Bovie Medical Corporation Announces Completion of Enrollment in J-Plasma®/RenuvionTM Dermal Resurfacing Study
14 Mai 2018 - 10:01PM
Business Wire
Bovie Medical Corporation (NYSEMKT: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 the completion of enrollment for the U.S.
Investigational Device Exemption (IDE) clinical study of its
J-Plasma/Renuvion technology for use in dermal skin
resurfacing.
“We are excited to announce that today we have enrolled the
final patient in our dermal skin resurfacing study, which
represents another important development in our strategy to build
clinical support for our Renuvion technology and expand its
clinical indications for use in the cosmetic surgery market,” said
Charlie Goodwin, Chief Executive Officer. “We look forward to
sharing the findings of this study, which we expect will provide
support for our planned 510(k) submission to the U.S. Food and Drug
Administration for an indication to market and sell
J-Plasma/Renuvion for use in dermal resurfacing procedures.”
About the J-Plasma/Renuvion Dermal
Resurfacing Study:
The clinical study is a multi-center, single arm,
evaluator-blind prospective study evaluating the safety and
efficacy of Bovie Medical’s J-Plasma/Renuvion technology for the
reduction of facial wrinkles and rhytides. The study is being
conducted at three investigational centers and consists of 55
subjects. Enrolled study subjects will receive one procedure with
the Company’s J-Plasma/Renuvion technology at enrollment and
wrinkle severity will be assessed using the Fitzpatrick Wrinkle and
Elastosis Scale (FWS) at baseline and at each follow-up time
point.
As of the publication of this release, additional details on the
study may be found at:
https://clinicaltrials.gov/ct2/show/NCT03286283?term=j-plasma&rank=1
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/Renuvion
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/Renuvion
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/Renuvion handpieces can
deliver three distinctly different energy modalities - further
increasing the utility and versatility of the system. Bovie Medical
Corporation is also a leader in the manufacture of a range of
electrosurgical products and technologies, marketed through both
private labels and the Company’s own well-respected brands (Bovie®,
IDS™ and DERM™) to distributors worldwide. 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/20180514005925/en/
Westwicke Partners on behalf of Bovie Medical CorporationMike
Piccinino, CFA443-213-0500investor.relations@boviemed.com
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