GAITHERSBURG, Md., Feb. 10, 2011 (GLOBE NEWSWIRE) -- Cytomedix, Inc. (OTCBB:CMXI) (the “Company” or “Cytomedix”) today announced that the Company has been issued a CE marking certification for its Angel(R) Whole Blood Separation System (“Angel”) and its activAT(R) Autologous Thrombin Processing Kit (“activAT”). CE is a mandatory European marking for certain product groups to indicate conformity with the essential health and safety requirements set out in European Directives, and allows Cytomedix to freely sell and distribute its products throughout the 28 countries of the European Economic Area (“EEA”).
The receipt of these certifications finalizes the transfer of control over the quality manufacture and distribution of these products in the EEA to Cytomedix in accordance with the terms of the acquisition from the Sorin Group in April 2010.
“With the acquisition of Angel and activAT, we gained an established presence in Europe for our platelet rich plasma products. The receipt of the CE mark allows us to continue to broaden our distribution network and to expand our European footprint,” commented Martin P. Rosendale, Chief Executive Officer of Cytomedix.
“This CE mark designation, along with our recent ISO 13485 certification, confirms that Cytomedix has the highest manufacturing standards and systems. We remain committed to upholding these stringent requirements to provide our customers and their patients with the quality they have come to expect from Cytomedix,” concluded Mr. Rosendale.
About Cytomedix, Inc.
Cytomedix develops, sells and licenses regenerative biological therapies primarily for wound care, inflammation and angiogenesis. The Company markets the AutoloGel(TM) 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(R) 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(R) Autologous Thrombin Processing Kit, which produces autologous thrombin serum from PPP. The activAT(R) 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(TM) 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 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. Such statements contained in this release are based on management’s exercise of business judgment as well as assumptions made by and information currently available to management. When used in this document, the words “may”, “will”, “anticipate”, “believe”, “estimate”, “expect”, “intend”, and words of similar import, are intended to identify any forward-looking statements. 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 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(TM) System as contemplated, our ability to successfully integrate the Angel(R) and activAT(R) product lines into our existing business, to assume and satisfy certain liabilities related to the Angel(R) and activAT(R) product lines, or our ability to service the deferred payments related to the acquisition of the Angel(R) and activAT(R) 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 (afields@lhai.com) (212) 838-3777 Bruce Voss (bvoss@lhai.com) (310) 691-7100
