Digital therapy and virtual care startup Biofourmis received a breakthrough device designation from the Food and Drug Administration (FDA) for a product that helps clinicians get heart-failure patients on the right medications, the company announced Thursday.
The FDA program, established as part of the 21st Century Cures Act, lets companies with "breakthrough" devices work closely with the the agency, which guides them on how to establish more efficient clinical study designs that get products approved more quickly.
Boston-based Biofourmis submitted paperwork to request breakthrough device status from the FDA after wrapping up a proof-of-concept trial this year. Dubbed BiovitalsHF, the product provides clinicians with recommendations about a patient's medications. The trial showed promising results and improvements in patients' health, according to Biofourmis.
BiovitalsHF is designed for patients who have heart failure with reduced ejection fraction, abbreviated as HFrEF.
The digital tool, which requires a prescription, monitors patients' vital signs, laboratory data, symptoms and medication-related side effects using wearable sensors and other digital tools. Using this information BiovitalsHF assists clinicians who want to align patients' medications and dosages with guidelines from the American Heart Association and the American College of Cardiology.
Very few HFrEF patients are prescribed the optimal doses of their medicines, according to a study published in the Journal of the American College of Cardiology in 2018.
Biofourmis plans to submit data to the FDA for full approval after its next clinical trial, CEO Kuldeep Singh Rajput said.
The trial, which will be led by the Duke Univeristy's Clinical Research Institute in Durham, North Carolina, will evaluate 30-day readmission, emergency department visit and mortality rates for heart failure patients. Researchers also will analyze whether patients get the best medicines and the right doses. The trial likely will take about a year to complete, Rajput said.
The U.S. and the European Union approved 27 digital health products during the first half of this year, according to data from Mercom Capital Group, a market research firm. Since 2017, regulators in the U.S. and the E.U. have approved nearly 280 digital health products. The most common types are wearable sensors (75 approvals), medical imaging (68), clinical decision support (43) and mobile wireless products (41).
The FDA has been fine-tuning how it regulates digital health products. Last year, the agency launched a new center tasked with developing new regulatory approaches and sharing best practices for digital health technologies categorized as medical devices—products that help healthcare providers and patients manage serious or critical conditions.
Should the FDA approve BiovitalsHF, Biofourmis plans to build a virtual heart failure clinic, Rajput said. The virtual clinic would comprise a team of medical professionals who use the application to adjust patients' medications and to order prescription drug deliveries for patients.
Biofourmis would try to contract with payers on value-based care arrangements for such a program, Rajput said. Linking care delivery, supply chain and logistics, and technology is the key to the company's business plans, he said.
Biofourmis, which also sells products to detect and remotely monitor other conditions and hospital-at-home tools, won FDA clearance for an artificial-intelligence monitoring tool and a software program that detects cardiac arrhythmias. The company plans to continue to develop digital products in areas like heart failure, pain management and oncology.