GAITHERSBURG, MD--(Marketwire - August 06, 2012) - Cytomedix, Inc. (OTCBB: CMXI) (OTCQB: CMXI) (the "Company"), a regenerative therapies company commercializing and developing innovative platelet and adult stem cell technologies for wound and tissue repair, today announced that the Centers for Medicare & Medicaid Services ("CMS") has issued a final National Coverage Determination ("NCD") for autologous blood-derived products for chronic non-healing wounds. As previously reported, on May 9, 2012 CMS posted its proposed NCD, which was followed by a 30-day public comment period that ended on June 8th. In the final decision memo released August 2nd, CMS responded to these comments, refined its decision and confirmed coverage for autologous platelet rich plasma ("PRP") in patients with diabetic, pressure and/or venous wounds via its Coverage with Evidence Development ("CED") program. CED is a process through which CMS provides reimbursement coverage for items and services while generating additional clinical data to demonstrate their impact on health outcomes.
In the final decision memo, CMS noted that it " ...has reviewed the medical literature on autologous PRP in patients with chronic wounds and believes that CED is appropriate for PRP treatment," and concluded that, "when reviewed as a body of evidence, it does indicate that PRP shows promise in the populations of interest to CMS."
"We are extremely pleased with the decision by CMS to provide coverage for autologous blood-derived products for chronic non-healing wounds through the CED program. This determination reverses a nearly 20 year non-coverage determination for PRP and provides for an appropriate research study with practical study designs we are confident will demonstrate that patients treated with our autologous PRP product, the AutoloGel™ System, experience clinically significant health outcomes," commented Martin P. Rosendale, Chief Executive Officer of Cytomedix.
"Importantly, we believe this decision by CMS bodes well for our ongoing discussions with a top 20 global pharmaceutical company for a favorable long-term arrangement in the U.S. wound care market, as clarity around the CED evidentiary requirements was a necessary element of the commercial market assessment," added Mr. Rosendale. "In the meantime, our discussions for a distribution agreement to be executed prior to month's end are progressing well."
Related to the evidentiary requirements, CMS outlined in the final decision memo that a research study that uses data collected by a registry can enhance its persuasiveness if it has the following attributes:
- It is a prospectively collected clinical research database for wound care that acquires certain standardized data elements.
- The information about the intervention is controlled and standardized, (i.e., the method of preparation of the PRP including the volume and concentration of platelets, lysate, anticoagulant or other additives, method and length of time of storage, centrifuge time, amount of blood taken for preparation, application schedule, etc.).
- There is longitudinal follow up whereby registry patients would have to be followed for pre-specified and well defined outcomes measured using standardized methods including:
- percentage of patients completely healed,
- time to healing,
- ulcer area reduction,
- durability of recovery,
- adverse events, and
- changes in functional status and mobility.
- There is a source of comparable patients who are treated with standard of care and for whom the data collection would have to be equivalent to that of the patients receiving PRP.
Mr. Rosendale added, "This decision appears to indicate that our recent interactions with CMS have been productive, as CMS has acknowledged the rationale we presented for a comprehensive research study that can appropriately encompass practical study designs to meet the evidentiary requirements of CMS. We look forward to continuing to work with CMS in the coming weeks in further defining the specifics of the protocols for the research studies and clinical questions to be answered through the CED program."
The complete final decision memo is available on the CMS website at: http://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=260.
About Coverage with Evidence Development Program
CED is a process through which CMS provides conditional payment for items and services while generating additional clinical data to demonstrate their impact on health outcomes. CED is an evolving paradigm used by CMS to bring a new rationale to coverage decisions and, ultimately, cost savings to the Medicare program.
First introduced in 2005 and then refined in 2006, CED links Medicare coverage of specific promising technologies to a requirement that patients participate in a registry or clinical trial. Ultimately, the data generated is intended to be used as the basis for future coverage decisions once it is determined whether a treatment is reasonable and necessary. CED has also been referred to as a way to develop a "learning-based health care system" and the coverage to support it.
About AutoloGel™ System
The AutoloGel System utilizes a proprietary unique technology that enables rapid isolation and activation of PRP from a patient's own blood. The PRP is subsequently processed to produce a gel for application to the wound bed, re-establishing a balance needed for natural healing to occur. In normal healing, platelets migrate from the blood into the wound site where they serve as the primary source of growth factors for effective wound healing. In chronic wounds, blood supply may be low and the delivery of platelets is impeded, disallowing adequate concentrations of growth factors.
The AutoloGel System is used at the point-of-care and is the only PRP system cleared by the U.S. Food and Drug Administration for use on exuding wounds, such as leg ulcers, pressure ulcers and diabetic ulcers, and for the management of mechanically or surgically-debrided wounds. Cytomedix's clinical studies have shown that AutoloGel rapidly and more effectively improved healing compared with control-treated wounds. This has been demonstrated in a variety of clinical studies including a systematic review of 21 comparison studies and a number of other observational and case series publications as well.
About Cytomedix, Inc.
Cytomedix, Inc. is a fully integrated regenerative medicine company commercializing and developing innovative platelet and adult stem cell separation products that enhance the body's natural healing processes. The Company's advanced autologous technologies offer clinicians a new treatment paradigm for wound and tissue repair. The Company's patient-derived PRP systems are marketed by Cytomedix in the U.S. and distributed internationally. Our commercial products include the AutoloGel™ System, cleared by the FDA for wound care and the Angel® Whole Blood Separation System. The Company is developing novel regenerative therapies using our proprietary ALDH Bright Cell ("ALDHbr") technology to isolate a unique, biologically active population of a patient's own stem cells. A Phase 2 trial evaluating the use of ALDHbr for the treatment of ischemic stroke is underway. For additional information please visit 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' 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 reimbursement related efforts, the Company's ability to capitalize on the benefits of the above-referenced CMS determination, the Company's ability to successfully and favorably conclude the negotiations and related discussions with the above-referenced global pharmaceutical company, 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 on Form 10-K for the year ended December 31, 2011 and other subsequent filings. These filings are available at www.sec.gov.