BOVIE MEDICAL RECEIVES FDA 510(K) CLEARANCE FOR ITS ‘PLAZXACT™’ ABLATOR
-New bipolar ablator offers precision and safety for arthroscopic procedures using lower power settings
–Compatible with standard electrosurgical generators –
-Aligned with Bovie’s strategy to develop advanced energy products through focused R&D activities–
CLEARWATER, FL – (August 16, 2016) Bovie Medical Corporation (NYSEMKT: BVX), a maker of medical devices and supplies and the developer of J-Plasma®, a patented new surgical product, announced today that it has received 510(k) clearance from the Food and Drug Administration for its new bipolar ablator, branded ‘PlazXactTM, an innovative tool that offers surgeons precision and safety when performing arthroscopic procedures.
The PlazXactTM received clearance for the cutting, vaporization and coagulation of soft tissue during arthroscopic surgical procedures, and will operate with a standard saline irrigation solution. The device’s efficient tip design results in lower saline temperatures, and it has the advantage of being compatible with standard electrosurgical generators found in ambulatory surgical centers and hospital operating rooms.
“This new product launch demonstrates our R&D capabilities around advanced energy products, and PlazXactTM, like other Bovie products, features a high level of precision combined with the additional safety of lower power requirements,” said Robert L. Gershon, Chief Executive Officer. “We see an important market opportunity among orthopedic surgeons treating sports injuries and age-related joint damage, and we are confident that the PlazXactTM has the potential to become an important tool in a broad range of arthroscopic procedures. Currently, we are evaluating options for full commercialization of the product, including the potential for sales channel partnerships.”
“Over the course of the last two years, we have invested in further developing Bovie’s R&D capabilities to take advantage of opportunities within our existing product portfolio as well as to leverage our deep domain experience in the manufacture of advanced energy products. The PlazXactTMis our first entry into the arthroscopic surgery market, and we expect to launch additional growth products in 2017 and beyond,” Mr. Gershon concluded.
The PlazXactTM will be available with shaft diameters of 3.3mm, 2.4mm and 1.8mm, which will operate with electrode face angles of 90°, 50° and 60° respectively. The 3.3mm models will be available in both aspirating and non-aspirating versions, while all others will be available as non-aspirating versions only. For further information on the product, please visit the Bovie Medical website at www.boviemed.com.
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 www.boviemed.com.
Cautionary Statement on Forward-Looking Statements
Certain matters discussed in this 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 release can be found in the Company’s filing with the Securities and Exchange Commission including the Company’s Report on Form 10-K for the year ended December 31, 2015 and subsequent 10-Q filings. For forward-looking statements in this 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.
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