Healthcare providers log on to Biofouris’ platform. The company’s software was awarded the title of breakthrough device, which can help doctors prescribe the correct dose of medicine for patients with heart failure.
The U.S. Food and Drug Administration (FDA) awarded a startup company the title of breakthrough device for building software to help doctors prescribe the correct dose of medicine for patients with heart failure. Biofouris in Boston extracts patient laboratory data, symptoms and vital signs to recommend specific doses of specific drugs to doctors.
The company’s software is designed for patients with heart failure with reduced ejection fraction, in which case the left ventricle of the heart cannot pump enough blood. According to a study, many patients with this type of heart disease did not receive the recommended medication or the correct dosage. Research published in the American College of Cardiology in 2018.
There are many reasons why patients may not receive the correct treatment. Part of the reason may be the changes in the months between appointments, the challenges of insurance coverage, and the long wait for many patients to see a cardiologist in the first place.
“In a physical institution, you can only see a patient once every three months,” said Dr. Maulik Majmudar, a trained cardiologist and former medical officer of Amazon, who recently joined Biofouris as the chief medical officer. “The patient may feel good that day. You don’t have time to have the right conversation. All this prevents the patient from receiving the medical treatment guided by the guidelines.”
Majmudar said the algorithm includes information about which drugs the patient is eligible to use and their medication history. Clinicians can choose to use the recommended treatment or reject it, and if they reject it, the developer will look for reasons so they can improve the algorithm.
With the FDA’s breakthrough designation, Biofouris will pass the expedited review process. The company plans to start a key clinical trial of its digital therapy soon and submit it through the FDA’s de novo route next year.
Biofouris has been focusing on heart failure for many years. Recently, one of its first customers, Novartis Obtained FDA approval Entresto is a drug that treats decreased ejection fraction. Patients can participate in a support program in which they use wearable devices to measure heart rate, respiration rate, oxygen saturation, and other vital signs. The goal is to reduce the readmission rate of patients taking Entresto.
Majmudar said that the FDA’s breakthrough designation is the key because it may indicate that Biofouris’ titration algorithm may be used in other important conditions.
“In many cases outside of cardiology and cardiology, there is a gap between practice and the evidence base,” he said.
Last year, Biofouris Raised $100 million Led by SoftBank’s second Vision Fund. It still mainly plans to focus on cardiovascular disease, but is also seeking to expand into oncology and pain management.
