2322197
Project Grant
Overview
Grant Description
Sbir Phase I: Novel Self-Closing, Transcatheter, Edge-To-Edge Repair Device to Percutanously Treat Tricuspid Valve Regurgitation Using Jugular or Femoral Vein Access -this small business innovation research (SBIR) phase I project develops a novel medical device enabling minimally invasive surgical revision and repair of the tricuspid valve.
More than 1.6 million patients in the U.S. suffer from moderate to severe tricuspid valve regurgitation (TR) resulting in a market-size exceeding $2.4 billion by 2028. The prevalence of this repair increases with age, with women over 4 times more likely to be affected with TR than men.
There are no food and drug administration (FDA)-approved percutaneous devices for TR treatment. Isolated TR surgery is rarely performed due to the inherent risks associated with major surgery with post-operative complications resulting in high morbidity and mortality rates of 36.1% among severe TR patients.
Hence, only about 8,000 of all U.S. patients with moderate to severe TR currently receive surgical treatment. This small business innovation research (SBIR) phase I project develops a novel, percutaneous, catheter-based device and procedure for surgically revising the tricuspid valve in patients suffering from tricuspid regurgitation (TR).
The tricuspid valve is the largest of the four heart valves presenting unique challenges due to its complex anatomy including 3 thin leaflets and location. The valve is difficult to access using traditional femoral vein access.
This project aims to provide a novel, low-profile catheter and implant device via the jugular vein. The phase I objectives include demonstrating the ability to grasp valve leaflets, validating the design using a benchtop model simulating human conditions, further designing, developing and validating an animal model, and performing a transcatheter tricuspid edge-to-edge repair (T-TEER) procedure via the jugular vein in a lab setting.
The results from the technology development, bench testing, and preclinical models will further the system towards eventual 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 not planned for this award.
More than 1.6 million patients in the U.S. suffer from moderate to severe tricuspid valve regurgitation (TR) resulting in a market-size exceeding $2.4 billion by 2028. The prevalence of this repair increases with age, with women over 4 times more likely to be affected with TR than men.
There are no food and drug administration (FDA)-approved percutaneous devices for TR treatment. Isolated TR surgery is rarely performed due to the inherent risks associated with major surgery with post-operative complications resulting in high morbidity and mortality rates of 36.1% among severe TR patients.
Hence, only about 8,000 of all U.S. patients with moderate to severe TR currently receive surgical treatment. This small business innovation research (SBIR) phase I project develops a novel, percutaneous, catheter-based device and procedure for surgically revising the tricuspid valve in patients suffering from tricuspid regurgitation (TR).
The tricuspid valve is the largest of the four heart valves presenting unique challenges due to its complex anatomy including 3 thin leaflets and location. The valve is difficult to access using traditional femoral vein access.
This project aims to provide a novel, low-profile catheter and implant device via the jugular vein. The phase I objectives include demonstrating the ability to grasp valve leaflets, validating the design using a benchtop model simulating human conditions, further designing, developing and validating an animal model, and performing a transcatheter tricuspid edge-to-edge repair (T-TEER) procedure via the jugular vein in a lab setting.
The results from the technology development, bench testing, and preclinical models will further the system towards eventual 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 not planned for this award.
Awardee
Funding Goals
THE GOAL OF THIS FUNDING OPPORTUNITY, "NSF SMALL BUSINESS INNOVATION RESEARCH (SBIR)/ SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAMS PHASE I", IS IDENTIFIED IN THE LINK: HTTPS://WWW.NSF.GOV/PUBLICATIONS/PUB_SUMM.JSP?ODS_KEY=NSF23515
Grant Program (CFDA)
Awarding / Funding Agency
Place of Performance
Newark,
California
94560-7311
United States
Geographic Scope
Single Zip Code
Medfree was awarded
Project Grant 2322197
worth $275,000
from National Science Foundation in January 2024 with work to be completed primarily in Newark California United States.
The grant
has a duration of 1 year and
was awarded through assistance program 47.084 NSF Technology, Innovation, and Partnerships.
The Project Grant was awarded through grant opportunity NSF Small Business Innovation Research / Small Business Technology Transfer Phase I Programs.
SBIR Details
Research Type
SBIR Phase I
Title
SBIR Phase I: Novel Self-Closing, Transcatheter, Edge-to-Edge Repair Device to Percutaneously Treat Tricuspid Valve Regurgitation Using Jugular or Femoral Vein Access
Abstract
This Small Business Innovation Research (SBIR) Phase I project develops a novel medical device enabling minimally invasive surgical revision and repair of the tricuspid valve. More than 1.6 million patients in the U.S. suffer from moderate to severe tricuspid valve regurgitation (TR) resulting in a market-size exceeding $2.4 billion by 2028. The prevalence of this repair increases with age, with women over 4 times more likely to be affected with TR than men. There are no Food and Drug Administration (FDA)-approved percutaneous devices for TR treatment. Isolated TR surgery is rarely performed due to the inherent risks associated with major surgery with post-operative complications resulting in high morbidity and mortality rates of 36.1% among severe TR patients. Hence, only about 8,000 of all U.S. patients with moderate to severe TR currently receive surgical treatment.
This Small Business Innovation Research (SBIR) Phase I project develops a novel, percutaneous, catheter-based device and procedure for surgically revising the tricuspid Valve in patients suffering from Tricuspid Regurgitation (TR). The tricuspid valve is the largest of the four heart valves presenting unique challenges due to its complex anatomy including 3 thin leaflets and location. The valve is difficult to access using traditional femoral vein access. This project aims to provide a novel, low-profile catheter and implant device via the jugular vein. The Phase I objectives include demonstrating the ability to grasp valve leaflets, validating the design using a benchtop model simulating human conditions, further designing, developing and validating an animal model, and performing a transcatheter tricuspid edge-to-edge repair (t-TEER) procedure via the jugular vein in a lab setting. The results from the technology development, bench testing. and preclinical models will further the system towards eventual 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
MD
Solicitation Number
NSF 23-515
Status
(Complete)
Last Modified 1/21/24
Period of Performance
1/15/24
Start Date
12/31/24
End Date
Funding Split
$275.0K
Federal Obligation
$0.0
Non-Federal Obligation
$275.0K
Total Obligated
Activity Timeline
Additional Detail
Award ID FAIN
2322197
SAI Number
None
Award ID URI
SAI EXEMPT
Awardee Classifications
Private Institution Of Higher Education
Awarding Office
491503 TRANSLATIONAL IMPACTS
Funding Office
491503 TRANSLATIONAL IMPACTS
Awardee UEI
R4V7MLYWDUN5
Awardee CAGE
7XAX6
Performance District
CA-17
Senators
Dianne Feinstein
Alejandro Padilla
Alejandro Padilla
Modified: 1/21/24