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Infrascan CEO expects FDA approval in 2012 for handheld brain bleed detector

When it comes to brain trauma, time is of the essence, or as Infrascan CEO Baruch Ben Dor puts it: time lost is brain lost. A handheld medical device designed to detect bleeding in the brain, the Infrascanner, is designed to be used as a sort of triage device by first responders and physicians to […]

When it comes to brain trauma, time is of the essence, or as Infrascan CEO Baruch Ben Dor puts it: time lost is brain lost. A handheld medical device designed to detect bleeding in the brain, the Infrascanner, is designed to be used as a sort of triage device by first responders and physicians to assess whether patients need an urgent CAT Scan.

The device spots the presence and location of brain bleeds up to two minutes based on differential near-infrared light absorption of a hematoma and normal brain tissue.

The company presented during the 2011 IMPACT Venture Summit in Philadelphia this week, the largest conference of its kind in the mid-Atlantic. The company is awaiting regulatory approval from the U.S. Food and Drug Administration that Ben Dor says should be coming within the next few months.

It was originally started in 2004 with the patented work of Dr. Britton Chance at the University of Pennsylvania and Dr. Claudia Robertson at Baylor College of Medicine.

The Philadelphia, Pennsylvania company is currently raising $3 million to $4 million in a series A round for a U.S. launch of the device and expanding its sales network for Europe where the Infrascanner is currently available.

Ben Dor is an officer in the Israeli army and a physicist who moved to the U.S. in 2004. The company initially received a grant from the National Institutes of Health’s Small Business Innovation Research program that provides funding to commercially viable companies. It inked a $2 million contract with the U.S. Marine Corp. and U.S. Navy in 2010. Four of its systems are currently being used in the Helmand Province of Afghanistan.

Ben Dor said the biggest challenge and frustration for his business is the FDA approval process. In Europe, the product is available for sale and estimated revenue from the device for 2011 are $650,000. Ben Dor worked with U.S. senators for Pennsylvania Robert P. Casey and Pat Toomey, and U.S. Rep. Allyson Schwartz earlier this year to help in the process.

“We have been in a long protracted review process,” Ben Dor said. He said regulators are concerned that physicians will be too reliant on the Infrascanner and use it to the exclusion of performing CAT Scans.

Ben Dor said he also sees uses for the device for clinics in remote rural areas that may not have the resources of a healthcare provider in more populated areas.

The device reflects the drive to develop technology to improve efficiencies in healthcare settings to reduce costs.

Another company in the earlier stages of developing a handheld medical device to detect concussions is Brain Computer Interface.

The early stage medical device company based in Doylestown, Pennsylvania seeks to transform where, when and how brain diagnostics occur, particularly for sports-related concussions and Alzheimer’s disease. Its portable brain diagnostic device called “MindReader” acquires EEG data wirelessly and can be used on an Android phone. The company said it wants to become the first brain diagnosis as a service business.

CEO Adam Simon said the company is raising $1.5 million for clinical testing and to apply for 510(k) approval from the FDA. The funding will also help with investing in its software and infrastructure. Although it is partially self-funded, like Infrascan it has been bolstered by backing from the U.S. military; it received investment from the U.S. Army last year under Phase I SBIR.

It aims to begin series A round financing in 2012.