Business Wire06.22.18
Bovie Medical Corporation, a maker of medical devices and supplies and the developer of J-Plasma, has completed enrollment for the U.S. Investigational Device Exemption (IDE) clinical study of its J-Plasma/Renuvion technology for use in dermal skin resurfacing.
“We are excited to announce that we have enrolled the final patient in our dermal skin resurfacing study, which represents another important development in our strategy to build clinical support for our Renuvion technology and expand its clinical indications for use in the cosmetic surgery market,” said Charlie Goodwin, CEO. “We look forward to sharing the findings of this study, which we expect will provide support for our planned 510(k) submission to the U.S. Food and Drug Administration for an indication to market and sell J-Plasma/Renuvion for use in dermal resurfacing procedures.”
The clinical study is a multi-center, single arm, evaluator-blind prospective study evaluating the safety and efficacy of Bovie Medical’s J-Plasma/Renuvion technology for the reduction of facial wrinkles and rhytides. The study is being conducted at three investigational centers and consists of 55 subjects. Enrolled study subjects will receive one procedure with the Company’s J-Plasma/Renuvion 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.
Bovie Medical Corporation is a maker of medical devices and supplies as well as the developer of J-Plasma (marketed and sold under the Renuvion™ Cosmetic Technology brand in the cosmetic surgery market), a patented plasma-based surgical product for cutting, coagulation and ablation of soft tissue. J-Plasma/Renuvion technology utilizes a helium ionization process to produce a stable, focused beam of plasma that provides surgeons with greater precision, and minimal invasiveness. The new J-Plasma/Renuvion 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/Renuvion handpieces can deliver three distinctly different energy modalities—further increasing the utility and versatility of the system. Bovie Medical Corporation also manufactures a range of electrosurgical products and technologies, marketed through both private labels and the company’s own 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.
“We are excited to announce that we have enrolled the final patient in our dermal skin resurfacing study, which represents another important development in our strategy to build clinical support for our Renuvion technology and expand its clinical indications for use in the cosmetic surgery market,” said Charlie Goodwin, CEO. “We look forward to sharing the findings of this study, which we expect will provide support for our planned 510(k) submission to the U.S. Food and Drug Administration for an indication to market and sell J-Plasma/Renuvion for use in dermal resurfacing procedures.”
The clinical study is a multi-center, single arm, evaluator-blind prospective study evaluating the safety and efficacy of Bovie Medical’s J-Plasma/Renuvion technology for the reduction of facial wrinkles and rhytides. The study is being conducted at three investigational centers and consists of 55 subjects. Enrolled study subjects will receive one procedure with the Company’s J-Plasma/Renuvion 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.
Bovie Medical Corporation is a maker of medical devices and supplies as well as the developer of J-Plasma (marketed and sold under the Renuvion™ Cosmetic Technology brand in the cosmetic surgery market), a patented plasma-based surgical product for cutting, coagulation and ablation of soft tissue. J-Plasma/Renuvion technology utilizes a helium ionization process to produce a stable, focused beam of plasma that provides surgeons with greater precision, and minimal invasiveness. The new J-Plasma/Renuvion 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/Renuvion handpieces can deliver three distinctly different energy modalities—further increasing the utility and versatility of the system. Bovie Medical Corporation also manufactures a range of electrosurgical products and technologies, marketed through both private labels and the company’s own 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.