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Wound Healing

Wound healing is a multi-phase process that requires a coordinated interplay of extracellular matrix, growth factors and cells, in particular mesenchymal stem cells. Grafix and Ovation are manufactured using a unique process that preserves matrix, cells and growth factors - key components to support wound healing.

Grafix is a living skin substitute allograft comprised of a biologic membrane with native mesenchymal stem cells used as a covering to promote healing and tissue repair in chronic wounds, limb salvage procedures, tendon repair and burns. 

Grafix contains components that are beneficial for wound healing and tissue repair including:

  • Allograft extracellular matrix (ECM) to provide 3-dimensional support for tissue repair;
  • Growth factors and proteins to support cell migration, proliferation and maturation; and
  • Mesenchymal stem cells (MSC), fibroblasts and epithelial cells to coordinate the tissue repair process and secrete a variety of growth factors.

Ovation multipotent cellular repair suspension  is an allograft product that provides the necessary elements for tissue repair in an easy-to-use formulation. Ovation provides a 3-dimensional collagen scaffold onto which other cells or growth factors can adhere and serves as a reservoir for native MSCs, BMPs and other bioactive factors which play a key role in the wound healing process.

Safety and profile testing

Grafix and Ovation are 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, please email us at Biosurgery@Osiris.com

 

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