The analysis from a randomized clinical trial shows clinically meaningful, statistically significant improvements in daily living and quality of life in essential tremor when using the Felix NeuroAI™ Wristband

MINNEAPOLIS: Fasikl, a trailblazing neuro-AI company redefining the intersection of advanced bioelectronic medicine and artificial intelligence (AI), today announced the publication of data in JAMA Neurology showing that its FDA-cleared Felix NeuroAI™ Wristband significantly improved daily function for people living with essential tremor (ET), the most common movement disorder worldwide.1

The multicenter, randomized, double-blind, sham-controlled clinical trial evaluated 125 adults with essential tremor across 12 neurology centers in the U.S. and China over 90 days.

Key outcomes included:

• Met primary endpoint: Felix NeuroAI Wristband users had a mean 6.9-point improvement on the modified Activities of Daily Living (mADL) score at 90 days, compared with 2.7 points for sham users (p <.001 for superiority).
• Real-world usability: The AI-driven, wearable design allowed participants to use the device during normal daily activities (average wear time 8.6 hours/day in the Felix group vs. 9.5 hours/day in the sham group).
• Safety and tolerability: No serious device-related adverse events reported in either group. The most common side effect was mild skin irritation (33.7% in the treatment group vs. 4.8% in the sham); most of which resolved without treatment.

“This study represents a step forward for people living with ET, many of whom have limited treatment options today,” said Rajesh Pahwa, M.D., Laverne and Joyce Rider Professor of Neurology at the University of Kansas School of Medicine, Director of the Movement Disorder Program at The University of Kansas Health System, and co-author of the JAMA Neurology publication. “We saw clinically meaningful improvements in patients’ ability to perform everyday activities. Patients also reported improvement in their quality of life. This therapy offers a much-needed option that bridges the gap between pharmacologic management and invasive procedures such as focused ultrasound or surgical intervention for ET.”

Affecting roughly 7 million Americans-seven times more than Parkinson’s disease-essential tremor is the most common movement disorder.1,2 The condition causes involuntary shaking, most often in the hands, that can make even routine tasks like holding a cup of coffee or tying a shoelace difficult.3 Traditional treatments fall short for many: medications may not work well or can cause side effects, while surgical procedures like deep brain stimulation are invasive and not suitable for everyone.4

Recently cleared by the FDA, Felix offers a noninvasive, wearable alternative to drugs or surgery. The wristband connects to Fasikl’s cloud-based AI system, which continuously learns and adapts to each user’s needs in real time. By adjusting stimulation patterns throughout the day, Felix provides personalized, all-day tremor relief that integrates seamlessly into daily life.

“Publication in JAMA Neurology marks a defining moment for Fasikl and for the entire field of neurotechnology,” said Zhi Yang, Ph.D., CEO of Fasikl. “With Felix, we are seeing tangible proof that AI and wearables can be seamlessly integrated into a powerful therapeutic solution. AI drives precision, adaptability, and scalability, while the wearable form ensures usability, comfort, and safety. Felix embodies the future of AI-driven medicine through intelligent therapy that learns from each individual, evolves over time, and integrates effortlessly into daily life to restore function and elevate quality of life.”

The Felix NeuroAI Wristband is now available by prescription through healthcare providers in select U.S. regions, with nationwide availability expected in 2026.

About the Felix NeuroAI™ Wristband

The FDA-cleared Felix NeuroAI™ Wristband from Fasikl is the first and only artificial intelligence (AI)-powered, non-invasive wearable designed to deliver all-day, personalized tremor relief for people with essential tremor (ET), without drugs or surgery. Using real-time AI, Felix stimulates peripheral nerves on the wrist to send therapeutic signals to the brain, reducing tremors and restoring motor control. Unlike traditional treatments, Felix continuously learns and adapts to each user’s unique tremor profile, optimizing therapy over time through Fasikl’s secure cloud-based AI platform. The wristband’s intelligent, adaptive, and wearable design allows patients to experience effective symptom relief while maintaining comfort, safety, and freedom in daily life.

About Fasikl

Based in Minneapolis, Fasikl, Inc. is a pioneering neuro-AI company dedicated to developing advanced artificial intelligence technologies that transform the way neurological diseases are treated. Founded in 2019 as a spin-off from the University of Minnesota, Fasikl leverages its proprietary platform to capture neural signals directly from peripheral nerves and to train disease-specific neuro-AI models, enabling therapies that are more effective, safe, and convenient. Fasikl’s portfolio includes the FDA-cleared Felix NeuroAI™ Wristband and the investigational Fasikl-X™ Nerve-Computer Interface. To learn more, visit fasikl.com.

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Fonte: Business Wire