Minneapolis-based Fasikl Earns FDA Nods for Mind-Controlled Prosthetic Tech
Cameron Slavens tests out Fasikl’s tech in a 2022 video by the University of Minnesota College of Science and Engineering. University of Minnesota College of Science and Engineering on YouTube

Minneapolis-based Fasikl Earns FDA Nods for Mind-Controlled Prosthetic Tech

The U.S. Food and Drug Administration has granted “breakthrough device designation” to two products developed by med-tech startup Fasikl.

Two products designed to reduce pain and give users better control of robotic prosthetics have received “breakthrough device designations” from the U.S. Food and Drug Administration.

Developed by Minneapolis-based med-tech startup Fasikl, the products are aimed at “bridging the gap between human cognition and computing systems,” according to the company. The FDA’s breakthrough designations essentially mean that the government will help accelerate further development, assessment, and review of the products. Fasikl CEO Zhi Yang anticipates securing full FDA approval within the next five to 10 years.

As Yang sees it, the devices mark another step in a “substantial transition towards intelligent bioelectronic medicine.”

The two products that earned the FDA’s nods are the MindForce nerve-computer-interface system and the Epione pain relief system. MindForce enables amputees to control a robotic hand or computer device simply by thinking, while Epione is designed to alleviate post-amputation pain, which is experienced by 80% of amputees, according to the company.

For the devices to work, an implantable neural recorder is inserted into an amputee’s residual limb and connected through Bluetooth to a computer or phone. The minimally invasive surgery makes this a Class III device, meaning the FDA considers it a high-risk device that must go through its Premarket Approval process.

“I wish it was ready right now,” said Cameron Slavens who lost his forearm after a machine accident in 2014. A couple years after his accident, Slavens was asked to participate in Fasikl’s trials. The decision was simple.

“Heck, yeah! I want to be a cyborg,” Slavens joked. “When I was first injured, I had fantasized about certain levels of prosthetics and how advanced they were.”

Slavens said he was able to use Fasikl’s prosthetic arm with very few adjustments, which he said was “astronomical.”

Furthermore, Fasikl was able to help Slavens’ pain, which he described as a hot coal that was zapping him with electricity, giving him “level 10” pain during his waking hours. Years after participating in the test, Slavens said his pain is still minimal.

In his experience, Slavens said existing technology doesn’t do enough to help with amputee pain.

“Nobody tried to help me with my residual limb pain,” he said. “They gave up. They were like, ‘We can’t do anything. That’s phantom pain. Take some pills.’ It didn’t work. There’s hundreds of thousands of people with that right now, and this can help them.”

The MindForce technology is not only relevant to amputees; it could also enable people to play video games with their mind, according to CEO Yang. Fasikl has tested it on various video games.

“A robotic hand can have a high degree of freedom because there are so many joints,” Yang said. “When you’re playing video games, you look at it: a mouse and a keyboard. You don’t really require that high degree of freedom. Therefore, [it’s] no problem with video games.”

Meanwhile, Fasikl is also designing a device to help reduce tremors in Parkinson’s patients. The wristband, known as the Felix NeuroAI, will likely be approved by the FDA by the end of 2024, according to Yang. If 1% of Parkinson’s patients buy the wristband, projected revenue will be $2 billion to $5 billion, Yang said.

Yang along with fellow researchers have been working on Fasikl’s technology since 2009. The company’s products originated from research at the U of M. As for the startup’s name? It’s a play on the word “fascicle,” which refers to a bundle of nerve fibers, according to the U.

In 2019, Yang said his team became confident the technology was ready for clinical study, prompting them to launch the company with the U of M’s technology commercialization office . Today, the company has 30 employees and has raised $17 million in total.