Skyline Medical and GLG Pharma Enter into Partnership to Develop Diagnostic Tests for Skyline’s STREAMWAY System
September 21 2016 - 8:30AM
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
SystemSkyline 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.
Contact:
Investors
LHA
Kim Sutton Golodetz
(212) 838-3777
kgolodetz@lhai.com
MoneyInfo, LLC
Charles Moskowitz
(781) 826-8882
cam@moneyinfo-llc.com
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