APYX MEDICAL CORPORATION RECEIVES 510(K) CLEARANCE FOR NEXT-GENERATION J-PLASMA® PRECISE HANDPIECE DESIGNED FOR LAPAROSCOPIC SURGERY
CLEARWATER, FL — August 5, 2019 – Apyx Medical Corporation, formerly Bovie Medical Corporation, (NASDAQ:APYX) (the “Company”), a maker of medical devices and supplies and the developer of its Helium Plasma Technology, marketed and sold as Renuvion® in the cosmetic surgery market and J-Plasma® in the hospital surgical market, announced today that it 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.”
Investor Relations Contact:
Westwicke Partners on behalf of Apyx Medical Corporation
Mike Piccinino, CFA
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.
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 filings with the Securities and Exchange Commission including the Company’s Report on Form 10-K for the year ended December 31, 2018 and subsequent Form 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.