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2335105

Cooperative Agreement

Overview

Grant Description
Sbir phase ii: in-vivo validation of a volume-manufacturable and factory-calibrated wearable nt-probnp monitoring system for heart failure treatment -the broader impact/commercial potential of this small business innovation research (SBIR) phase ii project will directly address the growing national economic and individual burden of cardiovascular disease as it becomes a reality for more than half of all americans entering their sixties.

Heart-failure is a cardiovascular disease that is particularly challenging given that many patients end up readmitted to the hospital just months after initial hospitalization. Greatly improved outcomes for patients are already possible, keeping patients from returning to the hospital, but only if the patient treatment can be rapidly optimized for the medications prescribed for heart failure.

This rapid optimization requires multiple trips back to the doctor for blood tests to guide the treatment plan, adjusting patient medication levels accordingly. Cardiologists have therefore been asking for new technologies to aid their ability to care for heart-failure patients, with an increasing call for remote monitoring technology. This small business innovation research (SBIR) phase ii project will create the first-ever wearable, heart-failure monitor for a peptide molecule released by the heart when the heart is struggling, therefore providing a direct and continuous measurement of how well heart-failure treatment is progressing. Specifically, aptamers, which are oligonucleotides, will be used to capture heart-failure peptide molecules on a tiny electrical wire sensor embedded painlessly a few millimeters beneath the skin surface.

As these aptamers capture the peptides, they provide a continuous measurement of the peptide concentrations in the form of an electrical signal. The project will create a working prototype that is like the proven success of wearable continuous glucose monitors, leveraging decades of investment in glucose monitors and significant doctor and patient trust in glucose monitors.

Under the phase ii project, the wearable heart-failure monitor prototype will be validated for more than one week of operation in an animal model, a key proof point that will enable further commercial investment in developing the wearable heart-failure monitor for human use. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the foundation's intellectual merit and broader impacts review criteria.- subawards are planned for this award.
Awardee
Funding Goals
THE GOAL OF THIS FUNDING OPPORTUNITY, "NSF SMALL BUSINESS INNOVATION RESEARCH PHASE II (SBIR)/ SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAMS PHASE II", IS IDENTIFIED IN THE LINK: HTTPS://WWW.NSF.GOV/PUBLICATIONS/PUB_SUMM.JSP?ODS_KEY=NSF23516
Place of Performance
Dayton, Ohio 45419-3545 United States
Geographic Scope
Single Zip Code
Analysis Notes
Amendment Since initial award the total obligations have increased 20% from $999,758 to $1,199,708.
Kilele Health was awarded Cooperative Agreement 2335105 worth $1,199,708 from in March 2024 with work to be completed primarily in Dayton Ohio United States. The grant has a duration of 2 years and was awarded through assistance program 47.084 NSF Technology, Innovation, and Partnerships. The Cooperative Agreement was awarded through grant opportunity NSF Small Business Innovation Research / Small Business Technology Transfer Phase II Programs (SBIR/STTR Phase II).

SBIR Details

Research Type
SBIR Phase II
Title
SBIR Phase II: In-vivo validation of a volume-manufacturable and factory-calibrated wearable NT-proBNP monitoring system for heart failure treatment
Abstract
The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project will directly address the growing national economic and individual burden of cardiovascular disease as it becomes a reality for more than half of all Americans entering their sixties. Heart-failure is a cardiovascular disease that is particularly challenging given that many patients end up readmitted to the hospital just months after initial hospitalization. Greatly improved outcomes for patients are already possible, keeping patients from returning to the hospital, but only if the patient treatment can be rapidly optimized for the medications prescribed for heart failure. This rapid optimization requires multiple trips back to the doctor for blood tests to guide the treatment plan, adjusting patient medication levels accordingly. Cardiologists have therefore been asking for new technologies to aid their ability to care for heart-failure patients, with an increasing call for remote monitoring technology. This Small Business Innovation Research (SBIR) Phase II project will create the first-ever wearable, heart-failure monitor for a peptide molecule released by the heart when the heart is struggling, therefore providing a direct and continuous measurement of how well heart-failure treatment is progressing. Specifically, aptamers, which are oligonucleotides, will be used to capture heart-failure peptide molecules on a tiny electrical wire sensor embedded painlessly a few millimeters beneath the skin surface. As these aptamers capture the peptides, they provide a continuous measurement of the peptide concentrations in the form of an electrical signal. The project will create a working prototype that is like the proven success of wearable continuous glucose monitors, leveraging decades of investment in glucose monitors and significant doctor and patient trust in glucose monitors. Under the Phase II project, the wearable heart-failure monitor prototype will be validated for more than one week of operation in an animal model, a key proof point that will enable further commercial investment in developing the wearable heart-failure monitor for human use. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.
Topic Code
BM
Solicitation Number
NSF 23-516

Status
(Ongoing)

Last Modified 4/4/25

Period of Performance
3/15/24
Start Date
2/28/26
End Date
80.0% Complete

Funding Split
$1.2M
Federal Obligation
$0.0
Non-Federal Obligation
$1.2M
Total Obligated
100.0% Federal Funding
0.0% Non-Federal Funding

Activity Timeline

Interactive chart of timeline of amendments to 2335105

Transaction History

Modifications to 2335105

Additional Detail

Award ID FAIN
2335105
SAI Number
None
Award ID URI
SAI EXEMPT
Awardee Classifications
Small Business
Awarding Office
491503 TRANSLATIONAL IMPACTS
Funding Office
491503 TRANSLATIONAL IMPACTS
Awardee UEI
YYQ9GCP29EA1
Awardee CAGE
None
Performance District
OH-10
Senators
Sherrod Brown
J.D. (James) Vance
Modified: 4/4/25