CYTOMEDIX ANNOUNCES PROPOSED NATIONAL COVERAGE DETERMINATION MEMO BY CMS FOR AUTOLOGOUS PRP GEL IN CHRONIC WOUND CARE
Conference Call Begins Thursday, May 10 at 9:00 a.m. ET
GAITHERSBURG, Md. (May 9, 2012) – Cytomedix, Inc. (OTC/BB: 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”) issued a proposed National Coverage Determination (“NCD”) memo for autologous blood-derived products for chronic non-healing wounds. In its decision memo CMS has proposed coverage through its Coverage with Evidence Development (“CED”) program for all three major wound categories: diabetic, venous and pressure wounds.
CED is a process through which CMS provides 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.
In the proposed decision memo, CMS noted that it, “appreciates the significant burden of chronic non-healing wounds on the beneficiary population, which may lead to frustration on the part of patients, their treating practitioners and their caregivers. Therefore, we believe that it is appropriate to use CED to support the generation of more informative evidence.”
“We are very pleased with the proposed NCD to cover autologous blood-derived products for chronic non-healing wounds through the CED program, particularly as CMS has proposed coverage for all three major wound types. One advantage to CED is that it provides a mechanism for promising therapies like AutoloGel to be covered in clinical practice while evidence generation is underway,” noted Martin P. Rosendale, Chief Executive Officer of Cytomedix.
“Importantly, this positive proposed decision by CMS bodes well for our ongoing discussions with a top 20 global pharmaceutical company for an exclusive U.S. supply and distribution agreement for AutoloGel in wound care,” added Mr. Rosendale.
The release of the proposed NCD follows six months of CMS analysis and consideration subsequent to formal approval of the reconsideration request made by the Company and several clinical practitioners and industry opinion leaders last fall. This request was accepted and initiated on November 9, 2011. Following this proposed NCD, an additional 30-day public comment period has now commenced and the final decision memo will be published on or about August 7, 2012.
Cytomedix’ comprehensive request for Medicare coverage reconsideration 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 sets 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.
The proposed memo also stated that CMS, “believes that PRP may have the potential to benefit Medicare beneficiaries. If PRP can be shown that it provides a meaningful clinical benefit for the treatment of chronic wounds, it could potentially lead to improved patient function, and decreased patient dependence on other aspects of the health care system.”
Mr. Rosendale continued, “We are confident that based on the substantial body of clinical data demonstrating the ability of AutoloGel to enhance and accelerate healing in difficult-to-heal wounds, a CED study will bear out the same positive data in support of a final, favorable coverage determination. In the interim, clinicians using AutoloGel will receive coverage provided they participate in the study. We look forward to continuing to work with CMS in advance of the final NCD in August to determine various aspects of the protocols and clinical questions to be answered through the CED program.”
The complete decision memo is available on the CMS website at:
Cytomedix management will hold a conference call to discuss the proposed NCD and the CED initiatives and to answer questions beginning at 9:00 a.m. Eastern time on Thursday, May 10, 2012. Shareholders and other interested parties may participate in the call by dialing 866-730-5769 (domestic) or 857-350-1593 (international) and entering passcode 40442064. The call will also be broadcast live on the Internet at www.streetevents.com, www.fulldisclosure.com and www.cytomedix.com.
A replay of the conference call will be available beginning two hours after its completion through May 17, 2012 by dialing 888-286-8010 (domestic) or 617-801-6888 (international) and entering passcode 61561051. The call will also be archived for 90 days at www.streetevents.com, www.fulldisclosure.com and www.cytomedix.com.
About Coverage with Evidence Development Program
Coverage with Evidence Development (“CED”) is a process through which the Centers for Medicare & Medicaid Services (“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 platelet rich plasma from a patient’s own blood. 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 for 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 to 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 regenerative therapies 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 platelet rich plasma (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 patients’ own stem cells. A Phase 2 trial evaluating the use of ALDHbr Bright Cells 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 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 for the year ended December 31, 2011 and other subsequent filings. These filings are available at www.sec.gov.
Cytomedix, Inc. Investor Inquiries
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