Madison, WI-based Stratatech has won a $4.6 million grant from the National Institute of Diabetes and Digestive and Kidney Diseases to support the first human clinical trial of the ExpressGraft antimicrobial skin substitute. The study will evaluate the safety and efficacy of the tissue as a treatment for chronic diabetic foot ulcers.
ExpressGraft is a living, cell-based tissue. When it is applied to non-healing ulcers, it provides immediate wound closure and is expected to gradually replace the patient's cells during the healing process, according to a statement. The tissue's unique ability to produce a potent immune system protein enables it to actively fight infections that routinely develop at the site of diabetic foot ulcers.
"Stratatech will advance its second therapeutic product into clinical testing with this award, bringing us another step closer to the multibillion dollar market for chronic skin ulcer treatments," said Lynn Allen-Hoffmann, Stratatech's chief executive and chief scientific officer.
More than 23 million people in the U.S. have diabetes and an estimated 900,000 new patients are afflicted with non-healing skin ulcers annually. Diabetic lesions also lead to more than 80,000 amputations each year. Furthermore, currently available skin substitutes are not approved for use in infected wounds.
"Given the rapid rise of antibiotic-resistant infections, their negative affect on costs and the dearth of new anti-infective drugs, Stratatech's innovative ExpressGraft tissue can have a significant impact on treating diabetic foot ulcers and other skin injuries" Dr. Allen-Hoffmann added.
Stratatech was founded in 2000 to commercialize NIKS cells, a discovery made at the University of Wisconsin-Madison. NIKS is a human keratinocyte cell line that produces living tissue nearly identical to native human skin, according to the company's website.
- read the Stratatech release