Soliton’s pivotal clinical trial for cellulite using its RAP device shows positive results.
Medical device company Soliton recently announced new data from its pivotal cellulite clinical trial at the American Academy of Dermatology (AAD) 2020 VMX Virtual Conference.
The trial examined a single 20- to 30-minute, non-invasive treatment with the Rapid Acoustic Pulse (RAP) device, which uses rapid pulses of acoustic waves across a 1.3-inch diameter treatment window to treat larger areas at once at a pulse rate of 100 per second. The device was applied to the study participant’s skin without the use of anesthesia. There were no unexpected or serious adverse effects and patients reported it to be relatively painless, rating the average pain score as 2.4 out of 10, according to the press release.
Other non-invasive cellulite treatment options available on the market recommend four to six treatments, according to the company.
Of the 62 patients that were evaluated, 85% responded to the treatment, with improvement in the Cellulite Severity Scores ranging from 6.7% to 85.7%, according to the release.
Overall, the study showed an average of 32.5% improvement in Cellulite Severity Scores, and patients were generally satisfied, with 91.9% agreeing or strongly agreeing that their cellulite was improved.
Soliton reports that it is reviewing the study results to include in a marketing application to the U.S. Food and Drug Administration (FDA). The company believes the data collected is sufficient to support its 510(k) submission for clearance consideration of its RAP technology for cellulite reduction.
Should the FDA deem the filing inadequate, Soliton says it will convert its application to a De Novo request, extending review processes for approximately six to nine months.