The clinical study also demonstrated a favorable safety profile for the Sofwave system. No serious or unanticipated adverse event were reported during the study.
Sofwave Medical Announces FDA Clearance of SUPERB Technology. (Credit: Erik Mclean on Unsplash)
Sofwave Medical Ltd (“the Company”) (TASE: SOFW), an emerging leader in energy-based non-invasive, aesthetic medical devices for practitioners worldwide, 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.
“Post-acne scarring has a high prevalence and is typically a result of active acne during adolescence and younger age,” said Louis Scafuri, CEO of Sofwave Medical. “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. Present energy based treat regimens are limited due to the risk of post inflammatory hyperpigmentation associated with other energy based treatments.”
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.
Source: Company Press Release