Apyx Medical Corporation Announces Peer-Reviewed Clinical Publication Evaluating the Safety of Renuvion® Following Liposuction in Multiple Areas of the Body
January 22 2024 - 7:30AM
Business Wire
Analysis of data from 483 patients with a total
of 1,184 body areas treated found the use of Renuvion for
subcutaneous soft tissue contraction following liposuction
demonstrated no new or increased risks for any area of the body,
compared to the use of liposuction alone
Apyx Medical Corporation (Nasdaq: APYX) (“Apyx Medical;” the
“Company”), the manufacturer of a proprietary helium plasma and
radiofrequency technology marketed and sold as Renuvion®, today
announced the publication of a peer-reviewed article in the
Aesthetic Surgery Journal Open Forum, which evaluated the use of
Renuvion for contracting subcutaneous soft tissue following
liposuction in multiple areas of the body.
“We are excited to see the publication of this real-world
483-patient analysis, demonstrating Renuvion’s impressive safety
when used after liposuction, which is now the most commonly
performed cosmetic procedure in the world.,” said Charlie Goodwin,
President and Chief Executive Officer of Apyx Medical. “In 2023,
data from this analysis was used to secure FDA 510(k) clearance for
the use of our Renuvion APR Handpiece with an indication ‘for
coagulation of subcutaneous soft tissues following liposuction for
aesthetic body contouring.’ We are pleased the results of this
analysis are now available to the public, further strengthening the
large portfolio of published clinical evidence supporting the use
of our Renuvion technology.”
The publication’s authors, Shridharani, MD, FACS et al.,
conducted an analysis of 6 published retrospective studies,
evaluating real-world data from 483 patients who were treated with
Renuvion for the contraction of the subcutaneous soft tissue
following liposuction on a total of 1,184 areas of the body,
including the abdomen, arms, back, buttocks, breast/axilla, face,
hips/flanks, legs and neck. Their objective was to examine the
practice of using Renuvion post-liposuction for contracting
subcutaneous soft tissue in these body areas and evaluate whether
its use posed any new or additional risks, compared to the use of
liposuction alone. Their analysis evaluated adverse event rates for
procedures performed with Renuvion on each part of the body,
comparing them to adverse event rates for the use of liposuction
alone sourced from a published systematic review of liposuction
safety studies.
Based on this analysis, the authors found that the use of
Renuvion following liposuction for any particular area of the body
demonstrated no new or increased risks, compared to published data
for patients having liposuction performed alone. Additionally, they
concluded that the risks associated with the use of Renuvion for
subcutaneous soft tissue contraction following liposuction do not
differ significantly by body area. The authors noted that there are
currently no alternative therapies to Renuvion cleared by the U.S.
Food and Drug Administration (“FDA”) which can claim use following
liposuction for the purpose of contracting the subcutaneous soft
tissue.
A digital version of the clinical publication is available via
the following link: https://doi.org/10.1093/asjof/ojad112
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, 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 (the “FDA”), 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 FDA and other governmental and regulatory bodies, both
domestically and internationally; the impact of the March 14, 2022
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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
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Investor Relations: ICR
Westwicke on behalf of Apyx Medical Corporation Mike Piccinino, CFA
investor.relations@apyxmedical.com
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