Healthcare Industry News: non-healing wounds
News Release - September 21, 2011
Cytomedix Announces Publication of Data From Wound Outcomes Registry in the International Wound JournalGAITHERSBURG, Md., Sept. 21, 2011 -- (Healthcare Sales & Marketing Network) -- Cytomedix, Inc. (OTCBB:CMXI.OB ) (the "Company"), a leading developer of biologically active regenerative therapies for wound care, inflammation and angiogenesis, today announced publication of an article entitled "Analysis of run-in and treatment data in a wound outcomes registry: clinical impact of topical platelet-rich plasma gel on healing trajectory" in the International Wound Journal as an ePublication ahead of print. The abstract of the publication may be viewed online at:
About the Study
Randomized controlled trials in chronic wounds typically exclude patients with comorbidities and other confounding factors. Well-designed observational studies can provide complementary clinical evidence that randomized trials cannot address. This study determined if wound care registry outcomes could be an alternative data source and if the results would be robust and valid.
The entire wound registry consisted of 285 wounds of various etiologies. Within the registry, historical run-in data on 46 wounds in a subset of patients was available and these wounds were representative of the full 285 wound group. The wounds in this subset were recalcitrant to standard and advanced wound care and had remained unhealed during the run-in period with the mean wound age at study start of 52.4 weeks. The results indicated that the short-term use of PRP appears to convert many non-healing wounds into actively healing ones.
Summary of Key Findings
* Statistically significant differences for wound area and depth were observed between run-in and post-treatment period at multiple time points.
* There was a 33% reduction in wound area and a 44% reduction in wound depth between the pre-treatment and post-treatment assessments.
* Wound trajectory comparisons between the last run-in pretreatment and post-PRP treatment showed statistically significant improvement in both wound area (p=0.028) and depth (p=0.00034).
* The length of time to reach the >=50% reduction marker was >2.5 weeks longer for area and >3.0 weeks longer for depth reduction during the run-in pretreatment time in contrast to the post-PRP treatment time.
"Using run-in pretreatment data and post-PRP treatment data provides insight into the clinical practice and realities encountered by chronic wound care clinicians. Wound care registries can be valuable in analyzing clinical practice outcomes and this unique approach for evaluating treatment results could set a new standard for wound care studies," noted Thomas E. Serena, MD, FACS, Founder and CEO of The Serena Group(TM).
"This is a particularly compelling study because each patient served as his or her own control and the pretreatment run-in periods were included. Moreover, the wound data and outcomes came from real-world patients with a variety of wound etiologies, comorbidities and other confounding factors," commented Martin P. Rosendale, Chief Executive Officer of Cytomedix.
About Cytomedix, Inc.
Cytomedix develops, sells and licenses regenerative biological therapies primarily for wound care, inflammation and angiogenesis. The Company markets the AutoloGel(TM) 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(R) 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(R) Autologous Thrombin Processing Kit, which produces autologous thrombin serum from PPP. The activAT(R) 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(TM) 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(TM) System as contemplated, the Company's ability to successfully integrate the Angel(R) and activAT(R) product lines into its existing business, to assume and satisfy certain liabilities related to the Angel(R) and activAT(R) 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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