Apyx Medical Corporation Initiates Enrollment in Study Evaluating the Use of Renuvion® Technology in Skin Laxity Procedures in the Neck and Submental Region

This Week’s News in Review

This Week's News in Review! Medical Device News Magazine keeps our readers up-to-date on breaking industry news! Learn how Medical Device News Magazine can help...

New Research Shows Nearly Half of Elderly Suffer Decreased Mobility During Lockdown

In a survey of UK adults with parents over the age of 75, while over half (52%) of respondents remain worried about their parents catching Covid, 48 percent are concerned about parental loneliness, and 46 percent about their parents falling alone and not being able to get up or get help. This figure remained high even among those whose parents are in care homes, with 37% of respondents still most concerned about parents falling over.

American College of Cardiology Names Ravee Kurian COO/CFO

Kurian comes to ACC following a 20-year stint at Publicis Sapient, a leading technology and communications consultancy, where he led critical and sensitive digital transformation initiatives for Fortune 500 and U.S. federal clients.

Today Apyx Medical Corporation announced today that it has initiated subject enrollment in an 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, Chief Executive Officer. “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 5 investigational centers in the U.S. 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 1 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 1 day, 1 week, 1 month, 3 months, and 6 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 6 months as determined by qualitative 2D photography assessment performed by three blinded Independent Photographic Reviewers. The study design assumes a 75% success rate of subjects with correctly identified images; therefore, greater than 75% of subjects must have their 6-month images correctly identified by 2 out of 3 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 will be made available on clinicaltrial.gov under the Renuvion technology trade name “Apyx Plasma/RF Handpiece” in October 2019.



Dr Jonathan Slotkin Appointed to Peer Well Board of Directors

Alongside the appointment, PeerWell is launching its new clinical practice, PeerWell Health.

Zimmer Biomet Announces New Appointments to Executive Leadership Team

Wilfred van Zuilen Appointed as President of Europe, Middle East and Africa. Nitin Goyal, M.D. Appointed to Newly Created Role of Chief Science, Technology and Innovation Officer.

Subscribe to Medical Device News Magazine here.

Related Articles