Cytomedix Inc. Announces Centers for Medicare & Medicaid Services Approval of Clinical Outcomes in Protocols for Autologous PRP (AutoloGel()) Under Coverage With Evidence Development Program
Published: Mar 05, 2013
GAITHERSBURG, MD--(Marketwire - March 04, 2013) - Cytomedix, Inc. (OTCQX: CMXI) (the "Company"), a regenerative therapies company commercializing and developing innovative platelet and adult stem cell technologies, announced today that the Center for Medicare & Medicaid Services (CMS) has granted formal approval of the clinical outcomes defined in four protocols developed and submitted by Cytomedix in response to the National Coverage Determination (NCD) memo for autologous blood derived products for chronic wound care issued last August by CMS. With these protocol approvals, clinicians can use AutoloGel™ to treat Medicare beneficiaries with chronic wounds and receive reimbursement for the product under the Coverage with Evidence Development (CED) program. Cytomedix expects to begin rolling out the protocols to wound care clinics during March, and anticipates the first patients will be treated under the protocols soon thereafter.
Martin Rosendale, Chief Executive Officer of Cytomedix stated, "To say we are pleased with this latest and important step of protocol approval would be an understatement. We have long believed that the AutoloGel System can be a significant addition to the complement of wound management therapies utilized by clinicians working to better address this unmet medical need. It is gratifying to see several years of diligent effort rewarded and we look forward to serving clinicians and offering chronic wound patients an advanced biologically active therapy while demonstrating meaningful clinical benefit in the Medicare beneficiary population."
"We are also excited about our relationship with Intellicure," stated Mr. Rosendale. "Their network and relationships with high quality wound care clinics across the country can facilitate rapid deployment of the AutoloGel System, while access to the U.S. Wound Registry provides a robust and cost effective means for data management. Together, we are setting a new standard for clinical evidence in wound care."
Caroline Fife, MD, Chief Medical Officer of Intellicure added, "Intellicure and the U.S. Wound Registry are excited to partner with Cytomedix in facilitating the clinical protocols for Coverage with Evidence of Autologel. Not only is the product a major advance in the area of wound healing, but the use of electronic health records is a novel and cost effective mechanism to capture the data needed for clinical studies."
Under the approved protocols, Cytomedix initially expects to treat more than 1,200 patients with AutoloGel in outpatient wound care centers affiliated with Intellicure and the US Wound Registry. The four approved protocols are:
- CM001: Multi-Center, randomized, controlled trial comparing the efficacy of AutoloGel therapy plus usual and customary care (UCC) to UCC alone in diabetic foot ulcers.
- CM002-CM004: Three independent multi-center, cohort studies designed to compare AutoloGel plus UCC with UCC alone in diabetic foot ulcers, pressure ulcers, and venous ulcers.
These protocols will be rolled out initially at up to 30 USWRRN (U.S. Wound Registry Research Network) centers, and up to 10 non-USWRRN centers. The protocols will be registered on the ClinicalTrials.gov website. CMS expects that the results of all CMS-approved CED studies will be published in peer-reviewed journals.
In general, Medicare coverage is limited to items and services that are reasonable and necessary for the diagnosis or treatment of an illness or injury and that are within the scope of a Medicare benefit category. CED is a determination that a product is reasonable and necessary, based on the best available clinical data, but where the evidence base is not yet sufficiently developed. In these cases, CMS agrees to provide reimbursement coverage while at the same time generating additional clinical data to demonstrate the impact on health outcomes. CMS-approved CED studies must be designed and conducted prospectively to produce evidence to inform future Medicare coverage.
Diabetic foot ulcers (DFUs) are a common complication of diabetes. In 2007, the treatment of diabetes and its complications in the United States generated at least $116 billion in direct costs. Despite aggressive treatment, hospitalizations for lower-extremity amputations are high. Failure to heal a diabetic foot ulcer, even a relatively non-severe ulcer, increases the risk of infection and can lead to subsequent amputation, especially if ischemia is present and the ulcer is non-responsive to standard of care and hyperbaric oxygen therapy.
Pressure ulcers (PUs) are a problem in all patient care settings, where about 1 million individuals in the United States have a PU at any given time. In nursing homes, the prevalence of PUs ranges from 2.6% - 24% with 25% of patients transferred from acute care hospitals having a PU. Given the significant morbidity associated with pressure ulcers and the high cost of their management there is a need to investigate novel treatment options. The results of AutoloGel to date when used to treat PUs have been promising; the planned CED study is the first controlled study.
Venous leg ulcers (VLUs) are a common condition, especially in the elderly, and are thought to arise as a result of prolonged inflammatory conditions associated with underlying venous disease and may be exacerbated by ischemia. In the U.S., VLUs account for 70-90% of ulcers found on the lower leg with a prevalence of about 600,000; 1.7% of the Medicare population are affected. VLUs cost 2 million working days annually and cost the healthcare system $2.5-3.5 billion. The planned CED study is the first controlled study with AutoloGel in VLUs.
About AutoloGel™ System
The AutoloGel System utilizes a proprietary unique technology that enables the rapid isolation and activation of PRP from a patient's own blood. The PRP is subsequently processed to produce a bioactive 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 impaired 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 an autologous regenerative therapies company commercializing innovative platelet technologies for orthopedics and wound care with a pipeline of adult stem cell therapies for tissue repair. 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 and the Angel® Concentrated Platelet Rich Plasma System, a blood processing device and disposable products used for the separation of whole blood or a mixture of blood and bone marrow, into red cells, platelet poor plasma ("PPP") and PRP in surgical settings On February 8, 2012 Cytomedix closed the acquisition of Aldagen, a biopharmaceutical company developing regenerative cell therapies based on its proprietary ALDH bright cell technology, currently in a Phase 2 trial for the treatment of ischemic stroke. For additional information please visit cytomedix.com
Intellicure provides innovative solutions that empower wound care providers across the healthcare continuum to deliver world-class outcomes. The company's certified clinical, financial, and connectivity for hospitals and physicians are the essential technologies that enable a connected healthcare community. To learn more about Intellicure, please visit www.Intellicure.com.
About the Registry The U.S. Wound Registry is the largest complete registry of wound, DFU, VLU, and Pressure Ulcer patients in the world. The USWR represents a broad geographic distribution of patients with records from over 50,000 patients, involving more than 125,000 wounds and nearly 2,000,000 patient encounters.
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 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.
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