Archive for February, 2016

(ELMD) Names John Kowalczyk Vice President of Sales

Electromed, Inc. (NYSE MKT: ELMD), maker of the SmartVest® Airway Clearance System, today announced that John Kowalczyk has joined the Company as Vice President of Sales and will oversee all domestic sales initiatives. Along with medical sales leadership, growing product lines, and the success of building new businesses, Kowalczyk brings to Electromed an outlook of promoting a culture of learning, improvement, and executing best practices.

“John has a proven track record of leading and developing high performing sales teams that deliver sustainable growth and profit. In addition, he has consistently created winning and positive cultures that reward achievement, engender loyalty, and celebrate success,” said Kathleen Skarvan, President and Chief Executive Officer.

Kowalczyk previously served as Vice President of Sales at Medtronic, Inc. in the areas of pain stimulation and target drug delivery, neuromodulation, gastroenterology, and urology. Most recently, he served as President of DorsaVi, an Australia-based company commercializing products for the elite sports, occupational health and safety, and medical physiotherapy markets. Kowalczyk holds a Bachelor of Arts Degree in International Relations from the University of Wisconsin, Madison. He will report to Skarvan.

About Electromed, Inc.
Electromed, Inc. manufactures, markets, and sells products that provide airway clearance therapy, including the SmartVest® Airway Clearance System, to patients with compromised pulmonary function. It is headquartered in New Prague, Minnesota and founded in 1992. Further information about the Company can be found at www.smartvest.com.

Electromed, Inc.
Kathleen Skarvan, 952-758-9299
President and Chief Executive Officer
kskarvan@electromed.com

Monday, February 29th, 2016 Uncategorized Comments Off on (ELMD) Names John Kowalczyk Vice President of Sales

(AST) Appoints Stephen L. Cartt President and Chief Executive Officer

Don M. Bailey Appointed to Board of Directors and Named Chairman

FREMONT, Calif., Feb. 29, 2016  — Asterias Biotherapeutics, Inc. (NYSE MKT: AST) today announced the appointment of pharmaceutical industry veteran Stephen L. Cartt as President and Chief Executive Officer and member of the Board of Directors. In addition, the Company announced the appointment of Don M. Bailey to its Board of Directors. Mr. Bailey, who previously served as President and Chief Executive Officer of Questcor Pharmaceuticals Inc. until its sale for $5.6 billion in 2014 to Mallinckrodt, plc, was named Chairman of the Board of Directors of Asterias. Both appointments are effectively immediately. Mr. Cartt replaces Pedro Lichtinger, who served as President, CEO and a member of the Board of Directors since June 2014. Mr. Bailey succeeds Alfred D. Kingsley as Chairman. Mr. Kingsley will remain on the Asterias Board of Directors.

“Steve Cartt and Don Bailey have superb track records of creating substantial shareholder value over time by building successful, high growth pharmaceutical businesses, advancing products through the development process, and commercializing therapies that address conditions with high unmet therapeutic needs. In addition, Steve and Don have an extraordinary history of success working together to build significant shareholder value,” said Mr. Kingsley. “Our Board is excited that both Steve and Don are joining Asterias in its efforts to realize the full potential of its AST-VAC1, AST-VAC2, and AST-OPC1 clinical programs. The Board also wishes to thank Pedro Lichtinger for his leadership through a crucial phase of the Company’s development.”

“During the past year and a half as a member of the BioTime Board, I’ve had the opportunity to learn about the exciting potential of the Asterias AST-VAC1, AST-VAC2, and AST-OPC1 clinical-stage programs,” said Mr. Cartt. “I look forward to working with the Asterias team, Don and the Board to further the company’s clinical development of these important treatments. We believe that over time, these efforts have the potential to build significant returns for our shareholders.”

Mr. Cartt began his career in the pharmaceutical industry with ALZA Corporation where he held a variety of R&D and commercial positions. He moved to Elan Pharmaceuticals and served as Senior Director of Strategic Marketing before joining Questcor in 2005. At Questcor, he served as Executive Vice President and Chief Business Officer prior to being appointed Chief Operating Officer in 2012. Questcor experienced high growth in revenues and earnings during this period, while its market valuation increased more than 200 fold from less than $25 million in 2007 to $5.6 billion at the time of its sale in 2014. After the acquisition of Questcor in August 2014, Mr. Cartt served in a transitional role as Chief Operating Officer of Mallinckrodt’s AutoImmune and Rare Diseases Business Unit until October 2014. Mr. Cartt has been a member of the BioTime, Inc. Board of Directors since November 2014, a position from which he has resigned in conjunction with accepting the CEO position at Asterias, a publicly traded subsidiary of BioTime (NYSE MKT: BTX). He holds a B.S. in biochemistry from the University of California, Davis and an MBA from Santa Clara University.

Mr. Bailey brings to Asterias substantial management, board, and corporate governance experience. From 2006 through 2014, Mr. Bailey served on the Board of Directors of Questcor, was its President and CEO from 2007 through 2014, and at various times, chaired or was a member of several board committees including Questcor’s Strategic Initiatives Committee. Since the sale of Questcor, Mr. Bailey has served on the Board of Directors and as Chairman of the Portfolio Committee of Mallinckrodt. He is also a director, audit committee chair, and a member of the Transaction Committee of Biotie Therapies Corp., a public pharmaceutical company headquartered in Turku, Finland. Biotie went public in the U.S. through an IPO in June 2015 and entered into a Combination Agreement with Acorda Therapeutics in January 2016. Previously, Mr. Bailey served as the non-executive chairman and chairman of the Nominating and Corporate Governance Committee of STAAR Surgical Company, an ophthalmic products company, from 2005 through June 2014. In addition to his public company experience, he serves on the board of the Argyos School of Business at Chapman University in Orange, Calif. and is a Founding Board member of the University of California Irvine’s Institute for Applied Innovation. Mr. Bailey is also a Senior Fellow in Entrepreneurship at Pepperdine University.

Asterias will report results for its fourth quarter and full year 2015 in March. Further information on the release and the conference call will be provided as timing is finalized.

About Asterias Biotherapeutics
Asterias Biotherapeutics, Inc. is a leading biotechnology company in the emerging field of regenerative medicine. The company’s proprietary, industry leading platforms are based on its pluripotent stem cell and dendritic cell immunotherapy technologies. Asterias is focused on developing therapies to treat conditions in several medical areas where there is high unmet medical need and inadequate available therapies. AST-OPC1 (oligodendrocyte progenitor cells) is currently in a Phase 1/2a dose escalation clinical trial in spinal cord injury. AST-VAC1 (antigen-presenting autologous dendritic cells) has demonstrated promise in a Phase 2 study in acute myelogenous leukemia. AST-VAC2 (antigen-presenting allogeneic dendritic cells) represents a second generation, allogeneic approach to dendritic cell vaccines. Additional information about Asterias can be found at www.asteriasbiotherapeutics.com.

Forward Looking Statements

Statements pertaining to future financial and/or operating results, future growth in research, technology, clinical development, and potential opportunities for Asterias, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates” and “potential”) should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the businesses of Asterias, particularly those mentioned in the cautionary statements found in Asterias’s filings with the Securities and Exchange Commission. Asterias disclaims any intent or obligation to update these forward-looking statements.

Monday, February 29th, 2016 Uncategorized Comments Off on (AST) Appoints Stephen L. Cartt President and Chief Executive Officer

(ALDX) Reports Positive Results From Phase IIa Clinical Trial

NS2 Demonstrates Statistically Significant and Sustained Clinical Effects

Data Suggest Aldehyde Trapping as Novel Approach for the Treatment of Inflammatory Diseases

Conference Call to Be Held Today at 8:00 am ET 

LEXINGTON, Mass., Feb. 29, 2016  — Aldeyra Therapeutics, Inc. (Nasdaq:ALDX) (Aldeyra), a biotechnology company focused on the development of products to treat diseases related to aldehydes, today reported that the results of a randomized, parallel-group, single-center, double-masked, vehicle-controlled Phase IIa clinical trial of topical ocular NS2 in subjects with induced allergic conjunctivitis demonstrated statistically significant activity of NS2 over vehicle in reducing ocular itching and tearing.

Aldehydes are thought to be related to inflammatory conditions including allergic conjunctivitis, as well as other forms of ocular and non-ocular inflammation. NS2, a small molecule aldehyde trap, was tested in a conjunctival allergen provocation test (CAPT) model of allergic conjunctivitis.  One hundred healthy men and women with at least a two-year history of allergic conjunctivitis to grass, tree or ragweed pollen were enrolled and randomized in equal groups for treatment with topical ocular NS2 or vehicle.  The clinical endpoints in the trial included patient assessment (on a 0 to 4 point scale) of ocular itching and tearing, two prominent inflammation-related symptoms of allergic conjunctivitis.

Statistically significant differences were demonstrated for ocular itching (p<0.05) and ocular tearing (p<0.05) between NS2 and vehicle after single dose and multiple dose administration.  NS2 demonstrated durable effects throughout the three hours following CAPT challenge.  The effects of NS2 persisted across substantially all time points for all CAPT challenges despite a stronger than expected vehicle effect.  The reductions from baseline scores were of the same magnitude seen in the CAPT model with existing therapies utilized in the treatment of allergic conjunctivitis, and peak changes exceeded one point for both ocular itching and ocular tearing scores.

NS2 was generally well tolerated and there were no safety concerns during the trial. Transient and generally mild stinging was noted in the treatment arm.  Two patients dropped out of the trial during treatment.

Commenting on the results, Todd C. Brady, M.D., Ph.D., President and CEO of Aldeyra, said, “To our knowledge, the data from this clinical trial represent the first example of clinical efficacy of an aldehyde trap in human disease. We are thrilled with the outcome of this trial and believe that the results suggest important insight into the physiology of inflammation and further applicability of aldehyde trapping in the treatment of inflammatory disease.”

Aldeyra is also performing a Phase II clinical trial of topical ocular NS2 in patients with noninfectious anterior uveitis, and a Phase II trial of dermatologic NS2 in patients with Sjögren-Larsson Syndrome.  The last visit for the last patient in the noninfectious anterior uveitis Phase II clinical trial occurred this month, and data from the trial are expected in the second quarter of 2016.

Conference Call

Aldeyra will hold a conference call on February 29, 2016 at 8:00 a.m. ET. Todd C. Brady, M.D., Ph.D., President and Chief Executive Officer; David J. Clark, M.D., Chief Medical Officer; and Stephen Tulipano, Chief Financial Officer, will host a conference call to discuss results of the clinical trial. The dial-in numbers are 1-877-407-0784 for domestic callers and 1-201-689-8560 for international callers.  The conference ID number for both is 13631657.  A live webcast of the conference call will also be available on the investor relations page of Aldeyra’s corporate website at www.aldeyra.com.

After the live webcast, the event will remain archived on Aldeyra’s website for 60 days.  In addition, a telephonic replay of the call will be available until March 7, 2016. The replay dial-in numbers are 1-877-870-5176 for domestic callers and 1-858-384-5517 for international callers.  Please use event passcode 13631657.

About NS2

NS2 is an aldehyde-binding small molecule based on an innovative platform technology focused on trapping aldehydes, which are toxic and pro-inflammatory mediators of numerous diseases. By decreasing aldehyde load, NS2 may mitigate excessive inflammation and address diseases where aldehyde metabolism is impaired, including certain inborn errors of metabolism.

About Allergic Conjunctivitis

Allergic conjunctivitis is a common allergic disease that is thought to be mediated in part by pro-inflammatory aldehydes, and is characterized by inflammation of the conjunctiva (a membrane covering part of the front of the eye), resulting in excessive tear production in addition to ocular itching, swelling, and redness.

About Aldeyra Therapeutics

Aldeyra Therapeutics, Inc. is a biotechnology company focused primarily on the development of products to treat diseases thought to be related to endogenous aldehydes, a naturally occurring class of toxic molecules. The company has developed NS2, a product candidate designed to trap aldehydes. Aldeyra has completed Phase IIa testing of NS2 in subjects with induced allergic conjunctivitis, and has initiated clinical testing of NS2 for the treatment of Sjögren-Larsson Syndrome and noninfectious anterior uveitis. NS2 has not been approved for sale in the U.S. or elsewhere. www.aldeyra.com

Safe Harbor Statement

This release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, including statements regarding Aldeyra’s plans for its product candidates and the development of NS2 and timing of the results from Aldeyra’s noninfectious anterior uveitis Phase II clinical trial. In some cases, you can identify forward-looking statements by terms such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “anticipate,” “project,” “target,” “design,” “estimate,” “predict,” “potential,” “aim,” “plan” or the negative of these terms, and similar expressions intended to identify forward-looking statements. Such forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Aldeyra is at an early stage of development and may not ever have any products that generate significant revenue. Important factors that could cause actual results to differ materially from those reflected in Aldeyra’s forward-looking statements include, among others, the timing of enrollment, commencement and completion of Aldeyra’s clinical trials, the timing and success of preclinical studies and clinical trials conducted by Aldeyra and its development partners; the ability to obtain and maintain regulatory approval to conduct clinical trials and to commercialize Aldeyra’s product candidates, and the labeling for any approved products; the scope, progress, expansion, and costs of developing and commercializing Aldeyra’s product candidates; the size and growth of the potential markets for Aldeyra’s product candidates and the ability to serve those markets; Aldeyra’s expectations regarding Aldeyra’s expenses and revenue, the sufficiency of Aldeyra’s cash resources and needs for additional financing; the rate and degree of market acceptance of any of Aldeyra’s product candidates; Aldeyra’s expectations regarding competition; Aldeyra’s anticipated growth strategies; Aldeyra’s ability to attract or retain key personnel; Aldeyra’s ability to establish and maintain development partnerships; Aldeyra’s expectations regarding federal, state and foreign regulatory requirements; regulatory developments in the United States and foreign countries; Aldeyra’s ability to obtain and maintain intellectual property protection for its product candidates; the anticipated trends and challenges in Aldeyra’s business and the market in which it operates; and other factors that are described in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Aldeyra’s Annual Report on Form 10-K for the year ended December 31, 2014 and Aldeyra’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2015, which are on file with the Securities and Exchange Commission (SEC) and available on the SEC’s website at www.sec.gov.  Additional factors may be described in those sections of Aldeyra’s Annual Report on Form 10-K for the year ended December 31, 2015, to be filed with the SEC in the first quarter of 2016.  In addition to the risks described above and in Aldeyra’s other filings with the SEC, other unknown or unpredictable factors also could affect Aldeyra’s results. No forward-looking statements can be guaranteed and actual results may differ materially from such statements. The information in this release is provided only as of the date of this release, and Aldeyra undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.

 

Corporate Contact:
Stephen Tulipano
Aldeyra Therapeutics, Inc.
Tel: +1 781-761-4904 Ext. 205
stulipano@aldeyra.com

Investor Contact: 
David Burke
The Ruth Group
Tel: +1 646-536-7009
dburke@theruthgroup.com
Monday, February 29th, 2016 Uncategorized Comments Off on (ALDX) Reports Positive Results From Phase IIa Clinical Trial

(GLBL) Declares Fourth Quarter Dividend

BETHESDA, Md., Feb. 29, 2016  — TerraForm Global, Inc. (Nasdaq:GLBL), a global owner and operator of clean energy power plants, today announced that its Board of Directors declared its 4Q 2015 dividend on the Company’s Class A common stock of $0.275 per share. This represents a dividend of $1.10 per share on an annualized basis. The dividend is payable on March 17, 2016 to shareholders of record as of March 10, 2016.

As a first-time filer, TerraForm Global’s annual Form 10-K report is required to be filed by March 30, 2016, and the Company expects to release its 4Q results closer to that date.

“We now have a geographically diverse fleet of high-quality wind and solar assets comprising 814 MW spread across 6 countries,” said Brian Wuebbels, Chief Executive Officer.  “This reflects the addition of 36 MW from two solar power plants in Thailand that were originally contributed by SunEdison at the IPO when they were still under construction. These two power plants, named NPS Star and WXA, have now reached commercial operation and were transferred into our fleet in the first quarter. Our fleet remains fully contracted with creditworthy power off-takers, including state utilities and government agencies, with an average remaining contract life of approximately 18 years.”

About TerraForm Global

TerraForm Global is a renewable energy leader that is changing how energy is generated, distributed and owned. TerraForm Global creates value for its investors by owning and operating clean energy power plants in high-growth emerging markets. For more information about TerraForm Global, please visit: www.terraform.com.

Safe Harbor Disclosure

This communication contains 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. Forward-looking statements can be identified by the fact that they do not relate strictly to historical or current facts. These statements involve estimates, expectations, projections, goals, assumptions, known and unknown risks, and uncertainties and typically include words or variations of words such as “expect,” “anticipate,” “believe,” “intend,” “plan,” “seek,” “estimate,” “predict,” “project,” “goal,” “guidance,” “outlook,” “objective,” “forecast,” “target,” “potential,” “continue,” “would,” “will,” “should,” “could,” or “may” or other comparable terms and phrases. All statements that address operating performance, events, or developments that TerraForm Global expects or anticipates will occur in the future are forward-looking statements. They may include estimates of expected adjusted EBITDA, cash available for distribution (CAFD), earnings, revenues, capital expenditures, liquidity, capital structure, future growth, financing arrangements and other financial performance items (including future dividends per share), descriptions of management’s plans or objectives for future operations, products, or services, or descriptions of assumptions underlying any of the above. Forward-looking statements provide TerraForm Global’s current expectations or predictions of future conditions, events, or results and speak only as of the date they are made.  Although TerraForm Global believes its expectations and assumptions are reasonable, it can give no assurance that these expectations and assumptions will prove to have been correct and actual results may vary materially.

By their nature, forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those suggested by the forward-looking statements. Factors that might cause such differences include, but are not limited to, our ability to integrate the projects we acquire from third parties or otherwise realize the anticipated benefits from such acquisitions; actions of third parties, including but not limited to the failure of SunEdison or other counterparties to fulfill their obligations; price fluctuations, termination provisions and buyout provisions in offtake agreements; delays or unexpected costs during the completion of projects under construction; our ability to successfully identify, evaluate and consummate acquisitions from SunEdison or third parties or changes in expected terms and timing of any acquisitions; regulatory requirements and incentives for production of renewable power; operating and financial restrictions under agreements governing indebtedness; the condition of capital markets and our ability to borrow additional funds and access capital markets; our ability to compete against traditional and renewable energy companies; hazards customary to the power production industry and power generation operations, such as unusual weather conditions, outages, and curtailment; and economic, social and political risks and uncertainties inherent in international operations, including our operations in emerging markets, the impact of foreign exchange rate fluctuations, the imposition of currency controls and restrictions on repatriation of earnings and cash, protectionist and other adverse public policies, including local content requirements, import/export tariffs, increased regulations or capital investment requirements; international business practices that may conflict with other customs or legal requirements to which we are subject, inability to obtain, maintain or enforce intellectual property rights, and being subject to the jurisdiction of courts other than those of the United States, including uncertainty of judicial processes and difficulty enforcing contractual agreements or judgments in foreign legal systems or incurring additional costs to do so. Furthermore, any dividends are subject to available capital, market conditions, and compliance with associated laws and regulations. Many of these factors are beyond TerraForm Global’s control.

TerraForm Global disclaims any obligation to publicly update or revise any forward-looking statement to reflect changes in underlying assumptions, factors, or expectations, new information, data, or methods, future events, or other changes, except as required by law. The foregoing list of factors that might cause results to differ materially from those contemplated in the forward-looking statements should be considered in connection with information regarding risks and uncertainties, which are described in TerraForm Global’s Registration Statement Form S-1 filed the Securities and Exchange Commission (the “SEC”) on July 31, 2015, as well as additional factors it may describe from time to time in other filings with the Securities and Exchange Commission. You should understand that it is not possible to predict or identify all such factors and, consequently, you should not consider any such list to be a complete set of all potential risks or uncertainties.

 

Contacts:

Media:
Anne Granfield
Finsbury for TerraForm Global
anne.granfield@finsbury.com 
+1 (646) 805-2033

Investors/Analysts:
Brett Prior
bprior@terraform.com 
+1 (650) 889-8628
Monday, February 29th, 2016 Uncategorized Comments Off on (GLBL) Declares Fourth Quarter Dividend

(OPCO) Reports Record 2015 Fourth Quarter and Full-Year Results

FAIRPORT HARBOR, OH–(February 29, 2016) – OurPet’s Company (OTCQX: OPCO) (www.ourpets.com), a leading proprietary pet supply company, today reported record net revenue and record net income for the three months and twelve months ended December 31, 2015.

Net income increased 10% to a record $450,592 for the 2015 fourth quarter from $409,341 for the same period in 2014. For the 2015 full-year, net income increased approximately 74% to a record $1,336,912 from $769,275 the prior year. Net income was $0.02 for both fourth quarter periods and increased to a full-year record $0.07 in 2015 from $0.04 in 2014. The 2015 fourth quarter and full-year results benefited from specific management initiatives that resulted in lower fixed costs, lower product costs and lower selling, general and administrative expenses.

Net revenue increased 1% to a record $6,648,394 for the 2015 fourth quarter compared to the same period a year ago. For the 2015 full-year, net revenue increased approximately 5% to a record $23,819,189 from $22,770,562 in 2014. These results were achieved despite a challenging retail environment and the negative impact of a stronger dollar on international sales throughout 2015.

Dr. Steven Tsengas commented, “Our record results for the 2015 fourth quarter and full-year reflect successful execution of our business strategy. We remain focused on growth initiatives in all three of our key product categories; feeding and storage, toys and accessories, and waste management and odor control. And we continue to grow our business in the Pet Specialty, Food, Drug and Mass Retail, and E-commerce sales channels. The 2015 fourth quarter sales benefited from a 27% increase in E-commerce sales and a 26% increase in waste and odor management sales compared to the same period a year ago. For the full year, sales in the Pet Specialty and E-commerce channels increased 12% and 6%, respectively, compared to 2014.”

Dr. Tsengas added, “During the past year we completed implementation of our dual brand strategy, whereby we created the OurPet’s brand for the Pet Specialty channel and the Pet Zone brand for the Food, Drug and Mass channel. There are additional growth opportunities, particularly with the Pet Zone brand where sales were relatively flat compared to the prior year and we have accordingly increased our initiatives in that sales channel. We are also adding exciting new products to our pipeline that involve game-changing technology that is new to the industry. These products include our Intelligent Pet Care product line, Fly-by-Spin toys, Kitty Potty and Switchgrass/BioChar Natural Litter and new bowl/feeder designs. All of these products and others will be launched at next month’s Global Pet Expo in Orlando, Florida.”

Dr. Tsengas concluded, “The Company’s improved performance in 2015, especially during the second half of the year, combined with our planned product launches and expanded sales force position us well for 2016. We hope to continue this positive momentum going forward.”

2015 Fourth Quarter Results

Net revenue increased 1% to $6,648,394 for the 2015 fourth quarter from $6,594,870 the same period in 2014, led by sales growth of 26% and 8%, respectively, in waste management and odor control and feeding and storage products, and a 27% increase in E-commerce sales compared to the 2014 fourth quarter. International sales for the 2015 fourth quarter increased 1% and were affected by the stronger U.S. dollar compared to other global currencies.

Product cost reductions and purchase discounts benefited 2015 fourth quarter gross profit which increased more than 1% to $2,124,922 compared to the 2014 fourth quarter. Gross profit margin increased to 32.0% for the 2015 fourth quarter from 31.8% for the same period a year ago.

Selling, general & administrative expenses decreased 6% to $1,393,106 for the 2015 fourth quarter versus the prior year due to lower marketing, consulting and stock option expenses.

Income from operations increased 19% to $731,816 for the 2015 fourth quarter compared to $615,562 for the same period in 2014. This was principally due to a $27,000 increase in gross profit combined with an $89,000 decrease in selling, general and administrative expenses.

Income tax expense for the 2015 fourth quarter was $253,751 versus $166,284 for the same period in 2014. The Company’s effective tax rate was 36.0% for the fourth quarter 2015 compared to 32.7% a year ago. These increases resulted from higher pre-tax income and adjustments to previous estimates of tax liabilities.

Net income increased 10% to $450,592 for the 2015 fourth quarter from $409,341 for the same period last year. Net income per diluted share was $0.02 for both periods.

EBITDA increased to $914,536 for the 2015 fourth quarter from $766,337 a year ago primarily due to higher tax expense and net income. A reconciliation of EBITDA to GAAP net income is provided in an attachment to the summary financial statements.

2015 Full-Year Results

Net revenue increased 5% to $23,819,189 for the twelve months ended December 31, 2015, from $22,770,562 the prior year. Product sales in the waste management and odor control, feeding and storage and toys and accessories categories increased 14%, 11% and 4%, respectively, compared to 2014. Solid gains were realized in the Pet Specialty and E-commerce sales channels, which increased 12% and 6%, respectively, versus 2014.

Gross profit increased 11% to $7,549,513 for 2015 for the 2015 full-year from $6,810,959 the prior year due to higher sales. Gross profit margin for 2015 increased to 31.7% from 29.9% for 2014 principally due to cost reductions in components, freight and negotiated payment discounts.

Selling, general and administrative expenses decreased 4% to $5,389,897 for the 2015 full-year from $5,608,934 in 2014. This year-over-year decrease was attributable to better control of staffing and outsourcing needs.

Income from operations increased 80% to $2,159,616 for the 2015 full-year from $1,202,025 for 2014. This increase was due to the solid increase in gross profit combined with the decrease in selling, general and administrative expense versus the prior year.

Income tax expense was $750,592 for 2015 compared to $373,007 the prior year as a result of higher income before taxes. The effective tax rate increased to 36.0% for 2015 from 32.7% the prior year.

Net income increased 74% to $1,336,912 for the 2015 full-year from $769,275 in 2014. Net income per share increased by a similar percentage to $0.07 for the twelve months ended December 31, 2015, from $0.04 per share a year ago.

EBITDA increased 51% to $2,899,227 for the 2015 full-year compared to $1,919,993 the prior year due to higher net income and higher income tax expense. A reconciliation of EBITDA to GAAP net income is provided in an attachment to the summary financial statements.

About OurPet’s Company

OurPet’s Company designs, produces and markets a broad line of innovative, high-quality accessory and consumable pet products in the U.S. and overseas. Investors and customers may visit www.ourpets.com for more information about the Company and its products. The Company’s websites include www.ourpets.com and www.petzonebrand.com. Certain of the matters set forth in this press release are forward-looking and involve a number of risks and uncertainties. Among the factors that could cause actual results to differ materially are the following: business conditions growth in the industry; general economic conditions; addition or loss of significant customers; the loss of key personnel; product development; competition; risks of doing business abroad; foreign government regulations; fluctuations in foreign currency rates; rising costs for raw materials and sources of supply that may be limited or unavailable from time to time; the timing of orders booked; and the other risks that are described from time to time in OurPet’s SEC reports.

OURPET’S COMPANY AND SUBSIDIARIES
CONSOLIDATED OPERATING RESULTS
For the Years Ended For the Quarter Ended
December 31, December 31,
2015 2014 2015 2014
Net revenue $ 23,819,189 $ 22,770,562 $ 6,648,394 $ 6,594,870
Cost of goods sold 16,269,676 15,959,603 4,523,472 4,497,009
Gross profit on sales 7,549,513 6,810,959 2,124,922 2,097,861
Selling, general and administrative expenses 5,389,897 5,608,934 1,393,106 1,482,299
Income from operations 2,159,616 1,202,025 731,816 615,562
Other (income) and expense, net (43,623 ) (67,028 ) (3,041 ) 10,685
Interest expense 115,735 126,771 30,514 29,252
Income before taxes 2,087,504 1,142,282 704,343 575,625
Income tax expense 750,592 373,007 253,751 166,284
Net Income $ 1,336,912 $ 769,275 $ 450,592 $ 409,341
Basic and Diluted Net Income Per Common
Share After Dividend Requirements For Preferred
Stock $ 0.07 $ 0.04 $ 0.02 $ 0.02
Weighted average number of common shares outstanding used to calculate basic earnings per share 17,569,744 17,046,577 17,604,342 17,527,282
Weighted average number of common and equivalent shares outstanding used to calculate diluted earnings per share 19,262,742 18,159,204 19,377,512 19,856,402
OURPET’S COMPANY AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
December 31,
2015 2014
ASSETS
Cash and equivalents $ 100,000 $ 192,448
Receivables, net 4,294,810 3,116,448
Inventories, net 7,914,613 6,894,115
Prepaid expenses 582,676 478,593
Total current assets 12,892,099 10,681,604
LONG TERM ASSETS
Property and equipment, net 1,873,260 1,769,548
Amortizable Intangible Assets, net 357,341 384,063
Intangible Assets 461,000 461,000
Goodwill 67,511 67,511
Deposits and Other assets 18,003 18,003
Total long term assets 2,777,115 2,700,125
Total assets $ 15,669,214 $ 13,381,729
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current maturities of long-term debt $ 276,890 $ 601,632
Accounts payable 1,582,849 1,489,982
Other Accrued expenses 571,858 565,491
Total current liabilities 2,431,597 2,657,105
LONG TERM LIABILITIES
Long-term debt – less current portion above 876,248 119,780
Revolving line of credit 3,267,170 2,862,032
Deferred income taxes 333,834 281,651
Total long term liabilities 4,477,252 3,263,463
Total liabilities 6,908,849 5,920,568
Stockholders’ Equity 8,760,365 7,461,161
Total liabilities and stockholders’ equity $ 15,669,214 $ 13,381,729
EBITDA Q4’15 Q4’14 2015
Full Year
2014
Full Year
Net Income $ 450,592 $ 409,341 $ 1,336,912 $ 769,275
Interest 30,514 29,252 115,735 126,771
Tax Expense 253,751 166,284 750,592 373,007
Depreciation 162,666 140,598 619,647 571,587
Amortization 17,013 20,862 76,341 79,353
Total EBITDA $ 914,536 $ 766,337 $ 2,899,227 $ 1,919,993

The above table reconciles the Company’s disclosure of Net Income per GAAP with the non GAAP financial measure EBITDA (Earnings before Interest, Taxes, Depreciation and Amortization). As the investment community has often requested the EBITDA calculation to help them evaluate performance, Management has chosen to provide this disclosure. Although EBITDA is widely used in the investment community as a benchmark to reflect operating performance, financing capability and liquidity, it is not regarded as a measure of operating performance and liquidity under generally accepted accounting principles (“GAAP”). It also does not represent cash flows from operating activities. In addition, the Company’s EBITDA may not be comparable to similar indicators provided by other companies. The Presentation of this additional information is not meant to be considered in isolation or as a substitute for net income (loss), or any component thereof, in accordance with GAAP.

Contact:
OurPet’s Company
Dr. Steven Tsengas
CEO
(440) 354-6500 x111

Investor Relations:
Dream Team
Michael McCarthy
(512) 758-8877

Monday, February 29th, 2016 Uncategorized Comments Off on (OPCO) Reports Record 2015 Fourth Quarter and Full-Year Results

(AVID) Customers Bring Home BRIT Awards

Winners and Nominees Embraced Avid Everywhere to Create Award-Winning Songs and Albums at the U.K.’s Most Prestigious Music Awards Ceremony

BURLINGTON, Mass., Feb. 26, 2016  — Avid® (Nasdaq:AVID) today congratulated its many customers recognized for their craft as winners and nominees at this year’s BRIT Awards, held at The O2 Arena in London on Wednesday, February 24. An overwhelming number of the world’s most respected artists embraced Avid EverywhereTM, using Avid Artist Suite creative solutions, including the industry-standard digital audio software Avid Pro Tools®, to craft internationally acclaimed songs and albums.

Adele took home the British Album of the Year award for 25. Fellow nominees who also relied on Pro Tools include Coldplay for A Head Full of Dreams and Florence + the Machine for How Big, How Blue, How Beautiful.

British producer and Pro Tools user Charlie Andrew was presented with the first 2016 BRIT Award for British Producer of the Year earlier this month at the annual Music Producers Guild (MPG) Awards ceremony in London. Andrew collected this year’s Best Producer Award for his work with Alt-J, Marika Hackman and Sivu. Pro Tools user and rock producer Tom Dalgety was also acknowledged with a nomination in the category.

Other BRIT Award-winning projects by artists, producers and engineers who use Avid solutions in their studios include, Coldplay (British Group), Bjork (International Female Solo Artist) and Tame Impala (International Group). Adele also took home three more awards, British Single for huge number one single Hello, Female Solo Artist and the converted Global Success Award.

“Once again, we’re honored that the world’s most talented music professionals continue to choose Avid’s industry-leading audio solutions to record and produce the best music in Britain and across the world,” said Avid Chairman, President and Chief Executive Officer, Louis Hernandez, Jr. “We congratulate our BRIT Award-winning and nominated customers who inspire us with their outstanding artistic and technical achievements.”

About Avid
Through Avid Everywhere™, Avid delivers the industry’s most open, innovative and comprehensive media platform connecting content creation with collaboration, asset protection, distribution and consumption. Media organizations and creative professionals use Avid solutions to create the most listened to, most watched and most loved media in the world—from the most prestigious and award-winning feature films, to the most popular television shows, news programs and televised sporting events, as well as a majority of today’s most celebrated music recordings and live concerts. Industry leading solutions include Pro Tools®, Media Composer®, ISIS®, Interplay®, ProSet and RealSet, Maestro, PlayMaker, and Sibelius®. For more information about Avid solutions and services, visit www.avid.com, connect with Avid on Facebook, Instagram, Twitter, YouTube, LinkedIn, or subscribe to Avid Blogs.

© 2016 Avid Technology, Inc. All rights reserved. Avid, the Avid logo, Avid Everywhere, iNEWS, Interplay, ISIS, AirSpeed, Media Composer, Pro Tools, and Sibelius are trademarks or registered trademarks of Avid Technology, Inc. or its subsidiaries in the United States and/or other countries. The Interplay name is used with the permission of the Interplay Entertainment Corp. which bears no responsibility for Avid products. All other trademarks are the property of their respective owners. Product features, specifications, system requirements and availability are subject to change without notice.

PR Contacts:
Sara Griggs
Avid
sara.griggs@avid.com
310-907-6909
Friday, February 26th, 2016 Uncategorized Comments Off on (AVID) Customers Bring Home BRIT Awards

(GRPN) Expands Its Enterprise Data Center Portfolio

Local Commerce Leader Leverages Advanced In-House Computing Systems and Wholesale Data Center Solutions From RagingWire to Drive Its Global Business

PALO ALTO, CA–(February 26, 2016) – RagingWire Data Centers, the nation’s premier data center provider and an NTT Communications group company, announced that Groupon, a global leader of local commerce, is expanding its enterprise data center portfolio by contracting for 1 MW of power and 5,000 square feet at RagingWire’s new CA3 data center in Sacramento, California. The five-year agreement between RagingWire and Groupon will take the majority of space and power in Vault 1 of CA3, which was recently opened in April 2015.

Since its debut in November 2008, Groupon has redefined local commerce by increasing consumer buying power and driving more business into local merchants through price and discovery. With nearly 50 million active customers and more than one million merchant relationships, the company offers a vast online and mobile marketplace of unbeatable deals all over the world. In addition, more than 115 million people worldwide have downloaded Groupon’s mobile apps worldwide.

“As a company that’s seen incredible growth throughout our seven-year history, it was important for us to find a wholesale data center provider that could meet our requirements for scalability, customizable high-density power, cooling containment, ISP neutrality and physical security,” said Harmail Chatha, Director Global Data Center Operations, Groupon. “RagingWire provided us with exactly what we needed in a timely and efficient manner, helping to ensure that we are able to support our increased traffic demands as our business grows.”

Groupon’s implementation at RagingWire’s CA3 data center supports their innovative computing platform and service oriented applications. These business critical systems run in active-active mode with Groupon’s other production data center in the United States to support users in Groupon’s largest markets in North America and Latin America. The Groupon deployment is highly energy efficient using advanced cold aisle containment systems and all white infrastructure. Space, power and cooling were optimized by Groupon using an in-house developed linear programming model.

“We are thrilled and honored to welcome Groupon to RagingWire,” said Tim Nicols, Vice President of Sales and Business Development at RagingWire. “Technology has forever changed the way that we shop, and Groupon relies on RagingWire to make sure their computing systems are always on for their customers and merchants.”

RagingWire is among the largest wholesale colocation providers in the world. Its Sacramento data center campus made up of the CA1, CA2, and CA3 data centers is home to enterprises looking to house their computers in the Western United States while avoiding the earthquake risk found in the Bay Area and Silicon Valley. The CA3 data center has 180,000 square feet of space, 14 MW of critical IT power, and 20,000 square feet of Class A office space. The entire site utilizes RagingWire patented 2N+2® power delivery architecture which is key to RagingWire’s ability to provide 100% availability and flexible power ramps.

About RagingWire Data Centers
RagingWire Data Centers designs, builds, and operates mission critical data centers that deliver 100% availability and high-density power. The company currently has over 80MW of critical IT load spread across nearly 1 million square feet of data center infrastructure in Northern California and Ashburn, Virginia, with significant growth plans in both locations, Texas, and other top North American data center markets. As an NTT Communications group company, RagingWire is one of the most financially strong companies in the data center industry and is part of the global network of 140 data centers operated by NTT Communications under the Nexcenter™ brand. For more information visit www.ragingwire.com.

About Groupon
Groupon (NASDAQ: GRPN) is a global leader of local commerce and the place you start when you want to buy just about anything, anytime, anywhere. By leveraging the company’s global relationships and scale, Groupon offers consumers a vast marketplace of unbeatable deals all over the world. Shoppers discover the best a city has to offer on the web or on mobile with Groupon Local, enjoy vacations with Groupon Getaways, and find a curated selection of electronics, fashion, home furnishings and more with Groupon Goods.

Groupon is redefining how traditional small businesses attract, retain and interact with customers by providing merchants with a suite of products and services, including customizable deal campaigns, credit card payment processing capabilities, and point-of-sale solutions that help businesses grow and operate more effectively. To search for great deals or subscribe to Groupon emails, visit www.Groupon.com. To download Groupon’s top-rated mobile apps, visit www.groupon.com/mobile. To learn more about the company’s merchant solutions and how to work with Groupon, visit www.GrouponWorks.com.

 

Press Contacts

RagingWire Data Centers
James Leach
571-383-8895 (mobile)
jleach@ragingwire.com

Groupon
Nick Halliwell
312-999-3812
nhalliwell@groupon.com

Friday, February 26th, 2016 Uncategorized Comments Off on (GRPN) Expands Its Enterprise Data Center Portfolio

(VASC) and Howard Root Found Not Guilty on All Charges in Short Kit Litigation

  • Jury finds Vascular Solutions and Howard Root not guilty on all charges in criminal prosecution concerning alleged “off-label” promotion of Vari-Lase® Short Kit
  • Jury’s verdict concludes litigation and is not subject to appeal
  • Vascular Solutions demands Department of Justice retract its prior false and misleading public statements 

MINNEAPOLIS, Feb. 26, 2016  — Vascular Solutions, Inc. (Nasdaq:VASC) today reported that the jury in its federal trial in the Western District of Texas in San Antonio has returned a unanimous verdict of not guilty on all charges against the company and its CEO Howard Root regarding the alleged “off-label” promotion of the Vari-Lase Short Kit. Senior U.S. District Judge Royce Lamberth has entered an order dismissing the case that is final and is not subject to appeal.

Howard Root made the following comments:

“The company and I are vindicated by today’s verdict, but outraged by the obscene legal process we were forced to endure.” 

“We are appalled by the malicious behavior and lack of substantive oversight of the government officials who pursued this matter – in particular Assistant U.S. Attorneys Bud Paulissen and Christina Playton of the Western District of Texas, Consumer Protection Branch Trial Attorneys Timothy Finley and Charles Biro, and FDA Special Agent George Scavdis. There simply is no excuse for abusive and dishonest conduct in any U.S. governmental agency, much less in the Department of Justice and our law enforcement agencies.”

“We greatly appreciate the jury’s complete rejection of the government’s false allegations. But to get to this result, we were subjected to five years of attacks which forced us to hire 10 separate law firms at a cost of over $25 million to defend against a criminal prosecution that clearly was never warranted by the facts. This case centered on just one version of just one of our more than 100 medical devices – a version that was FDA-cleared, made up only 0.1% of our sales, and, by the government’s own admission, never harmed a single patient. To say that this prosecution was wrong-headed and disproportionate would be the understatement of the year.”

“While this matter is now over for Vascular Solutions and me, an upcoming criminal trial remains scheduled for one of the company’s sales representatives on obstruction of justice charges because he refused to change his grand jury testimony to match what these prosecutors wanted to hear.  It should now be obvious that our sales rep’s indictment was merely a malicious retribution by misguided prosecutors, an action that needs to be corrected immediately.  And after his indictment is dismissed, if the U.S. Attorney in San Antonio still wants to prosecute someone for obstruction of justice in this case, in my opinion he wouldn’t even have to leave his own office to find the most suitable person to indict.”

“Vascular Solutions is fortunate to have had the financial strength and dedicated employees necessary not only to fight, but to win. Most other companies would have been destroyed before they even set foot in the courtroom. In order to ensure that what happened to Vascular Solutions doesn’t happen to a defenseless company or individual, changes need to be made in the personnel and culture at the Department of Justice.”

“Every investigation that is being conducted by the prosecutors who were assigned to our case needs to be independently reviewed by the Department of Justice to make sure that their abusive and dishonest tactics are not being used on others. Furthermore, every current investigation of a medical device company concerning “off-label” promotion needs to be reviewed by the Department of Justice to make sure their prosecutors’ theories comply with the law, not just their wishes.”

“Looking forward, starting tomorrow Vascular Solutions will return our full focus and resources to developing medical devices to improve patient lives and create American jobs – vital pursuits that were clouded while we were defending ourselves against a malicious prosecution. Fortunately, throughout this process our employees have continued to carry on with business as usual. That commitment and our successful business model has positioned Vascular Solutions very well for continued success, especially now that this senseless distraction is behind us.”  

In order to correct the multiple false and misleading public allegations made by the Department of Justice concerning this matter, Vascular Solutions demands a prompt and complete corrective press release.

In particular, on November 13, 2014 the Department of Justice, Office of Public Affairs issued a press release that quoted Joyce Branda, the Acting Assistant Attorney General for the Civil Division, alleging that this matter was “a deceptive sales campaign led by the CEO of a public company.” The press release further quoted Ms. Branda alleging that the “sales campaign persisted in the face of FDA warnings, a whistleblower’s complaint to the CEO and a failed clinical trial showing that the device was less safe and less effective than a product that had already been approved.” As demonstrated by the evidence presented under oath at trial, all of these allegations were false.

Similarly, in a press release issued on July 28, 2014 by the Department of Justice, Office of Public affairs, Assistant Attorney General Stuart F. Delery was quoted characterizing Vascular Solutions as a company that “put profits over patient safety.” In the same press release, U.S. Attorney Robert Pitman was quoted describing Vascular Solutions as a company that “knowingly promote[d] medical devices for unapproved uses, causing federal health care programs to pay for services that cannot be reimbursed.” Again, the evidence presented under oath at trial demonstrated that all of these allegations were false.

Furthermore, at a medical devices conference held on October 15, 2015, Julie Taitsman, MD, JD, the Chief Medical Officer at Health and Human Services, Officer of Inspector General, publicly stated that Vascular Solutions had persisted in off-label marketing even when a clinical trial failed, and that Vascular Solutions had data showing that the Short Kit was less safe than a competitor’s. She further stated that this case was “hand-picked” by the government because it was such a strong case, and that the government “went on the offensive” in prosecuting Vascular Solutions. Not only did the evidence presented under oath at trial demonstrate that Dr. Taitsman’s allegations were false when made, but her characterization of the prosecution strategy documented its malicious nature and violated judicial rules against the making of extrajudicial public statements during the pendency of a case.

Mr. Root concluded with the following statement:

“Gratuitous public allegations are easy for the Department of Justice to make when a lawsuit starts and the accused is unable to respond. But now that the trial is over and the jury has rejected all of the government’s accusations, the Department of Justice needs to set the record straight in the interests of justice.  And after that, the Department of Justice needs to investigate what went wrong in our case and make internal changes in order to ensure that its next ‘hand-picked’ and ‘offensive’ criminal prosecution isn’t based on false allegations made by a money-motivated disgruntled former employee, which is what happened here.”

Background

The Vari-Lase Short Kit was sold by Vascular Solutions in the U.S. from October 2007 through July 2014 under an FDA 510(k) clearance for the treatment of varicose veins and varicosities associated with superficial reflux of the great saphenous vein and for treatment of incompetence and reflux of superficial veins in the lower extremity. Sales of the Short Kit during the seven years it was on the U.S. market totaled $534,000, representing just 0.1% of Vascular Solutions’ U.S. sales of all products during those years.  Over two-thirds of Vascular Solutions’ sales representatives never sold even a single unit of the Short Kit, and the Short Kit was never the subject of any reported serious adverse event in any patient.

The allegations advanced by the prosecutors at trial concerned whether Vascular Solutions and Howard Root engaged in a promotional campaign to encourage members of Vascular Solutions’ sales force to speak to physicians about the use of the Short Kit to treat varicose perforator veins in the leg and whether that use was outside the Short Kit’s FDA-cleared labeled indications for use and therefore an “off-label” use.  The jury unanimously rejected all of the prosecutors’ allegations.

About Vascular Solutions

Since its founding by Howard Root in 1997, Vascular Solutions has developed over 100 new medical devices that are used by physicians to treat a wide variety of vascular diseases, from heart attacks to peripheral arterial disease. The company’s most recent major product in development is RePlas™ freeze-dried plasma, which is being developed in collaboration with the U.S. Army for use on the battlefield to save the lives of soldiers suffering blood loss, due to a bullet wound or roadside bomb. The Vari-Lase Short Kit matter is the only allegation of a legal compliance issue that the company has received in its 20-year history.

For further information on Vascular Solutions, connect to www.vasc.com.

 

Investors:

Phil Nalbone
VP of Vascular Solutions
PNalbone@vasc.com (763) 656-4371

Media:

Jon Austin
J Austin & Associates
jon@jaustingroup.com (612) 839-5172
Friday, February 26th, 2016 Uncategorized Comments Off on (VASC) and Howard Root Found Not Guilty on All Charges in Short Kit Litigation

(CTSO) Data Presented on First CytoSorb® Investigator-Initiated Septic Shock Study

Encouraging top line results fuel hopes for potentially life-saving treatment

MONMOUTH JUNCTION, N.J., Feb. 26, 2016  — CytoSorbents Corporation (NASDAQ: CTSO), a critical care immunotherapy leader commercializing its flagship CytoSorb® blood filter to treat deadly inflammation in critically-ill and cardiac surgery patients around the world, summarized data from the first CytoSorb® investigator-initiated septic shock study presented yesterday at the  26th Symposium for Intensive Medicine + Intensive Care in Bremen, Germany.

Dr. Sigrun Friesecke, Senior Intensivist of the medical intensive care unit (MICU) at Greifswald University in Germany, presented top line data from a prospective, single arm study in 22 patients with refractory late-stage septic shock and multiple organ failure at her institution.  All patients had refractory septic shock despite high doses of vasopressors, respiratory failure requiring artificial ventilation or extracorporeal membrane oxygenation (ECMO), anuric (no urine production) kidney failure requiring dialysis, and a significantly elevated initial mean lactate level of 8 mmol/L, indicating extreme metabolic and physiologic derangement.  In these patients, all intensive care therapeutic options had been exhausted.  Patients underwent consecutive twelve-hour extracorporeal  CytoSorb® treatments over several days, using a new CytoSorb® cartridge for each treatment.

As reported recently by Conrad (2015), a similar patient population (n=16) receiving standard of care treatment with persistent refractory septic shock that could not be reversed, with respiratory failure on mechanical ventilation, initial lactate levels of 6.1 ± 4 mmol/L, and 75% requiring renal replacement therapy had a mortality of 100% at 28 days1.

Preliminary key findings of the CytoSorb® Greifswald study:

  • 28-day-survival was 41%, an approximately 30-40% absolute improvement in survival compared to what was expected (0-10%)
  • Resolution of shock, the main cause for mortality in this patient population, was achieved in 68% of the patients with CytoSorb® therapy, which translated into improvement in clinical outcomes
  • Reduction of IL-6, one of the cytokines most closely associated with severity of illness, inflammation, and mortality in sepsis, decreased rapidly from initial mean values of approximately 87,000 pg/mL, to below 10,000 pg/mL after 24 hours of treatment

Data analysis continues and more details of this study are expected to submitted for publication in the near future.

Dr. Axel Nierhaus, senior consultant at the Department for Intensive Care Medicine at University of Hamburg – Eppendorf, Germany, who chaired the symposium session, summarized the study as a “significant step to establish CytoSorb as a regular therapy for those moribund patients”.

Sepsis is the result of an overzealous immune response to a serious infection often driven by an excessive production of cytokines, or “cytokine storm”, and other inflammatory mediators and toxins.  It is one of the leading causes of death and disability worldwide, striking an estimated 27 million people annually and killing a third of them, despite the use of antibiotics and the best medical care.  Septic shock is the most deadly form of the disease, where patients develop persistent, life-threatening low blood pressure that compromises blood and oxygen delivery to vital organs in the body.  Common to all septic shock patients is the need for vasopressors – potent drugs such as norepinephrine, dobutamine, and vasopressin – that attempt to artificially increase blood pressure by increasing cardiac output or shunting blood from non-vital organs and the arms and legs, to the core vital organs.  Patients who require maximal doses of multiple vasopressors represent the most challenging patients with the highest risk of death.  Refractory septic shock, despite the use of vasopressors, often results in irreversible organ injury due to ischemia and other factors.  The expected mortality of patients with prolonged refractory septic shock, particularly when combined with the failure of other organs, approaches 90-100%.  CytoSorb® is designed to reduce the inflammatory toxins that drive uncontrolled, deadly inflammation and refractory shock, and has been used to help stabilize blood pressure and regain control of many patients, particularly when used early and aggressively.

1 Conrad, M., et. al., “Early prediction of norepinephrine dependency and refractory septic shock with a multimodal approach of vascular failure”, J Crit Care, 2015; 30:739-743.

About CytoSorbents Corporation (NASDAQ: CTSO)

CytoSorb® is approved in the European Union with distribution in 32 countries around the world, as a safe and effective extracorporeal cytokine adsorber, designed to reduce the “cytokine storm” or “cytokine release syndrome” that could otherwise cause massive inflammation, organ failure and death in common critical illnesses such as sepsis, burn injury, trauma, lung injury, and pancreatitis, as well as in cancer immunotherapy.  These are conditions where the risk of death is extremely high, yet no effective treatments exist.  CytoSorb® is also being used during and after cardiac surgery to remove inflammatory mediators, such as cytokines and free hemoglobin, which can lead to post-operative complications, including multiple organ failure.  CytoSorb® has been used safely in more than 9,000 human treatments to date.

CytoSorbents’ purification technologies are based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and surface adsorption.  The Company has numerous products under development based upon this unique blood purification technology, protected by 32 issued U.S. patents and multiple applications pending, including HemoDefend™, ContrastSorb, DrugSorb, and others.  Additional information is available for download on the Company’s websites:  http://www.cytosorbents.com and http://www.cytosorb.com

Forward-Looking Statements

This press release includes forward-looking statements intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements about our plans, objectives, representations and contentions and are not historical facts and typically are identified by use of terms such as “may,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue” and similar words, although some forward-looking statements are expressed differently. You should be aware that the forward-looking statements in this press release represent management’s current judgment and expectations, but our actual results, events and performance could differ materially from those in the forward-looking statements. Factors which could cause or contribute to such differences include, but are not limited to, the risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 31, 2015, as updated by the risks reported in our Quarterly Reports on Form 10-Q, and in the press releases and other communications to shareholders issued by us from time to time which attempt to advise interested parties of the risks and factors which may affect our business. We caution you not to place undue reliance upon any such forward-looking statements. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, other than as required under the Federal securities laws.

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Cytosorbents Contact:
Amy Vogel
Investor Relations
(732) 329-8885 ext. *825
avogel@cytosorbents.com
Investor Contact:Lee Roth

The Ruth Group

646-536-7012

lroth@theruthgroup.com

Public Relations Contact:Eric Kim

The Ruth Group

646-536-7023

ekim@theruthgroup.com

Friday, February 26th, 2016 Uncategorized Comments Off on (CTSO) Data Presented on First CytoSorb® Investigator-Initiated Septic Shock Study

(RRM) to Merge With SES Platform Services

New Company to Be Formed, Creating a World-Leading Provider of Innovative Global Media Services and Solutions All-Cash Transaction Values RR Media at $242 Million; $13.291 per Share

AIRPORT CITY BUSINESS PARK, ISRAEL–(Feb 26, 2016) – RR Media (NASDAQ: RRM), a leading provider of global digital media services to the broadcast and media industries, announced today that it has agreed to be acquired by SES (EURONEXT PARIS: SESG) (LUXEM: SESG) and will merge its activities with SES Platform Services (“SES PS”) to form a new world-leading provider of media solutions.

SES will acquire a 100% ownership of RR Media, paying $13.291 per share, or a 52% premium to the closing price of the Company’s shares on February 25, 2016. This corresponds to an Enterprise Value of $242 million. The acquisition of RR Media by SES S.A. has been approved by the Boards of Directors of both companies, and is subject, among others, to regulatory approvals and the approval by the general meeting of shareholders of RR Media, which are expected to be completed in the second or third quarter of 2016.

Once the transaction is completed, RR Media and SES PS will join forces to create a new, stand-alone world-leading media services provider. The new organisation will offer full continuity and enhanced service to SES PS and RR Media’s existing customers.

The company will also provide customers with a comprehensive range of innovative video and media solutions on a global scale, with expanded services and the complementary capabilities of both RR Media and SES PS. This includes highly optimized content management and distribution solutions that utilize the combined network of both RR Media and SES PS. The newly formed company will be able to leverage its global content distribution network with optimized delivery over their multiple satellite positions, large fiber network and the Internet, in order to maximize audience reach and add new monetization capabilities.

Avi Cohen, Chief Executive Officer of RR Media, said: “We believe the agreement with SES PS unlocks tremendous value for our shareholders, offering a 52% premium to our share price. This valuation recognizes the success of the expansion and transition of our business over the past few years into a leading provider of digital media services.”

Mr. Cohen continued: “With the combined infrastructure and industry expertise of SES Platform Services and RR Media, the new organization will have the capability to deliver innovative solutions to upper tier clients, emerging markets and global customers. RR Media’s growth strategy has focused on engaging an increased number of upper tier customers with a broader set of services and increasing the scale of our operations, which this merger accelerates.”

Ayal Shiran, General Partner at Viola Private Equity, and Chairman of RR Media’s Board of Directors, said: “The merger of SES PS and RR Media brings together two companies that have each excelled in the provision of digital media services. By uniting their comprehensive service portfolio, infrastructure and distribution network, they are set to truly become a global digital media services powerhouse, with an unparalleled offering for television broadcasters, production companies and platform operators.”

Wilfried Urner, Chief Executive Officer of SES Platform Services, commented: ” RR Media has successfully developed the capability to manage and deliver premium content effectively, helping its customers to reach a global audience over multiple satellite, cable TV, IPTV, online and mobile platforms. SES, as the largest global platform for video in terms of reach and channels, adds global scale and considerable insights from the successful development of SES PS in Europe.”

Ferdinand Kayser, Chairman of SES Platform Services, added: “This is an exciting acquisition and an important milestone in the execution of SES’s differentiated strategy focused on Globalisation, Verticalisation and Dematuring. The addition of RR Media further accelerates the globalisation of SES’s services businesses, establishing a world-leading next generation video and media service provider.”

About RR Media

RR Media (NASDAQ: RRM) works in partnership with the world’s leading media players to transform content into valuable media assets. RR Media’s complete ecosystem of digital media services maximize the potential of media and entertainment content, covering four main areas: smart global content distribution network with an optimized combination of satellite, fiber and the Internet; content management and channel origination; sports, news & live events; and online video services. RR Media provides scalable, converged digital media services to more than 1,000 broadcasters, content owners, sports leagues and right holders. Every day, the company manages and delivers over 24,000 hours of broadcast content, over 4,000 hours of online video and VOD content and over 350 hours of premium sports and live events. The company delivers content to 95% of the world’s population reaching viewers of multiplatform operators, VOD platforms, online video and direct-to-home services. Visit the company’s website www.rrmedia.com.

Safe Harbor Statement
This press release contains forward looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements include, but are not limited to, statements about the expected timing of the transaction, the satisfaction or waiver of any conditions to the proposed transaction, anticipated benefits, growth opportunities and other events relating to the proposed transaction, projections about RR Media’s business and its future revenues, expenses and profitability. These forward-looking statements involve known and unknown risks and uncertainties and are based on current expectations, assumptions, estimates and projections about the companies and the industry as of the date of this press release. We undertake no obligation to update forward-looking statements to reflect subsequent occurring events or circumstances, or to changes in our expectations, except as may be required by law. Forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those contemplated by the forward-looking statements, including (1) RR Media may be unable to obtain required regulatory approvals or satisfy other conditions to the closing of the proposed transaction; (2) the proposed transaction may involve unexpected costs, liabilities or delays; (3) the occurrence of any event, change or other circumstances that could give rise to the termination of the merger agreement; (4) the ability to recognize benefits of the proposed transaction; (5) risks that the proposed transaction disrupts current plans and operations and the potential difficulties in employee retention as a result of the proposed transaction; (6) impact of the transaction on relationships with customers, distributors and suppliers and (7) other risks to consummation of the transaction, including the risk that the transaction will not be consummated within the expected time period or at all, as well as the risks indicated in our filings with the Securities and Exchange Commission (SEC). For more details, please refer to our SEC filings and the amendments thereto, including our Annual Report on Form 20-F for the year ended December 31, 2014 and our Current Reports on Form 6-K.

ADDITIONAL INFORMATION
In connection with the proposed transaction, RR Media intends to mail a proxy statement to its shareholders and furnish a copy of the proxy statement with the SEC on Form 6-K. Shareholders of RR Media are urged to read the proxy statement and the other relevant material when they become available because they will contain important information about RR Media, SES, the proposed transaction and related matters. Shareholders are urged to carefully read the proxy statement and other relevant materials when they become available before making any voting or investment decision with respect to the proposed transaction. The proxy statement (when available) may be obtained for free at the SEC’s website at www.sec.gov. In addition, the proxy statement will be available, without charge, at RR Media’s website at www.rrmedia.com.

This press release is neither a solicitation of proxy, an offer to purchase nor a solicitation of an offer to sell shares of RR Media. 

Corporate Contact:
Elad Manishviz
CMO
Tel: +1 201 655 7245
Email Contact

Media Contact:
Marilyn Gerber
Cutler PR
Tel: +1 917 225 2977
Email Contact

Friday, February 26th, 2016 Uncategorized Comments Off on (RRM) to Merge With SES Platform Services

(OGES) Appointment of Leading International Battery Consultants

Oakridge Global Energy Solutions:
A New Era In Battery Manufacturing

Oakridge Appointment of Leading International Battery Consultants to Ensure the Company Maintains its Technological Leadership

FOR IMMEDIATE RELEASE

Oakridge Corporate Headquarters

February 26, 2016 Melbourne, Florida – Oakridge Global Energy Solutions, Inc. (OTCQB: “OGES”) is excited to announce that IST Co. Ltd in Tokyo, Japan has joined Oakridge as battery technology consultants to ensure that Oakridge remains technologically state-of-the-art.

IST Co., Ltd. in Japan has a broad relationship with Electric Power companies, Energy companies, and Energy Technology companies including, but not limited to, all major Japanese lithium ion battery and material companies.  These companies have developed materials and products for the next generation of lithium ion batteries.    IST also has a broad relationship with University and Research organizations worldwide such as Tokyo Institute of Technology, Eidgenössische Technische Hochschule, Zürich.  IST will help to provide Oakridge with ongoing access to joint technology development opportunities for next generation rechargeable lithium batteries such as lithium air, lithium–sulfur, nano-silicone, and graphene negative electrodes in addition to assisting in the commercialization of the Thin Film Solid State lithium battery technology which Oakridge has already successfully developed.

The IST team joins the current Oakridge Global Energy Solutions advising team in Japan helping Oakridge establish a significant presence in Japan by way of collaboration with major Japanese technical universities and other research facilities, materials suppliers, and state-of-the-art lithium ion manufacturing equipment suppliers.  Oakridge will use its previously established subsidiary in Hong Kong for these purposes.

“We at Oakridge regard our relationship with Japan as highly important because of its technical prowess and also because it is a very strong ally to the United States and Australia which will be vitally important in the increasingly tumultuous international geopolitical situation,” said Oakridge Executive Chairman and CEO, Steve Barber. “We are excited to be working with the high caliber of people and companies that we have had the pleasure to meet in the Japanese lithium ion battery market.  Our goal is to continue to provide cutting edge technology, the highest quality and reliability, and affordable pricing to our customers.  Having quality advisors and consultants like IST and its team enhance our ability to maintain our high standards of technological advancement and demonstrates our commitment to continuing innovate and improve Oakridge’s product offerings so as to provide our customers with the latest technology in high power battery and portable energy systems.”

Oakridge is working with the highest quality Japanese equipment manufacturers in continuing the growth of its facilities in the US.  These manufacturers are providing leading edge equipment that will enable us to continue to produce state of the art high power lithium ion batteries for our customers.

“We are all about latest technology and products at Oakridge.  Oakridge is the battery company that has the talent and technology to overcome the competition in the design and manufacturing of high performance battery systems.   With IST complementing the existing Oakridge advising team in Japan we have now greatly expanded our presence and relationship with Japan, while at the same time providing a much higher quality of equipment and raw materials for building our battery systems,” adds Mr. Barber.

http://www.globenewswire.com/NewsRoom/AttachmentNg/8ad04b1a-591e-47ae-8413-9d37b5392879

Oakridge Thin Film Solid State Lithium Battery
[actual size]

About Oakridge Global Energy Solutions, Inc.

Oakridge Global Energy Solutions Inc., is a publicly traded company, trading symbol: OGES on the OTCQB with a market capitalization of approximately USD $ 200,000,000, whose primary business is the development, manufacturing and marketing of energy storage products. Additional information can be accessed on the company’s website www.oakridgeglobalenergy.com

Forward-Looking Statements Disclaimer: This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. In some cases, you can identify forward-looking statements by the following words: “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking statements are not a guarantee of future performance or results, and will not necessarily be accurate indications of the times at, or by, which such performance or results will be achieved. Forward-looking statements are based on information available at the time the statements are made and involve known and unknown risks, uncertainties and other factors that may cause our results, levels of activity, performance or achievements to be materially different from the information expressed or implied by the forward-looking statements in this press release. This press release should be considered in light of all filings of the Company that are contained in the Edgar Archives of the Securities and Exchange Commission at www.sec.gov.

Contact:
Oakridge Global Energy Solutions, Inc.
www.oakridgeglobalenergy.com
3520 Dixie Highway
Palm Bay, 32905, Florida, USA
Ph: (321) 610-7959
Email: ir@oakg.net

Investor Inquiries:

Benchmark Advisory Partners LLC
Timothy Connor
Toll Free: (866) 703-4778
admin@bmarkadvisory.com

And:

Dutch DeWaard
Business Development
DreamTeamNetwork (DTN)
Austin, TX
www.DreamTeamNetwork.com
512.758.8877 Office
480.734.5834 Mobile
Dutch@DTN.fm

And:

Mike King
Princeton Research
www.princetonresearch.com
702.650.3000
mike@princetonresearch.com

Friday, February 26th, 2016 Uncategorized Comments Off on (OGES) Appointment of Leading International Battery Consultants

(CAR) Launches Its Most Flexible Service Yet

Members Will Enjoy Greater Freedom and Cities and Campuses Will Benefit From a New Comprehensive Mobility Solution

BOSTON, Feb. 25, 2016 — Zipcar, the world’s leading car sharing network, today announced plans to launch a suite of new features representing the company’s next generation of mobility services. Zipcar’s new services include:

  • Choose your destination: Designated vehicles can be used either one-way or round trip, with parking included, providing members a variety of trip options.
  • Change destination mid-trip: Members can reserve a vehicle which can be returned to a different end destination as plans change during a trip, providing the freedom to enjoy the journey.
  • Extend reservations indefinitely: Members can continue the trip for as long as they choose.

Zipcar will now blend the best of its round-trip model — guaranteed parking, more than 50 vehicle types and advanced reservations — with the spontaneity and freedom of new flexible features, all available through the company’s website or mobile app.

For Zipcar, which was founded 16 years ago and today serves nearly a million members, this marks a significant expansion of its pioneering service that will provide an even wider set of mobility solutions.  Zipcar will begin to roll out its new flexible service in select North American markets throughout the year, including Los Angeles in the coming weeks.

“Zipcar is evolving to offer the most options, the most flexibility and the largest global network of any mobility provider,” said Kaye Ceille president of Zipcar. “Combined with our global network in more than 500 cities and towns, our proven round-trip model, as well as a choice of more than 50 different makes and models, this ‘most flexible Zipcar yet’ provides a comprehensive mobility service that solves transportation challenges for cities and enables our members even more freedom and spontaneity. We’ve known for the past 16 years that the future of mobility is paying for the trip, not the car, and this evolution will enable Zipcar to continue to lead the transformation in urban mobility.”

As the company looks to 2017 and beyond, the service will continue to evolve with an even greater focus on flexible mobility solutions. Zipcar will provide members with not only the right car for the trip, but also a wider variety of trip types – round trip, one-way with parking, one-way and park where you choose, and even the option to travel between cities.

“Our members are co-creators of our service, and this inflection is a result of their feedback as well as key learnings from our ONE>WAY beta program in Boston and in various test markets,” said Nichole Mace, vice president, product and member experience. “We plan to provide our members with the mobility solutions they want today, as well as have the foresight to provide members the solutions they will want tomorrow.”

Over the past year, Zipcar has employed an extensive member research effort to determine the current and future needs of its evolving member base. This includes both qualitative and quantitative research, member and non-member focus groups, as well as in-depth member roundtable events where the company has flown in members from across North America to better understand their transportation needs.

Zipcar launched its ONE>WAY beta program in partnership with Honda in late 2014 in Boston.  At launch, Zipcar’s new flexible offering will consist solely of select Honda vehicles including the Honda Fit – the fuel-efficient, versatile and fun subcompact that can fit up to five people and their gear. As a trusted mobility partner, additional Honda vehicles will be added into the service as it evolves.

For more than 15 years, members have trusted Zipcar for a variety of round trips from the ordinary (grocery store runs or a drive around town) to the extraordinary (weddings or bringing Baby home).  With the evolution of Zipcar’s service offering, members will soon have more flexibility in the types of trips they can take.  More information is available at: www.zipcar.com/flexible.

About Zipcar
Zipcar is the world’s leading car sharing network, driven by a mission to enable simple and responsible urban living. With its wide variety of self-service vehicles available by the hour or day, its industry-leading university, business and government fleet programs, and its operations on over 500 college campuses and in more than 500 cities and towns across eight countries, Zipcar offers the most comprehensive, most convenient and most flexible car sharing options available. Zipcar is a subsidiary of Avis Budget Group, Inc. (Nasdaq:CAR), a leading global provider of vehicle rental services. More information is available at www.zipcar.com.

Media Contact:
Lindsay Wester
Public Relations Manager
617-336-4749
lwester@zipcar.com
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(PODD) Insulet Announces Development Partner for the OmniPod Artificial Pancreas

Company’s Alliance with Algorithm Partner Marks Critical Step Forward in Advanced Diabetes Treatment

BILLERICA, Mass., Feb. 25, 2016  — Insulet Corporation (NASDAQ: PODD), the leader in tubeless insulin pump technology with its OmniPod® Insulin Management System (OmniPod System), today announced a license agreement and partnership with Mode AGC (Automated Glucose Control LLC), to develop and incorporate the advanced artificial pancreas algorithm created by renowned researchers Francis Doyle PhD, Eyal Dassau PhD, and Howard Zisser MD. This alliance marks a significant step forward in Insulet’s mission to improve the quality of life for individuals with insulin-dependent diabetes. Insulet’s artificial pancreas system will use the innovative and differentiated OmniPod platform, the latest DexCom Continuous Glucose Monitoring (CGM) technology and the algorithm licensed from Mode AGC.

The algorithm was created by Drs. Doyle, Dassau and Zisser during their tenure at the University of California, Santa Barbara, and further developed by Mode AGC, a California-based early-stage medical device company founded by prominent diabetes technology specialist Thomas Peyser PhD and diabetes advocate and entrepreneur Jennifer Schneider MD. Over the last several months, Insulet has worked with Mode AGC and the inventors to optimize the performance of the algorithm for incorporation into a commercial product. Coupled with the unique tubeless OmniPod platform, this system will be poised to deliver not only improved clinical outcomes, but the greatly desired improvement in quality of life for those living with insulin-dependent diabetes.

“Insulet continues to make substantial progress toward incorporating advanced artificial pancreas functionality into the future-generation of OmniPod,” said Patrick Sullivan, Insulet President and Chief Executive Officer. “The additional expertise the algorithm inventors bring to Insulet is exceptional, as is the clinical superiority of the algorithm. We are excited to integrate the algorithm into our OmniPod System and to deliver a seamless user experience.”

Dr. Howard Zisser, Medical Director of Insulet, worked with Professor Doyle and his colleagues for over a decade conducting clinical studies at the Sansum Diabetes Research Institute in Santa Barbara, California, as part of the Juvenile Diabetes Research Foundation (JDRF) Artificial Pancreas Project.

“I have had the privilege of working closely with Frank Doyle and his colleagues for many years,” said Dr. Zisser. “The Doyle Group is unquestionably one of the leading Artificial Pancreas algorithm groups in the world. I look forward to continued collaboration with Frank and Mode AGC on developing Insulet’s OmniPod Artificial Pancreas system.”

Insulet’s clinical feasibility study involving the algorithm and prototype of its future-generation OmniPod is underway. The Company expects to begin on-body clinical trials later this year.

About the OmniPod Insulin Management System:

The OmniPod Insulin Management System is an innovative continuous insulin delivery system that provides all the proven benefits of continuous subcutaneous insulin infusion (CSII) therapy in a way no conventional insulin pump can. The OmniPod System’s innovative design and features allows people living with diabetes to live their life—and manage their diabetes—with unprecedented freedom, comfort, convenience, and ease. The OmniPod System consists of two components: (i) a Pod that stores and delivers insulin; and (ii) a Personal Diabetes Manager (PDM) that wirelessly programs the user’s personalized insulin delivery, calculates suggested doses and insulin on board, and has a convenient, built-in blood glucose meter. The small, light-weight Pod can be worn in multiple locations, including the abdomen, hip, back of upper arm, upper thigh or lower back and, because it is waterproof (IPX8), there is no need to remove when showering, swimming or performing other activities. This means that OmniPod can provide up to three days of non-stop insulin delivery, without the need to disconnect a tube set or manually inject insulin. The Pod and PDM communicate wirelessly to offer precise, personalized and continuous insulin delivery with customizable basal and bolus delivery options, as well as important safety checks. The Pod’s auto-cannula insertion is quick, simple, and virtually pain-free. Users never have to handle a needle.  The user simply pushes a button on the PDM and the Pod’s automated insertion system inserts the cannula beneath the skin and begins delivering insulin according to the user’s programmed basal rate.

The OmniPod System is the world’s first commercially available tubeless insulin delivery system that allows users to live untethered by tubing and without the stress and anxiety of multiple daily injections. By breaking down the barriers to insulin pump therapy, the OmniPod System offers freedom for users to live life on their own terms and with the ease of use they deserve.

About Insulet Corporation:

Insulet Corporation (NASDAQ: PODD) is an innovative medical device company dedicated to making the lives of people with diabetes easier. Through its OmniPod Insulin Management System, Insulet seeks to expand the use of insulin pump therapy among people with insulin-dependent diabetes. The OmniPod is a revolutionary and easy-to-use tubeless insulin pump that features just two parts and a fully automated cannula insertion. Insulet’s Drug Delivery Systems business also partners with global pharmaceutical and biotechnology companies to tailor the OmniPod technology platform for the delivery of subcutaneous drugs across multiple therapeutic areas. To read inspiring stories of people with diabetes living their lives to the fullest with OmniPod, please visit the Company’s customer blog: http://suited.myomnipod.com. Founded in 2000, Insulet Corporation is based in Billerica, Massachusetts. For more information, please visit: http://www.myomnipod.com.

About Francis Doyle PhD:

Francis J. Doyle, III is Dean of the Harvard John A. Paulson School of Engineering and Applied Sciences. A distinguished scholar in chemical engineering, he previously served as Associate Dean for Research at the University of California, Santa Barbara’s College of Engineering and as Chair of the Department of Chemical Engineering. As a scholar, Professor Doyle applies systems engineering principles to the analysis of regulatory mechanisms in biological systems. In 2012, he was named Santa Barbara’s 2012 “Innovator of the Year” for the worldwide impact of his bioengineering research and development of artificial pancreas technology for treatment of type 1 diabetes. He led the development of process control software for the artificial pancreas system. Professor Doyle was named a Fellow of the American Association for the Advancement of Science (AAAS), the American Institute for Medical & Biological Engineering (AIMBE), the International Federation of Automatic Control, and the Institute of Electrical and Electronics Engineers (IEEE). He received his undergraduate degree from Princeton University, master’s degree from Cambridge University and doctoral degree in chemical engineering from the California Institute of Technology.

About Mode AGC:

Mode AGC (Automated Glucose Control LLC) is an early-stage medical device company in Palo Alto, CA developing closed-loop technology for insulin pumps. Mode AGC, was founded by Jennifer Schneider MD and Thomas Peyser PhD. Dr. Schneider is a Stanford-trained orthopedic surgeon, a noted diabetes advocate and entrepreneur. Dr. Peyser is a world-renowned expert on diabetes technology who has worked for two decades on continuous glucose monitoring. Most recently, Dr. Peyser was Vice President of Science & Technology at DexCom where he worked on the development of the G4 Platinum continuous glucose monitoring system. While at DexCom, Dr. Peyser led the company’s collaborations with artificial pancreas research groups around the world.

Forward-Looking Statement:

This press release may contain forward-looking statements concerning Insulet’s expectations, anticipations, intentions, beliefs or strategies regarding the future. These forward-looking statements are based on its current expectations and beliefs concerning future developments and their potential effects on Insulet. There can be no assurance that future developments affecting Insulet will be those that it has anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond its control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited, those described in its Annual Report on Form 10-K, which was filed with the Securities and Exchange Commission on February 26, 2015 in the section entitled “Risk Factors,” and in its other filings from time to time with the Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should any of its assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. Insulet undertakes no obligation to publicly update or revise any forward-looking statements.

Investor Relations and Media Contact:

Deborah R. Gordon
Vice President, Investor Relations and Corporate Communications
(978) 600-7717
dgordon@insulet.com

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(SPAR) City of Toronto Selects Spartan Vehicles

CHARLOTTE, Mich., Feb. 25, 2016  — Spartan Emergency Response (“Spartan”), a business unit of Spartan Motors, Inc. (NASDAQ:SPAR), announced today that the City of Toronto has selected Spartan and its authorized dealer, Dependable Emergency Vehicles, of Brampton, Ontario, to supply the city with a fleet of new custom pumpers. To date, the city has ordered 14 units, with the option to add more trucks to their fleet over the next three years. Each unit will be equipped with Spartan’s industry-leading Advanced Protection System® and a stainless steel body, delivering unparalleled safety and durability.

Expanding to Serve a Growing City

With a population growth rate of 18% since 2006, Toronto’s Downtown is growing at four times the rate of the city as a whole. Fueling that growth is the blistering pace of development occurring in Toronto’s core. At the end of 2015, new apartment units hit a 25-year high, with 26 buildings containing more than 6,500 rental units under construction. Construction of new commercial space will add even more structures and people to the downtown core.

The “Manhattanization” of Toronto, as some have dubbed this rapid growth, presents new challenges for those who serve the residents and workers flocking to Canada’s largest city. Toronto Fire Services has been diligently tracking the city’s growth to ensure that it can continue to meet its commitment to “provide high quality, efficient and effective emergency response along with fire prevention and educational services to those who live in, work in, and visit the City of Toronto”1.

Safety First

Providing protection for Toronto’s expanding residential and commercial spaces requires more and better equipped emergency response vehicles. Toronto Fire Services has responded in kind with an order for 14 new Spartan pumpers in 2016, with the option to expand the fleet and add more trucks over the next three years.  All units are custom built on Spartan’s purpose-built Metro Star chassis, and will be deployed across the city of Toronto, better equipping the force to respond to the needs of their rapidly growing metropolis.

“As residents ourselves of the greater Toronto area, we’re thrilled to have been selected to supply the city with vehicles that are so critical in protecting the safety of our residents, workers, and visitors,” said Pino Natale, Director of Emergency Vehicles, at Dependable Emergency Vehicles.

Safety was a top consideration when configuring the trucks, a process guided by National Fire Prevention Association (NFPA) regulations. The custom pumpers feature the Spartan Advanced Protection System (APS), a holistic and smart occupant restraint and protection system designed specifically for emergency response vehicles. APS includes eight strategically placed airbags, and outboard sensors that feed into an intelligent restraint control module, providing sophisticated protection for the driver and occupants.

The pumpers also feature Spartan’s Mobile Gateway, acting as its own wireless hotspot and providing uninterrupted connectivity – even when the communications infrastructure is compromised. Other features of the trucks, such as pull-out steps and a low hose bed configuration enable easy access to pump controls, and safe deployment of hoses, in confined metro areas.

“Spartan has had a long commitment to providing innovations that protect firefighter safety, and the safety of the communities they serve. We’re pleased that these custom pumpers have met the exacting needs of the Toronto Fire Service,” said John Slawson, President of Spartan Emergency Response.

1 Toronto Fire Services – Emergency Services. City of Toronto. 22 Feb. 2016. <http://www.toronto.ca/fire/>.

About Spartan Motors

Spartan Motors, Inc. is a leading designer, engineer, manufacturer and marketer of a broad range of specialty vehicles, specialty chassis, vehicle bodies and parts for the fleet and delivery, recreational vehicle (RV), emergency response, defense forces and contract assembly (light/medium duty truck: Class 3, 4 and 5) markets. The Company’s brand names – Spartan Motors, Spartan Specialty Vehicles, Spartan Emergency Response, Spartan Parts and Accessories, and Utilimaster®, a Spartan Motors Company – are known for quality, durability, performance, customer service and first-to-market innovation. The Company employs approximately 1,700 associates at facilities in Michigan, Pennsylvania, South Dakota and Indiana. Spartan reported sales of $507 million in 2014. Visit Spartan Motors at www.spartanmotors.com.

 

Contact:

Russell T. Chick
Corporate Director of Marketing
Spartan Motors, Inc.
517.997.3852
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(GTLS) and PPS Win Contract for LNG Reloading Station in Lithuania

CLEVELAND, Feb. 25, 2016  — Chart Industries, Inc. (Chart) (Nasdaq:GTLS) today announced that its wholly owned Czech subsidiary Chart Ferox and EPC consortium partner, PPS Pipeline Systems Germany, have been selected to provide an LNG reloading station for AB Klaipėdos nafta at the Port of Klaipeda, Lithuania. The consortium will deliver a total project scope including equipment engineering, production, installation, and commissioning, together with construction of the associated infrastructure, for €27.7 million. The contract between AB Klaipėdos nafta and the consortium will enter into full force after approval of conclusion of the EPC contract by the general meeting of shareholders of AB Klaipėdos nafta. Chart’s proven LNG technology combines the highest quality and safety standards with total operational reliability, while PPS is a leader in construction and other civil related activities in the natural gas sector.  Chart’s scope of supply is nearly 50% of total award value.

Five Chart cryogenic storage tanks, each measuring over 50 meters in length and with an external diameter of almost 6 meters, will provide 5,000 cubic meters of LNG storage at the station, which will be equipped with two loading areas for LNG trucks and jetty modules for ship bunkering. The Chart LNG regasification facility will have the capacity to provide 6000 Nm3/hour of natural gas. The LNG reloading station will be operational within 15 months with full scope delivery anticipated during the 2nd half of 2017. The overall plant design will also incorporate a potential future expansion, capable of doubling the storage capacity.

“We are delighted with this prestigious award and excited to be working with our new partner, PPS Pipeline Systems. Both companies are experts in their respective fields with the experience and pedigree to deliver the project within an extremely aggressive timescale,” said Miroslav Cerny, Business Director of Chart Ferox.

The main project aim is to develop Klaipeda as a Baltic hub and virtual pipeline to fuel ships and deliver LNG by truck to reduce the traditional dependence on imported pipeline gas.

To learn more about Chart LNG technology, visit : www.chartLNG.com

Certain statements made in this news release are forward-looking statements, such as statements concerning business plans, market trends, and other information that is not historical in nature.  These statements are made based on Chart’s expectations concerning future events and are subject to factors that could cause actual results to differ materially, such as economic downturns, a reduction in customer purchases, competition, changes in government energy policy, management of fixed-price contract exposure, reliance on the availability of key supplies and services, and modification or cancellation of customer contracts.  For a discussion of these and additional factors that could cause actual results to differ, see Chart’s filings with the U.S. Securities and Exchange Commission, including Item 1A – Risk Factors, of Chart’s most recent Annual Report on Form 10-K.  Chart undertakes no obligation to update or revise any forward-looking statement.

Chart is a leading independent global manufacturer of highly engineered equipment for the industrial gas, energy, and biomedical industries. The majority of Chart’s products are used throughout the liquid gas supply chain for purification, liquefaction, distribution, storage and end-use applications, the largest portion of which are energy-related. Chart has domestic operations located across the United States and an international presence in Asia, Australia, Europe and South America.  For more information, visit: http://www.chartindustries.com.

Contact:

Ken Webster
Vice President, Chief Accounting
Officer and Controller
216-626-1216
ken.webster@chartindustries.com

Thursday, February 25th, 2016 Uncategorized Comments Off on (GTLS) and PPS Win Contract for LNG Reloading Station in Lithuania

(DSKX) Replay of Call Discussing Acquisition Deal With Radiancy

Listen To DS Healthcare Leadership Team Detail Their Motivation And Excitement For This Acquisition

POMPANO BEACH, FL / February 25, 2016 / DS Healthcare Group, Inc. (NASDAQ:DSKX) held a conference call to discuss the recently announced agreement to acquire Radiancy, Inc., a leading developer of consumer medical devices and the Neova® dermatological products business.

The update call was hosted by Mark Brockelman (CFO), Manny Gonzeles (CCO) and Renee Barch-Niles (CEO) and took place on Thursday, February 25th, 2015, at 8:30 a.m. EST.

The DS Healthcare Group team shared their motivations and answered questions relating to the business fundamentals on the Radiancy deal, explaining how natural strategy alignment and synergies will lead to significant bottom line contribution.

The replay of the conference call can be heard by dialing 1-888-286-8010 in the United States and Canada or +1-617-801-6888 internationally, then referencing the Conference Passcode “56187013”. The replay will be available from Friday, February 26, 2016, 10:00 AM EST and accessible for 10 days thereafter. A recording of the call can also be heard on www.dshealthgroup.com.

About Radiancy

Founded in 1998, Radiancy Inc. is a developer and manufacturer of home-use and professional aesthetic and dermatological devices. The company sells a range of home-use devices under its proprietary brands for various indications including hair removal, acne reduction, skin rejuvenation and face lifting. The company also offers a professional product line that addresses acne clearance, skin tightening, psoriasis care and hair removal sold to physicians, clinics, and spas.

Radiancy’s products are supported by two core proprietary technologies known as LHE™ (Light Heat Technology) and Thermicon™. The company’s LHE™ technology is superior in cost performance, efficacy and ease of application to both laser and intense pulse light (IPL) technologies. LHE™ combines the use of direct heat and a wide-spectrum light source and allows very large treatment spot sizes with less discomfort and without the requirement of skin cooling.

LHE™ technology is incorporated in Radiancy’s FDA-cleared professional devices as well as its consumer products. The Thermicon™ technology, used in hair removal products, is the only technology currently on the market that allows for at-home painless and long-lasting hair reduction on all skin types and hair colors and body parts. For more information visit www.radiancy.com.

About Neova

NEOVA was the first clinical skin care brand to bring real innovation to the photo-aging category by introducing Copper Peptide Complex® technology products. Making the association between DNA damage and premature skin aging, NEOVA now introduces DNA repair and Copper Peptide Complex technologies providing complete, continuous, optimized care. These unique, award-winning Combination Therapy skin care formulas target photo-damaged skin. Scientific studies have demonstrated that DNA repair and copper play fundamental roles in skin health. Without advanced delivery systems, vital nutrients, proteins and enzymes are unable to reach their destination and revitalize the appearance of skin.

For more information, visit: www.neova.com.

About DS Healthcare Group

DS Healthcare Group Inc. is engaged in the development of biotechnology for topical therapies. It markets through online channels, specialty retailers, distributors, pharmacies, and salons. Its research has led to a highly innovative portfolio of personal care products and additional innovations in pharmaceutical projects. For more information on DS Health Group’s flagship brand, visit www.dslaboratories.com.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on current expectations of DS Healthcare and are subject to uncertainty and changes in circumstances. These forward-looking statements include, among others, statements regarding the expected benefits of a potential combination of Radiancy, Neova, and DS Healthcare, including the expected effect of the Mergers on financial results and profile (e.g., earnings per share and synergies); the anticipated benefits of geographic diversity that would result from the Mergers and the expected results of Radiancy’s, Neova’s, and DS Healthcare’s product portfolios; expectations about future business plans, prospective performance and opportunities; required regulatory approvals and the expected timing of the completion of the transaction. These forward-looking statements may be identified by the use of words such as “expect,” “anticipate,” “believe,” “estimate,” “potential,” “should”, “will” or similar words intended to identify information that is not historical in nature. The inclusion of such statements should not be regarded as a representation that such plans, estimates or expectations will be achieved. There is no assurance that the potential transaction will be consummated, and there are a number of risks and uncertainties that could cause actual results to differ materially from the forward-looking statements made herein. These risks and uncertainties include (a) the timing to consummate a potential transaction; (b) the ability and timing to obtain required regulatory approvals and satisfy or waive other closing conditions; (c) the possibility that the Mergers do not close when expected or at all; or that the companies may be required to modify aspects of the Mergers to achieve regulatory approval; (d) the ability of DS Healthcare to promptly and effectively integrate their respective businesses of Radiancy and Neova Technology; (e) the requirement to satisfy closing conditions to the Mergers as set forth in the Merger Agreements; (f) the outcome of any legal proceedings that may be instituted in connection with the transaction; (g) the ability to retain certain key employees of Radiancy or Neova; (h) that there may be a material adverse change affecting Radiancy, Neova, or DS Healthcare, or the respective businesses of PhotoMedex or DS Healthcare may suffer as a result of uncertainty surrounding the transaction; and (i) the risk factors disclosed in DS Healthcare’s filings with the Securities and Exchange Commission (the “SEC”), including its Annual Report on Form 10-K, which DS Healthcare filed on April 15, 2015. Forward-looking statements reflect DS Healthcare’s management’s analysis as of the date of this release, even if subsequently made available DS Healthcare on its website or otherwise. DS Healthcare does not undertake to revise these statements, whether written or oral, that may be made from time to time to reflect subsequent developments, except as required under the federal securities laws. Readers are cautioned not to place undue reliance on any of these forward-looking statements.

Additional Information and Where You Can Find It

This press release is not a solicitation of a proxy from any stockholder of DS Healthcare. In connection with the Merger Agreements, DS Healthcare intends to file relevant materials with the SEC, including proxy statements by DS Healthcare. Investors and security holders are urged to read these materials and any other relevant documents filed with the SEC when they become available because they will contain important information about Radiancy, Neova, DS Healthcare and the proposed transaction. The proxy statements, and other relevant materials (when they become available), and any other documents filed by DS Healthcare with the SEC, may be obtained free of charge at the SEC’s web site at www.sec.gov. In addition, investors and security holders of DS Healthcare may obtain free copies of the documents filed with the SEC by accessing DS Healthcare’s web site at www.dshealthgroup.com

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

Participants in the Solicitation

DS Healthcare and certain of its directors and executive officers may be deemed to be participants in the solicitation of proxies from its stockholders in connection with the proposed transactions. Certain executive officers and directors of DS Healthcare have interests in the transaction that may differ from the interests of stockholders generally. Information about DS Healthcare’s directors and executive officers is available in DS Healthcare’s definitive proxy statement, dated January 8, 2016, for its 2015 annual meeting of stockholders. These interests will be described in the proxy statement when it becomes available.

Contact

Investor Relations
DS Healthcare Group
(888) 404-7770 ext. 3
Investors@DSHealthGroup.com

Thursday, February 25th, 2016 Uncategorized Comments Off on (DSKX) Replay of Call Discussing Acquisition Deal With Radiancy

(MESO) First Allogeneic Cell Therapy Product Launched in Japan by Mesoblast Licensee

NEW YORK and MELBOURNE, Australia, Feb. 24, 2016  — Mesoblast Limited (Nasdaq:MESO) (ASX:MSB) announced that its licensee in Japan, JCR Pharmaceuticals Co. Ltd., today launched its mesenchymal stem cell product TEMCELL® HS Inj., for the treatment of acute graft versus host disease (aGVHD) in children and adults in Japan. TEMCELL is the first allogeneic cell therapy to be fully approved in Japan.

The Japanese Government’s National Health Insurance set reimbursement for TEMCELL at ¥868,680 (approximately US$7,700) per bag of 72 million cells. In Japan, the average adult patient is expected to receive at least 16 or up to 24 bags of 72 million cells. On this basis, Mesoblast expects a treatment course of TEMCELL in an adult Japanese patient to be reimbursed at a minimum of ¥13,898,880 (approximately US$123,000) or up to ¥20,848,320 (approximately US$185,000).

Under its agreement with JCR, Mesoblast is entitled to receive royalties and other payments at predefined thresholds of cumulative net sales.

In the world’s largest healthcare market, the United States, there are currently no approved therapies for patients with acute steroid-refractory GVHD, and off-label options have demonstrated mixed efficacy with high toxicity.

To support filing of a biologic license application (BLA) to the United States Food and Drug Administration for regulatory approval, Mesoblast is conducting a 60-patient, open label Phase 3 trial using MSC-100-IV as front-line therapy in children with steroid-refractory aGVHD. After filing a BLA for pediatric approval of MSC-100-IV, Mesoblast plans to conduct a further trial to support a product approval of its cell therapy in adults with gastrointestinal or liver aGVHD, the patient groups who have the highest mortality risk.

In the United States, pricing reimbursement methodology is expected to consider the burden of illness associated with steroid-refractory aGVHD as well as health utilization costs, and may result in a higher price than in Japan.

About Graft Versus Host Disease
Mesoblast is developing MSC-100-IV for the treatment of aGVHD following an allogeneic bone marrow transplant (BMT). In patients who have received a BMT, donor cells may attack the recipient (the person receiving the transplant), causing aGVHD, resulting in activation of pro-inflammatory T-cells and tissue damage in the skin, gut and liver which is often fatal.

According to the Center for International Blood and Marrow Transplant Research, there are approximately 30,000 allogeneic BMTs globally per year for diseases including hematological cancers, with 25% of all cases in the pediatric population. Nearly 50% of all allogeneic BMT patients develop aGVHD. Liver or gastrointestinal involvement occur in up to 40% of all patients with aGVHD and are associated with the greatest risk of death, with mortality rates of up to 85%.

About Mesoblast
Mesoblast Limited (Nasdaq:MESO) (ASX:MSB) is a global leader in developing innovative cell-based medicines. The Company has leveraged its proprietary technology platform, which is based on specialized cells known as mesenchymal lineage adult stem cells, to establish a broad portfolio of late-stage product candidates. Mesoblast’s allogeneic, ‘off-the-shelf’ cell product candidates target advanced stages of diseases with high, unmet medical needs including cardiovascular conditions, orthopedic disorders, immunologic and inflammatory disorders and oncologic/hematologic conditions.

Forward-Looking Statements
This press release includes forward-looking statements that relate to future events or our future financial performance and involve 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. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Forward-looking statements should not be read as a guarantee of future performance or results, and actual results may differ from the results anticipated in these forward-looking statements, and the differences may be material and adverse. You should read this press release together with our risk factors, in our most recently filed reports with the SEC or on our website. Uncertainties and risks that may cause Mesoblast’s actual results, performance or achievements to be materially different from those which may be expressed or implied by such statements, and accordingly, you should not place undue reliance on these forward-looking statements. We do not undertake any obligations to publicly update or revise any forward-looking statements, whether as a result of new information, future developments or otherwise.

 

For further information, please contact: 
Julie Meldrum 
Global Head of Corporate Communications 
Mesoblast Limited 
T: +61 3 9639 6036 
E: julie.meldrum@mesoblast.com
Wednesday, February 24th, 2016 Uncategorized Comments Off on (MESO) First Allogeneic Cell Therapy Product Launched in Japan by Mesoblast Licensee

(EFOI) Comments on UFC Change at the Department of Defense

DOD Now Allows Tubular LED Retrofits Without Requiring Project-by-Project Waivers at All Land Facilities

SOLON, Ohio, Feb. 24, 2016  — Energy Focus, Inc. (NASDAQ:EFOI), a leader in LED lighting technology, today announced the Department of Defense (“DOD”) Unified Facilities Criteria (“UFC”) has been changed to allow tubular LED (“TLED”) installation categorically without the requirement to submit a waiver request for each retrofit project. DOD facilities include military bases, administrative offices and housing structures for the Army, the Navy and the Air Force.

The DOD, through a change in the UFC, now permits all its land-based facilities to more cost-effectively and quickly upgrade to LED lighting by simply replacing existing fluorescent tubes with TLEDs. Prior to the change, a prohibition on tubular LEDs as a replacement for linear fluorescent lamps required a project-by-project waiver request to overcome. The UFC provides planning, design, construction, sustainment, restoration, and modernization criteria, and applies to the Military Departments, the Defense Agencies, and the DOD Field Activities.  It covers multiple aspects of electrical, mechanical, structural, and architectural features of construction, as well as policy and procedures, and specifies design practice and material selection with extensive details for lighting applications.

“We very much applaud and welcome this exemplary policy milestone that now enables all branches of the DOD, the nation’s single largest energy user, to accelerate TLED lighting adoption for its existing 550,000 plus buildings in a much swifter fashion,” said James Tu, Executive Chairman and Chief Executive Officer of Energy Focus, Inc.

In the revision issued on February 1, 2016, the UFC expanded the allowable formats for solid-state lighting, or LED lighting, to be installed on DOD facilities.  Included in the revision are new provisions for all DOD Departments, Agencies and Commands to utilize “Luminaire Conversion Kits” that upgrade existing fluorescent fixtures to LED.  Specifically, the UFC now allows both lamp-for-lamp replacements, known as Direct-Fit, which are compatible with existing ballasts, as well as conversion of existing fixtures by removing or replacing the ballast, lamp, reflector, wiring, and diffusers as necessary known as Direct-Wire. Energy Focus supplies both Direct-Fit and Direct-Wire solutions, which comply with the new UFC revision.

“Compared with full fixture replacement, retrofitting existing fixtures with TLEDs is far more economical and environmental friendly due to the lower material cost, lower installation cost, simpler conversion and greater flexibility for future upgrade,” added Eric Hilliard, President and Chief Operating Officer of Energy Focus, Inc. “Energy Focus is a pioneer in the development and mass adoption of TLEDs in the public sector, and has been working with leading Energy Service Companies (“ESCOs”) for energy upgrade projects with TLEDs for public facilities over the past three years. The UFC change is an exciting, historic breakthrough that now allows ESCOs to more easily and broadly introduce TLED lighting retrofits through performance contracts with guaranteed savings to DOD facilities with extremely compelling payback periods of a few short years or less for most projects. The maintenance cost for lighting could also be largely eliminated, spaces brighter and cleaner, and our service women and men happier and more productive.”

“We estimate that conservatively, on an annual basis, by retrofitting existing fluorescent lamps to Energy Focus TLED lamps, the DOD could save 2.8 million MWh of power, or over $300 million in energy cost, while removing 1.9 million tons of CO2 emissions—equivalent to removing 400,000 cars from the roads—without complicated, costly, time consuming, environmentally wasteful and easily outdated fixture replacements. Simply no other energy technology or measure alone could achieve such a drastic reduction of energy usage and carbon footprint with such project expediency and attractive return on investment,” commented Mr. Tu.

“Energy Focus, with our leading and proven TLED product portfolio in both military and commercial applications, as well as our ‘Buy American’ product offering, is an ideal LED lighting partner to assist the DOD in accomplishing its aggressive energy efficiency goals that aim to improve energy security and reduce greenhouse gas emissions. Through our ESCO channel partners, we will continue to vigorously advocate the immense economic and environmental benefits of our TLED solutions and pursue lighting retrofit opportunities within the DOD ecosystem where the TLED market dynamic is now vastly advanced,” concluded Mr. Tu.

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. World headquarters are located in Solon, Ohio with additional offices in Washington, D.C., New York City and Taiwan. For more information, see our web site at www.energyfocusinc.com.

CONTACT:
Media and Investor Contacts:
Energy Focus Inc.
Investor Relations
ir@energyfocusinc.com
440-715-1300

Or

Darrow Associates, Inc.
Peter Seltzberg
pseltzberg@darrowir.com
516-510-8768
Wednesday, February 24th, 2016 Uncategorized Comments Off on (EFOI) Comments on UFC Change at the Department of Defense

(FUEL) Names Rex Jackson as Chief Financial Officer

Rocket Fuel Names Rex Jackson as Chief Financial Officer

Rocket Fuel (NASDAQ: FUEL), a leading Programmatic Marketing Platform provider, today announced that Rex Jackson will join the company as chief financial officer. Jackson is an experienced executive and 30-year hardware, software and services veteran with a track record of success and will focus on enabling Rocket Fuel to strengthen its financial performance. His experience as a public company CFO and hands on approach equip him to provide financial, strategic and operational leadership to Rocket Fuel. He will join the company on March 16, 2016.

Rex Jackson, Chief Financial Officer at Rocket Fuel (Photo: Business Wire)

Jackson brings a remarkably well-rounded executive management background to Rocket Fuel, serving as CFO for three public companies, Synopsys, Symyx and JDS Uniphase, as general counsel to both private and public companies, and in a breadth of other senior business roles. Most recently, at JDSU (now Viavi Solutions), Jackson and his teams implemented Oracle’s ERP system internationally in just eight months, and drove improvements across the finance organization while reducing costs for his organization (finance, M&A, IT and real estate/facilities) by 15-20 percent. He was also instrumental in splitting JDSU into two public companies while driving further operating savings.

“Rocket Fuel is in a strong position to succeed. All the pieces are here — a newly formed, world-class executive team, superior technology and a fresh go-to-market approach. Rocket Fuel has a great opportunity to turn that into customer and shareholder value,” Jackson said.

“Rex has a sharp business mind, and an exceptional ability to cut to the chase, identify the right next task at hand and provide clarity on how to achieve it,” said Randy Wootton, CEO of Rocket Fuel. “Rex is a key addition to our leadership team, and represents another major step in the company’s commitment to operational excellence, strengthening our financial position and delivering consistent results. You will quickly see Rex taking clear, consistent and strategic action. I am eager to begin working with him.”

Continued Wootton, “I would like to extend a special thanks to Cal Hoagland, a partner with FLG Partners, LLC, who has served as our interim CFO since December and has led key financial strategies and negotiations while with us.” Hoagland will remain in his role as interim CFO until Jackson starts and will work closely with him to ensure a smooth transition.

About Rocket Fuel

A leading Programmatic Marketing Platform provider, Rocket Fuel (NASDAQ: FUEL) offers brands, agencies, and platform partners managed services, as well as a SaaS-based Data Management Platform (DMP) and Demand Side Platform (DSP), to optimize performance, awareness, and lift across marketing objectives, channels and devices. By applying artificial intelligence at big data scale, Rocket Fuel’s Moment Scoring™ technology performs a real-time calculation of each ad opportunity based on a marketer’s goal to determine the likelihood a consumer will engage in a desired action. Moment Scoring technology is designed to go beyond 1:1 marketing by learning to predict what marketing actions to take with a campaign at a precise moment in time, which results in a much more efficient use of marketing dollars. Rocket Fuel serves 96 of the Ad Age 100, three of the top five agency holding company trading desks, and partners with some of the world’s leading CRM platforms, marketing platforms and systems integrators. Headquartered in Redwood City, California, Rocket Fuel has more than 20 offices worldwide.

 

Investor Relations Contact:
The Blueshirt Group
Whitney Kukulka, 415-489-2187
ir@rocketfuel.com
or
Media Contact:
Rocket Fuel
Kristin Holloway, 650-481-6178
pr@rocketfuel.com

Wednesday, February 24th, 2016 Uncategorized Comments Off on (FUEL) Names Rex Jackson as Chief Financial Officer

(CNCK) and Kitchology Announce Partnership

LOS ANGELES, CA and GERMANTOWN, MD–(Feb 24, 2016) – Content Checked Holdings, Inc. (OTCQB: CNCK) (“Content Checked”), a creator of mobile applications for people with dietary restrictions, today announced a partnership with Kitchology, Inc. (“Kitchology”), a mobile platform that provides tailored recipes to consumers with special dietary needs. The partnership will give Kitchology access to Content Checked’s vast database of nutritional and ingredient information on over 300,000 packaged food products available for sale and distribution in the United States to power its platform. Content Checked will gain access to the Kitchology platform, including core recipes and curated recipes modified for and by consumers with dietary restrictions or allergies.

“We’re thrilled to partner with Kitchology and work in tandem to offer complementary solutions to families dealing with food allergies and sensitivities,” said Kris Finstad, CEO of Content Checked. “More than 15 million Americans suffer from food allergies, 60 million plus care about food sensitivity, so it’s important to educate consumers about what ingredients are in packaged foods, and empower them to take steps to cook sensibly.”

Content Checked will grant Kitchology a limited, non-exclusive and worldwide right to use, display, analyze and use results of the analysis and refer to Content Checked’s database to make decisions regarding information that Kitchology will present to users of the Kitchology Platform. The partnership will allow Content Checked to integrate Kitchology’s database of core recipes into its platform via recipe channels and will give existing users access at no additional fee. Content Checked users will also gain access to Kitchology’s integrated method to plan, purchase, cook and share the food, experience and items related to special diets.

“Having access to Content Checked’s database will take our platform to the next level of functionality and give our users the most comprehensive platform to cross check ingredients in recipes for hidden allergens,” said Alain Briancon, PhD, CEO of Kitchology. “Families with food allergies are at the forefront of Food as Wellness movement. With this partnership, we will leverage our assets to empower families and enhance their quality of life and safety, whether in the kitchen or on the go.”

For more information on Content Checked, or to download their apps, please visit: www.contentchecked.com.

For more information on Kitchology, or to download the app, please visit: www.kitchology.com.

About Content Checked

The Company (www.contentchecked.com) has created a revolutionary marketplace for people with dietary restrictions and the organizations who cater to them by creating and introducing the ContentChecked, MigraineChecked and SugarChecked smartphone applications. ContentChecked and MigraineChecked are the first applications with comprehensive and accurate content information, and in-depth allergen and migraine definitions for over 70% of conventional U.S. food products.

Each app gives consumers the ability to scan a product’s bar code and determine if it is safe for consumption based on their allergy settings. The apps will recommend a suitable alternative if a product does contain one or more of a user’s allergens. This enables the applications to meet the needs of millions of people in the U.S. In the U.S. alone, there are more than 15 million people who suffer from food allergies and 38 million people who suffer from migraines and chronic headaches. The food allergy and intolerances market has been valued at approximately US$13 billion in 2015. As a result, Content Checked has created a pivotal way for food manufacturers and producers to showcase their products to consumers who are actively seeking them at the point of purchase.

Content Checked has created a robust database of allergens, migraine triggers and food ingredients that directly correlate with food allergies, intolerances, migraines and chronic headaches. There are currently hundreds of thousands of products in its database, updated regularly. All applications serve as easy shopping tools for consumers to decipher often misleading food labels and receive recommendations for healthier alternative products as they shop in real time. Content Checked’s mission is to offer fast, reliable and efficient mobile apps that help consumers make more informed purchasing decisions and live healthier lives in accordance to their dietary preferences.

For more information on the Company, please visit its social media channels via Facebook (www.facebook.com/contentchecked), (www.facebook.com/migrainechecked) and (www.facebook.com/sugarchecked); Instagram (www.instagram.com/contentchecked), (www.instagram.com/migrainechecked) and (www.instagram.com/sugarchecked); or YouTube (www.youtube.com/channel/UCMihoaZILlRZ2C3hmx5vXhQ).

About Kitchology

Kitchology is the first company to create an integrated cooking platform for people dealing with food allergies and special diets. It allows consumers to overcome the limitations imposed by food restrictions. Kitchology applies machine learning to nutrition science, profiling and social curation to help the home cook match and modify recipes to satisfy the challenges of food allergies, intolerances and special diets. Kitchology enables meal planning based on ingredients previously used and explored, personalized, ingredient substitutions, purchasing with intelligent shopping lists, step-by-step cooking, and fosters influencer relationships.

For more information on Kitchology, please visit its blog and social media channels via Facebook, Pinterest, YouTube and follow @kitchology or @kitchenchick on Twitter.

Forward-Looking Statements:

This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Statements that are not a description of historical facts constitute forward-looking statements and may often, but not always, be identified by the use of such words as “expects”, “anticipates”, “intends”, “estimates”, “plans”, “potential”, “possible”, “probable”, “believes”, “seeks”, “may”, “will”, “should”, “could” or the negative of such terms or other similar expressions. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in the Company’s business. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s Annual Report on Form 10-K for the fiscal year ended March 31, 2015, the Company’s Quarterly Reports on Form 10-Q and other filings submitted by the Company to the SEC, copies of which may be obtained from the SEC’s website at www.sec.gov. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and the Company undertakes no obligation to revise or update this release to reflect events or circumstances after the date hereof.

Wednesday, February 24th, 2016 Uncategorized Comments Off on (CNCK) and Kitchology Announce Partnership

(OGES) Supplying Battery Systems to Fully Electric Interstate Trucking in the USA

Oakridge Global Energy Solutions: A New Era In Battery Manufacturing

Palm Bay, Florida, Feb. 24, 2016  — Oakridge Global Energy Solutions, Inc.
Info@oakg.net

Oakridge Global Energy Solutions:
A New Era In Battery Manufacturing

Oakridge Supplying Battery Systems to Fully Electric Interstate Trucking in the USA

FOR IMMEDIATE RELEASE

Fully electric interstate truck

February 24, 2016 Melbourne, Florida – Oakridge Global Energy Solutions, Inc. (OTCQB: “OGES”) is excited to announce that it will be supplying batteries to Freedom Trucking in Minnesota.

Freedom Trucking has developed a fully electric interstate truck propulsion system that will immediately enable interstate trucks with a gross vehicle weight of 80,000 pounds to travel more than 400 miles.  By utilizing a proprietary logistical system, powered by specially designed Oakridge battery systems, Freedom Trucking can now begin to utilize its revolutionary fully electric interstate trucks in the interstate logistics industry to move product from Chicago to Minneapolis on a daily basis commencing in the last half of 2016.

Using fully electric trucks to move this cargo will save each truck in excess of $0.60 per mile over traditional diesel fuel according to initial analysis for Freedom Trucking by the US Department of Transportation, which will completely revolutionize the economics of the interstate trucking business in the USA, by saving on fuel costs, maintenance costs, and weight.

“The custom battery design for Freedom Trucking is an absolute game changer,” said Oakridge Executive Chairman and CEO, Steve Barber. “We are excited to be working with Freedom Trucking and their team on such a revolutionary product.  We at Oakridge are continuing our mission to onshore manufacturing back to the US and this is a really big win for all of us.  We are reducing carbon emissions, reducing our dependence on foreign oil, and bringing manufacturing back to the US, while at the same time playing a pivotal role in revolutionizing the interstate trucking business.  This is a tremendous win for everyone in the USA.”

Freedom Trucking has been working on the design of the propulsion system with Ohio State University scientists and others for the past five years.  This product has been hampered by poor quality Chinese batteries, but is now ready for full scale production in 2016 with high quality, “Made in USA” Oakridge battery systems.

“We are all about game-changing technology and products at Oakridge.  Oakridge is THE “Made In The USA” battery company that has the talent and technology to overcome these types of obstacles for our customers in designing state-of-the-art high performance custom battery systems.   With our new custom battery systems, we have now greatly expanded the effective range of the electric truck, now making them a practical reality for immediate application to the interstate trucking business, while at the same time providing a much safer, low maintenance vehicle by virtue of the more robust chemistry and the battery management systems we have designed for this product,” adds Mr. Barber.

http://www.globenewswire.com/NewsRoom/AttachmentNg/12e24818-c6ed-42c9-a340-3444fe5edaea
Oakridge Battery Power in the Interstate Truck

About Oakridge Global Energy Solutions, Inc.

Oakridge Global Energy Solutions Inc., is a publicly traded company, trading symbol: OGES on the OTCQB with a market capitalization of approximately USD $ 200,000,000, whose primary business is the development, manufacturing and marketing of energy storage products. Additional information can be accessed on the company’s website www.oakridgeglobalenergy.com

Forward-Looking Statements Disclaimer: This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. In some cases, you can identify forward-looking statements by the following words: “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking statements are not a guarantee of future performance or results, and will not necessarily be accurate indications of the times at, or by, which such performance or results will be achieved. Forward-looking statements are based on information available at the time the statements are made and involve known and unknown risks, uncertainties and other factors that may cause our results, levels of activity, performance or achievements to be materially different from the information expressed or implied by the forward-looking statements in this press release. This press release should be considered in light of all filings of the Company that are contained in the Edgar Archives of the Securities and Exchange Commission at www.sec.gov.

Contact:
Oakridge Global Energy Solutions, Inc.
www.oakridgeglobalenergy.com
3520 Dixie Highway
Palm Bay, 32905, Florida, USA
Ph: (321) 610-7959
Email: ir@oakg.net

Investor Inquiries:

Benchmark Advisory Partners LLC
Timothy Connor
Toll Free: (866) 703-4778
admin@bmarkadvisory.com

And:

Dutch DeWaard
Business Development
DreamTeamNetwork (DTN)
Austin, TX
www.DreamTeamNetwork.com
512.758.8877 Office
480.734.5834 Mobile
Dutch@DTN.fm

Wednesday, February 24th, 2016 Uncategorized Comments Off on (OGES) Supplying Battery Systems to Fully Electric Interstate Trucking in the USA

(INVE) to Present at AGC Partners’ West Coast Security and Technology Growth Conference

FREMONT, Calif., Feb. 23, 2016  — Identiv, Inc. (NASDAQ:INVE) today announced that company management will present at AGC Partners’ West Coast Information Security and Technology Growth Conference. The conference runs February 29 – March 1, 2016 and the presentation will take place at the Westin St. Francis on Union Square in San Francisco, Calif. on Monday, February 29, 2016 at 8:20 AM PST (11:20 AM EST). In addition to the presentation, Identiv will participate in one-on-one meetings at the conference.

Event:              AGC Partners’ West Coast Information Security and Technology Growth Conference
Speaker:          Steven Humphreys, Identiv CEO
Date/Time:      Monday, February 29, 2016 at 8:20 – 8:40 AM PST (11:20 – 11:40 AM  EST)
Where:             The Westin St. Francis on Union Square in San Francisco, Calif.

About Identiv
Identiv is a global security technology company that establishes identity in the connected world, including premises, information, and everyday items. CIOs, CSOs, and product departments rely upon Identiv’s trusted identity solutions to reduce risk, achieve compliance, and protect brand identity. Identiv’s trust solutions are implemented using standards-driven products and technology, such as digital certificates, trusted authentication, mobility, and cloud services. For more information, visit identiv.com.

 

Investor Relations Contact:
IR@identiv.com

Media Contact: 
press@identiv.com
Tuesday, February 23rd, 2016 Uncategorized Comments Off on (INVE) to Present at AGC Partners’ West Coast Security and Technology Growth Conference

(TGEN) Announces First Sale of Innovative InVerde e+

Clean Cogeneration Technology to Power New Brooklyn Housing Development

WALTHAM, Mass., Feb. 23, 2016  — Tecogen® Inc. (NASDAQ: TGEN) is pleased to announce the first sale of the Company’s cutting-edge InVerde INV-100e+. Just weeks after the launch of Tecogen’s latest innovation in clean cogeneration (read about the InVerde e+ here: http://investors.tecogen.com/news-releases), the Company sold two units to be installed in a new mixed-income residential development in Brooklyn, NY.  The product’s unique power control and new improved engine design will provide the building managers with the best energy saving solution available.

Worth approximately half a million dollars, the sale includes the premier Ultera™ near-zero emissions control technology, various load modules, and factory engineered accessories. Thanks to the e+’s, qualification as an NFPA Type 10 Emergency Power System capable of providing backup power in case of grid failure, advanced power controls, and improved electrical efficiency, the new property will enjoy enhanced energy savings and building resilience, all while cutting its carbon footprint in half (when compared to traditional equipment solutions).

“Although the InVerde e+ has only been on the market a few weeks, this sale is a testament to the value proposition our innovative new features offer customers,” said Robert Panora, Tecogen’s president and chief of operations. “Through installation of our cutting edge clean technology, building managers are offered a more complete package for their site’s energy needs, including emergency backup power, with a fully integrated building energy management system.”

Providing on-site power generation as well as heating and cooling capabilities, the InVerde e+ offers best-in-class electrical efficiency, patented engine control technology, integrated Microgrid hardware, and customized power electronics. Requiring just 4 inches of water column gas pressure, the e+ allows customers to avoid installation of additional pressure enhancement equipment demanded by competitive products by connecting to virtually any standard gas pipe without modification of the gas supply line.  Similarly, the e+ meets the rapid 10 second blackstart requirement for Emergency Power Supply Systems as per the National Fire Protection Association’s specifications, giving customers the peace of mind they will never be left in the dark.

About Tecogen
Tecogen manufactures, installs, and maintains high efficiency, ultra-clean, combined heat and power products including natural gas engine-driven cogeneration, air conditioning systems, and high-efficiency water heaters for residential, commercial, recreational and industrial use. The company is known for cost efficient, environmentally friendly and reliable products for energy production that, through patented technology, nearly eliminate criteria pollutants and significantly reduce a customer’s carbon footprint.

In business for over 20 years, Tecogen has shipped more than 2,300 units, supported by an established network of engineering, sales, and service personnel across the United States. For more information, please visit www.tecogen.com or follow us on Twitter, Facebook, and LinkedIn.

Tecogen, InVerde, Ilios, Tecochill, Ultera, and e+, are registered trademarks of Tecogen Inc.

Forward Looking Statements
This press release contains forward-looking statements under the Private Securities Litigation Reform Act of 1995 that involve a number of risks and uncertainties. Important factors could cause actual results to differ materially from those indicated by such forward-looking statements, as disclosed on the Company’s website and in Securities and Exchange Commission filings. The statements in this press release are made as of the date of this press release, even if subsequently made available by the Company on its website or otherwise. The Company does not assume any obligation to update the forward-looking statements provided to reflect events that occur or circumstances that exist after the date on which they were made.

Tecogen Media & Investor Relations Contact Information:
Ariel F. Babcock, CFA  John N. Hatsopoulos
P: (781) 466-6413  P: (781) 622-1120
E: Ariel.Babcock@tecogen.com E: John.Hatsopoulos@tecogen.com
Tuesday, February 23rd, 2016 Uncategorized Comments Off on (TGEN) Announces First Sale of Innovative InVerde e+

(ZIOP) Announces Publication in Scientific Reports

Goal to Genetically Match Universal Biological Products Between One Donor and Multiple Recipients

BOSTON, Feb. 23, 2016  — ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP), a biopharmaceutical company focused on new cancer immunotherapies, today announced the publication of a study in Scientific Reports, a journal of the Nature Publishing Group, describing the genetic editing of human leukocyte antigen (HLA) in hematopoietic stem cells as a means of broadening the human application of these and other cell therapies. The article, titled “Genetic editing of HLA expression in hematopoietic stem cells to broaden their human application”, is available online first at http://www.nature.com/srep/.

Laurence Cooper, M.D., Ph.D., Chief Executive Officer of ZIOPHARM and senior author of the journal article, noted: “Genetic editing of HLA expression is a step towards generating universal biological products, where one donor’s cells may become suitable for sustained engraftment in multiple unrelated recipients. Unlocking the method by which HLA repertoire can be modified is one key to achieving this goal and fully harnessing the potential for off-the-shelf (OTS) therapies in immuno-oncology applications. Together with our partners at Intrexon and MD Anderson, we are bringing to bear multiple technologies to advance the findings of these studies and achieve this objective, with the goal of deploying it across our T-cell and natural killer (NK)-cell therapy platforms.”

Transplantation of allogeneic, or donor-derived, hematopoietic stem cells (HSCs) into recipients with hematologic disorders is used to restore bone marrow function, termed hematopoiesis. Finding a suitable donor can be challenging due to the need to match the constellation of HLA with the recipient. For the study, researchers at The University of Texas MD Anderson Cancer Center eliminated expression of one set of HLA molecules, termed HLA-A, on donor HSC using artificial zinc finger nucleases. Other HLA molecules, such as HLA B and C remained expressed to help prevent elimination by resident NK cells. Following genetic editing, the HSCs maintained their ability to engraft and reconstitute hematopoiesis. This paper reveals that genetically altered HSC harvested from a small pool of donors will then match with a large number of unrelated recipients, which has two implications. First, it broadens the number of recipients who might benefit from bone marrow transplantation, which has particular appeal for racial minorities underserved by the current genetic makeup of unrelated donors. Second, it paves the way for generating OTS cells that are HLA matched with multiple recipients, even though they were obtained from one donor.

ZIOPHARM is developing various cell-based immuno-oncology programs, including CAR-T, TCR and NK adoptive cell-based therapies, in collaboration with its partner Intrexon Corporation (NYSE:XON) and MD Anderson.

About ZIOPHARM Oncology, Inc.:

ZIOPHARM Oncology is a Boston, Massachusetts-based biotechnology company employing novel gene expression, control and cell technologies to deliver safe, effective and scalable cell- and viral-based therapies for the treatment of cancer. The Company’s synthetic immuno-oncology programs, in collaboration with Intrexon Corporation (NYSE:XON) and the MD Anderson Cancer Center, include chimeric antigen receptor T cell (CAR-T) and other adoptive cell based approaches that use non-viral gene transfer methods for broad scalability. The Company is advancing programs in multiple stages of development together with Intrexon Corporation’s RheoSwitch Therapeutic System® technology, a switch to turn on and off, and more precisely modulate gene expression in order to improve therapeutic index. The Company’s pipeline includes a number of cell-based therapeutics in both clinical and preclinical testing which are focused on hematologic and solid tumor malignancies.

Forward-Looking Safe-Harbor Statement:

This press release contains certain forward-looking information about ZIOPHARM Oncology, Inc. that is intended to be covered by the safe harbor for “forward-looking statements” provided by the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts, and in some cases can be identified by terms such as “may,” “will,” “could,” “expects,” “plans,” “anticipates,” and “believes.” These statements include, but are not limited to, statements regarding the progress, timing and results of preclinical and clinical trials involving the Company’s drug candidates, and the progress of the Company’s research and development programs. All of such statements are subject to certain risks and uncertainties, many of which are difficult to predict and generally beyond the control of the Company, that could cause actual results to differ materially from those expressed in, or implied by, the forward-looking statements. These risks and uncertainties include, but are not limited to: whether chimeric antigen receptor T cell (CAR T) approaches, Ad-RTS-IL-12, TCR and NK cell-based therapies, or any of our other therapeutic candidates will advance further in the pre-clinical or clinical trials process and whether and when, if at all, they will receive final approval from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies and for which indications; whether CAR T approaches, Ad-RTS-IL-12, TCR and NK cell-based therapies, and our other therapeutic products will be successfully marketed if approved; the strength and enforceability of our intellectual property rights; competition from other pharmaceutical and biotechnology companies; and the other risk factors contained in our periodic and interim SEC reports filed from time to time with the Securities and Exchange Commission, including but not limited to, our Annual Report on Form 10-K for the fiscal year ended December 31, 2014, and our Quarterly Reports on Form 10Q for the quarters ended March 31, 2015, June 30, 2015 and September 30, 2015. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date hereof, and we do not undertake any obligation to revise and disseminate forward-looking statements to reflect events or circumstances after the date hereof, or to reflect the occurrence of or non-occurrence of any events.

Trademarks

RheoSwitch Therapeutic System® (RTS®) technology is a registered trademark of Intrexon Corporation.

 

Contact:
Lori Ann Occhiogrosso
ZIOPHARM Oncology, Inc.
617-259-1987
locchiogrosso@ziopharm.com

David Pitts
Argot Partners
212-600-1902
david@argotpartners.com
Tuesday, February 23rd, 2016 Uncategorized Comments Off on (ZIOP) Announces Publication in Scientific Reports

(EYES) Second Sight to Announce Five-Year Data from Argus II Clinical Trial Program

Study Results Will Be Presented at 39th Annual Macula Society Meeting

Second Sight Medical Products, Inc. (NASDAQ:EYES) (“Second Sight” or “the Company”), a developer, manufacturer and marketer of implantable visual prosthetics to provide some useful vision to blind patients, announced it will unveil five-year outcomes associated with the Argus® II Retinal Prosthesis System (“Argus II”) during the 39th Annual Macula Society Meeting, being held February 24-27, 2016, at Eden Roc Miami Beach. James Handa, MD, the Robert Bond Welch Professor of Ophthalmology at the Johns Hopkins University Wilmer Eye Institute, will present the data for the first time during a session on Inherited Retinal Degeneration on Wednesday, February 24th at 6:12 p.m. Eastern Time.

Dr. Handa will present long-term results from an ongoing clinical trial (NCT00407602) assessing 30 individuals from 10 clinical centers blinded (i.e., with bare light perception or worse) from Retinitis Pigmentosa (RP) or similar disorders who were implanted with the Argus II. The data will represent over 200 cumulative patient-years of clinical trial follow-up and will demonstrate the ability for the retinal prosthesis to improve visual function over an extended duration.

“The release of this data represents a milestone in the fight against blindness, given the long-term benefits of the Argus II in restoring some useful vision to individuals blinded by RP. The extended follow-up data clearly demonstrate the utility of the Argus II system, and we have gained considerable knowledge about how best to utilize the device through this trial,” said Dr. Handa.

“We are excited about what this long-term follow up represents, both for patients and for our continued development efforts,” said Dr. Robert Greenberg, Chairman of Second Sight. “These data are compelling in demonstrating the validity of our approach and the reliability of our implants.”

One- and three-year data from the trial were previously published in the peer-reviewed journal Ophthalmology. For the study, three types of visual function tests were performed using computer-run assessments: square localization (i.e. object detection), direction of motion (i.e. motion detection) and discrimination of oriented gratings (i.e. visual acuity). Two types of real-world orientation and mobility (O&M) tests were also performed: a test where patients were asked to locate and touch a door, and a test where patients were asked to follow a white line on the floor. The Functional Low-Vision Observer Rated Assessment (FLORA), a multi-part instrument that was developed specifically for use in patients implanted with a retinal prosthesis who suffer from profound loss of vision or blindness, was used to assess the functional visual abilities of patients and how they use the Argus II to complete a series of common activities of daily living. Before the development of the FLORA, there were no accepted, standardized assessments of functional vision or quality of life that could be used to assess the kind of vision that is restored by a retinal prosthesis. Common assessment tools of functional vision that are available such as the National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) or the Massof Activity Inventory have only a few items that can be completed by those with ultra-low vision, with the majority of test items requiring higher levels of spatial vision (ability to read, recognize faces, identify colors).

Earlier results from this trial were used to gain approval of the Argus II by the FDA in addition to CE Mark in Europe. The Argus II System is the first and only retinal implant to have both approvals. Although there are several research efforts in retinal prostheses worldwide, none has demonstrated the same level of reliability and efficacy as the Argus II did in a multi-centered, long-term, controlled clinical trial involving 30 subjects. Today over 180 patients have been treated with the Argus II.

Current research efforts by Second Sight include a feasibility study of the Argus II for individuals with Dry Age-Related Macular Degeneration; hardware and software upgrades for existing and future Argus II patients; and the development of a prosthesis for the primary visual cortex, the Orion™ I Visual Cortical Prosthesis, suitable for patients with other forms of blindness.

About the Argus® II Retinal Prosthesis System

Second Sight’s Argus II System provides electrical stimulation that bypasses the defunct retinal cells and stimulates remaining viable cells inducing visual perception in individuals with severe to profound Retinitis Pigmentosa (RP). The Argus II works by converting images captured by a miniature video camera mounted on the patient’s glasses into a series of small electrical pulses, which are transmitted wirelessly to an array of electrodes implanted on the surface of the retina. These pulses are intended to stimulate the retina’s remaining cells, resulting in the perception of patterns of light in the brain. The patient then learns to interpret these visual patterns, thereby regaining some visual function. The system is controlled by software and is upgradeable, which may provide improved performance as new algorithms are developed and tested. The Argus II is the first artificial retina to receive widespread approval, and is offered at approved centers in Austria, Canada, France, Germany, Italy, Netherlands, Saudi Arabia, Spain, Switzerland, Turkey, United Kingdom and the United States.

About Second Sight

Second Sight’s mission is to develop, manufacture and market innovative implantable visual prosthetics to enable blind individuals to achieve greater independence. Second Sight has developed, and manufactures, the Argus® II Retinal Prosthesis intended to provide some useful vision to individuals with outer-retinal degenerations such as Retinitis Pigmentosa (RP). Second Sight is also developing the Orion I Visual Cortical Prosthesis to restore some vision to individuals who are blind due to causes other than those currently treated by Argus II or other therapies. U.S. Headquarters are in Sylmar, CA, and European Headquarters are in Lausanne, Switzerland. For more information, visit www.secondsight.com.

Safe Harbor

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange and Exchange Act of 1934, as amended, which are intended to be covered by the “safe harbor” created by those sections. All statements in this release that are not based on historical fact are “forward looking statements.” These statements may be identified by words such as “estimates,” “anticipates,” “projects,” “plans,” or “planned,” “seeks,” “may,” “will,” “expects,” “intends,” “believes,” “should” and similar expressions or the negative versions thereof and which also may be identified by their context. All statements that address operating performance or events or developments that Second Sight expects or anticipates will occur in the future are forward-looking statements. While management has based any forward looking statements included in this release on its current expectations, the information on which such expectations were based may change. Forward-looking statements involve inherent risks and uncertainties which could cause actual results to differ materially from those in the forward-looking statements, as a result of various factors including those risks and uncertainties described in the Risk Factors and in Management’s Discussion and Analysis of Financial Condition and Results of Operations sections of our Annual Report on Form 10-K as filed on March 17, 2015 and our other reports filed from time to time with the Securities and Exchange Commission. We urge you to consider those risks and uncertainties in evaluating our forward-looking statements. We caution readers not to place undue reliance upon any such forward-looking statements, which speak only as of the date made. Except as otherwise required by the federal securities laws, we disclaim any obligation or undertaking to publicly release any updates or revisions to any forward-looking statement contained herein (or elsewhere) to reflect any change in our expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based.

 

Second Sight
Media
Pascale Communications, LLC
Allison Potter, 412-228-1678
Manager of Professional Relations
allison@pascalecommunications.com
or
Institutional Investors
In-Site Communications, Inc.
Lisa Wilson, 212-452-2793
President
lwilson@insitecony.com
or
Individual Investors
MZ North America
Greg Falesnik, 949-385-6449
Senior Vice President
greg.falesnik@mzgroup.us

Tuesday, February 23rd, 2016 Uncategorized Comments Off on (EYES) Second Sight to Announce Five-Year Data from Argus II Clinical Trial Program

(NEWP) MKS Instruments Announces Agreement to Acquire Newport Corporation

  • Acquiring an Industry-Leading Technology Company that Serves Common Markets with Complementary Customer Solutions
  • Expands MKS’ Addressable Market by $4.8 Billion
  • Strengthens Presence in Key Strategic Markets – Semiconductor, Industrial, Research and Life Sciences
  • Expected to Realize $35 Million in Annualized Cost Synergies Within 18-36 Months
  • Expected to be Accretive to MKS’ Non-GAAP Earnings and Free Cash Flow in the First 12 Months Following the Closing

ANDOVER, Mass., Feb. 23, 2016  — MKS Instruments, Inc. (NASDAQ:MKSI), a global provider of technologies that enable advanced processes and improve productivity, and Newport Corporation (NASDAQ:NEWP), a worldwide leader in photonics solutions, today announced that they have entered into an agreement for MKS Instruments to acquire Newport Corporation for $23.00 per share.  The all-cash transaction is valued at approximately $980 million.

The combined company is expected to have approximately $1.4 billion in pro forma annual revenue, based on the two companies’ 2015 historical results.  The transaction is expected to be accretive to MKS Instruments’ Non-GAAP net earnings and free cash flow during the first 12 months post-closing.  The combined company expects to realize $35 million in annualized cost synergies within 18 to 36 months and anticipates revenue synergies from the expansion of MKS Instruments’ served addressable markets and leverage of complementary sales channels.

“The combination of MKS Instruments and Newport Corporation creates a premier supplier of critical components and subsystems for a diverse set of growing end markets, each with a common need for highly precise technology enabling solutions,” said Gerald Colella, MKS Instruments’ Chief Executive Officer and President.  “This acquisition is consistent with our strategy to pursue sustained profitable growth by expanding into adjacent markets while increasing our served addressable market in our core semiconductor business.  Our shared customer requirements and complementary technologies together with our increased scale will enable us to lead in our served markets, deliver innovative and cost-effective solutions for our customers, and drive profitable growth.”

“This combination represents a great outcome for all of Newport’s stakeholders,” said Robert Phillippy, President and Chief Executive Officer of Newport Corporation.  “The complementary nature of the two companies’ technologies and customer base will create exciting opportunities for our employees, and enable the combined company to deliver innovative solutions to our customers.  We look forward to working closely with the MKS Instruments team to ensure a smooth transition.”

MKS Instruments intends to fund the transaction with a combination of available cash on hand and up to $800 million in committed debt financing.  The combined company will maintain a very strong balance sheet, with combined pro forma net cash and investments on hand of approximately $425 million.

The transaction has been approved by MKS Instruments’ and Newport Corporation’s board of directors and is subject to customary approvals, including regulatory and approval by Newport Corporation’s shareholders, and is expected to close in the second quarter of 2016.

Lazard acted as financial advisor to MKS Instruments. JP Morgan acted as financial advisor to Newport Corporation.

Conference Call Details

The companies will hold a joint conference call to discuss this announcement on Tuesday, February 23, 2016 at 8:30 a.m. (Eastern Time).  To participate in the conference call, please dial (877) 212-6076 for domestic callers and (707) 287-9331 for international callers, and an operator will connect you.  Participants will need to provide the operator with the Conference ID of 52398857, which has been reserved for this call.  A live and archived webcast of the call will be available on the company’s website at www.mksinst.com.

Use of Non-GAAP Financial Results

Non-GAAP amounts exclude amortization of acquired intangible assets, costs associated with completed acquisitions, income related to the sale of excess and obsolete inventory previously written down to net realizable value, certain excess and obsolete inventory charges, inventory step-up adjustments related to acquisitions, restructuring charges, discrete tax benefits and charges, and the related tax effect of these adjustments. These non-GAAP measures are not in accordance with Accounting Principles Generally Accepted in the United States of America (GAAP). MKS Instruments’ management believes the presentation of these non-GAAP financial measures is useful to investors for comparing prior periods and analyzing ongoing business trends and operating results.

About MKS Instruments

MKS Instruments, Inc. is a global provider of instruments, subsystems and process control solutions that measure, control, power, monitor and analyze critical parameters of advanced manufacturing processes to improve process performance and productivity. Our products are derived from our core competencies in pressure measurement and control, materials delivery, gas composition analysis, control and information technology, power and reactive gas generation, and vacuum technology. Our primary served markets are manufacturers of capital equipment for semiconductor devices, and for other thin film applications including flat panel displays, solar cells, light emitting diodes, data storage media, and other advanced coatings. We also leverage our technology in other markets with advanced manufacturing applications including medical equipment, pharmaceutical manufacturing, energy generation and environmental monitoring.

About Newport Corporation

Newport Corporation is a leading global supplier of advanced-technology products and systems to customers in the scientific research, microelectronics, life and health sciences, industrial manufacturing and defense/security markets.  Newport’s innovative solutions leverage its expertise in advanced technologies, including lasers, photonics and precision motion equipment, and optical components and sub-systems, to enhance the capabilities and productivity of its customers’ manufacturing, engineering and research applications.  Newport is part of the Standard & Poor’s SmallCap 600 Index and the Russell 2000 Index.  Learn more about Newport at www.newport.com and follow the company on TwitterYouTube and Facebook.

IMPORTANT ADDITIONAL INFORMATION WILL BE FILED WITH THE SEC

Newport Corporation plans to file with the SEC and mail to its stockholders a Proxy Statement in connection with the transaction.  Additionally, Newport Corporation will file other relevant materials with the SEC in connection with the transaction.  The Proxy Statement will contain important information about MKS Instruments, Newport Corporation, the transaction and related matters.  Investors and security holders are urged to read the Proxy Statement carefully when it is available.

Investors and security holders will be able to obtain free copies of the Proxy Statement and other documents filed with the SEC by MKS Instruments and Newport Corporation through the web site maintained by the SEC at www.sec.gov.

In addition, investors and security holders will be able to obtain free copies of the Proxy Statement from Newport Corporation by contacting Chris Toth at 949-331-0337.

MKS Instruments and Newport Corporation, and their respective directors and executive officers, may be deemed to be participants in the solicitation of proxies in respect of the transactions contemplated by the Merger Agreement.  Information regarding MKS Instruments’ directors and executive officers is contained in MKS Instruments’ Form 10-K for the year ended December 31, 2014 and its proxy statement dated March 13, 2015, which are filed with the SEC.  Information regarding Newport Corporation’s directors and executive officers is contained in Newport Corporation’s Form 10-K for the year ended January 3, 2015 and its proxy statement dated April 8, 2015, which are filed with the SEC.  To the extent holdings of securities by such directors or executive officers have changed since the amounts disclosed in  each company’s 2015 proxy statement, such changes have been or will be reflected on Statements of Change in Ownership on Form 4 filed with the SEC. Additional information regarding the participants in the solicitation of proxies in respect of the transactions contemplated by the Merger Agreement and a description of their direct and indirect interests, by security holdings or otherwise, will be contained in the Proxy Statement and other relevant materials to be filed with the SEC when they become available.

SAFE HARBOR FOR FORWARD-LOOKING STATEMENTS

Statements in this press release regarding the proposed transaction between MKS Instruments and Newport Corporation, the expected timetable for completing the transaction, future financial and operating results, benefits and synergies of the transaction, future opportunities for the combined company and any other statements about MKS Instruments’ or Newport Corporation’s managements’ future expectations, beliefs, goals, plans or prospects constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.  Any statements that are not statements of historical fact (including statements containing the words “will,” “projects,” “intends,” “believes,” “plans,” “anticipates,” “expects,” “estimates,” “forecasts,” “continues” and similar expressions) should also be considered to be forward-looking statements.  There are a number of important factors that could cause actual results or events to differ materially from those indicated by such forward-looking statements, including: (1) the ability to consummate the transaction, (2) risks that the conditions to the closing of the transaction are not satisfied, including the risk that required approvals for the transaction from governmental authorities or the stockholders of Newport Corporation are not obtained; (3) litigation relating to the transaction; (4) the ability of MKS Instruments to successfully integrate Newport Corporation’s operations and employees; (5) unexpected costs, charges or expenses resulting from the transaction; (6) risks that the proposed transaction disrupts the current plans and operations of MKS Instruments and Newport Corporation; (7) the ability to realize anticipated synergies and cost savings; (8) competition from larger and more established companies in Newport Corporation’s markets; (9) MKS Instruments’ ability to successfully grow  Newport Corporation’s business; (10) potential adverse reactions or changes to business relationships resulting from the announcement or completion of the transaction; (11) the availability and terms of the financing to be incurred in connection with the transaction; (12) the retention of key employees; (13) legislative, regulatory and economic developments, including changing business conditions in the semiconductor industry overall and the economy in general as well as financial performance and expectations of  MKS Instruments’ and Newport Corporation’s existing and prospective customers, and the other factors described in MKS Instruments’ Annual Report on Form 10-K for the year ended December 31, 2014 and its most recent quarterly report filed with the SEC and in Newport Corporation’s Annual Report on Form 10-K for the year ended January 3, 2015 and its most recent quarterly report filed with the SEC.  MKS Instruments and Newport Corporation disclaim any intention or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.

Company Contact:  Seth H. Bagshaw
Vice President, Chief Financial Officer and Treasurer
Telephone:  978.645.5578

Investor Relations Contact:  Monica Gould
The Blueshirt Group
Telephone:  212.871.3927
Email:  monica@blueshirtgroup.com
Tuesday, February 23rd, 2016 Uncategorized Comments Off on (NEWP) MKS Instruments Announces Agreement to Acquire Newport Corporation

(UNIS) & (AMGN) Enter Strategic Collaboration for Injectable Drug Delivery Systems

Amgen to invest up to $75 million in leading technology platform Collaboration includes license agreement and master development and supply agreement

YORK, Pa., Feb. 22, 2016  — Unilife Corporation (NASDAQ: UNIS, ASX: UNS) today announced a strategic collaboration with Amgen (NASDAQ: AMGN), a leading biotechnology company, for injectable drug delivery systems. The collaboration, which includes licensing, investment, development and supply agreement components, is centered upon the use of Unilife’s portfolio of prefilled, customizable wearable injectors for medicines to enhance the patient experience.

Under the terms of the collaboration, Unilife has granted Amgen exclusive rights to Unilife’s wearable injectors within select drug classes for use with certain Amgen assets, while preserving rights previously granted to other Unilife customers. Unilife has also granted Amgen non-exclusive rights to all proprietary Unilife delivery systems within the therapeutic areas of oncology, inflammation, bone health, nephrology, cardiovascular and neuroscience.

“Unilife looks forward to a long-term strategic collaboration with Amgen to drive value for patients, prescribers and payers,” said Ian Hanson, senior vice president and general manager of Unilife’s Wearable Injector business unit. “Unilife is pleased to advance its leadership position in the wearable injectors market to meet growing demand for biologics and other medicines. Our prefilled, pre-assembled and ready-to-inject delivery systems are easy-to-use and enhance patient experience.”

“We are pleased to enter this collaboration with Unilife,” said Alison Moore, senior vice president of Process Development at Amgen. “One important pillar of Amgen’s strategy is to invest in leading drug delivery technologies to more effectively meet the needs of patients suffering from serious illnesses. Unilife continues to develop technology that could provide patients with innovative and meaningful enhancements to drug administration.”

Under the strategic collaboration, Unilife can receive up to $75 million. At closing, Amgen paid a nonrefundable $20 million license fee and purchased a $30 million senior secured convertible note from Unilife. Amgen may purchase up to an additional $25 million in senior secured convertible notes over the next two years ($15 million in January 2017 and $10 million in January 2018). These payments are in addition to Amgen’s $15 million payment to Unilife in connection with the exclusivity letter entered into on December 31, 2015.

In addition to these payments, Unilife expects to generate future revenue from the strategic collaboration with Amgen. The collaboration includes a master development and supply agreement that captures key terms for the development, production and supply of Unilife delivery systems. Development programs will commence in 2016.

About Unilife

Unilife Corporation (NASDAQ: UNIS / ASX: UNS) is a U.S.-based developer and commercial supplier of injectable drug delivery systems. Unilife’s portfolio of innovative, differentiated products includes prefilled syringes with automatic needle retraction, drug reconstitution delivery systems, auto-injectors, wearable injectors, insulin delivery systems, ocular delivery systems and novel systems. Products within each platform are customizable to address specific customer, drug and patient requirements. Unilife’s global headquarters and manufacturing facilities are located in York, Penn. For more information, visit www.unilife.com

General: UNIS-G

Investor Contacts (U.S.): Investor Contacts (Australia)
Todd Fromer / Garth Russell Jeff Carter
KCSA Strategic Communications Unilife Corporation
P: + 1 212-682-6300 P: + 61 2 8346 6500

Forward-Looking Statements
This press release contains forward-looking statements. All statements that address operating performance, events or developments that we expect or anticipate will occur in the future are forward-looking statements. These forward-looking statements are based on management’s beliefs and assumptions and on information currently available to our management. Our management believes that these forward-looking statements are reasonable as and when made. However, you should not place undue reliance on any such forward-looking statements because such statements speak only as of the date when made. We do not undertake any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. In addition, forward-looking statements are subject to certain risks and uncertainties that could cause actual results, events and developments to differ materially from our historical experience and our present expectations or projections. These risks and uncertainties include, but are not limited to, those described in “Item 1A. Risk Factors” and elsewhere in our Annual Report on Form 10-K, those described in the “Risk Factors” set forth in Unilife’s prospectus supplement, dated as of and filed with the U.S. Securities and Exchange Commission on February 22, 2016, and those described from time to time in other reports which we file with the U.S. Securities and Exchange Commission.

Monday, February 22nd, 2016 Uncategorized Comments Off on (UNIS) & (AMGN) Enter Strategic Collaboration for Injectable Drug Delivery Systems

(MESO) Cell Therapy Increases Survival in Children With Acute Graft Versus Host Disease

Results of 241 Patients Presented at Bone Marrow Transplant Tandem Meetings 2016

NEW YORK and MELBOURNE, Australia, Feb. 22, 2016  — Mesoblast Limited (Nasdaq:MESO) (ASX:MSB;) today announced that results have been presented showing that use of its proprietary Tier 1 mesenchymal stem cell product candidate remestemcel-L (MSC-100-IV) demonstrated clinically meaningful responses and significantly increased survival in children with steroid-refractory acute Graft Versus Host Disease (aGVHD).

The data from 241 children treated in Mesoblast’s Expanded Access Program, conducted across more than 50 sites in North America and globally, were presented at the tandem annual scientific meetings of the Center for International Blood & Marrow Transplant Research and the American Society of Blood and Marrow Transplantation in Hawaii on February 20.

The oral presentation was given by the study’s independent lead investigator, Dr Joanne Kurtzberg, who is the Jerome Harris Distinguished Professor of Pediatrics and Director of the Pediatric Blood and Marrow Transplant Program at Duke University Medical Center.

Dr Kurtzberg said: “There is a critical and urgent need for an effective and well–tolerated treatment for the very ill children who develop this life-threatening complication after a bone marrow transplant.

“While historically there is a high mortality rate associated with this complication, we are now seeing the majority of children who receive Mesoblast’s cell therapy respond and survive.”

Key results in the 241 children with steroid-refractory aGVHD were:

  • An overall response rate of 65% was seen at day 28 after treatment with MSC-100-IV
  • A response rate of 81% was seen when MSC-100-IV was used as front-line therapy following steroid failure
  • In patients with gastrointestinal and liver disease, who have the highest mortality risk, overall response rates were 65% and 62% respectively
  • Children who achieved overall response at day 28 had significantly improved survival (82% vs 39%, log rank p-value <0.0001)
  • Extending therapy beyond day 28 in children who had not achieved an overall response but had some improvement at day 28 resulted in significantly improved survival (72% vs 18%, log rank p-value 0.003).

To support filing of a biologic license application to the United States Food and Drug Administration for regulatory approval, Mesoblast is conducting a 60-patient, open label Phase 3 trial using MSC-100-IV as front-line therapy in children with steroid-refractory aGVHD.

Mesoblast Chief Executive Silviu Itescu said: “We are committed to making our cell therapy available to the many children suffering from this devastating disease.”

About Graft Versus Host Disease
Mesoblast is developing MSC-100-IV for the treatment of aGVHD following an allogeneic bone marrow transplant (BMT). In patients who have received a BMT, donor cells may attack the recipient (the person receiving the transplant), causing aGVHD, resulting in activation of pro-inflammatory T-cells and tissue damage in the skin, gut and liver which is often fatal.

According to the Center for International Blood and Marrow Transplant Research, there are approximately 30,000 allogeneic BMTs globally per year for diseases including hematological cancers, with 25% of all cases in the pediatric population. Nearly 50% of all allogeneic BMT patients develop aGVHD. Liver or gastrointestinal involvement occur in up to 40% of all patients with aGVHD and are associated with the greatest risk of death, with mortality rates of up to 85%.

Currently, there are no approved therapies for patients with acute steroid-refractory GVHD in the United States, and off-label options have demonstrated mixed efficacy with high toxicity.

About Mesoblast
Mesoblast Limited (ASX:MSB) (Nasdaq:MESO) is a world leader in developing innovative cellular medicines.  We have established what we believe is the industry’s most clinically advanced and diverse portfolio of cell-based products with five programs, two of which are partnered, in active Phase 3 clinical studies or Phase 3-ready, and four programs in Phase 2. All our clinical programs target significant, under-served therapeutic areas including cardiac diseases, spine orthopedic disorders, oncology and hematology diseases, and immune-mediated and inflammatory conditions.

Forward-Looking Statements
This press release includes forward-looking statements that relate to future events or our future financial performance and involve 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. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Forward-looking statements should not be read as a guarantee of future performance or results, and actual results may differ from the results anticipated in these forward-looking statements, and the differences may be material and adverse. You should read this press release together with our risk factors, in our most recently filed reports with the SEC or on our website.  Uncertainties and risks that may cause Mesoblast’s actual results, performance or achievements to be materially different from those which may be expressed or implied by such statements, and accordingly, you should not place undue reliance on these forward-looking statements. We do not undertake any obligations to publicly update or revise any forward-looking statements, whether as a result of new information, future developments or otherwise.

For further information, please contact:
Julie Meldrum
Global Head of Corporate Communications
Mesoblast Limited
T: +61 3 9639 6036
E: julie.meldrum@mesoblast.com
Monday, February 22nd, 2016 Uncategorized Comments Off on (MESO) Cell Therapy Increases Survival in Children With Acute Graft Versus Host Disease

(TRVN) Receives FDA Breakthrough Therapy Designation for Oliceridine

Trevena, Inc. (NASDAQ:TRVN), a clinical stage biopharmaceutical company focused on the discovery and development of biased ligands targeting G protein coupled receptors, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to the Company’s lead product candidate, intravenous oliceridine (TRV130), for the management of moderate-to-severe acute pain. Following two successful Phase 2 studies, oliceridine is now in Phase 3 development. The ATHENA-1 safety and tolerability study is ongoing, with pivotal studies expected to begin in the second quarter of 2016.

“We are delighted that the FDA has chosen to grant Breakthrough Therapy designation to oliceridine,” said Maxine Gowen, Ph.D., chief executive officer. “There is an urgent need for a novel analgesic that delivers powerful pain relief with improved safety and tolerability. We believe this designation recognizes our promising Phase 2 study data for oliceridine, which showed encouraging differentiation from morphine. We look forward to working even more closely with the FDA to facilitate our development of oliceridine.”

Breakthrough Therapy designation is granted by the FDA to new therapies intended to treat serious conditions, and for which preliminary clinical evidence indicates that the drug may demonstrate substantial clinical improvement over available therapies. For oliceridine, the designation request included the full study results of both of the Company’s recent Phase 2 studies. Breakthrough Therapy designation provides all the benefits of the Fast Track program, as well as more intensive FDA guidance on preparing an efficient drug development program and eligibility for rolling review and priority review.

About oliceridine

Oliceridine (TRV130) was designed to optimize μ opioid receptor pharmacology to deliver an improved analgesic profile, and was previously granted Fast Track designation by the FDA. Oliceridine is the first μ receptor G protein pathway selective modulator (μGPS) – a biased μ opioid receptor ligand that in preclinical studies activated pathways associated with analgesia while avoiding pathways that can promote respiratory depression and gastrointestinal dysfunction and limit analgesia. In Phase 2, intravenous oliceridine demonstrated rapid and powerful analgesic efficacy with reduced frequency of opioid-related adverse events including nausea, vomiting, and hypoventilation compared to intravenous morphine. Trevena believes that oliceridine may offer an improved safety and tolerability profile compared to conventional opioid analgesics while providing powerful pain relief to patients. Trevena anticipates that the initial market opportunity for oliceridine will be in the acute care settings, with a focus on moderate to severe acute pain in the hospital.

About Trevena

Trevena, Inc. is a clinical stage biopharmaceutical company that discovers, develops and intends to commercialize therapeutics that use a novel approach to target G protein coupled receptors, or GPCRs. Using its proprietary product platform, Trevena has identified four biased ligand product candidates – oliceridine (TRV130) to manage moderate to severe acute pain intravenously (Phase 3), TRV027 to treat acute heart failure (Phase 2b), TRV734 to manage moderate to severe acute and chronic pain orally (Phase 1), and TRV250 for acute migraine and other CNS disorders (preclinical).

Cautionary Note on Forward Looking Statements

Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company’s strategy, future operations, clinical development of its therapeutic candidates, plans for potential future product candidates and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “suggest,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” 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: uncertainties related to the Company’s intellectual property; the status, timing, costs, results and interpretation of the Company’s clinical trials, including for oliceridine; the uncertainties inherent in conducting clinical trials; whether interim results from a clinical trial will be predictive of the final results of the trial or results of early clinical trials, including the Phase 2 oliceridine studies, will be indicative of the results of future trials; expectations for regulatory approvals and the positive impact, if any, of the FDA’s grant of Breakthrough Therapy Designation status for oliceridine; availability of funding sufficient for the Company’s foreseeable and unforeseeable operating expenses and capital expenditure requirements; other matters that could affect the availability or commercial potential of the Company’s therapeutic candidates; and other factors discussed in the Risk Factors set forth in the Company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission (SEC) and in other filings the Company makes with the SEC from time to time. In addition, the forward-looking statements included in this press release represent the Company’s views only as of the date hereof. The Company anticipates that subsequent events and developments may cause the Company’s views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so, except as may be required by law.

 

Investor:
Trevena, Inc.
Jonathan Violin, Ph.D., 610-354-8840 x231
Sr. Director of Investor Relations
jviolin@trevenainc.com

Monday, February 22nd, 2016 Uncategorized Comments Off on (TRVN) Receives FDA Breakthrough Therapy Designation for Oliceridine

(ECTE) Announces New Patents for Non-Invasive Sensing Technology

ISELIN, N.J., Feb. 22, 2016  — Echo Therapeutics, Inc. (Nasdaq: ECTE), a medical device company focused on non-invasive continuous glucose monitoring (CGM) and associated technologies, today announced new patents covering its system and methods for non-invasive, transdermal sensing as key components of Echo’s continuous glucose monitoring system.

Echo Therapeutics received notice that its patent application entitled “System and Method for Analyte Sampling and Analysis with Hydrogel” issued as Canadian Patent No. 2,584,699 and will expire in 2025. Echo also recently received notice that its patent application entitled “Transdermal Analyte Monitoring Systems and Methods for Analyte Detection” was issued as Hong Kong Patent No. HK1143052 and will expire in 2028. Additionally, a notice of allowance was received for Japanese patent application 2013-250328, entitled “Sensor Assembly for an Analyte Monitoring System with Hydrogels and a Method for Monitoring an Analyte by Using the Sensor Assembly.” These patents join an already extensive U.S. and foreign intellectual property portfolio.

“The issuance of these foundational patents creates an opportunity for Echo to establish strategic partnerships in these important regions of the world,” said Scott W. Hollander, Echo’s President and CEO. “Furthermore, we expect several additional patents to be filed and issued worldwide for our next generation skin preparation and continuous glucose sensing technology as we build a solid foundation for future and sustainable growth.”

About Echo Therapeutics

Echo Therapeutics is developing its non-invasive, wireless, continuous glucose monitoring (CGM) system. A significant opportunity exists for the Company’s CGM to be used in the outpatient diabetes market and in the fitness, weight loss and personal lifestyle wearable-health space. A longer-term opportunity also exists in the hospital settings. Echo developed its needle-free skin preparation device as a platform technology that allows for enhanced skin permeation enabling extraction of analytes, such as glucose, and enhanced delivery of topical pharmaceuticals.

Cautionary Statement Regarding Forward Looking Statements

The statements in this press release that are not historical facts may constitute forward-looking statements that are based on current expectations and are subject to risks and uncertainties that could cause actual future results to differ materially from those expressed or implied by such statements. Those risks and uncertainties include, but are not limited to, risks related to regulatory approvals and the success of Echo’s clinical studies, the safety and efficacy of Echo’s CGM System, the failure of future development and preliminary marketing efforts related to Echo’s CGM System, Echo’s ability to secure additional commercial partnering arrangements, risks and uncertainties relating to Echo’s and its partners’ ability to develop, market and sell Echo’s CGM System, the availability of substantial additional equity or debt capital to support its research, development and product commercialization activities, and the success of its research, development, regulatory approval, marketing and distribution plans and strategies, including those plans and strategies related to its CGM System. These and other risks and uncertainties are identified and described in more detail in Echo’s filings with the Securities and Exchange Commission, including, without limitation, its Annual Report on Form 10-K for the year ended December 31, 2014, its Quarterly Reports on Form 10-Q, and its Current Reports on Form 8-K. Echo undertakes no obligation to publicly update or revise any forward-looking statements.

For More Information:
Christine H. Olimpio
Director, Investor Relations and Corporate Communications
(732) 201-4189                                                 

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Monday, February 22nd, 2016 Uncategorized Comments Off on (ECTE) Announces New Patents for Non-Invasive Sensing Technology