Cytomedix, Inc. (NYSE Amex:GTF) (the "Company" or "Cytomedix") a leading developer of biologically active regenerative therapies for wound care, inflammation and angiogenesis, today announced that its Japanese partner, Millennia Holdings, Inc. ("Millennia"), has compiled data on 100 wounds treated with the Company's AutoloGel™ System, and will use this initial data to support its regulatory and reimbursement filings in Japan. The full data set is expected to be released through presentations at scientific and medical meetings and through publication in a peer-reviewed journal.
The AutoloGel System is a device for the production of autologous platelet rich plasma ("PRP") gel and is the only PRP device cleared by the U.S. Food and Drug Administration ("FDA") for use on a variety of exuding wounds. Its patent-protected formulation provides physiologically relevant concentrations of PRP that are optimal for wound healing.
In August 2009, Cytomedix entered into a license and distribution agreement with Millennia under which Millennia is responsible for implementing regulatory and reimbursement processes for the AutoloGel System in Japan. Through its subsidiary wound management company, the sole wound management corporation in Japan, Millennia conducted its clinical evaluation of the AutoloGel System to treat wounds at its network of hospitals in Japan and will use the positive outcomes from these 100 wounds to support its application for regulatory and reimbursement approval in Japan.
"We are delighted with the positive data Millennia has compiled on its first 100 wounds treated with the AutoloGel System, especially as these data continue to support our U.S. findings in both clinical studies and in 'real world' clinical experience that show the AutoloGel System to be effective in treating chronic wounds. We look forward to continuing to work with Millennia in support of their application for regulatory approval of the AutoloGel System in Japan, where there is a large and growing market opportunity," commented Martin P. Rosendale, President and CEO of Cytomedix. "With the data from these wounds, combined with the data we have developed in the U.S., we now have data on over 500 wounds that demonstrate the clinical utility of our AutoloGel System to meaningfully accelerate and enhance the body's own natural healing process in a variety of exuding wounds. This cumulative and growing body of positive clinical data should provide additional support to our efforts to secure U.S. reimbursement."
Hiroki Tarui, President and Chief Executive Officer of Millennia Holdings, Inc., commented on the data stating, "The AutoloGel System's advanced technology has demonstrated superior clinical efficacy in treating a variety of chronic wounds as evidenced by our clinical evaluation of these 100 wounds. We were very pleased that the positive outcomes seen in U.S. studies were confirmed by our own clinical case studies. We expect to use this positive data to effectively advance the AutoloGel™ System as a foundation to succeed to the regulatory process and on to a successful commercial launch in Japan."
The diabetic population in Japan is estimated to be 22.1 million, including patients suspected to have diabetes, according to the National Heath and Nutrition Report 2008 by the Ministry of Health Labor and Welfare in Japan. This data indicates that nearly one out of five Japanese either has diabetes or is suspected to be diabetic, thus providing a significant market potential for diabetic wound healing in Japan.
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