GAITHERSBURG, Md., Aug. 31, 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 that, following a recent meeting with the Coverage and Analysis Group of the Centers for Medicare & Medicaid Services ("CMS"), the Company has gained greater clarity on the necessary conditions that can lead to a favorable reimbursement determination for its autologous platelet rich plasma ("PRP") gel in wound management.
As previously announced, Cytomedix submitted a comprehensive request for reimbursement reconsideration to CMS in late May 2011 that, in the Company's opinion, provides sufficient clinical evidence to support the conclusion that the use of autologous PRP gel for chronic, non-healing pressure ulcers and diabetic foot ulcers, compared with standard wound care, significantly and reliably improves the rate of complete healing, speed and progress to healing, and quality of life in the Medicare-eligible population.
CMS and Cytomedix recently met to discuss aspects of the clinical evidence and questions that arose as part of the initial review of the Company's submission, and to discuss whether CMS' policy on Coverage with Evidence Development (CED) can be used to answer the open questions. Over the course of the next several weeks, Cytomedix will work with CMS to propose appropriate treatment protocols and clinical data endpoints to be collected in an ongoing prospective wound care registry of patients with chronic wounds being treated with a standardized formulation of autologous PRP gel. As stated above, this data collection and analysis will likely be conducted under the auspices of CMS' Coverage with Evidence Development policy. CED allows for Medicare coverage for the appropriate use of an item or service while additional data is collected to support its ongoing use for Medicare beneficiaries. The clinical information in the database may also be used by wound care providers.
"We are pleased with our recent interaction with CMS and believe there is a shared objective for a comprehensive determination of the real world clinical benefit available to Medicare beneficiaries from the appropriate use of autologous PRP gel," said Martin P. Rosendale, Chief Executive Officer of Cytomedix. "We anticipate the CED wound care registry can be an extension of the registry we began in January 2009, which was always intended to demonstrate the clinical and economic value autologous PRP therapy brings to patients with chronic wounds. Cytomedix remains committed to this technology and the compelling scientific rationale at its core as an important and necessary part of the overall solution for non-healing chronic wounds that benefits all stakeholders interested in improving clinical wound care outcomes and lowering overall costs for Medicare beneficiaries."
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.