September 20, 2023
New York- based decentralized contract research organization (CRO) Curavit announced MedRhythms’ selected the company as its CRO of record. Importantly this news points to one of the first digital therapeutics (DTx) trials to focus on capturing evidence on the product’s financial impact on the U.S. healthcare system. This kind of study, which is also capturing health outcomes data, is increasingly vital to DTx companies struggling to secure broad market access to its products.
Right now, there is no infrastructure and a lack of private and government insurance coverage for many prescription and non-prescription digital therapeutics although they are proven to be a cost-efficient, less invasive form of treatment.
Pear Therapeutics’ bankruptcy was larging a result of these challenges. Akili Therapeutics, in response to this issue, has pivoted its go-to-market model by going direct to consumers, selling at a lower price point than a prescription product but circumventing insurers.
MedRhythms is committed to getting the financial validation of its product to help increase payer coverage and get its novel neurorehabilitation system to patients in need as fast as possible. As a specialist in DTx, Curavit understands and that is why they were selected by MedRhythms on this very important project that could lay the blueprint for more DTx companies to follow with the goal of driving market access.
TrialSite has engaged with Curavit in 2021, at the start of the venture’s journey. In an interview with President and Chief Commercial Officer Dave Hanaman, TrialSite learned more about the nascent decentralized research company’s business model, and value proposition.
According to TrialSite’s founder Daniel O’Connor, “Curavit’ s founders have deep expertise, pedigree and vocational certainty in the field of pharmaceutical-related services. They founded another services company that was ultimately acquired by Merck.”
That company was C3i, a business process outsourcing leader in healthcare. That company worked with several of the largest pharmaceutical companies to support e-clinical trials applications for example O’Connor shared.
Joel Morse, Chief Executive Officer, and Hanaman complement each other well. Both are obsessive about high quality delivery in complex, difficult regulatory environments and the Curavit team appears to embrace that founder’s culture.
With initial fundraising and about 30 employees, now the company seems poised to grow.
The Study
With the latest news Curavit reports to TrialSite that the company will power the OrcHESTRAS (Outcomes and Health Economics of Stroke using Rhythmic Auditory Stimulation) study – one that 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 entertainment, 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.”
Call to Action: Sponsors that are in the digital health and related space should do an assessment of Curavit’s capabilities.
