After seeing music help his patients, Brian Harris, a board-certified music therapist, turned his work into a digital therapeutic. Called MedRhythms, the Portland-based startup uses music in conjunction with sensors to help chronic stroke patients improve their walking.
The company made an important step toward bringing its first product to market: It received the FDA’s Breakthrough Device Designation, which can accelerate the regulatory process for medical devices. To qualify, companies must prove that no alternative exists and that it addresses a significant unmet need.
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“There is currently no standard of care for chronic stroke survivors with walking deficits, yet these impairments are strongly linked to fall risk, lack of independence, and decreased quality of life. We are thrilled the FDA has designated our product as a Breakthrough Device, recognizing its potential to impact an area of high unmet need and bringing us one step closer to reaching people who need this care,” Harris, CEO and co-founder of MedRhythms, said in a news release.
Danielle Briggeman, the company’s clinical and regulatory affairs manager, said she was hopeful that the designation would allow MedRhythms to bring its first product to market with an expedited timeline.
“Having this designation opens the door for swift, interactive discussions with FDA on our development efforts that we otherwise would not have under the current Pre-Submission Program,” she said in a news release.
MedRhythms developed sensors that patients can attach to their shoes. After calculating their current stride, the system begins playing music through headphones. It can change the tempo of the music so they can improve the speed of their walking.
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MedRhythms is currently testing the system in a randomized clinical trial between five rehabilitation hospitals and research centers, including the 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. It will evaluate the system’s impact on walking among stroke survivors with post-stroke walking impairments.
In the future, MedRhythms plans to develop additional products for Parkinson’s disease, multiple sclerosis, aging and fall prevention.
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