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InfraScan has received the CE mark for the Infrascanner hand-held brain hematoma detector and plans to launch international sales this fall.

The Infrascanner is a small, portable device that can detect the presence and location of a brain hematoma based on differential NIR light absorption of a hematoma and normal brain tissue. Results of a pivotal, 400-patient, multi-center study will be presented to the FDA by InfraScan later this year to support its 510(K) application and a subsequent anticipated U.S. launch of the device.



The device is the first hand-held device of its kind designed to assist first responders and hospital personnel in identifying life-threatening brain hematomas, allowing expedient assessment of patients and potentially facilitating crucial treatment. Intracranial hematomas resulting from a traumatic brain injury are life-threatening and patient outcomes can improve significantly if treated within an hour after an injury -- known as the "golden hour." 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. The Infrascanner can be used also in the intensive care unit as a method for following patients postoperatively for recurrence of hematomas or for the development of delayed hematomas.

DOTmed spoke with Dr. Baruch Ben Dor, President and CEO of InfraScan, Inc. who said, "Receiving our CE mark represents significant progress toward InfraScan's strategic goal of providing our potentially life-saving technology to patients in some of the world's top established and emerging markets. Every year 1.5 million people in the United States suffer from a head injury....Brain injuries are complex injuries. Brain-injured patients are now given CT scans to detect hematomas and not all hospitals can afford the $1 million price tag for a CT scanner, particularly those in developing countries with limited resources.

Ben Dor anticipates sales of the $15,000 Infrascanner to reach $400,000 this year, and the company already has commitments for another $2 million in foreign sales for 2009. Should the FDA approval come in early 2009 as anticipated, the company expects to generate another $1 million in domestic sales.

The Infrascanner technology was developed by Britton Chance, a University of Pennsylvania professor, in collaboration with Dr. Claudia Robertson, a neurosurgeon at Baylor College of Medicine.

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 based on near infrared (NIR) technologies. The company has received early-stage funding from the Office of Naval Research, BioAdvance, the Biotechnology Greenhouse of Southeastern Pennsylvania, Ben Franklin Technology Partners of Southeastern Pennsylvania and from the Philadelphia Industrial Development Corporation. For more information visit www.infrascanner.com.