SBIR-STTR Award

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.

Project Terms:
Advanced Development; Algorithm Design; Algorithmic Analysis; Algorithms; Ambulatory Monitoring; Animals; base; Blood Volume; Cardiac; Cardiac Catheterization Procedures; Clinical; Clinical Data; Congestive; Crystallization; Custom; Data; design; Devices; Diagnostic; Elderly; Experimental Animal Model; Freezing; Frequencies; Goals; Gold; Health Personnel; Heart failure; hemodynamics; Hospital Costs; Hospital Readmission; Hospitalization; Human; improved; indexing; Intellectual Property; Laboratories; Leg; Linux; Lung; Measurement; Measures; Mechanical ventilation; Methods; Monitor; mortality; Numerical value; Operating System; Outpatients; Patients; Phase; phase 1 study; phase 2 study; Physiological; pressure; prevent; prototype; Pulmonary Capillary Wedge Pressure; radiotracer; Records; Research; Shortness of Breath; Signal Transduction; Signs and Symptoms; Small Business Innovation Research Grant; Swelling; System; Tablets; Technology; Therapeutic; Tissues; tool; trend; Venous; Venous Pressure level; Venous system; Water; Wrist;

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.

Public Health Relevance Statement:
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.

NIH Spending Category:
Bioengineering; Cardiovascular; Clinical Research; Clinical Trials and Supportive Activities; Heart Disease

Project Terms:
Advanced Development; Algorithm Design; Algorithmic Analysis; Algorithms; Ambulatory Monitoring; Animals; base; Blood Volume; Cardiac; Cardiac Catheterization Procedures; Clinical; Clinical Data; Congestive; Crystallization; Custom; Data; design; Devices; Diagnostic; Elderly; Experimental Animal Model; Freezing; Frequencies; Goals; Gold; Health Personnel; Heart failure; hemodynamics; Hospital Costs; hospital readmission; Hospitalization; Human; improved; indexing; Intellectual Property; Laboratories; Leg; Linux; Lung; Measurement; Measures; Mechanical ventilation; Methods; Monitor; mortality; Numerical value; Operating System; Outpatients; Patients; Phase; phase 1 study; phase 2 study; Physiological; pressure; prevent; prototype; Pulmonary Capillary Wedge Pressure; radiotracer; Records; Research; Shortness of Breath; Signal Transduction; Signs and Symptoms; Small Business Innovation Research Grant; Swelling; System; Tablets; Technology; Therapeutic; Tissues; tool; trend; Venous; Venous Pressure level; Venous system; Water; Wrist