Assessing tissue oxygenation is critical in trauma care. Insufficient tissue oxygenation, which is not easily detected, can lead to shock and put patients at high risk of death. For instance, auto accident victims with no obvious external signs of trauma may have internal injuries that could lead to insufficient delivery of oxygenated blood to their organ and muscle tissues.

Because of the limitations of common methods of assessing tissue oxygenation, trauma physicians have long expressed a need for an objective, noninvasive, direct and continuous way to monitor tissue oxygenation. The InSpectra™ StO₂ Tissue Oxygenation Monitor, developed by our BioMeasurement Division, meets this need by providing a noninvasive, continuous and direct measurement of local tissue oxygenation.

This second generation device incorporates a number of changes to the original device, which was intended primarily for research studies. The changes, which were suggested by trauma physicians and nurses, support clinical use of the device in trauma and emergency medicine settings. Among them are improved portability, start-up speed, and ruggedness, backup battery power, and a trended display of StO₂ readings.

As our new year began, researchers presented the results of our multi-site StO₂ Trauma Study at a number of medical conferences in the United States and Europe. We initiated this study in 2004 to identify the role that StO₂ monitoring with our device could play in hemorrhagic shock and resuscitation. The study results confirmed the utility of StO₂ monitoring in helping physicians determine if patients are experiencing poor tissue oxygenation due to compromised circulation, which is commonly associated with shock. Obtaining marketing approval from the U.S. Food and Drug Administration in July 2006, completion of the multi-site StO₂ Trauma Study and securing the CE mark in October 2006 cleared the way for the commercial launch of the InSpectra™StO₂ Tissue Oxygenation Monitor in the first quarter of fiscal 2007.

From the very start, our entry into the medical device marketplace has emphasized a thorough understanding of the relevant science that characterizes our culture and problem-solving approach. In developing the InSpectra™ StO₂ Tissue Oxygenation Monitor, we also drew on engineering capabilities, leading-edge measurement expertise and process, quality and customer engagement disciplines core to our suspension assembly business. As a result, we were able to bring the medical marketplace an innovative product that fills a critical, widely recognized information gap in the monitoring of trauma patients.

Because tissue oxygenation is so fundamental to health, we also envision many other applications for this product. Our goal is to support each application with strong clinical data as we are doing now for the use of this device in trauma care.