ROCKVILLE, Md., Jan. 30, 2006 (PRIMEZONE) -- Cytomedix, Inc. (AMEX:GTF), a biotechnology company specializing in the research, development, licensing, and systems for treating non-healing chronic wounds including diabetic ulcers, today announced that the Company has submitted a premarket 510(k) application to the U.S. Food and Drug Administration (FDA) seeking clearance of its AutoloGel(tm) System for specific wound healing indications, based on the results of its diabetic foot ulcer clinical trial and other available data.
"We are pleased that our submission to FDA has been made in a very timely manner," stated Cytomedix Chairman and Chief Executive Officer Kshitij Mohan. "We believe that the data from our clinical trial indicates high levels of safety and effectiveness that more than meet the level of 'reasonable assurance of safety and effectiveness' and a highly favorable benefit-risk ratio, the two key considerations that underpin the regulatory review of medical devices under FDA's laws and regulations. While we do not presume to predict FDA's decision, we look forward to working with the Agency toward a timely and favorable decision to obtain a marketing clearance for our product for specific claims reflecting the high healing rates and safety of the AutoloGel(tm) System. This event puts us another step closer to receiving the FDA clearance and Medicare reimbursement for our product as well as achieving greater awareness and acceptance of AutoloGel(tm) by the clinical community."
In recently completed clinical trials of the AutoloGel(tm) System, analysis of the size of wounds showed that 35 out of the 40 patients, i.e. 88% of the patients, had wounds that were less than or equal to 7 sq. cm in area and 2 cubic cm in volume. For these most common wound sizes in the study, the healing rate for the AutoloGel(tm) group was 81.3% and that for the Control group, which was treated with a control treatment, was 42.1%. The difference of 39.2 % between these rates is strongly statistically significant, with a p-value of 0.036. The healing rates of AutoloGel(tm) at 81.3% for the most common wound sizes in the study and 68.4% for all wound sizes are, to our knowledge, better than any other wound care products cleared by the FDA. Cytomedix has completed all planned analysis of clinical lab data, such as blood chemistry and other safety parameters. No statistical or clinical significance difference with safety of the control treatment was reported.
The 510(k), submitted to the FDA's Center for Biologics Research and Evaluation (CBER), must undergo a 90-day statutory review period. The Agency may request additional information or a different regulatory pathway that may lengthen its review process. Cytomedix has provided the Agency information comparing the AutoloGel(tm) System to other marketed platelet-rich plasma separation systems and wound care products for the same intended use and similar indications and cleared through the 510(k) process. Cytomedix believes the comparisons to these marketed products, called predicate devices, provide a strong basis supporting a clearance of the AutoloGel (tm)System using the traditional 510(k) process.
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 concluded the blinded, prospective, multi-center clinical trial on the use of its technology in healing 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 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 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, there is no guarantee that the Company will receive Medicare reimbursement for AutoloGel(tm) even assuming the FDA grants the Company's request for marketing clearance. 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.