Healthcare Industry News: Cytomedix
News Release - November 29, 2012
Cytomedix Announces CE Mark Approval for Angel(R) cPRP System for Processing Blood and Bone Marrow AspirateGAITHERSBURG, MD--(Healthcare Sales & Marketing Network) - Cytomedix, Inc. ( OTCQX : CMXI ) (the "Company"), a regenerative therapies company commercializing and developing innovative platelet and adult stem cell technologies, announced today it has received CE Mark approval for the Angel® Concentrated Platelet Rich Plasma (cPRP) System for processing blood and bone marrow aspirate. Cytomedix is now free to market and distribute the Angel cPRP system with this new indication throughout the European Economic Area ("EEA") and in other countries where the CE Mark is recognized. The new indication creates potential for use in bone repair and regeneration procedures that includes spinal, periodontal and joint revision surgery.
Cytomedix has established a broad network of experienced distributors to promote and sell the Angel cPRP system in international markets. International Angel sales have tripled over the past year with rapid expansion in Europe and the Middle East fueling growth to over $1 million expected for full year 2012. Angel is well represented in key European markets such as United Kingdom, Netherlands, Italy, and Poland with plans to expand the European base in 2013. Sales growth in the Middle East will be driven by entry into new countries such as Kuwait, Saudi Arabia and Bahrain with the expanded indications.
"The CE Mark for the Angel cPRP System for use with bone marrow aspirate represents an important milestone for our overseas business," said Martin Rosendale, Chief Executive of Cytomedix. "We see this new indication having a noticeable impact on our promotional efforts and becoming a major driver of growth in various international markets. On the strength of this approval, we believe that international Angel revenues have the potential to double in 2013."
The Angel cPRP System is intended to be used in the clinic or intraoperatively at the point-of-care for the safe and rapid preparation of platelet rich plasma (PRP) from a small sample of whole blood or a small mixture of blood and bone marrow. The system is designed to produce consistently high platelet yields using a fully automated process and represents a significant engineering advance in autologous whole blood and bone marrow separation. Angel's advantages compared with other commercially available systems include: 1) high platelet yields, 2) significant reduction in pro-inflammatory cells, 3) rapid processing time, 4) adjustable hematocrit from 0%-25%, and 5) flexible final cPRP volumes. Proprietary software automatically adjusts the separation parameters to deliver a consistent, high quality product.
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.
About Cytomedix, Inc.
Cytomedix, Inc. is an autologous regenerative therapies company commercializing innovative platelet technologies for orthopedics and wound care with a pipeline of adult stem cell therapies for tissue repair. The Company markets the AutoloGel™ System, a device for the production of autologous platelet rich plasma ("PRP") gel for use on a variety of exuding wounds and the Angel® Concentrated Platelet Rich Plasma 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. On February 8, 2012 Cytomedix closed the acquisition of Aldagen, a biopharmaceutical company developing regenerative cell therapies based on its proprietary ALDH bright cell technology, currently in a Phase 2 trial for the treatment of ischemic stroke. For additional information please visit Cytomedix.com
Safe Harbor Statement
Statements contained in this press release 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' actual results may differ materially due to a number of factors, many of which are beyond Cytomedix' ability to predict or control, including among many others, risks and uncertainties related to the Company's ability to successfully integrate the Aldagen acquisition, to successfully manage contemplated clinical trials, to manage and address the capital needs, human resource, management, compliance and other challenges of a larger, more complex and integrated business enterprise, viability and effectiveness of the Company's sales approach and overall marketing strategies, 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, and Cytomedix's ability to execute on its strategy to market the AutoloGel™ System as contemplated. To the extent that any statements made here are not historical, these statements are essentially forward-looking. The Company uses words and phrases such as "believes", "forecasted," "projects," "is expected," "remain confident," "will" and/or similar expressions to identify forward-looking statements in this press release. Undue reliance should not be placed on forward-looking information. 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. Additional risks that could affect our future operating results are more fully described in our U.S. Securities and Exchange Commission filings, including our Annual Report for the year ended December 31, 2011 and other subsequent filings. These filings are available at www.sec.gov.
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