# Screening Under REgular assessment with hemoTAG (SURE TAG)

> **NIH NIH R44** · AVENTUSOFT, LLC · 2020 · $189,746

## Abstract

7. PROJECT SUMMARY/ABSTRACT
This SBIR Fast-Track project will develop a novel non-invasive device for left ventricular dysfunction
assessment to improve heart failure outcomes in patients with diabetes, validated through a multi-center
clinical trial to support FDA 510(k) clearance. According to national diabetes report, 33 million people in United
States suffered from diabetes. Abundant evidence shows diabetes is major independent risk factor for several
cardiovascular disorders including coronary heart disease, stroke, peripheral arterial disease, cardiomyopathy,
and congestive heart failure (HF). Large, randomized clinical trials for screening and revascularization of stable
macrovascular disease in diabetics, have failed to demonstrate a significant reduction in cardiac events and
HF episodes. Studies have demonstrated that early detection of left ventricular dysfunction and prevention of
microvascular complications through glycemic control in diabetes patients is a critical mechanism for reducing
the incidence and severity of left ventricular dysfunction and HF. Thus, given the clinical and economic impact
of diabetes and HF, and in view of the risk and cost of invasive monitoring there is a need for non-invasive,
affordable, accurate, absolute and actionable method that can provide point-of-care left ventricular dysfunction
assessment and facilitate optimized management of diabetes patients across the continuity of care. Towards
this goal, Aventusoft has developed a novel non-invasive medical device (HEMOTAG) enabling specific
measurements of left ventricular dysfunction, anywhere, anytime by anyone. Aventusoft has completed
multiple Institutional Review Board approved clinical studies to demonstrate the major clinical advancement.
Phase I and II activities will focus on larger multi-center clinical studies, enhancing the HEMOTAG technology
for hemodynamic guided assessment and management to reduce rates of left ventricular systolic dysfunction,
diastolic dysfunction, and improve HF outcomes in diabetes patients, reducing HF hospitalization, mortality,
and morbidity. Resulting in FDA 510(k) indications of use, for HEMOTAG guided treatment for diabetes
patients. The development of a non-invasive, accurate and easy-to-use solution to provide actionable targets
measurements without requiring blood tests, echocardiogram imaging or right heart catheterization, will have
great potential not only for HF management in diabetes but for many other etiologies as well. Communities
across the globe lack access to quality healthcare arising from shortages in medical expertise and availability
of medical diagnostic devices. The benefit of this pioneering work is the development of a low-cost and
portable solution that enable improved screening during routine annual checkups, doctor visits, at community
medical screenings, classes, and health fairs leading to healthier communities. It will make measuring left
ventricular dysfunction as routine as measuring...

## Key facts

- **NIH application ID:** 10200513
- **Project number:** 3R44HL149561-01A1S1
- **Recipient organization:** AVENTUSOFT, LLC
- **Principal Investigator:** Kaustubh Kale
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $189,746
- **Award type:** 3
- **Project period:** 2020-04-15 → 2021-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10200513

## Citation

> US National Institutes of Health, RePORTER application 10200513, Screening Under REgular assessment with hemoTAG (SURE TAG) (3R44HL149561-01A1S1). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10200513. Licensed CC0.

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