THUNDER BAY — The Lake Superior Centre for Regenerative Medicine expects its newly-won accreditation in the United States will boost its efforts to market a new product that promotes skin growth and wound healing.
The American Association of Tissue Banks recently accredited the Thunder Bay facility for processing human skin.
RegenMed Executive Director David Stezenko said that's important because the AATB holds the highest standards for tissue banking in the world.
Stezenko said even though RegenMed was already certified both by Health Canada and the Food and Drug Administration in the U.S., "there are certain clinicians who want to do business only with tissue banks who have the AATB accreditation, because it means you are firing on all cylinders, and you have to maintain the highest standard."
RegenMed, in partnership with Halifax-based DeCell Technologies Inc., is the only facility producing DermGEN, Canada's first acellular dermal matrix. It's made by removing cells from skin tissue, leaving a scaffold for transplant that allows the patient's own cells to grow and eventually replace the matrix.
DeCell founders and biomedical engineers Dr. Paul Gratzer and Sean Margueratt were the first researchers in the world to automate the process of decellularizing skin.
DermGEN has been touted as beneficial for wound healing for diabetic patients suffering from foot ulcers that might otherwise lead to amputation below the knee.
It will also be used to treat acute and chronic wounds in various other clinical applications.
The product has already had a "soft launch," but full commercialization requires a random clinical trial and case studies.
Stezenko said that If it weren't for the COVID-19 pandemic, the full launch would have happened this October, but some of the processes have been delayed.
"The sooner the world starts getting back to normal, the better, but obviously safety is paramount," he said.
RegenMed still hopes all the prepartions can be completed before the end of the year.
In addition to being unique in the country by processing acellular dermal matrix, the not-for-profit facility is Ontario's only processor of musculoskeletal tissues.
It was founded in 2006, and currently employs 15 people.