ROCKVILLE, Md., Sept. 10, 2004 (PRIMEZONE) -- Cytomedix, Inc. (OTCBB:CYME) today announced it has received a favorable ruling from the United States District Court for the District of Massachusetts in its lawsuit against Harvest Technologies for patent infringement of the company's platelet-derived therapies for treating wounds and other damaged tissue.
On September 9, 2004, Judge Patti B. Saris of the District of Massachusetts entered a summary judgment ruling of patent infringement against Harvest, finding that its SmartPReP (tm) System literally infringes Cytomedix's U.S. Patent No. 5,165,938 (the Knighton Patent). Concurrently, Judge Saris denied Harvest's summary judgment motion seeking a declaration that the SmartPReP (tm) System does not infringe the Knighton patent. Additionally, Judge Saris denied Harvest's motion for summary judgment of invalidity.
"This well-reasoned and favorable ruling is consistent with a previously announced decision of Judge James B. Zagel of the Northern District of Illinois on July 26, 2004, in which he ruled that the use of a process supplied by SafeBlood Technologies, Inc., known as the SafeBlood Graft(tm) procedure, infringes the Knighton patent. These decisions by Judge Zagel and Judge Saris, two highly-respected jurists from two different districts with extensive experience in adjudicating patent disputes, should send a strong and unequivocal message to all unlicensed device manufacturers and end-users.
"The ruling gives us all that we could have desired at this stage and further strengthens both our resolve and capability to aggressively pursue those who are infringing the company's intellectual property for the use of platelet releasates in healing tissue, including chronic wounds, intra-operative wounds or any similar applications," said Dr. Kshitij Mohan, chief executive officer of Cytomedix. Copies of the decisions of both Judge Saris and Judge Zagel are posted on Cytomedix's website (http://www.cytomedix.com/pressreleases.htm).
As previously announced, Cytomedix recently commenced the patient treatment phase of the clinical study for its AutoloGel(tm) System with the randomization of patients into the trials. The FDA-approved prospective, randomized, double-blinded controlled study against the standard of care for the treatment of chronic diabetic foot ulcers is one of the first of its type for this technology. It will involve over a dozen premier sites throughout the United States and is expected to be completed by the middle of 2005. The company expects to use the data from this study for obtaining favorable coverage and reimbursement decisions for use of this technology on Medicare patients and broaden the reimbursement by more private insurers and Medicaid payers at the state level.
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.