Osiris Announces 100% Medicare Coverage for Grafix®
COLUMBIA, MD – February 2, 2016 – Osiris Therapeutics, Inc. (NASDAQ: OSIR), a leading cellular and regenerative medicine company focused on developing and marketing products to treat conditions in wound care, orthopaedics and sports medicine, announced this week that all eight Medicare Administrative Contractors (MACs) have confirmed coverage for the treatment of chronic wounds with Grafix®, a cryopreserved placental membrane. These eight separate MACs provide Medicare benefits to over 54 million beneficiaries. Effective March 2016, Grafix is now available for 100 percent of the 54 million Medicare fee-for-service (FFS) beneficiaries.
A MAC is a multi-state and private health care insurer that has been awarded by the Centers for Medicare and Medicaid Services (CMS) a geographic jurisdiction to process Medicare Part A and Part B medical claims for Medicare FFS beneficiaries. CMS relies on this MAC network to serve as the primary operational contact between the Medicare program and enrolled health care providers and to process claims.
"Providing complete Medicare coverage and reimbursement has been a focus for the Osiris Market Access team. With this positive coverage update, Grafix is an available treatment for all Medicare fee-for-service beneficiaries with chronic wounds throughout the country," said Lode Debrabandere, Ph.D., President and CEO at Osiris. "MACs base these coverage decisions on the available clinical and scientific evidence, as well as medical necessity as deemed by the health care provider. We are confident that the studies Osiris has published provide ample proof of Grafix's ability to help patients with chronic wounds. Our Market Access team will continue to work with payers to broaden Grafix coverage with state Medicaid programs and large commercial plans."
Dr. Debrabandere continued, "Recently, our Contracting and Trade Team also made significant progress in securing access and contracts with the leading Integrated Delivery Networks (IDNs) and Group Purchasing Organizations (GPOs). As of today, Grafix has access to 37 of the top 50 IDNs in the country." An IDN is an organization or group of healthcare providers, which through ownership or formal agreements, aligns local health care facilities and manages them with one governing board. A GPO is an entity that helps health care providers, including hospitals, realize savings and efficiencies by aggregating purchasing volume.
About Osiris Therapeutics
Osiris Therapeutics, Inc., based in Columbia, Maryland, is a leader in researching, developing and marketing cellular regenerative medicine products that improve the health and lives of patients and lower overall healthcare costs. Having developed the world's first approved stem cell drug, Osiris works to further advance the medical field. Osiris' research and development in biotechnology focuses on innovation in regenerative medicine – including bioengineering, stem cell research and viable tissue based products. Osiris has achieved commercial success with products in orthopaedics, sports medicine and wound care, including BIO4®, a viable bone matrix, Cartiform®, a viable osteochondral allograft, Grafix, a cryopreserved placental membrane, TruSkin™, a viable human skin allograft and Stravix™, a durable placental allograft.
Grafix is a cryopreserved placental membrane comprised of an extracellular matrix (ECM) rich in collagen, growth factors, fibroblasts, mesenchymal stem cells (MSCs), and epithelial cells native to the tissue. Grafix is processed using Osiris' proprietary BioSmart™ technology; it is flexible and conforming and designed for application directly to hard-to-treat acute and chronic wounds, including but not limited to diabetic foot ulcers, venous leg ulcers and thermal burns.
This press release contains forward-looking statements. Forward-looking statements include statements about our expectations, beliefs, plans, objectives, intentions, assumptions and other statements that are not historical facts. Words or phrases such as "anticipate," "believe," "continue," "ongoing," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project" or similar words or phrases, or the negatives of those words or phrases, may identify forward-looking statements, but the absence of these words does not necessarily mean that a statement is not forward-looking. Examples of forward-looking statements may include, without limitation, statements regarding any of the following: our product development efforts; our clinical trials and anticipated regulatory requirements, and our ability to successfully navigate these requirements; the success of our product candidates in development; status of the regulatory process for our biologic drug candidates; implementation of our corporate strategy; our financial performance; our product research and development activities and projected expenditures, including our anticipated timeline and clinical strategy biologic drug candidates and marketed Biosurgery products (including Grafix, BIO4, Cartiform, TruSkin and Stravix); our cash needs; patents, trademarks and other proprietary rights; the safety and ability of our products and potential products to treat disease; our ability to supply a sufficient amount of our marketed products or product candidates and, if approved or otherwise commercially available, products to meet demand; our costs to comply with governmental regulations; our plans for sales and marketing; our plans regarding facilities; types of regulatory frameworks we expect will be applicable to our products and potential products; and results of our scientific research. Forward-looking statements are subject to known and unknown risks and uncertainties and are based on potentially inaccurate assumptions that could cause actual results to differ materially from those expected or implied by the forward-looking statements. Our actual results could differ materially from those anticipated in forward-looking statements for many reasons, including the factors described in the section entitled "Risk Factors" in our Annual Report on Form 10-K and other Periodic Reports filed on Form 10-Q, with the United States Securities and Exchange Commission. Accordingly, you should not unduly rely on these forward-looking statements. We undertake no obligation to publicly revise any forward-looking statement to reflect circumstances or events after the date of this press release or to reflect the occurrence of unanticipated events.