X2 Biosystems is Combating Football Concussions with Data and Devices

Starting in the 2013 season, the NFL is going to have a new tool in its fight against concussions - a neuro test developed by X2 Biosystems to assist in testing players for concussion symptoms. It's all part of X2's comprehensive plan to resolve the concussion issue once and for all using one-of-a-kind devices like its X-Guard mouthguard and X-Patch for impact measurement. But while the devices are certainly exciting in themselves, you can hear the passion in X2 co-founder and CEO Christoph Mack's voice as he emphasizes the real goal of his company. “What we want to do is build the definitive database of head impact exposure across this hugely diverse population and then be able to capture the clinical outcomes associated with that exposure to head impact and enable the research community to make real strides in understanding what kind of conditions lead to what kind of injury profiles,” Mack says. “The gizmos are what makes us really unique, but the real mission of our company is this database.”

With no currently established standard or threshold as to what type of impact can actually cause a concussion in a player, the X2 team believes the most important task at this step is to gather clinical data – to create a dataset large enough that could make creating these sorts of thresholds possible. Co-founder and chief marketing officer, Rich Able, is quick to clarify that the X-Guard and X-Patch are impact sensors – not intended to diagnose any condition. “We're actually just giving clinicians and athletic trainers data,” Able says. “There is no known threshold. Everyone is different. That's why clinicians are excited because we're going to be supplying millions of hits for them to analyze”

While giving all of the appearance and function of a mouthguard, X2's X-Guard is a sophisticated piece of technology able to measure impact to a player's skull and wirelessly transmit this data to a tablet or computer for monitoring. Using X2's software, a trainer or clinician on the sidelines can view realtime data the instant a player takes a hit. The data can then be stored and compared over time. Using the data, combined with tests such as the Sport Concussion Assessment Tool (SCAT), clinicians and trainers can then proceed toward a proper diagnosis.

“It's the repeated blows to the head that add up over time,” Able says. “If you see the hits add up at alarming rates, assessments by the clinician or athletic trainer can begin. They will ask questions and compare baseline tests of the individual from months prior and they’ll be better informed on what steps to take next.”

It was 2007 when Able first came face to face with the need for better impact sensing technology for sports – when his middle son, Kyle, took a bad hit at a high school football game. “I'm sitting there videoing this, watching my son not moving, and it just took my heart away,” Able recalls. Kyle recovered, but there were notable changes in the following months. Teachers reported he was having difficulty concentrating, complained of blurred vision, and of the bright lights in the classrooms. His family noticed behavioral changes in him as well. “Let's put it this way,” Able says, “The three years of varsity football - we're talking about 1500 hits to the head every year. This kid was an honors student all through ninth grade. When he got out of high school he was around a 2.6 GPA.”

It was Able's experience with his son that showed him the real need for an early warning system, something to monitor the hits that kids were taking on the field. He approached Mack with the idea and the two started X2 Impact (now X2 Biosystems) in 2009.

Developing the technology for this early warning system fell on Mack. “I started where I think anybody would, which is that the helmet is protecting these kids' heads so let's stick a sensor in there,” he says. But he soon discovered that helmet-based sensors were not ideal. “Sensors in the helmet were a fantastic way of figuring out what the helmet was experiencing; not such a great way of describing what the squishy stuff inside was experiencing. I become vary interested in how to bridge that gap. How do you get out of characterizing what protective gear is doing and toward what the human being is actually experiencing?”

He found the answer when he started thinking about the human jaw. “The upper jaw is essentially the skull exposed, right?” Mack reasoned that their sensor and telemetry technology could be miniaturized to fit into an otherwise normal protective mouthguard. Working with ST Microelectronics, X2 was able to develop a 6-axis accelerometer and proprietary wireless protocol that lies at the heart of the X-Guard. Using what X2 calls a virtual projected sensor (VPS) system, the X-Guard senses acceleration relative to the position of the players head and uses this data to determine impact.

X2 also had to create its own proprietary wireless protocol to deal with some of the challenges inherent in what it was trying to do. Among other challenges,there was power/battery life considerations, the challenge of minimizing and compressing waveforms, minimizing the payload over air, and tuning the antennae to the right range – too little range is ineffective while too much range eats up battery. “We also have to take into the account things like the fact that human beings are highly absorptive of radio energy. So if we've got one X-Guard or X-Patch at the bottom of a pile of 22 football players it has to do a very different thing than say a Bluetooth headset talking to your phone. So we've had to craft every single aspect of the radio protocol around government regulations and the specific needs of athletics.” Mack says.

X2's latest the development, the X-Patch could be seen as the next step in its sensing technology, but it was developed very much by accident. “Our very first prototype of the patch was literally a X-Guard strapped to the back of an athlete's head,” Mack says. “ We said, 'Let's just try it out and see how it works, all we have to do is change some of the parameters of where the target - in this case the brain - is relative to the device” The X2 team found that using the same VPS technology afforded a lot of freedom to place sensors anywhere on the target. The X-Patch, which is smaller and designed to unobtrusively adhere to a player's neck, does just this. “We can outfit an athlete with multiple devices and simply because we know where they are relative to the center of gravity of the head we can generate the same answers from all of them.” Ultimately, players being will be able to choose a form factor (mouthguard vs. patch, for example) based on comfort preference.

This degree of versatility becomes especially important as X2 branches out beyond sports into other arenas including industrial and military applications. Mack notes that everyone from construction workers to soldiers could benefit from X2's sensing technology. And as their dataset grows larger, so do the potential applications. “It's our belief that only by building a database of head impact exposure, and the subsequent clinical outcomes, diagnoses, therapies, recoveries, and return, when we have that full comprehensive picture, that's when human kind really understands and solves this concussion problem.”

-Chris Wiltz, Associate Editor, MD+DI
[email protected] 

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