The FDA clearance is backed by the results of a trial involving 68 women at four sites in the US who were assessed for the safety and effectiveness of the device for the non-invasive dermatological aesthetic improvement in the appearance of cellulite
Sofwave Medical has secured FDA clearance for its SUPERB technology for improving cellulite appearance. (Credit: National Cancer Institute on Unsplash)
Sofwave Medical has secured the US Food and Drug Administration’s (FDA) clearance for its SUPERB technology for the short-term improvement in cellulite appearance.
The aesthetic medical device maker has designed the SUPERB (synchronous ultrasound parallel beam) technology to address the increasing demand for non-invasive treatments. The technology is said to be capable of reducing facial wrinkles in 30- 45 minutes with no interruption to a patient’s daily routine.
To support the FDA clearance in cellulite, Sofwave Medical submitted results from a clinical trial that assessed the safety and effectiveness of the device for the non-invasive dermatological aesthetic improvement in cellulite appearance.
The company said that the trial evaluated 68 women at four sites in the US in which they were subjected to two treatments using SUPERB technology on the right or left of the lateral/posterior upper thigh or buttocks.
To evaluate them, serial clinical photographs were taken under standardised conditions prior to treatment and at the three-month follow-up visits.
According to the aesthetic medical device maker, blinded independent reviewers assessed the photos to spot pre-treatment images when compared to post-treatment images. They also graded the pre-treatment and post-treatment images using the Cellulite Severity Scale (CSS).
The trial also evaluated adverse events through physician examination during and following the treatment. In the post-study, the reviewers correctly identified the post-treatment images in 89% of the participants.
Sofwave Medical CEO Lou Scafuri said: “The FDA’s clearance of SUPERB for use in cellulite could not have come at a timelier moment. Our dedicated U.S. direct sales force is positioned to expand our growing presence and market share of the aesthetic medical device market in the U.S.
“In addition, our recent regulatory clearance in Brazil further extends our global footprint, letting us immediately launch sales in this important and sizeable market.
“Furthermore, our partnership in China with HTDK, one of Asia’s strongest healthcare solutions providers, covers our expansion in that territory.”
Last year, the US health regulator allowed additional indications for SUPERB technology including use in lifting the eyebrow and lifting lax submental tissue and neck tissue.
Additionally, the technology is cleared by the FDA for a non-invasive dermatological aesthetic treatment to enhance wrinkles and facial lines.