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Non-Invasive Venous Waveform Analysis (NIVA) in patients with Heart Failure (HF)

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 4R44HL140669-02
Agency Tracking Number: R44HL140669
Amount: $1,572,100.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: NHLBI
Solicitation Number: PA17-302
Solicitation Year: 2017
Award Year: 2019
Award Start Date (Proposal Award Date): 2019-03-15
Award End Date (Contract End Date): 2021-02-28
Small Business Information
Nashville, TN 37212-4808
United States
DUNS: 079852151
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (615) 322-5198
Business Contact
Phone: (678) 234-7792
Research Institution

Volume overload (congestion) occurs in patients with heart failure (HF) and is the leading cause
of hospitalization in the elderly worldwide. Unfortunately, clinical signs and symptoms;
laboratory values; and existing diagnostic tools are unreliable in providing accurate assessment
of volume status. Using a unique physiologic signal, Non-Invasive Venous waveform Analysis
(NIVA), VoluMetrix has developed a proprietary device (“VasaWatch”) and algorithm designed
for monitoring volume status in HF patients. Proof of concept data in humans and experimental
animal models, demonstrate that VasaWatch provides a reliable indication of intravascular
volume status. The studies in this Fast Track SBIR will establish that VasaWatch is a safe,
sensitive, inexpensive method for non-invasive volume status monitoring in patients with HF.Decompensated HF is the leading cause of hospitalization. HF leads to water
accumulation in the tissues (lungs and legs) resulting in shortness of breath and leg swelling.
This project will advance the development an accurate, inexpensive, easy to use device
(“VasaWatch”) for volume measurements in patients with HF. Use of these devices will
ultimately help health care providers and patients prevent water overload. The long term goal is
to prevent costly hospital readmissions, improve quality of live, and reduce mortality in patients
with HF.

* Information listed above is at the time of submission. *

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