ROCKVILLE, Md., Oct. 5, 2006 (PRIMEZONE) -- Cytomedix, Inc. (AMEX:GTF) today announced an update on the 510(k) Premarket Notification needed for marketing clearance for the AutoloGel(tm) System that has been filed with the U.S. Food and Drug Administration (FDA).
Chairman and Chief Executive Officer Kshitij Mohan, Ph.D., and other Company executives met with FDA officials in early September as part of the previously announced request from the agency for further information and analysis related to the conduct of the AutoloGel(tm) clinical trial. Cytomedix submitted its official responses to the FDA requests in late September.
"We are pleased to have clarified our understanding of the FDA's requests for additional information, and for the opportunity to review with them our draft responses. As a result of the meeting in early September, we have supplemented our draft responses with the additional information requested by the FDA at the meeting, and we have submitted the response to the agency," Dr. Mohan said. "We believe the results of our clinical trial, together with other data, as presented in our original application and subsequent information, continues to support our view that the data presented more than meet the standards of 'substantial equivalence' required under the 510(k) pathway for marketing clearance. We look forward to hearing from the FDA in a timely manner."
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 has submitted a 510(k) application for marketing clearance for a new product to the FDA 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 complete its review of the Company's 510(k) submission for a specific wound healing indication within any estimated timeframe, or that the FDA will fully agree with the Company in the interpretation of the data or the regulatory pathway and provide marketing clearance. 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 or that future funding will be available to the Company on acceptable terms. 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.
CONTACT: Cytomedix Kshitij Mohan, Ph. D., Chairman and CEO 240-499-2680 The Wall Street Group, Inc. Ron Stabiner 212-888-4848