Skyline Medical and Helomics expand into Next Generation Sequencing for Personalized Medicine

NGS platform to generate additional clinical data to build out the Skyline-Helomics D-CHIP bioinformatics platform


MINNEAPOLIS, Dec. 20, 2017 (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, today announced that it is expanding into Next Generation Sequencing (“NGS”) through the licensing of an NGS platform MiSeqDx®, from Illumina.

The MiSeqDx NGS platform will allow gene sequencing of tumor specimens from cancer patients which will provide rich genomic data for the D-CHIP™ AI-based bioinformatics platform being built out as part of the Skyline-Helomics joint venture. The D-CHIP platform then identifies the correlations between the patient demographic data, the tumor gene sequence (obtained by NGS), and the drug responses of the individual patient’s tumor. Pharma partners who subscribe to the D-CHIP service can mine the knowledgebase of tumor mutations and drug response to design the next generation of cancer treatments.

“Licensing the NGS platform is expected to drive commercial traction for both the D-CHIP platform and the additional CRO services offered by the Skyline-Helomics joint venture. We fully expect the NGS platform to drive revenue from new partnerships early in 2018,” stated Dr. Carl Schwartz, CEO of Skyline Medical. “This further demonstrates our commitment to establishing the Company at the frontier of the personalized medicine sector and to building value for our shareholders.”

“The NGS platform will allow us to add targeted sequence data from tumor specimens for a range of key cancer genes to the D-CHIP platform. Pharma companies which license our D-CHIP platform will benefit from these actionable insights to drive biomarker discovery and validation, aiding them in the selection of patients for clinical trials as well as drug-repurposing activities,” commented Gerald Vardzel, President and CEO, Helomics.

“The MiSeqDx is the only FDA approved platform for In Vitro Diagnostic (IVD) use. We believe that licensing the NGS platform will give us access to approved IVD tests which will attract clinical testing business from a variety of local hospitals, academic centers and small and medium size companies,” said Mark Collins PhD, VP of Innovation and Strategy, Helomics.

About Skyline Medical

Skyline Medical 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 that 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, thereby 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 each year in the U.S.  For additional information, please visit www.skylinemedical.com.

About Helomics Corporation

Helomics® is a precision diagnostic company and integrated clinical contract research organization whose mission is to improve patient care by partnering with pharmaceutical, diagnostic, and academic organizations to bring innovative clinical products and technologies to the marketplace.  In addition to its proprietary precision diagnostics for oncology, Helomics offers boutique CRO services that leverage our patient-derived tumor models, coupled to a wide range of multi-omics assays (genomics, proteomics and biochemical), and a proprietary bioinformatics platform (D-CHIP) to provide a tailored solution to our client’s specific needs.

Helomics® is headquartered in Pittsburgh, Pennsylvania where the company maintains state-of-the-art, CLIA-certified, clinical and research laboratories. 

For more information, please visit: www.Helomics.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 risks related to the proposed joint ventures, including the need to negotiate the definitive agreements for the joint ventures; possible failure to realize anticipated benefits of the joint ventures; and costs of providing funding to the joint ventures. Other risks and uncertainties relating to the Company 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; the Company's ability to enter into agreements with any necessary marketing and/or distribution partners and with any strategic or joint venture 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.

Contacts:

Skyline Medical
Carl Schwartz, Chief Executive Officer
(651) 389-4800
cschwartz@skylinemedical.com

Investors
KCSA Strategic Communications
Elizabeth Barker
(212) 896-1203
skln@kcsa.com