MissionIR News - Bovie Medical Corp. Receives 510K Clearance for J-Plasma™ Handpiece

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FDA’s 510k clearance allows Bovie to market handpiece and advance in electrosurgery marketplace

This is a significant development toward Bovie becoming a leader in plasma surgery and achieving increased prominence in the electrosurgery marketplace.

MissionIR would like to highlight Bovie Medical Corp., a publicly traded company actively engaged in the business of manufacturing and marketing a variety of electrosurgical medical products as well as developing related technologies and products. Recently, greater effort and resources have been directed towards manufacturing electrosurgical generators which are primarily used for outpatient surgical procedures.

In the company’s news yesterday,

Bovie Medical Corp. announced it has received 510k clearance from the U.S. Food and Drug Administration (FDA) to market its J-Plasma™ handpiece with retractable cutting feature to be used for soft tissue coagulation during surgery.

The J-Plasma handpiece will be powered by Bovie’s GS electrosurgical generator, which has also previously obtained 510k market clearance.

“This is a significant development toward Bovie becoming a leader in plasma surgery and achieving increased prominence in the electrosurgery marketplace,” Bovie CEO Andrew Makrides stated in the press release.

Bovie recently received a United States patent for a “Method to generate a plasma stream for performing electrosurgery,” adding to the company’s J-Plasma™ patent portfolio of four patents and three additional patent applications pending.

Bovie said it will continue to explore and review added applications for J-Plasma, which include gynecology, dermatology, plastic surgery, infection control, use in robotics, and other surgical techniques. In addition, it plans to introduce J-Plasma at selected hospital beta sites and several university teaching facilities to prepare for market launch later this year.

The J-Plasma device passes an inert gas such as helium over a sharp conductive point that produces a luminous discharge beam. This sharp conductive point can also be in the form of a retractable surgical blade, which can be used for incisions and other cutting procedures; when retracted, the blade is used to form the J-Plasma beam for coagulation.

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Forward-Looking Statement:
This release may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All forward-looking statements are inherently uncertain as they are based on current expectations and assumptions concerning future events or future performance of the company. Readers are cautioned not to place undue reliance on these forward-looking statements, which are only predictions and speak only as of the date hereof. Risks and uncertainties applicable to the company and its business could cause the company's actual results to differ materially from those indicated in any forward-looking statements.

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