Sofwave Medical Announces FDA Clearance of SUPERB™ Technology For Cellulite

San Clemente, California, December 19, 2022/ globenewswire/ – Sofwave Medical Ltd (“the Company”) (TASE: SOFW), an emerging leader in energy-based non-invasive, aesthetic medical devices announced the U.S. Food and Drug Administration’s (FDA) clearance of Sofwave’s SUPERB™ technology to be used for the short-term improvement in the appearance of cellulite.

In the clinical trials submitted to the FDA as part of the 510(k) application in support of the cellulite FDA clearance, the Company conducted a multi-site clinical study that 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 4 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% of the subjects. No serious or unanticipated adverse event was reported during the study.

In 2021, the FDA cleared additional indications for SUPERB™ technology, for lifting the eyebrow and lifting lax submental tissue (beneath the chin) 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.

*Source: Grand View Research: Link

About SUPERB™

Sofwave’s state-of-the-art SUPERB™ (Synchronous Ultrasound Parallel Beam) Technology addresses the growing demand for non-invasive treatments that deliver noticeable results in non-invasive treatment of highly desired aesthetic indications. The device’s cooled transducers are directly coupled 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. A single Sofwave treatment reduces facial wrinkles in a fast 30 to 45 minute non-invasive treatment with no interruption to a patient’s daily routine or post-treatment discomfort.

About Sofwave Medical

Sofwave Medical Ltd. has implemented an innovative approach to wrinkle reduction lifting and cellulite using proprietary breakthrough technology. SUPERB™, Synchronous Ultrasound Parallel Beam technology is FDA-cleared to improve facial lines and wrinkles, lifting the eyebrow and lifting lax submental tissue (beneath the chin) and neck tissue and the short term improvement in the appearance of cellulite providing physicians with smart yet simple, effective, and safe aesthetic solutions for their patients. Contact: Info@sofwave.com

Investor Contact:

Brian Ritchie

LifeSci Advisors LLC

(212) 915-2578

britchie@lifesciadvisors.com

Sources: