Two-Year FDA Award of up to $2.2 Million to Develop Wearable Digital Measures for CMT1A

CureCMT

Wearable sensors will track real-world changes in foot drop, walking, and hand function across four sites, a major step toward the first approved CMT treatment

NEW YORK, NY, UNITED STATES, October 22, 2026 /EINPresswire.com/ -- BioSensics LLC and CureCMT (Hereditary Neuropathy Foundation) today announced a two-year cooperative agreement award of up to $2.2 million from the U.S. Food and Drug Administration, with $1.1 million awarded for the first year, to develop wearable digital biomarkers of motor function as drug development tools for Charcot-Marie-Tooth disease type 1A (CMT1A), the most common inherited peripheral neuropathy. The project, Digital Biomarkers of Motor Function as Drug Development Tools in Charcot-Marie-Tooth Disease (Grant No. 1U01FD009005-01), is funded through the FDA's Center for Drug Evaluation and Research (CDER) under the program Use of Digital Health Technologies in Clinical Investigations to Support Drug and Biological Product Development. Funding officially began on September 25, 2026.

As a cooperative agreement, the award means FDA scientists will work collaboratively alongside the study team throughout the project. The project is 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. Having a patient advocacy leader serve as a principal investigator on an FDA drug development tools award is uncommon, keeping the patient voice built directly into the research infrastructure from the start.

CMT affects an estimated 1 in 2,500 people, yet no FDA-approved disease-modifying therapy exists. The disease causes progressive weakness in the feet, legs, and hands, and many people develop "foot drop," which makes it hard to lift the front of the foot, leading to frequent tripping and falls. One major barrier to treatment is measurement: CMT progresses slowly, and standard clinic assessments often cannot detect meaningful change within the tight timeframe of a clinical trial. This study aims to close that gap by measuring how people with CMT actually move in their daily lives.

"People living with CMT notice changes in how they walk, balance, and use their hands long before those changes show up on a clinic exam," said Allison Moore, CEO of CureCMT. "For years, our Clinical Trial Readiness Summits and our Global Registry for Inherited Neuropathies (GRIN) have been building the patient-driven foundation for studies like this. This award shows that investment pays off, and it brings us closer to a future with approved treatments for CMT."

The study, conducted under Protocol BioCMT-01 (Digital Health Technologies for Monitoring Motor Function in Charcot-Marie-Tooth Disease), 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. Over 18 months, participants will wear BioSensics' PAMSys sensors, a pendant plus wrist- and ankle-worn devices that continuously track posture, gait, and hand activity at home. Participants will also complete periodic finger-tapping and foot-drop tests on a tablet-based platform. Researchers will compare these digital measures with clinical exams and patient-reported outcomes to determine whether they can serve as sensitive, real-world endpoints for future CMT clinical trials.

"Wearable sensor technology can capture meaningful, real-world changes in gait, hand function, and mobility that traditional clinic visits often miss," said Ashkan Vaziri, PhD, Founder and CEO of BioSensics. "We're proud to partner with CureCMT and the CMT community to build a clearer picture of how CMT1A progresses and a stronger foundation for future treatment trials."

CureCMT plans to expand this work beyond CMT1A to other CMT subtypes. Organizations interested in partnership opportunities can contact Allison Moore, CEO of CureCMT, at [email protected].

Individuals with CMT1A interested in participating can sign up to be notified when enrollment opens. Learn more at www.CureCMT.org.

About Hereditary Neuropathy Foundation / CureCMT
The Hereditary Neuropathy Foundation (CureCMT) leads the Charcot-Marie-Tooth cure effort, globally uniting patients, innovation, and technology to build the world's largest CMT data infrastructure, accelerate breakthrough science through regulatory pathways, and deliver treatments that restore function, mobility, and quality of life. Learn more at www.CureCMT.org.

About BioSensics
BioSensics is the leader in developing clinical-grade wearable sensors and precision digital health technologies for clinical research. Founded in 2007 by three scientists from Harvard, BioSensics has created new paradigms in using wearable sensors in healthcare and revolutionized the medical alert industry by creating technologies that are now being used by thousands of older adults. BioSensics develops and provides end-to-end solutions and services for the collection of digital measures and biomarkers in clinical trials and research. BioSensics solutions and products have been deployed in more than 200 clinical studies in over 20 countries, including for collection of primary or secondary endpoints in more than 25 clinical trials. BioSensics has received over $50M in research and development program support from the U.S. National Institutes of Health (NIH). In 2022, NIH selected BioSensics to develop remote measurement technologies for clinical trials in rare diseases. Learn more at www.BioSensics.com.

Funding Support & Disclaimer
This project is supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award U01FD009005 totaling $1,100,000 with 100 percent funded by FDA/HHS. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA/HHS, or the U.S. Government.

Allison T. Moore
CureCMT (Hereditary Neuropathy Foundation)
+1 212-850-5405
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Two-Year FDA Award of up to $2.2 Million to Develop Wearable Digital Measures for CMT1A

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