Soliton, US Navy to Collaborate on Study of RAP for Fibrotic Scars
Soliton, Inc. will collaborate with the US Navy to conduct a multi-treatment proof-of-concept clinical study to evaluate the safety and efficacy of multiple treatments with Soliton's Rapid Acoustic Pulse (RAP) device for the improvement in the appearance of fibrotic scars. The study will be a US-based, single-center, prospective trial, examining a maximum of 25 patients.
"We are extremely pleased to collaborate with the US Navy and investigate the safety and efficacy of our RAP device in improving the appearance of fibrotic scars," says Brad Hauser, Soliton CEO and President. "The results from our previous proof-of-concept Keloid and Hypertrophic Scar trial were extremely encouraging, as the RAP device demonstrated reductions in both the volume of the scars and the height of the scars after a single 6-minute treatment. We look forward to building on the tremendous promise our RAP Device has demonstrated in this adjacent indication and exploring its ability to improve the standard of care in this large market, which size is expected to reach an estimated value of $10.0 billion by 2025."
Dr. Curtis L. Hardy, Dermatology Resident at the Naval Medical Center San Diego, will serve as the principal investigator for the trial. The trial will investigate efficacy, measured by improvement in fibrotic scar appearance using Global Aesthetic Improvement Scale (GAIS) as determined by the Investigator at the 12-week follow up visit, as a primary endpoint. Additionally, the trial will examine safety, measured by unexpected adverse events or serious adverse events attributable to the RAP device immediately post-treatments and at the 12-week follow-up visit as a second primary endpoint. The trial will be conducted in a single US-based center and examine a maximum of 25 patients. The US Navy will be responsible for the recruitment and treatment of the subjects, with Soliton providing equipment and contributing to the design of the clinical protocol.
Soliton previously announced positive results from its single-site proof-of-concept IRB-approved human clinical study to evaluate the safety, and efficacy of the RAP device for the temporary improvement in the appearance of fibrotic scars. A single 6-minute RAP session was used to treat 11 fibrotic scars in 10 participants. 3D scar assessment of the pre- and post-treatment photographs of 11 treated scars demonstrated an average reduction in volume of 29.6% (p<0.01) and an average reduction in height of 14.6% (p<0.005). While the 12-week data demonstrated an improvement in volume reduction over 6 weeks, this was without any additional treatment, suggesting that the scars continued to improve over time. Furthermore, the treatment of fibrotic scars using the RAP device was proven safe and tolerable during this POC study.