Breakthrough Device Designation for Chronic Stroke Digital Therapeutic Receives FDA Approval

Tuesday, July 14, 2020

MedRhythms, a Portland, Maine-based digital therapeutics company that is building direct stimulation, prescription digital therapeutics that use sensors, music, and software to improve walking impairments, announced today that it has received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for its patented digital therapeutic to treat chronic stroke walking deficits. This product is the first in the Company’s pipeline of digital therapeutics for neurologic disease and injury. The impact of the device on chronic stroke walking impairments is currently being studied in a randomized controlled trial (RCT) at the nation’s top rehabilitation hospitals and research centers.

Stroke is a leading cause of disability in the United States. More than half of stroke survivors, approximately 3.5 million people in the US, have persistent walking deficits. These long-term functional deficits negatively impact the lives of stroke survivors and their caregivers. This population is expected to grow with an increasing stroke survival rate and the aging population in the United States.

“This digital therapeutic has the potential to address a significant unmet need in healthcare,” said Brian Harris, CEO and co-founder of MedRhythms. “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.”

The FDA Breakthrough Device Program is intended to help patients receive more timely access to breakthrough technologies that have the potential to provide a more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions. Medical device developers must voluntarily request designation and demonstrate that their product meets applicable criteria in order to utilize the more flexible communication features of the program such as priority review, sprint discussions and clinical trial protocol agreement.

“I am pleased that our commitment to generating rigorous clinical evidence has allowed us to demonstrate our product’s merit and to be recognized as a Breakthrough Device,” said Danielle Briggeman, Clinical and Regulatory Affairs Manager at MedRhythms. “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. I am looking forward to our dialogue and hopeful that this will allow us to bring the product to market with an expedited timeline.”

In addition to the product for chronic stroke walking deficits, MedRhythms continues to expand its product pipeline for people suffering from the effects of other neurologic injuries and diseases. These focus areas include Parkinson’s disease (PD), multiple sclerosis (MS), aging, and fall prevention. In advance of the expected commercialization of these products, MedRhythms assembled Scientific Advisory Boards with world-renowned stroke, PD, and MS researchers and clinicians and is beginning a clinical trial of their MS asset at Cleveland Clinic. In addition, MedRhythms announced the establishment of the first Patient Advisory Board in the digital therapeutics industry this spring.

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