BOVIE MEDICAL CORPORATION ANNOUNCES ENROLLMENT OF FIRST PATIENT IN J-PLASMA® DERMAL RESURFACING CLINICAL STUDY
CLEARWATER, FL — January 23, 2018 – Bovie Medical Corporation (NYSEMKT:BVX) (the “Company”), a maker of medical devices and supplies and the developer of J-Plasma®, a patented new surgical product, today announced that it has enrolled the first patient in a U.S. Investigational Device Exemption (IDE) clinical study of its J-Plasma technology for use in dermal skin resurfacing.
The clinical study is a multi-center, single arm, evaluator-blind prospective study evaluating the safety and efficacy of Bovie Medical’s J-Plasma technology for the reduction of facial wrinkles and rhytides. The study will be conducted at up to five investigational centers and will enroll 55 eligible subjects. Enrolled study subjects will receive one procedure with the Company’s J-Plasma technology at enrollment and wrinkle severity will be assessed using the Fitzpatrick Wrinkle and Elastosis Scale (FWS) at baseline and at each follow-up time point. The first patient was enrolled with Dr. J. David Holcomb at the Institute for Integrated Aesthetics in Sarasota, Florida.
“At Bovie Medical, our long-term clinical strategy is focused on expanding J-Plasma’s clinical indications for use in the aesthetics market, beginning with dermal skin resurfacing procedures,” said Charlie Goodwin, Chief Executive Officer. “Enrolling the first patient in our dermal skin resurfacing clinical study is an important milestone towards this long-term strategy. The Company intends to use data from this study to demonstrate the safety and efficacy of our J-Plasma technology to support our planned 510(k) submission to the U.S. Food and Drug Administration for an indication to market and sell J-Plasma for use in dermal resurfacing procedures.”
As of the publication of this release, additional details on the study may be found at:
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 plasma-based surgical product for cutting, coagulation and ablation of soft tissue. J-Plasma® utilizes a helium ionization process to produce a stable, focused beam of plasma that provides surgeons with greater precision, minimal invasiveness and an absence of conductive currents through the patient during surgery. The new J-Plasma® handpieces with Cool-Coag™ technology deliver the precision of helium plasma energy, the power of traditional monopolar coagulation and the efficiency of plasma beam coagulation – enabling thin-layer ablation and dissection and fast coagulation with a single instrument, minimizing instrument exchange and allowing a surgeon to focus on their patient and their procedures. With Cool-Coag technology, the new J-Plasma handpieces can deliver three distinctly different energy modalities – further increasing the utility and versatility of the J-Plasma system. 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®, IDS™ and DERM™) 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 at 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 filings with the Securities and Exchange Commission including the Company’s Report on Form 10-K for the year ended December 31, 2016 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.
Investor Relations Contact:
Westwicke Partners on behalf of Bovie Medical Corporation
Mike Piccinino, CFA