InfraScan Receives FDA Approval of Next Generation, Noninvasive Handheld Brain Hematoma Detector

Device available now for military and civilian emergency medical services

PHILADELPHIA--(BUSINESS WIRE)--InfraScan, a medical device company specializing in brain injury diagnostic products, announced today that it has obtained U.S. Food and Drug Administration approval to market the Infrascanner™ Model 2000, a noninvasive handheld brain hematoma detector.

“FDA approval in the U.S. allows InfraScan to offer an industry first, powerful tool for use by civilian and military medical professionals to quickly triage head trauma patients”

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.

“FDA approval in the U.S. allows InfraScan to offer an industry first, powerful tool for use by civilian and military medical professionals to quickly triage head trauma patients,” said Baruch Ben Dor, President and CEO of InfraScan, Inc. “Shortening the time to treatment through effective detection of intracranial bleeding can mean preserving brain function in a patient and even saving lives.”

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.

“Before the Infrascanner, first responders had to rely on imprecise methods to detect brain bleeds in patients, potentially delaying treatment,” said Dr. Joseph Maroon, Professor and Vice Chairman of the Department of Neurological Surgery at the University Of Pittsburgh, team neurosurgeon for the Pittsburgh Steelers, and Medical Advisory Board member of civilian Infrascanner™ distributor, MedLogic, LLC.

“Whether on the field of battle with military medical personnel or on the thousands of playing fields with sports health professionals in professional, amateur or youth sports, the Infrascanner can potentially save lives by quickly detecting life-threatening brain bleeds earlier,” added Dr. Maroon.

The Infrascanner™ Model 2000 is available to US civilian customers through MedLogic (www.med-logic.us), the exclusive civilian market distributor of the Infrascanner™, and to US military customers through ADS Medical (www.adsinc.com), the exclusive military market distributor of the Infrascanner™. To contact a distributor in other countries, visit http://www.infrascanner.com/contact-us/distributor-directory/.

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.

For more information about the Infrascanner Model 2000, visit www.infrascanner.com.