GAITHERSBURG, MD--(Marketwired - May 2, 2013) - Cytomedix, Inc. (
Saturday, May 5, 2013 from 4:30pm-5:30pm
Oral - 40.4
Poster - CR-23
Harnessing Electronic Medical Record Capabilities for Prospective Clinical Research: The Platelet Rich Plasma (PRP) Registry for Coverage with Evidence Development (CED)
Colorado Convention Center, Denver, Colorado
Dr. Fife's oral presentation will outline the benefits of the EHR (electronic health record) system that is being used in the CED (Coverage with Evidence Development) program for AutoloGel. An EHR system with structured language has been customized to automatically perform the acquisition of data and verification of source in both the randomized trial and non-randomized cohort trials that make up the AutoloGel CED program. Only wound centers utilizing this EHR or who can adapt to it will be able to participate in the program.
The presentation and poster will describe the benefits of using an EHR system for patient recruitment, data management and integrity, and data analysis. Dr. Fife will discuss how an EHR can decrease the cost of a clinical trial, reduce time needed by site staff and monitors, increase data accuracy, reduce training required for investigators and improve safety in monitoring. A well-designed system improves overall data analysis and ensures adequate power in a clinical trial by delivering essentially real time results.
The Centers for Medicare and Medicaid Services (CMS) has agreed to provide reimbursement coverage for AutoloGel in patients with non-healing ulcers under the Coverage with Evidence Development (CED) program. CED is a determination made by the CMS that a medical product is reasonable and necessary, based on the best available clinical data, but where the evidence base has not yet been sufficiently developed.
About the SAWC-SPRING
The Symposium on Advanced Wound Care and Wound Healing Society (SAWC/WHS) meeting is the premier interdisciplinary wound care program within this clinical field and is the largest annual gathering of wound care clinicians in the United States. More than 2,000 physicians, podiatrists, nurses, therapists, and researchers are expected to attend the 2013 SAWC Spring/WHS meeting.
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.
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 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 ability to successfully execute its Angel and AutoloGel sales strategies, to achieve AutoloGel expected reimbursement rates in 2013, to meet its stroke trial enrollment rates, the Company's ability to successfully integrate the Aldagen acquisition, the Company's ability to expand patient populations as contemplated, its ability to provide Medicare patients with access as expected, the Company's expectations of favorable future dialogue with potential strategic partners, and its ability 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, 2012, as amended to date, and other subsequent filings. These filings are available at www.sec.gov.
- Health Care Industry
- Platelet Rich Plasma
Chief Executive Officer
LifeSci Advisors, LLC