Healthcare Industry News: diabetic foot ulcers
News Release - June 26, 2007
Cytomedix Announces CMS to Reconsider Coverage for Platelet Rich Plasma TechnologyPublic Comment Period Open for 30 Days
ROCKVILLE, Md., June 26, 2007 (Healthcare Sales & Marketing Network) -- Cytomedix, Inc. (AMEX:GTF ) today announced that the Centers for Medicare and Medicaid Services (CMS) has agreed to Cytomedix's request to reconsider a non-coverage decision for autologous blood-derived products when used for the treatment of chronic non-healing wounds.
The national non-coverage decision issued in 1992 and amended in 2003 broadly disallows Medicare coverage for autologous blood-derived products for chronic non-healing wounds. This non-coverage decision currently applies to Cytomedix's proprietary platelet rich plasma (PRP) technology known as AutoloGel(tm), as well as products marketed by the Company's licensees and used by physicians.
The non-coverage decision cited lack of sufficient clinical evidence to justify coverage. Cytomedix included in its reconsideration request significant new published data on the use of PRP gel to heal damaged tissue, including data from its own prospective, randomized, controlled trial on the use of AutoloGel(tm) to treat diabetic foot ulcers. The total body of published data reflected six randomized controlled trials, four non-randomized controlled trials, and eight additional studies. Significant unpublished data was also provided. The overwhelming majority of all the data is favorable to the use of PRP. The primary evidence indicates increased percentage of wound closure and time to healing when using PRP gel as compared to controls to treat open cutaneous wounds including chronic wounds. Secondary corroborative evidence indicates diminished hospital stays and reduced incidence of infection.
Cytomedix has submitted this new evidence and has requested an evaluation of the coverage of PRP gel for the following open-cutaneous wounds, including chronic wounds:
1. Wounds caused by an acute surgical incision or dehiscence.
2. Full-thickness chronic wounds that have failed an adequate course of standard wound therapy.
In agreeing to the reconsideration request, CMS has opened a national coverage determination (NCD) to reconsider coverage of PRP gel. CMS is requesting public comments on this issue. After considering the public comments, CMS will release a proposed decision memorandum. The period of public comment is open until July 25, 2007. Those organizations or individuals wishing to submit a comment regarding the use of PRP gel may do so via the following link: https://www.cms.hhs.gov/mcd/viewtrackingsheet.asp?id=208.
Cytomedix does not anticipate that this decision will be referred to an external review panel, and according to CMS, the expected National Coverage Analysis (NCA) completion date is March 24, 2008. Cytomedix has pledged its full cooperation and support to CMS as it considers coverage for this very important technology.
Cytomedix Chairman and CEO, Dr. Kshitij Mohan stated, ``We are very pleased that CMS agreed to reconsider coverage for PRP gel in light of the significant new data. Most importantly, we are optimistic that patients who suffer terribly from chronic wounds and other open cutaneous wounds may soon benefit by ready access to this technology which is also available through a number of our licensees. This also represents a significant accomplishment for Cytomedix, the leading developer and licensor of PRP gel patents and technology.''
The 2003 CMS decision number is CAG-00190N. The tracking number assigned by CMS to this reconsideration is CAG-00190R2.
Cytomedix, Inc. is a biotechnology company specializing in processes and products derived from autologous platelet releasates for uses in the treatment of wounds and other applications. The current offering is AutoloGel(tm), a technology that utilizes an autologous platelet gel composed of multiple growth factors and fibrin matrix. The Company has announced favorable results from its multi-center, blinded, prospective, randomized, controlled clinical trial on the use of its technology in treating diabetic foot ulcers. The Company is appealing the FDA's ruling related to its 510(k) application for marketing clearance for a new product seeking specific labeled indications for the use in chronic wounds. Additional information regarding Cytomedix is available at: http://www.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'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 success of new sales initiatives, governmental regulation, acceptance by the medical community and competition.
There is no guarantee that CMS will reverse its 2003 non-coverage decision which applies to AutoloGel(tm). Even assuming that CMS does reverse its previous non-coverage decision, there is no guarantee that such reversal will occur within the immediate future, or that the Company will be able to capitalize on this reversal in commercializing the AutoloGel System(tm). Based on the Company's current levels of operations and cash flows, a substantial delay in obtaining a reversal on the non-coverage decision may render the Company unable to take advantage of such a decision.
Even if the Company were to achieve Medicare reimbursement, it still may be unable to adequately commercialize its product offerings if it fails to obtain other regulatory approvals the Company is currently seeking. As of this date, the FDA has not granted marketing clearance for the AutoloGel(tm) Systems, and there is no guarantee that the FDA will reverse its decision on the Company's 510(k) submission for a specific wound healing indication. Further, there is no guarantee that a response from the FDA will be received within any estimated timeframe. Further, even assuming the FDA grants the Company's request for marketing clearance and CMS reverses its non-coverage decision, there is no guarantee that the Company will receive other third-party reimbursement for its product, the Company's marketing efforts will be successful, or that it will be able to achieve its other strategic goals. There is also no guarantee that the Company's current capitalization will be sufficient to attain its goals, that future funding will be available to the Company on acceptable terms, or that the Company will ever be able to sustain itself from ongoing operations.
The forward-looking statements in this press release 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., including the Company's Form 10-K for the year ended December 31, 2006. 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.
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