ROCKVILLE, Md., Jan. 19, 2005 (PRIMEZONE) -- Cytomedix, Inc. (OTCBB:CYME) today announced the enrollment of its 50th patient in the company's clinical study for its AutoloGel(tm) System for the treatment of diabetic foot ulcers. The company plans to enroll a total of 72 patients in the study.
As previously announced, the FDA-approved prospective, randomized, blinded and controlled study of AutoloGel(tm) commenced in July 2004. It involves over a dozen premier sites throughout the United States. The patients undergo up to twelve weeks of treatment and healed patients are followed for another twelve weeks. Total healing of the wounds is one of the key clinical end points being examined in the study.
"The study is a blinded-trial, so we will not know which patient is enrolled in the Autologel(tm) versus control arm until the blind is removed after the last patient has received the full treatment. We are, however, encouraged that there have been no unanticipated or other serious adverse effects related to the interventions in the treatment group or in the control group of patients since the commencement of the treatment phase. Based upon the current progress in enrolling patients, we are still on target to complete the trials in the second half of 2005," said Dr. Kshitij Mohan, chief executive officer of Cytomedix.
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 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 well- 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 an advanced therapy at the point-of-care in multiple settings. Additional information is available at www.cytomedix.com.
Forward Looking Statements
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, 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.