COLUMBIA, Md.--(BUSINESS WIRE)--Osiris Therapeutics, Inc. (NASDAQ: OSIR), the leading stem cell company focused on developing and marketing products in orthopedics, sports medicine and wound care, announced today that, on November 27, 2013, the Centers for Medicare and Medicaid Services (CMS) released their proposed ruling for the reimbursement of skin substitutes in the hospital outpatient setting. CMS decided to package the reimbursement for products used in advanced wound care with the related surgical procedure into a two-tier system.
The proposed ruling means that the current payment methodology for Grafix® will not immediately be impacted by the changes described in the proposed ruling. Grafix will maintain its current transitional pass-through status and that may continue until late 2015. Grafix will be exempt from the current rule and available to patients in the Hospital Outpatient Department and Ambulatory Surgical Center settings under the current Ambulatory Payment Classification payment system. Once the transitional pass-through status expires, Osiris expects Grafix to be reimbursed as a part of a packaged rate in the higher tier of the two-tier system.
“We are very well-positioned to gain market share in the chronic wound market place,” said Frank Czworka, General Manager of Wound Care for Osiris. “The overwhelming efficacy demonstrated in the controlled, randomized, multicenter study, combined with our multiple size offerings of Grafix, provides clinical and cost-effective solutions for our patients, physicians and payers.”
Grafix is a human cellular matrix containing living stem cells for acute and chronic wounds. It is a flexible, conforming membrane that provides a high quality source of living MSCs and growth factors directly to the site of the wound. Grafix is produced by BioSmartTM Intelligent Tissue Processing of human placental membrane. The manufacturing process maintains the integrity of the extracellular matrix, the viability of the neonatal MSCs, and the biologically active growth factors.
About Osiris Therapeutics
Osiris Therapeutics, Inc. is the leading stem cell company, having developed the world’s first approved stem cell drug, remestemcel-L for graft versus host disease. Osiris’ products include Grafix and Ovation® for acute and chronic wounds, Cartiform®, a viable cartilage mesh for cartilage repair and the latest addition to Osiris’ line of products, OvationOSTM, a viable bone matrix. Osiris is a fully integrated company with capabilities in research, development, manufacturing and distribution. Osiris has developed an extensive intellectual property portfolio to protect the company's technology and commercial interests.
Osiris, Grafix, Ovation and Cartiform are registered trademarks of Osiris Therapeutics, Inc. More information can be found on the company's website, www.Osiris.com. (OSIR-G)
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