Apyx Medical Corporation Announces New Additions to Clinical and Regulatory Affairs Teams
31 July 2019 - 10:48PM
Business Wire
Kari Larson Appointed as Senior Director of
Clinical Studies; Libet Garber, Ph.D. Appointed as Global Director
of Regulatory Affairs
Apyx Medical Corporation, formerly Bovie
Medical Corporation, (NASDAQ:APYX) (the “Company”), a maker of
medical devices and supplies and the developer of Helium Plasma
Technology, which is marketed and sold as Renuvion® in the cosmetic
surgery market and J-Plasma® in the hospital surgical market, today
announced that the company has enhanced its clinical and regulatory
affairs teams with the appointment of Kari Larson and Libet Garber,
Ph.D. to the positions of Senior Director of Clinical Affairs and
Director of Global Regulatory Affairs, respectively.
“I’m very pleased to welcome Ms. Kari Larson and Dr. Libet
Garber to our clinical and regulatory affairs teams as they assume
these newly created leadership positions,” said Charlie Goodwin,
Chief Executive Officer. “Libet and Kari are both highly
experienced professionals, and we hope to leverage their strategic
insight and leadership capabilities as we evaluate and pursue new
specific clinical indications enabling us to market and sell
Renuvion for our target procedures and secure additional clinical
evidence demonstrating the safety and effectiveness of our Renuvion
technology in the cosmetic surgery market.”
Kari Larson - Senior Director of
Clinical Affairs:
Ms. Larson joins Apyx Medical with over 15 years of clinical
research experience at both healthcare companies and clinical
sites. Prior to joining Apyx Medical, Ms. Larson was the Director
of Clinical Research for Lutronic Global from 2017 until 2019 where
she was responsible for the execution and management of the
company’s U.S. clinical trials. Lutronic Global is a division of
Lutronic Corp., a global aesthetic laser company based in Korea and
listed on the KOSDAQ. From 2011 until 2017, she was the Senior
Director of Clinical Affairs for Ulthera, Inc. which was acquired
during her tenure by Merz North America, Inc., a Raleigh, North
Carolina based healthcare company focused on the aesthetics market.
While at Merz/Ulthera, she was instrumental in achieving soft
tissue lifting claims with the FDA for the Ultherapy System. From
2008 until 2011, Ms. Larson was a Manager of Clinical Applications
& Education for Myoscience, Inc., a privately held medical
device company based in Fremont, California developing targeted
peripheral nerve therapies to relieve acute and chronic pain. Prior
to joining Myoscience, Inc., she was a Manager involved in the
business startup and development of Premier Clinical Research, an
independent pharmaceutical research company based in Spokane,
Washington. Ms. Larson has worked in healthcare management since
1994 and held positions at dental, physician and hospital business
offices. She holds a B.A. in General Management and an M.B.A. from
Eastern Washington State University in Cheney, Washington.
Libet Garber, Ph.D. - Director of
Global Regulatory Affairs:
Prior to joining Apyx Medical, Dr. Garber led reviews of over
700 regulatory submissions (including complex De Novos,
Pre-Submissions, IDEs, PMAs and 510(k)s for multiple types of
devices) as a Master Scientific Reviewer at the U.S. Food and Drug
Administration’s Office of Device Evaluation from 2009 until 2019.
In her tenure with the FDA, Dr. Garber gained extensive regulatory
writing experience including authoring FDA guidance documents, and
developing pre-clinical test methods and clinical study designs for
novel devices that did not have existing performance standards. She
actively participated and led internal regulatory and clinical
strategy meetings, clinical seminars, and FDA advisory panel
assignments; interacting daily with industry sponsors and other
members of the medical community to provide scientific information
and consultation on agency guidelines and regulatory requirements
concerning medical devices. From 2007 until 2008, she worked for
Johns Hopkins University’s Applied Physics Laboratory as an
Electrical Engineer. Dr. Garber also worked as a research assistant
at Johns Hopkins University’s Cardiac Bioelectric Laboratory, from
2003 until 2006, and at the University of Miami’s Environmental
Engineering Laboratory from 2000 until 2001. She holds a B.S. and
M.S.E. in Biomedical Engineering from Johns Hopkins University in
Baltimore, Maryland, and a Ph.D. in Biomedical Engineering from the
University of Maryland in Baltimore, Maryland and was the recipient
of notable scholarships and grants, including Bill Gates
Undergraduate and Master Scholarships, NIH training grants and a
Sloan Foundation Fellowship.
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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20190731005555/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 Apr 2024 to May 2024
Apyx Medical (NASDAQ:APYX)
Historical Stock Chart
From May 2023 to May 2024