FDA has designated Stratatech's universal human skin substitute, StrataGraft, as an orphan drug for the treatment of partial and full thickness skin burns.
As per the orphan drug status, the company will be able to market StrataGraft once it receives FDA clearance, and could get 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.
Stratatech chief executive and chief scientific officer Lynn Allen-Hoffmann said the designation marks an important milestone in Stratatech's regulatory strategy and complements the clinical results the company reported at the end of April.
"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," Allen-Hoffmann said.
A multicenter clinical study on StrataGraft skin substitute, which a living, cell-based tissue with the physical, chemical and histological characteristics of human skin, is being carried out to assess its effectiveness in the treatment of patients with second-degree deep partial-thickness burns.
The trial compares a single treatment of StrataGraft on one burn site to a control autograft on a comparable burn site of each patient.
Autografting was not required in the burns treated with StrataGraft tissue in the first cohort of 10 patients by day 28, the study's primary efficacy endpoint.