MINNEAPOLIS, Nov. 02, 2016 (GLOBE NEWSWIRE) -- Skyline Medical Inc. (NASDAQ: SKLN ) (“Skyline” or “the Company”), producer of the FDA-approved STREAMWAY® System for automated, direct-to-drain medical fluid disposal, announces that it has agreed to grant GLG Pharma, LLC (“GLG”) exclusive rights to market and distribute the STREAMWAY® System in Poland and certain other countries in Central Europe. This builds upon a previously announced arrangement granting GLG exclusive rights to market and distribute STREAMWAY in the U.K. and an initial agreement to develop rapid diagnostic tests that utilize fluid and tissue collected by the STREAMWAY System during procedures.
GLG will be responsible for all sales and marketing activities, including hiring and training the appropriate number of direct sales representatives to cover the 3,800 operating rooms in Poland. Marketing is expected to begin immediately upon receipt of the CE Mark and will be managed from GLG’s facility in Gdansk, Poland.
The agreement will also include the Czech Republic, Latvia, Estonia and Lithuania, with sales activities expected to begin in those countries soon after the introduction in Poland. Skyline applied for CE Mark approval to market STREAMWAY in the European Union and certain other countries in July 2016, following receipt of ISO 13485:2003 certification.
“We are excited to further solidify and expand our relationship with Skyline Medical with this expansion of our exclusive sales and marketing territory, the second agreement we have we have announced this week,” said Richard Gabriel, Co-founder and Chief Operating Officer of GLG Pharma. “Central Europe is expected to be a very attractive market for STREAMWAY System sales, orchestrated by our general manager in Poland. We currently have pharmaceutical and diagnostic development laboratories in Poland, which are supported by grants from the Polish government. The STREAMWAY System will make an excellent addition to our portfolio of products in development.”
In June 2016 STREAMWAY received ISO 13485:2003 certification, an internationally recognized quality standard for medical devices that is awarded when an organization demonstrates its ability to provide medical devices and related services that consistently meet customer and regulatory requirements applicable to medical devices and related services, and is a requirement for medical device clearance in Canada, the EU and a majority of other countries that require products meet EU safety, health and environmental requirements.
Under the terms of an agreement announced in September 2016, GLG intends to develop rapid diagnostic tests that utilize fluid and tissue collected by the STREAMWAY System during procedures. Initial tests are anticipated to include cancer biomarkers and infectious diseases. The oncology test panels will feature GLG's patented inhibitors of Signal Transducers and Activators of Transcription 3 (STAT3), which are in preclinical development for a new generation of targeted therapies.
About GLG, LLC. Founded in 2009 and located in Jupiter, Fla., GLG Pharma, LLC is a privately held, early stage, biotechnology company developing personalized therapies for patients with cancer and other proliferative diseases. GLG Pharma’s therapeutics are expected to aid in the treatment of a wide variety of cancers and address unmet needs in the multi-billion dollar anti-cancer market with potentially greater efficacy and fewer side effects than existing therapies. For more information on GLG Pharma visit: http://www.glgpharma.com .
About the STREAMWAY System Skyline Medical's revolutionary, FDA-cleared STREAMWAY System is the first true direct-to-drain fluid disposal system designed specifically for medical applications, such as radiology, endoscopy, urology and cystoscopy procedures. It connects directly to a facility's plumbing system to automate the collection, measurement and disposal of waste fluids, and minimizes human intervention for better safety while improving compliance with Occupational Safety and Health Administration (OSHA) and other regulatory agency safety guidelines. It also provides unlimited capacity for increased efficiency in the operating room, which leads to greater profitability. The STREAMWAY eliminates canisters to reduce overhead costs and provides greater environmental stewardship by helping to eliminate the approximately 50 million potentially disease-infected canisters that go into landfills annually in the U.S.
About Skyline Medical Inc. Skyline Medical Inc. produces a fully automated, patented, FDA-cleared, waste fluid disposal system that virtually eliminates staff exposure to blood, irrigation fluid and other potentially infectious fluids found in the healthcare environment. Antiquated manual fluid handling methods — which require hand carrying and emptying filled fluid canisters — present an exposure risk and potential liability. Skyline Medical's STREAMWAY System fully automates the collection, measurement and disposal of waste fluids and is designed to: 1) reduce overhead costs to hospitals and surgical centers, 2) improve compliance with OSHA and other regulatory agency safety guidelines, 3) improve efficiency in the operating room, and radiology and endoscopy departments — leading to greater profitability, and 4) provide greater environmental stewardship by helping to eliminate the approximately 50 million potentially disease-infected canisters that go into landfills annually in the United States. For additional information, please visit www.skylinemedical.com .
Forward-looking Statements: Certain of the matters discussed in this announcement contain forward-looking statements that involve material risks to and uncertainties in the Company's business that may cause actual results to differ materially from those anticipated by the statements made herein. Such risks and uncertainties include, among other things, current negative operating cash flows and a need for additional funding to finance our operating plan; the terms of any further financing, which may be highly dilutive and may include onerous terms; unexpected costs and operating deficits, and lower than expected sales and revenues; uncertain willingness and ability of customers to adopt new technologies and other factors that may affect further market acceptance, if our product is not accepted by our potential customers, it is unlikely that we will ever become profitable, adverse economic conditions; the potential delisting of the Company’s common stock on The Nasdaq Capital Market as a result of the Company’s failures to comply with listing standards, in which case the liquidity of our common stock would likely be impaired and there would likely be a reduction in our coverage by security analysts and the news media, thereby resulting in lower prices for our common stock than might otherwise prevail; adverse results of any legal proceedings; the volatility of our operating results and financial condition; inability to attract or retain qualified senior management personnel, including sales and marketing personnel; our ability to establish and maintain the proprietary nature of our technology through the patent process, as well as our ability to possibly license from others patents and patent applications necessary to develop products; the Company's ability to implement its long range business plan for various applications of its technology, including the possibility that the development of applicable technologies by GLG Pharma, LLC will be delayed, will not occur or will not receive applicable regulatory approvals on a timely basis; the Company’s ability to consummate its joint venture with Electronic On-Ramp, Inc.; the Company's ability to enter into agreements with any necessary marketing and/or distribution partners; the impact of competition, the obtaining and maintenance of any necessary regulatory clearances applicable to applications of the Company's technology; and management of growth and other risks and uncertainties that may be detailed from time to time in the Company's reports filed with the Securities and Exchange Commission, which are available for review at www.sec.gov . This is not a solicitation to buy or sell securities and does not purport to be an analysis of the Company's financial position. See the Company's most recent Annual Report on Form 10-K, and subsequent reports and other filings at www.sec.gov .
Contact: Investors LHA Kim Sutton Golodetz (212) 838-3777 kgolodetz@lhai.com MoneyInfo, LLC Charles Moskowitz (781) 826-8882 cam@moneyinfo-llc.com
