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BOSTON – Biofourmis announced Monday it has been selected by Novartis, a global healthcare company, to collaborate on a commercial project for managing patients with heart failure (HF) beginning in Southeast Asia, with potential plans to expand globally. The goal of the program is to improve clinical outcomes by using Biofourmis’ lead product BiovitalsHF, which captures data from wearable biosensors and leverages the FDA-cleared BiovitalsTM Analytics Engine to identify early signs of HF exacerbations to enable early interventions in patients with HF with reduced ejection fraction.
HF is a life-threatening, progressive disease with debilitating symptoms and is the top global cause of hospitalizations for patients older than age 65. About 85% of hospitalized patients suffer from an acute HF event at least once, and 43% of patients are admitted at least four times. Recent data from the CHAMP-HF registry demonstrate that fewer than one in four HF patients with reduced ejection fraction are on Guideline Directed Medication Therapy (GDMT), and only 1% are receiving target doses of medications.
The program’s initial phase, which kicks off this month, is expected to be rolled out across Southeast Asian countries for recently discharged HF patients, with plans to scale across multiple geographies. Patients will be onboarded in a 3-month program at the point of discharge and sent home with a wearable biosensor called Everion and the patient-facing companion mobile app BiovitalsHF to enable patients to remotely monitor their physiology parameters, report their symptoms, manage their medications, and securely communicate with their care teams. The Biovitals Analytics Engine then processes the data captured from patients in real time, captures HF exacerbation in advance, and provides software-based therapeutic recommendations for clinicians and care teams to intervene early.
“The ultimate goal of this alliance is to work with Novartis to drive better patient-centric outcomes and arm providers across the globe with the right actionable information early enough to better manage their patients with heart failure,” said Kuldeep Singh Rajput, chief executive officer and founder of Biofourmis. “We are excited for this opportunity and look forward to working with Novartis, an organization known to be a leader in providing better treatments for patients with heart failure.”
Biofourmis is also participating in digital therapeutics-focused HF research with the Yale University-Mayo Clinic Center of Excellence in Regulatory Science and Innovation (CERSI). BiovitalsHF will be leveraged in a study of patients with heart failure to monitor functional capacity and quality of life to see if greater emphasis should be placed on these measures in the 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.
