Fasikl Product Studies Show Improved Functioning for Patients With Movement Disorders

Wearable technology provides all-day tremor relief in studies

(MINNEAPOLIS, Minn.) January 29, 2024 – Fasikl, a Minnesota-based neuro-AI company, announces the completion of two prospective studies for their Felix™ NeuroAI™ Wristband, a wearable technology specifically engineered to offer all-day relief from tremors for adults suffering from a condition known as essential tremor. Results from the studies simultaneously conducted in the United States (US) and China show that the device compares favorably against existing and emerging essential tremor therapies with minimal side effects and a high satisfaction rate among patients.

Essential tremor is a debilitating neurological disorder affecting an estimated 10 million people in the United States making it one of the most common movement disorders. It often causes shaking in the hands and can affect other parts of the body as well. If left untreated or undertreated, it may lead to declining quality of life.

“In the pilot study conducted at our site, this device was straightforward to tune and use, effective in improving tasks in meaningful ways, and was tolerated well without significant side effects,” said Dr. Richard Dewey III, Co-Principal Investigator of the study at the Parkinson’s Disease and Movement Disorders Center. “I believe this approach to reducing tremor is a desirable alternative to the pills and surgeries that are currently available.”

“I found Felix™ an advancement in wearable medical devices,” said Dr. Rajesh Pahwa, Co-Principal Investigator at the University of Kansas Medical Center. “The initial results in the pilot study are exciting and Felix could be a treatment option for my tremor patients.”­­

The Felix™ NeuroAI™ Wristband is equipped with Fasikl’s artificial intelligence platform, uniquely tailored for essential tremor. This advanced technology enables Felix™ to deliver closed-loop neurostimulation to adaptively optimize tremor relief for patients across a diverse range of activities and environments throughout the day. The system’s sophisticated artificial intelligence algorithms continuously learn and adjust to the user’s specific needs, ensuring personalized and effective tremor management.

“ET is a debilitating neurological disorder. Unfortunately, the current treatment options are limited. The current medications often have side effects or are not beneficial, and many patients are not comfortable with invasive surgical procedures. This advancement has the potential to help millions of patients affected by ET.” said Dr. Kelly Lyons, Research Professor of Neurology at the University of Kansas Medical Center, President of the International Essential Tremor Foundation (IETF).

Based on the promising results from the current studies, Fasikl is now initiating a pivotal study of the Felix device, TRANQUIL, in both the US and China in Q1 2024. The TRANQUIL study is a prospective, randomized, sham-controlled, double-blinded, multi-center, and multi-region clinical trial. A total of 120 patients will be enrolled and followed up to one year. The primary endpoint of the study is change in Tremor Research Group Essential Tremor Rating Assessment Scale (TETRAS)  modified Activities of Daily Living (mADL) score from baseline pre-stimulation to 90 days.

Learn more about Fasikl and their technology by visiting: fasikl.com

Disclaimer: Felix™ NeuroAI™ Wristband is currently not FDA approved or cleared. It is being studied in clinical trials to support a future marketing application to the FDA.

About Fasikl:

Fasikl Inc., established in 2019 as a spin-off from the University of Minnesota, is a pioneering neuro-AI company focused on developing technologies that synchronize sensory and motor neural signals. Fasikl’s innovative approach targets the treatment of movement disorders. In addition to Felix^TM, , Fasikl is also developing implantable peripheral nerve systems for intuitive end-effector control and pain management. Fasikl has obtained two simultaneous FDA Breakthrough Device Designations for its implantable systems, with MindForce^TM Nerve-Computer Interface (NCI) admitted into FDA’s Total Product Life Cycle Advisory Program (TAP). With a steadfast commitment to advancing Neuro-AI technologies, Fasikl Inc. is dedicated to harnessing these technology breakthroughs to improve human wellbeing.