ROCKVILLE, Md., Sept. 10, 2007 (PRIME NEWSWIRE) -- Cytomedix, Inc. (AMEX:GTF) today announced that remarks submitted during the public comment period of the National Coverage Assessment (NCA) for Platelet Rich Plasma (PRP) gel by the Centers for Medicare and Medicaid Services (CMS) were overwhelmingly positive.
On June 25, 2007, CMS agreed to Cytomedix's request to reconsider a 2003 CMS non-coverage decision for autologous blood-derived products when used for the treatment of chronic non-healing wounds by physicians in their practice of medicine using a variety of products that have been marketed by several companies. As such, an NCA was initiated and a 30 day public comment period was opened. More than 40 public comments were received from medical doctors, clinicians, medical device companies, and others involved with PRP gel. These comments have been archived and may be viewed by visiting: https://www.cms.hhs.gov/mcd/viewpubliccomments.asp?nca_id=208
The overwhelming majority of the comments were favorable to the use of PRP in treating wounds. The comments reflected significant positive results observed in various settings when PRP gel was used to treat a wide variety of wounds, the cost effective nature of the therapy, and the efficacious performance of PRP gel on wounds that did not respond to other treatments.
According to the NCA Tracking Sheet maintained by CMS, the proposed decision memorandum due date is December 25, 2007, and the expected NCA completion date is March 24, 2008. Cytomedix will be submitting additional materials to CMS during the period leading up to the decision memorandum and as requested prior to completion of the NCA. These materials will include the final results of a Company-commissioned economic study analyzing the cost and quality of life benefits of the Company's AutoloGel(tm) System, as compared to standard of care and other treatment modalities, most of which are covered by CMS. A draft report of the economic study indicates that AutoloGel(tm) is more effective and less costly than standard wound care or other treatment modalities reported in recent literature.
The Company will continue its open and constructive dialogue with CMS, including additional face-to-face meetings from those already held, if required.
"We are extremely pleased by the significant support we are seeing for this technology. The breadth of submissions and the positive experience with platelet rich plasma therapy is compelling," said Dr. Kshitij Mohan, Chairman and CEO of Cytomedix. "We believe that PRP gel offers a meaningful solution to many wound care issues and in many patients may help in avoiding the need for amputations. We look forward to working with CMS to make this important technology accessible to those patients who could benefit by it," he added.
Interested parties may view the status of this NCA via the CMS website by visiting: https://www.cms.hhs.gov/mcd/viewtrackingsheet.asp?id=208
ABOUT CYTOMEDIX
Cytomedix, Inc. is a biotechnology company specializing in processes and products derived from autologous platelet releasates for uses in the treatment of wounds and other applications. The current offering is AutoloGel(tm), a technology that utilizes an autologous platelet gel composed of multiple growth factors and fibrin matrix. The Company has announced favorable results from its multi-center, blinded, prospective, randomized, controlled clinical trial on the use of its technology in treating diabetic foot ulcers. The Company is appealing the FDA's ruling related to its 510(k) application for marketing clearance for a new product seeking specific labeled indications for the use in chronic wounds. Additional information regarding Cytomedix is available at: http://www.cytomedix.com.
SAFE HARBOR STATEMENT
Statements contained in this press release not relating to historical facts are forward-looking statements that are intended to fall within the safe harbor rule for such statements under the Private Securities Litigation Reform Act of 1995. The information contained in the forward-looking statements is inherently uncertain, and Cytomedix's actual results may differ materially due to a number of factors, many of which are beyond Cytomedix's ability to predict or control, including among others, the success of new sales initiatives, governmental regulation, acceptance by the medical community and competition.
Comments received by CMS in response to the NCA are not necessarily indicative of actual results of PRP gel under controlled conditions. There is no guarantee that CMS will be able to complete its decision memorandum or final action on the NCA by the proposed dates, and even if completed, there is no guarantee that CMS will reverse its 2003 non-coverage decision which applies to AutoloGel(tm). Even assuming that CMS does reverse its previous non-coverage decision, there is no guarantee that such reversal will occur within the immediate future, or that the Company will be able to capitalize on this reversal in commercializing the AutoloGel(tm) System. Based on the Company's current levels of operations and cash flows, a substantial delay in obtaining a reversal on the non-coverage decision may render the Company unable to take advantage of such a decision.
Even if the Company were to achieve Medicare reimbursement, it still may be unable to adequately commercialize its product offerings if it fails to obtain other regulatory approvals the Company is currently seeking. As of this date, the FDA has not granted marketing clearance for the AutoloGel(tm) System, and there is no guarantee that the FDA will reverse its decision on the Company's 510(k) submission for a specific wound healing indication. Further, there is no guarantee that a response from the FDA will be received within any estimated timeframe. Further, even assuming the FDA grants the Company's request for marketing clearance and CMS reverses its non-coverage decision, there is no guarantee that the Company will receive other third-party reimbursement for its product, the Company's marketing efforts will be successful, or that it will be able to achieve its other strategic goals. There is also no guarantee that the Company's current capitalization will be sufficient to attain its goals, that future funding will be available to the Company on acceptable terms, or that the Company will ever be able to sustain itself from ongoing operations.
The forward-looking statements in this press release are subject to known and unknown risks and uncertainties that could cause actual events to differ from the forward-looking statements. More information about some of these risks and uncertainties may be found in the reports filed with the Securities and Exchange Commission by Cytomedix, Inc., including the Company's Form 10-K for the year ended December 31, 2006. Except as is expressly required by the federal securities laws, Cytomedix undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, changed circumstances or future events or for any other reason.