Apyx Medical Adds to its Clinical and Regulatory Affairs Teams

Apyx Medical Corporation, formerly Bovie Medical Corporation, a maker of medical devices and supplies and the developer of Helium Plasma Technology, 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, CEO. “Libet and Kari are both 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.”

Larson joins Apyx Medical with over 15 years of clinical research experience at both healthcare companies and clinical sites. Prior to joining Apyx Medical, 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, N.C.-based healthcare company focused on the aesthetics market. While at Merz/Ulthera, she was instrumental in achieving soft tissue lifting claims with the U.S. Food and Drug Administration (FDA) for the Ultherapy System. From 2008 until 2011, Larson was a manager of Clinical Applications & Education for Myoscience Inc., a privately held medical device company based in Fremont, Calif., 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, Wash. Larson has worked in healthcare management since 1994 and held positions at dental, physician and hospital business offices. She earned a bachelor of arts degree in general management and an MBA from Eastern Washington State University in Cheney, Wash.
 
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 FDA’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 earned a bachelor of science degree and MSE in biomedical engineering from Johns Hopkins University in Baltimore, Md., and a Ph.D. in biomedical engineering from the University of Maryland in Baltimore, and was the recipient of notable scholarships and grants, including Bill Gates Undergraduate and Master Scholarships, NIH training grants and a Sloan Foundation Fellowship.
 
Apyx Medical Corporation (formerly Bovie Medical Corporation) is an advanced energy technology company known for its 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 expertise and experience in unique waveforms through original equipment manufacturing (OEM) agreements with other medical device manufacturers.