Apyx Medical Corp. Receives 510(k) Clearance for Next-Generation J-Plasma® Precise Handpiece Designed for Laparoscopic Surgery
August 05 2019 - 7:30AM
Business Wire
Apyx Medical Corporation, formerly Bovie Medical
Corporation, (NASDAQ:APYX) (the “Company”), a maker of medical
devices and supplies and the developer of its Helium Plasma
Technology, marketed and sold as Renuvion® in the cosmetic surgery
market and J-Plasma® in the hospital surgical market, announced
today that it received U.S. Food and Drug Administration (FDA)
510(k) clearance to market and sell its next-generation J-Plasma
Precise Handpiece.
The Company’s J-Plasma handpieces are indicated for cutting,
coagulation and ablation of soft tissue during open and
laparoscopic surgical procedures. The original and next-generation
of this J-Plasma Precise Handpiece is designed specifically for use
in laparoscopic surgical procedures. Importantly, this
next-generation handpiece incorporates the Company’s Cool-Coag®
Technology, enhancing its utility by enabling surgeons to alternate
between delivering precise, tissue-sparing J-Plasma energy,
standard monopolar coagulation energy, and a non-contact ‘spray’
called Plasma Beam Coagulation, in the same handpiece. This
next-generation handpiece is also 39% lighter than its predecessor
for improved ergonomics.
“We are pleased to announce the receipt of 510(k) clearance for
our next-generation J-Plasma Precise Handpiece. It is an important
achievement for our Company that was made possible by the efforts
of both our Research and Development and Regulatory Affairs teams,”
said Charlie Goodwin, Chief Executive Officer. “This
next-generation J-Plasma Precise Handpiece was designed in response
to demand from our surgeon customers outside the U.S. These
customers requested a handpiece designed for use in laparoscopic
surgery procedures that would enable them to deliver the precision
of J-Plasma energy as well as the power of a monopolar coagulation
waveform when needed for wider areas of coagulation. In response to
this demand, we leveraged our research & development and
manufacturing expertise to create this next-generation version of
our J-Plasma Precise Handpiece, which features our Cool-Coag®
Technology and enhanced ergonomics. We look forward to beginning a
limited launch of this product in Europe later this quarter.”
About Apyx Medical
Corporation:
Apyx Medical Corporation (formerly Bovie Medical Corporation) is
an advanced energy technology company with a passion for elevating
people’s lives through innovative products in the cosmetic and
surgical markets. Known for its innovative Helium Plasma
Technology, Apyx is solely focused on bringing transformative
solutions to the physicians and patients it serves. The company’s
Helium Plasma Technology is marketed and sold as Renuvion® in the
cosmetic surgery market and J-Plasma® in the hospital surgical
market. Renuvion offers plastic surgeons, fascial plastic surgeons
and cosmetic physicians a unique ability to provide controlled heat
to the tissue to achieve their desired results. The J-Plasma system
allows surgeons to operate with a high level of precision and
virtually eliminating unintended tissue trauma. The Company also
leverages its deep expertise and decades of experience in unique
waveforms through original equipment manufacturing (OEM) agreements
with other medical device manufacturers. For further information
about the Company and its products, please refer to the Apyx
Medical Corporation website at www.ApyxMedical.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, 2018 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/20190805005190/en/
Investor Relations:
Westwicke Partners on behalf of Apyx Medical Corporation Mike
Piccinino, CFA investor.relations@apyxmedical.com
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