Rockville, MD, Jan. 30, 2008 – Cytomedix, Inc. (AMEX: GTF) today announced that its public comment, submitted in response to the Centers for Medicare and Medicaid Services’ (CMS) proposed decision memorandum (PDM), is now available at CMS’s website. A copy of the full comment is available via the link below. CMS has preliminarily proposed not to change its existing 2003 National Coverage Decision which includes non-covered Autologous Blood-Derived Products for Chronic Non- Healing Wounds, such as AutoloGel. CMS has stated that a public comment period on the PDM ended on January 19, 2008 with a final decision expected to be issued by March 19, 2008.
http://www.cytomedix.com/pressreleases/CytomedixCommentsCAG00190R220080118.pdf
In this detailed submission, posted on January 29, 2008, Cytomedix focused its request on chronic wounds and divided them into diabetic foot ulcers and other chronic wounds. The Company introduced new, high quality data that was not considered as part of the PDM and highlighted other evidence not reflected in the preliminary decision. The Company also narrowed its coverage request to only those PRP gel products produced via a PRP separation system.
ABOUT CYTOMEDIX
Cytomedix, Inc. is a biotechnology company specializing in processes and products derived from autologous platelet releasates for uses on chronic 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 and is intended for use on diabetic ulcers, pressure ulcers, leg ulcers and mechanically or surgically debrided 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 sales initiatives, governmental regulation, acceptance by the medical community and competition.
Cytomedix cannot predict whether CMS will reverse its preliminary non-coverage decision which applies to AutoloGel™, and there is no guarantee that CMS will provide any level of coverage, even limited coverage or coverage with evidence development. Even if CMS reversed its preliminary 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 non-coverage 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.