Clinical Evaluations: The value of the CareGuide^™ technology has been demonstrated with prototype devices in numerous clinical studies.

In collaboration with the US Army Institute of Surgical Research, a CareGuide^™ prototype has been shown to be a very early and reproducible indicator of central hypovolemia in humans, significantly earlier than pulse oximetry, blood pressure and heart rate and highly correlated with stroke volume (Soller et al, J Appl Physiol, 104, 475-481; 2008, Ward et al, Resuscitation, 81, 987-993, 2010).

In the same human model of progressive hemorrhage the CareGuide^™ prototype has also been shown to be significantly more sensitive than the Hutchinson Technology InSpectra tissue oxygen monitor (Soller et al, Crit Care Med 36, 176-182, 2008). The CareGuide^™ sensor adheres to the skin over an arm or leg muscle, reporting peripheral muscle oxygenation and pH as surrogates for end-organ perfusion in the splanchnic circulation. Animal studies have confirmed excellent correlation between muscle and liver pH during swine hemorrhage and resuscitation (Soller et al, J Surg Res 114, 195-201, 2003).

The CareGuide^™ prototype was shown to provide a very reproducible measure of muscle oxygen saturation on 24 human subjects, each measured 5 times spaced at least 2 days apart (Yang et al, Opt Exp 15, 13715-13730, 2007). The non-invasive measurement of pH has been validated against invasive methods on human subjects during handgrip exercise and the "lactate threshold" was demonstrated during cycling (Yang et al, Appl Spectrosc 61, 223-229, 2007 and Soller et al, J Appl Physiol, 104, 837-844, 2008) and treadmill exercise (Lee et al, Eur J Appl Physiol, epub ahead of print Jan 7, 2011).