Apyx Medical Corp. Announces Subject Enrollment Initiated in New Study Evaluating the Use of Renuvion® Technology in Dermal ...
December 03 2019 - 7:00AM
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 a U.S.
Investigational Device Exemption (IDE) clinical study evaluating
the use of its Renuvion technology in dermal resurfacing
procedures.
“The initiation of subject enrollment in this clinical study
marks the continued advancement of our regulatory strategy to
expand our addressable market opportunity in the U.S. cosmetic
surgery market by pursuing new clinical indications for target
procedures,” said Charlie Goodwin, Chief Executive Officer. “We
expect the data from this study to support our submission for a new
regulatory clearance that would enable us to market our Renuvion
technology for dermal resurfacing procedures.”
The study is a prospective, multi-center, single arm,
evaluator-blinded clinical study designed to demonstrate the safety
and effectiveness of Renuvion technology for use in dermal
resurfacing procedures. The study will be conducted at up to 5
investigation centers in the U.S. and consist of up to 55 subjects
who are at least 30 years of age and seeking a procedure to improve
facial appearance by reducing wrinkles and rhytides. Follow-up will
occur immediately following the procedure, at 1 day, 6 days, 10
days, 30 days, 90 days and 180 days.
The study’s primary effectiveness endpoint is the proportion of
subjects with at least a one-point improvement from baseline in the
Fitzpatrick Wrinkle and Elastosis Scale at 90 days, as determined
in a randomized order by at least 2 out of 3 blinded Independent
Photographic Reviewers (IPR). The primary effectiveness endpoint
will have been met if the proportion of subjects achieving at least
a one-point improvement, as determined by 2 out of 3 IPRs, is at
least 70%. The study’s primary and secondary safety endpoints will
be the evaluation of adverse events and the evaluation of the
change in pain and discomfort after treatment. The study also
includes additional endpoints which will be listed in an overview
of the study on clinicaltrials.gov.
An overview of the study will be made available on
clinicaltrials.gov under the Renuvion technology trade name
“Renuvion Dermal System” in December 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. 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20191203005167/en/
Investor Relations Contact:
Westwicke Partners on behalf of Apyx Medical Corporation Mike
Piccinino, CFA investor.relations@apyxmedical.com
Apyx Medical (NASDAQ:APYX)
Historical Stock Chart
From Aug 2024 to Sep 2024
Apyx Medical (NASDAQ:APYX)
Historical Stock Chart
From Sep 2023 to Sep 2024