MADISON, Wis., Nov. 16, 2010 – 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.
The NIAID grant will fund development work that will focus on the efficacy of a genetically-modified living human skin substitute called ExpressGraftEnhance 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 ExpressGraftEnhance 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 ExpressGraftEnhance 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 ExpressGraftEnhance 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.)
About Stratatech Corp. and StrataGraft Skin Substitute Tissue
Stratatech Corp. is a Madison, Wis.-based regenerative medicine company focused on the development and commercialization of cell-based, tissue-engineered skin substitute products for therapeutic and research applications. The company’s flagship product, StrataGraft® tissue, is proceeding through clinical trials designed to support U.S. Food and Drug Administration approval of StrataGraft® tissue for the treatment of traumatic skin loss. The company’s valuable product pipeline is based on its patented NIKS® human keratinocyte cells and is comprised of the next generation of genetically-enhanced skin substitute products that have numerous advantages over skin substitutes generated from human skin sourced by conventional means.
Stratatech’s StrataGraft® tissue is a second-generation human skin substitute that exhibits normal human skin structure and function. It is produced using the company’s proprietary NIKS® human keratinocytes, which were discovered at the University of Wisconsin. Keratinocytes are the cells that make up approximately 90 percent of the epidermis, the outer layer of human skin. NIKS® cells are a consistent source of pathogen-free, non-tumor-producing, long-lived adult progenitor cells. When cultured appropriately the NIKS® cells faithfully reproduce normal human skin tissue architecture and barrier function. These cells also produce a number of factors that like natural skin promotes wound healing. For more information about Stratatech, its technology, and product pipeline; please visit the company’s website at http://www.stratatechcorp.com.
