Soliton Explodes After FDA Approves Tattoo Removal Device

02:45 06/02/2019

Last week the Food & Drug Administration approved Soliton's SOLY  tattoo removal device sending shares of the company skyrocketing.

The FDA approved the medical device maker's Rapid Acoustic Pulse (RAP) device for tattoo removal, an accessory for its black ink tattoo removal system for the arms, legs and torso. The device had been awarded 'best in show' by the American Society for Laser Medicine and Surgery.

'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,' remarked Chris Capelli, president, CEO and co-founder of Soliton.

'This clearance to market allows us to begin the transition from R&D to expanded product development and commercialization within the tattoo removal segment.'

According to Soliton, the device safely converts 3,000 volts into finely controlled acoustic shockwaves at a rate of up to 100 pulses per second. The therapy does not cause heat or collateral tissue damage resulting in little potential for bruising, according to Soliton.

Clinical trials have shown that the Rapid Acoustic Pulse device removes tattoos in 2-3 office visits. Tattoo owners in the trial had reported needing 10 or more office visits in the laser-only standard of care.

Results of the trials showed that 72% of the tattoos treated with the laser and RAP achieved 25% or greater fading at 12 weeks; when treated by laser alone, only 40% of tattoos faded by 25% or more. There was also 75% or greater fading in 19% of the RAP-treated tattoos, something that only happened in 3% of tattoos treated by laser alone.

This article has been provided by a Chasing Markets contributor. All content submitted by this author represent their personal opinions, and should be considered as such for entertainment purpose only. All opinions expressed are those of the writer, and may not necessarily represent fact, opinions, or bias of Chasing Markets.
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