Tigermed US proudly served as the clinical research partner for Fasikl’s Felix™ NeuroAI™ Wristband—the first and only FDA-approved, AI-powered wearable for treating upper limb tremors in adults with essential tremor. This landmark achievement, enabled by Tigermed US’s clinical operations support, marks a breakthrough in non-invasive, drug-free neuromodulation therapy.

Source：https://www.fasikl.com/

Developed by Minnesota-based neuro-AI company Fasikl, the Felix™ NeuroAI™ Wristband delivers real-time, personalized neuromodulation through cloud-based AI. Designed for daily, non-invasive use, the device can be used alone or alongside medication, offering greater therapeutic flexibility and improved quality of life for millions living with essential tremor1.

To bring this pioneering technology to market, Fasikl partnered with Tigermed US to lead the U.S. arm of its registration trial—marking a strategic step forward for Tigermed US in clinical trial execution and in meeting regulatory requirements in the United States.

This successful collaboration highlights the strength of a well-aligned sponsor-CRO partnership. Through proactive site engagement, cross-functional coordination, and rigorous quality oversight, Tigermed US delivered a high-impact trial support with measurable results.

Operational Excellence to Help Sponsor Navigate the U.S. Landscape
Tigermed US led the full clinical operations for the U.S. arm of Fasikl’s multi-national registration study, which enrolled 125 participants across sites in the United States and China. Over 50% of participants were enrolled at eight U.S. sites, highlighting Tigermed's strong capability in executing complex, multi-site trials within compressed timelines. The team managed the entire operational lifecycle—from protocol and consent review to monitoring, project management, and data management—with precision and efficiency.

Following site selection, Tigermed US’s Clinical Research Associates (CRAs) quickly established strong, collaborative relationships with site staff, ensuring clear communication and timely issue resolution. The Felix trial introduced technological complexities—including mobile app tracking and digital diary reporting—which the Tigermed US team managed with agility and precision. This reflects the broader industry shift toward hybrid and AI-enabled studies, where CROs must adapt to real-time data and patient-centric trial designs.

The study also presented several operational challenges, particularly during the U.S. enrollment phase. In response, Tigermed US implemented a proactive strategy that included weekly follow-ups, enhanced site engagement, and comprehensive pre-screening support. Through close collaboration with Fasikl, the team successfully enrolled all U.S. participants within a compressed timeline.

After enrollment, the team encountered another critical challenge: a compressed two-month timeline to clean and lock all U.S. data for interim analysis. To meet this deadline, the Tigermed US team implemented a phased approach, organizing subjects into batches with clearly defined timelines for EDC entry, source data verification (SDV), and query resolution. Through focused execution and close collaboration with both sites and the sponsor, the interim database was locked on schedule, supporting the early submission of the Clinical Study Report (CSR).

Strategic CRO Partner for Global Clinical Success
Tigermed US continues to exemplify the qualities sought by today’s biotech and medtech innovators—speed, adaptability, regulatory insight, and global operational strength.

“This achievement underscores our shared commitment to innovation and improving patient outcomes. Tigermed is proud to contribute to a solution that may improve daily function and independence for millions of patients worldwide,” said Jessie Mao, President of Tigermed America LLC. “We are proud to have partnered with Fasikl on this groundbreaking milestone. For companies advancing novel therapies, Tigermed US offers the expertise and operational excellence needed to navigate the U.S. landscape and accelerate development.”

As clinical development continues to evolve, Tigermed US stands as a committed partner for local and global sponsors, advancing transformative therapies through deep scientific expertise, operational excellence, and an unwavering commitment to improving patient lives.



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.

About Tigermed
Tigermed (Stock code: 300347.SZ/3347.HK) is a leading global provider of integrated research and development solutions for biopharmaceutical and medical device industry. With a broad portfolio of services and a promise of quality, from preclinical development to clinical trial to commercialization, we are collaborating with over 3,200 customers and committed to moving their development journey efficiently and cost-effectively. Tigermed currently represents a worldwide network of more than 180 locations with over 10,000 employees across Asia Pacific, Europe, North America, Latin America and Africa. We are devoted to building an integrated platform that enables the boundless possibilities for the healthcare industry, embracing challenges to fulfill our commitment to serving unmet patients’ needs, and ultimately saving lives.


Reference:
https://www.fasikl.com/felix/