Digital therapeutics have been pitched for conditions ranging from substance abuse to ADHD, but now Biofourmis is putting forward its program for heart failure—and the FDA hopes to expedite its use in the clinic.
The Boston-based company’s BiovitalsHF solution has received a breakthrough designation from the agency, for software designed to run alongside standard heart failure medications and therapies.
The program aims to bring regimens in line with professional treatment guidelines from the American Heart Association and the American College of Cardiology. Biofourmis cites estimates that less than 1% of heart failure patients receive the optimal dose of their medication on a regular basis.
The BiovitalsHF app aims to help automate the process of making sure that drugs are begun at the correct time and in the proper escalating amounts—based on a person’s medical history and active changes in their heart rate and blood pressure, in addition to other lab test results and measurements of symptoms.
Traditionally, manual adjustments to a patient’s drug regimen may happen more periodically, following scheduled in-person or telehealth appointments spanning a matter of months.
"In a proof-of-concept study, in patients using BiovitalsHF, we demonstrated statistically significant improvements in adherence to [guideline-directed medical therapy]; reduction in levels of the key blood biomarker of heart failure NT-ProBNP; and improvements in health status," Biofourmis’ co-founder and chief medical officer, Maulik Majmudar, said in a statement.
"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,” said Majmudar, who joined the company this past May after helping to lead healthcare-related projects at Amazon, including the launch of its Halo wearable device.
Prior to that, Majmudar was associate director of the Healthcare Transformation Lab at Massachusetts General Hospital and an assistant professor at Harvard Medical School, and has served on Biofourmis’ clinical advisory board since its 2015 launch.
Now, he will help guide recent additions to the company’s Biovitals platform, including the digital Hospital@Home solution, which helps stand up remote care programs with clinical and non-clinical services, such as support for management, operations, supply chain and billing.
"Our vision is to become the most comprehensive and tightly integrated care-at-home platform across a range of patient acuity levels and medical conditions," Majmudar said at the time.