Biofourmis Receives FDA Breakthrough Device Designation for Heart Failure Therapy
Biofourmis Receives FDA Designation for Heart Failure Monitoring Platform
Kuldeep Singh Rajput, founder of Boston-based Biofourmis, envisions a future where individuals with heart failure receive a prescription accompanied by a wearable sensor and a dedicated mobile application. A recent FDA designation brings the company closer to realizing this innovative approach to patient care.
Company Overview and Funding
Established in 2015, Biofourmis operates as a digital therapeutics firm, concentrating on the development of software solutions designed to enhance patient care. To date, the company has secured approximately $145 million in funding and currently employs around 350 individuals, according to Rajput’s estimation.
Breakthrough Device Designation
On Thursday, Biofourmis BiovitalsHF, a platform specifically engineered for monitoring medication in heart failure patients, was granted a breakthrough device designation by the FDA. This designation doesn’t guarantee FDA clearance, but it facilitates an accelerated review process and provides the company with access to valuable expertise from the federal agency during the development phase.
Core Focus Areas
Rajput outlines two primary areas of focus for Biofourmis. The first involves creating digital therapies in collaboration with pharmaceutical companies, such as applications for managing dosage or sensors for tracking health metrics. The second centers on delivering follow-up care at home for patients recovering from acute medical conditions.
BiovitalsHF: A Pioneering Digital Therapy
BiovitalsHF exemplifies the company’s efforts within its initial focus area. Biofourmis has developed digital therapies for a range of conditions, including coronary artery disease and atrial fibrillation, and is currently working on therapies for chemotherapy patients and individuals experiencing chronic pain. However, BiovitalsHF is the first to receive FDA breakthrough designation, positioning it as the company’s “lead digital therapy.”
Managing Medication for Heart Failure
The BiovitalsHF product is a software platform intended to optimize medication management for patients diagnosed with heart failure. The system addresses the challenge of adjusting medication levels after patients return home from the hospital.
The Importance of Medication Titration
Treatment for heart failure frequently involves multiple medications, and dosages often require adjustments over time. Specifically, medications like ACE inhibitors and beta-blockers may necessitate titration – a gradual process of increasing dosage from a low starting point to achieve the optimal therapeutic effect.
Challenges in Real-World Titration
Achieving effective titration in clinical practice can be difficult. A 2020 study indicated that fewer than 25 percent of heart failure patients are on their ideal dosages. Other research suggests this figure may be even lower, with some estimates falling below one percent. A 2017 commentary published in Cardiac Failure Review reported that only 29 percent of patients were at their target ACE inhibitor dose and 18 percent at their target beta-blocker dose.
Bridging the Gap Between Trials and Reality
In contrast, clinical trials often demonstrate that 50-60 percent of patients achieve optimal dosages. This discrepancy highlights a gap between medication adherence in controlled study settings and real-world patient behavior.
Streamlining Titration with BiovitalsHF
BiovitalsHF aims to simplify the titration process for patients after hospital discharge by collecting and analyzing data from a wearable device. This data could then be utilized to adjust medication based on the patient’s health status.
Data-Driven Dosage Adjustments
The software adjusts medication dosages using information gathered from the patient, the wearable sensor, and external laboratory results. The wearable device monitors vital signs such as heart rate, respiration rate, stroke volume, and cardiac output. Patients can also report their symptoms through a mobile app, and physicians can input lab results.
“We are able to automatically up titrate or down titrate and switch medication, based on the data collected from patients using sensors and the mobile platform, ensuring they are on the right, optimal dose,” explains Rajput.
Patient Notifications and Feedback
Patients receive notifications informing them of any planned medication adjustments.
Expanding Applications of the Biovitals Platform
While BiovitalsHF has undergone only one proof-of-concept study thus far, the broader Biovitals patient monitoring platform has been tested for other conditions as well.
COVID-19 Monitoring in Hong Kong
For instance, the Biovitals system was adapted to monitor 34 patients with mild COVID-19 at Queen Mary Hospital in Hong Kong, who wore a biosensor for 23 hours each day. A study published in Scientific Reports revealed that the platform could predict patient deterioration with 93 percent accuracy and forecast hospital length of stay with 78 percent accuracy.
BiovitalsHF: A Treatment Program
The BiovitalsHF system differs slightly, as it aims to function not just as a monitoring tool, but as a complete treatment program. Rajput hopes to see the technology itself administered as a treatment program.
A "Prescription" for Digital Therapy
The concept envisions a physician “prescribing” a three-month course of BiovitalsHF, during which the software autonomously monitors patient outcomes and adjusts dosages.
Beyond Decision Support: A Digital Drug
The goal is to market BiovitalsHF not merely as a decision support tool, but as a therapeutic regimen. This subtle distinction signifies the company’s ambition to transcend the role of a delivery device and become akin to a pharmaceutical drug.
“The label of the product for digital therapy will have actual treatment claims as compared to just a monitoring tool for clinical decision support,” Rajput states.
Clinical Trial Results and FDA Submission
Robust clinical results are essential to support these claims. The company completed an initial proof-of-concept clinical trial in March 2021, and plans to conduct further testing to demonstrate efficacy.
Study Design and Endpoint
The study involved 282 patients monitored over 90 days, comparing those using BiovitalsHF to those receiving standard care. The primary objective was to determine whether the platform could optimize medication dosage – defined as achieving a dose within 50 percent of the optimal level.
Positive Preliminary Findings
While the full study results have not yet been publicly released, Rajput reports that the trial successfully met its primary endpoint and appeared to correlate with improvements in patients’ quality of life and cardiac health.
“Patients had, within three months, significant increases in quality of life, cardiac function, as well as reduction in a blood biomarker NT-proBNP [a marker of heart failure]. Based on this, we submitted the data to the FDA and received the breakthrough designation,” he says.
The company has submitted the data for publication in a peer-reviewed journal.
Looking Ahead: Pivotal Trial and FDA Submission
With the breakthrough designation secured, progress on BiovitalsHF is expected to accelerate. However, full FDA approval or even premarket approval remains some time away.
“We will be kicking off our pivotal trial anytime now. And we expect to make a formal submission to the FDA sometime in June [or] July next year,” Rajput concludes.
