Bovie Medical Receives 510K Clearance For Its J-Plasma Precise Flex Handpiece

CLEARWATER, Fla.--(BUSINESS WIRE)--Bovie Medical (NYSE MKT:BVX) announced today that it has received 510K clearance from the FDA for a new J-Plasma® Precise Flex handpiece. The J-Plasma® Precise Flex handpiece is designed to be used in robotic-assisted procedures including those with Intuitive Surgical’s da Vinci Surgical System. The J-Plasma® Precise Flex includes Bovie Medical’s Cool-Coag™ technology that combines the unique benefits of J-Plasma®, namely increased precision with minimal thermal spread, with standard monopolar coagulation and helium spray coagulation capabilities, all in one handpiece.

The J-Plasma® Precise Flex handpiece has a flexible shaft that can be controlled with graspers, forceps or grasping instruments and was designed to be used through an accessory port. When used in robotic-assisted procedures, the J-Plasma® Precise Flex can be controlled entirely from a surgeon’s console using a robotic grasper which allows a surgeon the ability to access and visualize a wide variety of surgical planes.

“This new Precise Flex version of J-Plasma® offers surgeons the ability to use J-Plasma® in areas of the anatomy that otherwise couldn’t be reached with the laparoscopic version,” said Vipul Patel, M.D., Medical Director of Global Robotics Institute at Florida Hospital Celebration Health. “Combining this flexibility with the Cool-Coag™ technology may also allow the surgeon to complete all aspects of cutting, coagulating and ablating tissue with one instrument potentially reducing the need to use other instruments.”

“The clearance of the J-Plasma® Precise Flex is an important milestone for our company as part of our strategy to increase utilization of our innovative technologies in robotic surgery,” said Robert L. Gershon, Chief Executive Officer. “This clearance comes on the heels of the recently announced 510k clearances of both our Cool-Coag™ generator and our new open handpiece; together, the J-Plasma® Precise Flex handpiece and Cool-Coag™ technology allows surgeons to benefit from using a single device that offers greater control of tissue effect while being able to switch to a monopolar or helium spray coagulation mode from the robotic console. We look forward to a commercial launch of this innovative technology for use in both open and minimally invasive surgical procedures, including laparoscopic and robotic approaches in the second half of 2017.”

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 new plasma-based surgical product for cutting and coagulation. J-Plasma® utilizes a helium ionization process to produce a stable, focused beam of ionized gas that provides surgeons with greater precision, minimal invasiveness and an absence of conductive currents through the patient during surgery. 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®, Aaron®, IDS™ and ICON™) 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’s website www.boviemed.com.