ROCKVILLE, Md., Dec. 27, 2006 (PRIME NEWSWIRE) -- Cytomedix, Inc. (AMEX:GTF) today announced that it has submitted its written appeal to the FDA. Cytomedix staff and its external experts are scheduled to meet with the agency on January 30, 2007 to present its appeal.
As previously disclosed, by way of a well-established informal review process at the FDA, Cytomedix is appealing the recent denial of the Company's claims under its 510(k) Pre-Market Notification for AutoloGel(tm). Since the FDA's decision in October 2006, Cytomedix has been working closely with the agency to fully understand the issues to be considered by the review panel and has fully addressed those considerations in the written appeal. Although the informal review process does not contain any statutorily defined timeframes, the Company estimates that the FDA would render its decision within a few weeks after the presentation.
"We continue to feel very strongly that our product merits 510(k) clearance and are pleased to have the opportunity to present additional expert analysis and other clarifications to assist the FDA in its review process," commented Dr. Kshitij Mohan, Cytomedix Chairman and CEO. "We appreciate the responsiveness of the agency thus far and the ongoing open and candid communications between our organizations."
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 blinded, prospective, multi-center clinical trial on the use of its technology in healing diabetic foot ulcers and 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 healing of 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. There is no guarantee that the FDA will reverse its decision on the Company's 510(k) submission for a specific wound healing indication, or that this matter will be settled within any estimated timeframe. Further, even assuming the FDA grants the Company's request for marketing clearance, there is no guarantee that the Company will receive Medicare 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. 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.