Proof of Concept Trial Reveal Significant Reduction in Cellulite with No Bruising, No Swelling and No Downtime after single 20-Minute non-invasive Procedure; Justifies proceeding with Pivotal Trial.
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 its decision to move forward with a pivotal trial in cellulite after positive data from its proof of concept clinical trial for the reduction of cellulite (the “POC Trial”) confirmed.
The Pivotal cellulite study is being designed to take place at multiple clinical sites across the country with between 45 and 60 patients to be treated in the study. We hope to begin the study within the next three months.
Cellulite affects up to 90% of women and over a billion dollars per year is spent on treatment in the U.S. Now, results from this Trial suggest the potential for a totally new approach to treating cellulite. In a single 20-minute, non-invasive treatment, the Rapid Acoustic Pulse (RAP) device was applied to the surface of the patients’ skin. The treatments required no anesthesia, caused no bruising, swelling or bleeding, and were evaluated as relatively painless by the trial participants, none of whom experienced any post-treatment discomfort or downtime. The data was originally presented at the SCALE (Symposium for Cosmetic Advances and Laser Education) conference in Nashville, Tennessee, by Dr. Elizabeth Tanzi on May 11, 2019.
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