InfraScan Expands in Asia with Regulatory Approvals of its Ruggedized Handheld Brain Hematoma Detector

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Infrascanner™ Model 2000, a ruggedized handheld brain hematoma detector, received regulatory approvals in Japan, Singapore, Taiwan, and Thailand.

There is a great fit between the need of the trauma market in Asia and the Infrascanner.

InfraScan, a medical device company specializing in brain injury diagnostic products, announced today that it has obtained regulatory clearances in Japan, Singapore, Taiwan, and Thailand for the Infrascanner™ Model 2000, a ruggedized handheld brain hematoma detector. The Infrascanner™ Model 2000 has also received clearances from the US FDA, the European CE Mark, and Health Canada.

The Infrascanner™ Model 2000 is a handheld device with a disposable patient interface that uses Near-Infrared (NIR) technology to detect intracranial bleeding, identifying those patients who would most benefit from immediate referral to a CT scan and neurosurgical intervention. In the triage of head trauma patients, the Infrascanner can identify patients most likely to have intracranial bleeding. The Infrascanner is being used in the following applications: for battlefield triage of soldiers with traumatic brain injury, for triage in remote and suburban locations, on the sidelines of sporting events, and by first responders in ambulances. It is also being used for triage in emergency rooms of hospitals, and for bedside monitoring in intensive care units.

"The regulatory approvals in Asia allow InfraScan to offer an industry first, powerful tool for use by medical professionals in some of the main world markets to quickly triage head trauma patients, and provide further validation of Infrascanner value proposition," said Yosef Ben Dor, Vice President of Sales and Marketing of InfraScan, Inc. "There is a great fit between the need of the trauma market in Asia and the Infrascanner."

The Infrascanner™ Model 2000 was developed in partnership with U.S. Navy and Marine Corps. The Model 2000 features upgrades that meet the specifications of the U.S. Marine Corps and is a ruggedized, integrated, user-friendly unit.

About Traumatic Brain Injury

An estimated 1.5 million individuals seek medical treatment for head trauma in the U.S. each year, and a total of 10 million individuals seek head trauma treatment annually worldwide. Intracranial hematomas resulting from a traumatic brain injury are life-threatening and have been reported to occur as the primary injury in 40% of patients with severe head injury.

Successful treatment often relies upon timely diagnosis and intervention prior to neurological deterioration. The early identification of a brain hematoma can play a significant role in facilitating transportation of critically injured patients to facilities, which can both verify Infrascanner’s early diagnosis and offer surgical intervention.

About InfraScan

InfraScan, Inc. is a medical device company that focuses on developing, commercializing, and distributing hand-held diagnostic devices for head injury and stroke assessment based on near infrared (NIR) technology. The company has received funding from the U.S. Marine Corps, the Office of Naval Research, BioAdvance, the Biotechnology Greenhouse of Southeastern Pennsylvania, the Ben Franklin Technology Partners of Southeastern Pennsylvania, and from the Philadelphia Industrial Development Corporation.

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Baruch Ben Dor
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