It started with a few steps.

For over three years, members of the CMT community have been attending our annual Clinical Trial Readiness Summits, strapping on wearable sensors, and walking, balancing, and moving for science. No hospital rooms, no lab coats. Just our community showing up and putting one foot in front of the other.

Those steps just carried us somewhere no one in CMT has been before.

Why this matters: you can’t treat what you can’t measure

From 2024 to 2026, CureCMT (the Hereditary Neuropathy Foundation) partnered with BioSensics to test its clinical-grade wearable sensors at every Summit. We were going after one of the biggest roadblocks to CMT treatments: measurement.

CMT moves slowly, and a standard clinic exam often can’t catch meaningful change in the short window of a clinical trial, so a treatment that works might look like it doesn’t. Wearable sensors close that gap by capturing how people with CMT actually walk, balance, and use their hands in daily life, including subtle shifts in foot drop that a clinic visit can miss.

A first-of-its-kind FDA milestone

On September 22, 2026, the FDA accepted BioSensics’ Letter of Intent into its ISTAND program for wearable sensor-derived foot drop measures in CMT1A.

ISTAND is the FDA’s pathway for qualifying new kinds of drug development tools, and this is the first digital health technology ever accepted into the program. It’s step one of a three-stage qualification process, and it puts CMT at the front of the line.

$2.2 million to keep moving

Days later, the momentum kept building. The FDA awarded BioSensics and CureCMT up to a $2.2 million cooperative agreement (Award No. U01FD009005), with funding beginning September 25, 2026. As a cooperative agreement, it means FDA scientists will work side by side with the study team from start to finish.

Here’s what comes next:

  • About 120 adults with CMT1A will take part
  • Four U.S. sites: University of Kansas Medical Center (lead site), Massachusetts General Hospital, Hackensack Meridian School of Medicine and Scottish Rite for Children
  • 18 months of participants wearing sensors at home, in real life
  • One big question: can these digital measures become the sensitive, real-world endpoints future CMT trials need?

The patient voice, at the head of the table

The project is led by three principal investigators: Ashkan Vaziri, PhD, of BioSensics; Mazen Dimachkie, MD, of KUMC; and Allison Moore, CEO of CureCMT.

That last name is a big deal. It’s rare for a patient advocacy leader to serve as a principal investigator on an FDA award. It means people living with CMT aren’t just being studied; we’re helping lead the science from day one.

This one is yours

This milestone belongs to everyone who showed up: every Summit attendee who wore a sensor, every clinician and researcher who gave their time, and every sponsor and donor who made the Summits possible. CureCMT and HNF built the patient-driven foundation, and this award is proof that your investment is moving us closer to the first approved treatments for CMT.

Living with CMT1A? Be part of what’s next. Sign up here to be notified when enrollment opens.

This project is 100% funded by the U.S. Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award totaling $2.2 million. The content is solely the responsibility of the authors and does not necessarily represent the official views of HHS or the FDA.