Edina-based Prevent Biometrics, maker of a concussion impact monitoring mouthguard, has signed World Rugby as its first major sports client.

The international rugby federation, which represents 8 million players around the world including the most elite teams, will invest an initial $2.5 million to equip athletes with the smart mouthguard as part of a 2024 head injury assessment that will guide updated safety protocol for the sport. The partnership, announced Monday by Prevent Biometrics CEO Mike Shogren, kicks off this month with an elite women’s rugby competition.

The deal is a decade in the making for Prevent Biometrics, which was founded in 2015 by Steve Washburn and Frank Grazzini II as a spin-off from Cleveland Clinic, where the technology was developed. Prevent’s wearable device measures and reports head impacts in real time. It calculates the force, location, direction and number of impacts while filtering out false-positive non-head impact incidents. In a 2022 independent study, the high-tech mouthguard outperformed competing products. It data has been validated by Stanford University, Virginia Tech, and the U.S. Army Research Laboratory, among others.

The Prevent mouthguard is not a diagnostic tool, Shogren explains. The idea is that armed with that real-time data, teams can make more informed decisions about whether or not to play an athlete and how to minimize dangerous moves. World Rugby, which does not require helmets, plans to make the mouthguard an integral part of it off-field assessment, according to Prevent Biometrics.

It’s a milestone that almost didn’t happen. Prevent has raised north of $20 million—mostly from local angel investors led by the Mortensen family. But by 2019, the company had burned through most of its capital, “and the product didn’t work,” said Shogren, who became CEO in 2020 and had to layoff staff. During the pandemic, the research team, which includes engineers, software developers, and a board of neurosurgeons and scientists, went back to the drawing board and worked out the bugs, eliminating false positives and improving data transfer and battery life.

Since then, Shogren has been meeting with leadership of every sports organization willing to talk. World Ruby was first to bite. “It’s just going to accelerate from here,” Shogren said.