Study assessed efficacy, safety and satisfaction of patients receiving Rotational Fractional Resection (RFR) for the improvement of submental contour
SAN DIEGO, May 20, 2019 /PRNewswire/ -- Recros Medica, Inc. today announced positive 90-day results from its CONFORM study assessing the efficacy, safety and patient satisfaction of Rotational Fractional Resection (RFR) procedure for submental contouring. RFR is a novel, proprietary alternative to traditional approaches to treat skin laxity (loose skin). The study results were revealed at a scientific presentation by Hema Sundaram, MD, FAAD at the 2019 American Society for Aesthetic Plastic Surgery (ASAPS) meeting.
In the CONFORM study, adults with mild to moderate skin laxity (loose skin) and excess fat were treated to improve submental contouring (neck and jawline area) At baseline, 99% of subjects were dissatisfied with their neck and jawline appearance, while at 7-days after a single RFR procedure, 84% were now satisfied. Satisfaction with the appearance of the neck and jawline persisted and at the 90-day timepoint was 82% which represented a statistically significant change from baseline. In addition, 94% of patients at Day 90, indicated they were likely to recommend this procedure to friends and family.
"The initial results we have seen from the CONFORM study are promising," commented Dr. Sundaram. "In addition to presenting favorable safety and satisfaction profiles, RFR demonstrated visible improvements when assessed by independent, blinded physician evaluators not affiliated with the clinical trial. These physicians were able to identify 95% of Day 90 post-treatment images compared to baseline photographs. Digital image analysis performed by Canfield Scientific provided quantitative correlation with these blinded evaluations, indicating that 72% of treated patients had a significant reduction in measured surface area."
The most common adverse events related to the RFR procedure included: bruising (16%), erythema (6%), contact dermatitis (6%), hypoesthesia (6%) and bleeding (4%) at the treatment site. The safety of RFR has been demonstrated by showing that there were no serious device- or procedure-related adverse events.
About CONFORM and RFR
CONFORM was a multicenter study undertaken to evaluate the efficacy and safety of a new tissue contouring technology, Rotational Fractional Resection (RFR), for the improvement of submental contour. RFR uses small rotating, cylindrical scalpets to resect lax skin and a small lipectomy cannula to perform focal lipectomy through fractionally resected access ports. The procedure is performed with aseptic technique under local anesthesia, typically in an office-based treatment room equipped for an ambulatory procedure. An elastic adhesive membrane, applied immediately after the procedure, helps achieve directional closure of the resected sites to facilitate post-procedural recovery and optimize contouring results.
About Recros Medica, Inc.
Recros Medica, a privately held company focused on the research and development of aesthetic products to enhance appearance. The company was co-founded in 2014 by Edward Knowlton, MD, a board-certified plastic surgeon who invented Thermage® and the Viveve System. Dr. Knowlton's newest invention, Rotational Fractional Resection, is a platform technology for use by dermatologists, plastic surgeons and other aesthetic physicians to reduce skin laxity and enhance focal aesthetic contouring. For more information, visit https://www.recrosmedica.com.
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