ROCKVILLE, Md., April 22, 2008 (PRIME NEWSWIRE) -- Cytomedix, Inc. (AMEX:GTF) today announced that it had recently met with the Centers for Medicare and Medicaid Services (CMS) to determine the optimal path forward for obtaining Medicare coverage for its AutoloGel(tm) System. While CMS does not provide specific commitments regarding any future decision on coverage, the Company sought and received from CMS valuable guidance on the data and information that are likely to be useful during any future reconsideration of the Company's request for a National Coverage Determination (NCD) supporting the use of its AutoloGel System on chronic wounds such as diabetic foot ulcers.
Based on the discussions with CMS, and its decision memorandum in which it denied the Company's request for coverage for the use of platelet gel in chronic wounds, Cytomedix will initiate a study to gather additional data to meet CMS' requirements for a favorable coverage decision. In its decision memorandum, CMS stated that the results of the clinical trial conducted by Cytomedix, with other studies presented for review, were "suggestive" but "inadequate" to satisfy the CMS requirement that a therapy should be "reasonable and necessary" to be covered. Therefore, the company believes that a future prospective study or wound registry which yields favorable data supporting the results of the previous trial is likely to be the most efficient and cost effective means to meet CMS' requirements. As discussed with CMS, the Company will draft a protocol for a study to gather additional data on AutoloGel(tm). This draft protocol will be submitted to CMS for review and further refinement prior to the commencement of enrollment in the study. While the full scope and size of the study is yet to be determined, Cytomedix believes that it may be less complex, less time-consuming, and less expensive than its randomized, controlled, clinical trial completed in 2005. The company can provide no assurance that by submitting data from a study pursuant to the most recent CMS guidance, as described above, it will be successful in its efforts to gain a favorable National Coverage Determination.
"We are encouraged by our discussions with CMS, and are focused on providing them with the additional data they require while at the same time minimizing the timeline to completion and the costs to Cytomedix," stated Dr. Kshitij Mohan, Cytomedix Chairman and CEO. "We look forward to developing further evidence to support the benefits indicated in the previous studies and respond to the concerns of CMS," he added.
Meanwhile, the Company is proceeding with its previously announced plans to commercialize its AutoloGel System in the non-Medicare market.
ABOUT CYTOMEDIX
Cytomedix, Inc. is a biotechnology company specializing in processes and products derived from autologous platelet releasates for use on wounds and other applications. The current offering is the AutoloGel System, a process that utilizes an autologous platelet gel composed of multiple growth factors, other platelet releasates, and fibrin matrix. Additional information regarding Cytomedix is available at: http://www.cytomedix.com.
SAFE HARBOR STATEMENT
All statements in this news release that are not based on historical fact are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 and the provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements in this press release, include, without limitation, the Company's plans, intentions, and expectations relating to its contemplated additional study on AutoloGel and its on-going efforts to secure CMS coverage, its ability to generate the data that would be satisfactory for CMS to arrive at a positive coverage decision, and the estimated costs, time, or complexity involved in its contemplated study. Further, there can be no assurance that if and when a final protocol is developed, that the Company will be able to execute it without seeking additional outside financing, the obtainment of which, on terms acceptable to the Company, is not assured. There is no assurance that the Company's efforts to penetrate the non-Medicare market will be successful. While management has based any forward-looking statements contained herein on its current expectations, the information on which such expectations were based may change. These forward-looking statements rely on a number of assumptions concerning future events and are subject to a number of risks, uncertainties, and other factors, many of which are outside of the Company's control, including among others, the success of sales initiatives, governmental regulation, acceptance by the medical community and competition, that could cause actual results to materially differ from such statements. Such risks, uncertainties, and other factors include, but are not necessarily limited to, those set forth under Item 1A "Risk Factors" in the Company's Annual Report on Form 10-K for the year ended December 31, 2007. Cytomedix operates in a highly competitive and rapidly changing environment, thus new or unforeseen risks may arise. Accordingly, investors should not place any reliance on forward-looking statements as a prediction of actual results. We disclaim any intention to, and undertake no obligation to, update or revise any forward-looking statements. Readers are also urged to carefully review and consider the other various disclosures in the Company's Annual Report on Form 10-K for the year ended December 31, 2007, as well as other public filings with the SEC since such date.