GAITHERSBURG, Md., May 31, 2011 (GLOBE NEWSWIRE) -- Cytomedix, Inc. (OTCBB:CMXI) (the "Company"), a leading developer of biologically active regenerative therapies for wound care, inflammation and angiogenesis, announces the Company has made a formal submission to the Centers for Medicare & Medicaid Services ("CMS") requesting reimbursement reconsideration for autologous platelet rich plasma ("PRP") gel, including the AutoloGel™ System.
The comprehensive request proposes that there is sufficient clinical evidence to support the conclusion that the use of autologous PRP gel for chronic, non-healing pressure ulcers and diabetic foot ulcers, compared with standard wound care, significantly and reliably improves the rate of complete healing, speed and progress to healing, and quality of life in the Medicare-eligible population.
Cytomedix believes that the clinical evidence presented convincingly documents the effectiveness of PRP gel, including demonstrating improved and accelerated wound healing, re-animation of stalled wounds onto a positive wound healing trajectory, reduction and closure of undermining and sinus tracts/tunneling, growth of new wound bed granulation tissue, reduced infection, and reduced pain.
More specifically, Cytomedix believes that the large body of published literature on the use of PRP gel for the treatment of wounds meets the U.S. Food and Drug Administration guidance document recommendation (Guidance for Industry: Chronic Cutaneous Ulcer and Burn Wounds – Developing Products for Treatment), the individual guidelines published by the Wound Healing Society for Pressure, Diabetic, Venous, and Arterial Insufficiency Ulcers, the Agency for Healthcare Research and Quality ("AHRQ") standard of evidence, and the Medicare Coverage Advisory Committee "(MEDCAC") wound therapy evaluation recommendations.
The body of published literature detailed in the submission includes:
- A systematic review of PRP literature published over the past 10 years. The systematic review, which is generally considered to be the highest level of objective evidence, includes 21 comparative studies.
- Nine PRP case series observational studies covering 323 wounds, including the 285 wounds in the Cytomedix prospective wound registry (this data has been peer-reviewed and has been accepted for publication), which demonstrates that wounds in Medicare beneficiaries had the same healing progression as wounds in non-Medicare beneficiaries.
- A tabulation of the Net Health Benefit (Quality of Life) features described in the systematic review and case series, as well as a qualitative research survey conducted regarding the impact of AutoloGel on the lives of patients and their families.
"This submission is the culmination of three years of experience and data collection with the AutoloGel System in wound care. I am very pleased with the body of evidence we have built in support of our request, and am confident that the scientific and clinical data combined with the evidence of cost effectiveness meets the requirements of the guidelines to support a favorable reimbursement determination by CMS," said Martin P. Rosendale, Chief Executive Officer of Cytomedix. "This submission was joined and submitted with the signatures of five key opinion leaders in the wound care field. We believe their endorsement and support further validates the technology and enhances our prospects for a successful decision."
"A positive reimbursement decision by CMS will improve wound care for Medicare beneficiaries, lower the cost of care for CMS, improve the quality of life for patients with non-healing wounds, and reduce the number of amputations for Medicare beneficiaries with diabetes," concluded Mr. Rosendale.
About AutoloGel in Wound Healing:
PRP gel is an autologous blood product containing proteins that regulate tissue growth for wound healing and is used successfully as a therapy to address the chronic wound care problem. Upon activation, platelets release cytokines, growth factors, and chemokines to act on cell receptors to cause cellular growth and migration while the fibrinogen in the plasma converts to a fibrin matrix scaffold upon which the cells can adhere. This biological system is integral to normal wound healing. To help understand this complex biological system, the Company's submission to CMS provides a detailed description of the established scientific mechanism of wound healing and the role of these PRP proteins in facilitating wound healing, and describes the importance of specific formulations and standardization of PRP gel to achieve consistent wound healing outcomes.
Cytomedix's submission further outlines the epidemiology of the chronic wound care problem both within the broad population as well as the Medicare-eligible population. The data clearly demonstrates that effective wound care therapies are greatly needed and remain a large unmet medical need.
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 platelet rich plasma ("PRP") gel derived from the patient's own blood 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. Cytomedix also seeks to monetize other product candidates in its pipeline through strategic partnerships, out-licensing or sale. Most notably is its anti-inflammatory peptide (designated CT-112), which has shown promise in preclinical testing. 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 on the 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, the outcome of development or regulatory review of CT-112, 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, the Company's ability to successfully integrate the Angel® and activAT® product lines into its existing business, to assume and satisfy certain liabilities related to the Angel® and activAT® 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.