June 13, 2012
Stratatech’s StrataGraft Skin Substitute® Granted FDA Orphan Drug Designation
MADISON, Wis.,June 13, 2012 – Stratatech Corp., a leader in regenerative medicine, today announced that StrataGraft®, the company’s universal human skin substitute, has been designated an orphan drug by the U.S. Food and Drug Administration for the treatment of partial and full thickness skin burns.
Orphan drug designation provides a number of benefits to the company, including seven years of market exclusivity once StrataGraft receives FDA clearance, assistance from the FDA with guiding StrataGraft through the regulatory approval process, waiver or partial payment of application fees and tax credits for clinical testing expenses conducted after orphan designation is received.
“This orphan drug designation marks an important milestone in Stratatech’s regulatory strategy and complements the highly encouraging clinical results we reported at the end of April,” said Lynn Allen-Hoffmann, Ph.D., Stratatech’s chief executive and chief scientific officer. “The FDA’s designation underscores the need for new treatments for severely burned patients. We look forward to working with the agency to expedite the continuing clinical testing and regulatory review of StrataGraft.”
StrataGraft® skin substitute is a living, cell-based tissue with the physical, chemical and histological characteristics of human skin. It is being evaluated in a multicenter clinical study designed to assess its safety and utility in the treatment of patients with second-degree deep partial-thickness burns. The trial enables a direct comparison of a single treatment of StrataGraft on one burn site to a control autograft on a comparable burn site of each patient. None of the burns treated with StrataGraft tissue in the first cohort of 10 patients required autografting by day 28, the study’s primary efficacy endpoint.
There is an urgent need for new treatment options for burns. Severe burns and other major skin trauma are life-threatening injuries that require immediate surgical intervention. Frequently, this involves temporary coverage of the wound site with cadaver skin or synthetic dressings to prevent infection and dehydration because there are no full-thickness skin substitutes commercially available for the treatment of burns. Permanent closure of the wound is generally accomplished through split-thickness skin autografting after the wound bed is sufficiently stable that it will accept the transplanted tissue. Although this regimen is the standard of care for severe burns, the limited availability of and potential for pathogen transmission from cadaver skin, as well as the painful surgery associated with autografting, are serious drawbacks to this approach. The American Burn Association estimates that 1.1 million people suffer burns annually in the United States. Approximately 45,000 patients require hospitalization.
About Stratatech Corporation
Stratatech Corp. is a privately-held regenerative medicine company focused on the development and commercialization of cell-based, tissue-engineered skin substitute products for therapeutic and research applications. These products are made using the company’s proprietary NIKS® cells – a human keratinocyte progenitor cell line that faithfully reproduces normal epidermal skin architecture and barrier function. The company is using this progenitor cell line to create a portfolio of therapeutic products to treat severe burns, non-healing ulcers, and other complex skin defects. The company’s flagship product, StrataGraft® tissue, is in human clinical testing for the treatment of severe burns and other traumatic skin loss. The company’s second therapeutic product, ExpressGraft™ antimicrobial tissue, is expected to enter clinical testing in 2013 to treat non-healing diabetic foot ulcers.