COLUMBIA, Md.--(BUSINESS WIRE)--
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 GrafixPRIME and GrafixCORE. These product-specific Q-Codes will assist healthcare providers in seeking coverage for their patients. The Q-Codes that have been established for GrafixPRIME and GrafixCORE 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.
About Grafix
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 worlds 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.
More here:
Osiris Therapeutics Establishes Direct Sales Force for Grafix®