Osiris Therapeutics, Inc.
(NASDAQ: 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 9
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.