GAITHERSBURG, Md., Sept. 1, 2011 (GLOBE NEWSWIRE) -- Cytomedix, Inc. (OTCBB:CMXI) (the "Company"), a leading developer of biologically active regenerative therapies for wound care, inflammation and angiogenesis, announced today the recent submission of a 510(k) to the U.S. Food and Drug Administration ("FDA") for use of the Angel® Whole Blood Separation System for processing a bone marrow aspirate. The expanded indication includes processing a mixture of blood and bone marrow, a rich source of stem cells.
In vitro performance testing supporting the 510(k) compared Cytomedix's Angel System to the predicate device for preparing platelet rich plasma ("PRP") from blood and bone marrow. The test results yielded statistically significant data showing the Angel System:
- increased the concentrations of hematopoietic progenitor/stem cells;
- reduced the presence of pro-inflammatory cells that can be detrimental for treating certain medical indications; and
- provided better separation of PRP and red blood cells compared with the predicate device
Expanded use of the Angel System for the production of PRP containing stem cells increases Cytomedix's ability to support and advance markets within personalized regenerative medicine. In the U.S., approximately 300,000 spinal fusion procedures are performed each year and the application of bone marrow or bone marrow concentrates has been the historical gold standard to support effective fusion. The biologics market associated with spinal fusion procedures is approximately $800 million annually. While the Angel System is currently being used at a limited number of clinical sites for this purpose, FDA clearance for this expanded indication will allow Cytomedix to market the Angel System for this significant opportunity. The ease-of–use, separation efficiencies, and high quality output, are of notable benefit and competitive advantage compared with other commercially available systems.
In addition to spinal fusion procedures, the stem cell enriched concentrates produced by the Angel System offer clinical opportunities currently being evaluated for the treatment of critical limb ischemia and cardiac ischemia. Significant clinical investigation is underway in numerous studies in both therapeutic conditions involving various aspects of autologous stem cells. The Angel System is well positioned as a best-in-class device to participate in this evolving therapeutic arena.
"We are pleased to have filed this 510(k) for a bone marrow concentrate indication as it expands the versatility and competitive positioning of the Angel System for both new and existing customers. Importantly, this indication serves a number of large markets that we believe the Angel System is well-poised to penetrate," said Martin P. Rosendale, Chief Executive Officer of Cytomedix. "We continue to explore a variety of indications where the Angel System can provide added therapeutic benefit and expect its clinical results and ease-of-use will help drive sales in these expanded market indications."
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. 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, the likelihood of obtaining a positive reimbursement determination by the CMS following the Company's submission, the likelihood and the extent of beneficial effect of such determination on CMS costs and care, 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, and Cytomedix's ability to execute on its strategy to market the AutoloGel™ System as contemplated, the Company's ability to successfully integrate the Angel® and activAT® product lines into its existing business, to assume and satisfy certain liabilities related to the Angel® and activAT® product lines. 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, 2010, filed with the SEC and other subsequent filings. These filings are available at http://www.sec.gov.