# Administrative Supplement to Promote Diversity in Research and Development  Small Businesses-SBIR (Rodrigo Jordao)

> **NIH NIH R44** · AVENTUSOFT, LLC · 2021 · $134,079

## Abstract

7. PROJECT SUMMARY/ABSTRACT
This SBIR Fast-Track project will develop an innovative non-invasive cloud connected device for
hemodynamic-guided therapy to improve outcomes in Heart Failure (HF) patients, validated through a multi-
center clinical trial to support FDA 510(k) clearance. The standard telemonitoring interventions involving
objective monitoring of blood pressure, weight, electrocardiograms, or rhythm strips for review, have not
demonstrated reduction with respect to readmission for any reason or death of any cause within 180 days after
enrollment. Invasive devices have demonstrated that ambulatory pulmonary artery pressures (PAPs)
hemodynamic measurement allow more effective HF management leading to fewer hospitalizations. Thus,
given the clinical and economic impact of HF hospitalizations, and in view of the risk and cost of invasive
monitoring there is a need for non-invasive, affordable, accurate, absolute and actionable hemodynamic
measurement methods that can monitor HF patients in the clinic and at home. Providing an effective method
for early detection of congestion and guided therapy intervention to avoid hospitalization. The ability of a device
to allow the management of HF patient across the continuity of care from the emergency department, to in-
patient, to out-patient clinic, and to the home, would be of tremendous value. Towards this goal of HF
management, Aventusoft has developed a novel non-invasive medical device (HEMOTAG) enabling specific
measurements of hemodynamics, 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 therapy to improve outcomes in heart failure patients, reducing HF hospitalization,
mortality, morbidity, and improving quality of care through remote monitoring and timely intervention. Resulting
in FDA 510(k) indications of use, for HEMOTAG guided treatment for HF patients. The development of a non-
invasive, accurate and easy-to-use solution that can provide actionable targets measurements without
requiring an echocardiogram imaging or right heart catheterization, will have great potential not only for HF
management but for many other etiologies as well. Aventusoft’s HEMOTAG provides a complement or
replacement for expensive devices currently required for measuring the pulmonary artery pressures. The
HEMOTAG device can enable reliable, accurate, absolute, actionable and easy-to-use application by
healthcare professionals and by patients at home, for the early detection of congestive exacerbations due to
fluid overload. It overcomes the limitations of cost, size, accessibility and availability of skilled personnel
requirements of existing devices. HEMOTAG verification and validation would be completed during the Phase
II. Followed by commercialization in Flori...

## Key facts

- **NIH application ID:** 10403370
- **Project number:** 3R44HL145941-03S1
- **Recipient organization:** AVENTUSOFT, LLC
- **Principal Investigator:** Kaustubh Kale
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $134,079
- **Award type:** 3
- **Project period:** 2019-06-01 → 2023-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10403370

## Citation

> US National Institutes of Health, RePORTER application 10403370, Administrative Supplement to Promote Diversity in Research and Development  Small Businesses-SBIR (Rodrigo Jordao) (3R44HL145941-03S1). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10403370. Licensed CC0.

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