Today Sofwave Medical Ltd announced in a press release that they have received 510(k) FDA Clearance for marketing Sofwave to treat acne scars. A clinical study involving 67 participants was utilized for the FDA clearance, showcasing the safety and effectiveness of the SUPERB technology. According to evaluations conducted by treated participants, 97% showed visible improvement in the appearance of acne scars.
No serious or unanticipated adverse event were reported during the study.
“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 treatment regimens are limited due to the risk of post-inflammatory hyperpigmentation associated with other energy based treatments.”
