Wound healing is a multi-phase process that requires a coordinated interplay of extracellular matrix, growth factors and cells, in particular mesenchymal stem cells or MSCs. Grafix is manufactured using a unique process that preserves matrix, cells and growth factors - key components to support wound healing.
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, multipotent MSCs and growth factors directly to the site of the wound while the matrix protects the area from inflammation, scarring and infection.
Grafix contains components that are beneficial for wound healing and tissue repair including:
Safety and profile testing
Grafix is regulated by the FDA under 21 CFR Part 1271 Human Cells, Tissues and Cellular and Tissue-based Products (HCT/Ps). Osiris Therapeutics, Inc. is registered with the FDA as a tissue establishment and accredited by the American Association of Tissue Banks (AATB).
Extensive donor screening, serological testing, bioburden testing and sterility testing is performed on every lot to demonstrate suitability for transplantation. Each lot is tested to confirm cellular viability post thaw.
For additional information or to place an order, please email us at Biosurgery@Osiris.com