Soliton, a medical device company, announced that the company has partnered with a Maryland-based site as well as the supervising physician for its upcoming expanded pivotal Cellulite Trial.
The trial builds upon the proof-of-concept trial conducted earlier this year. The proof-of-concept trial was conducted by Dr. Michael S. Kaminer at SkinCare Physicians in Boston in collaboration with Elizabeth L. Tanzi, MD FAAD of Capital Laser and Skin Care in Chevy Chase, MD. Dr. Tanzi will supervise the treatment of patients occurring in the expanded Cellulite Clinical Trial at Capital Laser. Three additional trial sites and supervising physicians are in discussions at this time.
Dr. Chris Capelli, President, CEO and co-founder of Soliton, commented, “This pivotal cellulite trial is being designed to support our submission to the U.S. Food and Drug Administration. It ultimately will take place in 4 sites located across the country and enroll up to 75 patients. Dr. Tanzi and Dr. Kaminer are amongst the country’s leading physicians and researchers.”
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.
Source: Company Press Release.