Westborough, MA, December 12, 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
second generation product, the Mobile CareGuide™ 2100 Oximeter. The Mobile 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. Along with the first generation product, the CareGuide™ 1100
Oximeter, they continue to be the only FDA-cleared devices to continuously monitor SmO2 and
assess tissue perfusion on patients with pigmented skin.
The Mobile CareGuide™ Oximeter is designed to easily interface with a smart device
(e.g. tablet) or a patent monitor providing parameter trend data; Reflectance expects to enter into
multiple distribution agreements with leading device manufacturers to bring its continuous
monitoring technology to multiple strategic markets.
Reflectance Medical also announced today the consummation of multi-year, non-exclusive
re-seller agreement with Sotera Wireless to incorporate and sell the Mobile CareGuide™ system
with the Sotera Wireless ViSi Mobile® system.
Reflectance Medical expects to soon file a 510(k) application for a next-generation version of
Mobile CareGuide™ to assess muscle pH and hematocrit simultaneously with SmO2.
“FDA clearance of the Mobile CareGuide™ 2100 is an important step in our commercialization
strategy for our innovative product.” said the Founder and Chief Executive Officer of
Reflectance Medical, Babs Soller. “Reflectance Medical is now in a position to engage leading
medical device companies to help bring our technology to patients whose condition puts them at
risk for life-threatening events that result from low levels of tissue oxygenation”.
“We’re very pleased that Sotera will be the first to integrate the Mobile CareGuide™ sensor into
our patient monitoring platform.” commented Tom Watlington, Chief Executive Officer of
Sotera Wireless. “Combined with our other continuous vital sign measurements, the SmO2
sensor will add significant clinical value - especially during patient resuscitation.”
About the CareGuide™ Oximeter
Reflectance Medical’s patent-protected continuous monitoring platform is comprised of the
• Mobile CareGuide™ 2100 Sensor: The sensor is self-contained housing: innovative
optical elements to collect muscle spectra from the patient, a micro-processor to perform
all computations, a battery and a USB or serial interface. Values are updated regularly
and easily interfaced to a smart device or patient monitor for displaying current and
• Mobile CareGuide™ 2100 Disposable: A single-use disposable provides a clean patient
contact surface. The disposable is packaged with a proprietary material to ensure that the
reusable sensor optics remain within specification.
About Reflectance Medical
Reflectance Medical Inc. is a privately held, commercial-stage company focused on the
development of innovative, patented-protected physiologic sensors to non-invasively and
continuously assess patient metabolic status. 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.
About Sotera Wireless
Sotera Wireless, Inc. is a San Diego, California based medical device company dedicated to the
development, marketing and sale of a new generation of comprehensive vital signs monitoring.
Sotera's mission is to improve patient safety by empowering clinicians to detect early signs of
deterioration in virtually any care setting and enable early intervention and rapid response, all
without limiting the patient's freedom of movement. More information on the company can be
obtained at www.soterawireless.com or by sending an email to firstname.lastname@example.org
ViSi Mobile® is a registered trademark of Sotera Wireless, Inc.
Founder and CEO
Reflectance Medical, Inc.
116 Flanders Road, Suite 1000
Westborough, MA 01581