Osiris Therapeutics, Inc.
(NASDAQ: OSIR) announced today that the company has been selected by the Biomedical Advanced Research and Development Authority (BARDA) to submit a full proposal for a Broad Agency Announcement (BAA) to fund advanced research and development of countermeasures, specifically in the area of mass casualty thermal burn injuries. The company’s Biosurgery product, Grafix®, was the focus of a submission to BARDA in early March. BARDA carefully reviewed white papers it received in response to the BAA in order to select definitive care products acceptable for submission of a full proposal.
BARDA is seeking safe and effective medical products that can be used to treat a wide range of types of burn injuries, resulting from any cause, and importantly from any mass-casualty incident. Grafix is currently used at burn centers across the country to treat thermal burns of differing thicknesses in both pediatric and adult patients. To most effectively address the government’s needs in mass casualty situations, Osiris’ research-based proposal to BARDA will focus on additional clinical development and large scale manufacturing.
The Biomedical Advanced Research and Development Authority, within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services, provides an integrated, systematic approach to the development and purchase of the necessary vaccines, drugs, therapies, and diagnostic tools for public health medical emergencies.
Grafix is a three-dimensional cellular matrix designed for application directly to acute and chronic wounds, including diabetic foot ulcers and burns. Flexible, conforming and immune neutral, this cellular repair matrix provides a rich source of viable mesenchymal stem cells and growth factors directly to the site of the wound, while the matrix protects the area from inflammation, scarring, and infection. Grafix is manufactured using a unique proprietary process that preserves the matrix, cells and growth factors needed for successful healing.