The Food and Drug Administration granted breakthrough device designation to a startup building software to help physicians prescribe the right dose of medication to patients with heart failure. Boston-based Biofourmis pulls in patients’ lab data, symptoms and vitals to recommend specific medications at a specific dose to their doctor.
The company’s software is designed for heart failure patients with reduced ejection fraction, a condition where the heart’s left ventricle is not pumping out enough blood. Many patients with this heart condition aren’t receiving recommended medications or the right doses, according to a study published in the American College of Cardiology in 2018.
There’s a plethora of reasons why patients might not be getting the right treatment. Part of it might be chalked up to changes in the months between appointments, challenges with insurance coverage, and the long wait for many patients to see a cardiologist in the first place.
“At a brick and mortar facility, you’re only seeing patients once every three months,” said Dr. Maulik Majmudar, a trained cardiologist and former medical officer for Amazon who recently joined Biofourmis as its chief medical officer. “The patients might be feeling well that day. You don’t have time for the right dialogue. All of these things get in the way of getting patients to guideline-directed medical therapy.”
The algorithm includes information on what drugs patients are eligible for and their medication history, Majmudar said. A clinician can choose to use the recommended treatment or reject it, and if they do reject it, developers look for the reason so they can improve the algorithm.
With the FDA’s breakthrough designation, Biofourmis will go through an expedited review process. The company plans to begin a pivotal clinical trial of its digital therapeutic soon, and submit it through the FDA’s de novo pathway next year.
Biofourmis has been focusing on heart failure for years. One of its first customers, Novartis, recently got FDA approval for Entresto, a medication to treat reduced ejection fraction. Patients could enroll in a support program where they use a wearable device to measure their heart rate, respiration rate, oxygen saturation and other vital signs. The goal was to reduce hospital readmissions for patients taking Entresto.
The FDA’s breakthrough designation is key, Majmudar said, because it might indicate that Biofourmis’ approach with its titration algorithm could potentially be used for other important conditions.
“There are a lot of conditions in cardiology and beyond cardiology where there’s a gap between practice and evidence base,” he said.
Last year, Biofourmis raised $100 million led by Softbank’s second vision fund. It still largely plans to focus on cardiovascular conditions, but also is looking to expand into oncology and pain management.