ROCKVILLE, Md., Sept. 22, 2005 (PRIMEZONE) -- Cytomedix, Inc. ("Cytomedix" or the "Company") (AMEX:GTF) has launched a comprehensive audit of its prospective, randomized, double-blinded, controlled trial of the AutoloGel(tm) System for the treatment of diabetic foot ulcers, and has appointed Jennifer Grayson, a former FDA manager, and now consultant, to lead the audit of clinical trial information and data at its investigational study sites and contract research organization, it was announced today by Dr. Kshitij Mohan, Chairman and Chief Executive Officer.
The comprehensive audit plan will ensure that the Company's study follows good clinical practices, that the documentation complies with regulatory requirements, and that the AutoloGel(tm) study was conducted according to the protocol.
Ms. Grayson has more than twenty years of experience in regulatory compliance of clinical studies having served with the U.S. Food and Drug Administration (FDA) as Chief of the Bioresearch Monitoring Branch for medical devices and, later, as acting Associate Division Director of the Office of Compliance in Center for Devices and Radiological Health.
Dr. Mohan stated that the audit program is Cytomedix's next step in the company's overall plan to obtain FDA clearance or approval for the AutoloGel(tm) System's use for the treatment of non-healing diabetic foot ulcers. The treatment phase of this trial was completed at the end of July 2005. The follow up of the healed patients to determine whether any of the wounds reopen within a 12-week period after healing, will be completed at the end of October 2005 after which the final analysis will be conducted.
The independent audits to be conducted by Ms. Grayson are part of an attempt to understand the preliminary results, which showed a healing rate of 58% for the treatment group and an unexpectedly high rate of healing of about 50% in the control group of the trial.
In addition, the Company plans to seek reviews of the data by an independent physician to determine if differences in clinical practices such as wound cleaning (debridement) prior to treatment at different study centers, or other similar factors, may have affected the outcomes of the trial. The Company anticipates that, depending on findings as the reviews continue, the analysis and review of the trial results will conclude in the fourth quarter of 2005. Thereafter, Cytomedix will seek FDA guidance on the appropriate regulatory pathway for the clearance or approval of AutoloGel(tm) for specific wound healing indications.
ABOUT THE COMPANY
Cytomedix, Inc. is a biotechnology company specializing in processes and products derived from autologous platelet releasates for uses in the treatment of wounds and other applications. The current offering is the AutoloGel(tm) System, a technology that utilizes an autologous platelet gel composed of multiple growth factors and fibrin matrix. Additional information is available at: www.cytomedix.com.
Safe Harbor Provision
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'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 results of the Company's audit of the clinical trial results, the attainment of clinical trial data sufficient to support the Company's application for regulatory approvals or third-party reimbursements, the success of new sales initiatives, governmental regulation, acceptance by the medical community and competition. Should the audit of the clinical trial results result in unfavorable information, or if Cytomedix receives unfavorable results in further clinical trials or studies of AutoloGel(tm), the Company's ability to obtain FDA clearance or approval or third party reimbursement may be materially affected. 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.