SBIR-STTR Award

A Device for Monitoring Heart Failure Patients
Award last edited on: 2/16/2024

Sponsored Program
SBIR
Awarding Agency
NIH : NHLBI
Total Award Amount
$1,676,625
Award Phase
2
Solicitation Topic Code
837
Principal Investigator
Richard H Sandler

Company Information

Biomedical Acoustics Research Company (AKA: BARC)

4079 Conway Place Circle
Orlando, FL 32812
Location: Single
Congr. District: 09
County: Orange

Phase I

Contract Number: 1R43HL099053-01A1
Start Date: 8/17/2011    Completed: 7/31/2013
Phase I year
2011
Phase I Amount
$339,058
About five million patients currently suffer from heart failure (HF) in the US, resulting in about one million hospitalizations annually and a yearly cost of over 35 billion USD. The long-term objective of this project is to develop an innovative technology to assist HF outpatient management. The proposed device will be used by ambulatory individuals to alert them and their healthcare providers to deterioration of HF status (e.g., via wireless/cell phone or other methods). This will facilitate early therapeutic intervention, which may result in reduced hospitalization, morbidity, cost and potentially mortality. The technology relies on detecting changes in low-frequency chest wall vibrations due to the physical motion of the heart, blood flow and valves. These sub-audible vibrations can be detected and analyzed with appropriate sensors and digital signal processing methods. The proposed first-generation novel device is not intended for initial diagnosis of HF patients (i.e., distinguishing normal from abnormal subjects); rather it is intended for early ambulatory detection of changes in chest wall vibrations that may be associated with clinical changes in HF individuals. The proposed device would be non-invasive, safe, and require brief measurement time (~ 60 sec). There would not be a need to wear the device constantly. Instead, patients would typically test themselves once daily and as needed. During Phase I, candidate sensors will be tested and a first-generation prototype built. Reproducibility of chest wall vibration signals will be tested in normal and HF subjects. These human studies will help delineate chest vibration correlates of HF status changes. If the project is successful, the proposed novel technology would be used by HF outpatients for self monitoring, for automated remote assessment (e.g. via internet or phone), or as a rapid assessment and monitoring tool during healthcare provider visits. It is expected that the envisioned device would be compact, easy and comfortable to use, rapid, inexpensive and safe.

Public Health Relevance:
This project proposes to develop a device to help improve monitoring and treatment of out-patients with heart failure by alerting them and their providers to worsening disease. This will allow improved early therapeutic intervention, which should result in reduced hospitalizations, illness, cost and potentially deaths.

Public Health Relevance Statement:
This project proposes to develop a device to help improve monitoring and treatment of out-patients with heart failure by alerting them and their providers to worsening disease. This will allow improved early therapeutic intervention, which should result in reduced hospitalizations, illness, cost and potentially deaths.

Project Terms:
Transducers; Sickness Cost; Disease Costs; Cost of Illness; vibration; human study; Information Technology; laptop; Vibrocardiography; Kinetocardiography; therapy cooperation; therapy compliance; patient adherence; compliance cooperation; Treatment Compliance; Patient Cooperation; Patient Compliance; Compliance behavior; Vendor; Followup Studies; Follow-Up Studies; Outpatient Monitoring; Ambulatory Monitoring; cardiac motion; heart motion; world wide web; web; WWW; Internet; Cellular Telephone; Cell Phone; Cellular Phone; Phone; Telephone; Digital Signal Processing; Health Personnel; treatment provider; medical personnel; healthcare personnel; health provider; health care worker; health care personnel; Healthcare worker; Healthcare Providers; Health Care Providers; innovative technologies; Healthcare professional; Health Care Professional; Health Professional; Detection; Process; Life; Diagnosis; Modern Man; Man (Taxonomy); Human; novel technologies; new technology; biological signal transduction; Signaling; Signal Transduction Systems; Intracellular Communication and Signaling; Cell Signaling; Cell Communication and Signaling; Signal Transduction; Mortality; Mortality Vital Statistics; tool; computer program/software; Software; Computer software; Monitor; Sales; Death; Cessation of life; Surface; heart muscle; cardiac muscle; Myocardium; Patients; Testing; Weight; Generations; Measurement; sensor; Out-patients; Outpatients; disease/disorder; Disorder; Disease; Time; cost; International; Clinical; Frequency; Frequencies (time pattern); Figs; Figs - dietary; Devices; meetings; intervention therapy; Therapeutic Intervention; Individual; Technology; Goals; Data; Phase; response; improved; Skin; Blood flow; Female; base; pricing; Price; male; Methods; Marketing; novel; Morbidity; Morbidity - disease rate; Production; Cardiac; Provider; Heart failure; cardiac failure; Visit; prototype; Reproducibility; Deterioration; Thorax; Thoracic; Thorace; Chest; Thoracic Wall; Chest Wall; Chest wall structure; Hospitalization; Penetration; human subject; wireless; Wireless Technology

Phase II

Contract Number: 2R44HL099053-02A1
Start Date: 8/17/2011    Completed: 12/31/2019
Phase II year
2017
(last award dollars: 2019)
Phase II Amount
$1,337,567

About five million patients currently suffer from heart failure (HF) in the US, resulting in about one million hospitalizations annually and a yearly cost of > 30 billion USD. The long-term objective of this project is to develop an innovative technology to assist HF outpatient management. The proposed device will be used by health care providers to detect HF deterioration, which may facilitate early therapeutic intervention, and possibly reduced hospitalization, morbidity, cost and potentially mortality. The project is an important step in later building a follow up device for in home monitoring. The technology relies on detecting changes in low-frequency chest wall vibrations due to heart contraction. These sub-audible vibrations can be detected and analyzed with appropriate sensors and digital signal processing methods. The proposed first-generation novel device is not intended for initial diagnosis of HF patients (i.e., distinguishing normal from abnormal subjects); rather it is intended for early ambulatory detection of changes in chest wall vibrations that may be associated with clinical changes in HF individuals. The proposed device would be non-invasive, safe, and require brief measurement time (1-2 minutes) once a week or as needed. All objectives of Phase I were met or exceeded. During Phase II, certain device enhancements will be implemented and a first-generation prototype will be built. The device will be tested in HF subjects during hospitalization and post-discharge. These human studies will help delineate chest vibration correlates of HF status changes. If the project is successful, the proposed novel technology would be used by healthcare providers (and later by HF outpatients at home) as a rapid assessment and monitoring tool during healthcare provider visits. It is expected that the envisioned device would be compact, easy and comfortable to use, rapid, inexpensive and safe.

Public Health Relevance Statement:


Project narrative:
This project proposes to develop a device to help improve monitoring and treatment of out-patients with heart failure by alerting them and their providers to worsening disease. This will allow improved early therapeutic intervention, which should result in reduced hospitalizations, illness, cost and potentially deaths.

Project Terms:
Achievement Attainment; Achievement; Acoustic; Acoustics; Data Collection; Death; Cessation of life; Diagnosis; Digital Signal Processing; Disorder; Disease; Florida; Future; treatment provider; medical personnel; healthcare personnel; health provider; health care worker; health care personnel; Healthcare worker; Healthcare Providers; Health Care Providers; Health Personnel; cardiac failure; Heart failure; Hospitalization; Modern Man; Human; Methods; Morbidity - disease rate; Morbidity; mortality; Myocardial Contraction; heart contraction; Nurses; Outpatients; Out-patients; Patients; Pharmacology; Physicians; Public Health; Research; Resources; Research Resources; Risk; Signal Transduction; biological signal transduction; Signaling; Signal Transduction Systems; Intracellular Communication and Signaling; Cell Signaling; Cell Communication and Signaling; Computer software; Software; Supervision; Syndrome; Tablets; Technology; Testing; Time; Universities; Weight; Work; Generations; base; human subject; sensor; improved; Thoracic Wall; Chest Wall; Chest wall structure; Acute; Clinical; Phase; Ensure; Training; Individual; Data Quality; Measurement; Collaborations; tool; Frequencies; Event; Home environment; Home; System; vibration; EFRAC; Ejection Fraction; Visit; innovative technologies; monitoring device; Performance; laptop; novel; new technology; novel technologies; Devices; Reporting; Positioning Attribute; Position; Therapeutic Intervention; intervention therapy; Chest; Thorax; Thoracic; Thorace; Deterioration; Modeling; Adverse event; Adverse Experience; Current Procedural Terminology Codes; CPT Codes; Cellular Phone; smartphone; smart phone; iPhone; Cellular Telephone; Cell Phone; Provider; Detection; Monitor; followed up; follow up; Active Follow-up; follow-up; Cardiac; Healthcare professional; Health Care Professional; Health Professional; cost; Population; novel diagnostics; next generation diagnostics; new diagnostics; prototype; high risk; Biological Markers; biomarker; biologic marker; bio-markers; industry partner; industry partnership; industrial partnership; temporal measurement; time measurement; temporal resolution; improved outcome