What You Should Know:
– Biofourmis, a Boston-based global leader in virtual care and digital therapeutics, announced 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).
– The Breakthrough Devices Program was created to provide patients and providers with timely access to medical devices (in this case, software as a medical device, or SaMD) 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.
BiovitalsHF: How It Works
BiovitalsHF® is a software medical app that augments guideline-directed use of heart failure medications to manage patients in combination with traditional pharmacotherapy. 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.
Why It Matters
This heart failure DTx was a great candidate for a Breakthrough Designation, given that 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. Unfortunately, less than 1% of heart failure patients are on the optimal dose of their HF medication and less than 25% of eligible patients receive guideline-directed medical therapy (GDMT).
This DTx fills some of those gaps to help clinicians get their patients titrated more quickly on the right dosages of their heart failure medications to improve outcomes and quality of life—especially important given that HF currently has no cure.
“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.”