The Food and Drug Administration has granted breakthrough device designation to software for creating startups to help doctors prescribe the right dose of medicine to patients with heart failure. Boston-based Biofourmis extracts lab data, symptoms, and vital signs from patients to recommend specific drugs at a specific dose to their doctor.
The company’s software is designed for patients with heart failure with reduced ejection fraction, a condition in which the heart’s left ventricle does not pump enough blood. Many patients with this heart disease don’t get the recommended medications or the right doses, according to a study published in the American College of Cardiology in 2018.
There are a multitude of reasons why patients might not be receiving the right treatment. Part of this could be due to changes in the months between appointments, issues with insurance coverage, and the long wait for many patients to see a cardiologist in the first place.
“In a brick and mortar facility, you only see patients once every three months,” said Dr. Maulik Majmudar, a qualified cardiologist and former Amazon chief medical officer who recently joined Biofourmis as a chief doctor. “The patients might feel good that day. You don’t have time for the right dialogue. All of these things prevent patients from receiving medical treatment as directed. “
The algorithm includes information about which drugs patients are eligible for and their drug history, Majmudar said. A clinician can choose to use the recommended treatment or reject it, and if he rejects it, the developers investigate the reason in order to improve the algorithm.
With the revolutionary designation from the FDA, Biofourmis will go through an expedited review process. The company plans to begin a pivotal clinical trial of its digital therapeutics soon and submit it to the FDA de novo route next year.
Biofourmis has focused on heart failure for years. One of its first customers, Novartis, recently obtained FDA approval for Entresto, a drug to treat reduced ejection fraction. Patients can enroll in a supportive program in which they use a portable device to measure their heart rate, respiratory rate, oxygen saturation, and other vital signs. The aim was to reduce hospital readmissions for patients taking Entresto.
The breakthrough designation from the FDA is critical, said Majmudar, as it could 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 is a gap between the practice and the evidence base,” he said.
Last year, Biofourmis raised $ 100 million through Softbank’s second vision fund. He still largely plans to focus on cardiovascular disease, but is also looking to expand into oncology and pain management.