Soliton, announced that the company has retained Emergent Clinical Consulting, to serve as the Company's Contract Research Organization and manage its upcoming pivotal Cellulite Trial.
Dr. Chris Capelli, President, CEO and co-founder of Soliton, said, “We are proud to have selected Emergent to assist us with this important next step in the development of our treatment for cellulite. Their strengths in strategic clinical planning, study management, trial monitoring, patient recruitment and patient retention allow Soliton to focus on the science application and protocol in the trial.” Dr. Capelli continued, “We have been gratified at the interest in and response to the results of our Cellulite Proof-of-Concept trial and look forward to launching this next trial late in summer of this year.”
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 totally new approach to treating cellulite. In the proof of concept trial, in a single 20-minute, non-invasive treatment, the Soliton Rapid Acoustic Pulse (RAP) device was applied to the surface of the patients’ skin.
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.