Apyx Medical Corporation Announces FDA 510(k) Clearance for the Renuvion® Micro Handpiece
14 Junho 2023 - 8:30AM
Business Wire
Apyx Medical Corporation (NASDAQ:APYX) (the “Company”),
the manufacturer of a proprietary helium plasma and radiofrequency
technology marketed and sold as Renuvion®, today announced it has
received 510(k) clearance from the U.S. Food and Drug
Administration (“FDA”) for the Renuvion Micro Handpiece, a new
addition to the Renuvion product family. The Renuvion Micro
Handpiece is cleared with an indication “for the delivery of
radiofrequency energy and/or helium plasma where
coagulation/contraction of soft tissue is needed. Soft tissue
includes subcutaneous tissue.”
“The Renuvion Micro Handpiece represents a new addition to our
Advanced Energy product portfolio, designed with the needs of our
surgeon customers in the cosmetic surgery market in mind,” said
Charlie Goodwin, President and Chief Executive Officer. “Most
notably, our Renuvion Micro Handpiece features include a smaller
instrument shaft, which is 10 cm long and 1.5mm wide, half the
width of our Renuvion APR Handpiece. It complements our existing
product portfolio, providing our customers with a new option to
facilitate soft tissue contraction in those cases that may benefit
from the use of a handpiece with a smaller profile. The Renuvion
Micro Handpiece is designed for use with the Apyx One Console, our
next-generation generator system which we launched at the beginning
of 2023.”
Mr. Goodwin continued: “We are delighted to receive 510(k)
clearance for the Renuvion Micro Handpiece and look forward to
initiating our limited commercial launch of the product during the
third quarter of this year.”
About Apyx Medical
Corporation:
Apyx Medical Corporation is an advanced energy technology
company with a passion for elevating people’s lives through
innovative products, including its Helium Plasma Technology
products marketed and sold as Renuvion in the cosmetic surgery
market and J-Plasma® in the hospital surgical market. Renuvion and
J-Plasma offer surgeons a unique ability to provide controlled heat
to tissue to achieve their desired results. The Company also
leverages its deep expertise and decades of experience in unique
waveforms through 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.
All statements other than statements of historical fact are
statements that could be deemed forward-looking statements,
including but not limited to, any statements regarding the
potential impact of the COVID-19 pandemic and the actions by
governments, businesses and individuals in response to the
situation; projections of net revenue, margins, expenses, net
earnings, net earnings per share, or other financial items;
projections or assumptions concerning the possible receipt by the
Company of any regulatory approvals from any government agency or
instrumentality including but not limited to the U.S. Food and Drug
Administration, supply chain disruptions, component shortages,
manufacturing disruptions or logistics challenges; or macroeconomic
or geopolitical matters and the impact of those matters on the
Company’s financial performance.
Forward-looking statements and information are 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 the Company’s actual results to
differ materially and that could impact the Company and the
statements contained in this release include but are not limited to
risks, uncertainties and assumptions relating to the regulatory
environment in which the Company is subject to, including the
Company’s ability to gain requisite approvals for its products from
the U.S. Food and Drug Administration and other governmental and
regulatory bodies, both domestically and internationally; the
impact of the recent FDA Safety Communication on our business and
operations; factors relating to the effects of the COVID-19
pandemic; sudden or extreme volatility in commodity prices and
availability, including supply chain disruptions; changes in
general economic, business or demographic conditions or trends;
changes in and effects of the geopolitical environment; liabilities
and costs which the Company may incur from pending or threatened
litigations, claims, disputes or investigations; and other risks
that are described in the Company’s Annual Report on Form 10-K for
the fiscal year ended December 31, 2022 and the Company’s other
filings with the Securities and Exchange Commission. 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/20230614938043/en/
Investor Relations: ICR
Westwicke on behalf of Apyx Medical Corporation Mike Piccinino, CFA
investor.relations@apyxmedical.com
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