CMS APPROVES RECONSIDERATION REQUEST FOR REIMBURSEMENT OF AUTOLOGOUS PRP GEL IN CHRONIC WOUND CARE

GAITHERSBURG, Md. (November 11, 2011) – Cytomedix, Inc. (OTC/BB: CMXI) (the “Company”), a leading developer of biologically active regenerative therapies for wound care, inflammation and angiogenesis, announced today that the Centers for Medicare & Medicaid Services (“CMS”) formally initiated a reconsideration of its National Coverage Determination for blood-derived products for chronic non-healing wounds to determine whether autologous platelet rich plasma (“PRP”) gel is reasonable and necessary under the Medicare program. The action was taken on November 9, 2011 with the initiation of a tracking sheet and the commencement of a 30 day public comment period, both of which can be found at the link below. Following its analysis, CMS proposes to publish an initial decision memo by May 9, 2012.

As previously announced, a comprehensive request for Medicare coverage reconsideration submitted by Cytomedix in late May 2011 and amended in September 2011 proposed that there is sufficient and compelling clinical evidence to validate the use of autologous PRP gel to treat chronic, non-healing pressure ulcers, venous ulcers, and diabetic foot ulcers. The request set out the reasons why PRP gel significantly and reliably improves the rate of complete healing, speed and progress to healing, and quality of life as compared with standard wound care in the Medicare-eligible population. In the Company’s most recent update on the status of the reconsideration request (August 31, 2011), Cytomedix indicated its belief that a potential path forward towards reimbursement could involve CMS’ Coverage with Evidence Development (“CED”) program. In the official tracking sheet, CMS encourages the submission of comments that would pertain to clinical studies falling under the CED paradigm.

“We are encouraged by CMS’ approval of the reconsideration request for Medicare coverage of autologous PRP gel for chronic non-healing wounds. We have had extensive discussions with CMS covering the clinical evidence, and explained the support for the coverage of autologous PRP gel among key opinion leaders and advocacy groups within the broad wound care community,” said Martin P. Rosendale, Chief Executive Officer of Cytomedix. “We believe that there is a strong case to revise Medicare’s National Coverage Determination to cover autologous PRP gel for the benefit of the various stakeholders interested in improving clinical wound care outcomes while lowering overall costs for Medicare beneficiaries. Cytomedix remains committed to this technology and to the compelling scientific rationale at its core as an important and necessary part of the overall solution to non-healing chronic wounds.”

CMS website link:

National Coverage and Analysis (NCA) Tracking Sheet for Autologous Blood-Derived Products for Chronic Non-Healing Wounds (CAG-00190R3)