Biofourmis first to be granted FDA breakthrough status for heart failure DTx

Biofourmis announced Thursday that its BiovitalsHF solution, a software medical application that augments traditional guideline-directed medical therapy (GDMT) for heart failure, has been granted breakthrough device status by the FDA, making it the first digital therapeutic (DTx) for heart failure to get the designation. "If approved at the end of this expedited process, we look forward to introducing a new virtual heart failure care model that leverages BiovitalsHF to improve the use and dosing of [GDMT] among patients with heart failure, for better patient outcomes and reduced healthcare expenditures," CEO Kuldeep Singh Rajput said.

Enhanced clinical decision-making

The DTx solution integrates physiological monitoring, symptoms and signs reporting, patient engagement, medication management and communication to provide clinicians with personalised and specific medication recommendations for heart failure patients with reduced ejection fraction (HFrEF). Chief medical officer Maulik Majmudar noted that "in a proof-of-concept study, in patients using BiovitalsHF, we demonstrated statistically significant improvements in adherence to GDMT, reduction in levels of the key blood biomarker of heart failure NT-ProBNP, and improvements in health status."

In 2019, Biofourmis partnered with Novartis on a commercial project for managing patients with heart failure, initially in Southeast Asia, with plans to expand globally. The goal of the programme was to improve clinical outcomes by using BiovitalsHF to identify early signs of heart failure exacerbations, enabling early interventions in HFrEF patients.

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