SBIR Phase II: In-vivo validation of a volume-manufacturable and factory-calibrated wearable NT-proBNP monitoring system for heart failure treatment

Kilele Health Llc, Oakwood OH

Investigators

Abstract

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project will directly address the growing national economic and individual burden of cardiovascular disease as it becomes a reality for more than half of all Americans entering their sixties. Heart-failure is a cardiovascular disease that is particularly challenging given that many patients end up readmitted to the hospital just months after initial hospitalization. Greatly improved outcomes for patients are already possible, keeping patients from returning to the hospital, but only if the patient treatment can be rapidly optimized for the medications prescribed for heart failure. This rapid optimization requires multiple trips back to the doctor for blood tests to guide the treatment plan, adjusting patient medication levels accordingly. Cardiologists have therefore been asking for new technologies to aid their ability to care for heart-failure patients, with an increasing call for remote monitoring technology. This Small Business Innovation Research (SBIR) Phase II project will create the first-ever wearable, heart-failure monitor for a peptide molecule released by the heart when the heart is struggling, therefore providing a direct and continuous measurement of how well heart-failure treatment is progressing. Specifically, aptamers, which are oligonucleotides, will be used to capture heart-failure peptide molecules on a tiny electrical wire sensor embedded painlessly a few millimeters beneath the skin surface. As these aptamers capture the peptides, they provide a continuous measurement of the peptide concentrations in the form of an electrical signal. The project will create a working prototype that is like the proven success of wearable continuous glucose monitors, leveraging decades of investment in glucose monitors and significant doctor and patient trust in glucose monitors. Under the Phase II project, the wearable heart-failure monitor prototype will be validated for more than one week of operation in an animal model, a key proof point that will enable further commercial investment in developing the wearable heart-failure monitor for human use. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.