MedRhythms has entered a collaboration with EVERSANA to launch and market its software-based medical device, MR-001, to treat chronic stroke walking impairments.

The US-based digital therapeutics company, MedRhythms, received the US Food and Drug Administration’s breakthrough device designation for MR-001 in June last year.

Stroke is a major cause of disability in the US with over half of the survivors developing lasting walking deficits that have no standard of care. These long-term functional deficits can have a negative impact on the stroke survivor’s life.

Last month, MedRhythms commenced a clinical trial to assess the effect of MR-001 on acute stroke walking outcomes. The trial is being carried out along with UMass Memorial Healthcare.

MedRhythms president and co-founder Owen McCarthy said: “Today’s announcement marks a significant milestone in our commitment to serve chronic stroke survivors who have waited lifetimes for a standard of care.

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“After years of development and testing, we stand ready to successfully launch this ground-breaking innovation with a best-in-class commercialisation partner.”

To facilitate the planned launch of the device, MedRhythms will use EVERSANA’s marketing services, which comprise market access, agency services and clinical and commercial field groups.

In addition, EVERSANA also provides medical science liaisons, channel management, patient services, compliance and health economics and outcomes research.

Each of these services is data and predictive analytics augmented, the company noted.

EVERSANA CEO Jim Lang said: “This breakthrough device demands a breakthrough, transformative approach to launch and commercialisation.

“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.”

In 2019, MedRhythms launched its five-site randomised controlled trial at rehabilitation hospitals and research centres to examine the device.