SBIR-STTR Award

Innovative, non-invasive, battery-less, disposable cardiac biosensor for hemodynamic monitoring
Award last edited on: 4/3/2022

Sponsored Program
SBIR
Awarding Agency
NIH : NIBIB
Total Award Amount
$225,000
Award Phase
1
Solicitation Topic Code
286
Principal Investigator
Kaustubh Kale

Company Information

AventuSoft LLC

3651 Fau Bouelvard Suite 400
Boca Raton, FL 33431
   (954) 399-3335
   info@aventusoft.com
   www.aventusoft.com
Location: Single
Congr. District: 23
County: Palm Beach

Phase I

Contract Number: 1R43EB029884-01A1
Start Date: 9/20/2021    Completed: 3/19/2022
Phase I year
2021
Phase I Amount
$225,000
This SBIR Phase I project will design and develop an innovative, miniature, battery-less, disposable cardiacbiosensor, to provide easy home assessment of heart and lung function. The biosensor will deliver comparablehemodynamic measurements to the gold standard assessments. Economic impetus has led to early dischargeof complex and elderly patients with cardiovascular disease. Older adults discharged from hospitals followingdiagnoses of congestive heart failure exacerbation, myocardial infarction, coronary artery bypass graftingsurgery or other high-risk cardiac procedures are at higher risk for re-hospitalizations and increased mortalityresulting from gaps in care following hospital discharge. The assessment solutions available for patientmonitoring at home, namely, blood pressure, weight, electrocardiograms, have not demonstrated reduction inreadmission for any reason or death of any causes after discharge. Invasive implant devices, such asCardioMEMS, have demonstrated that hemodynamic measurements allow more effective management leadingto fewer hospitalizations and lower deaths. Thus, aging adults are in need of reliable, robust, safe (non-invasive),and simple technologies that can provide hemodynamic assessment post hospitalization. There is need formeaningful interventions through a phone consultation or outpatient primary care visits that reduce re-admissionsand mortality. Using this SBIRs technology, it will be possible for a patient to have access to gold standardhemodynamic measurements, through an integrated, wearable, battery-less, cardiac biosensor. The biosensor'sdata can be read with a smart phone using secure near field communication, enabling patients and their healthcare providers to have easy access to their hemodynamic measurements via a smartphone application. Earlyobjective measurements of hemodynamic changes will lead to early and prompt outpatient interventions. Thiswill improve the quality of life for individuals with chronic cardiovascular conditions enabling them to remain athome longer. We have a multidisciplinary team of scientists and practice stakeholders who will work together todevelop and test the conceptual model that will be applicable across diverse patient populations. The overallgoal of this project it to demonstrate that new technology can meaningfully accommodate the needs of olderadults and address their unique problems and challenges. For the first time there will be a biosensor that trulyaddresses the market need of an un-obstructive, non-invasive, accurate, absolute and actionable system forpost-discharge use at home. This will facilitate close self-monitoring and outpatient monitoring of our mostvulnerable patients, while maintaining close supervision by the health care teams. This battery-less, disposablebiosensor technology for providing in-depth hemodynamics has additional far reaching benefits. Such a devicedoes not exist today thus opening up numerous commercial possibilities.

Public Health Relevance Statement:
8. PROJECT NARRATIVE Overall this project provides direct relevance to public health by facilitating new insights through the development of an innovative wireless, battery-less, disposable cardiac biosensor useful for self- monitoring by ageing adult individuals at home. The novel device will significantly impact the current known methods for detection, monitoring, of heart and lung function, and support evidence-based clinical practice. The device will have great potential for many other etiologies as well.

Project Terms:
Adhesives ; Adult ; 21+ years old ; Adult Human ; adulthood ; Elderly ; advanced age ; elders ; geriatric ; late life ; later life ; older adult ; older person ; senior citizen ; Aging ; Algorithms ; Blood ; Blood Reticuloendothelial System ; Blood Pressure ; Cardiovascular Diseases ; cardiovascular disorder ; Cardiovascular system ; Cardiovascular ; Cardiovascular Body System ; Cardiovascular Organ System ; Heart Vascular ; circulatory system ; Communication ; Consultations ; Coronary Artery Bypass ; Aortocoronary Bypass ; Coronary Artery Bypass Grafting ; Coronary Artery Bypass Surgery ; coronary bypass ; Cessation of life ; Death ; Diagnosis ; Echocardiography ; Echocardiogram ; Transthoracic Echocardiography ; heart sonography ; Economics ; Education ; Educational aspects ; Electrocardiogram ; ECG ; EKG ; Electrocardiography ; Environment ; Goals ; Gold ; Health Personnel ; Health Care Providers ; Healthcare Providers ; Healthcare worker ; health care personnel ; health care worker ; health provider ; health workforce ; healthcare personnel ; medical personnel ; treatment provider ; Heart ; Congestive Heart Failure ; Cardiac Failure Congestive ; Heart Decompensation ; chronic heart failure ; Heart Rate ; Cardiac Chronotropism ; Heart Valves ; Cardiac Valves ; hemodynamics ; Hospitalization ; Hospital Admission ; Hospitals ; Human ; Modern Man ; implantable device ; biomedical implant ; implant device ; indwelling device ; Lead ; Pb element ; heavy metal Pb ; heavy metal lead ; Lung ; Lung Respiratory System ; pulmonary ; Medical Device Designs ; mortality ; Myocardial Infarction ; Cardiac infarction ; Myocardial Infarct ; cardiac infarct ; coronary attack ; coronary infarct ; coronary infarction ; heart attack ; heart infarct ; heart infarction ; Outpatients ; Out-patients ; Legal patent ; Patents ; Patient Education ; Patient Instruction ; Patient Training ; Patient Monitoring ; Patients ; pressure ; Primary Health Care ; Primary Care ; Primary Healthcare ; Public Health ; Pulmonary artery structure ; Pulmonary Artery ; Quality of life ; QOL ; Radio communications ; Signal Transduction ; Cell Communication and Signaling ; Cell Signaling ; Intracellular Communication and Signaling ; Signal Transduction Systems ; Signaling ; biological signal transduction ; Computer software ; Software ; Sternum ; Supervision ; Tachycardia ; Technology ; Telephone ; Phone ; Testing ; Time ; Weight ; Work ; Measures ; Healthcare ; health care ; Medical Care Team ; Health Care Team ; Healthcare Team ; Caring ; base ; improved ; Procedures ; Left ; Chronic ; Phase ; Medical ; Ensure ; pulmonary function ; lung function ; heart function ; cardiac function ; function of the heart ; insight ; Individual ; Recovery ; Measurement ; Ambulatory Monitoring ; Outpatient Monitoring ; lightweight ; light weight ; Companions ; Scientist ; Bradycardia ; Complex ; Event ; System ; non-compliant ; noncompliance ; noncompliant ; non-compliance ; vibration ; Operative Procedures ; Surgical ; Surgical Interventions ; Surgical Procedure ; surgery ; Operative Surgical Procedures ; Visit ; empowered ; hospital re-admission ; re-admission ; re-hospitalization ; readmission ; rehospitalization ; hospital readmission ; biological sensor ; Biosensor ; HIPAA ; Kennedy Kassebaum Act ; PL 104-191 ; PL104-191 ; Public Law 104-191 ; United States Health Insurance Portability and Accountability Act ; Health Insurance Portability and Accountability Act ; novel ; novel technologies ; new technology ; Devices ; Reporting ; Congestive ; Modeling ; time interval ; portability ; Intervention Strategies ; interventional strategy ; Intervention ; Skin ; Cell Phone ; Cellular Telephone ; iPhone ; smart phone ; smartphone ; Cellular Phone ; Diameter ; Caliber ; Causality ; causation ; disease causation ; Etiology ; Address ; Data ; Harvest ; Reader ; Small Business Innovation Research Grant ; SBIR ; Small Business Innovation Research ; Validation ; Wireless Technology ; wireless ; Monitor ; trend ; Ventricular ; Cardiac ; Development ; developmental ; design ; designing ; older patient ; elderly patient ; innovation ; innovate ; innovative ; multidisciplinary ; prototype ; high risk ; evidence base ; patient population ; clinical practice ; Secure ; radio frequency ; radiofrequency ; Heart Abnormalities ; Cardiac Abnormalities ; Cardiac Malformation ; Cardiac defect ; Heart Malformation ; heart defect ; Accelerometer ; accelerometry ; activity monitor ; activity tracker ; Android ; dashboard ; smartphone Application ; Android App ; Android Application ; Cell Phone Application ; Cell phone App ; Cellular Phone App ; Cellular Phone Application ; Smart Phone App ; Smart Phone Application ; Smartphone App ; iOS app ; iOS application ; iPhone App ; iPhone Application ; smart watch ; smartwatch ; care providers ; primary care provider ; detection method ; detection procedure ; detection technique ; Data Store ; Home ;

Phase II

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