Commercialization Readiness Pilot Program support for: HATS-OFF

7. PROJECT SUMMARY/ABSTRACT Heart Failure (HF) effects 6 million Americans resulting in more than 1 million annual hospitalizations, over 25% re-hospitalizations and $20 billion in cost of care and higher. The standard recommended practice of monitoring weights and symptoms has not demonstrated reduction in hospitalizations. Thus, given the clinical and economic impact of HF hospitalizations, there is a need for a non-continuous, non-invasive, easy-to-use- at-home method for long-term monitoring to detect HF decompensation early and therapy intervention to avoid hospitalization. The R&D and clinical trial funded by the parent SBIR Phase II grant (1R44HL145941) has developed the needed non-invasive heart failure hemodynamic monitoring technology, called, HEMOTAGÒ HATS-OFF (Hemotag AssessmenT for Short-term Outcomes oF heart Failure) that provides accurate, absolute, and actionable hemodynamic measurements, enabling the monitoring of fluid congestion in a heart failure patient at home. Clinical results from the Phase II surpassed our milestones, in addition the randomized clinical trial demonstrated statistically and clinically significant reduction in hospitalizations. Along with very strong commercial engagements with our clinical partners, demonstrate the success of the Phase II. While our phase II grant resulted in a safe and functional product, critical funding gap remains before the device can achieve commercialization. Specifically, we must: lower manufacturing cost, based on recognition of a need to install a larger number of systems at home; enable electrocardiogram (ECG) functionality needed to monitor rhythm related heart failure events; and perform all activities necessary for FDA 510(k) clearance with the desired clinical indication of use. In this work we propose three major task areas for this late-stage development project: 1) To manufacture the HATS-OFF device with ECG functionality and HF monitoring capabilities resulting in a simple, reliable, and cost-effective device configuration for longer-term home use. 2) Finalize and implement a quality system to bring the development process under design and quality systems control. Optimization of device manufacturing necessary to ensure consistent and scale-up manufacturing according to recognized quality standards and in compliance with expected good manufacturing practices (GMPs) and applicable FDA requirements, including measures and activities to control manufacturing of upstream and downstream processes, in-process sampling, testing, process validation and related production requirements. 3) Regulatory Assistance to include strategy, documentation, submission of 510(k) application to the Food and Drug Administration (FDA). This will greatly enhance our ability to obtain additional funding and strategic partnerships. Successful completion of the proposed aims will result in a new technology to allow rapid, accurate and frequent surveillance of HF to maximize quality of life and prevent hospitalizations. After HATS-OFF is approved for HF monitoring, and with commercial scale manufacturing in place, our plan is to raise additional capital to build a sales force and launch the product.