2321818
Project Grant
Overview
Grant Description
Sbir phase I: treatment of type 2 diabetes through cryoablation of the duodenum -this small business innovation research phase (SBIR) I project is a novel procedural treatment for the 5-10 million people in the U.S. with medical refractory type 2 diabetes. Current treatments require self-management of insulin injections and/or medication, frequent visits to specialists, and a controlled diet.
Patients can fail to achieve optimal glycemic control due to the individual medication dosing requirements, safety, and tolerance limits. Poorly managed patients can suffer from adverse events including heart attack, stroke, nerve damage, blindness, and early death. This duodenal cryoablation system aims to provide an outpatient, minimally invasive procedure for controlled ablation of the duodenum utilizing a standard, cost-effective endoscopic approach.
If successful, the novel therapy will decrease or eliminate insulin and/or medical therapies in patients suffering from medical refractory type 2 diabetes. This SBIR phase I project aims to develop a novel cryoablation system that delivers a highly controlled and targeted cryoablative agent for freezing the duodenum. The system is based on emerging evidence of duodenum remodeling upon ablation resulting in restoration of glucose control and regulation.
The technical engineering milestones include managing high pressures of the cryogenic fluid within extreme dimensions including small luminal diameters and long length, within a unique and tortuous path. A key objective is to produce a system ensuring consistent cryogenic fluid delivery down a small diameter, insulated, long length lumen to a set of sprayers placed in the duodenum.
A second objective is the development of a method of consistent cryogenic fluid distribution through the sprayers to the target tissue. The final objective is the development of bench methods and testing capabilities validating consistent cryogenic fluid delivery. The design will be tested in preclinical models and the harvested tissue evaluated via histopathological analysis for ablation efficacy.
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.
Patients can fail to achieve optimal glycemic control due to the individual medication dosing requirements, safety, and tolerance limits. Poorly managed patients can suffer from adverse events including heart attack, stroke, nerve damage, blindness, and early death. This duodenal cryoablation system aims to provide an outpatient, minimally invasive procedure for controlled ablation of the duodenum utilizing a standard, cost-effective endoscopic approach.
If successful, the novel therapy will decrease or eliminate insulin and/or medical therapies in patients suffering from medical refractory type 2 diabetes. This SBIR phase I project aims to develop a novel cryoablation system that delivers a highly controlled and targeted cryoablative agent for freezing the duodenum. The system is based on emerging evidence of duodenum remodeling upon ablation resulting in restoration of glucose control and regulation.
The technical engineering milestones include managing high pressures of the cryogenic fluid within extreme dimensions including small luminal diameters and long length, within a unique and tortuous path. A key objective is to produce a system ensuring consistent cryogenic fluid delivery down a small diameter, insulated, long length lumen to a set of sprayers placed in the duodenum.
A second objective is the development of a method of consistent cryogenic fluid distribution through the sprayers to the target tissue. The final objective is the development of bench methods and testing capabilities validating consistent cryogenic fluid delivery. The design will be tested in preclinical models and the harvested tissue evaluated via histopathological analysis for ablation efficacy.
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
San Francisco,
California
94112-1227
United States
Geographic Scope
Single Zip Code
Agil Therapeutics was awarded
Project Grant 2321818
worth $275,000
from National Science Foundation in February 2024 with work to be completed primarily in San Francisco 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: Treatment of Type 2 Diabetes through Cryoablation of the Duodenum
Abstract
This Small Business Innovation Research Phase (SBIR) I project is a novel procedural treatment for the 5-10 million people in the U.S. with medical refractory Type 2 Diabetes. Current treatments require self-management of insulin injections and/or medication, frequent visits to specialists, and a controlled diet. Patients can fail to achieve optimal glycemic control due to the individual medication dosing requirements, safety, and tolerance limits. Poorly managed patients can suffer from adverse events including heart attack, stroke, nerve damage, blindness, and early death. This Duodenal Cryoablation system aims to provide an outpatient, minimally invasive procedure for controlled ablation of the duodenum utilizing a standard, cost-effective endoscopic approach. If successful, the novel therapy will decrease or eliminate insulin and/or medical therapies in patients suffering from medical refractory Type 2 Diabetes.
This SBIR Phase I project aims to develop a novel cryoablation system that delivers a highly controlled and targeted cryoablative agent for freezing the duodenum. The system is based on emerging evidence of duodenum remodeling upon ablation resulting in restoration of glucose control and regulation. The technical engineering milestones include managing high pressures of the cryogenic fluid within extreme dimensions including small luminal diameters and long length, within a unique and tortuous path. A key objective is to produce a system ensuring consistent cryogenic fluid delivery down a small diameter, insulated, long length lumen to a set of sprayers placed in the duodenum. A second objective is the development of a method of consistent cryogenic fluid distribution through the sprayers to the target tissue. The final objective is the development of bench methods and testing capabilities validating consistent cryogenic fluid delivery. The design will be tested in preclinical models and the harvested tissue evaluated via histopathological analysis for ablation efficacy.
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 2/7/24
Period of Performance
2/1/24
Start Date
1/31/25
End Date
Funding Split
$275.0K
Federal Obligation
$0.0
Non-Federal Obligation
$275.0K
Total Obligated
Activity Timeline
Additional Detail
Award ID FAIN
2321818
SAI Number
None
Award ID URI
SAI EXEMPT
Awardee Classifications
Small Business
Awarding Office
491503 TRANSLATIONAL IMPACTS
Funding Office
491503 TRANSLATIONAL IMPACTS
Awardee UEI
FK72TXK22CF7
Awardee CAGE
99ZY3
Performance District
CA-11
Senators
Dianne Feinstein
Alejandro Padilla
Alejandro Padilla
Modified: 2/7/24