"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.
"This clearance to market allows us to begin the transition from R&D to expanded product development and commercialization within the tattoo removal segment.
Development of our breakthrough shockwave device, which was recently awarded "Best in Show" by the American Society for Laser Medicine and Surgery (ASLMS), has taken us over 5 years and more than $25 million in research and development to create. This required collaborating with a wide range of industry-leading experts, including engineers responsible for the Space Shuttle ignition system, scientists specializing in the plasma physics involved in nuclear fusion and physicists specializing in acoustic engineering.
The device, which is now covered by 8 patent families with 68 patents issued or pending, safely converts 3,000 volts at 3,000 amps (9,000,000 watts of power) into finely-controlled acoustic shockwaves at a rate of up to 100 pulses per second through our replaceable treatment cartridge. While this is a significant amount of power being converted into an acoustic pulse, it is extremely brief in time, with both a very short rise time and a similarly short fall time. This results in microscopic mechanical disruption to the targeted cellular level structures and vacuoles. Importantly, the negative pressure component of each acoustic pulse is attenuated so therapy can be provided without creating the cavitation, heat or collateral tissue damage that would give the patient the sensation of significant pain. As a result, Soliton's RAP technology can provide meaningful results with little potential for bruising or other treatment related downtime.
In the clinical trials submitted to the FDA as part of the 510(k) application that was just cleared, Soliton demonstrated that the 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.
Taking into consideration that the tattoo removal industry is estimated to grow to approximately $4.8 billion annually by 2023, Soliton is eager to further commercialization plans and move towards launch and revenue generation as early the first half of 2020.
Importantly, this FDA clearance represents only the first of many indications Soliton is pursuing with RAP technology. The company believes its RAP technology offers the potential for significant breakthrough treatments in a variety of aesthetic market segments. The company looks forward to building upon this initial FDA clearance in combination with compelling results from various clinical trials in these other aesthetic segments to advance the influence of RAP technology."