Business Wire11.21.19
Apyx Medical Corporation, formerly Bovie Medical Corporation, a maker of medical devices and supplies and the developer of its Helium Plasma Technology, has initiated subject enrollment in a U.S. Food and Drug Administration (FDA)-approved U.S. Investigational Device Exemption (IDE) clinical study evaluating the use of its Renuvion technology in skin laxity procedures in the neck and submental region.
“This clinical study is part of our strategy to expand the portfolio of clinical support for our Renuvion technology and pursue new clinical indications for cosmetic surgery procedures,” said Charlie Goodwin, CEO. “We expect to use data from the study to support our submission for a new regulatory clearance that would expand our addressable market opportunity for our Renuvion technology in the U.S. cosmetic surgery market.”
The study is a prospective, multi-center, multi-phase, evaluator-blinded study designed to evaluate the safety and effectiveness of Renuvion technology when used to improve the appearance of lax tissue in the neck and submental region. The study will be conducted at up to five investigational centers in the United States and consist of 52 subjects ranging from 35 to 65 years of age. The study will be conducted in two phases. Phase I will include 20 subjects, whose one month safety data will be reported to the FDA for a safety review. Following approval from the FDA, phase II of the study will be initiated, and will include 32 subjects. Effectiveness data will be collected for all 52 subjects in both phases of the study. Follow-up will occur one day, one week, one month, three months, and six months post procedure.
The study’s primary effectiveness endpoint will be improvement in the appearance of lax tissue in the neck and submental region at six months as determined by qualitative 2D photography assessment performed by three blinded Independent photographic reviewers. The study design assumes a 75 percent success rate of subjects with correctly identified images; therefore, greater than 75 percent of subjects must have their six-month images correctly identified by two out of three blinded independent photographic reviewers. The study’s primary and secondary safety variables will be the evaluation of post-treatment pain and discomfort as reported by the subject on a visual analog scale and the evaluation of adverse events, respectively.
An overview of the study is available on clinicaltrial.gov under the Renuvion technology trade name “Apyx Plasma/RF Handpiece.”
Apyx Medical Corporation (formerly Bovie Medical Corporation) is an advanced energy technology company with a passion for elevating people’s lives through products in the cosmetic and surgical markets. Known for its Helium Plasma Technology, Apyx is solely focused on bringing 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 an 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 expertise and decades of experience in waveforms through original equipment manufacturing (OEM) agreements with other medical device manufacturers.
“This clinical study is part of our strategy to expand the portfolio of clinical support for our Renuvion technology and pursue new clinical indications for cosmetic surgery procedures,” said Charlie Goodwin, CEO. “We expect to use data from the study to support our submission for a new regulatory clearance that would expand our addressable market opportunity for our Renuvion technology in the U.S. cosmetic surgery market.”
The study is a prospective, multi-center, multi-phase, evaluator-blinded study designed to evaluate the safety and effectiveness of Renuvion technology when used to improve the appearance of lax tissue in the neck and submental region. The study will be conducted at up to five investigational centers in the United States and consist of 52 subjects ranging from 35 to 65 years of age. The study will be conducted in two phases. Phase I will include 20 subjects, whose one month safety data will be reported to the FDA for a safety review. Following approval from the FDA, phase II of the study will be initiated, and will include 32 subjects. Effectiveness data will be collected for all 52 subjects in both phases of the study. Follow-up will occur one day, one week, one month, three months, and six months post procedure.
The study’s primary effectiveness endpoint will be improvement in the appearance of lax tissue in the neck and submental region at six months as determined by qualitative 2D photography assessment performed by three blinded Independent photographic reviewers. The study design assumes a 75 percent success rate of subjects with correctly identified images; therefore, greater than 75 percent of subjects must have their six-month images correctly identified by two out of three blinded independent photographic reviewers. The study’s primary and secondary safety variables will be the evaluation of post-treatment pain and discomfort as reported by the subject on a visual analog scale and the evaluation of adverse events, respectively.
An overview of the study is available on clinicaltrial.gov under the Renuvion technology trade name “Apyx Plasma/RF Handpiece.”
Apyx Medical Corporation (formerly Bovie Medical Corporation) is an advanced energy technology company with a passion for elevating people’s lives through products in the cosmetic and surgical markets. Known for its Helium Plasma Technology, Apyx is solely focused on bringing 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 an 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 expertise and decades of experience in waveforms through original equipment manufacturing (OEM) agreements with other medical device manufacturers.
