Westborough, MA, July 31, 2012: 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.
About Reflectance Medical
Reflectance Medical Inc. is a privately held, commercial-stage company focused on the
development of physiologic sensors to non-invasively and continuously assess metabolic status.
In July 2012, Reflectance Medical received FDA 510(k) clearance for its initial product, the
CareGuide ™ Oximeter, to non-invasively monitor muscle oxygen saturation, or SmO2.
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.
Reflectance Medical’s innovative, patent-protected platform has the potential to non-invasively
and continuously assess the metabolic status of muscle tissue. The company’s platform has the
potential to provide information that helps physicians identify life-threatening events earlier than
standard vital sign parameters, and uniquely provide real-time information to guide the
application of treatment to avoid costly and harmful patient complications.
Contact:
Babs Soller
Founder, President and CEO
Reflectance Medical, Inc.
116 Flanders Road, Suite 1000
Westborough, MA 01581
Phone: 508-366-4700