CAMBRIDGE, Mass.--(BW HealthWire)--June 14, 2002--Hemedex, Inc., announced today that it has received clearance from the U.S. Food and Drug Administration, pursuant to its 510(k) pre-market notification, to market its Bowman Perfusion Monitor(TM), Model 500 in the United States. The Bowman Perfusion Monitor was developed to provide clinicians a powerful prognostic tool by quantifying tissue blood flow in continuous real time, and absolute units.
Hemedex, Inc., a privately held company, designs, develops and markets tissue perfusion-measuring devices that address unmet clinical needs in numerous critical medical and surgical situations. The Bowman Perfusion Monitor, Model 500, is the first commercially available device that monitors tissue blood flow continuously at the capillary level in real time and absolute units of ml/100g-min. The Bowman Perfusion Monitor utilizes a proprietary thermal diffusion technology through its minimally-invasive, QFlow 500 Probe, which physicians can implant in any target soft tissue.
One application of the new device is monitoring the cerebral blood flow in patients with traumatic brain injury to help identify those at risk for secondary, permanent ischemic injury to the brain. Approximately 370,000 Americans suffer a traumatic head injury annually. By using the Bowman Perfusion Monitor to measure continuous, real time cerebral tissue blood flow, clinicians can identify patients at risk from cerebral edema (brain swelling), and measure patient tissue blood flow response to therapies implemented to correct the pathology. In addition, other critical neurosurgical interventions such as aneurysm procedures and procedures to relieve patients suffering subarachnoid hemorrhage will benefit from the valuable prognostic data provided by the Hemedex technology.
According to H. Frederick Bowman, Ph.D, Hemedex Chairman and CEO, "The measurements made by the Company's technology are a long sought after and important parameter in understanding and managing many critical medical situations, and prior to the development of our technology, the capability to get continuous, real time, soft tissue perfusion measurements in absolute units did not exist. The high clinical value of our platform technology has been well documented in life-saving neurological and organ transplantation surgery cases, and we intend to expand into clinical indications beyond neurosurgery and organ transplantation where our technology can help clinicians manage their patients to improved outcomes."
Hemedex believes that clinicians involved in cardiovascular medicine, peripheral vascular surgery, oncology, plastic/reconstructive surgery, and trauma, among others, can all benefit from the valuable prognostic data provided by the Hemedex perfusion monitor.
Gregory T. Martin, Ph.D., Hemedex Vice President of Research and Development, stated: "the Company's successful clinical studies in neurosurgery and organ transplantation will continue at the current sites in Europe and Asia, and new, expanded studies are slated to begin immediately at multiple, leading medical centers in the U.S. The Company is currently in the process of ramping up its manufacturing capabilities to meet the expected demand for its perfusion monitoring devices."
The Bowman Perfusion Monitor, Model 500, was recently debuted successfully at the American Association of Neurological Surgeons' meeting in Chicago, Illinois where neurosurgeons from around the world confirmed the high clinical value of absolute tissue perfusion measurements, and expressed their intent to begin using the device. Hemedex expects worldwide sales of the Company's perfusion monitoring technology to begin in early Q3 2002.
The potential market for tissue perfusion measuring devices is estimated by the company to include millions of annual procedures, globally, and the Company has established its first distribution channels to address the neurosurgical market. In addition, Hemedex seeks to form partnerships with segment leading healthcare companies that have critical mass in other target markets, and which sell devices that are synergistic with the ability to quantify perfusion rates in soft tissue.

About Hemedex, Inc. 

Hemedex, Inc., located in Cambridge, Massachusetts, is a vertically integrated medical device company that designs, develops and markets minimally invasive, perfusion-measuring devices that address critical medical problems in areas that include neurosurgical monitoring, organ transplantation, cardiovascular monitoring and reconstructive surgery. Hemedex's products are based on a proprietary, platform perfusion quantification technology, licensed from Thermal Technologies, Inc. of Cambridge, MA, which was developed with funding from the National Institutes of Health.