CHICAGO - JULY 17, 2003 Vasc-Alert LLC announced today that it has received FDA clearance to actively market the Vasc-Alert software and monitoring service. This new technology provides the first economical approach for pro-active surveillance of access sites for hemodialysis patients. The application provides a means for early detection of significant stenosis, which, if allowed to progress, culminates in thrombosis or inadequate dialysis, resulting in shortening of the useful life of the access site, alteration in quality of life, and increased morbidity.

Vasc-Alert software is now being provided as a service to dialysis centers for a nominal yearly fee per patient. At the end of each day, individual treatment data for patients dialyzed is either entered into the Vasc-Alert software via the Internet or electronically delivered from the dialysis center to the Vasc-Alert data monitoring center over a secure encrypted data link. Vasc-Alert then notifies the center of those patients who are at risk for clotting in the next 3 to 6 months. This technology provides a cost effective mechanism by which dialysis centers can accomplish the goals for access monitoring established by the CMS Renal Networks and the K/DOQI Guidelines.

Vasc-Alert, developed by a team of physicians and engineers at Henry Ford Hospital, is based upon prior studies of Anatole Besarab, M.D., the Director of Clinical Research in the Division of Nephrology and Hypertension at the Henry Ford Hospital. Vasc-Alert represents an extension and advancement of these observations and utilizes intra-access pressure to actively monitor for the onset of stenosis. According to Dr. Besarab: "A system was needed that reduced the burden of labor associated with access surveillance. Vasc-Alert is rapid data analysis and delivery of pipelined real-time hemodialysis pressure and flow-related data, and represents a marriage of computer science with a clinical imperative."

Vascular access issues continue to be the "Achilles' Heel" for patients undergoing hemodialysis care. Studies have shown that early detection of vascular access stenotic lesions, followed by timely corrective procedures, reduces the thrombosis rate and prolongs access survival.¹ Once the site begins to narrow, it produces progressive reduction in access flow, ultimately leading to clotting and possible loss of the site. With early detection of stenosis, elective intervention can be provided to restore the integrity of the access site before thrombosis can occur. This benefits the patient by reducing their risk of unrecognized access recirculation, missed dialyses, the need for central venous catheter implantation, and from the "urgency" of having no functional access. Elective intervention(s) can be performed repeatedly to extend the useful life of the access site. With only six permanent access sites on the body, it is imperative to maintain patency of access sites as long as possible. Performance of access site maintenance on an elective rather than an emergency basis will reduce the cost of dialysis care.

The Vasc-Alert system pro-actively identifies patients at risk for stenosis by analyzing treatment data routinely collected from dialysis machines. The patient's access site is examined at each treatment, rather than monthly, the norm of other technologies. Vasc-Alert analyzes sequential treatment data in order to determine trend analyses. If the trending profile indicates a problem, the system automatically delivers a notification to the medical staff, alerting them to the situation. The major benefit for the staff is that they no longer must spend relatively long periods of time performing tests in order to monitor patients for development of access stenosis.

According to John Kennedy, President of Vasc-Alert LLC, "Vasc-Alert provides dialysis centers with a unique opportunity to pro-actively monitor vascular access sites without imposing increased hemodialysis staff requirements. By monitoring access sites for the onset of stenosis with each treatment, patients don't have to cope with the stress and uncertainty of an access site closing." Since the application provides an early warning indication of a potential life-threatening problem with an access site, medical staff at dialysis centers can now plan for anticipated interventions that promote access patency, rather than simply reacting to the emergent situation of a clotted access.