SFIA Member Spotlight – Prevent Biometrics

prevent

Prevent Biometrics introduces never-before-seen technology with their new mouthguards, which will be a game-changer in regard to head impact and safety in sports.

steve  david

                           Steve Washburn, CEO    &    David Sigel, CMO

What is Prevent Biometrics?

Prevent is an early stage company based in Minneapolis that has developed a highly accurate system for measuring head impacts in sports.

Can you give me a little background on the company?

The company is a spinoff of the Cleveland Clinic, a renowned research hospital system. They started developing the technology back as early as 2009 with grants from the National Institute of Health. The inventors of the product from the Cleveland Clinic were two doctors, Dr. Ed Benzel, Chairman of the neurosurgery department, and Dr. Vince Miele, a neurosurgeon, along with Adam Bartsch, a Ph.D. in biomechanical engineering and Sergey Samarezov, a mathematician.

The genesis for the idea was that Dr. Miele was a ring-side physician for professional boxing. He saw the punishment that the boxers were taking as the ref made subjective decisions to call the match, and as a neurosurgeon, he knew that they were suffering brain injuries and he thought there had to be a much better objective way to call a match. And that’s how they started to think about a device to measure head impacts.

They came to the early conclusion from some earlier work that had been done in the automotive industry that they needed a secure coupling of the skull in order to get an accurate head impact measurement; which led them to the understanding that the only practical way to get that secure coupling to the skull was with a mouthguard that was attached to the upper arch of your teeth, which are part of the skull. The team received grant funding to develop this technology over four years. By 2014, they were able to successfully publish a study in the peer-reviewed Stapp Journal, validating the accuracy of their device in measuring head impacts.

At that point, the Cleveland Clinic looked for a partner to commercialize the technology. I had been the CEO of Shock Doctor, the leading mouthguard company, for 16 years and left at the end of 2009. I had done a medical device startup, and was just finishing that up and knew one of the people involved in the project. We were able to get a worldwide exclusive license to the technology from the Cleveland Clinic to create a consumer product. And that’s how Prevent Biometrics was formed in 2015.

We have since raised $9 million in funding and taken that research prototype of their technology and turned it into a commercial product that anyone will be able to use on the field of play. We’re going to launch the product in July of this year.

How exactly does the mouthguard work?

Embedded in the mouthguard is an electronic package built on a flexible circuit board. The reason we use a flexible circuit board is because, of course, the mouthguard needs to be able to bend and flex. We have about 100 electronic components that go on the flexible circuit board. But the heart of it is that there are four accelerometers, a microprocessor, Bluetooth, a battery and a wireless charging coil. The secret sauce is an algorithm that calculates a point in space that is the center of gravity of your head and dynamically measures impacts to that point. We display those impacts in a couple of different ways, but we really measure five different things at this point. We measure peak linear acceleration (in G’s), Peak angular acceleration (in Rads), the location of the impact, the direction the impact came from, and then the count or number of impacts over the course of a game, week, month, year or years. We do that for each athlete and that’s all done wirelessly, and then each of those mouth pieces that the athlete wears is connected by Bluetooth to an app that the trainer will have on the sideline to collect all of the data. If an athlete receives an impact above a preset threshold, then an alert goes off and that gives the trainer an indication that [s]he should assess that player for a potential concussion.

When did Prevent Biometrics officially start?

In 2015.

Can your product detect when a concussion is healed?

No, it cannot. Nor can it detect when a concussion exists. We’re not a medical device that is diagnosing or determining concussions. We are a measurement device that measures head impacts accurately and can alert the athlete and sideline personnel about particular impacts of a magnitude that could be concussion-causing. Currently, estimates are that half of all concussions go undetected. They go undetected because the method for identifying when a player may have a concussion is totally observational and subjective. So, by measuring the head impact and sending an alert in the case of an impact that is of high magnitude, we’re able to help coaches, trainers and referees know when player needs to be pulled off the field and evaluated. One of the features of our system is that it helps the trainer or coach who is supervising a player to manage return to play protocol where a player is in the process of returning from a concussion. But we don’t actually clear a player on returning.

So currently, you only produce mouthguards?

Well, it’s really a system, it’s not just the mouthguard. We also have the team app for viewing the data in real time and a web portal for administering the system at a team or association level and viewing detailed head impact analytics that allow coaches to instruct players on better technique. There’s a charging case that wirelessly charges and sanitizes the mouthguard, and a team case that does that for up to 27 mouthguards at a time.

How many different types of mouthguards do you currently produce?

Basically, two types. We make the impact monitor mouthguard in a custom form where we take a dental scan of a player’s teeth and custom fabricate the mouthguard to that impression. Or we have a lower cost boil-and-bite model which is really the main, commercially available product, that can be personally fit by the user.

For the custom mouthguard, do you have a facility where customers come in for customization?

No, we get the dental impressions from a dentist and we have primarily been using digital scanning, instead of physical impressions. They take a scan of the upper arch of an athlete’s teeth and we take that file and use a 3-D printer to print out a model, and then we custom fabricate the mouth guard from that. And with the boil-and-bite, it’s just like a normal boil-and-bite that you’ve probably used when you were in sports, very easy to use.

Have you found that concussions are more common, less common or as expected with the inception of Prevent Biometrics mouthguards?

As stated before, our product is not a diagnostic tool. Our primary objective is making sure that athletes don’t continue playing after they’ve had a concussion. The research has said that about 50 percent of concussions go undetected, and if they are undetected, then that means they go undiagnosed and untreated. This means the athlete continues to play with a concussion. When they do that, that’s when they’re at higher risk for permanent neurological damage, or even in some cases, second impact syndrome, which can lead to death. So, what’s really important is that if the athlete has received an impact of a certain magnitude, where there is a potential concussion, that we get that athlete pulled and that the trainer does the sideline assessment of that athlete. And if they are showing symptoms of concussions, they get diagnosed and treated and recover fully before returning to play and receiving more impacts. That’s a critical part to making sports safer.

What has been your biggest challenge so far?

We’re the only ones who have ever done this successfully before. It’s breaking new ground, in terms of being able to accurately measure these head impacts in real time. There’s two parts to it; measuring head impacts accurately, but also being able to filter out false positive or non-head impacts. Our technology very accurately filters out false positives. The next challenge is really introducing a whole new idea to sports which going to require educating people and changing behavior.

Where do you see Prevent Biometrics in the next 5 years?

Well, it’s our goal to continuously improve the effectiveness of the product and we would like to see it mandated in sports where concussions are a problem. That would be not only contact sports like football, hockey and lacrosse, but also other sports where there are high rates of concussions like soccer.

Have you had any indications that this is something to become mandated in the future?

We’ve done a lot of work with the country’s leading concussion researchers. In order to advance concussion science, meaning developing better assessments, better diagnostics, better treatment tools, etc., they need to be able to accurately measure impacts. So, we think the research community is really supportive of this and we think once we can validate the technology and its effectiveness, the supporting governing bodies will certainly be interested implementing them and potentially mandating them. But we have not spoken to any of them yet, because we were not ready to.

In closing, we strongly believe in the high value that comes from playing organized sports and want to see as many people as possible benefit. If we can make the games safer, that should only encourage participation.