Skyline Medical Announces CE Mark for the STREAMWAY® System
June 15 2017 - 7:30AM
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 that
its European Authorized Representative, Emergo Europe B.V., has
notified the Dutch Competent Authority that the Company’s STREAMWAY
System meets all requirements and can now be affixed with the CE
mark and marketed in 32 European countries.
“Receipt of the CE mark is an important
milestone for Skyline Medical and we are very excited to be able to
expand the reach of our STREAMWAY System to Europe,” said Dr. Carl
Schwartz, chief executive officer of Skyline Medical. “We have
already held preliminary discussions with a few European
distributors, and with the CE mark in hand we can now advance those
negotiations while beginning dialogues with others.
“We are optimistic that we can record our first
product sale under the CE mark before year-end, and ramp up
STREAMWAY’s availability throughout Europe by early 2018. Europe
presents a rich market opportunity we are eager to pursue,” Dr.
Schwartz added.
About the STREAMWAY System
Skyline'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. As of March 31, 2017,
Skyline Medical customers have installed 103 STREAMWAY Systems in
52 facilities across 20 states, and in Canada.
The STREAMWAY minimizes human intervention for
better safety and improves 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. Furthermore, 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. For a demonstration please visit
www.skylinemedical.com or call 855-785-8855.
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.
Forward-looking
StatementsCertain 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; 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 Investor Relations
Kim Sutton Golodetz
(212) 838-3777
kgolodetz@lhai.com
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