Soliton Completes Second-Generation Device Further Enhancing Aesthetic Capabilities

Soliton Inc., a medical technology company developing a new acoustic shockwave device, has built a second-generation product that potentially can deliver 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 U.S. Food and Drug Administration (FDA) prior to commercialization.
 
Soliton CEO Dr. Chris Capelli 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. The company believes 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 that the firm’s own recent clinical trials have shown to achieve tattoo removal results in two to three 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, the company believes 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.”
 
Soliton Inc. has developed a proprietary platform technology licensed from MD Anderson. The company’s first commercial product uses rapid pulses of designed acoustic shockwaves to dramatically accelerate the removal of unwanted tattoos. The company is based in Houston, Texas, and is actively engaged in bringing this device to the market. The company expects to file for premarket clearance with the FDA for its first device in the first quarter of 2019 and expects to receive clearance to market the device in mid 2019. This initial filing is limited to the company’s device used in conjunction with the 1064 nm Q-switched laser to enable effective multiple pass laser treatments in a single office session to accelerate removal of black tattoos on the arms, legs and torso in Fitzpatrick Skin Type I-III individuals. While the company believes its’ technology has many potential applications, the company has initially focused on the removal of tattoos, where both animal and human studies have shown promising results. The current standard of care for tattoo removal is to use a Q-switched (pulsed) laser to ablate the tattoo ink particles into pieces small enough for the body’s natural processes to remove them. Unfortunately, this current method is highly inefficient, requiring up to 10 or more office visits to achieve acceptable results. A clinical trial has demonstrated that using the company’s RAP device, in conjunction with a Q-switched laser, has the potential to produce similar results in just two to three office visits. The company believes this “Soliton” method can not only dramatically accelerate tattoo removal, but also has the potential to lower removal cost for patients, while increasing profitability to practitioners, and to reduce the potential for unwanted side effects from current laser removal methods.