Israeli company SofWave received FDA approval for the treatment of acne scars, the company announced.
"The FDA approval for the treatment of acne scars marks another important milestone in building SofWave's leading position in the development and marketing of breakthrough solutions for non-invasive aesthetic treatments,” said Lou Scafuri, CEO.
The aesthetic medical device company’s FDA approval will also allow it to expand treatment options using the company's SUPERBTM technology.
In order to receive the approval, SofWave performed a clinical study among 67 patients at 4 different medical centers in the US. The results of the trial demonstrated the safety and effectiveness of the treatment, with 97% of the participants treated showing an improvement in the appearance of acne scars after 3 rounds of treatment.
The scope of the global acne scar treatment market value is expected to reach approximately $4.9 billion by 2029.
Scafuri said they received approval to improve the appearance of cellulite in the short term, approval for non-invasive treatment to improve face and neck wrinkles, and approval for additional indications for lifting the eyebrows and lifting loose tissues under the chin (Lax submental tissue), and in the neck area.
In addition, the company received FDA approval for the marketing of the Precise applicator (treatment handle), which allows easy access to the treatment of small and curved areas.