Study Indicates AutoloGel(tm) Treatment May Enhance Healing, Prevent
Amputations, and is Safe
Company Updates Status of 510(K) Premarket Notification With FDA
ROCKVILLE, Md., June 28, 2006 (PRIMEZONE) -- Cytomedix, Inc. (AMEX:GTF), a biotechnology company specializing in developing and licensing systems for the treatment of non-healing chronic wounds including diabetic ulcers, today announced the publication of the results of its diabetic foot ulcer prospective trial for the AutoloGel(tm) System.
The article, entitled "A Prospective, Randomized, Controlled Trial of Autologous Platelet-Rich Plasma Gel for the Treatment of Diabetic Foot Ulcers," was published as the feature article in the June 2006 issue of Ostomy/Wound Management (OWM). The authors are: Vickie M. Driver, DPM, MS, FACFAS, Director of Clinical Research at the Center for Lower Extremity Ambulatory Research; Dr. William M. Scholl College of Podiatric Medicine, and Chief of the National Center for Limb Preservation at the Advocate Lutheran General Hospital of Niles, IL.; Jason Hanft, DPM, FACFAS, Director of the Doctors Research Network of South Miami, Fla.; Carelyn P. Fylling, RN, MSN, Vice President of Professional Services for Cytomedix, Inc.; Judy M. Beriou, RN, MHA, Senior Research and Clinical Coordinator for Cytomedix, Inc.; and the AutoloGel Diabetic Foot Ulcer Study Group. The clinical trial was sponsored and funded by Cytomedix, conducted under a U.S. Food and Drug Administration (FDA) approved Investigational Device Exemption (IDE) by independent clinical researchers and managed and monitored by an external Contract Research Organization.
Ostomy Wound Management (OWM), the premiere journal for information on wound care and the related, overlapping fields of skin care, ostomy care, incontinence care, and nutrition, is the only peer-reviewed, multidisciplinary publication specifically targeted to the advanced wound care practitioner. Indexed in MEDLINE(r) and CINAHL(r), OWM is the official journal of the Association for the Advancement of Wound Care (AAWC). OWM is published monthly and distributed to 25,000 subscribers.
The published results document that in the 40 wounds per-protocol group, 13 out of 19 (68.4%) of the AutoloGel and nine out of 21 (42.9%) of the control wounds healed, i.e. the wounds achieved full closure. After adjusting for wound size outliers (n = 5), significantly more AutoloGel (13 out of 16, 81.3%) than control gel (eight out of 19, 42.1%) treated wounds healed (P = 0.036, Fisher's exact test). These wound sizes are typical of the wound area treated in published prospective trials for competitive wound products. The Kaplan-Meier time-to-healing also was significantly different between groups (log-rank, P = 0.0177). No treatment-related serious adverse events were reported.
"The conclusions in this article by the medical professionals who conducted the study endorse the use of AutoloGel as an effective, efficient treatment for diabetic foot ulcers," according to Cytomedix Chairman and Chief Executive Officer Kshitij Mohan, Ph.D. "The healing rates of AutoloGel at 81.3% for the most common wound sizes in the study and 68.4% for all wound sizes are very competitive with, or better than, most other wound care products cleared by the FDA and covered by Medicare reimbursement. The Control group patients were not on placebo; rather, they were treated using a saline gel cleared by the FDA for use on chronic and surgical wounds. It is important to point out that if the Control group patients healed at the originally anticipated rate of 20-30% (which was based on published literature), the difference between the healing rates in the AutoloGel group versus the Control group would have been even more strongly statistically significant."
The authors added that AutoloGel "may not only enhance healing, but it may also prevent lower extremity amputations caused by nonhealing wounds." Dr Mohan commented that there are two million cases of diabetic foot ulcers in the U.S. at any one time and statistics show that between 14 and 24% of the patients will require amputations.
He added, "We are pleased that the researchers concluded that AutoloGel may reduce or prevent the need for amputations. The publication of the clinical trial results referenced above details the data that was submitted to the FDA as part of the Premarket Notification 510(k) by the Company. The Company received an Agency request for further information and analysis related to the conduct of the study. The Company has completed the collation of the requested information and the additional statistical analysis and will send it shortly to FDA for a preliminary review. After FDA's review, feedback, and if necessary, discussion in face to face meetings depending on the Agency's convenience, Cytomedix will formally submit the responses to FDA for their decision on the Premarket Notification application."
ABOUT CYTOMEDIX
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 AutoloGel(tm), a technology that utilizes an autologous platelet gel composed of multiple growth factors and fibrin matrix. The Company has announced favorable results from its blinded, prospective, multi-center clinical trial on the use of its technology in healing diabetic foot ulcers and has submitted a 510(k) application for marketing clearance for a new product to the FDA seeking specific labeled indications for the healing of chronic wounds. Additional information regarding Cytomedix is available at: http://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'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 success of new sales initiatives, governmental regulation, acceptance by the medical community and competition. There is no guarantee that the FDA will complete its review of the Company's 510(k) submission for a specific wound healing indication within any estimated timeframe, or that the FDA will fully agree with the Company in the interpretation of the data or the regulatory pathway and provide marketing clearance. Further, even assuming the FDA grants the Company's request for marketing clearance, there is no guarantee that the Company will receive Medicare reimbursement for its product; the Company's marketing efforts will be successful; or that it will be able to achieve its other strategic goals.
There is no guarantee that the information reported by the authors in the article detailed above is accurate or that further review of the authors' conclusions or testing of AutoloGel (tm) will prove such information to be accurate. There is also no guarantee that the Company's current capitalization will be sufficient to attain its goals or that future funding will be available to the Company on acceptable terms. 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. 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.