Stratatech receives SBIR grant to develop anti-infective living human skin substitute

Stratatech Corp., a privately-held regenerative medicine company, today announced that it has been awarded a $3.5 million Fast-Track SBIR grant to expand the development of its anti-infective living human skin substitute. Stratatech was one of only a few companies that received an award from the National Institute of Allergy and Infectious Diseases (NIAID) under a special request for applications to foster partnerships to develop therapeutics and diagnostics for drug-resistant bacteria. For this project, Stratatech is partnering with the Armed Forces Institute of Pathology, the University of Wisconsin-Madison and the Waisman Clinical Biomanufacturing Facility.

“There is an urgent need to develop a robust therapeutic skin substitute capable of disrupting and preventing wound biofilms”

The NIAID grant will fund development work that will focus on the efficacy of a genetically-modified living human skin substitute called ExpressGraft_Enhance tissue in the prevention and disruption of biofilms. A biofilm is a community of bacteria growing in a matrix that adheres to a surface. Biofilms inhibit wound healing and are highly resistant to antibiotic treatment. In addition, the naturally-occurring dispersal of biofilms is thought to play an important role in the aggravation and spread of disease. The National Institutes of Health estimates that biofilms play a role in 80 percent of human infectious disease.

"There is an urgent need to develop a robust therapeutic skin substitute capable of disrupting and preventing wound biofilms," said Lynn Allen-Hoffmann, Ph.D., chief scientific officer and chief executive of Stratatech. "Because of the initial work we've done on our ExpressGraft _Enhance skin substitute tissue, we believe it can be a frontline tool in fighting wound infection, improving skin graft take and advancing patient care. Our goal is to commercialize the ExpressGraft_Enhance skin substitute for use in treating skin wounds that are difficult to heal because of bacterial colonization and biofilm formation by wound pathogens. The studies funded by this NIAID grant are designed to generate the preclinical data that's required to support translation of the ExpressGraft_Enhance tissue into human clinical trials."

There is a multi-billion-dollar market for the anti-infective ExpressGraft Enhance living human skin substitute in the United States alone. Among the most valuable severe and chronic wound management market segments Stratatech's tissue would address is the market for the treatment of diabetic ulcers and other diabetes-related wounds, which is estimated to be $1.6 billion a year.

Stratatech last year announced that it had modified its StrataGraft^® living human skin substitute to actively fight the costly bacterial infections, including those caused by multi-drug resistant bacteria, that routinely develop at the site of burns and other severe skin injuries. The modified ExpressGraft tissue was found to contain greater than 100-fold more anti-infective proteins called host defense peptides than unmodified tissue. Another study showed that the ExpressGraft tissue reduced the growth of Acinetobacter baumannii, a pathogenic, multi-drug-resistant bacterium, by 100-fold compared to unmodified tissue. (Molecular Therapy. 2009 Mar.;17(3):562-9.)