FDA Clears Sofwave’s SUPERB Technology for Treating Acne Scars

Fully 97% of the people in the trial showed improvement in the appearance of acne scars as assessed by masked evaluations.

The U.S. Food and Drug Administration (FDA) has cleared Sofwave’s SUPERB technology for treating acne scars.

“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,” says “Louis Scafuri, CEO of Sofwave Medical, in a news release. “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. “

Marketing approval was based on a multicenter study that evaluated the Sofwave SUPERB system for improvement in the appearance of acne scars.  The study included 67 people who were treated at four sites in the United States.  

Following three treatment sessions, 97% of people treated showed improvement in acne scars appearance, as assessed by at least two out of three masked evaluators. 

The study demonstrated a mean improvement level of 1.05±0.53 units based on the acne scar severity scale, which reflected an average improvement of 46% relative to the average baseline acne scars severity grading.  People in the trial were highly satisfied and 88% of the subjects reported improvement in their acne scars appearance.

No serious or unanticipated adverse event were reported during the study.

In the U.S., Sofwave’s technology has been cleared as a treatment to improve facial lines and wrinkles, lift the eyebrow, and lift lax submental and neck tissue. The Sofwave system is also cleared for short-term improvement in the appearance of cellulite.