Wearable Sensors Boost CMT Clinical Trials Progress

NEW YORK, NY, UNITED STATES, October 22, 2026 /CourierPR/ -- The U.S. Food and Drug Administration (FDA) has awarded a two-year cooperative agreement to BioSensics LLC and CureCMT (Hereditary Neuropathy Foundation) worth up to $2.2 million. The award, which includes $1.1 million for the first year, will support the development of wearable digital biomarkers for Charcot-Marie-Tooth disease type 1A (CMT1A).

The project, led by three principal investigators: Ashkan Vaziri, PhD, Founder and CEO of BioSensics; Mazen Dimachkie, MD, of the University of Kansas Medical Center; and Allison Moore, CEO of CureCMT, aims to address a significant barrier in the treatment of CMT1A. The disease, the most common inherited peripheral neuropathy, affects an estimated 1 in 2,500 people and currently has no FDA-approved disease-modifying therapy. The primary issue is the difficulty in measuring how CMT1A progresses, as standard clinic assessments often cannot detect meaningful changes within the tight timeframe of a clinical trial.

To overcome this challenge, the project will use wearable sensors developed by BioSensics, which include a pendant and wrist- and ankle-worn devices. These sensors continuously track posture, gait, and hand activity in participants' daily lives. The study will enroll approximately 120 adults with CMT1A across four U.S. sites: the University of Kansas Medical Center (lead clinical site), Massachusetts General Hospital, Hackensack Meridian School of Medicine, and Scottish Rite for Children. Participants will wear the BioSensics sensors for 18 months and complete periodic finger-tapping and foot-drop tests on a tablet-based platform.

Researchers will compare the digital measures collected from the sensors with clinical exams and patient-reported outcomes to determine whether they can serve as sensitive, real-world endpoints for future CMT clinical trials. The study aims to capture meaningful, real-world changes in gait, hand function, and mobility that traditional clinic visits often miss. The wearable sensor technology can provide a clearer picture of how CMT1A progresses and a stronger foundation for future treatment trials.

CureCMT, the patient advocacy organization, has played a crucial role in this project by serving as a principal investigator. Having a patient advocate on the research team ensures that the patient voice is built directly into the research infrastructure from the start, aligning the project with the needs of those living with CMT1A.

The project is a significant step toward the development of a first-in-class FDA-approved treatment for CMT1A. The award from the FDA underscores the importance of digital health technologies in advancing medical research and clinical trials. BioSensics, the leader in clinical-grade wearable sensors and precision digital health technologies, has deployed its solutions in over 200 clinical studies in more than 20 countries, including for collection of primary or secondary endpoints in over 25 clinical trials. The company has received over $50 million in research and development program support from the U.S. National Institutes of Health (NIH).