MedRhythms Chronic Stroke Digital Therapeutic Receives FDA Breakthrough Designation

MedRhythms Inc., a digital therapeutics startup based in Portland, Maine, has received FDA breakthrough device designation for its Rhythmic Auditory Stimulation (RAS) treatment platform for people with chronic walking impairments due to stroke. This product is the first in the Company’s pipeline of digital therapeutics for neurologic disease and injury.

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.

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. Music has been demonstrated to globally activate the human brain, including areas that are responsible for movement, language, attention, memory, executive function, and emotion. Specific to movement and walking, there is profound evidence that rhythm is able to engage the motor system to improve functional outcomes. 

MedRhythms digital therapeutic uses sensors, music and software to create evidence-based, neurologic interventions to measure and improve walking. The device is currently being studied in a randomized controlled trial to evaluate the impact of the device on chronic stroke walking impairments. There are over 50 clinical research studies demonstrating improvements in movement when using RAS (Rhythmic Auditory Stimulation). Specifically, walking speed has been shown to be highly correlated to fall risk. A study showed that each 0.1 m/s increase in walking speed was correlated to a 7% decrease in fall risk (Verghese et al., 2009).

This digital therapeutic has the potential to address a significant unmet need in healthcare. 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.

Brian Harris, CEO and co-founder of MedRhythms

About Digital Therapeutics

Digital therapeutics (DTx) deliver evidence-based therapeutic interventions to patients that are driven by high quality software programs to prevent, manage, or treat a broad spectrum of physical, mental, and behavioral conditions. While the term digital therapeutic may sound futuristic, these therapies are already a reality.Digital therapeutics come in many varieties, each requiring different strategies to drive adoption. As this new category of medicine continues to be integrated across the healthcare ecosystem, digital therapeutics will increasingly influence the way healthcare is delivered and consumed across the world.

Recently, the digital therapeutics industry has seen significant growth and market traction, as evidenced by multiple FDA approvals, reimbursement from payors, large commercial deals, successful clinical trials, and investment in the area. Investments in digital-therapeutics companies in the United States have grown by an average of 40 percent a year over the past seven years to reach more than $1 billion in 2018. These developments have enabled the further differentiation of digital therapeutics from other digital health modalities.

Companies such as MedRhythms, Akili Interactive, Cognito Therapeutics, Kaia Health, Hinge Health, and Palo Alto Health Sciences, are developing digital therapeutics that directly target neural circuitry and other physiological systems through external sensory stimuli, including music and video games. The distinction between delivery methods does not make one mode superior to the other from a health economic or clinical outcomes standpoint. However, to fully understand digital therapeutics, it’s important to understand the clinical principles, delivery methods, and mechanisms of action employed by the industry leaders.

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.

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