MedRhythms Announces FDA Listing of InTandem™ (MR-001) to Improve Walking and Ambulation in Adults with Chronic Stroke

News provided by

Jul 06, 2023, 09:38 ET

Stroke is a leading cause of long-term disability, and over half of people aged 65 or older who have had a stroke experience reduced mobility and gait deficits

PORTLAND, Maine, July 6, 2023 /PRNewswire/ -- MedRhythms today announced that MR-001, the company's evidence-based neurorehabilitation system to improve walking and ambulation in adults with chronic stroke walking deficits, has been listed as a Class II medical device with the U.S. Food and Drug Administration (FDA). The system delivers an intervention based on the principle of Rhythmic Auditory Stimulation (RAS), a well-researched clinical intervention utilizing the mechanism of auditory-motor entrainment, through which the motor and auditory systems in the brain subconsciously synchronize to an external cue, such as music.

MedRhythms also unveiled the brand name for MR-001: InTandem™. The InTandem name reflects both the synchronization inherent in the device's mechanism of action and the partnership formed between patient and device.

"Today is a historic day for MedRhythms and an essential accomplishment as we work to bring a new care solution to the 3.5 million people who struggle with mobility and independence long after the incidence of a stroke," said Brian Harris, CEO and Co-Founder of MedRhythms. "During my time as a clinician at Spaulding Rehabilitation Hospital, I saw the positive impact that standardized interventions using music could have on the mobility of my patients. I am honored and proud that our team has committed to our mission of translating these interventions into evidence-based medical devices that can be utilized in home settings, breaking down several historic barriers to access. This important milestone enables the world's first prescription music platform, and is a remarkable day for our company, for music, for healthcare, and most importantly for stroke survivors."

Every 40 seconds, a person in the United States experiences a stroke, according to the Center for Disease Control (CDC), and the total financial impact of stroke in the United States exceeded $56 billion between 2018 and 2019. The burden on patient functioning is also profound. More than half of stroke survivors aged 65 and older experience reduced mobility, and stroke has become a leading cause of long-term disability.

InTandem, which is designed to be used independently by a patient in a home setting, received Breakthrough Device Designation from the FDA in 2020. Earlier this year, MedRhythms announced successful completion of a pivotal clinical trial for InTandem.

"The listing of InTandem demonstrates MedRhythms' unwavering commitment to developing a safe, effective product that adheres to the stringent guidelines set forth by the FDA," said Danielle Parker, Head of Regulatory and Quality at MedRhythms. "As we prepare for the next phase of InTandem's product life cycle, we remain committed to meeting the needs of our patients while upholding the highest quality standards."

InTandem is anticipated to be available soon in select market segments.
To learn more about InTandem visit: medrhythms.com/intandem

Media Inquiries: [email protected]

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.

SOURCE MedRhythms