six-month data from our two trials will show safety and efficacy. We look forward to being able to announce the top-line results from the first trial at the end of this year.”

About Medidur. Medidur is an injectable micro-insert designed to treat posterior uveitis that provides sustained release of flucinolone acetonide (a corticosteroid) for three years. Medidur comprises the same micro-insert (same design, same polymers, same drug, same dose) as ILUVIEN® for DME. ILUVIEN has been approved in the U.S. and 17 EU countries and is sold in the U.S., the U.K., Germany and Portugal.

About Posterior Uveitis. Posterior uveitis is a chronic, non-infectious inflammatory disease affecting the posterior segment of the eye, often involving the retina, which is a leading cause of blindness in the developed and developing countries. It afflicts people of all ages, producing swelling and destroying eye tissues, which can lead to severe vision loss and blindness. In the U.S. posterior uveitis is estimated to affect approximately 175,000 people, resulting in approximately 30,000 cases of blindness and making it the third leading cause of blindness in the U.S.

Patients with posterior uveitis are typically treated with systemic steroids but over time frequently develop serious side effects that can limit effective dosing. Patients then often progress to steroid-sparing therapy with systemic immune suppressants or biologics, which themselves can have severe side effects including an increased risk of cancer. Medidur is designed to provide improved outcomes compared to standard of care but with a significant reduction in side effects.

About Medidur’s Phase III Trials. pSivida’s two Phase III trials for Medidur are double-masked studies comparing injections of Medidur to sham injections on a two-to-one basis. The primary end point of both trials is recurrence of uveitis within six months. The first trial is fully enrolled with 129 patients in 16 centers in the U.S. and 17 centers outside the U.S. The last scheduled visit for the last patient in this trial is in September 2015, and top-line data is expected in December 2015. The second trial will enroll up to 150 patients in approximately 15 centers in India. Patients in both trials will be followed for three years. pSivida plans to seek approval for Medidur for posterior uveitis based on six-month data from the two trials and data from a utilization study of pSivida’s redesigned proprietary inserter together with data referenced from the Phase III trials of ILUVIEN® for DME. With favorable results, pSivida expects to file a New Drug Application in the first half of 2017.

About pSivida Corp. pSivida Corp., headquartered in Watertown, MA, is a leader in the development of sustained release, drug delivery products for treating eye diseases. pSivida has developed three of only four FDA-approved treatments for back-of-the-eye diseases. The most recent, ILUVIEN, a micro-insert for diabetic macular edema, is licensed to Alimera Sciences and sold in the U.S. and three EU countries. Retisert®, an implant for posterior uveitis, is licensed to and sold by Bausch & Lomb. pSivida’s lead product candidate, Medidur™, a micro-insert for posterior uveitis, is currently in pivotal Phase III clinical trials with an NDA anticipated in the first half of 2017. pSivida’s pre-clinical development program is focused on using its core platform technologies, Durasert™ and/or Tethadur™, to deliver drugs and biologics to treat wet and dry age-related macular degeneration (AMD), glaucoma, osteoarthritis and other diseases. To learn more about pSivida please visit www.psivida.com and connect on Twitter, LinkedIn, Facebook and Google+.

SAFE HARBOR STATEMENTS UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995: Various statements made in this release are forward-looking, and are inherently subject to risks, uncertainties and potentially inaccurate assumptions. All statements that address activities, events or developments that we intend, expect or believe may occur in the future are forward-looking statements. Some of the factors that could cause actual results to differ materially from the anticipated results or other expectations expressed, anticipated or implied in our forward-looking statements include uncertainties with respect to: our ability to achieve profitable operations and access to capital; further impairment of our intangible assets; fluctuations in our operating results; declines in Retisert royalties; successful commercialization of, and receipt of revenues from, ILUVIEN for DME; the effect of pricing and reimbursement decisions on sales of ILUVIEN for DME; consequences of flucinolone acetonide side effects; safety and efficacy results of Medidur Phase III trials, timing of filing and acceptance of the Medidur NDA, if at all; fluctuations in our operating results; ability to use of data in a U.S. NDA from trials outside the U.S.; any exercise by Pfizer of its option with respect to the latanoprost product; our ability to develop Tethadur to successfully deliver large biologic molecules and develop products using it; our ability to successfully develop product candidates, initiate and complete clinical trials and receive regulatory approvals; our ability to market and sell products; the success of current and future license agreements; termination or breach of current license agreements; effects of competition and other developments affecting sales of products; market acceptance of products; effects of guidelines, recommendations and studies; protection of intellectual property and avoiding intellectual property infringement; retention of key personnel; product liability; industry consolidation; compliance with environmental laws; manufacturing risks; risks and costs of international business operations; legislative or regulatory changes; volatility of stock price; possible dilution; absence of dividends; and other factors described in our filings with the SEC. You should read and interpret any forward-looking statements in light of these risks. Should known or unknown risks materialize, or should underlying assumptions prove inaccurate, actual results could differ materially from past results and those anticipated, estimated or projected in the forward-looking statements. You should bear this in mind as you consider any forward-looking statements. Our forward-looking statements speak only as of the dates on which they are made. We do not undertake any obligation to publicly update or revise our forward-looking statements, even if experience or future changes makes it clear that any projected results expressed or implied in such statements will not be realized.

(RJET) Teamsters Local 357, Republic Airways Reach Tentative Agreement on New Contract

Teamsters Local 357 and Republic Airways Holdings Inc. (NASDAQ/NM: RJET) announced today that they have reached a consensual tentative agreement on the terms of a new three-year contract for the 2,100 Republic pilots represented by the International Brotherhood of Teamsters.

“This milestone is long overdue,” said Captain Jim Clark, Teamsters Local 357 president. “Our members are extraordinary aviators and safety professionals who come to work every day ready to do the job asked of them. They deserve pay, job security, benefits and work rules that match their leadership position in our industry. The Executive Board of Local 357 recommends this tentative agreement to our members for ratification. We were able to reach this positive outcome because of the support of our members who stayed united even in the face of constant challenges.”

“This is a positive outcome,” said Matt Koscal, Republic vice president of human resources. “This consensual agreement respects the role our pilots play in our airline’s success and it puts them at the forefront of our industry. We are pleased that we could reach a consensual agreement with the leadership of Local 357 that allows us to make a significant investment in our Pilots and our future.”

The parties are preparing the document for publication, at which point Local 357 will distribute copies of the tentative agreement to its members. The union plans to hold a series of road shows and other forums to afford its members the opportunity to review the tentative agreement and to ask questions. Ratification voting is scheduled to conclude in late October. Further details on this process will be provided to our Pilots by the union in the coming days.

The company will post a copy of the tentative agreement on www.myrjetcontract.com for the convenience of Local 357 members and has agreed to host an FAQ and other content on the site as requested by the union.

Both parties wish to express their thanks to the National Mediation Board, and specifically to board member Linda Puchala and to senior mediator Terri Brown, for their ongoing guidance and assistance during this process. The parties also express their appreciation to the staff and specifically, Director, Captain David Bourne of the Teamster’s Airline Division for their assistance.

(RENT) Acquires SponsorHub

-SponsorHub’s Proprietary Measurement Platform, Specializing in Social Media and Mega Events, Enhances Rentrak’s Unsurpassed Position in Precisely Measuring Movies and TV Everywhere-

PORTLAND, Ore., Sept. 25, 2015  — Rentrak (NASDAQ: RENT), the leader in precisely measuring movies and TV everywhere, today announced it has acquired SponsorHub, the premiere Big Data platform for the sports and entertainment industry, offering proprietary social media measurement for sports, political and advertising brands.

SponsorHub offers the most trusted industry benchmarking for top brands in the sports technology and entertainment space. Its tools measure and track brand engagement in sports and branded entertainment initiatives, ranging from the Olympics and World Cup, to TV and movies.

Rentrak’s acquisition of SponsorHub advances its mission of providing unprecedented audience measurement and targeting to enable marketers to reach the right audience at the right time. Through its acquisition of SponsorHub, Rentrak will offer products that measure the effect of social media on television, dynamic ad insertion, online video advertising, movies and branded content integration.

“TV continues to be more social and our industry-leading analytics greatly complement Rentrak’s services,” said SponsorHub Chief Executive Officer, Robert Johnston. “The combination of Rentrak’s current products with SponsorHub’s social media SaaS platform will provide the most precise set of tools to measure the effect of social media. We’re looking forward to the new products that will be developed through this acquisition.”

“We are excited to add social media measurement to our TV Everywhere products, as it will give additional transparency and purchasing flexibility for brands and agencies through SponsorHub’s social media products,” said Rentrak’s Vice Chairman & Chief Executive Officer, Bill Livek.

SponsorHub has pioneered social media analytics in sports, across multiple platforms. Its X-Stream product helps advertisers better appropriate the billions of dollars spent on sports and entertainment campaigns. X-Stream provides a real-time consumer impact index and key emotional metrics derived from billions of social conversations around athletes, celebrities, teams, leagues and brands.

About Rentrak

Rentrak (NASDAQ: RENT) is the entertainment and marketing industries’ premier provider of worldwide consumer viewership information, precisely measuring actual viewing behavior of movies and TV everywhere. Using our proprietary intelligence and technology, combined with Advanced Demographics, only Rentrak is the census currency for VOD and movies. Rentrak provides the stable and robust audience measurement services that movie, television and advertising professionals across the globe have come to rely on to better deliver their business goals and more precisely target advertising across numerous platforms including box office, multiscreen television and home video. For more information on Rentrak, please visit www.rentrak.com.

About SponsorHub

SponsorHub provides elegant yet powerful enterprise-grade software tools to help brands measure their most important sports and entertainment campaigns. SponsorHub’s proprietary technology provides a dynamic mover board of public sentiment towards brands, products, mega events, teams, leagues, athletes and celebrities. For more information, please visit www.sponsorhub.com

RENTM

Contact for Rentrak:
Antoine Ibrahim
646.722.1561
aibrahim@rentrak.com

Contact for SponsorHub:
Katie Campisano
908 247 8678
katie.campisano@CodeMorris.com

(GLBL) GPM Announces Investigation on Behalf of TerraForm Global, Inc. Investors

Glancy Prongay & Murray LLP (“GPM”) announces that it is investigating potential claims on behalf of investors of TerraForm Global, Inc. (“TerraForm” or the “Company”) (NASDAQ:GLBL) concerning the Company’s and its officers’ possible violations of federal securities laws. GPM is preparing a lawsuit to recover damages on behalf of TerraForm investors.

TerraForm owns and operates renewable energy generation assets worldwide, and operates as a subsidiary of SunEdison, Inc. On August 4, 2015, the Company completed its initial public offering of 45 million shares at an offering price of $15 per share. However, over the course of several disclosures in the past two months, regarding SunEdison, Inc.’s and TerraForm’s poor performance the Company’s stock price has fallen nearly 50% below its IPO price, thereby damaging investors. GPM is investigating whether investors were misled by the Company and its officers and directors during the course of the initial public offering.

If you purchased TerraForm securities, have information or would like to learn more about these claims including whether you qualify to serve as a class representative, or have any questions concerning this announcement or your rights or interests with respect to these matters, please contact Lesley F. Portnoy, Esquire, of GPM, 1925 Century Park East, Suite 2100, Los Angeles, California 90067 at 310-201-9150, Toll-Free at 888-773-9224, by email to shareholders@glancylaw.com, or visit our website at http://www.glancylaw.com. If you inquire by email please include your mailing address, telephone number and number of shares purchased.

This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.

(LQDT) to Divest Jacobs Trading Business to Tanager Acquisitions for $17M

Liquidity Services (NASDAQ: LQDT), a global solution provider in the reverse supply chain with the world’s largest marketplace for business surplus, today announced that it has entered into a definitive agreement to sell its Jacobs Trading business to Tanager Acquisitions, LLC, a Minnesota-based reseller of closeout merchandise, in an approximately $17 million transaction. The companies expect to complete the transaction by September 30th. Final timing will depend on satisfaction of customary closing conditions.

The agreed upon consideration to Liquidity Services for the Jacobs Trading business is approximately $13 million, subject to final closing adjustments and payable in the form of a five-year note, plus the opportunity to receive up to an additional $2 million in cash based on achievement of earn-out targets in calendar year 2019, and up to an additional $2 million in cash based on achievement of earn-out targets in calendar year 2020.

Additionally, the sale of the Jacobs Trading business allows Liquidity Services to utilize approximately $127 million in tax losses resulting in an anticipated near term cash benefit of approximately $35 million from tax refunds and a tax loss carry forward of approximately $31 million generating another approximately $13 million of tax benefit against future earnings. The transaction is expected to result in an approximately $29 million credit to income tax expense for fiscal year 2015. This divestment follows the termination of the legacy Jacobs Trading Wal-Mart contract which materially reduced the scope of the Jacobs Trading business.

“This transaction unlocks substantial near term growth capital that we will reinvest in our core Retail Supply Chain Group business focused on providing Fortune 1000 retailers and manufacturers with a complete reverse logistics solution for managing customer returns, shelf pulls, excess and overstock inventory,” said Jim Rallo, President of Liquidity Services’ Retail Supply Chain Group.

Forward-Looking Statements

This document contains forward-looking statements made pursuant to the Private Securities Litigation Reform Act of 1995. These statements are only predictions. The outcome of the events described in these forward-looking statements is subject to known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. These statements include, but are not limited to, statements regarding the Company’s business outlook, plans to increase investments in technology infrastructure, our proprietary e-commerce marketplace platform, product development and marketing initiatives, the LiquidityOne Transformation program, the supply and mix of inventory under the DoD Surplus Contract, expected future effective tax rates, and trends and assumptions about future periods, including the fourth quarter FY15 and the full year FY15. You can identify forward-looking statements by terminology such as “may,” “will,” “should,” “could,” “would,” “expects,” “intends,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continues” or the negative of these terms or other comparable terminology. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

There are a number of risks and uncertainties that could cause our actual results to differ materially from the forward-looking statements contained in this document. Important factors that could cause our actual results to differ materially from those expressed as forward-looking statements are set forth in our filings with the SEC from time to time, and include, among others, our dependence on our contracts with the DoD for a significant portion of our revenue and profitability; our ability to successfully expand the supply of merchandise available for sale on our online marketplaces; our ability to attract and retain active professional buyers to purchase this merchandise; the timing and success of upgrades to our technology infrastructure; our ability to successfully complete the integration of any acquired companies into our existing operations and our ability to realize any anticipated benefits of these or other acquisitions; the success of our business realignment and LiquidityOne integration and enhancement initiative. There may be other factors of which we are currently unaware or deem immaterial that may cause our actual results to differ materially from the forward-looking statements.

All forward-looking statements attributable to us or persons acting on our behalf apply only as of the date of this document and are expressly qualified in their entirety by the cautionary statements included in this document. Except as may be required by law, we undertake no obligation to publicly update or revise any forward-looking statement to reflect events or circumstances occurring after the date of this document or to reflect the occurrence of unanticipated events.

About Liquidity Services

Liquidity Services is a global solution provider in the reverse supply chain with the world’s largest marketplace for business surplus. We partner with global Fortune 1000 corporations, middle market companies, and government agencies to intelligently transform surplus assets and inventory from a burden into a liquid opportunity that fuels the achievement of strategic goals. Our superior service, unmatched scale, and ability to deliver results enable us to forge trusted, long-term relationships with over 8,000 clients worldwide. With nearly $6 billion in completed transactions, and approximately 3 million buyers in almost 200 countries and territories, we are the proven leader in delivering smart surplus solutions. Let us build a better future for your surplus. Visit us at LiquidityServices.com.

(EFOI) Closes Follow-On Public Offering of Common Shares

Net Proceeds of $23.7 Million to Support Continuing Growth

SOLON, Ohio, Sept. 25, 2015  — Energy Focus, Inc. (NASDAQ:EFOI), a leader in LED lighting technologies, today announced that on September 16, 2015 it closed its follow-on offering of 3 million shares of its common stock at a price to the public of $17.00 per share. 1.5 million shares were sold by the Company and 1.5 million shares were sold by various investors who provided the necessary financing to see the company through its 2012-2013 restructuring, and remain significant stockholders in the company. Total net proceeds to Energy Focus, Inc. from the offering after deducting underwriting discounts and commissions and estimated offering expenses, were approximately $23.7 million. The Company and the selling stockholders granted the underwriters a 30-day option to purchase up to an additional 450,000 shares of common stock on a pro rata basis.

“This public offering represents another key corporate milestone for Energy Focus,” stated James Tu, Executive Chairman and Chief Executive Officer. “The closing of this transaction provides us with numerous benefits, first and foremost a substantially strengthened balance sheet, including cash of $34 million on a pro forma basis and virtually no long-term debt. A stronger balance sheet enhances our ability to compete for business by mitigating potential concerns about our financial stability or our ability to provide the long-term product warranties and services that customers demand. The additional capital allows us to hire additional personnel as we build our direct sales force while enabling us to take on new initiatives and projects, such as expanding our “Made in America” product lines that we believe will add to our leadership in the military and government sectors, and to provide financing alternatives that could expedite the decision making process by key accounts that we desire to penetrate. Last but not least, the transaction improves our capital structure and liquidity, as we expanded the public float of our shares by approximately 30 percent, with a diverse group of new institutional investors participating in the transaction, now shareholders in our company.”

“The dramatic transformation of Energy Focus which began in mid-2013, up through this equity raise, has our company now positioned to address the most impactful needs for LED lighting adoption to replace fluorescent and high-intensity discharge lighting. Together, according to the Department of Energy’s recent estimate, these retrofit opportunities account for over 60% of energy savings potential through the upgrade of traditional lighting to LEDs. We are as excited as ever about our future as we continue to aggressively develop the pipeline of long-term opportunities with our customers in the specific vertical markets we are targeting – primarily the U.S. and allied foreign navies, military bases, healthcare institutions, K-12 schools, industrial and manufacturing facilities, and national retail chains,” concluded Mr. Tu.

The offering of these securities was made only by means of a prospectus and pursuant to two effective shelf Registration Statements on Form S-3 that have been filed with the Securities and Exchange Commission (the “SEC”). A final prospectus supplement and accompanying base prospectuses related to the offering have been filed with the SEC and are available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectuses relating to the offering may also be obtained from Oppenheimer & Co. Inc., Attention: Syndicate Prospectus Department, 85 Broad Street, 26th Floor, New York, NY 10004, Phone: (212) 667-8563, Email: EquityProspectus@opco.com.

This press release is neither an offer to sell nor a solicitation of an offer to buy any of these securities and shall not constitute an offer or a solicitation of any offer to buy, or a sale of, these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful.  

Forward Looking Statements:

Forward-looking statements in this release are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Generally, these statements can be identified by the use of words such as “believes,” “estimates,” “anticipates,” “expects,” “seeks,” “projects,” “intends,” “plans,” “may,” “will,” “should,” “could,” “would” and similar expressions intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include all matters that are not historical facts. By their nature, forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from Energy Focus’ forward-looking statements. These risks and uncertainties include, but are not limited to our history of operating losses; general economic conditions in the United States and in other markets in which we operate; our reliance on a limited number of customers, in particular our sales of products for the U.S. Navy, for a significant portion of our revenue; our ability to implement and manage our growth plans and control expenses to increase sales and improve margins; our dependence on government customers and on the levels of funding available to such customers and our ability to satisfactorily fulfill our contractual obligations to such customers; market acceptance of LED lighting technology; our ability to respond to new lighting technologies and market trends with safe and reliable products; our ability to compete effectively against companies with greater resources; our ability to protect our intellectual property rights and the impact of any type of legal claim or dispute; our ability to obtain critical components and finished products from third-party suppliers on acceptable terms; risks inherent in international markets, such as economic and political uncertainty, changing regulatory and tax requirements and currency fluctuations; and our ability to maintain effective internal controls and otherwise comply with our obligations as a public company. In light of the foregoing, we caution you not to place undue reliance on our forward-looking statements. For more information about potential factors that could affect the financial results of Energy Focus, please refer to the Company’s SEC reports, including its Annual Reports on Form 10-K and its quarterly reports on Form 10-Q. These forward-looking statements speak only as of the date hereof. Energy Focus disclaims any intention or obligation to update or revise any forward-looking statements.

About Energy Focus, Inc.:

Energy Focus, Inc. is a leading provider of energy efficient LED lighting products and a developer of energy efficient lighting technology. Our LED lighting products provide energy savings, aesthetics, safety and maintenance cost benefits over conventional lighting. Our long-standing relationship with the U.S. Government continues to enable us to provide energy efficient LED lighting products to the U.S. Navy and the Military Sealift Command fleets. Customers include national, state and local U.S. government agencies as well as Fortune 500 companies and many other commercial and industrial clients. Company headquarters are located in Solon, OH. For more information, see our web site at www.energyfocusinc.com.

CONTACT: Investor Contacts:

         Energy Focus, Inc.
         Investor Relations
         (440) 715-1300
         ir@energyfocusinc.com

         or

         Darrow Associates, Inc.
         Peter Seltzberg, Managing Director
         (516) 510-8768
         pseltzberg@darrowir.com

(UBIC) Consulting Services for a New Tool which Visualizes the Learning Process of its AI

An Approach to Boost Review Accuracy by Dynamically Visualizing the Text Analysis Process

NEW YORK, Sept. 25, 2015  — UBIC, Inc. (Nasdaq:UBIC) (TSE:2158) (“UBIC” or “the Company”), a leading provider of AI-based, big data analysis services, today announced that it has invented a visualization analytics tool, which offers users a tangible data representation of the dynamic learning process of its AI. UBIC will begin providing consulting services that leverage this tool to enhance the efficiency and accuracy of document review.

UBIC provides solutions to companies trying to protect themselves from preventable risks that could lead to antitrust investigations involving ESI. Lit i View EMAIL AUDITOR, UBIC’s AI-driven proprietary email auditing system, automatically processes vast amounts of corporate emails to search for these risks.

Virtual Data Scientist (VDS), the AI integrated into the EMAIL AUDITOR, can teach itself to analyze data just like a seasoned Auditor by learning from the Auditor’s previous experiences and judgments during eDiscovery or antitrust investigations. When the learning process ends, the VDS can step in on behalf of the Auditor, analyze an astonishing volume of texts and emails, and expose suspicious communications and actions that may be associated with information leakages and cartels. Moreover, its productivity rate far surpasses human capacity.

UBIC introduced this consulting service to address questions often raised by clients after implementing the LiV EMAIL AUDITOR, including, “How proficient is AI-driven e-mail auditing?” and “How long will it take for the AI to gain traction and become a practical auditing tool?”

Previously, UBIC created tables when presenting the analytical results of the VDS, but using graphs and time series for visualization has made it much easier for users to understand how the AI’s analytical abilities develop and improve. This is at the very core of UBIC’s new consulting services.

The growth of the AI is measured by constantly checking whether the AI can score documents in line with the results of human judgments. In other words, the AI’s intellectual evolution is determined by tracking how the distribution of relevant vs. irrelevant documents changes over time.

There are three steps in the progress of the AI’s intellectual growth: 1. Initial Growth; 2. Continued Growth; and 3. Maturity. If the AI reaches Maturity, this indicates that the email auditing system is stable and working consistently.

Distributional changes representing the AI’s intellectual growth pattern (a typical sample vs. the actual VDS performance)

To give an illustration, the following sets of graphs show a sample of a typical AI’s intellectual growth on the right-hand side, and a distribution resulting from the VDS’s actual performance on the left-hand side. If the results of the two become more and more similar, it signifies that the VDS is progressing in the right direction. By having the graph’s horizontal axis represent the scores from the latest round, and the vertical axis the scores of the previous round, users can trace a trend over a period of time.

Initial Growth Period

According to the sample on the right, the Auditor’s assessment criteria and those of the VDS are still a little different at this stage, as indicated by the scattered dots representing the assessment results. The discrepancies are apparent, and this causes scores to vary. Even in the actual case, (covering the period from Day 1 to Day 10) such variation is apparent, indicating that the VDS’s learning process is incomplete, or in other words, the VDS does not completely “get it” yet.

Figure #1 accompanying this release is available at http://media.globenewswire.com/cache/26105/file/37573.pdf

Continued Growth Period

As the VDS is given more and more time to learn, it will assign high scores to an increasing number of documents judged as relevant by the human auditor. In the typical graph, the red dot distribution of “relevant documents” begins to move towards the lower right portion of the layout. A dot in this area indicates that “a document previously assigned a low score is now assigned a high score.” By contrast, the cluster of “not relevant” dots begins to move more towards the area signifying that “the previous score was high, but the current score is low”. For the actual case covering the period from Day 17 to Day 24, more and more dots are appearing in the high score area representing “relevance”, and this indicates that the discerning power of the AI is improving.

Figure #2 accompanying this release is available at http://media.globenewswire.com/cache/26105/file/37574.pdf

Maturity

As the AI progresses even more from Day 24 to Day 59, the typical model and the actual model both begin to feature email clusters in the high-score area. A dot in this area indicates that the Auditor believes the document is relevant to the case. In contrast, the ones not relevant are concentrating in the low score area. The concentration of dots along the standard growth line indicates that the AI’s learning process has progressed ideally and stabilized.

Figure #3 accompanying this release is available at http://media.globenewswire.com/cache/26105/file/37575.pdf

At UBIC, the Advanced Data Analysis & Product Dept. provides consulting services based on analysis of the VDS learning process. Also, the visual analytics presented here were developed by Yuki Hikone, the Forensic Team Leader and member of this department, based on ideas originated and findings gathered during his projects. This new method offering visualization enables users to intuitively measure the AI’s growth and to understand whether the growth rate and precision rate are on the right track.

Kazumi Hasuko, Senior Fellow of the Behavior Informatics Laboratories at UBIC Inc. commented, “Every time an Auditor introduces additional assessments to the AI, the AI teaches itself to learn from the properties of these assessments and to optimize its own scoring task. As shown in the Figures, each learning and scoring iteration widens the gap between the score distribution of relevant vs. irrelevant documents, and this means that the VDS, by extrapolating from the Auditor’s assessments, is learning to classify the documents more accurately.”

About UBIC, Inc.

UBIC, Inc. (Nasdaq:UBIC) (TSE:2158) supports the analysis of big data based on behavior informatics by utilizing its technology, “VIRTUAL DATA SCIENTIST” or VDS. UBIC’s VDS technology is driven by UBIC AI based on knowledge acquired through its litigation support services. The VDS incorporates experts’ tacit knowledge, including their experiences and intuitions, and utilizes that knowledge for big data analysis. UBIC continues to expand its business operations by applying VDS to new fields such as healthcare and marketing.

UBIC was founded in 2003 as a provider of e-discovery and international litigation support services. These services include the preservation, investigation and analysis of evidence materials contained in electronic data, and computer forensic investigation. UBIC provides e-discovery and litigation support by making full use of its data analysis platform, “Lit i View®”, and its Predictive Coding technology adapted to Asian languages.

For more information about UBIC, contact usinfo@ubicna.com or visit http://www.ubic-global.com.

Safe Harbor Statement

This announcement contains forward-looking statements. These forward-looking statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements can be identified by terminology such as “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates” and similar statements. Among other things, the amount of data that UBIC expects to manage this year and the potential uses for UBIC’s new service in intellectual property-related litigation, contain forward-looking statements. UBIC may also make written or oral forward-looking statements in its reports filed with, or furnished to, the U.S. Securities and Exchange Commission, in its annual reports to shareholders, in press releases and other written materials and in oral statements made by its officers, directors or employees to third parties. Statements that are not historical facts, including statements about UBIC’s beliefs and expectations, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties. A number of factors could cause actual results to differ materially from those contained in any forward-looking statement, including but not limited to the following: UBIC’s goals and strategies; UBIC’s expansion plans; the expected growth of the data center services market; expectations regarding demand for, and market acceptance of, UBIC’s services; UBIC’s expectations regarding keeping and strengthening its relationships with customers; UBIC’s plans to invest in research and development to enhance its solution and service offerings; and general economic and business conditions in the regions where UBIC provides solutions and services. Further information regarding these and other risks is included in UBIC’s reports filed with, or furnished to the Securities and Exchange Commission. UBIC does not undertake any obligation to update any forward-looking statement, except as required under applicable law. All information provided in this press release and in the attachments is as of the date of this press release, and UBIC undertakes no duty to update such information, except as required under applicable law.

CONTACT: UBIC Global PR
         UBIC North America, Inc.
         Tel: (212) 924-8242
         global_pr@ubic.co.jp

(PBMD) to Present at LEERINK Partners Rare Disease Roundtable

(MRVL) Announces Significant Restructuring of Mobile Platform Business

SANTA CLARA, Calif., Sept. 24, 2015  — Marvell Technology Group Ltd. (NASDAQ: MRVL) today announced a significant restructuring of its mobile platform business in order to focus the mobile product line on anticipated more profitable opportunities and right-size its expenses in line with corporate targets.  Marvell will continue its strong commitment to wireless connectivity such as WiFi and other wireless standards needed to support its strategies in existing markets as well as expanding into emerging opportunities in IoT and automotive.

As approved by the Company’s Board of Directors, the Company plans to significantly downsize the mobile platform organization to refocus its technology to emerging opportunities in IoT, automotive, and networking.

Operational Summary:

• Based on preliminary estimates for the first half of fiscal 2016, the Company’s mobile platform generated roughly $122 million in revenues and roughly $13 million in gross profit.
• The successful restructuring of the mobile business is currently expected to result in annualized operating expense savings in the range of $170 million to $220 million. Included in this operating expense savings is estimated share based compensation in the range of $15 million to $20 million.
• The downsizing of the mobile platform organization is currently expected to result in an approximately 17% reduction in global headcount.
• The restructuring will begin immediately and the Company expects the major activities to take place through the end of fiscal 2016. As a result, the Company expects to incur total charges of approximately $100 million to $130 million. The major components of the total charge include severance and employee-related costs expected to be incurred in the third and fourth quarters of fiscal 2016 and are expected to be in the range of $45 million to $55 million. Other major components include facilities and asset impairment charges in the range of $30 million to $40 million and an inventory write down charge in the range of $25 million to $35 million. Given the early stages of this restructuring process, the amount and timing of the aforementioned charges may be updated.

Marvell does not plan to hold a conference call with investors and analysts in association with this press release.  The Company will discuss the restructuring of the mobile platform business in more detail during its next quarterly earnings conference call, the date of which is yet to be determined.

Safe Harbor Statement Under the Private Securities Litigation Reform Act of 1995:

This press release contains forward-looking statements. Words such as “anticipates,” “expects,” “intends,” “plans,” “believes,” “seeks,” “estimates,” “may,” “will,” “should,” and their variations identify forward-looking statements. These statements include those relating to the proposed restructuring, reduction in headcount, reduction in operating expenses, changes in termination benefits, impairment, inventory write-down, and settlement charges, increases in the gross margin and operating margin and the market opportunity for Marvell created by the restructuring.  These statements are not guarantees of results and are subject to risks and uncertainties that could cause actual results to differ materially from those anticipated in the forward-looking statements. These risks and uncertainties include, but are not limited to, the magnitude and timing of certain activities, the benefits of and the costs to be incurred in conducting the restructuring activities, the ability of the Company to redeploy technology and assets to and compete in other markets, the size of market opportunities, the timing and outcome of the Audit Committee’s investigation and the conclusions of the Audit Committee, actions that may be taken or required as a result of the Audit Committee’s investigation, actions by the United States Securities and Exchange Commission (“SEC”) or other regulatory agencies in connection with the Audit Committee’s investigation, and the outcome of NASDAQ’s review of Marvell’s plan of compliance and the timing and outcome of any NASDAQ decision. For other factors that could cause actual results to vary from expectations, please see the sections titled “Risk Factors” in Marvell’s quarterly report on Form 10-Q for the fiscal quarter ended May 2, 2015 and other factors detailed from time to time in Marvell’s filings with the SEC. Marvell undertakes no obligation to revise or update publicly any forward-looking statements.

About Marvell

Marvell (NASDAQ: MRVL) is a global leader in providing complete silicon solutions and Kinoma® software enabling the “Smart Life and Smart Lifestyle.” From storage to Internet of Things (IoT), cloud infrastructure, digital entertainment and in-home content delivery, Marvell’s diverse product portfolio aligns complete platform designs with industry-leading performance, security, reliability and efficiency. At the core of the world’s most powerful consumer, network and enterprise systems, Marvell empowers partners and their customers to always stand at the forefront of innovation, performance and mass appeal. By providing people around the world with mobility and ease of access to services adding value to their social, private and work lives, Marvell is committed to enhancing the human experience.

As used in this release, the term “Marvell” and the “Company” refers to Marvell Technology Group Ltd. and its subsidiaries. For more information, please visit www.Marvell.com.

Marvell® and the Marvell logo are registered trademarks of Marvell and/or its affiliates.

(OCLS) Introduces MicrocynAH Next-Generation Dermatology Products

PETALUMA, Calif., Sept. 24, 2015  — Oculus Innovative Sciences, Inc. (NASDAQ:OCLS) (tradable warrants OCLSW), a specialty pharmaceutical company that develops and markets solutions for the treatment of dermatological conditions and advanced tissue care in both humans and animals, today announced the introduction of two new MicrocynAH® dermatology products for animals. MicrocynAH® Anti-Itch Spray Gel and MicrocynAH® Hot Spot Spray Gel both contain the soothing dimethicone skin protectant in combination with the patented Microcyn® Technology, which is supported by 45 patents and over 30 clinical studies worldwide. They effectively help to relieve the pain and itch of skin irritations, lacerations, abrasions and minor burns and are also cleared for the management of irritation and pain from minor sunburn.

“This major advance in MicrocynAH animal dermatology products is most significant,” said Dan McFadden, vice president of animal wellness for Oculus Innovative Sciences. “Now, for the first time ever, consumers will have available to them a unique and patented dermatology spray gel with dimethicone for the management of hot spots and pruritus that is proven effective. These next-generation products relieve the itch and pain associated with annoying skin afflictions in all animals including dogs, cats, horses, rabbits, exotics and even livestock.”

For more information or to order in the United States, distributors and retailers can phone SLA Brands at (415) 747-1001. More information and a consumer online store are also available at www.microcynah.com.

Hot Spots and Itching

Hot spots, also known as acute moist dermatitis, are red, moist, hot and irritated lesions that are typically found on a dog’s head, hip or chest area. Hot spots often grow at an alarming rate within a short period of time because dogs tend to lick, chew and scratch the affected areas, further irritating the skin. Hot spots can become quite painful. Anything that irritates the skin and causes a dog to scratch or lick himself can start a hot spot. Hot spots can be caused by allergic reactions, insect, mite or flea bites, poor grooming, underlying ear or skin infections and constant licking and chewing prompted by stress or boredom.

Itching or pruritus is an unpleasant sensation within the skin that provokes the desire to scratch. Itching is a sign, not a diagnosis or specific disease. The most common causes of itching are parasites, infections and allergies.  Itching may develop because of secondary bacterial or yeast infections.

Animal Healthcare Market

According to the Freedonia Group, an international industry market research firm, the demand for animal health products in the United States is forecast to increase 3.9% annually to $12.7 billion in 2016. Animal healthcare is a relatively recession-resistant industry as it is regarded as a necessary expense of animal ownership or husbandry. Furthermore, as pet owners increasingly treat their companion animals as members of the family, pets’ lifespans will continue to lengthen, driving strong sales of health products.

About Oculus Innovative Sciences, Inc.

Oculus Innovative Sciences is a specialty pharmaceutical company that develops and markets solutions for the treatment of dermatological conditions and advanced tissue care. The company’s products, which are sold throughout the United States and internationally, have improved outcomes for more than five million patients globally by reducing infections, itch, pain, scarring and harmful inflammatory responses. The company’s headquarters are in Petaluma, California, with manufacturing operations in the United States and Latin America. European marketing and sales are headquartered in Roermond, Netherlands. More information can be found at www.oculusis.com.

Forward-Looking Statements

Except for historical information herein, matters set forth in this press release are forward-looking within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including statements about the commercial and technology progress and future financial performance of Oculus Innovative Sciences, Inc. and its subsidiaries (the “company”). These forward-looking statements are identified by the use of words such as “introduces” and “available,” among others. Forward-looking statements in this press release are subject to certain risks and uncertainties inherent in the company’s business that could cause actual results to vary, including such risks that regulatory clinical and guideline developments may change, scientific data may not be sufficient to meet regulatory standards or receipt of required regulatory clearances or approvals, clinical results may not be replicated in actual patient settings, protection offered by the company’s patents and patent applications may be challenged, invalidated or circumvented by its competitors, the available market for the company’s products will not be as large as expected, the company’s products will not be able to penetrate one or more targeted markets, revenues will not be sufficient to fund further development and clinical studies, the company may not meet its future capital needs, the company may not be able to obtain additional funding, as well as uncertainties relative to varying product formulations and a multitude of diverse regulatory and marketing requirements in different countries and municipalities, and other risks detailed from time to time in the company’s filings with the Securities and Exchange Commission including its annual report on Form 10-K for the year ended March 31, 2015. The company disclaims any obligation to update these forward-looking statements, except as required by law.

Oculus®, MicrocynAH® and Microcyn® Technology are trademarks or registered trademarks of Oculus Innovative Sciences, Inc. All other trademarks and service marks are the property of their respective owners. High-resolution product photos are available. Please call or email request.

CONTACT: Media and Investor Contact:

         Oculus Innovative Sciences, Inc.
         Dan McFadden
         VP of Animal Wellness
         (425) 753-2105
         dmcfadden@oculusis.com

(AIQ) Provides Business Update

Alliance HealthCare Services, Inc. (NASDAQ:AIQ) (the “Company” or “Alliance”), a leading national provider of outsourced diagnostic imaging through its Alliance HealthCare Radiology Division (“Alliance Radiology”), interventional radiology & pain management services through its Interventional Services Division (“Alliance HealthCare Interventional Partners”) and radiation therapy services through its Alliance HealthCare Oncology Division (“Alliance Oncology”), announced today that it is affirming the guidance issued for its fiscal year 2015 and is pleased to provide a business update to its shareholders.

Recent Business Highlights

• Growth strategy for the core business remains intact and the Company affirms 2015 fiscal year guidance
• Purchase of majority interest by Fujian Thai Hot Investment Co., Ltd (“Thai Hot”)
• Expects to appoint three new board members from Thai Hot including Kisum Wong, Yong Ge and Tao Zhang

Full Year 2015 Guidance

Alliance is affirming its full year 2015 guidance as noted in its second quarter 2015 earnings call on August 6, 2015. Tom Tomlinson, Chief Executive Officer and President of Alliance HealthCare Services, stated, “The recent news regarding a change in ownership for approximately 51.5% of the company’s shares does not imply a change in strategic direction or financial outlook for the company. As we noted in last week’s press release related to the sale of shares by Oaktree Capital Management, L.P. (‘Oaktree’) and other parties, the company remains very focused on executing the strategic initiatives in the U.S. that we have previously articulated. In making its investment, Thai Hot performed extensive due diligence utilizing world-class advisors and confirmed their strong support for the company’s strategic direction and leadership.”

Tomlinson continued, “While we view the transaction between Oaktree and Thai Hot as a positive development for the Company, we see it primarily as an investor event more than a company event. As clearly evidenced by the progress we are making in returning Alliance to growth, as we have discussed on recent earnings calls, the leadership team remains confident in our strategy and execution. Based on discussions with the prospective new Board members, we will remain focused on the strategic growth plan we have outlined as we strive to create long-term value for our shareholders. To reiterate, the key components of this plan include (1) leveraging our strong value proposition and pipeline in our oncology business to drive continued strong growth in that business, (2) deploying our expanded radiology offering, called RAD360™, through new and existing hospital relationships, and (3) expanding our newest platform, Alliance HealthCare Interventional Partners, across both new and existing geographic markets.”

Further Background on Fujian Thai Hot Investment Co., Ltd

As previously announced on September 16, 2015, Fujian Thai Hot Investment Co., Ltd (“Thai Hot”) agreed to purchase approximately 51.5% of the outstanding common stock of the Company. Thai Hot is an investment holding company with a diversified portfolio of assets in various industries including investments in biomedicine and healthcare with assets totaling more than $1 billion dollars. Thai Hot’s healthcare investments include a controlling ownership of 92.5% of the total equity in Fujian Huitian Biomedicine Company, which is a large-scale pharmaceutical company with more than 80 kinds of active pharmaceutical ingredients and drugs. Thai Hot also has strong relationships with premier hospitals in China, including the General Hospital of Chinese Liberation Army and Beijing Union Medical College Hospital. Management does not believe that any of Thai Hot’s investments create any conflicts for the Company.

Thai Hot Investment is also the majority shareholder of Thai Hot Group, a listed company on the Shenzhen Stock Exchange. It holds 609,400,795 shares, accounting for 59.91% of Thai Hot Group’s total equity. Thai Hot Group is a company with its core focus on real estate development with additional investments in the finance, fluorine chemical engineering and mining industries. Annual revenue for 2015 is expected to exceed approximately $4.7 billion.

Kisum Wong, the founder and Chairman of the Thai Hot Group, explained the rationale for Thai Hot’s investment in Alliance. “We made our strategic investment in Alliance primarily because of our assessment of the strong growth opportunities present in the U.S. healthcare market. Based on our due diligence, we believe that Alliance, with its 1,000 hospital customer relationships, is uniquely positioned to capitalize on this growth. We have a strong conviction that Tom and his team will execute upon their strategic plan and drive value for all shareholders.”

Mr. Tomlinson added, “Alliance has a bright future with compelling growth opportunities in its core markets. We welcome the new board members from Thai Hot and look forward to continuing to work closely with the Board to determine the best ways to maximize long-term shareholder value, which may include capitalizing on opportunities in China and other global markets.”

Anticipated New Board Members

Kisum Wong is the founder and Chairman of the Thai Hot Group, a company he founded approximately 19 years ago. He has also served as Chairman and general manager of Thai Hot since March 2013 and is expected to be appointed Non-Executive Chairman of the Board for Alliance. The current Chairman of the Board, Larry C. Buckelew, will continue to serve on the Board of Directors. Mr. Wong has been a representative of the 12th National Committee of the Chinese People’s Political Consultative Conference since February 2013, and is also the Vice President of the Fujian Chamber of Commerce, and Director of Fujian Haixia Bank. Mr. Wong has a BA in engineering from Fuzhou University.

Yong Ge and Dr. Tao Zhang will also be appointed to the Board together with Chairman Wong and will replace Michael P. Harmon, Curtis S. Lane and Aaron A. Bendikson. Mr. Ge has been the deputy general manager of Thai Hot Group since February 2014. Previously, Mr. Ge was the deputy general manager of Dalian Zhonggeng Real Estate Development Co. Ltd. from 2008 to 2010 and assistant to the president of Fujian Junshi Energy Co. Ltd. from 2010 to 2012.

Dr. Zhang founded United Pacific Healthcare in August 2014 in order to capitalize on the dynamic growth opportunities in the Chinese healthcare marketplace. Previously, Dr. Zhang worked directly under Dr. Thomas Frist, Jr., the co-founder of HCA, for six years, three years of which Dr. Zhang was in the U.S. on a part time basis. Dr. Zhang spent the remaining three years in China as the full-time chairman and CEO of CHC, Dr. Frist’s China venture in the healthcare delivery sector. Dr. Zhang earned his MD degree in China and underwent cardiac surgery training for three years before he joined CITIC Pacific in 2001. Dr. Zhang worked at CITIC Pacific for four years in the healthcare division and invested and built two of the top ten private hospitals in China. Dr. Zhang also holds an MBA and a Master’s Degree in Health Sector Management from Duke University.

About Alliance HealthCare Services

Alliance HealthCare Services (NASDAQ: AIQ) is a leading national provider of outsourced healthcare services with a 30+ year track record of award-winning patient care/satisfaction and service line expertise. Providing diagnostic radiology services through its Radiology Division (Alliance HealthCare Radiology), interventional radiology & pain management services through its Interventional Services Division (Alliance HealthCare Interventional Partners) and radiation oncology services through its Oncology Division (Alliance HealthCare Oncology), Alliance is the nation’s largest provider of advanced diagnostic mobile imaging services, an industry-leading operator of fixed-site imaging centers, and a leading provider of stereotactic radiosurgery nationwide. As of June 30, 2015, Alliance operated 522 diagnostic imaging and radiation therapy systems, including 117 fixed-site imaging centers across the country; and 32 radiation therapy centers and stereotactic radiosurgery (SRS) facilities. With a strategy of partnering with hospitals, health systems and physician practices, Alliance provides quality clinical services for over 1,000 hospitals and other healthcare partners in 44 states where approximately 1,800 Alliance Team Members are committed to providing exceptional patient care and exceeding customer expectations. For more information, visit www.alliancehealthcareservice-us.com.

About Fujian Thai Hot Investment

Thai Hot is an investment holding company based in Fuzhou, China holding a diversified portfolio of assets in various industries including real estate development, securities, hospitality, biomedicine and fluorine. They were founded in 1996 and have assets exceeding $10 billion as of December 31, 2014 which includes subsidiary investments traded on the Shenzhen Stock Exchange and Shanghai Stock Exchange. In early 2015, Thai Hot made healthcare and medical services one of its top priorities, including radiology and oncology, and it intends to expand healthcare services in mainland China to an underserved healthcare marketplace.

Forward-Looking Statements

This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements relate to, without limitation, the director appointments to the Company’s board of directors, the expected closing of the transaction and the Company’s competitive position, long-term value proposition, growth and international market and other opportunities. Forward-looking statements can be identified by the use of forward looking language such as “believe,” “anticipate,” “expect,” “estimate,” “intend,” “plan,” “project,” “will be,” “will continue,” “will result,” “could,” “may,” “might,” or any variations of such words with similar meanings. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. These statements involve risks and uncertainties that could cause actual results to differ materially from those projected. For a complete list of risks and uncertainties, please refer to the Risk Factor section of the Company’s Form 10-K for the year ended December 31, 2014 filed with the Securities and Exchange Commission.

(ORMP) Patent Allowed in the US for Oral Administration of Proteins

JERUSALEM, September 24, 2015  —

Oramed Pharmaceuticals Inc. (NASDAQ: ORMP) (http://www.oramed.com), a developer of oral drug delivery systems, announced today that the Company’s patent for its invention, titled “Methods and Compositions for Oral Administrations of Proteins” has been allowed by the United States Patent and Trademark Office.

Nadav Kidron, CEO of Oramed, stated, “This is an important milestone which paves our entrance into the US diabetes market which is the largest single diabetes market worldwide.”

About ORMD-0801 Capsule for Type 2 Diabetes

ORMD-0801 has the potential to create a new paradigm in the treatment of diabetes by oral delivery of insulin at an earlier stage of treatment, potentially slowing disease progression and delaying or even eliminating late-stage complications. Orally administered insulin should bring with it enhanced patient compliance. In addition, intestinally absorbed-oral insulin actually mimics insulin’s natural location and gradients in the body by first passing through the liver before entering the bloodstream.

About Oramed Pharmaceuticals

Oramed Pharmaceuticals is a technology pioneer in the field of oral delivery solutions for drugs currently delivered via injection. Established in 2006, Oramed’s Protein Oral Delivery (POD^[TM]) technology is based on over 30 years of research by top scientists at Jerusalem’s Hadassah Medical Center. Oramed is seeking to revolutionize the treatment of diabetes through its proprietary flagship product, an orally ingestible insulin capsule (ORMD-0801).  Having completed multiple Phase IIa clinical trials, the company has started its Phase IIb on type 2 diabetes under an Investigational New Drug application with the U.S. Food and Drug Administration. In addition the company is developing an oral GLP-1 analog capsule (ORMD-0901).

For more information, the content of which is not part of this press release, please visit http://www.oramed.com

Forward-looking statements: This press release contains forward-looking statements. For example, we are using forward-looking statements when we discuss that our US patent is an important milestone which paves our entrance into the US diabetes market, that ORMD-0801 has the potential to create a new paradigm in the treatment of diabetes, potentially slowing disease progression and delaying or even eliminating late-stage complications, that orally administered insulin should bring with it enhanced patient compliance or revolutionizing the treatment of diabetes with our products. These forward-looking statements are based on the current expectations of the management of Oramed only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements, including the risks and uncertainties related to the progress, timing, cost, and results of clinical trials and product development programs; difficulties or delays in obtaining regulatory approval or patent protection for our product candidates; competition from other pharmaceutical or biotechnology companies; and our ability to obtain additional funding required to conduct our research, development and commercialization activities. In addition, the following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; delays or obstacles in launching our clinical trials; changes in legislation; inability to timely develop and introduce new technologies, products and applications; lack of validation of our technology as we progress further and lack of acceptance of our methods by the scientific community; inability to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties that may develop with our process; greater cost of final product than anticipated; loss of market share and pressure on pricing resulting from competition; laboratory results that do not translate to equally good results in real settings; our patents may not be sufficient; and final that products may harm recipients, all of which could cause the actual results or performance of Oramed to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Oramed undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Oramed, reference is made to Oramed’s reports filed from time to time with the SEC.

Company Contact
Oramed Pharmaceuticals
Ariella Vaystooch
Office: +972-2-566-0001 ext. 2
US: +1-718-831-2512 ext. 2
Email: ariella@oramed.com

(CUR) Investigator to Provide Update on ALS and Alzheimer’s

GERMANTOWN, Md., Sept. 24, 2015  — Neuralstem, Inc. (Nasdaq: CUR), a biopharmaceutical company using neural stem cell technology to develop small molecule and cell therapy treatments for central nervous system diseases, announced that principal investigator, Eva Feldman, MD, PhD, will give an update on NSI-566 Phase I and Phase II trial data in amyotrophic lateral sclerosis (ALS) at the American Neurological Association Annual Meeting in Chicago, Il on Monday, September 28, 2015.

Dr. Feldman will review the current state of cell-based therapies being studied for the treatment of neurological disorders, including Neuralstem’s NSI-566, an investigational spinal cord-derived stem cell therapy in development for ALS, in “The Current State of Stem Cell Therapies” session. The Phase I and II trials are the first in the world to use intraspinal stem cell transplantation. She will also discuss NSI-532.IGF, Neuralstem’s next-generation cell therapy for Alzheimer’s disease, at the meeting as part of the “Dementia and Aging” special interest group symposium. Dr. Feldman is Director of the A. Alfred Taubman Medical Research Institute and Director of Research of the ALS Clinic at the University of Michigan Health System, and an unpaid consultant to Neuralstem.

Dr. Feldman will appear within the following ANA sessions:

Interactive Lunch Workshop: Current State of Stem Cell Therapies
Monday, September 28, 2015 – 11:45am to 1:00pm

Special Interest Group Symposia 3: Dementia and Aging
Monday, September 28, 2015 – 3:30pm to 5:30pm

• Data Blitz Presentation featuring Dr. Feldman (5:20 – 5:30 pm):  Human Neural Stem Cells Expressing IGF-1: A Novel Cellular Therapy for Alzheimer’s Disease

About Neuralstem

Neuralstem’s patented technology enables the commercial-scale production of multiple types of central nervous system stem cells, which are under development for the potential treatment of central nervous system diseases and conditions.

Neuralstem’s ability to generate human neural stem cell lines for chemical screening has led to the discovery and patenting of compounds that Neuralstem believes may stimulate the brain’s capacity to generate neurons, potentially reversing pathologies associated with certain central nervous system (CNS) conditions. The company has completed Phase Ia and Ib trials evaluating NSI-189, its first neurogenic small molecule product candidate, for the treatment of major depressive disorder (MDD), and is expecting to initiate a Phase II study for MDD and a Phase Ib study for cognitive deficit in schizophrenia in 2015.

Neuralstem’s first stem cell product candidate, NSI-566, a spinal cord-derived neural stem cell line, is under development for treatment of amyotrophic lateral sclerosis (ALS). Neuralstem has completed two clinical studies, in a total of thirty patients, which met primary safety endpoints. In addition to ALS, NSI-566 is also in a Phase I trial in chronic spinal cord injury at UC San Diego School of Medicine, as well as in clinical development to treat ischemic stroke.

Neuralstem’s next generation stem cell product, NSI-532.IGF, consists of human cortex-derived neural stem cells that have been engineered to secrete human insulin-like growth factor 1 (IGF-1). In animal data presented at the Congress of Neurological Surgeons 2014 Annual Meeting, the cells rescued spatial learning and memory deficits in an animal model of Alzheimer’s disease.

For more information, please visit www.neuralstem.com or connect with us on Twitter, Facebook and LinkedIn.

Cautionary Statement Regarding Forward Looking Information:

This news release contains “forward-looking statements” made pursuant to the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements relate to future, not past, events and may often be identified by words such as “expect,” “anticipate,” “intend,” “plan,” “believe,” “seek” or “will.” Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Specific risks and uncertainties that could cause our actual results to differ materially from those expressed in our forward-looking statements include risks inherent in the development and commercialization of potential products, uncertainty of clinical trial results or regulatory approvals or clearances, need for future capital, dependence upon collaborators and maintenance of our intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements. Additional information on potential factors that could affect our results and other risks and uncertainties are detailed from time to time in Neuralstem’s periodic reports, including the Annual Report on Form 10-K for the year ended December 31, 2014, and Form 10-Q for the three and six months ended June 30, 2015, filed with the Securities and Exchange Commission (SEC), and in other reports filed with the SEC.

(BLPH) Positive Data From Interim Analysis of Phase 2 Long-Term Extension Study of INOpulse

Conference Call/Webcast to Be Held September 25, 2015 at 9:00am ET

Interim Data Reinforces Earlier Phase 2 Data and Indicates Sustainability of Benefits for PAH Patients

FDA Issues a Special Protocol Assessment (SPA) for Phase 3 PAH Program

HAMPTON, N.J., Sept. 24, 2015  — Bellerophon Therapeutics, Inc. (Nasdaq:BLPH), a clinical-stage biotherapeutics company, today announced positive data from an interim analysis of the Company’s Phase 2 long-term extension study of INOpulse for the treatment of Pulmonary Arterial Hypertension (PAH) (Part 2 of the Company’s Phase 2 trial). The data reinforce the results from Part 1 of the Phase 2 trial and indicate a sustainability of benefit to PAH patients who received INOpulse therapy. Bellerophon also reported today that the U.S. Food and Drug Administration (FDA) has issued a Special Protocol Assessment (SPA) for the Company’s Phase 3 PAH program for INOpulse, which will include two confirmatory clinical trials, undertaken either sequentially or in parallel, with the first patient expected to be enrolled later this year. A conference call to discuss today’s news will be held tomorrow, Friday, September 25, 2015 at 9:00am ET. Details on the conference call are provided below.

Data From Interim Analysis

Following 16 weeks of blinded therapy in Part 1 of the trial, in Part 2 of the trial 65 patients were randomized to receive INOpulse doses of either 25 or 75 mcg/kg ideal body weight per hour (iNO 25 or iNO 75). The interim analysis was performed after patients had completed between 8 and 12 months of INOpulse treatment, and data from the interim analysis was compared to baseline measurements taken at the beginning of Part 1 of the trial. All patients in the trial were on at least one approved PAH therapy, and several were on two or three PAH therapies.

The interim analysis showed the following:

• The 20 patients who were on Long-Term Oxygen Therapy (LTOT) in the iNO 75 dose treatment arm completed the six minute walk distance test (6MWD) and had a mean improvement of 31.6 meters as compared to baseline;
• Ten of the 20 LTOT patients in the iNO 75 dose treatment arm demonstrated at least a 50 meter improvement in 6MWD as compared to baseline; and
• Eleven of the 20 LTOT patients in the iNO 75 dose treatment arm remained on INOpulse therapy for at least 12 hours a day, and these patients had an even greater mean improvement of 41.6 meters as compared to baseline.

A total of 14 LTOT patients in the iNO 75 dose treatment arm  underwent right heart catheterizations, which showed a mean improvement in pulmonary vascular resistance (PVR) — the primary endpoint in Part 1 of the Phase 2 trial — of 87.3 dynes.sec.cm-5. LTOT patients randomized from placebo to iNO 75 in Part 2 did particularly well.

Moreover, LTOT patients in the iNO 75 dose treatment arm also showed an overall improvement in WHO Functional Classification.

The Company also reported that LTOT patients in the iNO 25 dose treatment arm who remained on therapy for 8-12 months in the long-term extension study showed an improvement in 6MWD and PVR though less significant than LTOT patients in iNO 75 dose treatment arm. Patients who were not on LTOT in both treatment arms had mixed results over the same period.

Jonathan Peacock, Chairman and Chief Executive Officer of Bellerophon Therapeutics, stated, “The interim analysis is very encouraging for PAH patients, as the data indicates a clinically significant and sustained benefit for patients on the higher iNO 75 dose, when combined with Long-Term Oxygen Therapy. More specifically, the analysis supports the hypothesis, generated from Part 1 of the Phase 2 study, that the optimal benefit of INOpulse is with the iNO 75 dose in patients on LTOT who stay on therapy for at least 12 hours each day. The SPA recently issued by the FDA for our Phase 3 program, and agreed to by the European Medicines Agency through a Scientific Advice Working Party, is well aligned with these findings.”

Phase 3 Development Program

The key elements of the planned U.S. and EU Phase 3 development program are:

• The Phase 3 program will consist of two clinical trials totaling 450 patients; one trial with two treatment arms (iNO 75 and placebo) and one with three treatment arms (iNO 75, iNO 50 and placebo). Each treatment arm will consist of approximately 90 patients.
• All patients in the trials will be on LTOT.
• The primary endpoint is improvement in 6MWD compared to placebo after 16 weeks.
• The secondary endpoint is Time to Clinical Worsening (TTCW), with analysis pooled across both trials. Patients will stay on therapy until the last patient visit measuring 6MWD.
• Each trial is 90% powered for a 40 Meter improvement in 6MWD compared to placebo and for a positive trend on TTCW.
• Each trial will have a run-in period of two weeks to ensure compliance. Patients who do not stay on the therapy for at least 16 hours a day during this period will be replaced.

The Phase 3 trials will utilize the second-generation INOpulse Mark 2 device, which is considerably smaller and lighter (approximately 2.5 lbs.) than the original INOpulse device used in the Phase 2 study (approximately 7.5 lbs.).  In addition to the significant reduction in size and weight, the INOpulse Mark 2 device also has an improved user interface and better breath detection technology, made possible by the Company’s proprietary tri-lumen cannula.

Conference Call and Audio Webcast Details

Management will hold a conference call tomorrow, Friday, September 25, 2015, to discuss today’s announcement.

Time: 9:00 am ET
Dial-in numbers: (855) 539-0895 (U.S. and Canada) or (412) 455-6027 (Outside U.S. and Canada)
Conference ID: 46225664
Live webcast: www.bellerophon.com, under “Investors” tab

The teleconference replay will be available three hours after completion through September 30, 2015 at (855) 859-2056 or (404) 537-3406. The replay passcode is 46225664.

About Pulmonary Arterial Hypertension

Pulmonary Arterial Hypertension (PAH) is a rare, chronic and currently incurable disease that causes the walls of the arteries of the lungs to tighten and stiffen. Estimates suggest that there are about 15,000 patients diagnosed with PAH in the United States and about 20,000 diagnosed patients in Europe. In PAH patients, the right side of the heart has to work harder to pump blood through narrowed arteries in the lungs, which can decrease blood flow through the body. Eventually, the extra stress causes the heart to enlarge and become less flexible, further compromising its ability to pump blood out of the heart, through the lungs, and into the rest of the body. Patients with PAH have symptoms ranging from dizziness and fainting to shortness of breath during exercise. This range of symptoms, combined with the rare nature of the condition, often makes diagnosis difficult, and many PAH patients are not diagnosed until the disease has progressed.  According to Thenappan et al, European Respiratory Journal 2007, even with today’s currently available therapies, the average mortality remains high, at 60% after five years.

About Bellerophon

Bellerophon Therapeutics is a clinical-stage biotherapeutics company focused on developing innovative therapies at the intersection of drugs and devices that address significant unmet medical needs in the treatment of cardiopulmonary and cardiac diseases. The Company is currently developing two product candidates under its INOpulse® program, a proprietary pulsatile nitric oxide delivery device. The first is for the treatment of pulmonary arterial hypertension (PAH), for which the Company intends to commence Phase 3 clinical trials in 2015, and the other for the treatment of pulmonary hypertension associated with chronic obstructive pulmonary disease (PH-COPD), which is in Phase 2 development. The Company’s plans also call for the completion of further work on the use of INOpulse to treat Pulmonary Hypertension associated with COPD and Idiopathic Pulmonary Fibrosis during 2016. Additionally, management is reviewing alternative paths forward for its Bioabsorbable Cardiac Matrix program. For more information, please visit www.bellerophon.com.

Forward-looking Statements

Any statements in this press release about Bellerophon’s future expectations, plans and prospects, including statements about the clinical development of its product candidates, regulatory actions with respect to the Company’s clinical trials and expectations regarding the sufficiency of the Company’s cash balance to fund clinical trials, operating expenses and capital expenditures, 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: the uncertainties inherent in the initiation of future clinical trials, availability and timing of data from ongoing and future clinical trials and the results of such trials, whether preliminary or interim results from a clinical trial will be predictive of the final results of that trial or whether results of early clinical trials will be indicative of the results of later clinical trials, expectations for regulatory approvals, the FDA’s substantial discretion in the approval process, availability of funding sufficient for our foreseeable and unforeseeable operating expenses and capital expenditure requirements and other factors discussed in the “Risk Factors” section of the Company’s most recent filings with the Securities and Exchange Commission. In addition, any forward-looking statements included in this press release represent Bellerophon’s views only as of the date of this release and should not be relied upon as representing the Company’s views as of any subsequent date. The Company specifically disclaims any obligation to update any forward-looking statements included in this press release.

CONTACT: At Bellerophon:
         Amy Edmonds, Vice President
         Head of Clinical Operations &
         Administration
         (908) 574-4765

         At Rx Communications Group:
         Melody Carey
         (917) 322-2571

(SYRX) LG Electronics MobileCom, Sprint, Sysorex to Sponsor Go Mobile 2015 Conference

LG’s Leading Role in Go Mobile 2015 Signifies Its Commitment to Enterprise IT and Mobile Decision-Makers

(FNJN) USPTO Grants 23rd US Patent to Finjan for Malicious Mobile Code Protection

Bolstering Patent Coverage for Technologies Used in Cloud Enabled Cybersecurity Platforms

(PULM) to Report Clinical Data on PUR0200 in Patients with COPD

– Results to be Presented September 29th at 2015 European Respiratory Society Congress –

LEXINGTON, Mass., Sept. 23, 2015  — Pulmatrix, Inc. (NASDAQ: PULM) will report data from a Phase 1B study evaluating PUR0200, an iSPERSE formulation of a long acting muscarinic antagonist (LAMA) bronchodilator, on September 29^th at the 2015 European Respiratory Society Congress. PUR0200 is being developed under the PK bio-equivalence pathway in Europe.

The two-part, single dose, placebo controlled dose-ranging clinical study in 38 patients was designed to evaluate the pharmacokinetics (PK), pharmacodynamics (PD) and safety and tolerability of PUR0200 compared to the reference product, a once daily LAMA bronchodilator. The main phase of the study was a 5-period crossover design with each patient receiving 3, 6, and 9 micrograms of PUR0200, 18 micrograms of the reference product, and an inhalation of placebo. PK results demonstrated that administration of PUR0200 resulted in dose proportional increases in plasma drug levels and all doses of PUR0200 improved pulmonary function compared to the placebo.  Further, inhalation of PUR0200 3 micrograms resulted in similar PK and PD as the reference at a nominal dose that is 80% less than the reference product, demonstrating the delivery advantages of the iSPERSE™ technology.  All doses of PUR0200 were safe and well tolerated.

Additional data from the study will be presented by David Hava, Ph.D., Chief Scientific Officer of Pulmatrix in a poster presentation. Details of the presentation are as follows:

About Pulmatrix

Pulmatrix is a clinical stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary disease using its patented iSPERSE™ technology. The Company’s proprietary product pipeline is focused on advancing treatments for rare diseases, including PUR1900, an inhaled anti-fungal for patients with cystic fibrosis (CF), as well as PUR1500, an inhaled product for the treatment of idiopathic pulmonary fibrosis. In addition, Pulmatrix is pursuing opportunities in major pulmonary diseases through collaborations, including PUR0200, a branded generic in clinical development for chronic obstructive pulmonary disease (COPD).  Pulmatrix’s product candidates are based on iSPERSE™, its proprietary dry powder delivery platform, which seeks to improve therapeutic delivery to the lungs by maximizing local concentrations and reducing systemic side effects to improve patient outcomes.

(CTIC) To Submit NDA For Pacritinib In Q4

– Decision Follows Pre-NDA Meeting with the FDA to Request Accelerated Approval for Patients with Myelofibrosis and Low Platelet Counts – – Accelerated Approval to Be Requested Based on Single Trial, Potentially Reducing Time to Market –

SEATTLE, Sept. 23, 2015  — CTI BioPharma Corp. (CTI BioPharma) (NASDAQ and MTA: CTIC) today announced its plan to submit a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) following a productive pre-NDA meeting for pacritinib, an investigational oral kinase inhibitor with specificity for JAK2, FLT3, IRAK1 and CSF1R. The company expects to submit the NDA in the fourth quarter of 2015 and to request accelerated approval for the treatment of patients with intermediate and high-risk myelofibrosis with low platelet counts of less than 50,000 per microliter (<50,000/uL). The NDA will be based primarily on data from the PERSIST-1 Phase 3 trial – as well as data from Phase 1 and 2 studies of pacritinib – and additional information requested by the FDA, including a separate study report and datasets for the specific patient population with low platelet counts of less than 50,000 per microliter (<50,000/uL) for whom there are no approved drugs. Submission of an NDA after a single Phase 3 trial under accelerated approval, instead of waiting to complete two Phase 3 trials, could potentially reduce time to market by up to 14 months.

Myelofibrosis is a rare and serious chronic blood cancer that can affect patients of all ages with a median age of 65 years, with an estimated prevalence in the United States of approximately 18,000 patients.

“This improved timing on the plan to submit an NDA – which is supported by data after completion of the PERSIST-1 trial – will allow us the potential for making pacritinib available to patients with low platelet counts earlier than expected,” said James A. Bianco, M.D., President and CEO of CTI BioPharma. “We look forward to working with the FDA on the submission and review of this application.”

PERSIST Update
Pacritinib is currently being evaluated in two Phase 3 clinical trials, known as the PERSIST program, for patients with myelofibrosis. PERSIST-1 is a randomized, open-label, multicenter Phase 3 trial comparing the efficacy and safety of pacritinib with that of best available therapy (exclusive of a JAK inhibitor) in 327 enrolled patients with myelofibrosis (primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis), regardless of the patients’ platelet counts. PERSIST-2 is a randomized, open-label, multicenter Phase 3 clinical trial evaluating pacritinib compared to best available therapy (BAT), including the approved JAK1/JAK2 inhibitor dosed according to product label for patients with myelofibrosis whose platelet counts are less than or equal to 100,000 per microliter. In October 2013, CTI BioPharma reached agreement with the FDA on a Special Protocol Assessment (SPA) for the PERSIST-2 trial. The SPA is a written agreement between CTI BioPharma and the FDA regarding the design, endpoints and planned statistical analysis approach of the trial to be used in support of a potential NDA submission. The design of PERSIST-1 and PERSIST-2 allows for patients on the BAT arm to crossover and receive treatment with pacritinib if their disease progresses or after they achieve the 24-week measurement endpoint. Although crossover design of clinical trials may confound evaluation of survival, such designs are frequently used in cancer studies, and the FDA has approved multiple oncology drugs that utilized crossover design in Phase 3 trials. The Independent Data Monitoring Committee (IDMC) for the PERSIST program recommended patients on the best available therapy arm should not crossover to receive pacritinib due to non-statistically significant safety concerns in patients who crossover after 24 weeks, which crossover confounds evaluation of survival. After receiving input from external independent experts and providing the FDA the PERSIST-1 data, IDMC’s recommendation and correspondence, CTI BioPharma and Baxalta notified the FDA of the decision to proceed per protocol. Following a written response in lieu of a Type C meeting with the FDA, CTI BioPharma and Baxalta determined that no modifications to the ongoing trials were required. Enrollment in PERSIST-2, which is designed to enroll up to 300 patients in North America, Europe, Australia, New Zealand and Russia is continuing. Based on current timelines, PERSIST-2 enrollment is expected to be completed in the first quarter of 2016. Additional details on PERSIST-2 are available at www.clinicaltrials.gov or www.PERSISTprogram.com.

About Pacritinib
Pacritinib is an investigational oral kinase inhibitor with specificity for JAK2, FLT3, IRAK1 and CSF1R. In August 2014, pacritinib was granted Fast Track designation by the FDA for the treatment of intermediate and high risk myelofibrosis, including but not limited to patients with disease-related thrombocytopenia, patients experiencing treatment-emergent thrombocytopenia on other JAK2 inhibitor therapy, or patients who are intolerant of, or whose symptoms are sub-optimally managed on other JAK2 inhibitor therapy. The FDA’s Fast Track process is designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. Pacritinib does not have regulatory approval and is not commercially available.

CTI BioPharma and Baxalta (NYSE:BXLT) are parties to a worldwide license agreement to develop and commercialize pacritinib. CTI BioPharma and Baxalta will jointly commercialize pacritinib in the U.S. while Baxalta has exclusive commercialization rights for all indications outside the U.S.

About CTI BioPharma
CTI BioPharma Corp. (NASDAQ and MTA: CTIC) is a biopharmaceutical company focused on the acquisition, development, and commercialization of novel targeted therapies covering a spectrum of blood-related cancers that offer a unique benefit to patients and healthcare providers. CTI BioPharma has a commercial presence in Europe and a late-stage development pipeline, including pacritinib, CTI BioPharma’s lead product candidate, which is currently being studied in a Phase 3 program for the treatment of patients with myelofibrosis. CTI BioPharma is headquartered in Seattle, Washington, with offices in London and Milan under the name CTI Life Sciences Limited. For additional information and to sign up for email alerts and get RSS feeds, please visit www.ctibiopharma.com.

Forward Looking Statements
This press release includes forward-looking statements related to pacritinib and related clinical trials conducted pursuant to a collaboration between CTI BioPharma Corp. and Baxalta Inc., which are within the meaning of the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. Such statements are subject to a number of risks and uncertainties, the outcome of which could materially and/or adversely affect actual future results and the trading price of the issuers’ securities. Such statements include, but are not limited to, statements regarding expectations with respect to the potential therapeutic utility of pacritinib and the prevalence of myelofibrosis in the United States, plans and intentions with respect to the submission of an NDA requesting accelerated approval in the fourth quarter of 2015 or any other regulatory filings in Europe and other locations outside the US, the ability of the PERSIST-1 and Phase 1 and Phase 2 trials and additional information about pacritinib requested by the FDA to support a potential regulatory submission on an accelerated basis or otherwise, CTI BioPharma’s ability to provide the FDA with the additional data and information requested, potential for making pacritinib available to patients with significant thrombocytopenia earlier than expected and to shorten the time to market for pacritinib by 14 months, the ability to complete enrollment for PERSIST-2 by in the first quarter 2016 and the ability of pacritinib to meet unmet medical needs and future regulatory, development and commercialization plans. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release and are based on assumptions about many important factors and information currently available to us to the extent we have thus far had an opportunity to evaluate such information in light of all surrounding facts, circumstances, recommendations and analyses. A number of results and uncertainties could cause actual results to differ materially from those in the forward-looking statements: CTI BioPharma’s NDA requesting accelerated approval for pacritinib may not be accepted by the FDA; additional pre-approval trials or post-approval Risk Evaluation and Mitigation Strategy (REMS) or Post-Marketing Requirements (PMR) may be required; satisfaction of regulatory and other requirements; clinical trial results; changes in laws and regulations; product quality, product efficacy, trial design and study protocol, data integrity, dataset size, patient safety issues, the smaller population size for the specific patient population; product development risks; and other risks identified in each issuer’s most recent filings on Form 10-K and other Securities and Exchange Commission filings. Except as required by law, CTI BioPharma undertakes to update its forward-looking statements.

CTI BioPharma Contact:
Monique Greer
206-272-4343
mgreer@ctibiopharma.com

(ZAGG) Debuts InvisibleShield Glass Luxe and Accessories for New Apple iPhones

ZAGG Offers Leading Screen Protection, Keyboards, Audio and Power Accessories for the New iPhone 6s and iPhone 6s Plus.

SALT LAKE CITY, Sept. 10, 2015  — ZAGG Inc (NASDAQ:ZAGG), a leading global mobile accessories company, announces a full range of accessories for the newest Apple smartphones, the iPhone™ 6s and iPhone 6s Plus. From top-selling screen protection and mobile keyboards to award-winning backup batteries and audio gear, Zagg is the leading brand for protecting and enhancing the iPhone experience.

“Zagg products are designed to bring out the best in Apple iPhones,” said Randy Hales, chief executive officer for Zagg. “Having the top-selling screen protection and keyboards as well as Zagg’s full range of power, audio, and cases have made us the go-to expert for outfitting Apple’s amazing phones and tablets.”

Along with its industry-leading InvisibleShield® HDX and InvisibleShield Glass screen protection, Zagg is introducing the InvisibleShield Glass Luxe^TM, which features enhanced, edge-to-edge durability and a seamless look from a polycarbonate border and high quality tempered glass shield. The glass maintains an ultra-smooth feel and precision touch sensitivity, ideal for the 3D Touch interactivity of the iPhone 6s and iPhone 6s Plus screens. Glass Luxe is available in multiple colors to accent the newly introduced smartphones.

All InvisibleShield products for the iPhone feature patented EZ Apply™ tabs for quick, easy application, and come with a lifetime guarantee. The InvisibleShield line includes:

• InvisibleShield Glass Luxe: Made of premium tempered glass and surrounded by a polycarbonate border, it provides edge-to-edge protection with maximum image clarity, an ultra-smooth feel, tapered edges, and remarkable touch sensitivity; available in coordinating with the new iPhones.
• InvisibleShield HDX: Features HD clarity and three-times greater shatter protection than most industry-leading phone glass. The InvisibleShield HDX also offers EZ Apply tabs for quick and simple application.
• InvisibleShield Glass: Made from multiple premium protective layers, including tempered scratch-resistant glass, it delivers ultimate image clarity with a silky smooth feel and unique tapered edges.

Zagg has a full range of accessories to complement the various Apple iPhone models. Examples include the Pocket Keyboard — the first mobile Bluetooth keyboard designed for smartphones — and a full range of power and audio products including the GoLite 2.0 and ZR-Six Earbuds. All Zagg’s accessories are available online at www.zagg.com or through Zagg’s select retail partners.

iPhone is a trademark of Apple Inc.

About ZAGG Inc:

ZAGG Inc (NASDAQ:ZAGG) creates best-in-class accessories that protect and enhance mobile devices for consumers around the globe. The company offers a broad range of products, from the No. 1 selling industry-standard InvisibleShield® screen protectors and mobile keyboards, to power management solutions, mobile audio, and cases. Zagg is the trusted brand that makes products consumers can rely on to make the most of their mobile lives. More information about the company and its brands, including iFrogz®, is available at www.zagg.com or on Facebook and Twitter.

CONTACT: Investor Relations:
         ZAGG Inc
         Kim Rogers
         801-506-7008
         kim.rogers@zagg.com

         Media:
         Edelman
         Jillian Gerig
         415-486-3222
         jillian.gerig@edelman.com

         Company:
         ZAGG Inc
         Nathan Nelson
         801-506-7341
         nnelson@zagg.com

(ACRX) European Commission Marketing Authorization for Zalviso

Approval triggers $15 million milestone payment to AcelRx from Grunenthal

REDWOOD CITY, Calif., Sept. 22, 2015  — AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX) (AcelRx) announced today that the European Commission (EC) has approved Zalviso™ (15 micrograms sufentanil sublingual tablets) for the management of acute moderate-to-severe post-operative pain in adult patients. The marketing authorization is granted for the 28 EU member states as well as for the European Economic Area (EEA) countries, Norway, Iceland and Liechtenstein. Zalviso is a system combining a drug and a device designed to deliver a sublingual tablet formulation of sufentanil 15 mcg via a proprietary, pre-programmed, non-invasive, patient-controlled analgesia (PCA) device. Grunenthal Group, AcelRx’s licensee in Europe and Australia, expects the product to be available to Western European patients in the first half of 2016.

“This is a significant event for AcelRx. Not only is this the Company’s first marketing approval, but it represents the successful development and commercialization of a product that we believe will provide a new way for physicians and their patients to treat acute moderate-to-severe post-operative pain using an innovative delivery method,” stated Howie Rosen, interim chief executive officer of AcelRx Pharmaceuticals. “Our partner Grunenthal will be working with the member states of the EU and EEA to ensure that Zalviso is made available to those patients who would benefit from an effective and reliable solution for their moderate-to-severe post-surgical pain.”

Zalviso is designed to offer sustained (for up to 72 hours) and reliable pain relief for acute moderate-to-severe post-operative pain. In a Phase 3 clinical trial in patients who had undergone major joint replacement or open abdominal surgery, a higher percentage of study participants who self-administered Zalviso over a 48-hour period rated the method of pain control “good” or “excellent” compared to those using intravenous (IV) morphine PCA (p=0.007). Moreover, patients surveyed in this study rated their overall ease of care (p<0.001) and overall satisfaction (p=0.004) with Zalviso as higher than with IV morphine PCA. Zalviso was also rated by nurses to provide higher treatment satisfaction (p<0.001) and overall ease of care (p=0.017) compared with IV morphine PCA. Adverse events reported in the study were generally mild or moderate in nature and similar in both placebo and treatment groups, however fewer patients using Zalviso™ experienced oxygen desaturation episodes < 95% (p=0.028).

Dott. Alberto Grua, chief commercial officer Europe, Australia, North America & Global Product Supply (CCO EU, AUS, NA & GPS) from Grunenthal, adds, “We are delighted to bring a new, innovative way to manage post-operative pain to European healthcare professionals and patients. By combining the benefits of patient-controlled analgesia with those of a non-invasive route of administration, Zalviso offers a unique solution to address unmet needs of adult patients suffering from acute moderate-to-severe post-operative pain.”

On an annual basis, there are 19 million surgical procedures with associated acute moderate-to-severe post-operative pain in the European Union. A recent German survey in patients after surgery has shown that 55% of all patients are not satisfied with their treatment for post-operative pain¹. Even more so, 30% mention that their pain management has been inadequately effective [¹ Maier C et al. Dtsch Arztebl Int. 2010; 107; 607-614].

About Zalviso
Zalviso is an innovative pre-programmed, non-invasive, handheld system that allows hospital patients with acute moderate-to-severe post-operative pain to self-dose with sufentanil sublingual tablets, 15 mcg, to manage their pain. The system is designed to help address certain problems associated with post-operative analgesia, such as the drug-related side effects and delayed analgesic effect of morphine, the invasive intravenous (IV) route of delivery of current systems for patient-controlled analgesia (PCA) and the complexity of infusion pumps used for IV PCA delivery.

Grunenthal holds the rights for Zalviso in Europe and Australia while AcelRx retains all rights in North America, Asia, Latin America and Middle East/Africa. Under the terms of the collaboration, Grunenthal is responsible for maintaining the regulatory approval for the drug product and all commercial activities for Zalviso, in the Grunenthal territory. AcelRx will be responsible for maintaining device regulatory approval in the Grunenthal territory, as well as manufacturing and supply of Zalviso to Grunenthal for commercial sales and clinical trials.

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 acute pain. In the US, the Company’s late-stage pipeline includes ARX-04 (sufentanil sublingual tablet, 30 mcg) for the treatment of moderate-to-severe acute pain in a medically supervised setting; and Zalviso (sufentanil sublingual tablet system) for the management of moderate-to-severe acute pain in adult patients in the hospital setting.

ARX-04 delivers 30 mcg sufentanil sublingual, a high therapeutic index opioid, through a disposable, pre-filled, single-dose applicator (SDA). AcelRx has reported positive results from the pivotal Phase 3 SAP301 ambulatory surgery study, and will be advancing ARX-04 into a study in emergency room patients in 2015. Zalviso delivers 15 mcg sufentanil sublingual tablets through a non-invasive delivery route via a pre-programmed, patient-controlled analgesia device. Zalviso is approved in the EU as well as Norway, Iceland and Liechtenstein and is in late-stage development in the U.S. In response to the New Drug Application (NDA) AcelRx submitted to the U.S. Food and Drug Administration (FDA) seeking approval for Zalviso, the Company received a Complete Response Letter (CRL) on July 25, 2014. The FDA has requested an additional clinical study prior to the resubmission of the Zalviso NDA.

The Company has two additional pain treatment product candidates, ARX-02 and ARX-03, which have completed Phase 2 clinical development. 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 timing of any commercial launch of Zalviso; commercial success of Zalviso in the market place, the therapeutic and commercial potential of AcelRx Pharmaceuticals’ product candidates, including Zalviso and ARX-04, the process and timing of anticipated future development of AcelRx’s product candidates, including Zalviso and ARX-04, and any regulatory approval of AcelRx product candidates in the US.

These forward-looking statements are based on AcelRx Pharmaceuticals’ current expectations and inherently involve significant risks and uncertainties. AcelRx Pharmaceuticals’ actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks related to: therapeutic and commercial potential for AcelRx Pharmaceuticals’ product candidates, including Zalviso and ARX-04; ability to complete Phase 3 development for ARX-04, file an NDA and to receive regulatory approval for ARX-04; the success, cost and timing of all product development activities and clinical trials, including the Phase 3 ARX-04 trial. AcelRx Pharmaceuticals 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.

(OPGN) to Present Data on Acuitas for Investigating Transmission of “Super Bugs”

Acuitas Resistome Test and Whole Genome Sequence Analysis Showcased at American Society for Microbiology Conference on Next Generation Sequencing for Epidemiologic Investigation of Pathogens

GAITHERSBURG, Md., Sept. 22, 2015  — OpGen, Inc. (NASDAQ:OPGN) today announced that data on its Acuitas^® Resistome Test and Acuitas Whole Genome Sequence (WGS) Analysis for multidrug-resistant organisms (MDROs) will be presented at the American Society for Microbiology’s First Conference on Rapid Next-Generation Sequencing and Bioinformatic Pipelines for Enhanced Molecular Epidemiologic Investigation of Pathogens, to be held from September 24 to 27 in Washington, D.C.

Terry Walker, OpGen Senior Vice President of Research and Development and a presenter at the OpGen-sponsored symposium at the ASM conference, said, “Our symposium presentation and three posters underscore our technologies’ rapid and highly accurate approach to determine the genetic variability underlying multidrug resistant organisms, and how to use that variability to investigate transmission events, help stop spread, and prevent outbreaks.”

Dr. Walker’s presentation, entitled “High Resolution Genomic Analysis of Multidrug-Resistant Organisms using Acuitas Resistome Test and Whole Genome Sequence Analysis,” is scheduled for September 25 at 12:00 p.m. EDT in the Capitol Room at the Omni Shoreham Hotel. The lunch symposium will review the two Acuitas tests and demonstrate OpGen’s Whole Genome Sequencing capabilities for epidemiologic investigations by analyzing thousands of genes and show the triaging utility of the Acuitas Resistome Test, saving time and reducing costs associated with high resolution analysis.

The three posters will be on display September 25 and 26. Details are as follows:

1. “Acuitas Resistome Test—a high-throughput triage tool for strain typing by whole genome sequencing.” Genotype resolution of OpGen’s Acuitas Resistome test examines its utility as a hospital triage tool to determine transmission events and possible treatments.

2. “MLST+ strain typing of multidrug-resistance organisms (MDROs) using Acuitas Whole Genome Sequence Analysis.” OpGen’s Acuitas WGS Analysis was used to create MLST+ schemas for eight species of drug-resistant bacteria.

3. “Comprehensive analysis of antibiotic resistance in multidrug-resistant organisms (MDROs) by whole genome sequencing using Acuitas Whole Genome Sequence Analysis.” OpGen’s Acuitas WGS Analysis was used to test a new database of all beta-lactamase genes to determine antibiotic resistance in multidrug-resistance organisms.

About MDROs

Multi-drug resistant organisms (MDROs) are common bacteria that have developed resistance to multiple classes of antibiotics. They are a leading cause of hospital-acquired infections and are associated with an increase in morbidity and mortality. Each year, more than two million Americans acquire infections that are resistant to antibiotics and of those, 23,000 will die of those infections. Asymptomatic carriers are at a higher risk of an MDRO infection and become reservoirs for transmission to other patients in health care systems if not accurately identified early. Since there are many types of antibiotic resistant organisms, and the way they cause disease is dictated by their genetics, knowing the exact genetic profile of these organisms is a key step to preventing their ability to infect.

About OpGen

OpGen, Inc. is an early commercial-stage molecular testing and bioinformatics company focused on assisting healthcare providers to combat multi-drug resistant organism (MDRO) bacterial infections – “Superbugs.” The Company is addressing this growing public health threat by rapidly delivering precise, actionable information to help identify, combat, and prevent the spread of these complex infections that jeopardize the safety of our hospitals and other long-term care facilities. OpGen offers a full portfolio of Acuitas® products including the MDRO Gene Test, the Resistome Test, microbial Whole Genome Sequence Analysis, Acuitas Lighthouse™ MDRO Management System and QuickFISH™, a suite of FDA-cleared and CE-marked diagnostics for rapid molecular testing of positive blood cultures designed to assure appropriate antibiotic therapy.  Learn more at www.opgen.com

OpGen Forward-Looking Statements 

This press release includes statements relating to the company’s products and services. These statements and other statements regarding our future plans and goals constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and are intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties that are often difficult to predict, are beyond our control, and which may cause results to differ materially from expectations. Factors that could cause our results to differ materially from those described include, but are not limited to, the rate of adoption of our products and services by hospitals, the success of our commercialization efforts, the effect on our business of existing and new regulatory requirements, and other economic and competitive factors. For a discussion of the most significant risks and uncertainties associated with OpGen’s business, please review our filings with the Securities and Exchange Commission (SEC). You are cautioned not to place undue reliance on these forward-looking statements, which are based on our expectations as of the date of this press release and speak only as of the date of this press release. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

CONTACT: OpGen
         Michael Farmer
         Director, Marketing
         (240) 813-1284
         mfarmer@opgen.com
         InvestorRelations@opgen.com

         Investors
         LHA
         Kim Sutton Golodetz
         (212) 838-3777
         kgolodetz@lhai.com

         or

         Bruce Voss
         (310) 691-7100
         bvoss@lhai.com

         Media
         Lisa Guiterman
         (301) 217-9353
         lisa.guiterman@gmail.com

(CETX) Sees Surge in Demand for its IS 2500 In-Situ NDIR Multi Gas Analyzer

Cemtrex (NASDAQ: CETX) announced today that it is seeing a surge in demand for its innovative IS 2500 Multi Gas Analyzer. The company has received multitude of orders from a diverse set of companies around the world for its proprietary state of the art emissions monitoring analyzer.

The IS 2500 Multi Gas Analyzer is an In-situ stack mounted emissions monitoring system that can measure several process gases at a fraction of the cost of comparable extractive systems. Due to recent advances in technology, Cemtrex has made it possible to have a low cost in-situ type analyzer instead of an expensive extractive type system that can deliver precise measurements of methane, carbon dioxide, oxygen, nitrogen oxides, carbon monoxide and others. The IS 2500 has a plethora of applications in virtually all manufacturing and industrial trades, from large utilities to small asphalt plants.

Cemtrex’ CEO, Saagar Govil, commented, “In many emerging economies, companies cannot afford a high priced extractive system so they are looking for our high-quality economical alternative. With the IS 2500 we have delivered exactly that. I am pleased to say that we are expanding our production capability to keep up with the strong demand.”

According to a recent report from McIlvane & Co., the worldwide CEMS market is around $1.2B with the majority of growth to be in emerging markets over the next five years.

About Cemtrex, Inc.

Cemtrex, Inc. (NASDAQ:CETX) is a world leading diversified industrial and manufacturing company that provides a wide array of solutions to meet today’s technology challenges. Cemtrex provides manufacturing services of advanced custom engineered electronics, emission monitors & instruments for industrial processes, and environmental control & air filtration systems for industries & utilities.
www.cemtrex.com

Safe Harbor Statement

This press release contains forward-looking statements. Actual results could differ materially from those projected in the forward-looking statements as a result of a number of risks and uncertainties. These forward looking statements are not a guarantee of future performance. This release may contain Non-GAAP financial information and are not calculated or presented in accordance with US GAAP. The Company believes that the presentation of non-GAAP financial measures provides useful information to management and investors regarding underlying trends in its consolidated financial condition and results of operations. The Company’s management regularly uses these supplemental non-GAAP financial measures internally to understand, manage and evaluate the Company’s business and make operating decisions. These risks and uncertainties are discussed in our filings with the Securities and Exchange Commission, including our annual report on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K. Statements made herein are as of the date of this press release and should not be relied upon as of any subsequent date. Except as may be required by applicable securities laws, we do not undertake any obligation to revise or update any forward-looking statements contained in this release.

(HRTX) Positive Top-Line Results from Phase 2 Study of HTX-011

Heron Therapeutics, Inc. (NASDAQ: HRTX), a biotechnology company focused on improving the lives of patients by developing best-in-class medicines that address major unmet medical needs, today announced positive, top-line results from its Phase 2 clinical study of HTX-011 in the management of post-operative pain in patients undergoing bunionectomy. HTX-011, which utilizes Heron’s proprietary Biochronomer^® drug delivery technology, is a long-acting formulation of the local anesthetic bupivacaine in a fixed-dose combination with the anti-inflammatory meloxicam. The primary and all key secondary endpoints in the study were met with a high degree of statistical significance.

This randomized, placebo-controlled, double-blind, Phase 2 clinical study in 64 patients undergoing bunionectomy evaluated the efficacy and safety of HTX-011, containing 200 mg or 400 mg of bupivacaine combined with meloxicam, compared to placebo. The primary endpoint was the difference as compared to placebo in pain intensity as measured by the Summed Pain Intensity (SPI) score in the first 24 hours post-surgery (SPI 0-24). Key secondary endpoints included: the difference in SPI in the first 48 hours post-surgery (SPI 0-48); the difference in SPI in the first 72 hours post-surgery (SPI 0-72); time to the first use of opiate rescue medication; and the percent of patients who received no opiate rescue medication in the first 72 hours post-surgery. The study’s major efficacy findings for the more effective, 400 mg dose of HTX-011 as compared to placebo include:

• Pain intensity in the first 24 hours post-surgery was reduced by 69% (SPI of 38.5 versus 124.2, p<0.0001).
• Pain intensity in the first 48 hours post-surgery was reduced by 52% (SPI of 106.9 versus 224.8, p<0.0001).
• Pain intensity in the first 72 hours post-surgery was reduced by 40% (SPI of 170.2 versus 285.9, p=0.0064).
• Time to the first use of opiate rescue medication was increased by 488% (48.2 hours versus 8.2 hours, p<0.0001).
• 32% of patients received no opiate rescue medication during the entire 72-hour period post-surgery, compared to 5% for placebo (p<0.0001).

HTX-011 was generally well tolerated in the study. The most frequent adverse events reported were headache, nausea, vomiting, erythema, cellulitis, dizziness, and hypoxia, none of which were considered drug-related.

“Although opioid analgesics are standard of care for post-operative pain management, too often they are associated with unacceptable adverse effects often prolonging hospitalization and recovery,” stated Jeffrey A. Gudin, MD, Director, Pain Management and Palliative Care, Englewood Hospital and Medical Center, Englewood, NJ. “Thus, there is a major unmet need for a pain management treatment that can substantially reduce our dependence on post-operative opioids. The ability of HTX-011, administered once during surgery, to significantly reduce pain and the need for pain medications for three days following surgery (as compared to a control group) is truly promising.”

“At Heron, we are dedicated to the development of best-in-class medicines that can have a major impact on patients’ lives,” commented Barry D. Quart, Pharm.D., Chief Executive Officer of Heron. “We are very pleased with these results, and we now will turn our attention to executing on a broad-based development program designed to enable us to bring HTX-011 to the many patients undergoing a wide range of surgeries who experience significant post-operative pain.”

Conference Call and Webcast

Heron Therapeutics will host a conference call and webcast on Wednesday, September 23 at 8:30 a.m. ET (5:30 a.m. PT). The conference call can be accessed by dialing (877) 311-5906 for domestic callers and (281) 241-6150 for international callers. Please provide the operator with the passcode 46461973 to join the conference call. The conference call will also be available via webcast under the investor relations section of Heron’s website at www.herontx.com and will be archived there for 90 days following the call. Please connect to Heron’s website several minutes prior to the start of the broadcast to ensure adequate time for any software download that may be necessary.

About HTX-011 for Post-Operative Pain

HTX-011, which utilizes Heron’s proprietary Biochronomer^® drug delivery technology, is a long-acting formulation of the local anesthetic bupivacaine in a fixed-dose combination with the anti-inflammatory meloxicam for the prevention of post-operative pain. By delivering sustained levels of both a potent anesthetic and an anti-inflammatory agent directly to the site of tissue injury, HTX-011 was designed to deliver superior pain relief while potentially reducing the need for systemically administered pain medications such as opioids, which carry the risk of harmful side effects, abuse and addiction. In September 2015, Heron reported positive top-line results from a Phase 2 study of HTX-011 in patients undergoing bunionectomy. In this study, HTX-011 significantly reduced pain intensity, significantly reduced the need for opioid rescue medications, and significantly increased the time to first use of rescue medications. HTX-011 is the subject of a broad-based development program designed to target the many patients undergoing a wide range of surgeries who experience significant post-operative pain.

About Heron Therapeutics, Inc.

Heron Therapeutics, Inc. is a biotechnology company focused on improving the lives of patients by developing best-in-class medicines that address major unmet medical needs. Heron is developing novel, patient-focused solutions that apply its innovative science and technologies to already-approved pharmacological agents. Heron’s goal is to build on therapeutics with well-known pharmacology by improving their tolerability and efficacy as well as broadening their potential field of use. Heron is currently developing four pharmaceutical products for patients suffering from cancer or pain. SUSTOL^® (granisetron) Injection, extended release is being developed for the prevention of both acute and delayed chemotherapy-induced nausea and vomiting (CINV) associated with moderately emetogenic chemotherapy (MEC) or highly emetogenic chemotherapy (HEC). CINV is one of the most debilitating side effects of chemotherapy and is a leading cause of premature discontinuation of cancer treatment. Heron recently reported positive, top-line results from its Phase 3 MAGIC study. In July 2015, Heron resubmitted its New Drug Application (NDA) for SUSTOL to the U.S. Food and Drug Administration (FDA), and the FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of January 17, 2016. HTX-019, also being developed for the prevention of CINV, has the potential to become the first polysorbate 80-free, intravenous formulation of aprepitant, a neurokinin-1 (NK₁) receptor antagonist. Heron intends to file an NDA for HTX-019 using the 505(b)(2) regulatory pathway in the second half of 2016. HTX-011 is Heron’s long-acting formulation of the local anesthetic bupivacaine in a fixed-dose combination with the anti-inflammatory meloxicam. In September 2015, Heron reported positive, top-line results from a Phase 2 study of HTX-011 in patients undergoing bunionectomy. In this study, HTX-011 significantly reduced pain intensity and the need for opioid rescue medications. HTX-011 is the subject of a broad-based development program designed to target the many patients undergoing a wide range of surgeries who experience significant post-operative pain. HTX-003, a long-acting formulation of buprenorphine, is being developed for the potential management of chronic pain and opioid addiction. All of Heron’s product candidates utilize Heron’s innovative science and technology platforms, including its proprietary Biochronomer^® drug delivery technology, which can deliver therapeutic levels of a wide range of otherwise short-acting pharmacological agents over a period of days to weeks with a single injection.

For more information, please visit www.herontx.com.

Forward Looking Statements

This news release contains “forward-looking statements” as defined by the Private Securities Litigation Reform Act of 1995. Heron cautions readers that forward-looking statements are based on management’s expectations and assumptions as of the date of this news release and are subject to certain risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include, but are not limited to, those associated with: whether the U.S. Food and Drug Administration (FDA) approves the SUSTOL NDA as submitted or supports as broad of a labeled indication for SUSTOL as requested, the progress in the research and development of HTX-019, HTX-011, HTX-003 and our other programs, including the timing of preclinical, clinical, and manufacturing activities, safety and efficacy results from our studies that may not justify the pursuit of further development of our product candidates, the launch and acceptance of SUSTOL and new products generally, our financial position and our ability to raise additional capital to fund operations, if necessary, or to pursue additional business opportunities, strategic business alliances we may pursue or the potential acquisition of products or technologies, and our ability to grow our organization to sustain the commercial launch for SUSTOL, and other risks and uncertainties identified in the Company’s filings with the Securities and Exchange Commission. Forward-looking statements reflect our analysis only on their stated date, and Heron takes no obligation to update or revise these statements except as may be required by law.

Heron Therapeutics, Inc.
Investor Relations Contact:
Jennifer Capuzelo, 858-703-6063
Associate Director, Investor Relations
jcapuzelo@herontx.com
or
Corporate Contact:
Barry D. Quart, Pharm D., 650-366-2626
Chief Executive Officer

(ISCO) Names Ms. Ebrahimi as Chief Financial Officer