Biofourmis, a global leader in digital therapeutics, has entered a research partnership with Yale University-Mayo Clinic Center of Excellence in Regulatory Science and Innovation (CERSI). The study, which involves patients with heart failure, will leverage Biofourmis’ mobile platform BiovitalsHFTM to see if greater emphasis should be placed on functional capacity and quality of life of these individuals during drug approval process.

The Yale-Mayo CERSI is a joint effort between Yale University, Mayo Clinic and the U.S. Food & Drug Administration (FDA). CERSIs are collaborations between FDA and academic institutions to advance regulatory science through innovative research, training and scientific exchanges, Biofourmis said in a press release.

“This joint project has the potential to advance the science of clinical trial design,” said Kuldeep Singh Rajput, CEO of Biofourmis. “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.

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In the United States, 6.5 million people are afflicted by heart failure, and globally, this number is 26 million. FDA recognizes in its recent draft guidance, Treatment for Heart Failure: Endpoints for Drug Development Guidance for Industry, that an effect on symptoms or physical function, without a favorable effect on survival or risk of hospitalization, can be a basis for approving drugs to treat heart failure.

How BiovitalsHFTM Will Be Used in This Study

Starting in August 2019, Biofourmis and Yale-Mayo CERSI will conduct a multicenter study on recently discharged patients with heart failure. The patients will be screened and then monitored at home for 60 days.

To monitor the patients, researchers will use Biofourmis’ BiovitalsHFTM – a sensor-agnostic mobile health platform compatible with leading clinically validated, FDA cleared, and medical CE-marked wearable biosensors. The platform captures raw biosensor data and uses advanced machine learning to derive dozens of physiology biomarkers and is able to detect heart failure decompensation using multi-variate physiology analytics, weeks in advance.

In this study, BiovitalsHFTM will be used to capture multiple physiology biomarkers and physical activity continuously in real-world settings, using two wearable biosensors: a medical-grade device called Everion® and the consumer wearable smartwatch Apple Watch Series 4. Apart from using the BiovitalsHFTM patient-facing companion app for syncing physiology data from sensors, it will be used to capture 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.

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“Biofourmis is a leader in the emerging field of digital therapeutics, and we are thrilled to be partnering with them on this important study,” said Nilay Shah, PhD, Principal Investigator at the Yale University-Mayo Clinic CERSI. “This study will not only advance science, but will also provide insights to the FDA on how these measures can be used as alternative trial endpoints.”