FDA clears Reflectance Medical's CareGuide Oximeter

Reflectance Medical, a commercial-stage company focused on the development of physiologic sensors to non-invasively and continuously assess patient metabolic status, announced today that it has received FDA 510(k) clearance for its initial product, the CareGuide ™ Oximeter. The CareGuide Oximeter has been approved as an adjunct, non-invasive monitor of the hemoglobin oxygen saturation of microvascular blood in skeletal muscle tissue, commonly referred to as muscle oxygen saturation or SmO2. The CareGuide Oximeter is first FDA-cleared device to continuously monitor SmO2 and the first device to assess tissue perfusion on patients with pigmented skin.

"FDA clearance is a major milestone for our company and the first step in a potential paradigm shift in monitoring critically and chronically ill patients," said John L. Brooks III, Chairman of Reflectance Medical. "This approval represents the culmination of over a decade of work by our scientific founder Babs Soller and we are thrilled with this result for her and her team."

At the core of Reflectance Medical's novel approach are a spectroscopic, body worn sensor and proprietary algorithms designed to calculate medical parameters from over two hundred wavelengths of near infrared (NIR) light. Unlike pulse oximetry, which measures the oxygen carrying capacity of the blood, SmO2 provides caregivers with critical information concerning whether or not enough oxygen is being delivered to meet the muscle's metabolic demand.

Reflectance Medical expects to file a 510(k) application for a mobile version of the CareGuide Oximeter in the third quarter of 2012, and a 510(k) application for a next-generation version of CareGuide to assess muscle pH and hematocrit simultaneously with SmO2 before the end of the year.

"We look forward to future dialogue with FDA regarding our next-generation devices," said the founder, President and Chief Executive Officer of Reflectance Medical, Babs Soller. "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."

Reflectance Medical's patent-protected patient-monitoring platform includes the following components:   

• CareGuide™ Sensor: The sensor contains innovative optical elements to collect muscle spectra from the patient. Values are updated regularly and displayed on a monitor screen.

• CareGuide™ Disposable: A single-use disposable provides a clean patient contact surface and ensures that the reusable sensor optics remain within specifications prior to use.

• CareGuide™ Display: Pole mountable, 8" touch screen display of SmO2 values and trends. The next generation CareGuide™ sensor will be available to be interfaced to third-party display units.

Reflectance has received over $16 million in federal and state grants to commercialize its technology and evaluate it for military use.