Bovie Medical Corporation (“Bovie” or the “Company”) (NYSE Amex: BVX), a manufacturer and marketer of electrosurgical products, today announced that the Company received 510k clearance from the Food and Drug Administration (FDA) to market its J-Plasma™ handpiece with retractable cutting feature for soft tissue coagulation during surgery. The handpiece will be powered by Bovie’s GS electrosurgical generator, which has prior 510k market clearance.
J-Plasma™ is formed by passing an inert gas, such as helium, over a sharp conductive point which is held at high voltage and high frequency, producing a luminous discharge beam. The sharp conductive point can also be in the form of a retractable surgical blade, providing multiple modes of operation in a single instrument. The extended surgical blade can be used for incisions and other cutting procedures, and when retracted, the blade is used to form the J-Plasma beam for coagulation. The extended blade can also be used in combination with the J-Plasma beam, providing an enhanced cutting capability with minimal impact on surrounding tissue.
The Company, assisted by leading surgeons, will introduce J-Plasma™ at selected hospital beta sites including several university teaching facilities, in preparation for a market launch later this year by its independent sales distribution network.
Bovie continues to explore and review added applications for J-Plasma™ which include gynecology, dermatology, plastic surgery, infection control, use in robotics and other surgical techniques.
Bovie Medical Corporation CEO Andrew Makrides commented, “This is a significant development toward Bovie becoming a leader in plasma surgery and achieving increased prominence in the electrosurgery marketplace.”
Bovie recently announced the granting of a United States patent for a “Method to generate a plasma stream for performing electrosurgery”, adding to the Company’s J-Plasma™ patent portfolio. Bovie has four patents related to its J-Plasma™ technology with three additional patent applications pending.
Cautionary Note on Forward-Looking Statements
Certain matters discussed in this news 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.