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 initiated its partnership with EVERSANA™, a leading provider of global commercialization services to the life sciences industry, to launch and commercialize MR-001, its patented software-based medical device designed to treat chronic stroke walking deficits.
As previously announced, the product received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) in June 2020. Stroke is a leading cause of disability in the United States. More than half of stroke survivors, approximately 3.5 million people in the U.S., have persistent walking deficits. There is no standard of care for these long-term functional deficits, which 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.
To support its anticipated launch, MedRhythms will utilize EVERSANA’s fully integrated commercialization services that include market access, agency services, clinical and commercial field teams, medical science liaisons, channel management, patient services, health economics and outcomes research, and compliance, with each service optimized by data and predictive analytics.
“Today’s announcement marks a significant milestone in our commitment to serve chronic stroke survivors who have waited lifetimes for a standard of care. After years of development and testing, we stand ready to successfully launch this groundbreaking innovation with a best-in-class commercialization partner,” said Owen McCarthy, President and Co-founder of MedRhythms.
“This breakthrough device demands a breakthrough, transformative approach to launch and commercialization,” said Jim Lang, Chief Executive Officer of EVERSANA. “We’re ready to deploy the full power of our infrastructure and experts to navigate the complexities of digital therapy launches to ensure this innovation quickly reaches the millions of chronic stroke patients desperately in need of treatment and a better quality of life.”