ROCKVILLE, Md., Sept. 30, 2009 (GLOBE NEWSWIRE) -- Cytomedix, Inc. (NYSE Amex:GTF), a leading developer of biologically active regenerative therapies for wound care, inflammation and angiogenesis, announces that the Company has entered into a license and distribution agreement with Millennia Holdings, Inc. ("Millennia") for the Company's AutoloGel(TM) System in Japan. The AutoloGel(TM) System is the Company's proprietary, point-of-care device for the production of Platelet Rich Plasma ("PRP") gel derived from the patient's own blood and is indicated for use in exuding wounds such as leg ulcers, pressure ulcers, diabetic ulcers and for the management of mechanically or surgically-debrided wounds. The agreement provides territorial exclusivity for 10 years with the option to extend terms upon agreement by both parties.
Millennia will be responsible for implementing regulatory and reimbursement processes for the AutoloGel(TM) System in Japan. Through its subsidiary wound management company, which is the sole wound management corporation in Japan, Millennia will work with its network of hospitals in Japan to conduct the necessary clinical studies for regulatory approval. Thereafter, Millennia plans to sell and distribute Cytomedix's AutoloGel(TM) System for the treatment of a variety of chronic wounds, including diabetic wounds which represent a growing and underserved patient population in Japan.
"We are very excited to be expanding the clinical and commercial footprint for the AutoloGel(TM) System with this new agreement with Millennia," said Martin Rosendale, Chief Executive of Cytomedix. "Millennia has a strong commitment to building a world class wound healing franchise and bringing premier wound healing technologies to the Japanese market. This is an excellent opportunity for us to bring the AutoloGel(TM) System into this important market while allowing us to focus our own efforts on building our franchise and growing sales in the U.S."
"We look forward to bringing the AutoloGel(TM) System to the Japanese market as its advanced technology has demonstrated superior clinical efficacy in treating a variety of chronic wounds," commented Hiroki Tarui, President and Chief Executive Officer of Millennia Holdings, Inc. "We believe our experience in successfully bringing new products to market, along with our established network of hospitals and home health care systems will provide the platform to effectively advance the AutoloGel System through 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
Cytomedix develops, sells and licenses regenerative biological therapies including the AutoloGel(TM) System, a device for the production of Platelet Rich Plasma ("PRP") gel derived from the patient's own blood. The AutoloGel(TM) System is cleared by the U.S. Food and Drug Administration for use on a variety of exuding wounds. The Company is pursuing a multi-faceted strategy to penetrate the chronic wound market with its AutoloGel(TM) System. The Company is also moving forward with the development of other product candidates in its pipeline. Most notably is its CT-112 product, an anti-inflammatory peptide that has shown promise in preclinical testing. Additional information regarding Cytomedix is available at www.cytomedix.com.
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, viability and effectiveness of the Company's 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, the Company's ability to raise additional capital and to continue as a going concern, its ability to successfully commercialize its product in Japan under the terms of the license agreement, and Cytomedix's ability to execute on its strategy to market the AutoloGel(TM) System as contemplated. 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.