MedRhythms Announces FDA Class II Listing for Movive™ to Support Gait Rehabilitation and Motor Function for Parkinson’s Disease

PORTLAND, Maine, March 6, 2025 /PRNewswire/ -- MedRhythms today announced that MR-005, the company’s neurorehabilitation system to support gait rehabilitation and motor function in adults with Parkinson’s disease (PD), has been listed as a Class II, Rx-only medical device with the U.S. Food and Drug Administration (FDA). The company unveiled the system’s brand name: Movive.

“Movive leverages the well-researched power of rhythmic auditory stimulation (RAS) for people with PD and is the second device to launch from MedRhythms’ proprietary platform,” said Brian Harris, Co-Founder and CEO of MedRhythms. “This is an exciting step for MedRhythms as we advance our mission to use music to address significant mobility challenges for people with neurologic injury and disease, including PD. We look forward to Movive’s potential to support gait rehabilitation in PD, addressing a significant need.”

PD is the fastest growing neurodegenerative disease in the world. According to the Parkinson’s Foundation, nearly one million Americans have PD, including 110,000 Veterans, making it the second most common neurodegenerative disease. Gait impairment and loss of motor function are defining symptoms of PD, with walking and mobility as the number one patient-reported challenge. Rhythmic auditory stimulation (RAS) and other neurologic music therapy interventions are well-established strategies for gait and motor rehabilitation in PD. However, use of RAS has been limited due to historic barriers to access.

Movive is designed to expand access to individualized, progressive, and engaging RAS that is delivered autonomously in the patient’s home.

Movive is expected to launch in select US markets in Q2 2025. To learn more about Movive and its music-based mechanism-of-action, visit: www.medrhythms.com.

Join MedRhythms at the Association of VA Neurology Services (AVANS) Annual Meeting, March 7-9

About MedRhythms

MedRhythms is pioneering the development of next-generation neurotherapeutics designed to improve walking, mobility and related functional outcomes via a proprietary, patented technology platform. The company’s platform combines sensors, software, and music (via a partnership with Universal Music Group) with advanced neuroscience to target neural circuitry. The company is developing a pipeline of digital therapeutics across a range of neurological conditions, including stroke, multiple sclerosis and Parkinson’s disease. The company’s product for chronic stroke walking deficits received Breakthrough Device Designation in 2020, and the company raised a Series B financing round in 2021 led by Morningside Ventures and Advantage Capital. MedRhythms is headquartered in Portland, Maine. For more information, 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.

Contact

press@medrhythms.com

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SOURCE MedRhythms

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