GAITHERSBURG, Md., Nov. 11, 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 the Centers for Medicare & Medicaid Services ("CMS") formally initiated a reconsideration of its National Coverage Determination for blood-derived products for chronic non-healing wounds to determine whether autologous platelet rich plasma ("PRP") gel is reasonable and necessary under the Medicare program. The action was taken on November 9, 2011 with the initiation of a tracking sheet and the commencement of a 30 day public comment period, both of which can be found at the link below. Following its analysis, CMS proposes to publish an initial decision memo by May 9, 2012.
As previously announced, a comprehensive request for Medicare coverage reconsideration submitted by Cytomedix in late May 2011 and amended in September 2011 proposed that there is sufficient and compelling clinical evidence to validate the use of autologous PRP gel to treat chronic, non-healing pressure ulcers, venous ulcers, and diabetic foot ulcers. The request set out the reasons why PRP gel significantly and reliably improves the rate of complete healing, speed and progress to healing, and quality of life as compared with standard wound care in the Medicare-eligible population. In the Company's most recent update on the status of the reconsideration request (August 31, 2011), Cytomedix indicated its belief that a potential path forward towards reimbursement could involve CMS' Coverage with Evidence Development ("CED") program. In the official tracking sheet, CMS encourages the submission of comments that would pertain to clinical studies falling under the CED paradigm.
"We are encouraged by CMS' approval of the reconsideration request for Medicare coverage of autologous PRP gel for chronic non-healing wounds. We have had extensive discussions with CMS covering the clinical evidence, and explained the support for the coverage of autologous PRP gel among key opinion leaders and advocacy groups within the broad wound care community," said Martin P. Rosendale, Chief Executive Officer of Cytomedix. "We believe that there is a strong case to revise Medicare's National Coverage Determination to cover autologous PRP gel for the benefit of the various stakeholders interested in improving clinical wound care outcomes while lowering overall costs for Medicare beneficiaries. Cytomedix remains committed to this technology and to the compelling scientific rationale at its core as an important and necessary part of the overall solution to non-healing chronic wounds."
CMS website link:
https://www.cms.gov/medicare-coverage-database/details/nca-tracking-sheet.aspx?NCAId=260&ver=1&NcaName=Autologous+Blood-Derived+Products+for+Chronic+Non-Healing+Wounds&TimeFrame=7&DocType=All&bc=AQAAIAAAIAAA&.
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 autologous platelet rich plasma ("PRP") gel 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 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, 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(TM) System as contemplated, the Company's ability to successfully integrate the Angel(R) and activAT(R) product lines into its existing business, to assume and satisfy certain liabilities related to the Angel(R) and activAT(R) 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.