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Reflectance Medical Receives Its 2nd 510(k) Clearance in 5 Months and Announces Distribution Agreement With Sotera Wireless


12/12/2012 10:19:12 AM

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 following components:

• 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 trended value.

• 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 info@soterawireless.com ViSi Mobile® is a registered trademark of Sotera Wireless, Inc.

Contact:

Babs Soller

Founder and CEO

Reflectance Medical, Inc.

116 Flanders Road, Suite 1000

Westborough, MA 01581

Phone 1-508-366-4700

www.reflectancemedical.com



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