MedRhythms reaches milestone as first medical device enters clinical trials

MedRhythms Inc., a Portland-based medical-device startup, has begun clinical trials of its first product, which combines music, wearable sensors, and artificial intelligence to help people who have suffered strokes regain their mobility.

The clinical trials will occur at five of the country’s top rehabilitation hospitals and research centers and examine the product’s impact on walking among a group of subjects who are stroke survivors with post-stroke walking impairments. The randomized controlled trial (or RCT), and its resulting collection of clinical data, are a crucial step in the journey toward commercialization of the product, which the company calls Stride. Upon completion of the trials, the product will be ready for submission to the U.S. Federal Food and Drug Administration, the final step before the product can enter the market. 

“This clinical trial marks an important milestone toward MedRhythms’ mission to make this high-quality intervention available to those who need and deserve to have it,” Brian Harris, MedRhythms’ co-founder and CEO, said in a news release. “As this new industry grows, it is important for digital therapeutics to demonstrate efficacy with the support of rigorous clinical trials, and this RCT is an integral step in MedRhythms’ evidence generation strategy to do so.”

There are an estimated 3.5 million people in the United States who live with walking deficits caused by chronic stroke, a number that rises by 465,000 individuals annually, according to the company. Given that walking impairments can have a profound negative impact on personal independence and quality of life, and that there are limited walking-rehabilitation solutions on the market, the company says it is addressing “a significant unmet medical need.”

The Stride’s genesis was in Harris’ experience working at Spaulding Rehabilitation Hospital in Boston, where he launched its first neurologic music therapy program in 2013. Neurologic music therapy—or NMT—is the therapeutic use of music to address cognitive, sensory, and motor dysfunctions stemming from neurologic disease.

While he was able to generate excellent results for his patients while they were at the hospital, Harris didn’t have options for his patients to continue the therapy when they went home. So he began thinking about what a take-home NMT device would have to be able to do to continue helping his patients. He discussed options with a college friend, Owen McCarthy (the pair graduated from UMaine), and the pair eventually founded MedRhythms in 2015 to turn those ideas into scientifically proven and commercially viable medical devices.

Fast forward four years and the company has raised more than $5 million from investors, completed a successful feasibility study, and begun clinical trials of its first product.

Those trials are being conducted at the Shirley Ryan AbilityLab in Chicago, the Kessler Foundation in New Jersey, Mt. Sinai Hospital in New York, Spaulding Rehabilitation Hospital in Boston, and the Boston University Neuromotor Recovery Laboratory in Boston.

“Right now, the MedRhythms digital therapeutic technology is a novel treatment for a subset of individuals that have few, if any, effective treatment options,” said David Putrino, the Director of Abilities Research Center (ARC) for the Department of Rehabilitation and Human Performance at the Mount Sinai Health System and the Principal Investigator at MedRhythms’ Mount Sinai clinical trial site. “The mission of the ARC is to identify and validate novel technologies that have the potential to significantly enhance the rehabilitation of people who are recovering from brain injuries and neurological conditions, including chronic stroke. The digital therapeutics industry has the potential to transform rehabilitation and disrupt healthcare, and it is imperative for companies in this space to run full-scale, multisite RCTs like MedRhythms is doing.”