MedRhythms Selects Curavit as its Contract Research Organization (CRO) for a Chronic Stroke Decentralized Clinical Trial

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Sep 20, 2023, 07:05 ET

Curavit to research patient engagement, response durability, and health economics of MR-001, a medical device that aims to improve walking and ambulation in adults with chronic stroke

NEW YORK, Sept. 20, 2023 /PRNewswire/ -- Curavit Clinical Research, a virtual contract research organization (VCRO) that specializes in decentralized clinical trials (DCTs) for digital therapeutics (DTx), announced that it was selected as the VCRO for a study of MR-001, MedRhythms' neurorehabilitation system designed to improve walking and ambulation in adults with chronic stroke walking impairments. The goal of the study is to further characterize the long-term economic and clinical benefits of MR-001 beyond what has been established in a multi-center, randomized clinical trial. This will also include evaluating patient engagement and therapeutic response durability.

The study – known as OrcHESTRAS (Outcomes and Health Economics of Stroke using Rhythmic Auditory Stimulation) – is a prospectively enrolled study, with a novel design that focuses on evidence generation and exploration of the product's impact on reducing financial impact on the U.S. healthcare landscape.

Curavit is responsible for managing all aspects of MedRhythms' hybrid decentralized clinical trial (DCT) – from protocol finalization and Institutional Review Board (IRB) approvals to patient recruitment, testing at physical sites, remote site and patient monitoring and healthcare economics and outcomes analysis. The partnership between the companies began in June 2023, and the 12-month trial aims to enroll 225 participants by the end of the year.

"As innovators in healthcare, it's essential to show that new technologies not only have the power to transform patients' lives but are also economically prudent. Health economics research quantifies the long-term financial impact for patients, providers, and payers," said Owen McCarthy, President and co-founder of MedRhythms. "Curavit's tech-enabled approach to research lets us launch quickly while delivering a premier experience for everyone involved. As important, the study will be open to participants nearly nation-wide, thanks to Curavit's virtual site solution, patient recruitment process, and smart strategies for collecting real-world healthcare economics data."

MR-001 is based on Rhythmic Auditory Stimulation (RAS), a clinical intervention utilizing the mechanism of auditory-motor entrainment ("entrainment"). During entrainment, the motor and auditory systems in the brain subconsciously synchronize to an external auditory cue, such as music.

"We are honored to work with MedRhythms to manage such an important study of an innovative neurorehabilitation system to help stroke patients improve walking without invasive therapy or pills," said Joel Morse, CEO and co-founder of Curavit. "We believe it is going to become increasingly important for DTx companies to capture health economics data to enable broader market access."

Learn more at DTx East (September 26-28, 2023) where MedRhythms' Owen McCarthy will be participating in a panel discussion "The Key Components of Building a Successful DTx product" on Sept., 26th at 12:30pm EST. To schedule a meeting, email [email protected].

About Curavit
Curavit Clinical Research is a full-service, virtual contract research organization (VCRO), focused on designing and executing digital-first decentralized clinical trials (DCTs). Founded in 2020 by experts with decades of experience in technology and clinical research, Curavit leverages emerging technologies in digital health, cloud computing, and data science to recruit, engage, and monitor diverse patient populations without borders, ultimately bringing trials to patients in the cloud. Curavit's digital-first DCTs improve timelines, reduce costs, yield real-world data, and increase patient access for therapies that more effectively represent patient populations. For more, visit www.curavit.io.

SOURCE Curavit Clinical Research