Medical device company Soliton presents results from their 12-week study looking at the treatment of fibrotic scars via their RAP device at Maui Derm.
Soliton, a novel medical device company based out of Houston, Texas, announced the debut of their 12-week proof-of-concept study results examining its Rapid Acoustic Pulse (RAP) device for the treatment of keloids and hypertrophic scars at the Maui Derm meeting Jan. 27.
Soliton’s RAP device utilizes rapid pulses of acoustic shockwaves for the removal of tattoos. The company is also investigating other uses for the device including fat reduction, cellulite improvement and fibrotic scars treatment.
The goal of the study was to examine the safety, tolerability and efficacy of Soliton’s RAP device on the appearance of fibrotic scars.
During a pre-treatment 3D scar assessment, 11 fibrotic scars were observed for volume and height in 10 patients. Participants then each received a single 6-minute RAP treatment. Scar volume and height were subsequently examined at the 12-week follow-up.
Soliton cited patients experienced minimal pain but expressed post-treatment satisfaction with scar improvement.
Results of the clinical trial exhibited a 14.6% (P<0.005) average reduction in height and a 29.6% (p<0.01) average reduction in volume in the 11 examined scars.
Soliton announced prior to the meeting that at the study’s week 6 benchmark, patients displayed a 27% average volume reduction in the treated scars. The newly published results suggest that fibrotic scars improved over time with the single RAP treatment (a 2.6% improvement during the last 6 weeks), according to a company press 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 initial single 6-minute treatment is continuing without the need for further dosing,” says Christopher Capelli, M.D., founder, president and CEO of Soliton.
While the RAP device is Soliton’s first cleared product by the U.S. Food and Drug Administration, it is not currently available on the market.
“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,” says Dr. Capelli in a company press release.
Soliton, Inc. Soliton To Announce Keloid and Hypertrophic Scar Clinical 12-Week Trial Data at Maui Derm Meeting. PR Newswire: press release distribution, targeting, monitoring and marketing. https://www.prnewswire.com/news-releases/soliton-to-announce-keloid-and-hypertrophic-scar-clinical-12-week-trial-data-at-maui-derm-meeting-300985456.html. Published January 13, 2020. Accessed January 17, 2020.
Soliton Announces Positive Data from Extended Keloid and Hypertrophic Scar Trials. Soliton, Inc. https://ir.soliton.com/press-releases/detail/83/soliton-announces-positive-data-from-extended-keloid-and. Published January 27, 2020. Accessed January 29, 2020.