Wednesday, April 24, 2019
Soliton, Inc.,, 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 its development team has completed final testing of the Company's second generation rapid acoustic pulse ("Gen 2 RAP") device at Sanmina, Inc., the Company's global manufacturing partner.
The Gen 2 RAP device is intended to be used in Company's upcoming pivotal registration clinical trial to submit to the FDA for 510(k) clearance of the device. This new device is designed to be capable of functioning both as the Gen 1 device does for the acceleration of tattoo removal, and as a stand-alone device for potential reduction of cellulite and other future indications. In this second model, the Gen 2 RAP should be capable of delivering higher-powered acoustic pulses at greater depths, making it a platform device with a wide range of potential future uses. This device has not been cleared by the FDA.
The treatment head of the Gen 2 RAP device is automated to allow continuous feeding of electrode material enabling the electrohydraulic pulse generator to operate for longer treatment times at higher and more consistent peak acoustic pressures. As well, the treatment head can now accommodate varying reflector designs to allow for treatment depths that are optimized for addressing the fibrotic structures that contribute to cellulite.
"Given the excitement surrounding the proof of concept cellulite trial results that are about to be presented to the scientific community," commented Dr. Chris Capelli, President and CEO of Soliton, "we needed to be ready to launch an expanded clinical trial for the cellulite indication. The Gen 2 RAP device is the key to being able to start this expanded trial and seek FDA clearance."
Dr. Capelli continued: "The Gen 2 RAP device represents the kind of multi-indication platform potential that we believe may make our RAP system an indispensable tool for clinicians."
