Biofourmis has signed a research partnership with the Yale University-Mayo Clinic Center of Excellence in Regulatory Science and Innovation (CERSI).
The Yale-Mayo CERSI is a joint effort between Yale University, Mayo Clinic and the US Food & Drug Administration.
BiovitalsHF, a sensor-agnostic mobile platform of digital therapeutics firm Biofourmis, will be used in a heart failure study to monitor functional capacity and quality of life.
The objective is to see whether special importance should be placed on these measures in the drug approval process.
More than 6.5 million patients in the US and 26 million worldwide are affected with heart failures, affecting physical function and quality of life.
Biofourmis CEO Kuldeep Singh Rajput said: “This joint project has the potential to advance the science of clinical trial design.
“Ultimately, this study could open the door for regulatory agencies to consider including patient-centric endpoints in the drug approval process—which could potentially speed the regulatory approval process.”
Starting from next month, Biofourmis and Yale-Mayo CERSI will conduct a multicentre study on recently discharged patients with heart failure.
The patients will be screened and then monitored at home for 60 days.
Biofourmis’ BiovitalsHF is compatible with leading clinically validated, FDA cleared, and medical CE-marked wearable biosensors.
According to Biofourmis, the platform will use two wearable biosensors, namely Everion and smartwatch Apple Watch Series 4.
Using these devices, continuous multiple physiology biomarkers and physical activity will be captured in real-world environments.
Furthermore, electronic patient-reported outcomes (ePROs) such as medication adherence, symptoms, the Kansas City Cardiomyopathy Questionnaire (KCCQ) responses, and the guided mobile-based 2-minute-step-test will also be captured.
The study’s primary goal is to measure the correlation between physiology and actigraphy biomarkers. Clinical endpoints include lab results, the KCCQ, and the six-minute walk test (6MWT).
Rajput added: “Not only is the quality of life important in a disease such as heart failure, but patient-centric endpoints can be identified much more quickly than traditional hard outcomes.”