Minnesota engineers pivot from gaming to medtech, treating hand tremors with AI wristband

In a Bloomington office recently, an employee with a high-tech wristband flicked his fingers to control fictional character Terry Bogard sparring onscreen with an opponent in a King of Fighters match. Using only this sensor-studded wristband, he beat an opponent wielding a remote.

This isn’t a futuristic video game company — it’s a startup called Fasikl, which is making an AI-fueled, wrist-worn medical device to stop hand tremors.

Fasikl’s wristband, which looks a bit like a watch, uses AI to automatically adjust electric stimulation to ease a user’s essential tremor, a movement disorder affecting millions that may otherwise be treated with medication or surgery. Some of the same engineering concepts resulting in the gaming gadget led to the tremor system.

“This company has a key to the future of health care,” co-founder and CEO Zhi Yang said, explaining that it can lead to other AI-enabled therapies in the future that may be cheaper than other options on the market.

Fasikl’s Felix NeuroAI Wristband received FDA clearance earlier this month following a 126-participant study, which was more rigorous than those typical for its category of medical device. Yang said the company has raised more than $30 million and now looks to grow ahead of commercialization.

Yang didn’t set out to create a medical device. While he was a graduate student, he transformed his love of AI and video games into a mission to create a brain-machine interface to level up gamers’ abilities. Before the pandemic, he wondered: “How can we translate that research” that started with the gaming tech “into some product that other people may need?”

Movement and neurodegenerative disorders seemed like obvious targets. Essential tremor, which causes limbs to shake, is one of the most common.

Patrick McCartney, the executive director of the International Essential Tremor Foundation, said an estimated 7 million to 10 million people in the United States have the malady, which can make it difficult to hold a coffee cup or brush teeth.

Yang considered creating a surgically implanted device or one that works in tandem with medication. After sensing anxiety from a patient’s family before surgery, he decided to create a device that was as noninvasive as possible, landing on the no-incision-necessary design of the Felix.

To use the device, patients straps on a daily disposable sensor to their wrist after taking a quick digital measurement. Then, they cover the device with the battery pack.

The stimulation needed to treat tremors varies from moment to moment. The device streams data sensed in the patient’s tremor to the digital cloud via a cellphone app, Yang said. That allows AI to analyze the tremor and adjust stimulation parameters in real time.

The device delivers mild electric stimulation through several peripheral nerves stretching from the hand to the central nervous system. This stimulation changes the activities in a patient’s sensory and neural pathways to provide tremor relief.

“It’s really a communication channel between your nervous system and the artificial intelligence,” Yang said, “and they’re together trying to reduce the tremor.”

Depending on the level of the stimulation, some patients may feel a little tingling or numbness, said Dr. Rajesh Pahwa, a University of Kansas Medical Center professor who was an investigator on the study. Another device on the market stimulates for about 40 minutes and provides a few hours of relief. But patients wear the Felix much longer, Pahwa said.

In a study including 12 hospitals, Felix demonstrated superior results compared with a placebo device in a 90-day period, the company said. It reported nearly two-thirds of participants achieving at least a 20% reduction in their modified activities of daily living score, which reflects a person’s dependence on others for everyday tasks. The only side effect patients have experienced to date, Yang said, is mild skin irritation.

Companies seeking a regulatory nod through the U.S. Food and Drug Administration’s 510(k) application process, designed for technologies substantially equivalent to others on the market, often don’t undergo a clinical trial. Yang said he took the extra step in order to use the “highest possible standard” of evidence to prove the device’s effectiveness.

“The good news is: It’s really working and in this case it has set up a new entry point for future AI therapeutics,” Yang said.

The clinical trial process, Pahwa said, shows the Felix is clinically useful and helps ”the payers understand that this is not just a device you can buy over the counter.”

McCartney said patients don’t have many treatment options for essential tremor, which includes medications that might only work about half the time, and surgical options. He called the AI component of the device “really exciting.”

“It just looks like you’re wearing something like everybody else is wearing,” McCartney said. “You’re not wearing some big bulky device that’s making you stand out.”

Patients can reserve a Felix on the company’s website, Yang said. The company believes the device has a path to insurance and Medicare coverage, and the system is typically cheaper than surgical options, the founder said. Yang hopes to make future versions of the device less bulky.

As Fasikl, whose name is a nod to groupings of nerve fibers called fascicles, looks to commercialize the device, Yang said, “we’ll have to expand.”

Pahwa wondered if future technologies building off Fasikl’s work could help Parkinson’s patients improve their movement.

“There might be other ways we can use AI to help patients,” he said.