LITTLE ROCK, Ark., March 26, 2004 (PRIMEZONE) -- Cytomedix, Inc. (CYME:OTC.OB) today announced it has received a favorable ruling from United States District Court Judge James B. Zagel of the Northern District of Illinois affirming Cytomedix's position regarding the scope of the claims in U.S. Patent No. 5,165,938 (the Knighton Patent), which relates to the use of platelet-derived therapies for treating wounds and other damaged tissue.
Judge Zagel's ruling was issued in connection with a pending patent infringement lawsuit initiated by Cytomedix against Little Rock Foot Clinic. This ruling also favorably impacts Cytomedix's position in its lawsuit against Perfusion Partners and Associates, Inc., which had previously agreed to be bound by Judge Zagel's claim construction ruling in the Little Rock Foot Clinic case. A copy of Judge Zagel's opinion can be found on the company's website at www.cytomedix.com. Judge Zagel concluded that the claims of the Knighton Patent should be broadly construed to cover any treating composition that contains all of the materials released by platelets during the platelet release reaction. In so doing, Judge Zagel rejected the defendant's assertion, echoed by all defendants in other pending cases, that the claims of the Knighton Patent are limited in scope to platelet-releasate compositions that are free of other cellular materials.
"The court's well-reasoned opinion establishes a compelling legal precedent that confirms the company's long-standing position concerning the breadth and scope of the claims of the Knighton Patent. Since we believe that the compositions of virtually every platelet gel wound healing therapy offered in the marketplace today contains all the materials released by platelets in the platelet release reaction, we feel Judge Zagel's ruling strongly supports our contention that all unlicensed purveyors of such platelet gel therapies are infringing the Knighton Patent," said Mark Cline, president of Cytomedix.
He noted that this ruling represents a significant milestone for Cytomedix in its ongoing licensing strategies within the company's core chronic wound care market, as well as within a host of ancillary markets where platelet gel therapies are currently utilized to enhance the quality of healing. He added that he believes the ruling will now better enable the company to fully realize the significant value of the Knighton Patent and also benefit the millions of patients who are treated each year for debilitating chronic wounds.
Cytomedix recently received FDA approval to initiate clinical trials for its AutoloGel(TM) System for the treatment of chronic diabetic foot ulcers. The trial, a randomized, double-blinded controlled study against the standard of care for the treatment of chronic wounds, will be conducted at up to 12 premier sites throughout the United States, with enrollment of approximately 74 patients expected to commence in mid-April.
About Cytomedix
Cytomedix, Inc. is a biotechnology company specializing in processes and products derived from autologous platelet releasates. The current product offering is the AutoloGel(TM) System, which produces an autologous platelet gel composed of multiple growth factors and fibrin matrix for treatment of chronic wounds. Cytomedix is working with healthcare providers to offer an advanced therapy at the point-of-care in multiple settings. Additional information is available at the company's website at www.cytomedix.com.
Forward Looking Statements
Statements contained in this press release not relating to historical facts are forward-looking statements that are intended to fall with 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, governmental regulation, acceptance by the medical community and competition. 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.