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Press Release

Skyline Medical and GLG Pharma Enter into Partnership to Develop Diagnostic Tests for Skyline’s STREAMWAY System


Posted on: 21 Sep 16

MINNEAPOLIS, Sept. 21, 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 the signing of a partnership and exclusive reseller agreement with GLG Pharma, LLC (“GLG”).

Under the terms of the agreement, GLG intends to develop rapid diagnostic tests that utilize fluid and tissue collected by the STREAMWAY System during procedures.  Skyline Medical will issue common stock to GLG in four separate tranches, with each tranche released after the achievement of certain development milestones.  In addition, Skyline will pay a royalty to GLG on the sale of individual tests.

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.

“This partnership provides Skyline Medical with access to exciting new technology that we believe will allow future enhancements in the collection of cells and fluid waste and how it is utilized prior to disposal,” said Dr. Carl Schwartz, Interim Chief Executive Officer of Skyline Medical.  “The first of these developments may include point-of-care companion testing that assists oncologists, both in operating rooms and in interventional radiology suites, in personalizing treatments based on results of the fluid collected. In addition, testing of the cells that are sloughed off during procedures may provide physicians with valuable information as to the progress of a surgery. The sale of diagnostic tests in conjunction with STREAMWAY provides an attractive opportunity to leverage our sales and marketing organization, while providing both new and enhanced sources of revenue to Skyline.” 

Commenting on the agreement, Richard Gabriel, Co-founder and Chief Operating Officer of GLG Pharma, said, “We are very excited about the potential of this partnership to fulfill the unmet rapid diagnostic need of oncologists and patients. The use of STREAMWAY fluids is a creative answer to improving patient care.”

Bob Beringer, Chief Executive Officer of Electronic On-Ramp, said, “The ability to identify infectious diseases, especially in disaster situations, could make STREAMWAY an even more powerful product than it already is.  EOR looks forward to finalizing our joint venture agreement with Skyline to enhance operating rooms for our existing Government customers around the world. EOR looks forward to bringing new funded contracts that make important contributions to healthcare and generate additional revenue for all of our shareholders.”

The first diagnostic tests are expected to be launched in the first quarter of 2017.

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; 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 will be delayed, will not occur or will not receive applicable regulatory approvals on a timely basis; 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.

GlobeNewswire
globenewswire.com

Last updated on: 22/09/2016

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