Curavit specializes in decentralized trials (DCTs) for digital therapeutics (DTx) and will be part of the study that MedRhythm believes has the goal of further characterizing the long-term economic and clinical benefits of MR-001. The company says this goes 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.
The hybrid DCT will be fully managed by Curavit 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.
Health economics research
Owen McCarthy, president and co-founder of MedRhythms, said: “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.
“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. 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.”