Location: Philadelphia, PA
Start-up InfraScan is developing the Infrascanner (pictured), a hand-held imaging device using near infrared technologies for the detection of hematoma in head trauma patients. It is a small, portable handheld device based on a PDA platform with wireless detector probes.
As CEO Baruch Ben Dor (photo) told FierceMedicalDevices, the company is attempting to address a vast unmet need with its technology, which he says some people have referred to as a tricorder. Roughly 2 million individuals seek medical treatment for head trauma in the U.S. each year, and the worldwide incidence is about 10 million, according to the company's website. However, some brain hematoma patients don't receive the prompt medical attention they need because they don't immediately get a CT scan--the current gold standard for hematoma diagnosis. This is where InfraScan's technology can help.
The Infrascanner detects hematoma during the first hour after head trauma--the so-called "golden hour"--to determine what treatment is necessary to prevent further damage to the brain, Ben Dor told FMD. The Infrascanner can help in these instances and can be used in a number of settings, including hospital emergency rooms and ICU units. In addition, it could potentially be used in emergency medical vehicles, developing world medical clinics and war and disaster zones, the company notes on its website.
InfraScanner works because of the unique light-absorbing properties of hemoglobin and the non-invasive, non-ionizing nature of NIR technology. Hematoma detection is based on the differential light absorption of the injured versus the non-injured part of brain. When additional underlying extra vascular blood is present due to internal bleeding, there is a greater local concentration of hemoglobin and consequently the absorbance of the light is greater while the reflected component is commensurately less. This differential can be identified by detectors placed on symmetrical lobes of the skull.
Infrared will have to address a problem a number of U.S. companies are facing--the ability to get their products in the market three to four years in their home country after being able to do so abroad. The company already markets its product in a number of countries, including Russia, Romania, Saudi Arabia and India, but has yet to get regulatory sign-off in the U.S. However, the U.S. Marines/Navy have been supportive. The military branches concluded a $2 million contract in July 2010 that will provide for advanced technology development safety testing and field evaluation activities to develop a next-generation version of the Infrascanner. Ben Dor says the company has received more than $3 million to date to develop its technology.
Currently, the company is three and a half years into the process of working with the FDA to get its technology to market in the U.S., and Ben Dor hopes the company its getting closer to obtaining a regulatory sign-off. There has been a lot of back and forth, and Ben Dor told FMD the company will reach its fullest potential after gaining FDA approval. After receiving the FDA's ok, the company hopes to triple its job count.