Osiris Therapeutics Inc.

Radiology shows bone neoformation in a long bone defect, and advanced microscopy shows the delivered cells sixteen weeks after implantation.

Bone Repair

Bone repair is a multi-phase process that requires a coordinated interplay of extracellular matrix, growth factors and cells, in particular mesenchymal stem cells or MSCs. Ovation is manufactured using a unique process that preserves matrix, cells and growth factors - key components to support bone repair.

Ovation, a novel cellular repair matrix derived from placental mesenchyme, provides the three essential components of periosteum - extracellular matrix, endogenous mesenchymal stem cells and a replenishing source of growth factors - without the need for autografting.

Ovation is similar in structure and composition to the cambium layer of the periosteum and is also of mesodermal origin. The cambium layer mediates the repair and regeneration of orthopedic tissues. Periosteum can not be allografted due to immunogenicity and supply concerns. Ovation resolves these concerns and is an optimal choice for periosteal supplementation in orthopedic procedures.

Ovation contains components that are beneficial for natural bone repair:

Rich extracellular matrix (ECM) to provide 3-dimensional support for tissue repair;
Regenerative growth factors and anti-inflammatory cytokines; and
Endogenous MSCs to coordinate the tissue repair process.

Safety and profile testing

Ovation isregulated 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