GAITHERSBURG, Md., Dec. 22, 2010 (GLOBE NEWSWIRE) -- 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.
About Cytomedix, Inc.
Cytomedix develops, sells and licenses regenerative biological therapies primarily for wound care, inflammation and angiogenesis. The Company markets the AutoloGel™ System, a device for the production of platelet rich plasma (PRP) gel derived from the patient's own blood for use on a variety of exuding wounds; the Angel® Whole Blood Separation System, a blood processing device and disposable products used for the separation of whole blood into red cells, platelet poor plasma (PPP) and PRP in surgical settings; and the activAT® Autologous Thrombin Processing Kit, which produces autologous thrombin serum from PPP. The activAT® kit is sold exclusively in Europe and Canada, where it provides a completely autologous, safe alternative to bovine-derived products. The Company is pursuing a multi-faceted strategy to penetrate the chronic wound market with its products, as well as opportunities for the application of AutoloGel™ and PRP technology into other markets such as hair transplantation and orthopedics while actively seeking complementary products for the wound care market. Cytomedix also seeks to monetize other product candidates in its pipeline through strategic partnerships, out-licensing or sale. Most notably is its anti-inflammatory peptide (designated CT-112) that has shown promise in preclinical testing. Additional information regarding Cytomedix is available at .
Safe Harbor Statement
Statements contained in this communication 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, our ability to maintain listing of our securities on the NYSE Amex, viability and effectiveness of our sales approach and overall marketing strategies, the outcome of development or regulatory review of CT- 112, commercial success or acceptance by the medical community, competitive responses, our ability to raise additional capital and to continue as a going concern, our ability to execute on our strategy to market the AutoloGel™ System as contemplated, our ability to successfully integrate the Angel® and activAT® product lines into our existing business, to assume and satisfy certain liabilities related to the Angel® and activAT® product lines, or our ability to service the deferred payments related to the acquisition of the Angel® and activAT® product lines. 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. Cytomedix operates in a highly competitive and rapidly changing business and regulatory environment, thus new or unforeseen risks may arise. Accordingly, investors should not place any reliance on forward-looking statements as a prediction of actual results. Except as is expressly required by the federal securities laws, Cytomedix undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, changed circumstances or future events or for any other reason.
CONTACT: Cytomedix, Inc. David Jorden, Executive Board Member Martin Rosendale, CEO Andrew Maslan, CFO (240) 499-2680 Lippert/Heilshorn & Associates Anne Marie Fields (212) 838-3777 afields@lhai.com Bruce Voss (310) 691-7100 bvoss@lhai.com