Soliton, Inc. (“Soliton” or the “Company”), a medical technology company that has developed a new acoustic shockwave device, announced that it has built a second generation device that is potentially capable of delivering treatment for cellulite reduction, tattoo removal and other future indications.
The device will be used in clinical trials and will require premarket clearance by the FDA prior to commercialization.
Dr. Chris Capelli, CEO of Soliton, explained “This is a tremendous step forward for our technology that allows us to target not only tattoo removal but also cellulite reduction. Our second generation device is now a platform technology that provides healthcare professionals with the flexibility to potentially to treat multiple indications with a single device by simply changing the replaceable single treatment cartridge.”
The second generation Rapid Acoustic Pulse (‘RAP”) device may be capable of treating both tattoos and cellulite conditions. In order to properly target cellulite, the device needed to be capable of running a specifically designed cartridge which required a runtime 20 times longer than the tattoo removal cartridge and a customized waveform which would penetrate deeper into the skin. Further, the device needed to impart acoustic output twice as powerful as that used to remove tattoos in order to potentially treat cellulite and other fibrotic disorders, such as keloid scarring. We believe this more powerful device may also be better suited to assist existing fat reduction technologies. The second generation technology allows different therapies to be delivered by simply changing out the replaceable cartridge on the same device.
Soliton is a medical device company focused on the development of a new form of acoustic shockwave (“Rapid Acoustic Pulse” or “RAP”) that the Company’s own recent clinical trials have shown to achieve tattoo removal results in 2-3 treatments versus the industry average of 10 or more with a stand-alone laser. Soliton has discovered other capabilities of the RAP technology during preclinical testing, including the potential to assist existing fat reduction technology in the reduction of fat as well as reducing the appearance of cellulite by creating mechanical stress at the cellular level and inducing significant collagen growth. Importantly, we believe these potential indications could position Soliton RAP as a stand-alone device, without the need for lasers or other procedures. The Company has initiated a proof of concept study in humans for the treatment of cellulite and has collaborated with a large global aesthetics company in a clinical study to determine if the RAP technology can improve their fat reduction technology. These clinical trials are in early stages and there is no guarantee that any specific outcome will be achieved.
Soliton is currently engaged in an Initial Public Offering to list its common stock on Nasdaq Capital Markets under the ticker symbol “SOLY,” pursuant to an offering circular (File No. 024-10854), which was qualified on November 27, 2018. This announcement shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of such securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. Being qualified by the Securities and Exchange Commission (“SEC”), does not mean that the SEC has approved, passed upon the merits, or passed upon the accuracy or completeness of the information.
Source: Company Press Release