Bovie Medical Receives FDA Approval for New Generator

Bovie Medical Corporation has received U.S. Food and Drug Administration (FDA) 510(k) approval for the Bovie Ultimate generator.

The Bovie Ultimate is a high frequency electrosurgical generator that can be used for delivery of radio frequency energy and/or helium gas plasma to cut, coagulate and ablate soft tissue during open and laparoscopic surgical procedures. The generator offers users monopolar, bipolar and plasma features, including one J-Plasma helium gas outlet, in a single generator, the company noted in a news release. Its pad-sensing system reduces the risk of patient burns, but this feature is not required when using helium gas mode for soft tissue coagulation. The Bovie Ultimate replaces Bovie’s ICON GS plasma system.

“We are pleased to have received FDA approval for this leading edge product, which combines J-Plasma technology with the highest wattage operating room electrosurgical generator,” CEO Robert L. Gershon said. “We designed the Bovie Ultimate to provide medical practitioners with greater flexibility, including the ability to easily incorporate our J-Plasma product. This is an excellent illustration of our strategy to leverage synergies between our core product and J-Plasma businesses to drive future revenue growth.”

Based in Clearwater, Fla., Bovie Medical Corporation manufactures and supplies medical devices. Its J-Plasma surgical product uses a gas ionization process that produces 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 also manufactures a range of electrosurgical products and technologies, marketed through both private labels and the company’s own brands (Bovie, Aaron, IDS and ICON) to distributors worldwide.

For full year 2014, Bovie’s total sales were $27.7 million, up 17 percent from $23.7 million in 2013. Gross profit was $9 million, down slightly from the previous year’s gross profit of $9.2 million. Adjusted gross margin, which excludes costs related to excess and obsolete inventory and other adjustments, was 40.7 percent, an increase of nearly 2 percent from the 38.9 percent adjusted margin recorded in 2013.