Sofwave Scores FDA Clearance to Improve Cellulite

Sofwave Scores FDA Clearance to Improve Cellulite image

The technology is also cleared for lifting the eyebrow and lax submental and neck tissue and improving facial lines and wrinkles.

Sofwave’s SUPERB technology is now US Food and Drug Administration (FDA)-cleared to improve the appearance of cellulite.

SUPERB (Synchronous Ultrasound Parallel Beam) technology couples cooled transducers directly to the epidermis, creating a unique 3D array of volumetric thermal zones that deliver parallel energy simultaneously, heating precisely at the right depth in the mid-dermis.

Clinical trials submitted to the FDA as part of the 510(k) application in support of the cellulite FDA clearance evaluated the safety and effectiveness of the device for the non-invasive dermatological aesthetic improvement in cellulite appearance.  A total of 68 women were treated at four sites in the United States. Eligible patients received 2 treatments (2-4 weeks apart) using SUPERB technology on one side (right or left) of the lateral / posterior upper thigh or buttocks. Serial clinical photographs were collected under standardized conditions before treatment (baseline) and at the 3-month follow-up visits. Photographs were assessed by blinded independent reviewers to identify pre-treatment images when compared to post treatment images and to grade the pre-treatment and post-treatment images using the Cellulite Severity Scale (CSS). Improvement was also evaluated using the Global Aesthetic Improvement Scale (GAIS) and Laxity Scale (LS). Safety assessments included evaluation of adverse events via physician examination during and after the treatment.

Post-study, the blinded reviewers correctly identified the post treatment images for 89 percent of the subjects. No serious or unanticipated adverse event was reported during the study.

“The FDA's clearance of SUPERB for use in cellulite could not have come at a timelier moment,” says Lou Scafuri, Sofwave's CEO, in a news release. “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. Our focused commitment across these major markets, will go a long way towards further accelerating global sales and brand-recognition of our devices in the upcoming new year.”

In 2021, the FDA cleared additional indications for SUPERB technology for lifting the eyebrow and lifting lax submental tissue and neck tissue; which can also affect the appearance of lax tissue in the submental neck regions. In addition, the Sofwave SUPERB technology is also cleared by the U.S. FDA for a non-invasive dermatological aesthetic treatment to improve facial lines and wrinkles.

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