Apyx Medical Corp. Announces Subject Enrollment Initiated in Study Evaluating the Use of Renuvion® Technology in Skin Laxity...
October 14 2019 - 7:30AM
Business Wire
Apyx Medical Corporation, formerly Bovie Medical
Corporation, (NASDAQ:APYX) (the “Company”), a maker of medical
devices and supplies and the developer of its Helium Plasma
Technology, marketed and sold as Renuvion® in the cosmetic surgery
market and as J-Plasma® in the hospital surgical market, announced
today that it has initiated subject enrollment in an FDA approved
U.S. Investigational Device Exemption (IDE) clinical study
evaluating the use of its Renuvion technology in skin laxity
procedures in the neck and submental region.
“This clinical study is part of our strategy to expand the
portfolio of clinical support for our Renuvion technology and
pursue new clinical indications for cosmetic surgery procedures,”
said Charlie Goodwin, Chief Executive Officer. “We expect to use
data from the study to support our submission for a new regulatory
clearance that would expand our addressable market opportunity for
our Renuvion technology in the U.S. cosmetic surgery market.”
The study is a prospective, multi-center, multi-phase,
evaluator-blinded study designed to evaluate the safety and
effectiveness of Renuvion technology when used to improve the
appearance of lax tissue in the neck and submental region. The
study will be conducted at up to 5 investigational centers in the
U.S. and consist of 52 subjects ranging from 35 to 65 years of age.
The study will be conducted in two phases. Phase I will include 20
subjects, whose 1 month safety data will be reported to the FDA for
a safety review. Following approval from the FDA, phase II of the
study will be initiated, and will include 32 subjects.
Effectiveness data will be collected for all 52 subjects in both
phases of the study. Follow-up will occur 1 day, 1 week, 1 month, 3
months, and 6 months post procedure.
The study’s primary effectiveness endpoint will be improvement
in the appearance of lax tissue in the neck and submental region at
6 months as determined by qualitative 2D photography assessment
performed by three blinded Independent Photographic Reviewers. The
study design assumes a 75% success rate of subjects with correctly
identified images; therefore, greater than 75% of subjects must
have their 6-month images correctly identified by 2 out of 3
blinded Independent Photographic Reviewers. The study’s primary and
secondary safety variables will be the evaluation of post-treatment
pain and discomfort as reported by the subject on a visual analog
scale and the evaluation of adverse events, respectively.
An overview of the study will be made available on
clinicaltrial.gov under the Renuvion technology trade name “Apyx
Plasma/RF Handpiece” in October 2019.
About Apyx Medical
Corporation:
Apyx Medical Corporation (formerly Bovie 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 plastic surgeons, fascial plastic surgeons
and cosmetic 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 and
virtually eliminating 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.
Forward-looking information is 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 actual results to differ materially and that could impact
the Company and the statements contained in this release can be
found in the Company’s filings with the Securities and Exchange
Commission including the Company’s Report on Form 10-K for the year
ended December 31, 2018 and subsequent Form 10-Q filings. 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/20191014005161/en/
Investor Relations:
Westwicke Partners on behalf of Apyx Medical Corporation Mike
Piccinino, CFA investor.relations@apyxmedical.com
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