LITTLE ROCK, Ark., March 8, 2004 (PRIMEZONE) -- Cytomedix, Inc. (OTCBB:CYME) today announced it has received approval from the U.S. Food and Drug Administration to initiate clinical trials for its AutoloGel(tm) System for the treatment of chronic diabetic foot ulcers.
The trial, a randomized, double-blinded controlled study against the standard of care for the treatment of chronic wounds, will be conducted at up to 12 premier sites throughout the United States, with enrollment of approximately 74 patients expected to commence in mid-April.
"The commencement of clinical trials represents a milestone in the company's evolution and an important first opportunity to demonstrate the safety and efficacy of the AutoloGel(tm) System under guidelines established by the FDA in a rigorously controlled clinical environment," said Mark Cline, president of Cytomedix, in response to the agency's approval of the company's investigational device exemption (IDE) application.
The AutoloGel(tm) System involves the production of a treating composition that delivers multiple growth factors to the affected wound bed. "The benefits of autologous multiple growth factors in tissue and wound repair have long been published within the scientific research community. Clinical trials position Cytomedix one step closer to being able to secure coverage and reimbursement for the AutoloGel(tm) System in all healthcare provider settings," Cline added.
Dr. Charles R. Baxter, chief medical advisor and chairman of the medical advisory board of Cytomedix, and a world-renowned expert in the field of chronic wounds and burns commented, "We look forward to the opportunity to study the use of the AutoloGel(tm) System for the treatment of chronic diabetic foot ulcers. The medical results reported to date from clinicians utilizing the AutoloGel(tm) System have been extremely encouraging. The replication of this data in the forthcoming FDA clinical trials could very well establish a ground-breaking advancement for the treatment of chronic diabetic foot wounds."
"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. We look forward to the results of clinical data to support our belief that the AutoloGel(tm) System is a highly effective and superior treatment for chronic diabetic ulcers, providing tremendous clinical and economic benefits to patients and healthcare providers," said Cline.
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% of all people in this age group), with a much higher incidence of diabetes of 18.3% 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