MedRhythms Receives FDA Breakthrough Device Designation for Chronic Stroke Digital Therapeutic

News provided by

Jun 15, 2020, 08:00 ET

PORTLAND, Maine, June 15, 2020 /PRNewswire/ -- 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.

About MedRhythms
MedRhythms, a privately held company headquartered in Portland, ME, is a digital therapeutics company that uses sensors, music, and software to build evidence-based, neurologic interventions to measure and improve walking. MedRhythms is dedicated to developing direct stimulation digital therapeutics, meaning that each therapeutic provides, via prescription music, direct stimulation to enable the mechanism of action in each relevant population. The company has an active pipeline of prescription digital therapeutics targeting rehabilitation and prevention in areas of neurologic injury and disease. The MedRhythms team has extensive experience in rehabilitation techniques utilizing music. The company has roots as a therapy services company that launched out of Spaulding Rehabilitation Hospital, which the U.S. News & World Report named the No. 3 ranked rehabilitation hospital in the country. To learn more, visit: www.medrhythms.com.

Forward-Looking Statements
THIS MANAGEMENT COMMENTARY CONTAINS CERTAIN FORWARD-LOOKING STATEMENTS AND INFORMATION RELATING TO THE COMPANY THAT ARE BASED ON INFORMATION AVAILABLE TO US AS OF THE DATE HEREOF. STATEMENTS THAT ARE NOT HISTORICAL FACTS, INCLUDING STATEMENTS ABOUT THE COMPANY'S BELIEFS, DESIGNS, ANTICIPATION, AIMS, GOALS, EXPECTATIONS AND POTENTIAL RESULTS ARE FORWARD-LOOKING STATEMENTS. IN ADDITION, THE WORDS "WILL," "MAY," "BELIEVE," "ANTICIPATE," "INTEND," "ESTIMATE," "EXPECT," "PROJECT," "PLAN," "SHOULD," "COULD," AND SIMILAR EXPRESSIONS, AND THEIR VARIATIONS AND NEGATIVES, AS THEY RELATE TO THE COMPANY OR THE FUTURE PERFORMANCE OF THE COMPANY, ARE INTENDED TO IDENTIFY FORWARD-LOOKING STATEMENTS. SUCH FORWARD LOOKING STATEMENTS INVOLVE KNOWN AND UNKNOWN RISKS, UNCERTAINTIES, ASSUMPTIONS AND OTHER IMPORTANT FACTORS THAT COULD CAUSE THE COMPANY'S ACTUAL RESULTS, PERFORMANCE OR ACHIEVEMENTS OF RESULTS TO DIFFER MATERIALLY FROM ANY FUTURE RESULTS, PERFORMANCE OR ACHIEVEMENTS EXPRESSED OR IMPLIED BY SUCH FORWARD LOOKING STATEMENTS. THIS MANAGEMENT COMMENTARY SPEAKS ONLY AS OF THE DATE HEREOF AND THE COMPANY DOES NOT UNDERTAKE ANY OBLIGATION TO UPDATE THIS COMMENTARY IN THE FUTURE.

SOURCE MedRhythms