Apyx Medical Corporation Announces FDA 510(k) Submission for the Use of the Renuvion® APR Handpiece for the Coagulation of Subcutaneous Soft Tissues Where Needed, Following Liposuction
01 February 2023 - 11:30PM
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
submitted a 510(k) premarket notification (“510(k) submission”) for
the Renuvion APR Handpiece to the U.S. Food and Drug Administration
(“FDA”), supported by a clinical study and real-world evidence. The
510(k) submission is intended to expand Renuvion’s indications for
use to include a specific indication for the use of the Renuvion
APR Handpiece for the coagulation of subcutaneous soft tissues
where needed, following liposuction.
“We are pleased to announce the submission of this request for
510(k) clearance for a new clinical indication, which is intended
to enable Apyx Medical to market and sell our Renuvion APR
Handpiece for use following liposuction,” said Charlie Goodwin,
President and Chief Executive Officer. “This 510(k) submission
leverages the substantial history of safe use of the Renuvion APR
handpiece following liposuction procedures, and as such, Apyx
Medical was able to assess the device based on a large set of
retrospective chart reviews. Importantly, our analysis of Renuvion
treatment adverse events, when compared to the real-world evidence
gathered for liposuction treatments in the literature review,
demonstrated that there are no new or increased risks for Renuvion
procedures following liposuction procedures compared to liposuction
alone.”
Mr. Goodwin continued: “We appreciate the continued engagement
from the FDA in recent months as we prepared this important 510(k)
submission, and we continue to believe the receipt of 510(k)
clearance for this new clinical indication would directly address
the remaining limitations of the Medical Device Safety
Communication. We look forward to, and support, the FDA’s continued
focus on ensuring that everyone in the industry is adhering to the
safe and effective use of cosmetic surgery technologies, especially
those used during or after liposuction procedures.”
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, 2021 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/20230201005210/en/
Investor Relations: ICR
Westwicke on behalf of Apyx Medical Corporation Mike Piccinino, CFA
investor.relations@apyxmedical.com
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