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Felix™ NeuroAI™ Wristband

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A Revolutionary Device Powered by Cutting-Edge Artificial Intelligence

For years, people have anticipated the day when AI would transform disease treatment. Felix™ is that breakthrough technology – an innovative solution combining advanced artificial intelligence and neurotechnology to help patients with movement disorders.

The first approved indication for Felix™ is Essential Tremor (ET), a condition affecting millions of people across the U.S. Felix™ is the world’s first AI-empowered wearable that modulates the nervous system to help alleviate tremor-related functional limitations in individuals with ET.

Worn on the wrist, Felix™ connects to the cloud, where Fasikl’s proprietary AI technology continuously adjusts stimulation parameters to deliver personalized, dynamic therapy that calms tremors and restores motor control. Unlike other treatments, data from the pivotal clinical trial show that Felix™ provides all-day relief for both hands and is effective for patients with mild, moderate, or severe tremors. It can be used independently or alongside medication, offering a flexible and comprehensive solution for tremor management.

“I am having something monitoring information coming from my body actively and responding to it. And if I ever want to, I can take it off. You can’t take off a pill. So I think this is a great solution, and it’s worked for me.”

David

“It’s fun to see how fast it works. I can go from shaking in the morning to putting it on to being calm. If I notice that tremors are breaking through, I just up the intensity and it calms things down. And it’s nice that I can control that myself, that I can monitor it and make those adjustments. My drives to work are less exciting because my hands would shake on the steering wheel.”

Cindy

“So he basically said if there are side effects, take it off. And I was like, oh my God, it’s just like the medication. If you have a bad side effect just don’t take it today, but this is basically doing what a major invasive surgery would do. It was kind of that, if somebody threw you a life preserver when you fell off the side of the boat. You couldn’t get me on the phone quick enough.”

Christian

Frequently Asked Questions

Yes. Felix has undergone a series of clinical trials. The pivotal trial employed a randomized, double-blind, placebo-controlled design. Patients were randomly assigned to either the treatment group (receiving the actual Felix device) or the control group (receiving a sham device). Neither the patients nor the physicians knew which group participants were in.

After 90 days, the groups were unblinded and outcomes were compared. To further validate the study’s integrity, participants were also asked to guess whether they had received the actual or sham device, confirming the quality of the blinding.

The results demonstrated highly significant improvements in the treatment group, based on the TETRAS m-ADL score (primary endpoint, p value <0.0001) and secondary endpoints.

For detailed results, please refer to the FDA 510(k) summary.

Devices will be distributed on a first-come, first-served basis. Please check our website for updates or reserve a device to join the waitlist. Once reserved, you will receive additional information.

Results vary by individual. Some users experience improvement within hours, while others may require weeks or months. Continuous use over several months has been associated with progressively better outcomes.

Yes. A large portion of patients in our clinical trials experienced bilateral tremors. The data show that wearing a single device can reduce tremors in both hands.

Yes. Felix is designed to provide all-day tremor relief and to support upper limb function affected by tremor.

Yes. Felix is classified as a non-significant risk device. In the 90-day clinical trial, the most common adverse event was mild skin irritation.

Felix will be available first in the United States. 

We plan to expand to other countries in the future. Because the pivotal clinical trial meets the rigorous standards of many regulatory bodies, additional clinical trials may not be required for international approvals.

Interested in purchasing Felix?

Fasikl is proud to introduce Felix – an AI therapeutic and the first of its kind – for the treatment of essential tremor, a condition affecting millions of individuals with limited effective options. While we are actively ramping up production and expanding our cloud-AI capacity, demand is expected to exceed supply in the near term.

If you’re interested in obtaining Felix, please reserve a device to join the waitlist. Upon reservation, you will receive a queue number and detailed instructions via email, including how to obtain the device and information about insurance and billing. You will also be able to schedule a short call with our team. As your place in the queue approaches the top, we will contact you and collect the necessary information.

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Information you provide on this form will be collected on behalf of Fasikl Medical Solutions and is subject to its Notice of Privacy Practices.

How AI and Neuromodulation Work Together

Fasikl’s AI technology is fundamentally different. Its model architecture and processing are built on neural signals from the human peripheral nervous system. Fasikl’s advanced neurotechnology enables single-fiber resolution recording from human peripheral nerves, along with simultaneous recording during electrical stimulation – capabilities that are unprecedented and represent the leading edge of neural engineering research.

The AI model has been further refined using multimodal data collected from essential tremor patients during real-world daily activities, ensuring the therapy is tailored to the clinical population’s specific needs and functional limitations. Through a novel mechanism of action that harnesses the body’s inherent redundancy, the system delivers both immediate and sustained relief from essential tremor.

A peer-reviewed publication detailing this mechanism of action will be made available.

Felix clinical studies have been presented at the following conferences and published in the following journals:

  • Ondo W, Lv W, Zhu X, Hu Y , Isaacson S, Yuan Y, Espay A, Kreitzman D, Kuo SH, Brillman S, Shill H, Lyons K, Yang Z, Zhao Q, Zhang Z, Pahwa R.
    TRANQUIL: Pivotal Study of the Felix™ NeuroAI™ Wristband in Patients with Essential Tremor
    The 77th American Academy of Neurology Annual Meeting, 2025 (selected as one of three studies featured in the annual Top Science Press Conference and presented as a Late-Breaking Science presentation)
  • Dewey R III, Isaacson S, Dewey R Jr, Betté S, Lyons KE, Yang Z, Nguyen AT, Zhao Q, Zhang Z, Pahwa R.
    A Pilot Study of AI-Controlled Transcutaneous Peripheral Nerve Stimulation for Essential Tremor.
    Tremor Other Hyperkinet Mov (N Y). 2025 Mar 21;15:10. doi: 10.5334/tohm.991. PMID: 40125447; PMCID: PMC11927668.
  • Dewey R III, Isaacson S, Dewey R Jr, Lyons K, Nguyen AT, Zhao Q, Zhang Z, Pahwa R.
    Pilot Study of the Felix™ NeuroAI™ Wristband in Patients with Essential Tremor
    Advanced Therapeutics in Movement & Related Disorders Congress, 2024 (best poster award)