Soliton, Inc., (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 Company has initiated patient recruitment for its upcoming pivotal cellulite trial across all four trial sites. The Company is seeking approximately 60 patients to enroll in the trial. Each trial site is responsible for reviewing prospective patients to determine if enrollment criteria is met by the individual.
Dr. Chris Capelli, President, CEO and co-founder of Soliton, commented, “Patient recruitment is now active in Boston, Washington, D.C., Chicago and Scottsdale.” He continued, “We anticipate enrolling our targeted patient population quickly and moving rapidly towards patient treatment in these four trial sites. We look forward to the tabulation of the treatment results and the potential for a dramatic advance in the treatment of cellulite.”
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 required no anesthesia, caused no bruising, swelling or infection, and were evaluated by the trial participants as a “0” on a pain scale of 0-10 in 97% of the treatments. None of the patients experienced any post-treatment downtime. 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.
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