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CYTOMEDIX PROVIDES UPDATE ON
EFFORTS TO SECURE MEDICARE REIMBURSEMENT
FOR ITS AutoloGel™ SYSTEM
Rockville, MD, April 22, 2008 – 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™ 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™. 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 timeconsuming,
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 forwardlooking
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. |
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