Bovie Medical Corp. Files 510(k) Submission with the FDA for a New Indication to Market & Sell J-Plasma/Renuvion for Use in D...
December 21 2018 - 7:30AM
Business Wire
Bovie Medical Corporation (NYSE:BVX) (the “Company”), a
maker of medical devices and supplies and the developer of
J-Plasma®, a patented surgical product marketed and sold under the
Renuvion® Cosmetic Technology brand in the cosmetic surgery market,
today announced a Premarket Notification 510(K) submission to the
U.S. Food and Drug Administration (FDA) for a new indication for
J-Plasma/Renuvion for use in dermal resurfacing procedures.
“We are pleased to announce this 510(K) submission requesting
clearance for a new clinical indication to market and sell our
Renuvion Cosmetic Technology for dermal resurfacing procedures,
which represents another important step towards our strategic
objective to expand Renuvion’s clinical indications for use in the
cosmetic surgery market,” said Charlie Goodwin, Chief Executive
Officer. “Our submission is supported by data from our
multi-center, single arm, evaluator-blind prospective study
evaluating the safety and efficacy of our Renuvion technology for
the reduction of facial wrinkles and rhytides, which was conducted
at three investigational centers and consisted of 55 patients. We
were very pleased with the clinical results of this study and we
are optimistic in receiving regulatory clearance for this
differentiated technology in 2019.”
About Bovie Medical
Corporation:
Bovie Medical Corporation is a leading maker of medical devices
and supplies as well as the developer of J-Plasma® (marketed and
sold under the Renuvion™ Cosmetic Technology brand in the cosmetic
surgery market), a patented plasma-based surgical product for
cutting, coagulation and ablation of soft tissue. J-Plasma
technology utilizes a helium ionization process to produce a
stable, focused beam of plasma that provides surgeons with greater
precision, and minimal invasiveness. The new J-Plasma handpieces
with Cool-Coag™ technology deliver the precision of helium plasma
energy, the power of traditional monopolar coagulation and the
efficiency of plasma beam coagulation – enabling thin-layer
ablation and dissection and fast coagulation with a single
instrument, minimizing instrument exchange and allowing a surgeon
to focus on their patient and their procedures. With Cool-Coag
technology, the new J-Plasma handpieces can deliver three
distinctly different energy modalities – further increasing the
utility and versatility of the system. The Company also leverages
its expertise through original equipment manufacturing (OEM)
agreements with other medical device manufacturers. For further
information about the Company and its products, please refer to the
Bovie Medical Corporation website at www.boviemedical.com.
Cautionary Statement on Forward-Looking
Statements:
Certain matters discussed in this release and oral statements
made from time to time by representatives of the Company may
constitute forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995 and the Federal
securities laws. Although the Company believes that the
expectations reflected in such forward-looking statements are based
upon reasonable assumptions, it can give no assurance that its
expectations will be achieved.
Forward-looking information is subject to certain risks, trends
and uncertainties that could cause actual results to differ
materially from those projected. Many of these factors are beyond
the Company's ability to control or predict. Important factors that
may cause actual results to differ materially and that could impact
the Company and the statements contained in this release can be
found in the Company's filings with the Securities and Exchange
Commission including the Company's Report on Form 10-K for the year
ended December 31, 2017 and subsequent Form 10-Q filings. For
forward-looking statements in this release, the Company claims the
protection of the safe harbor for forward-looking statements
contained in the Private Securities Litigation Reform Act of 1995.
The Company assumes no obligation to update or supplement any
forward-looking statements whether as a result of new information,
future events or otherwise.
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version on businesswire.com: https://www.businesswire.com/news/home/20181221005018/en/
Investor Relations Contact:Westwicke Partners on behalf
of Bovie Medical CorporationMike Piccinino,
CFA443-213-0500investor.relations@boviemed.com
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