CLEARWATER, Fla.--(BUSINESS WIRE)--Bovie Medical Corporation (NYSEMKT:BVX) (the "Company"), a maker of medical devices and supplies and the developer of J-Plasma®, a patented new surgical product, today announced the appointment of 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, Chief Executive Officer. “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, Dr. 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, Dr. 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. Dr. 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, Dr. 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.
Dr. Kirlew holds 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.
About Bovie Medical Corporation:
Bovie Medical Corporation is a leading 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 is also a leader in the manufacture of a range of electrosurgical products and technologies, marketed through both private labels and the Company’s own well-respected 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. For further information about the Company’s current and new products, please refer to the Investor Relations section of Bovie Medical Corporation at www.boviemed.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, 2016 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.