Soliton has received approval for the trial protocol from the independent Institutional Review Board (IRB) for its upcoming proof-of-concept fibrotic scar trial
Image: Soliton secures IRB approval for Keloid Trial. Photo: Courtesy of ilovetattoos/Pixabay
Soliton, a medical device company with a novel and proprietary platform technology licensed from The University of Texas on behalf of the MD Anderson Cancer Center (MD Anderson), today announced that the Company has received approval for the trial protocol from the independent Institutional Review Board (IRB) for its upcoming proof-of-concept fibrotic scar trial.
The Institutional Review Board (IRB) is an FDA registered constituted group that has been formally designated to review and monitor biomedical research involving human subjects. In accordance with FDA regulations, an IRB has the authority to approve, require modifications (to secure approval), or disapprove research. This group review serves an important role in the protection of the rights and welfare of human research subjects.
“We are very excited to begin this new clinical trial,” commented Dr. Chris Capelli, Soliton’s President, CEO and co-founder. “Not only would this represent a third potential indication (in addition to tattoo removal and reduction of cellulite), but in the case of keloid and hypertrophic scars, if we can demonstrate activity in this trial, it may well support the use of our RAP technology in a wider range of fibrotic disorders. Grand View Research estimates the global market for keloid and hypertrophic scars may reach $10.2 billion by 2025.”
Source: Company Press Release