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Biofourmis Earns FDA’s First-Ever Breakthrough Device Designation for a Novel Digital Therapeutic for Heart Failure

July 29, 2021

BOSTON, July 29, 2021 B iofourmis, a Boston-based global leader in virtual care and digital therapeutics, announced today its BiovitalsHF® solution is the first-ever heart failure digital therapeutic to receive a Breakthrough Device designation from the U.S. Food and Drug Administration (FDA). BiovitalsHF® is a software medical application that augments guideline-directed use of heart failure medications to manage patients in combination with traditional pharmacotherapy.


The Breakthrough Devices Program was created to provide patients and providers with timely access to medical devices by speeding up their development, assessment and review while preserving the statutory standards for premarket approval, 510(k) clearance, and De Novo marketing authorization, according to the FDA.


“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. This is evidenced by research that shows less than 1% of heart failure patients are on the optimal dose of their HF medication and less than 25% of eligible patients receive GDMT. Clinical decisions regarding the use and dosing of GDMT among HFrEF patients must take into consideration various factors, including medical history, vital signs (e.g., heart rate, blood pressure), laboratory data (e.g., electrolytes, creatinine), and patient symptoms, as well as medication-related side effects. Currently, these decisions are made by the clinical care team periodically during in-person or virtual clinical interactions based on data gathered from disparate data sources (e.g., patients, electronic medical record, etc.).


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 and 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 less 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.”

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 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.”


About Biofourmis

Biofourmis is a global leader in virtual care and digital therapeutics, offering an innovative and comprehensive Care@Home platform that enables clinicians to deliver personalized predictive care to patients outside of a traditional hospital or clinic across the continuum of care, including acute, post-acute, and chronic care. Biovitals®, a highly sophisticated AI-powered health analytics platform, utilizes medical-grade wearables to continuously collect patient data to predict clinical exacerbation in advance of a critical event, which enables earlier interventions and leads to better clinical and financial outcomes. For more information, visit: