FDA approval given to non-invasive oxygen monitor

Professor emeritus develops device to monitor oxygen in muscle tissue

By Jim Fessenden	August 15, 2012
UMass Medical School Communications

Reflectance Medical Inc., a biomedical device company built on the work of founder Babs Soller, PhD, professor emeritus of anesthesiology and surgery, has received FDA clearance for its initial product, the CareGuide Oximeter. Approved as an adjunct, non-invasive monitor of muscle tissue oxygen levels, the CareGuide Oximeter is the first FDA-cleared device to continuously monitor oxygen saturation of microvascular blood in skeletal muscle tissue, commonly referred to as muscle oxygen saturation or SmO2, and is the culmination of more than a decade’s worth of research by Dr. Soller at UMMS.

“FDA approval is an important milestone for Dr. Soller and her team at Reflectance,” said Terence R. Flotte, MD, the Celia and Isaac Haidak Professor in Medicine, executive deputy chancellor, provost, dean of the School of Medicine and professor of pediatrics and microbiology & physiological systems. “All of us at UMass Medical School are tremendously excited by this next step in Babs’ evolution from researcher to entrepreneur. Her work is a shining example of the ability for bench to bedside research to directly impact patient care and the reason why our faculty are so passionate about translation research.”

Unlike standard pulse oximetry, which measures the oxygen-carrying capacity of the blood, SmO2 levels provide caregivers with critical information concerning whether enough oxygen is being delivered to meet the muscle’s metabolic demand. The device will allow medical personnel to more efficiently monitor pediatric and intensive care patients. It could also be used in critical care settings to assess patients with traumatic injuries and those at risk for cardiovascular collapse.

At the core of Reflectance Medical’s novel approach is a spectroscopic, body-worn sensor and proprietary algorithms designed to calculate medical parameters from more than 200 wavelengths of near infrared (NIR) light recorded by the device. Placed directly on the skin, sensor uses near infrared light (that is just beyond the visible spectrum) to take the measurements. Blood in tiny blood vessels absorbs some of the light, but the rest is reflected back to the sensor. The monitor analyzes the reflected light to determine tissue oxygen. One unique advantage of Soller’s near infrared device is that its measurements are not impacted by skin color or body fat.

“We believe our innovative patient-monitoring platform has the potential to noninvasively and continuously deliver healthcare providers with real-time, critical, patient care information to help physicians identify and reverse conditions associated with low muscle pH,” said Soller.