Healthcare Industry News:  Bovie 

Devices Regulatory FDA

 News Release - October 28, 2008

Bovie Medical Corporation Announces CE Mark and Submission of 510(K) Application for SEER Tissue Resection Device; Commences SEER Shipments in European Union

MELVILLE, N.Y.--(HSMN NewsFeed)--Bovie Medical Corporation (the “Company”) (NYSE Alternext US: BVX), a manufacturer and marketer of electrosurgical products, today announced a CE Mark for its SEER tissue resection device intended for initial use in liver oncology surgery, allowing for the sale of the device in the European Union (EU) and all countries recognizing the CE Mark. The Company will immediately commence shipping the SEER to customers in the EU through its previously established network of distributors.

Additionally, the Company reported that it filed a 510(k) pre-market notification application to the U.S. Food and Drug Administration (FDA) requesting regulatory clearance for the SEER.

Bovie Medical Corporation also received 510(k) clearance from the FDA to market its ICON GP generator to be used in general surgery and in conjunction with Bovie’s Polarian vessel sealing instruments. As of this date, a 510K application has not been filed for the Polarian instruments.

Andrew Makrides, president of Bovie stated, “These are significant milestones and are testaments to Bovie’s continued commitment to be an innovative player in the field of medical equipment. The Company is progressing in the development of its Polarian vessel sealing device and is developing prototypes for additional areas of surgery for the SEER. We believe the Polarian and the SEER product lines target new and significantly larger markets for Bovie.

As previously stated, discussions continue with larger companies regarding possible strategic partnerships involving some of the Company’s new product efforts.”

This document may contain some forward looking statements, particularly regarding operational prospects in 2008 and beyond, which involve a number of risks and uncertainties that could cause actual results to differ materially. These risks are listed from time to time in the Company’s SEC filings. www.Boviemedical.com


Source: Bovie Medical

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