SOLY - Soliton, Inc. Discussion

HOUSTON, Dec. 18, 2019 /PRNewswire/ -- Soliton, Inc., (Nasdaq: 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 Rapid Acoustic Pulse ("RAP") device successfully completed the IEC 60601 safety testing being conducted at SGS, the world's leading inspection, verification, testing and certification company. The testing was led by a team at Sanmina Corporation, a leading electronics manufacturing services provider.

Soliton, Inc. is a medical device company with a novel and proprietary platform technology licensed from MD Anderson. The Company’s first planned commercial product is designed to use rapid pulses of designed acoustic shockwaves in conjunction with existing lasers to accelerate the removal of unwanted tattoos (RAP device). In addition, higher energy versions of acoustic pulse devices are in early stages of development for potential stand-alone treatment of cellulite and other indications. (PRNewsfoto/Soliton, Inc.)

This safety testing is a requirement of the supplemental 510(k) filing for the Company's RAP device for tattoo removal, improvement in the appearance of cellulite, keloid (scarring) and additional pipeline indications. The tests are intended to insure that devices meet standard safety metrics to protect users and patients. The supplemental 510(k) filing will provide an update to Soliton's current FDA 510(k) clearance, which was received in May 2019 for tattoo removal, with respect to the step changes made to the device to improve usability in the field.

Dr. Chris Capelli, Soliton's President, CEO and co-founder, commented, "We are pleased, but not surprised by the safety testing results of our RAP device. The safety of our second generation device mirrors that of our first, and these results reinforce this. We look forward to submitting this safety data in early 2020, simultaneous with the Special 510k filing of our second generation RAP device. This step is an important one in our plans to commercialize the device being launched for tattoo removal to a select and limited number of dermatologists in mid-2020."