ROCKVILLE, Md., May 9, 2005 (PRIMEZONE) -- Cytomedix, Inc. (OTCBB:CYME) today announced that it has completed the planned enrollment of 72 patients in the company's ongoing clinical trial to test the safety and effectiveness for its AutoloGel(TM) System for the treatment of diabetic foot ulcers.
As previously announced the clinical trial is an FDA-approved, prospective, randomized, blinded and controlled study of AutoloGel(TM). It involves over a dozen premier sites throughout the United States. The patients undergo up to 12 weeks of treatment and healed patients are followed for another 12 weeks. Total healing of the wounds is one of the key clinical end points being examined in the clinical trial.
"With the completion of enrollment for the blinded-trial we have reached an important clinical milestone and we are still on schedule to complete the trials in the second half of 2005," said Dr. Kshitij Mohan, chief executive officer of Cytomedix.
While the company remains blinded as to which patients are in either the treatment or control group, Mohan indicated that there have been no device-related unanticipated serious adverse effects related to the interventions in any of the patients since the commencement of the treatment phase. "Based on our current plans and expectations, we should have an adequate number of patients completing the trial in order to prove rigorously the safety and effectiveness of The AutoloGel(TM) System in healing diabetic foot ulcers. An important milestone will be the completion of the 12-week treatment of the patients currently enrolled. The data is expected to be unblinded at the time and we will know the rate of success in the healing of these wounds using our technology versus that of the traditional treatment. It should be noted that even though the enrollment of patients will now be stopped, it can be restarted should the need arise as a result of any further discussions with the FDA or the Centers for Medicare and Medicaid Services (CMS)."
He also highlighted the company's successful ongoing strategy to license its platelet-gel therapy to healthcare companies and medical device providers for utilization in a variety of clinical applications for the treatment of wounds and other damaged tissue.
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. 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.
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. For example, the clinical trial discussed in this communication may or may not result in proving conclusively that The AutoloGel(TM) System is safe and effective for the treatment of diabetic foot ulcers and the FDA or CMS may or may not be persuaded enough to clear or approve this technology. 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.