GAITHERSBURG, Md., Dec. 7, 2010 (GLOBE NEWSWIRE) -- Cytomedix, Inc. (NYSE:GTF) (the "Company" or "Cytomedix") today announced that it has received certification for the ISO 13485 Quality Management Standard for Medical Devices as well as Canadian Medical Device Certification for its Gaithersburg facility. The announcement certifies Cytomedix as a provider of high-quality devices for the medical industry and allows the Company to operate commercially in Europe and in Canada.
The ISO 13485 certification recognizes Cytomedix's compliance with medical industry standards. The ISO 13485 registration recognizes Cytomedix as a highly efficient, cost-effective and stable organization with advanced manufacturing processes to deliver product and service quality.
"Receipt of these certifications is the culmination of a great deal of cross-functional diligence and hard work by our employees. It is reflective of our mission to meet, if not exceed, all quality standards, and allows us to expand our global footprint and advance the international launch of our platelet rich plasma products," commented Martin P. Rosendale, President and CEO of Cytomedix. "Our customers in the medical industry understand the value of the ISO 13485 certification. We remain committed to the clinicians and patients we serve, and to continuously improving the effectiveness of the quality management system under which we operate."
About ISO 13485
ISO 13485:2003was created by the International Organization for Standardization (ISO) as an international quality management standard for medical devices. Manufacturers of medical electronics must be certified with ISO 13485 in order to secure global business contracts. ISO 13485:2003 supplements ISO 9001:2000 with additional requirements for the medical industry in the areas of design and process controls, special processes, traceability, record retention and regulatory actions.
Complete details of the ISO 13485:2003 standard can be viewed on the ISO website at .
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