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 (“MD Anderson”). Today they announced that the company has submitted its pivotal cellulite clinical trial protocol for independent Institutional Review Board (“IRB”) approval.
Dr. Chris Capelli, President, CEO and co-founder of Soliton explained, “We have submitted our protocol for the pivotal cellulite study to Advara for review and approval. Based on the encouraging results we recently announced from our proof of concept cellulite trial, we expect this larger pivotal trial to form the basis for FDA clearance of our Rapid Acoustic Pulse (RAP) device. We hope to receive approval from the IRB in the very near future which will enable us to move forward with the site initiation visits and ultimate treatment of patients in this important study.”