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MedRhythms Initiates Clinical Trial into Acute Stroke

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MedRhythms Initiates Clinical Trial and Expands Pipeline into Acute Stroke | Pharmtech Focus

MedRhythms, a digital therapeutics company building direct stimulation solutions that use clinical-grade sensors, software and music to help restore function lost to neurologic disease or injury, today announced the launch of a clinical trial that will study MR-010, MedRhythms’ acute stroke asset. The trial will be in partnership with UMass Memorial Healthcare and will examine the impact of MR-010 on acute stroke walking outcomes.

Stroke is the world’s top cause of long-term disability due to the high prevalence of stroke across the globe as well as its devastating health impacts. Over a third of stroke survivors live in the United States and, according to the CDC, approximately 800,000 people in the US suffer a stroke annually. Research shows that more than 80% of stroke survivors experience gait dysfunction. MedRhythms is dedicated to meeting this substantial unmet need by validating the efficacy of MR-010 in clinical trials.

This trial is funded by UMass and will be led by Dr. Brian Silver, Interim Chair in the Department of Neurology. It will assess the feasibility of MR-010 to address walking impairments in those in the acute phase of stroke. The study will consist of two phases: the first phase will look at the impact of MR-010 within the acute hospital setting, and the second phase will look at the continued impact of the therapeutic post-discharge.

“Given the prevalence and profound impact of walking deficits on stroke survivors, we are excited to be a part of investigating a promising new intervention in the acute stroke setting that could change the trajectory of rehabilitation for stroke patients,” said Dr. Brian Silver.

“We are honored to be collaborating with the nation’s leading researchers and institutions to build the evidence necessary to bring important care to all those who need it,” said Brian Harris, the CEO and co-founder of MedRhythms. “Strokes have devastating effects on mobility, which significantly impacts independence and quality of life. We look forward to making a positive impact on these patients throughout their entire recovery journey.”

This announcement follows MedRhythms’ recent announcement about the initiation of their clinical trial, in collaboration with Boston University and one of the world’s leading hospitals, of their asset MR-005 in Parkinson’s disease (PD) that will also begin in the next few weeks. MedRhythms also has an ongoing pivotal trial for MR-001, the Company’s asset in chronic stroke that is being studied in a multi-site randomized controlled trial that has expanded to include 8 trial sites. Additionally, MR-004, the Company’s pipeline product for walking rehabilitation in MS, is currently being studied at Cleveland Clinic in a pilot-scale randomized controlled trial to evaluate its safety and efficacy.

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