Cytomedix Announces Publication in ePlasty of Systematic Review and Meta-Analysis on Use of Platelet Rich Plasma Gel in Wound Healing


GAITHERSBURG, Md., Sept. 22, 2011 (GLOBE NEWSWIRE) -- Cytomedix, Inc. (OTCBB:CMXI) (the "Company"), a leading developer of biologically active regenerative therapies for wound care, inflammation and angiogenesis, today announced that findings from a comprehensive systematic review and meta-analysis (statistical pooling) of the use of platelet rich plasma (PRP) gel in wound healing were published online in ePlasty, the open-access journal of the Journal of Plastic Surgery. The article, entitled "Use of Platelet Rich Plasma Gel on Wound Healing: A Systematic Review and Meta-Analysis," can be viewed at the ePlasty website at:

http://www.eplasty.com/index.php?option=com_content&view=article&id=582&catid=15&Itemid=116

According to the review, "On the basis of the last 10 years of research, the results of this systematic review and meta-analysis suggest that PRP therapy can positively impact wound healing and associated factors such as pain and infection in both chronic and acute cutaneous wounds."

The systematic review was performed to assess studies in cutaneous skin wounds treated with autologous PRP gel. Studies assessing healing efficacy such as complete or partial wound healing, time to heal, healing trajectory, velocity or rate, and wound size reduction were considered critical for this systematic review.

For assessment of PRP treatment human intervention trials, only randomized, controlled trials and comparative studies published in peer-reviewed journals or presented at scientific meetings were considered. There were 21 published studies that met these criteria and were included in this systematic review. Given the physiological and healing differences between acute surgical and chronic wounds, the citations were divided by study design and by type of wound prior to review and meta-analysis. The primary outcomes assessed in this systematic review were the impact of PRP on wound healing and related measures such as infection and pain. Meta-analysis was carried out on those studies that had the following compatible outcomes and reasonable clinical homogeneity: (1) complete wound healing; (2) infection reduction; and (3) pain reduction.

The review showed that in both chronic and acute surgical wound studies, complete wound closure was more likely in wounds treated with PRP therapy. Similar partial healing and wound area/volume reduction outcomes were noted more frequently with the PRP-treated wounds. 

The meta-analysis of chronic wound studies revealed PRP therapy is significantly favored for complete healing. Additionally, studies of acute surgical wounds with primary closure demonstrated that the presence of infection and pain was reduced in PRP-treated wounds. Finally, this meta-analysis and other systematic reviews show PRP has sufficient efficacy to stimulate wound healing.

"A systematic review is the highest standard of evidence-based medicine in the scientific community. We are pleased that this comprehensive review and analysis confirms the effectiveness of PRP to successfully treat both chronic and acute surgical wounds, underscoring the value of our AutoloGel™ PRP in chronic wounds and our Angel® PRP to treat acute surgical wounds. In addition, the review revealed that the use of PRP in acute surgical wounds reduced pain levels and infection rates," noted Martin P. Rosendale, Chief Executive Officer of Cytomedix.

"Compelling clinical data such as these should continue to drive adoption of our regenerative biotherapies. Additionally, this publication and other peer-reviewed publications recently released are important components of the growing body of relevant clinical evidence that underscores our commitment to appropriate coverage and payor reimbursement for standardized autologous PRP as a treatment option for chronic wounds," added Mr. Rosendale. 

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. 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.



            

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