Latest news with #TRANQUIL
Business Wire
01-07-2025
- Health
- Business Wire
Fasikl Receives FDA Clearance for Felix NeuroAI Wristband, the First and Only AI-Powered Treatment for Essential Tremor
MINNEAPOLIS--(BUSINESS WIRE)-- Fasikl, a trailblazing neuro-AI company redefining the intersection of advanced bioelectronic medicine and artificial intelligence (AI), today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the first-of-its-kind Felix™ NeuroAI™ Wristband for tremor-related functional limitations in the upper limbs in adults with essential tremor. 'The Felix wristband represents a significant step forward in noninvasive, personalized treatment options for essential tremor,' 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. 'For many patients, current treatment options fall short — pharmaceutical treatments are helpful for less than 50% of the patients, and deep brain stimulation and focused ultrasound, while effective, require surgical intervention. This new AI wearable wristband backed by clinical evidence is an effective treatment option in patients with essential tremor.' Essential tremor is the most common type of tremor disorder, affecting approximately 7 million people in the U.S., and is about seven times more common than Parkinson's disease. 1,2 It causes involuntary, rhythmic shaking, most often in the hands, which can make simple and everyday activities like drinking from a glass or tying shoelaces difficult. 3 Traditional treatment options are limited, with oral medications providing inconsistent relief and often accompanied by undesirable side effects. 4 Surgical interventions such as deep brain stimulation (DBS), while effective, require invasive procedures, carry surgical risks, and may not be suitable or desirable for all patients, particularly older adults or those with coexisting health conditions. 4 Unlike surgical or pharmacologic interventions, Felix is a noninvasive, wearable device that effortlessly connects to Fasikl's cloud-based AI platform, enabling continuous brain-AI co-adaptation and personalized therapy. Worn on the wrist, it uses the cloud to dynamically adjust stimulation, offering all-day symptom relief while seamlessly fitting into the wearer's lifestyle. The FDA clearance of Felix is supported by compelling data from the TRANQUIL study, a randomized, double-blind, sham-controlled trial that met its primary endpoint. Results showed that the Felix wristband significantly reduced tremors and displayed statistically and clinically significant improvement in the users' ability to perform daily activities compared to those using the sham device ('placebo effect'). Efficacy was consistent across demographics, with no serious device-related adverse events reported. Results were presented as Late-breaking Science at the American Academy of Neurology annual meeting in April 2025, reinforcing Felix's safety and potential as a first-of-its-kind, noninvasive, AI-powered treatment. 'FDA clearance of Felix marks a defining moment for Fasikl and the millions of people living with essential tremor who have long been underserved by existing therapies,' said Zhi Yang, Ph.D., CEO of Fasikl. 'This breakthrough in noninvasive, intelligent, and personalized neuromodulation marks the emergence of AI therapeutics in disease treatment. It offers a new option that is potentially more effective, safer, and more scalable. Our next step is to execute the commercialization plan to support Felix's initial product launch." The Felix NeuroAI Wristband will be available by prescription through healthcare providers in select U.S. regions starting in 2025, with nationwide availability expected in 2026. About Fasikl Based in Minneapolis, Fasikl, Inc. is a pioneering neuro-AI company dedicated to developing advanced, AI-powered neural technologies. A 2019 spin-off from the University of Minnesota, Fasikl leverages its proprietary platform to capture neural signals directly from peripheral nerves, enabling intelligent, adaptive therapy. The company is on a mission to transform the treatment landscape for movement disorders, paralysis, and other neurological impairments through cutting-edge neuromodulation innovations. Fasikl's portfolio includes the FDA-cleared Felix™ NeuroAI™ Wristband and the investigational Fasikl-X™ Nerve-Computer Interface. To learn more, visit References:
Yahoo
09-04-2025
- Health
- Yahoo
Fasikl Announces Breakthrough Pivotal Data Demonstrating Superiority of Felix NeuroAI Wristband over Sham Device for Essential Tremor
—Wristband is a first-of-its-kind investigational wearable designed to provide dynamic, all-day, personalized relief for people with essential tremor (ET); powered by advanced AI to continuously adapt stimulation based on real-time feedback— —TRANQUIL study results presented in late-breaker at the 2025 American Academy of Neurology (AAN) annual meeting demonstrate clinically meaningful improvements in ET symptoms and ability to perform daily activities— SAN DIEGO, April 09, 2025--(BUSINESS WIRE)--Fasikl, a trailblazing neuro-AI company redefining the intersection of advanced bioelectronic medicine and artificial intelligence (AI), today announced that its pivotal TRANQUIL study met its primary endpoint of superiority for the company's Felix™ NeuroAI™ wristband over a sham device. The Felix wristband significantly reduced tremors and showed statistically and clinically significant improvement in the users' ability to perform daily activities compared to those using the sham device. "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, 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 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." At the end of the 90-day period the Felix group showed clear superiority over the sham group. The Felix group experienced a statistically and clinically significant improvement in ET treatment, with 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). Nearly two-thirds of participants using Felix achieved at least a 20% reduction in mADL scores versus just one-quarter in the sham group. Efficacy benefits were consistent across age, gender, tremor severity, and ET medication use. Secondary outcomes further highlighted the impact of Felix. Both clinicians and patients reported greater symptom improvement with Felix, and quality of life scores improved more substantially in the treatment group. Importantly, no serious device-related adverse events were reported, confirming the device's strong safety profile. The Felix NeuroAI Wristband is a first-of-its-kind investigational wearable designed to deliver all-day, personalized relief for people with ET. Powered by advanced AI, Felix continuously adapts stimulation based on real-time feedback, providing dynamic, individualized therapy. Unlike surgical or pharmacologic interventions, Felix is non-invasive and wearable, connecting seamlessly to Fasikl's cloud-based AI platform for ongoing optimization and learning. "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," said 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." About Essential Tremor (ET) Essential tremor (ET) is the most common type of tremor disorder, affecting approximately 7 million people in the United States.¹ It causes involuntary, rhythmic shaking, most often in the hands, which can make everyday activities like drinking from a glass or tying shoelaces difficult.² Over time, ET can worsen and significantly impact a person's quality of life.² The TRANQUIL Study The TRANQUIL study, a randomized, double-blind, sham-controlled clinical trial, enrolled 125 adults across 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 study's primary endpoint was change in the modified Activities of Daily Living (mADL) score from the Tremor Research Group Essential Tremor Rating Assessment Scale (TETRAS), a commonly used tremor assessment that combines 10 activities of daily living (ADLs) and 2 clinical assessments of tremor.3 The mADL has a maximum score of 52. About Fasikl Based in Minneapolis, Fasikl, Inc. is a pioneering neuro-AI company dedicated to developing advanced, AI-powered neural technologies. A 2019 spin-off from the University of Minnesota, Fasikl leverages its proprietary platform to capture neural signals directly from peripheral nerves, enabling intelligent, adaptive therapy. The company is on a mission to transform the treatment landscape for movement disorders, paralysis, and other neurological impairments through cutting-edge neuromodulation innovations. Fasikl's portfolio, currently under FDA review, includes the Felix™ NeuroAI™ Wristband and the MindForce™ Nerve-Computer Interface. To learn more, visit References: Louis ED, Ottman R. How many people in the USA have essential tremor? Deriving a population estimate based on epidemiological data. Tremor Other Hyperkinet Mov (N Y). 2014;4:259. Mayo Foundation for Medical Education and Research. (2025, March 15). Essential tremor. Mayo Clinic. Elble R, Comella C, Fahn S, Hallett M, Jankovic J, Juncos JL, Lewitt P, Lyons K, Ondo W, Pahwa R, Sethi K, Stover N, Tarsy D, Testa C, Tintner R, Watts R, Zesiewicz T. Reliability of a new scale for essential tremor. Mov Disord. 2012 Oct;27(12):1567-9. View source version on Contacts Media Contact: Jenna KaneHealth+Commerce480-388-9587jennakane@
