SV95C wearable cited in trials
Discussions in biotech circles mention the SV95C wearable being used in clinical trials—Sarepta is named—and note that the device has EMA approval for use as an endpoint. That underscores growing regulatory acceptance for wearables as clinical data sources. (x.com)
A clinical-trial wearable called SV95C has moved from exploratory measurement to a regulator-qualified endpoint in Duchenne muscular dystrophy studies. (nature.com) SV95C stands for stride velocity 95th centile: the speed of a patient’s fastest 5% of strides during daily life, captured by ankle-worn sensors over about 180 hours. Researchers use it to measure how well someone walks outside the clinic, not just during a single hospital test. (nature.com) The European Medicines Agency’s Committee for Medicinal Products for Human Use said in a 2023 qualification opinion that, for ambulant Duchenne patients age 5 and older, SV95C can serve as a primary endpoint in superiority studies as an alternative to the 6-minute walk test, if secondary endpoints support the result. (ema.europa.eu) A 2024 Scientific Reports paper described that July 2023 decision as the first time a digital endpoint received European Medicines Agency qualification for use as a primary endpoint, and said the qualification covered Duchenne patients age 4 and older. (nature.com) Sarepta has publicly said it incorporated SV95C into its Phase 3 EMBARK trial in Duchenne. In a company profile of one participant, Sarepta said the boy enrolled in late 2021 and that topline results from the trial showed meaningful improvements in SV95C. (sarepta.com) The ClinicalTrials.gov record for EMBARK, sponsored by Sarepta and last updated on July 8, 2025, lists “change from baseline in stride velocity 95th centile at Week 52” as an outcome measure collected with wearable devices worn on each ankle. The same record shows the study was first posted on October 27, 2021, and is marked completed. (clinicaltrials.gov) The argument for the metric is straightforward: a clinic walk test captures one visit, while a wearable captures many days of ordinary movement at home. The European Medicines Agency document says SV95C is less sensitive to the timing of an assessment and less dependent on motivation or subjective scoring than established tests. (ema.europa.eu) The evidence package behind the qualification was built over years of natural-history studies, clinical trials, and patient surveys. The 2024 paper said SV95C correlated with standard Duchenne assessments, detected decline earlier than some traditional measures, and identified clinically meaningful changes in walking performance. (nature.com) Sysnav Healthcare, which developed the wearable system used to capture SV95C, said the August 8, 2023 opinion marked the first qualification of a digital outcome measure for use as a primary endpoint in pivotal drug trials. The company said the endpoint can be captured with its ActiMyo and Syde ankle-worn devices. (healthcare.sysnav.com) For drug developers in rare diseases, the shift is practical as much as technical: fewer patients, long travel distances, and variable day-to-day performance make trial measurement hard. SV95C’s rise shows regulators are willing to accept data from wearables when the validation work is deep enough and the endpoint tracks established measures closely. (nature.com)
