Soliton Inc announces that it is planning a proof of concept (POC) clinical trial for the use of its Rapid Acoustic Pulse (RAP) technology for the treatment of keloid and hypertrophic scars.
Keloid and hypertrophic scars represent wound healing gone awry. A typical example would be a post-surgical scar that grows beyond its boundaries. Existing published research suggests that factors relating to the wound-healing environment (including tension at the boundary of the scar) can cause fibroblasts to become stuck in a hyper-productive loop, unable to stop the production of collagen that leads to the thickened, raised and dense structures often associated with these fibrotic scars.
The American Osteopathic College of Dermatology estimates that keloids affect around 10 percent of people, whereas hypertrophic scars are more common. Keloid scars a more prevalent among populations with darker pigmentation. Hypertrophic scars affect men and women from any racial group equally, although people between the ages of 10 and 30 years old are more likely to be affected, a media release from Soliton explains.
Grand View Research estimates the global market for keloid and hypertrophic scars may reach $10.2 billion by 2025. There are few treatment options available for fibrotic scars, which in addition to being disfiguring, can also cause significant discomfort. Current treatment methods include surgical excision of the scar of corticosteroid injections, laser treatment or cryotherapy. Some patients even receive radiation to help prevent the return of the scar. The most common treatment is the direct injection of steroids into the scar. However this can require multiple injections and may not be a permanent solution.
“Our preclinical studies combined with published literature on the behavior of fibrotic tissue have suggested that our acoustic shockwaves may be capable of disrupting stiff, sclerotic structures created by unwanted fibrosis, of which keloids and hypertrophic scars are just one example. Beyond this, we may also be able to help reset the targeted tissue to more normal fibroblast activity for lasting effects,” Dr Chris Capelli, CEO, president and co-founder, says in the release.
The Company’s device for use as an accessory to a 1064 Q switch laser for tattoo removal was cleared on May 24, 2019. However technology for the treatment of cellulite and fibrotic scars is investigational and not available for sale in the United States. Soliton will file additional 510(k) applications for the use of RAP technology in these indications, the release continues.
[Source(s): Soliton Inc, PR Newswire]