Soliton Devices

Soliton Receives FDA 510(k) Clearance of its Acoustic Shockwave RAP Device

Posted on May 29, 2019 by Medtech[y] Staff


Houston-based Soliton (Nasdaq: SOLY) announced the FDA clearance to market their Rapid Acoustic Pulse ("RAP") device for tattoo removal. The device is indicated as an accessory to the 1064 nm Q-Switched laser for black ink tattoo removal on the arms, legs and torso in Fitzpatrick Skin Type I-III individuals.

The tattoo removal industry is expected to grow to approximately $4.8 billion annually by 2023, giving Soliton a big runway as they move towards launch as early as the first half of 2020.

"Receiving clearance from the FDA, while inline with our expectations, is nonetheless gratifying and validating, representing a bedrock for the commercialization plan of our RAP technology," commented Dr. Chris Capelli, President, CEO and co-founder of Soliton.

In the clinical trials submitted to the FDA, Soliton demonstrated that their RAP device can enable tattoo removal in just 2-3 office visits. In contrast, a separate independent study of 397 tattoo owners, demonstrated that the standard of care laser-only method required 10 or more office visits to achieve acceptable results.

In addition to the FDA clearance for tattoo removal, Soliton also announced their decision to move forward with a pivotal trial for the reduction of cellulite after they received positive data from its proof of concept trial, which revealed a significant reduction in cellulite with no bruising, no swelling and no downtime after a single 20-minute non-invasive procedure.

Houston-based Soliton rode the high of that approval by announcing plans to advance a pivotal study of its device for reducing cellulite. The short-targeted company has seen shares quintuple in the last two sessions to trade as high as $29 on Wednesday compared to Friday’s close of $5.73.

Soliton Cellulite Reduction

The company is not without its detractors as their stock has a high short interest. Up to this point though, these two announcements have helped the stock quintuple from $5.73 to as high as $29 at the time of writing. The stock is up almost 400% since their mid-February IPO.

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