Soliton, U.S. Navy to Partner on Fibrotic Scar Trial

Soliton Inc. is teaming up with the U.S. Navy to conduct a clinical study on a device designed to improve the appearance of fibrotic scars.

The multi-treatment, proof-of-concept trial will evaluate the safety and efficacy of multiple treatments with Soliton’s Rapid Acoustic Pulse (RAP) device. The study will be based in the United States, occur at one location, and comprise a maximum of 25 patients. The U.S. 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. 

Dr. Curtis L. Hardy, a 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. 
 
“We are extremely pleased to collaborate with the U.S. Navy and investigate the safety and efficacy of our RAP device in improving the appearance of fibrotic scars,” commented 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 six-minute treatment. We look forward to building on the 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 billion by 2025.”
  
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 six-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 percent (p<0.01) and an average reduction in height of 14.6 percent (p<0.005). While the 12-week data demonstrated an improvement in volume reduction over six 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.