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

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

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.

Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

Stay Connected


Don't Miss

Hinge Health Acquires the Most Advanced Computer Vision Technology for Tracking Human Motion

CEO Daniel Perez explained, “We won’t stop investing in technology to deliver the most patient-centered digital clinic that improves member experience and outcomes while reducing costs. wrnch allows us to take a giant leap forward in all respects.”

Dale W Wood Congratulates the Huma Team on Raising $130 Million

Major health and technology companies across the world have committed upwards of $130 million to Huma Therapeutics, the health-tech company backed by Dale Ventures.

Rhaeos Awarded $4 Million NIH SBIR Grant

Under the NIH SBIR grant, Rhaeos will leverage their existing wireless sensor hardware to provide additional quantitative flow data to the clinician, giving insight into this currently inaccessible and highly relevant shunt performance metric.

Gynesonics Announces FDA Clearance of Next Generation Sonata System

“This clearance brings significant system improvements that expand the location of fibroids that can be treated while allowing the physician to control all aspects of the treatment from within the sterile field,” said Jiayu Chen, Ph.D. Vice President, Engineering and Advanced Technologies at Gynesonics.

Blackrock Neurotech Invests In Groundbreaking Auditory Nerve Implant With University Of Minnesota And MED-EL

The new investment will enable the development and translation of a new ANI through preclinical studies and later, a pilot clinical trial, where the ANI is then implanted in up to three deaf patients.

Jonathan Chapman: New President/CEO of Trividia Health

Chapman said, “I’m honored to join the Trividia team as President and CEO. This organization has a long history of leadership within the healthcare industry as a provider of accurate, accessible, and affordable point-of-care solutions for the management of diabetes.”

SOLOPASS® System (Bedside Neuro-Navigation Device) Receives FDA 510(k) Clearance

inTRAvent’s SOLOPASS® system brings simple, portable, bedside neuro-navigation into the intensive care unit.

Skyhawk Therapeutics Completes New Investment Round

A $133 million round of investment will allow Skyhawk to accelerate development of its novel small molecule RNA-modifying drug candidates into the clinic.

By using this website you agree to accept Medical Device News Magazine Privacy Policy