Soliton, Inc. is 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
The US FDA Center for Devices and Radiological Health. (Credit: The U.S. Food and Drug Administration.)
Soliton, Inc., (Nasdaq: SOLY) (“Soliton” or the “Company”), a medical device company with a novel and proprietary aesthetic platform technology, today announced that its 510(k) application for premarket clearance filed with the U.S. Food and Drug Administration (“FDA”) for its second generation Rapid Acoustic Pulse (“RAP”) device for cellulite reduction has cleared the agency’s acceptance review. The application now moves to a substantive review. The device is already indicated as an accessory to the 1064 nm Q-Switched laser for black ink tattoo removal in Fitzpatrick Skin Type I-III patients and this latest new application is for the temporary improvement of the appearance of cellulite. Clinical trials have demonstrated an average 32.5% improvement in the Cellulite Severity Score in our subjects and strong patient satisfaction with 91.9% of subjects agreeing or strongly agreeing that their cellulite appeared improved. Further, there were no unexpected or serious adverse events and the average pain scores were 2.4 on a 10-point scale.
Dr. Christopher Capelli, president and CEO of Soliton, said, “We are very pleased with the progress of our premarket notification through the FDA review process.” Dr. Capelli continued, “Having found that our submission contained all the necessary elements and information, we look forward to the substantive review and FDA clearance of the RAP device.”
Cellulite affects between 80% and 90% of women and over a billion dollars per year is spent on treatment in the U.S. The Soliton clinical trial protocol provided for a single 20 to 30-minute, non-invasive treatment in which the Rapid Acoustic Pulse (RAP) device was applied to the surface of the subjects’ skin. The treatment required no anesthesia, caused no unexpected or serious adverse events, and was evaluated as relatively painless by the trial subjects, with an average pain score of 2.4 out of 10.
The Company believes there is a reasonable expectation that the FDA will allow it to remain on the 510(k) clearance pathway in order to market the product. However, acceptance of our application does not indicate that the FDA has accepted the Company’s predicate argument. Should the FDA deem our choice of predicate device to be inadequate, we would be required to convert our application to a De Novo request, which we estimate would extend the filing and review process by approximately six to nine months.
Source: Company Press Release