Sofwave Medical Secures FDA Clearance for Acne Scar Technology

Sofwave Medical Ltd (TASE: SOFW) has received FDA clearance to market SUPERB™ for the treatment of acne scars. The approval clears the way for Sofwave™ to expand treatment indication of the Company’s SUPERB™ system to be used for the treatment of acne scars.

Louis Scafuri, CEO of Sofwave Medical, said, “Gaining FDA clearance to market SUPERB™ for the treatment of acne scarring not only paves the way to positively impact patients seeking improved appearances but also in situations where the presence of post-acne scarring has negatively impacted an individual’s perceived body image, self-esteem and mental health. Further, we will mirror our efforts to bring this new acne scarring treatment to the U.S. with our other key territories while continuing to expand regulatory approvals for additional medical aesthetic treatment indications.

Highlights

Sofwave Medical conducted a multicenter study to evaluate the SUPERB™ system for improvement in the appearance of acne scars, treating 67 subjects at four sites in the US.

97% of treated subjects showed improvement in acne scars appearance following three treatment sessions.

The study demonstrated an average improvement of 46% relative to the average baseline acne scars severity grading.

Subjects in the trial were highly satisfied and 88% of the subjects reported improvement in their acne scars appearance.

About Sofwave Medical

Sofwave Medical Ltd. has implemented an innovative approach to wrinkle reduction lifting and cellulite using its 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.

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Sofwave Medical Secures FDA Clearance for Acne Scar Technology

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