Exclusive Apyx Medical Device Delivers
State-Of-The-Art Plasma Energy To Improve Appearance of
Loose Skin on The Neck and Chin Available for
Physicians and Patients
CLEARWATER, Fla., July 18,
2022 /PRNewswire/ -- Apyx Medical Corporation
(NASDAQ: APYX), the manufacturer of Renuvion®, a proprietary helium
plasma and radiofrequency technology, announces the receipt of
510(k) clearance from the U.S. Food and Drug Administration ("FDA")
for the use of Renuvion for use in subcutaneous dermatological and
aesthetic procedures to improve the appearance of lax skin in the
neck and submental region. This clearance offers a new option for
physicians and patients to improve loose skin on the neck and
submental region.
With this clearance Renuvion is the only product that is
FDA-cleared to improve the appearance of loose skin on the neck and
chin. Renuvion's patented technology offers a game-changing option
in cosmetic surgery for neck laxity procedures.
Loss of jawline definition with age is inevitable and can add
years to one's appearance. Renuvion provides a minimally-invasive
and cost-effective option with minimal downtime. The results reveal
a more contoured and smoother neck and jawline.
Within the fat layer beneath the skin, there is a web-like
structure of collagen fibers. These fibers provide support
and elasticity to the skin itself. Age, weight fluctuations, and
sun exposure contribute to the breakdown of these fibers, causing
the skin to sag. Surface treatments often can't delivery
energy deep enough to effectively treat these fibers, and invasive
surgery can be painful and is associated with having a long
downtime. The Renuvion energy is used in a minimally-invasive
procedure to directly treat the collagen fibers and address the
root cause of neck and chin laxity.
"We are very pleased to receive FDA clearance enabling Apyx
Medical's Renuvion technology to be used in neck and chin
laxity procedures," said Charlie
Goodwin, President and Chief Executive Officer.
"We've seen a considerable uptick in the market for these cosmetic
procedures and are thrilled to be able to offer our unique
technology to physicians and their patients to meet this growing
demand – it's the next generation option for neck contouring
procedures."
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 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 surgeons and 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 while minimizing
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.
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.
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