Digital Therapeutic Device Augments HF Management

The system is intended to alleviate some of the problems that prevent GDMT titration by enabling patient health status and drug tolerance to be accurately assessed through continuous physiology monitoring and inclusion of lab assessment results for analysis.

In addition, it reduces clinical inertia by prompting clinicians and patients on medication initiation and up-titration; reduces the burden of clinical visits through a patient-clinician communication system, which becomes essential in circumstances such as a pandemic; and finally, it requires fewer resources than nurse-led programs, since titration recommendations from the HFrEF GDMT are distilled in the system. BiovitalsHF has received the first-ever digital therapeutic device designation from the U.S. Food and Drug Administration (FDA).

“The BiovitalsHF digital therapeutic is a software medical application that enables providers to rapidly initiate and intensify life-saving and guideline-recommended medical therapies for patients with HFrEF in a way that is nearly automated,” said Maulik Majmudar, MD, chief medical officer and co-founder of Biofourmis. “BiovitalsHF gets patients on the right therapies faster, which studies have shown helps save lives, prevents emergency department visits and hospital admissions, and enables patients to have a better quality of life.”

“This important breakthrough designation will help accelerate FDA's final review of BiovitalsHF,” said Kuldeep Singh Rajput, CEO and co-founder of Biofourmis. “If approved at the end of this expedited process, we look forward to introducing a new virtual heart failure care model that leverages the BiovitalsHF digital therapeutic to improve the use and dosing of guideline-directed medical therapy among patients with HF, for better patient outcomes and reduced healthcare expenditures.”

There are two types of HF; HFrEF (systolic heart failure), and heart failure with preserved or mid‐range ejection fraction (HFpEF/HFmrEF), previously called diastolic heart failure. HFpEF accounts for approximately 50% of all HF, but treatment options are limited, consisting mainly of diuretics and fluid balance control. Although the pathophysiology of HFpEF is complex, many of the symptoms are a result of excessive rises in left atrial pressure, in particular during exercise.

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