Healthcare Industry News: diabetic foot ulcers
News Release - April 18, 2007
Cytomedix Provides Update On FDA ReviewActive Review Still Underway
ROCKVILLE, Md., April 18, 2007 (Healthcare Sales & Marketing Network) -- Cytomedix, Inc. (AMEX:GTF ) today provided an update on the Food and Drug Administration's (FDA) review of the Company's appeal regarding marketing clearance for it's AutoloGel(tm) System. The application for marketing clearance continues to be under active review by the FDA.
Since a January 30th meeting, the Company has maintained open lines of communication with the FDA in order to ensure all questions are clarified and any relevant additional information is provided. In particular, within the last five weeks in response to the FDA's request, the Company outlined a post-marketing surveillance study, addressing the FDA's concerns on the use of bovine thrombin that could be conducted should marketing clearance be granted. All requested information has been provided to the FDA in a timely manner.
The Company has recently learned that the FDA plans to consult with external experts in the wound care area and hematology who serve on panels for the FDA's Center for Devices and Radiological Health (CDRH) to seek their opinions on the safety of bovine thrombin as it is used in the AutoloGel(tm) System. The Company understands that such a consultation will be performed by individual experts through a review of the company's submissions to date and not as part of a formal panel meeting of the type required for pre market approval applications (PMAs).
The Company reiterated that this review process is informal and, therefore, does not carry with it any statutorily defined deadlines. However, the Company believes that the FDA continues to treat the review with a sense of urgency and seriousness and is diligently working toward a decision. While FDA has not provided the Company with any assurances on either the decision or the timeline and, therefore, neither can be predicted with any certainty, the Company hopes a decision would come within the next 60 to 90 days.
``We have done and will continue to do all we can to achieve the desired outcome as quickly as possible; namely marketing clearance for a specific indication for AutoloGel(tm),'' stated Dr. Kshitij Mohan, Cytomedix Chairman and Chief Executive Officer. ``While we had originally anticipated a decision by this time, we respect that the FDA is giving thorough consideration to our appeal.''
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.
As of this date, the FDA has not granted marketing clearance for the AutoloGel(tm) Systems, and there is no guarantee that the FDA will reverse its decision on the Company's 510(k) submission for a specific wound healing indication. Further, there is no guarantee that a response from the FDA will be received 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 or 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. 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.
The forward-looking statements in this press release 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., including the Company's Form 10-K for the year ended December 31, 2006. 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.
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