ROCKVILLE, Md., Aug. 10, 2005 (PRIMEZONE) -- Cytomedix (AMEX:GTF) today announced it has completed the treatment phase of the company's clinical trial involving 72 patients at 14 sites designed to test the safety and effectiveness of its AutoloGel(tm) System for diabetic foot ulcers.
Data was obtained through a 12-week patient treatment program under a FDA-approved, prospective, randomized, blinded and controlled study. This data is now in the process of being evaluated under strict quality control guidelines, with the company and investigators remaining blinded as to the results. Cytomedix anticipates the compilation of patient information and the subsequent analysis of the data by an independent statistician will require approximately two months at which time the results will be unblinded, i.e. it will be revealed which patients were in the treatment group and which were in the control group. Patients whose wounds have healed during this study will be followed up for an additional 12 weeks after the completion of the treatment phase to determine whether any of the healed wounds reopen again during that period.
"The completion of the treatment phase of this pivotal trial is yet another important milestone for the company. We are on target to complete the clinical trial during the fourth quarter and remain optimistic that the results of the study will demonstrate the safety and effectiveness of our AutoloGel(tm) System for wound care treatment," said Dr. Kshitij Mohan, chairman and chief executive officer of Cytomedix.
ABOUT THE COMPANY
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 the AutoloGel(tm) system, a technology that utilizes an autologous platelet gel composed of multiple growth factors and fibrin matrix. The company is conducting a controlled, blinded, prospective, multi-center clinical trial on the use of its technology in healing diabetic foot ulcers. Cytomedix is working with healthcare providers to offer this advanced therapy at the point-of-care in multiple settings. Additional information is available at: www.cytomedix.com.
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. 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.