Healthcare Industry News: mesenchymal stem cells
News Release - March 1, 2013
Osiris Therapeutics Establishes Direct Sales Force for Grafix(R)Clinical and commercial progress advance novel cell therapy in wound care
COLUMBIA, Md.--(Healthcare Sales & Marketing Network)--Osiris Therapeutics, Inc. (OSIR), the leading company focused on developing and marketing stem cell products to treat serious medical conditions, announced today the introduction of a proprietary, direct sales force for Grafix®, a premium cellular repair matrix for serious wounds including diabetic foot ulcers. The team of biologics sales professionals will initially be deployed in 10 major metropolitan areas throughout the United States and is expected to double over the coming year. Field representatives are supported by the Osiris medical affairs staff and a world-class team of stem cell scientists. This organization will enable Osiris to offer wound care practitioners a uniquely sophisticated service, only available from the cell therapy leader with 20 years of experience in the space.
"The decision to take Grafix into the wound care market with our own proprietary sales force was based upon a number of factors, including meaningful progress being made in reimbursement and favorable market dynamics," said Frank Czworka, Executive Director, Wound Care of Osiris Therapeutics. "However, the primary driver behind this initiative is the positive clinical results our physicians and surgeons are experiencing with Grafix. We continue to invest significant resources in Grafix to further demonstrate the clinical benefit it offers patients while favorably impacting overall healthcare costs. A product of this importance deserves a specialized, highly trained sales force."
In 2012, Osiris announced that it had received transitional pass-through status from the Center for Medicare & Medicaid Services ("CMS"), with C-Codes being designated for Grafix. More recently, specific codes were added to the Healthcare Common Procedure Coding System, or HCPCS code set, for Grafix®PRIME and Grafix®CORE. These product-specific Q-Codes will assist healthcare providers in seeking coverage for their patients. The Q-Codes that have been established for Grafix®PRIME and Grafix®CORE are Q4133 and Q4132, respectively.
Grafix has been the focus of active research in the fields of chronic wounds and burns. A 62-patient pilot study, presented at the Desert Foot 9th Annual High Risk Diabetic Foot Conference, was conducted in documented chronic wounds recalcitrant to treatment with standard of care and advanced therapies. The data demonstrated a 70% probability of wound closure by week 12, with a median time to closure of 5.6 weeks. Importantly, closure required a median of only 3 applications of Grafix, resulting in a potential savings over more costly treatments.
Clinical research for Grafix is continuing, including a multicenter, randomized, controlled trial for the treatment of non-healing diabetic foot ulcers. The study is actively enrolling up to 266 patients across 20 sites within the U.S.
Grafix is a human cellular repair matrix containing living stem cells for acute and chronic wound repair. It is a flexible, conforming membrane that provides a high quality source of living mesenchymal stem cells (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., having developed the world’s first approved stem cell drug, Prochymal®, is the leading stem cell company. The company is focused on developing and marketing products to treat medical conditions in inflammatory, cardiovascular, orthopedic and wound healing markets. In Biosurgery, Osiris currently markets Grafix® for burns and chronic wounds, and Ovation® for orthopedic applications. Osiris is a fully integrated company with capabilities in research, development, manufacturing and distribution of stem cell products. Osiris has developed an extensive intellectual property portfolio to protect the company's technology, including 50 U.S. and 156 foreign patents.
Osiris, Prochymal, Grafix and Ovation are registered trademarks of Osiris Therapeutics, Inc. More information can be found on the company's website, www.Osiris.com. (OSIR-G)
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 for mesenchymal stem cells and biologic drug candidates and marketed Biosurgery products (including Prochymal, Chondrogen®, BioSmartTM, Grafix and Ovation); 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.
Source: Osiris Therapeutics
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