The FDA has cleared a new indication statement for Cellfina that shows the benefits of treatment last for five years, an increase from the previous three-year indication. Cellfina from Merz demonstrated five-year improvement in the appearance of cellulite on the buttocks and thighs of adult females. Five-year durability makes Cellfina the longest-lasting FDA-cleared treatment for cellulite on the market.
The new indication is based on observations by an independent physician using before and after patient photographs at five years post-treatment. Results showed that after a single in-office treatment, 100 percent of follow-up patients still had noticeable improvements. Follow-up studies at one, three and five years after a single in-office treatment showed sustained improvements.
“Cellfina is the benchmark and continues raising the bar for any other cellulite treatments, with both longevity of results and effectiveness,” said board-certified Miami cosmetic dermatologist Jeremy Green, MD “Cellulite is an emotionally charged medical condition that affects 85 percent of women worldwide. While the data has clearly shown that Cellfina works, and does so for five years, the FDA clearance indicates to consumers that they can, and should, expect to see proven, long-lasting results after treatment with Cellfina.”
“This formal recognition from the FDA is a significant milestone for Cellfina customers, their patients and Merz. Research shows women oftentimes feel defeated by their battle with cellulite, and we want to make sure our customers have an effective cellulite treatment option,” says Merz Americas CEO Bob Rhatigan. “Cellfina is the only cellulite treatment FDA-cleared for visible results that last five years. We are proud of this new indication, and it is a true testament to Cellfina’s efficacy and our commitment to bring customers the latest innovations in medical aesthetics.”
The study data for five years were first presented at the 2018 American Society for Dermatologic Surgery (ASDS) annual meeting.