FDA grants Breakthrough Device designation to digital therapeutic

The BiovitalsHF, from Biofourmis, is intended to augment decision-making in clinical environments, and to supplement traditional pharmaceutical therapies.
The US Food and Drug Administration (FDA) has granted its first-ever heart failure digital therapeutic Breakthrough Device designation to Biofourmis, a digital therapeutics company. BiovitalsHF is a medical software tool designed to augment guideline-directed use of heart failure (HF) medications used to manage heart patients, in tandem with traditional pharmaceutical therapeutics.

Kuldeep Singh Rajput, Biofourmis CEO and founder, said the designation is a significant step for the advancement of the digital therapeutic, and for heart patients.

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

Initially launched in 2018, the FDA’s Breakthrough Devices Program​ was created to help improve the access by caregivers and patients to effective medical devices, and device-led combination therapies. The program (which updates and replaces the previous Expedited Access Pathway and Priority Review program) is designed to promote the accelerated development, assessment and review while preserving the statutory standards for premarket approval, 510(k) clearance, and De Novo marketing authorization, according to the FDA.

According to Biofourmis, approximately 6.2m people in the US live with heart failure. The estimated annual cost of treating the condition is expected to hit the $70b USD mark by 2030.

Additionally, guideline-directed medical therapy (GDMT) is a common strategy for managing heart failure patients with reduced ejection fraction (HFrEF, a condition in which the left ventricle muscle is underperforming). However, researchers have found it challenging to deal with timely initiation and dose intensifications of GDMT.

The BiovitalsHF technology is intended to augment clinical decision-making and to personalize and improve the use and dose of GDMT among patients with HFrEF. It combines physiological monitoring, symptoms, and signs reporting, patient engagement, medication management, and communication to give clinical teams personalized and specific medication recommendations.

Maulik Majmudar, co-founder and chief medical officer of Biofourmis, said the BiovitalsHF therapeutic empowers providers to quickly initiate and intensify GDMT for heart-failure patients with HFrEF in a virtually automated manner.

“In a proof-of-concept study, in patients using BiovitalsHF, we demonstrated statistically significant improvements in adherence to GDMT,” Majmudar related. “Reduction in levels of the key blood biomarker of heart failure NT-ProBNP; and improvements in health status.”

Also, Majmudar added, the technology can help connect patients with the proper therapies faster, which can save lives and prevent ER admissions.

“The FDA Breakthrough Devices program was created to help bring effective treatment of life-threatening or irreversibly debilitating conditions to market sooner, and BiovitalsHF is a perfect candidate for this program due to its clinical importance and impact,​” he said. Outsourcing Pharma