Initial Animal Validation of a Multimodal Molecular Monitor for Heart Failure Treatment

Project Summary Recently the STRONG-HF trial exceeded initial expectations by demonstrating that heart failure re-admissions can be reduced by 44%, and patients can be up-titrated on their medications remarkably faster, but only by increasing the number of outpatient visits by four to monitor key molecular biomarkers such as NT-proBNP and potassium. Given the strain already on the health-care system, a major need that has been directly requested by cardiologists is to achieve STRONG-HF outcomes but in a more decentralized care format. If STRONG-HF care can be implemented in largely ambulatory/home setting, it could represent the next largest leap forward in the management of newly diagnosed heart failure. Kilele Health has performed rigorous discovery work to confirm strong significance for remote post-discharge monitoring of heart failure patients: in interviews of 20 cardiologists 100% cited value for remote monitoring of NT-proBNP for treatment efficacy and 90% cited value for remote monitoring of potassium for adverse events caused by treatment. Kilele Health’s goal is to develop a factory-calibrated continuous multi-modal molecular monitor of NT-proBNP and potassium for heart failure patients during the first 30-90 days after discharge. Kilele’s investor-vetted financial modeling points to a $4.1B market opportunity in heart failure alone. For comparison, this is even larger than the initial beach-head market for glucose monitors in Type 1 diabetes ($2.6B). The proposed device is highly innovative, as it would be the first ever continuous molecular monitor for cardiovascular diseases. Continuous remote molecular monitoring will shift current clinical practice, with automatic data to the patient and to electronic health-care records, not only improving patient outcomes (greater accuracy, more timely) but reducing the enormous $16B annual costs of heart failure readmissions. The investigators are exceptionally prepared due to their recent breakthroughs in creating robust aptamer sensors for molecular monitoring, existing relationships with glucose monitor companies, enagement with clinical experts in cardiovascular disease, and due to decades of experience for Kilele’s leadership in commercializing diagnostic devices. The team will achieve the Phase SBIR 1 overall objectives through the following three aims: Aim 1 – create a skin-insertable sensor strip that can measure both NT-proBNP and potassium; Aim 2 – demonstrate a ‘factory-calibrated’ batch fabrication process for the sensors; Aim 3 – perform at least 3 day testing in rats with a stretch goal of >10 days with >0.7 blood correlation. The expected outcomes of this work will enable Phase 2 SBIR support to pursue both human testing, wearable product development, and initiation of the regulatory approval process.