BioDirection aims to rapidly identify head injury severity

NewCo on the Block

BioDirection aims to rapidly identify head injury severity

MONDAY, MARCH 26, 201 2

By AMANDA PEDERSEN

Medical Device Daily Senior Staff Writer

Every single day somebody somewhere hits their head. A child on the playground at school or in gym class. An athlete during practice or a competitive game. An elderly person falls. A soldier on the battle field faces the wrath of an IED blast.

The problem is, there is currently no good, fast way to distinguish a minor hit from a severe concussion. Symptoms may not appear for weeks or months after the injury occurs so even post-injury examinations are often inconclusive.

The founders of a new company, BioDirection(Tuscon, Arizona), has found a better way to provide early identification and medical intervention following a head injury. The privately-held company has developed the Tbit – a handheld device based on dual biomarker and

nanowire technology – designed to diagnose the severity of a head injury at the point of care and, potentially, at the point of injury.

And the test only takes about 60 seconds to analyze a single drop of blood taken within minutes of an injury. BioDirection anticipates launching the Tbit in 2013. “This is the absolute opportunity for us, for the first time, to do a biomarker review . . . from a point of care

device,” Brian McGlynn, president/CEO of BioDirection, told Medical Device Daily. He said that current assays that are used to assess the severity of a head injury can take anywhere from 90 minutes to three hours to deliver results and are “very expensive” and only analyze one biomarker protein at a time. BioDirection’s technology uses a drop of blood and is designed to detect two biomarker proteins known for brain injury.
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“We have to find these people. We have to identify them at the point of injury – everyone agrees on that point,” McGlynn said.

McGlynn noted that the kids in sports, professional athletes, and even military service members who receive a head injury tend to want to continue on in the game or in their mission, especially if the only symptom they experience is a little dizziness or a headache. “If they actually get through the game and ultimately go into another game and receive another hit . . . it could be catastrophic,” he said. “The best thing we can do right now is identify that there is an portfolio will solidify our proprietary position in the field of brain injury management,” McGlynn said.

Interestingly, he noted that 13% of sports concussions happen during practice alone.

“We’re not trying to eliminate competitive sports . . .we just have to be able to identify the injuries because this allows them to go forward,” he said.

In addition to being a useful device for contact sports and military medicine, the Tbit would also be useful in ambulances for paramedics treating accident victims.

BioDirection recently signed an exclusive license agreement with Nanosys (Palo Alto, California), an advanced materials architect, for an extensive portfolio of Harvard University (Cambridge, Massachusetts) generated nanowire patents and patent applications. The agreement grants the company exclusive worldwide rights to use nanowires for biosensor applications in the field of brain injury detection and monitoring. The IP portfolio, invented by Charles Lieber, PhD, a pioneer in the field of nanowire technology, includes 11 issued U.S. patents, five pending applications and broad filing in key foreign jurisdictions. “The quality and depth of the licensed intellectual portfolio will solidify our proprietary position in the field of brain injury management,” McGlynn said.

The company has been self-funded to date, McGlynn said, and is in discussions with private and venture capital investors for some possible investments and some grants. Other companies and researchers have also recognized the need for a better assessment tool to manage head injuries. At last year’s Cleveland Clinic Medical Innovation Summit, a concussion management system was identified as third on the organization’s list of Top 10 medical innovations for 2012 (Medical Device Daily, Oct. 7, 2011).

The new concussion management system includes a special assessment tool that is used to establish an athlete’s baseline cognitive and motor skills at the beginning of his or her athletic season. This is the first tool that objectively and accurately assesses cognitive and motor function simultaneously, according to the Cleveland Clinic experts. During practice and games, the athletes use a special instrumented mouthguard dosimeter that records all hits to the head.

The mouthguard looks exactly like an ordinary sports model, the experts note, but it is able to monitor all the energy imparted by a blow to the head of any kind, recording and reporting this impact via Bluetooth technology in real time. Another effort reported on last year is a sideline visual test that effectively detected concussions in collegiate athletes last year, according to researchers from the Perelman School of Medicine at the University of Pennsylvania (Philadelphia).

The researchers reported that concussed athletes scored an average of 5.9 seconds slower (worse) than the best baseline scores in healthy controls on the timed test, in which athletes read a series of numbers on cards and are scored on time and accuracy (MDD, Sept. 2, 2011).