Medical Device sponsor Soliton, Inc. (SOLY), a medical device company with a novel and proprietary platform technology licensed from the University of Texas on behalf of MD Anderson Cancer Center (MD Anderson), has selected Clear Dermatology & Aesthetic Center in Scottsdale, AZ, as the clinical research site for its proof-of-concept (POC) clinical trial for the use of its Rapid Acoustic Pulse (RAP) technology for the treatment of fibrotic scars. Dr. Brenda LaTowsky will serve as Principal Investigator.
Keloid and hypertrophic scars (also called “fibrotic scars”) represent wound healing gone awry. A typical example of a keloid scar 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.
How Pervasive is the Problem?
The American Osteopathic College of Dermatology estimates that keloids affect around 10 percent of people, whereas hypertrophic scars are more common. Keloid scars are more prevalent among populations with darker skin 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.
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. Currently, 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.
The study will include a blinded evaluation of treated scars before and 12 weeks after a single RAP treatment session, reports Dr. Chris Capelli, CEO of Soliton. He continued “Our hope is to be able to demonstrate a clinically significant reduction in the volume and height of these scars that currently have limited treatment options. 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 structures that help reset the targeted tissue to more normal fibroblast activity of lasting effects.”
Principle Investigator Comments
Dr. Brenda LaTowsky reports, “We are proud to have Clear Dermatology & Aesthetic Center selected as the clinical site for what could be a ground-breaking new treatment for keloid and hypertrophic scars.” She continued, “Unfortunately for many of our patients, the current available treatment options are unacceptable, so a new non-invasive procedure could be quite important.”
The Sponsor’s Device
The device for use as an accessory to 1064nm Q-switched lasers for tattoo removal was cleared on May 24, 2019. However, technology for the treatment of cellulite and fibrotic scars is investigational and not available in the United States. Soliton will file additional 510(k) applications for the use of RAP technology in these indications.
What is RAP?
Soliton’s RAP (Rapid Acoustic Pulse) Device works in partnership with a short pulse laser to achieve superior results in activities such as tattoo removal. See the link for more details.
Soliton, Inc. is a medical device company with a novel and proprietary platform technology licensed from MD Anderson. The Company’s first FDA-cleared commercial product will use rapid pulses of acoustic shockwaves as an accessory to lasers for the removal of unwanted tattoos. The Company is based in Houston, Texas, and is actively engaged in bringing the Rapid Acoustic Pulse (“RAP”) device to the market. The Company believes this “Soliton” method has the potential to lower tattoo removal costs for patients, while increasing profitability to practitioners, compared to current laser removal methods. Soliton is investigating potential additional capabilities of the RAP technology in preclinical testing, including the potential to improve fibrotic conditions, such as keloid or hypertrophic scars, as well as improving the appearance of cellulite by creating mechanical stress at the cellular level and inducing significant collagen growth.
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