Commercialization readiness pilot program support for: hemolink - 7. Project summary/abstract cardiovascular disease remains the leading cause of mortality for both men and women in the united states,…

The National Heart, Lung, and Blood Institute awarded Aventusoft LLC $500,000 on September 1, 2026, under the Cardiovascular Diseases Research program (CFDA 93.837) to advance commercialization of HEMOLINK, a skin-adhered disposable patch for non-invasive hemodynamic monitoring.

HEMOLINK is a first-in-class wearable medical device featuring a synchronous quad-sensor array designed to estimate left ventricular end-diastolic pressure (LVEDP) for remote cardiac monitoring. The patch incorporates a novel multilayer biomaterial system optimized for 30-day skin contact, with an ultra-thin lightweight profile, water resistance, one-button interface, and LED status indicator. The system requires no recharging or electrode replacement and is designed for maintenance-free operation. This award supports late-stage development and regulatory preparation to translate a validated non-invasive LVEDP estimation algorithm—developed under prior SBIR Phase II support (1R44HL167296)—into an FDA-cleared commercial device.

Aventusoft LLC, a minority-owned small disadvantaged business located in Boca Raton, Florida, is the recipient. The company specializes in biosensor and mobile health technologies focused on cardiovascular innovations.

Performance period extends from September 1, 2026, through August 31, 2027, with work performed in Boca Raton, Florida. The award is structured as a Project Grant, a competitive research award under the SBIR program, which supports technological innovation and private-sector commercialization of innovations derived from federal research and development funding.

Commercialization readiness pilot program support for: hemolink - 7. Project summary/abstract cardiovascular disease remains the leading cause of mortality for both men and women in the united states, accounting for approximately 33.6% of all deaths. The economic burden is equally significant, with total annual costs estimated at $363 billion, underscoring the urgent need for innovative, cost-effective approaches to disease management. Left ventricular end-diastolic pressure (LVEDP) serves as a critical hemodynamic parameter, reflecting ventricular compliance as well as intravascular volume and pressure. Clinically, LVEDP correlates with both acute and chronic conditions impacting cardiac function, making IT a valuable biomarker for guiding diagnosis and therapeutic management. Personalized, home-based monitoring of LVEDP has the potential to transform cardiac care by enabling timely clinical decision-making and reducing hospitalizations. Through prior support from a parent sbir phase II award (1R44HL167296), we successfully developed and validated a novel non-invasive algorithm for LVEDP estimation, yielding absolute, accurate, and actionable hemodynamic data suitable for remote monitoring. Our development efforts have been bolstered by strong collaborations with clinical partners, demonstrating the feasibility and clinical utility of our approach. However, a critical funding GAP remains to translate the validated algorithm into a commercially viable, FDA-cleared medical device. To address this GAP, we propose late-stage development and regulatory preparation for hemolink™, a first-in-class, skin-adhered, disposable patch featuring a synchronous quad-sensor array for true hemodynamic monitoring, novel multilayer biomaterial system optimized for long-term skin-contact designed for 30-day use, with an ultra-thin, lightweight profile, water resistance, one-button interface, and led status indicator. The system is maintenance-free, requiring no recharging or electrode replacement. The proposed project comprises three integrated technical objectives: 1) device manufacturing and engineering optimization - finalize the hemolink device manufacturing protocol to ensure reliability, scalability, and cost-efficiency for long-term, home-based use. This includes optimization of power budget, device thickness, direct wireless communication, and signal integrity. 2) quality system development and GMP compliance - implement a comprehensive quality management system encompassing design controls, process validation, in-process testing, and compliance with good manufacturing practices (GMPS) and FDA quality system regulations (QSR). 3) regulatory strategy and 510(K) submission - develop and execute a regulatory strategy leading to the preparation and submission of a 510(K) application to the U.S. Food and drug administration (FDA), including all necessary documentation and testing. Successful completion of these aims will position hemolink™ as a breakthrough platform for non- invasive hemodynamic monitoring, enabling high-frequency, accurate surveillance of cardiac status from home. This will not only improve clinical outcomes and reduce healthcare utilization but also support downstream commercialization efforts through enhanced investor confidence and strategic partnerships.