Kuldeep Singh Rajput is the founder of Biofourmis in Boston. He envisions a future where patients with heart failure can return home with a prescription and a wearable sensor. The company is now one step closer to achieving this goal with the FDA's new designation.Biofourmis, a digital therapeutics company founded in 2015, develops software that augments patient care. Rajput estimates that the company has raised approximately $145 million in funding so far and has 350 employees.Biofourmis BiovitalsHF received an FDA breakthrough device design designation on Thursday. This platform is designed to monitor heart failure medication. Although FDA approval does not guarantee breakthrough device status, it allows for expedited review and provides the company with access to federal expertise during development.Rajput says that Biofourmis is focused on two main areas. Rajput says that the first is to develop digital therapies with drug companies (apps that deliver dosage or sensors that monitor health). The second is to provide home care for patients suffering from acute conditions.BiovialsHF is one example of the company's first forays into this area. The company has already developed digital therapies to treat a variety of conditions such as atrial fibrillation or coronary artery disease. It also has digital therapies in development for people who are undergoing chemotherapy or dealing with chronic pain. Rajput says that BiovitalsHF is the company's first FDA-approved breakthrough therapy.BiovitalsHF is a software platform that helps patients with heart disease manage their medication. Patients may receive a prescription at first, but they might have to modify the dosage once they get home.Many doctors will treat heart failure using multiple medications. Doses may need to be adjusted over time. Two types of medication, ACE inhibitors and beta-blockers, may require medication to be titrated. This is a process in which a patient starts treatment with a low dose and gradually increases the dose over time until they reach their desired dose.Titration in real life is difficult to achieve. One 2020 study indicates that less than 25% of patients with heart failure are receiving their optimal doses. Other studies indicate it may be less than 1%. Cardiac Failure Review also estimates that only 29 percent of patients are on the target doses for ACEs, and 18% on the target beta blocker dose.Contrary to this, clinical trials show that between 50-60% of patients are able to get their best dosages. This suggests that there is a difference in how people use medicine in real life and how they do it in research.BiovitalsHF collects and analyzes data from wearable devices to speed up the titration process for patients who have left hospitals. The data could be used to adjust the dosage of medication based on patient health.Software adjusts medication dosage using data from the patient, a watchable and external lab results. The wearable device could collect data such as heart rate, respiratory rate, stroke volume, or cardiac output. A patient could report their symptoms to the app and a doctor might enter lab results.Rajput says that we can automatically adjust titrate, down titrate, or switch medications based on data from patients via sensors and the mobile platform. This allows patients to be on the correct dose.The patient would receive notification that their medication was being modified.Although the BiovitalsHF program was only tested in one proof of concept study (more details later), the Biovitals patient monitor platform has been used to test other diseases.The Biovitals system was used to monitor 34 COVID-19 mild patients at Queen Mary Hospital in Hong Kong. They wore a biosensor for 23 hours each day. Scientific Reports published a paper indicating that the platform could predict whether a patient would become worse with 93% accuracy and predict how long he or she will stay in hospital with 78% accuracy.BiovitalsHF is a slightly different system. Rajput hopes to use the technology to treat patients.A doctor may prescribe three months of BiovitalsHF. The software might track patient outcomes and determine dosage.BiovialsHF HF is being promoted as a treatment program and not as decision support software. This distinction is subtle but it indicates that Biovials HF is more than just a delivery device. It is a drug.Rajput says that the digital therapy product label will contain actual treatment claims, as opposed to being a monitor for clinical decision support.These claims can only be made if you have solid results. Although the company has done some initial testing with the concept in a proof of concept clinical trial, which concluded in March 2021; further rounds of testing will be required to confirm its efficacy.For 90 days, the study followed 282 patients and compared them to regular care. The trial's goal was to find out if the platform could optimize medication dose. This would mean getting patients within 50% of their optimal dose.The study's results have not yet been made public. Rajput says that the study met that endpoint and was linked to other improvements in patient life quality and heart health.Within three months, patients experienced significant improvements in their quality of life and cardiac function. There was also a reduction in the blood biomarker, NT-proBNP, which is a sign of heart failure. We submitted these data to FDA and were awarded the breakthrough designation.The data have been submitted by the company for publication in a peer reviewed journal.We can expect BiovitalsHF's breakthrough designation to be in place soon, even though it is still far from FDA approval or premarket approval.Our pivotal trial will begin as soon as possible. Rajput states that we will submit a formal submission to FDA in June or July next year.
