ROCKVILLE, Md., Oct. 25, 2005 (PRIMEZONE) -- Cytomedix, Inc. (AMEX:GTF) Chairman and Chief Executive Officer Kshitij Mohan, Ph.D., told the annual meeting of shareholders that in the last eighteen months the Company:
-- Has settled all outstanding court cases related to infringement
of its patents.
-- Has granted six significant patent licenses to small and large
companies that manufacture, market or sell products or services
related to platelet-gel therapies.
-- Has built a strong management team, an outstanding board
and a strong governance structure leading to its listing on the
American Stock Exchange.
-- Is actively pursuing opportunities and partnerships to
strengthen its sales and marketing efforts, and
-- Has engaged several former U.S. Food and Drug Administration
experts to advise the Company in its efforts to complete the
audit of its clinical trial data and define its strategy to
obtain product clearance from the FDA.
Regarding the ongoing clinical trial for the Company's AutoloGel product for diabetic foot ulcers, Dr. Mohan stated that even though there was an unexpectedly high healing rate in the control group of patients, preliminary results indicate that AutoloGel has a strong safety profile and a healing rate of 58%, which are very competitive with other competing products in the market. The enhanced rigorous standard treatment that was requested by and agreed upon with the U.S. Food and Drug Administration (FDA) as a control in the double blinded, randomized trial appears, based on the preliminary analysis, to have a higher rate of healing than expected and not statistically significantly different from the treatment group. "Jennifer Grayson, a former U.S. Food and Drug Administration (FDA) manager, is leading an audit of the preliminary results, due to be completed in the fourth quarter," Dr. Mohan said. "Once the results are fully audited and analyzed, we will confer with the FDA to determine the next step in the approval process. Several other former FDA experts with experience in the areas of medical devices as well as biologics, some of whom have recently retired from the agency, are advising us on our regulatory strategy."
Dr. Mohan also discussed the Company's activities related to licensing its intellectual properties. "We have experienced growing interest from a number of companies that manufacture or market products covered by our patents," Dr. Mohan said. "Licensing agreements are a key component of our growth strategy and Cytomedix has established a strong legal precedence and defense of its key patents.
"As part of our growth strategy, we are building a steady royalty income stream from our licensing agreements, while pursuing and developing our own proprietary products as potential future revenue sources, including the Cytomedix AutoloGel System for treating chronic wounds. Because our licensing activities are quite recent and may be changing the dynamics of the market, it is premature to predict the resulting royalty streams from those half a dozen licensing agreements, most of which we have made public in their entirety in our submissions to the Securities and Exchange Commission."
The Company's over-all strategy is to prove its technology and products through clinical trials and cost effectiveness studies, obtain FDA approval and Medicare coverage for specific clinical indications and to license patents. At the same time, it plans to commercialize current and future products, including those based on other technologies and patents that Cytomedix possesses or may acquire.
"In addition, we will seek strategic relationships where they are advantageous, but develop enough critical mass to proceed on our own," Dr. Mohan said. "We believe that we have an excellent core technology which addresses a multi-billion dollar market that currently appears to be under-served."
Shareholders attending the annual meeting on Friday and those voting by proxy also re-elected all six members of the Board of Directors for a one-year term. They are: Dr. Mohan; James S. Benson, a retired healthcare industry executive and former Deputy Commissioner and Acting Commissioner of the FDA; David P. Crews, Executive Vice President of brokerage house Crews and Associates, Inc.; Arun K. Deva, President of Deva & Associates, P.C., an accounting and consulting firm; David F. Drohan, retired Senior Vice President of Baxter Healthcare Corp.; and Mark T. McLoughlin, Vice President and General Manager of the Scientific Products Division of Cardinal Health, Inc.
Shareholders also voted to ratify the appointment of L. J. Soldinger Associates, LLC, as the Company's independent registered public accounts for the fiscal year ending Dec. 31, 2005.
Slides from Dr. Mohan's presentation at the annual meeting are available on the Company's home page www.cytomedix.com
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 the AutoloGel system, a technology that utilizes an autologous platelet gel composed of multiple growth factors and fibrin matrix. The Company has concluded the treatment phase of a blinded, prospective, multi-center clinical trial on the use of its technology in healing diabetic foot ulcers. 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. The preliminary results from the clinical trial discussed in this press release are also likely to change as a result of the ongoing audit and analysis. There is no guarantee, with or without such changes in the data, that the FDA will accept these results as sufficient for the purpose of granting a marketing clearance. 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.