Apyx Medical Receives 510(k) Clearance for Next-Generation J-Plasma® Precise Handpiece

Apyx Medical Corporation received U.S. Food and Drug Administration (FDA) 510(k) clearance to market and sell its next-generation J-Plasma Precise Handpiece.

The Company’s J-Plasma handpieces are indicated for cutting, coagulation and ablation of soft tissue during open and laparoscopic surgical procedures. The original and next-generation of this J-Plasma Precise Handpiece is designed specifically for use in laparoscopic surgical procedures. Importantly, this next-generation handpiece incorporates the Company’s Cool-Coag® Technology, enhancing its utility by enabling surgeons to alternate between delivering precise, tissue-sparing J-Plasma energy, standard monopolar coagulation energy, and a non-contact ‘spray’ called Plasma Beam Coagulation, in the same handpiece. This next-generation handpiece is also 39% lighter than its predecessor for improved ergonomics.

“We are pleased to announce the receipt of 510(k) clearance for our next-generation J-Plasma Precise Handpiece. It is an important achievement for our Company that was made possible by the efforts of both our Research and Development and Regulatory Affairs teams,” said Charlie Goodwin, Chief Executive Officer. “This next-generation J-Plasma Precise Handpiece was designed in response to demand from our surgeon customers outside the U.S. These customers requested a handpiece designed for use in laparoscopic surgery procedures that would enable them to deliver the precision of J-Plasma energy as well as the power of a monopolar coagulation waveform when needed for wider areas of coagulation. In response to this demand, we leveraged our research & development and manufacturing expertise to create this next-generation version of our J-Plasma Precise Handpiece, which features our Cool-Coag® Technology and enhanced ergonomics. We look forward to beginning a limited launch of this product in Europe later this quarter.”

About Apyx Medical Corporation

Apyx Medical Corporation (formerly Bovie Medical Corporation) is an advanced energy technology company with a passion for elevating people’s lives through innovative products in the cosmetic and surgical markets. Known for its innovative Helium Plasma Technology, Apyx is solely focused on bringing transformative solutions to the physicians and patients it serves. The company’s Helium Plasma Technology is marketed and sold as Renuvion® in the cosmetic surgery market and J-Plasma® in the hospital surgical market. Renuvion offers plastic surgeons, fascial plastic surgeons and cosmetic physicians a unique ability to provide controlled heat to the tissue to achieve their desired results. The J-Plasma system allows surgeons to operate with a high level of precision and virtually eliminating unintended tissue trauma. The Company also leverages its deep expertise and decades of experience in unique waveforms through original equipment manufacturing (OEM) agreements with other medical device manufacturers. For further information about the Company and its products, please refer to the Apyx Medical Corporation website at www.ApyxMedical.com.

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