APYX Medical's Renuvion Becomes the Only
Device that is FDA-cleared for Use Following Liposuction in
Aesthetic Body Contouring Procedures
CLEARWATER,
Fla., May 2, 2023 /PRNewswire/ -- Apyx
Medical Corporation (NASDAQ: APYX), the manufacturer of the
proprietary helium plasma and radiofrequency technology marketed
and sold as Renuvion®, today announced that it has
received 510(k) clearance from the U.S. Food and Drug
Administration ("FDA") for the use of its APR Handpiece in
procedures for coagulation of soft tissues following liposuction,
the most popular plastic surgery procedure in the world.
"We are thrilled to announce this newest
clearance, making Renuvion the only device cleared to be used after
liposuction procedures," said Todd
Hornsby, Executive Vice President. "This is the
4th 510(k) clearance we have received from the FDA
in the past 11 months and highlights our commitment to providing
evidence-based outcomes and clearances to further demonstrate the
safety and efficacy of our Renuvion technology."
Already cleared by the FDA for the treatment of
neck laxity, facial renewal procedures, and the contraction of soft
tissue, Renuvion's latest 510(k) clearance allows physicians to set
a new standard for liposuction results when it comes to minimally
invasive body contouring.
Liposuction effectively removes fat volume,
leaving behind empty space which may increase the appearance of
excess or loose skin. Renuvion goes beneath the surface and applies
precise energy directly to the source of the loose skin. This
energy contracts the collagen fibers and pulls the skin down,
closer to the muscle, for a more contoured appearance. By
adding Renuvion to these procedures, physicians have another tool
to help them obtain optimal liposuction results.
"Renuvion is a game changer in the field of
plastic surgery," said board certified plastic surgeon Dr.
Matthew J. Nykiel. "Using
Renuvion after liposuction allows patients, with minimal to
moderate skin redundancy, to attain high-definition results that
were once only available with skin excision. Renuvion and
liposuction is the gold standard for amazing body contouring
results."
For a list of physicians, by state, offering
Renuvion in their practice visit
https://RenuvionFinder.com. For more information visit
Renuvion.com.
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.
Media Contact:
Jane Sparango
Coterie Media (for Renuvion)
jane@coteriemedia.com
310-339-1214
Investor Relations Contact:
ICR Westwicke on behalf of Apyx Medical
Corporation
Mike Piccinino, CFA
investor.relations@apyxmedical.com
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SOURCE Renuvion