Feb 01, 2012 - Bovie Medical Receives 510 K Clearances to Market J-Plasma Technology
Bovie Medical Corporation Receives 510 K Clearances to Market Patented J-Plasma Technology
MELVILLE, N.Y.--(BUSINESS WIRE)--Feb 1, 2012 - 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.
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 news 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, 2010. For forward-looking statements in this new release, the Company claims the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. The Company assumes no obligation to update or supplement any forward-looking statements whether as a result of new information, future events or otherwise.