The proof-of-concept study, conducted 12 weeks after a single treatment with the device, showed that 10 patients’ keloid and hypertrophic scars were with smaller. Soliton licensed the technology from the University of Texas on behalf of the MD Anderson Cancer Center in Houston.
“We were excited to share the 12-week follow-up results at this key dermatology conference, amongst some of the top physicians in this field,” said Soliton president & CEO Dr. Christopher Capelli in a news release. “The clinical results clearly demonstrate that an overall average reduction in both the volume of the scars and the height of the scars at the 12-week follow-up after the intial single 6-minute treatment is continuing without the need for further dosing. We are very encouraged by these positive results that further substantiate the merit of our RAP device and look forward to continuing the development and enhancement of its clinical program.”
The data were presented at the Maui Derm for Dermatologists 2020 meeting. 3D scar assessment of the pre- and post-treatment photographs demonstrated an average reduction in volume of 29.6% (p<0.01) and an average reduction in height of 14.6% (p<0.005).
The scars were also smaller than they had been at six weeks, according to Soliton. Keloid scars are prone to recurrence after treatment with existing therapies. Patients treated with steroid injections see recurrence rates as high as 50%, while patients treated with a chemotherapeutic agent have recurrence rates as high as 47%, the company noted.
Soliton’s rapid acoustic pulse device won 510(k) clearance from the FDA in May 2019. The company raised $9.5 million in a private placement in June, led by a $5 million investment by its largest backer, Remeditex Ventures. It is also targeting the tattoo-removal market.
Grand View Research estimates the global market for keloid and hypertrophic scars may reach $10.2 billion by 2025.