2332648
Cooperative Agreement
Overview
Grant Description
Sttr phase II: Development of a antibiotic releasing intramedullary nail for treatment of fracture related infections.
The broader impact/commercial potential of this small business technology transfer (STTR) phase II project is a novel implantable orthopedic medical device and procedure to reduce the recovery duration and infection risks associated with severe traumatic fractures of the long bones.
The system aims to reduce existing issues with open fractures that pose incremental risks to the wound and surrounding tissue due to prolonged exposure to the environment.
The system aims to improve the current standard-of-care using metallic plates, screws, and nail implants.
These frequently become colonized by bacteria, and systemic antibiotics are not always effective for preventing or treating fracture related infections.
Effective treatment of fractures and prevention of infectious complications will expedite healing and weight-bearing rehabilitation, and ultimately reduce overall medical care cost.
The device has an estimated market of 24,000 US cases each year and aims to provide a new standard of care for the total $500M annual intramedullary nail market.
This small business technology transfer (STTR) phase II project aims to advance and optimize a novel intramedullary nail providing local antibiotic release at the fracture site.
The proposed work advances the company’s biocompatible 3D printed photoresin embedded within an orthopedic implant that elutes commercially available antibiotic.
During this project the objectives are to complete (1) preliminary mechanical and drug release testing, (2) complete simulated testing of the device and new procedure with orthopedic trauma surgeons in cadavers, (3) develop the manufacturing processes, (4) complete initial safety testing in a preclinical ovine model to demonstrate fracture healing and systemic safety of the antibiotic release.
The success criteria include demonstration of safety and effectiveness through the combined benchtop and preclinical models.
The results will establish the procedural confines, safety profile and systemic release characteristics of local antibiotic delivery.
Upon completion, the company will move to first in human clinical phase to further establish the device's safety and efficacy performance towards the future goal of US regulatory approval.
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.
The broader impact/commercial potential of this small business technology transfer (STTR) phase II project is a novel implantable orthopedic medical device and procedure to reduce the recovery duration and infection risks associated with severe traumatic fractures of the long bones.
The system aims to reduce existing issues with open fractures that pose incremental risks to the wound and surrounding tissue due to prolonged exposure to the environment.
The system aims to improve the current standard-of-care using metallic plates, screws, and nail implants.
These frequently become colonized by bacteria, and systemic antibiotics are not always effective for preventing or treating fracture related infections.
Effective treatment of fractures and prevention of infectious complications will expedite healing and weight-bearing rehabilitation, and ultimately reduce overall medical care cost.
The device has an estimated market of 24,000 US cases each year and aims to provide a new standard of care for the total $500M annual intramedullary nail market.
This small business technology transfer (STTR) phase II project aims to advance and optimize a novel intramedullary nail providing local antibiotic release at the fracture site.
The proposed work advances the company’s biocompatible 3D printed photoresin embedded within an orthopedic implant that elutes commercially available antibiotic.
During this project the objectives are to complete (1) preliminary mechanical and drug release testing, (2) complete simulated testing of the device and new procedure with orthopedic trauma surgeons in cadavers, (3) develop the manufacturing processes, (4) complete initial safety testing in a preclinical ovine model to demonstrate fracture healing and systemic safety of the antibiotic release.
The success criteria include demonstration of safety and effectiveness through the combined benchtop and preclinical models.
The results will establish the procedural confines, safety profile and systemic release characteristics of local antibiotic delivery.
Upon completion, the company will move to first in human clinical phase to further establish the device's safety and efficacy performance towards the future goal of US regulatory approval.
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
Grant Program (CFDA)
Awarding / Funding Agency
Place of Performance
Durham,
North Carolina
27701-3109
United States
Geographic Scope
Single Zip Code
Reselute was awarded
Cooperative Agreement 2332648
worth $998,921
from National Science Foundation in July 2024 with work to be completed primarily in Durham North Carolina 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
STTR Phase II
Title
STTR Phase II: Development of a Antibiotic Releasing Intramedullary Nail for Treatment of Fracture Related Infections
Abstract
The broader impact/commercial potential of this Small Business Technology Transfer (STTR) Phase II project is a novel implantable orthopedic medical device and procedure to reduce the recovery duration and infection risks associated with severe traumatic fractures of the long bones. The system aims to reduce existing issues with open fractures that pose incremental risks to the wound and surrounding tissue due to prolonged exposure to the environment. The system aims to improve the current standard-of-care using metallic plates, screws, and nail implants. These frequently become colonized by bacteria, and systemic antibiotics are not always effective for preventing or treating fracture related infections. Effective treatment of fractures and prevention of infectious complications will expedite healing and weight-bearing rehabilitation, and ultimately reduce overall medical care cost. The device has an estimated market of 24,000 US cases each year and aims to provide a new standard of care for the total $500M annual intramedullary nail market.
This Small Business Technology Transfer (STTR) Phase II project aims to advance and optimize a novel intramedullary nail providing local antibiotic release at the fracture site. The proposed work advances the company’s biocompatible 3D printed photoresin embedded within an orthopedic implant that elutes commercially available antibiotic. During this project the objectives are to complete (1) preliminary mechanical and drug release testing, (2) complete simulated testing of the device and new procedure with orthopedic trauma surgeons in cadavers, (3) develop the manufacturing processes, (4) complete initial safety testing in a preclinical ovine model to demonstrate fracture healing and systemic safety of the antibiotic release. The success criteria include demonstration of safety and effectiveness through the combined benchtop and preclinical models. The results will establish the procedural confines, safety profile and systemic release characteristics of local antibiotic delivery. Upon completion, the company will move to first in human clinical phase to further establish the device's safety and efficacy performance towards the future goal of US regulatory approval.
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 23-516
Status
(Ongoing)
Last Modified 7/23/24
Period of Performance
7/15/24
Start Date
6/30/26
End Date
Funding Split
$998.9K
Federal Obligation
$0.0
Non-Federal Obligation
$998.9K
Total Obligated
Activity Timeline
Additional Detail
Award ID FAIN
2332648
SAI Number
None
Award ID URI
SAI EXEMPT
Awardee Classifications
Small Business
Awarding Office
491503 TRANSLATIONAL IMPACTS
Funding Office
491503 TRANSLATIONAL IMPACTS
Awardee UEI
JBMRHJGSMFD6
Awardee CAGE
91CW5
Performance District
NC-04
Senators
Thom Tillis
Ted Budd
Ted Budd
Modified: 7/23/24