LITTLE ROCK, Ark., July 14, 2004 (PRIMEZONE) -- Cytomedix, Inc. (OTCBB:CYME) today announced it has commenced the patient treatment phase of the clinical study for its AutoloGel(tm) System with the randomization of patients into the trials.
The FDA-approved prospective, randomized, double-blinded controlled study against the standard of care for the treatment of chronic diabetic foot ulcers will involve over a dozen premier sites throughout the United States.
"Chronic diabetic ulcers is a debilitating condition that affects millions of patients. Existing treatments represent a significant and increasing burden to both public and private healthcare providers nationwide at a cost of billions of dollars. I look forward to the results of clinical data to support Cytomedix's approach to the treatment for chronic diabetic ulcers," said Alexander M. Reyzelman, D.P.M., a principal investigator of the clinical trials and associate professor and chairman, Department of Medicine, California School of Podiatric Medicine at Samuel Merritt College.
"Initiation of the patient treatment phase of our trials represents an important milestone for Cytomedix. While medical results reported to date from clinicians utilizing this technology have been extremely encouraging, we look forward to the opportunity of having the AutoloGel(tm) System tested under rigorous FDA-based guidelines. Our goal is to confirm the safety and efficacy of our product for well defined and specific clinical indications, reduce amputation rates and improve the quality of life for patients," said Kshitij Mohan, Ph.D., chief executive officer of Cytomedix. "We also expect that the data from this study will help us in obtaining favorable coverage and reimbursement decisions at the national and local levels," Mohan added.
About Diabetes
Diabetes is a group of diseases characterized by high levels of blood glucose resulting from defects in insulin production, insulin action, or both. Diabetes can be associated with serious complications and premature death. More than 18 million people in the United States age 20 years or older suffer from diabetes (8.7 percent of all people in this age group), with a much higher incidence of diabetes of 18.3 percent among those aged 60 years or older. Each year more than two million diabetic foot ulcers are treated in the United States. More than sixty percent of non-traumatic lower-limb amputations in the United States occur among people with diabetes, resulting in 6.5 amputations per 1,000 persons with diabetes, and more than 82,000 diabetes-related amputations in 2001. (1), (2), (3)
About Cytomedix
Cytomedix, Inc. is a biotechnology company specializing in processes and products derived from autologous platelet releasates. The current product offering is AutoloGel(tm), an autologous platelet gel composed of multiple growth factors and fibrin matrix, which is used to treat chronic wounds. 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 with 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.
(1) American Diabetes Association, National Diabetes Fact Sheet, February 2004
(2) Centers for Disease Control, Diabetes Public Health Resource, Non-traumatic Amputations with Diabetes
(3) Medical Data International, 1997