Sofwave Medical Ltd. announced clearance by the U.S. Food and Drug Administration (FDA) for the Company?s 510(k) premarket notification submission 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. About the clinical study leading to FDA clearance of premarket notification submission: A multicenter study was conducted to evaluate the Sofwave SUPERB?

system for improvement in the appearance of acne scars. A total of 67 subjects were treated at 4 sites in the United States. Following 3 treatment sessions, 97% of treated subjects showed improvement in acne scars appearance, as assessed by at least 2 out of 3 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. Subjects in the trial were highly satisfied and 88% of the subjects reported improvement in their acne scars appearance. The clinical study also demonstrated a favorable safety profile for the Sofwave system.

No serious or unanticipated adverse event were reported during the study. In the U.S., Sofwave?s technology has been cleared for use as a non-invasive dermatological aesthetic treatment to improve facial lines and wrinkles, lift the eyebrow, and lift lax submental (beneath the chin) and neck tissue; which can also affect the appearance of lax tissue in the submental and neck regions for subjects aged 22 and older. The Sofwave system is also cleared for short-term improvement in the appearance of cellulite.