Transonic wins Court of Appeals Ruling on its Hemodialysis Access Flow Measurement Patent.

ITHACA, N.Y. -- Transonic Systems Inc. announced today that the United States Court of Appeals for the Federal Circuit issued a ruling in favor of Transonic, in its patent dispute with Non-Invasive Medical Technologies Corporation (dba HemaMetrics, maker of the Crit-Line monitor) on Transonic's U.S. Patent No. 5,685,989. Transonic prevailed on all counts. The Court of Appeals reviewed a decision of the United States District Court of Utah that had determined the Crit-Line Delta-H and Go/No-Go methods did not infringe Transonic's patent for measurement of access flow during dialysis. Citing that the District Court of Utah had erred on three fronts, the Court of Appeals reversed and vacated the lower court's ruling of non-infringement.

According to Mr. Cornelis Drost, President of Transonic Systems: "We are very pleased with this new ruling. The invention of our Senior Scientist Dr. Krivitski is widely recognized as a pioneering contribution to hemodialysis patient care that prevents much patient harm and suffering. This new Court of Appeals ruling confirms that our patent on his inventions has a similar broad and ground-breaking scope. Transonic is committed to protecting its intellectual property both in this case and in a parallel case against Fresenius USA and Fresenius Medical Care Holdings. We will now push for a rapid jury trial to bring this patent dispute and its financial impact on our company to a successful conclusion."

The Court of Appeals ruling confirms that a jury could find that HemaMetrics' Delta H and Go/No-Go methods for determining shunt flow during dialysis infringe claims of the Transonic patent, and remands the case back to the lower court for further proceedings.

Mr. Drost expressed that this ruling significantly strengthens Transonic's position in both the case against HemaMetrics and Fresenius. Transonic was represented by the intellectual property law firm of Knobbe, Martens, Olsen and Bear, LLP on the appeal.

The blood line reversal method of measuring access blood flow, which is the subject of the '989 patent, was invented by Transonic's Senior Scientist Dr. Nikolai Krivitski and co-worker Dr. David MacGibbon. The Transonic inventions led to a breakthrough improvement in the management of stenotic disease in the hemodialysis access shunt: periodic surveillance of shunt blood flow with interventions to restore flow when indicated by a critical reduction in flow. Before the Transonic invention, a dialysis patient could expect to undergo full surgery annually to create a new hemodialysis shunt. Under the novel shunt flow screening program, this surgery is averted in most instances and replaced with a minimally-invasive procedure to restore flow. The Transonic inventions were followed by 3 years of NIH-sponsored R&D, during which time Transonic provided hardware and technical support to researchers in the USA and Europe to prove that flow-based surveillance of the access may enable reduced patient morbidity and hospitalization and prolonged life of the hemodialysis access shunt. Transonic's "Krivitski Method" was incorporated in the "Dialysis Outcome Quality Initiative" guidelines published by the National Kidney Foundation in 1997 as the preferred method for surveillance of patients during their routine dialysis treatment, and is now a cornerstone of vascular access patency management programs in many dialysis clinics worldwide. Approximately 340,000 USA patients are on hemodialysis because they have lost functionality of their kidneys, and a well-functioning dialysis shunt (A/V graft or fistula) is their link to life.

Transonic Systems manufactures and sells a broad range of blood flow measurement devices for intraoperative surgery, hemodialysis, biomedical research, and is embedded in devices such as organ preservation and ventricular assist devices.