GAITHERSBURG, MD--(Marketwire - Mar 4, 2013) - Cytomedix, Inc. ( OTCQX : CMXI ) (the "Company"), a regenerative therapies company commercializing and developing innovative platelet and adult stem cell technologies, announced today that the Center for Medicare & Medicaid Services (CMS) has granted formal approval of the clinical outcomes defined in four protocols developed and submitted by Cytomedix in response to the National Coverage Determination (NCD) memo for autologous blood derived products for chronic wound care issued last August by CMS. With these protocol approvals, clinicians can use AutoloGel™ to treat Medicare beneficiaries with chronic wounds and receive reimbursement for the product under the Coverage with Evidence Development (CED) program. Cytomedix expects to begin rolling out the protocols to wound care clinics during March, and anticipates the first patients will be treated under the protocols soon thereafter.
Martin Rosendale, Chief Executive Officer of Cytomedix stated, "To say we are pleased with this latest and important step of protocol approval would be an understatement. We have long believed that the AutoloGel System can be a significant addition to the complement of wound management therapies utilized by clinicians working to better address this unmet medical need. It is gratifying to see several years of diligent effort rewarded and we look forward to serving clinicians and offering chronic wound patients an advanced biologically active therapy while demonstrating meaningful clinical benefit in the Medicare beneficiary population."
"We are also excited about our relationship with Intellicure," stated Mr. Rosendale. "Their network and relationships with high quality wound care clinics across the country can facilitate rapid deployment of the AutoloGel System, while access to the U.S. Wound Registry provides a robust and cost effective means for data management. Together, we are setting a new standard for clinical evidence in wound care."
Caroline Fife, MD, Chief Medical Officer of Intellicure added, "Intellicure and the U.S. Wound Registry are excited to partner with Cytomedix in facilitating the clinical protocols for Coverage with Evidence of Autologel. Not only is the product a major advance in the area of wound healing, but the use of electronic health records is a novel and cost effective mechanism to capture the data needed for clinical studies."
Under the approved protocols, Cytomedix initially expects to treat more than 1,200 patients with AutoloGel in outpatient wound care centers affiliated with Intellicure and the US Wound Registry. The four approved protocols are:
• CM001: Multi-Center, randomized, controlled trial comparing the efficacy of AutoloGel therapy plus usual and customary care (UCC) to UCC alone in diabetic foot ulcers.
• CM002-CM004: Three independent multi-center, cohort studies designed to compare AutoloGel plus UCC with UCC alone in diabetic foot ulcers, pressure ulcers, and venous ulcers.
These protocols will be rolled out initially at up to 30 USWRRN (U.S. Wound Registry Research Network) centers, and up to 10 non-USWRRN centers. The protocols will be registered on the ClinicalTrials.gov website. CMS expects that the results of all CMS-approved CED studies will be published in peer-reviewed journals.
In general, Medicare coverage is limited to items and services that are reasonable and necessary for the diagnosis or treatment of an illness or injury and that are within the scope of a Medicare benefit category. CED is a determination that a product is reasonable and necessary, based on the best available clinical data, but where the evidence base is not yet sufficiently developed. In these cases, CMS agrees to provide reimbursement coverage while at the same time generating additional clinical data to demonstrate the impact on health outcomes. CMS-approved CED studies must be designed and conducted prospectively to produce evidence to inform future Medicare coverage.
Diabetic foot ulcers (DFUs) are a common complication of diabetes. In 2007, the treatment of diabetes and its complications in the United States generated at least $116 billion in direct costs. Despite aggressive treatment, hospitalizations for lower-extremity amputations are high. Failure to heal a diabetic foot ulcer, even a relatively non-severe ulcer, increases the risk of infection and can lead to subsequent amputation, especially if ischemia is present and the ulcer is non-responsive to standard of care and hyperbaric oxygen therapy.
Pressure ulcers (PUs) are a problem in all patient care settings, where about 1 million individuals in the United States have a PU at any given time. In nursing homes, the prevalence of PUs ranges from 2.6% - 24% with 25% of patients transferred from acute care hospitals having a PU. Given the significant morbidity associated with pressure ulcers and the high cost of their management there is a need to investigate novel treatment options. The results of AutoloGel to date when used to treat PUs have been promising; the planned CED study is the first controlled study.
Venous leg ulcers (VLUs) are a common condition, especially in the elderly, and are thought to arise as a result of prolonged inflammatory conditions associated with underlying venous disease and may be exacerbated by ischemia. In the U.S., VLUs account for 70-90% of ulcers found on the lower leg with a prevalence of about 600,000; 1.7% of the Medicare population are affected. VLUs cost 2 million working days annually and cost the healthcare system $2.5-3.5 billion. The planned CED study is the first controlled study with AutoloGel in VLUs.
About AutoloGel™ System
The AutoloGel System utilizes a proprietary unique technology that enables the rapid isolation and activation of PRP from a patient's own blood. The PRP is subsequently processed to produce a bioactive gel for application to the wound bed, re-establishing a balance needed for natural healing to occur. In normal healing, platelets migrate from the blood into the wound site where they serve as the primary source of growth factors for effective wound healing. In chronic wounds, blood supply may be impaired and the delivery of platelets is impeded, disallowing adequate concentrations of growth factors.