MedRhythms announces that its pivotal trial for MR-001, a novel digital intervention in development to treat gait deficits in chronic stroke, was successfully completed and met its primary endpoint.
“There are at least three and a half million chronic stroke survivors living with gait deficits for which there is currently no standard of care in the US,” said Brian Harris, CEO and Co-Founder of MedRhythms. “The topline results from our pivotal trial in chronic stroke suggest that our product can help address this unmet need to improve walking. Successfully completing our pivotal trial with MR-001 is a critical milestone and represents significant progress towards getting this solution into the hands of patients who need it.”
The multi-site randomized controlled trial was conducted at eight of the top rehabilitation hospitals and research institutions in the US, including Shirley Ryan AbilityLab, Spaulding Rehabilitation Hospital, the Boston University Neuromotor Recovery Laboratory, Kessler Foundation, Mount Sinai Health System, Atrium Health, and The University of North Carolina at Chapel Hill. The trial included adult chronic stroke survivors who participated in 30-minute sessions three times per week over a five-week intervention period. The study participants either used MR-001 or were part of an active control group. MedRhythms intends to submit this important clinical data for peer review in a scientific journal and to present the data at a major conference later this year.
MedRhythms has a robust pipeline of next-generation neurotherapeutics in active development. The company aims to bring these solutions to a wide range of patients with neurologic injury and disease. MR-001, in development to treat chronic stroke gait deficits, is anticipated to be the first product the company brings to market. Other advanced pipeline programs include MR-004, a novel, investigational prescription digital therapeutic targeting gait deficits in multiple sclerosis for which the company entered into a license agreement with Biogen. Furthermore, the company has initiated feasibility studies of MR-005, in development to treat gait deficits in Parkinson’s disease, and MR-010, in development to treat gait deficits in post-acute stroke.
[Source(s): MedRhythms, PR Newswire]