Bovie Medical Corporation Appoints Director of Regulatory Affairs

Bovie Medical Corporation, a maker of medical devices and supplies and the developer of J-Plasma, has appointed Dr. Topaz J. Kirlew as director of Regulatory Affairs.
 
“Dr. Kirlew joins Bovie Medical with more than 25 years of experience in the healthcare industry in a variety of regulatory, clinical and other managerial positions for public and private companies, as well as academic institutions,” said Charlie Goodwin, CEO. “We are excited to add her to our team, and expect to benefit from her strategic guidance and expertise as we focus on obtaining new clinical indications for our J-Plasma technology in the cosmetic surgery market.”
 
Prior to joining Bovie Medical, Kirlew worked for nearly five years at Beckman Coulter Inc., a subsidiary of Danaher Corporation. She joined Beckman Coulter in 2013 as senior manager of Regulatory Affairs, where her responsibilities included developing the company’s regulatory strategy and managing the U.S. and international regulatory submissions for its in-vitro diagnostic products. She was promoted in 2015 to director of Post Market Quality & Regulatory, where she led all post-market quality and regulatory functions for Beckman Coulter’s in-vitro diagnostic products.
 
From 2004 until 2013, she was the vice president of Quality, Regulatory and Clinical Affairs at TissueTech, a privately-held biotechnology company focused on regenerative medicine, and its subsidiary Bio-Tissue. During her nine-year tenure at TissueTech, Kirlew managed several Phase I trials for the company’s biologic products, developed the internal operational procedures for clinical trial management and prepared and submitted two investigational new drug applications and two requests for orphan drug designation that were successfully cleared by the U.S. Food and Drug Administration. Kirlew also assisted in TissueTech’s product development and successful commercialization of a Class II combination medical device. From 2002 to 2003, she was the associate vice president of Clinical, Regulatory and Quality for Bioheart Inc., a privately-held company biotechnology company developing stem cell therapies, where she designed and wrote the company’s Phase II Clinical Trial for a Class III medical device.
 
Beginning in 1997, Kirlew worked for five years at the University of Miami School of Medicine’s Diabetes Research Institute, where she was general manager of its cGMP Human Cell Processing Facility. In this role, she directed the operational and strategic development of this facility and advanced its program for islet cell therapy from Phase I through Phases II and III of clinical trials. Prior to 1997, she held a series of positions of increasing responsibility for institutions including the American Red Cross, Georgetown University Hospital, the National Institute of Health, and University of Maryland Medical Center.
 
Kirlew has a bachelor of science degree in medical technology from Florida International University, as well as an MBA and a doctor of business administration degree with a specialty in health sciences, both from the School of Business & Entrepreneurship at Nova Southeastern University.
 
Bovie Medical Corporation is a maker of medical devices and supplies as well as the developer of J-Plasma, a patented plasma-based surgical product for cutting, coagulation and ablation of soft tissue. J-Plasma utilizes a helium ionization process to produce a stable, focused beam of plasma that provides surgeons with greater precision, minimal invasiveness and an absence of conductive currents through the patient during surgery. The new J-Plasma handpieces with Cool-Coag technology deliver the precision of helium plasma energy, the power of traditional monopolar coagulation and the efficiency of plasma beam coagulation—enabling thin-layer ablation and dissection and fast coagulation with a single instrument, minimizing instrument exchange and allowing a surgeon to focus on their patient and their procedures. With Cool-Coag technology, the new J-Plasma handpieces can deliver three distinctly different energy modalities—further increasing the utility and versatility of the J-Plasma system. Bovie Medical Corporation also manufactures electrosurgical products and technologies, marketed through both private labels and the company’s own brands (Bovie, IDS and DERM) to distributors worldwide. The company also leverages its expertise through original equipment manufacturing (OEM) agreements with other medical device manufacturers.