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 it has begun the first follow-up visits for patients in its pivotal cellulite trial.
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Dr. Chris Capelli, President, CEO and co-founder of Soliton, commented, "The start of the follow-up visits is a significant milestone. We are hopeful that the results from our pivotal trial will be as strong as those seen in our proof-of-concept study in cellulite. This would support the filing of our 510(k) application with the FDA for the treatment of cellulite, which we expect to occur in the first half of 2020. With the planned limited launch of our device in 2020 for the indication of tattoo removal, regulatory clearance for this new indication would put us on track to expand nationally and internationally with two indications in 2021."
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 patient's 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.
[ To read a detailed description of acoustic subcision, read page 10 of our shareholder letter here: https://www.soliton.com/shareholder-letter-2019 ]
Together with the device's demonstrated ability to stimulate new collagen production in animal models, this represents what the Company believes is a potentially important new way to treat cellulite and improve the appearance of the skin. The Soliton device used in this trial has not been reviewed or cleared by the FDA for marketing and, accordingly, none of the information in this press release is intended to promote the sale or use of the device. The device is investigational and is not available for sale in the United States.