Biofourmis Receives FDA Breakthrough Device Designation for Novel Digital Therapeutic for Heart Failure

Boston-based virtual care provider Biofourmis dreams of a future where heart failure patients ...


Boston-based virtual care provider Biofourmis dreams of a future where heart failure patients will stay home where they will be remotely monitored via a wearable sensor and an app. The company has now come one step closer to that goal. The FDA for the first time gave the company’s BiovitalsHF® solution a Breakthrough Device designation. BiovitalsHF is a software medical application that augments guideline-directed use of heart failure medications to manage patients in combination with traditional pharmacotherapy.

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“This important breakthrough designation will help accelerate FDA's final review of BiovitalsHF,” said Kuldeep Singh Rajput, CEO and 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 heart failure, for better patient outcomes and reduced healthcare expenditures.”

Heart failure remains the leading cause of hospitalization for patients over age 65. In the U.S., approximately 6.2 million patients live with heart failure, which carries an annual cost that is expected to reach $70 billion by 2030. Guideline-Directed Medical Therapy (GDMT) is a cornerstone of the management of individuals with heart failure with reduced ejection fraction (HFrEF). Timely initiation and dose intensifications of GDMT continue to be a major challenge in realizing clinical trial outcomes in the real world, despite the availability of guidelines from professional societies such as the American Heart Association and the American College of Cardiology, according to a press release.

BiovitalsHF augments clinical decision-making with the goal of personalizing and improving the use and dose of GDMT among patients with HFrEF. The device integrates physiological monitoring, symptoms, signs reporting, patient engagement, medication management, and communication to provide clinicians with personalized and specific medication recommendations. The system alleviates some of the problems that prevent GDMT titration because a) it enables patient health status and drug tolerance to be accurately assessed through continuous physiology monitoring and inclusion of lab assessment results for analysis; b) it reduces clinical inertia by prompting clinicians and patients on medication initiation and up-titration; c) it reduces the burden of clinical visits through a patient-clinician communication system, which becomes essential in circumstances such as a pandemic; and d) it requires fewer resources than nurse-led programs because titration recommendations from the HFrEF management guidelines are distilled in the system.

"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 heart failure with reduced ejection fraction in a way that is nearly automated," said Maulik Majmudar, MD, cardiologist and chief medical officer and co-founder of Biofourmis. "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.”

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Dr. Majmudar added: "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. The FDA Breakthrough Devices program was created to help bring the 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.”

Sam Draper
September 8, 2021

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