FDA backs wearable biomarkers for CMT1A trial development

BioSensics and CureCMT won a two-year FDA cooperative agreement worth up to $2.2 million to develop wearable digital measures for Charcot-Marie-Tooth disease type 1A. The project could help create real-world endpoints for future trials in a disease with no FDA-approved treatment.

Why it matters: - Charcot-Marie-Tooth disease type 1A affects an estimated 1 in 2,500 people. - No FDA-approved disease-modifying therapy exists for CMT1A. - Better digital measures could help detect changes that clinic visits often miss and speed up drug development. - The work is designed to support future clinical trials with more sensitive, real-world endpoints.

What happened: - BioSensics LLC and CureCMT announced a two-year cooperative agreement award of up to $2.2 million from the U.S. Food and Drug Administration. - The FDA awarded $1.1 million for the first year. - Funding began on Sept. 25, 2026. - The project is titled Digital Biomarkers of Motor Function as Drug Development Tools in Charcot-Marie-Tooth Disease. - The grant number is 1U01FD009005-01. - The FDA's Center for Drug Evaluation and Research is funding the work through its program Use of Digital Health Technologies in Clinical Investigations to Support Drug and Biological Product Development. - The study is led by Ashkan Vaziri, PhD, founder and CEO of BioSensics; Mazen Dimachkie, MD, of the University of Kansas Medical Center; and Allison Moore, CEO of CureCMT. - FDA scientists will work collaboratively with the study team throughout the project.

The details: - The study, under Protocol BioCMT-01, will enroll about 120 adults with CMT1A. - The trial will run across four U.S. sites: University of Kansas Medical Center, Massachusetts General Hospital, Hackensack Meridian School of Medicine, and Scottish Rite for Children. - Participants will wear BioSensics' PAMSys sensors for 18 months. - The system includes a pendant plus wrist- and ankle-worn devices. - The sensors will 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 the digital measures with clinical exams and patient-reported outcomes. - The goal is to determine whether the measures can serve as sensitive endpoints for future CMT trials. - CMT can cause progressive weakness in the feet, legs, and hands. - Foot drop can make it difficult to lift the front of the foot and can lead to tripping and falls.

Between the lines: - Having a patient advocacy leader as a principal investigator on an FDA drug development tools award is uncommon. - That setup keeps the patient perspective inside the research process from the start. - CureCMT has spent years building trial-readiness infrastructure through its Clinical Trial Readiness Summits and Global Registry for Inherited Neuropathies. - The award suggests regulators see value in wearable data as a drug-development tool for a rare disease with slow progression. - BioSensics said wearable sensor technology can capture real-world changes in gait, hand function, and mobility that traditional clinic visits often miss.

What's next: - CureCMT plans to extend the work beyond CMT1A to other CMT subtypes. - People with CMT1A can sign up to be notified when enrollment opens at More information. - Organizations interested in partnership opportunities can contact Allison Moore at allison@hnf-cure.org. - More information is available at the company's announcement.

The bottom line: - The FDA award gives BioSensics and CureCMT a regulatory-backed path to test whether wearables can measure CMT progression well enough to support future treatment trials.