Image: Soliton completes treatment of all patients in cellulite trial . Photo: Courtesy of valelopardo from Pixabay.
Soliton, Inc., (Nasdaq: SOLY) (“Soliton” or the “Company”), a medical device company with a novel and proprietary platform technology licensed from The University of Texas on behalf of the MD Anderson Cancer Center (“MD Anderson”), today announced that the pivotal cellulite trial has been completed, with all required patients having been successfully treated across the four clinical sites.
“With the successful completion of all 67 required patients, our defined regulatory path remains on track as we prepare for the follow-up site visits,” said Dr. Chris Capelli, President, CEO and co-founder of Soliton. “We are immensely grateful to all the patients who participated and for the effort and speed with which the four sites completed enrollment and treatment. Having successfully treated all patients, we are one step closer to bringing a non-invasive treatment for the reduction of cellulite to the market.”
Cellulite affects up to 90% of women and over a billion dollars per year is spent on treatment in the U.S. Results from our initial proof of concept clinical trial suggest the potential for a new approach to treating cellulite. In the proof of concept trial, the Soliton Rapid Acoustic Pulse (“RAP”) device was applied to the surface of the patients’ skin for a single 20-minute, non-invasive treatment. The treatments in the pivotal study required no anesthesia, caused no bruising, swelling or infection, and were evaluated by the trial participants as an average of 2.4 on a pain scale of 0-10. None of the patients experienced any post-treatment downtime.
Based on biopsies from our own animal studies, Soliton’s RAP device appears to be capable of selective disruption of the fibrotic septa that contribute to the appearance of cellulite. The new discovery, referred to as “acoustic subcision,” helps explain the recent proof-of-concept trial results showing an improvement in the appearance of cellulite following use of the Company’s RAP device.
Source: Company Press Release