Fasikl’s Felix NeuroAI Wristband Shows Superiority in Treating Essential Tremor

Fasikl, a neuro-AI (artificial intelligence) company focused on the intersection of advanced bioelectronic medicine and AI, revealed its pivotal TRANQUIL study met the primary endpoint of superiority for its Felix NeuroAI wristband over a sham device for essential tremor (ET).

The wristband is an investigational wearable that delivers all-day, personalized relief for patients with ET. It’s powered by advanced AI, continuously adapting stimulation based on real-time feedback.

Felix is non-invasive and connects to Fasikl’s cloud-based AI platform for ongoing optimization and learning.

The TRANQUIL study enrolled 125 adults at 12 clinical sites in the U.S. and China. Participants were randomized 2:1 to receive either the Felix NeuroAI Wristband or a sham device and wore it during waking hours for 90 days.

The Felix wristband was found to significantly reduce tremors and showed improvement in users’ ability to perform daily activities compared to those using the sham device. There was a mean reduction of 6.9 points in modified Activities of Daily Living (mADL) scores compared to 2.7 points in the sham group (P < 0.0001).

Almost two-thirds of participants using Felix had an at lease 20% reduction in mADL scores versus one-quarter in the sham group. Efficacy benefits were found to be consistent across age, gender, tremor severity, and ET medication use.

Clinicians and patients reported greater improvement of symptoms with Felix. Quality of life scores improved more substantially in the treatment group and no serious device-related adverse events were reported.

“This wearable technology delivered significant improvement in tremor, with both clinicians and patients more likely to report benefit by the end of the study,” said Rajesh Pahwa, MD, 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 the principal investigator for TRANQUIL. “The TRANQUIL study represents what could be a shift in how we approach essential tremor treatment, a condition for which new options are sorely needed. Although oral medications are often used to treat essential tremor, they can be frequently unsatisfactory, and while deep brain stimulation and focused ultrasound are effective, they require surgical intervention.”

“The TRANQUIL study marks a breakthrough as the first multicenter, double-blind, sham-controlled, non-surgical randomized controlled trial in essential tremor to meet its primary endpoint in over two decades,” added Zhi Yang, Ph.D., CEO of Fasikl. “Felix is a transformative advancement in AI-powered therapeutics, offering a safe, non-invasive, and personalized treatment option for ET patients and their physicians. With the efficacy and safety of Felix now validated and presented, we believe this represents a pivotal moment in the treatment of essential tremor and the broader landscape of movement disorders.”