cytomedix wounds
cytomedix woundsCytomedix Taking the Science of Wound Repair ...and Using It to Treat Wounds

CYTOMEDIX SUBMITS COST EFFECTIVENESS STUDY FOR AUTOLOGEL™ TO CMS
Study Shows AutoloGel™ “Dominates” Standard of Care and Other Advanced Therapies

ROCKVILLE, Md., Oct. 8, 2007 – Cytomedix, Inc. (AMEX: GTF) today announced that it has submitted, to the Centers for Medicare and Medicaid Services (CMS), a cost effectiveness analysis of AutoloGel™ as compared to certain alternative therapies for patients with diabetic foot ulcers. Results of the study show that AutoloGel™ is both more effective and less costly than standard of care and other therapies analyzed in the study.

The study was conducted by B&D Consulting (B&D), an independent, national, advisory and advocacy firm located in Washington, DC. B&D developed the research methodology, model structure, assumptions, and inputs from the peer-reviewed literature, including the publication of Cytomedix’s completed clinical trial. Cytomedix paid B&D a fee for its work. This fee was not dependent on the results of the economic study.

This model developed by B&D simulates the clinical, cost, and quality-adjusted life years (QALYs) outcomes associated with using the AutoloGel™ System versus certain other treatment modalities in treating non-healing diabetic foot ulcers over a five-year period. The research shows that AutoloGel™ represents a potentially attractive treatment alternative for insurers and providers to address the cost burden and debilitating health effects associated with non-healing diabetic foot ulcers.

B&D’s model relies upon published data regarding health outcomes as well as costs associated with AutoloGel™, a saline gel control, standard wound care, and certain other treatment modalities. The model varies rates of healing, recurrence, infection, amputation, and death and associated costs reported in the literature for a hypothetical group of 200,000 diabetic foot ulcer patients.

The estimated 5-year average direct wound care costs (exclusive of lost work, disability, etc.) when AutoloGel™ was used to treat the most commonly sized diabetic foot ulcers was approximately $15,000. This was markedly less than similar costs ranging from approximately $24,000 to $47,000 when either standard of care or other enhanced therapies were simulated. Furthermore, the model suggests a measurable increase in QALYs (a function of increased survival rates and fewer wound complications) when AutoloGel™ is used. Alternative treatments studied in this model included such therapies as some tissue engineered grafts, ultrasound, and single growth factor therapies. Therapies that did not have published, peer-reviewed studies of their use, with full wound healing as the primary endpoint, were not considered in the study.

The Company submitted this study to CMS for consideration as CMS works through its open National Coverage Assessment (NCA) on platelet-rich plasma (PRP) gel. 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. The Company also anticipates that it will use this report and other data in its marketing efforts.

While cost is not an official factor in determination of national or local coverage decisions, the Company believes that the information may be helpful to CMS in considering the various data submitted regarding AutoloGel™. The Company also believes that the information from this study may be helpful to the Healthcare Common Procedure Coding System (HCPCS) Workgroup as they review the unique and specialized nature of PRP gel versus other wound care products in an effort to determine whether or not to grant a new HCPCS code appropriate for AutoloGel™.

“We are very pleased with the results of this study”, said Dr. Kshitij Mohan, Cytomedix Chairman and CEO. “It is gratifying to note that, according to the findings in this study, AutoloGel™ can provide patients with improved rates of healing and, therefore, better quality of life, and it also represents a significant cost-savings opportunity. We expect that this study will be of particular interest to CMS, commercial insurance companies, and other third-party payers, as well as to care providers such as long-term acute care facilities, nursing homes, or Veterans Administration hospitals sensitive to the cost savings provided by AutoloGel.”


ABOUT CYTOMEDIX

Cytomedix, Inc. is a biotechnology company specializing in processes and products derived from autologous platelet releasates for uses with wounds and other applications. The current offering is AutoloGel™System, a process that utilizes an autologous platelet gel composed of multiple growth factors, other platelet releasates, and fibrin matrix. The Company has announced favorable results from its blinded, prospective, multi-center clinical trial on the use of its technology with diabetic foot ulcers. 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 forwardlooking 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.

Although Cytomedix paid a fee to B&D Consulting to perform the cost effectiveness study, Cytomedix was not involved with the structure or conduct of the study, and can make no guarantees regarding the adequacy or accuracy of the information contained in the study. The economic model discussed above was developed by B&D through a review of the published literature available at the time the model was developed. Results reported in the cost effectiveness study are derived from a simulation of the probabilities of various health outcomes of cohorts of hypothetical subjects. These results are not intended to predict or guarantee actual treatment outcomes associated with any of the products discussed. Further, the study conducted by B&D did not consider all available treatment modalities. A broader study, including more treatment modalities, might render different results.

There is no guarantee that CMS, third-party payers such as insurers, or care providers will consider the study in determining whether to provide reimbursement coverage for AutoloGel™ or to provide AutoloGel™ as a treatment alternative. Even if the CMS considers the cost effectiveness study discussed above, there is no guarantee that that CMS will reverse its 2003 non-coverage decision which applies to AutoloGel™, or that third-party payers will provide reimbursement coverage for AutoloGel™. 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™ System. Based on the Company’s current levels of operations and cash flows, a substantial delay in obtaining a reversal on the noncoverage decision may render the Company unable to take advantage of such a decision.

Further, even assuming 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. Even if reimbursement from CMS and other third-parties is obtained, there is no guarantee that such reimbursement will be at levels sufficient to implement the Company’s current business plan. 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.

These forward-looking statements 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. 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.