Apyx Medical Corporation Receives 510(k) Clearance for the Apyx Plasma/RF Handpiece
October 14 2019 - 7:00AM
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 as 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 the Apyx Plasma/RF Handpiece, a
new addition to the Renuvion product family.
The Apyx Plasma/RF Handpiece was cleared as a sterile, single
use electrosurgical (monopolar) device intended to be used in
conjunction with compatible generators for the percutaneous
delivery of radiofrequency energy and/or helium plasma for cutting,
coagulation and ablation of soft tissue. The Apyx Plasma/RF
Handpiece features several important enhancements compared to prior
generations, including a smaller diameter instrument shaft (3mm in
diameter vs. 5mm in diameter), a bullet-shaped instrument tip that
directs the flow of plasma energy from ports on the side of the
instrument tip, as opposed to the front of the instrument tip, and
a new handle design with improved ergonomics. The handpiece is
designed to be used percutaneously.
The handpiece will be available in three configurations: a
handpiece with a twin port tip and either a 27cm or 15cm long shaft
and a handpiece with a single port tip and a 15cm long shaft. All
configurations of the Apyx Plasma/RF Handpiece include features to
help minimize unwanted energy application near the incision entry
site. Specifically, each handpiece configuration has distance
indicators on its tip and will be sold with accompanying epidermal
marking templates to help surgeons determine the proximity of the
device tip to the entry of the insertion site.
“Apyx Medical Corporation is pleased to announce FDA 510(k)
clearance of the Apyx Plasma/RF Handpiece, the latest addition to
our Renuvion product family,” said Charlie Goodwin, Chief Executive
Officer. “The Apyx Plasma/RF Handpiece is designed specifically for
subdermal coagulation and features important enhancements to meet
the needs of our surgeon customers in the cosmetic surgery market.
During the product development process, we obtained extensive
feedback and input from our surgeon customers, as well as the
distinguished plastic and cosmetic surgeons on our Medical Advisory
Board. We are proud of this robust product development process, and
look forward to initiating a limited commercial launch of the Apyx
Plasma/RF Handpiece during the fourth quarter of 2019.”
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/20191014005157/en/
Investor Relations:
Westwicke Partners on behalf of Apyx Medical Corporation Mike
Piccinino, CFA investor.relations@apyxmedical.com
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