Tuesday, February 18, 2020

Tuesday, February 18, 2020

SOLITON: Announces Successful Completion of Safety Testing at SGS to Support FDA Filing for Second Generation Device


Soliton, Inc. recently issued the following announcement. 

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"), 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.

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."

Join our more than 200K fans here to follow the Company: https://soly-investors.com

About Soliton, Inc.

Soliton, Inc. is a medical device company with a novel and proprietary platform technology licensed from MD Anderson. The Company's first FDA cleared commercial product will use rapid pulses of acoustic shockwaves as an accessory to lasers for the removal of unwanted tattoos. The Company is based in Houston, Texas, and is actively engaged in bringing the Rapid Acoustic Pulse ("RAP") device to the market. The Company believes this "Soliton" method has the potential to lower tattoo removal costs for patients, while increasing profitability to practitioners, compared to current laser removal methods.  Soliton is investigating potential additional capabilities of the RAP technology in clinical and preclinical testing, including the potential to improve the appearance of cellulite by creating mechanical stress at the cellular level and inducing significant collagen growth and the potential to treat keloid and hypertrophic scars by targeting the stiffened environment in the intracellular matrix. 

Original source can be found here.

Organizations in this Story

Soliton, Inc.

More News

FDA Reporter