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2322411

Project Grant

Overview

Grant Description
SBIR Phase I: Design and development of minimally-invasive orthopedic fracture fixation using intramedullary sleeve and injectable, light-triggered bone cement - The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project addresses the current challenges associated with an increase in the incidence of orthopedic injuries and surgeries.

The technology will stabilize and repair broken bones in the US and globally. Trauma, degenerative bone diseases, and bone tumors often result in broken bones that require a procedure called intramedullary nailing. Intramedullary nailing involves nailing metallic implants to bones stabilize bone fractures. This procedure often results in complications such as infection, rotated limbs, and failure to achieve complete rigidity, which may eventually lead to patient discomfort and significantly increased costs due to revision surgeries.

Consequently, there is an urgent need for an intramedullary nail technology that is less invasive, cost effective, and customizable to the patient's anatomical requirements to enable improved bone fracture healing and avoid burdensome revision surgeries. When additional corrective surgery is required to treat any post-operative infections or surgical placement mistakes, the implant removal should be less invasive and not cause any additional morbidity. There are currently no such proven technologies available that meet the above criteria.

This project will primarily focus on the development of an intramedullary (IM) sleeve system with an in situ, photocurable, and removable polymeric resin system. There are four main objectives: 1) design and development of a multi-layered IM sleeve prototype, 2) synthesis and optimization of an in situ photopolymerizable polymeric resin system in the IM sleeve, 3) removal of the cured polymeric resin system from the IM sleeve using minimally invasive tools and methods, and 4) in vitro, in vivo biocompatibility, and demonstration of the customized IM prototype device in a sheep cadaveric tibia bone.

The research will generate new knowledge in designing and synthesizing a novel polymer formulation with additives that helps in fast setting with improved mechanical properties. The project will also enable extraction of photocured polymers using existing removal technologies. For physicians, this research could result in novel, minimally invasive treatments that could drastically reduce the surgical time and improve the patient recovery times.

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 (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
Awarding / Funding Agency
Place of Performance
Tucson, Arizona 85716-1518 United States
Geographic Scope
Single Zip Code
Medicarbone was awarded Project Grant 2322411 worth $273,563 from National Science Foundation in October 2023 with work to be completed primarily in Tucson Arizona 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:Design and Development of Minimally-Invasive Orthopedic Fracture Fixation Using Intramedullary Sleeve and Injectable, Light-Triggered Bone Cement
Abstract
The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project addresses the current challenges associated with an increase in the incidence of orthopedic injuries and surgeries.The technology will stabilize and repair broken bones in the US and globally. Trauma, degenerative bone diseases, and bone tumors often result in broken bones that require a procedure called intramedullary nailing. Intramedullary nailing involves nailing metallic implants to bones stabilize bone fractures. This procedure often results in complications such as infection, rotated limbs, and failure to achieve complete rigidity, which may eventually lead to patient discomfort and significantly increased costs due to revision surgeries. Consequently, there is an urgent need for an intramedullary nail technology that is less invasive, cost effective, and customizable to the patient’s anatomical requirements to enable improved bone fracture healing and avoid burdensome revision surgeries. When additional corrective surgery is required to treat any post-operative infections or surgical placement mistakes, the implant removal should be less invasive and not cause any additional morbidity. There are currently no such proven technologies available that meet the above criteria._x000D__x000D_ This project will primarily focus on the development of an intramedullary (IM) sleeve system with an in situ, photocurable, and removable polymeric resin system. There are four main objectives: 1) design and development of a multi-layered IM sleeve prototype, 2) synthesis and optimization of am in situ photopolymerizable polymeric resin system in the IM sleeve, 3) removal of the cured polymeric resin system from the IM sleeve using minimally invasive tools and methods, and 4) in vitro, in vivo biocompatibility, and demonstration of the customized IM prototype device in a sheep cadaveric tibia bone. The research will generate new knowledge in designing and synthesizing a novel polymer formulation with additives that helps in fast setting with improved mechanical properties.The project will also enable extraction of photocured polymers using existing removal technologies. For physicians, this research could result in novel, minimally invasive treatments that could drastically reduce the surgical time and improve the patient recovery times._x000D_ _x000D_ 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 23-515

Status
(Complete)

Last Modified 10/6/23

Period of Performance
10/1/23
Start Date
9/30/24
End Date
100% Complete

Funding Split
$273.6K
Federal Obligation
$0.0
Non-Federal Obligation
$273.6K
Total Obligated
100.0% Federal Funding
0.0% Non-Federal Funding

Activity Timeline

Interactive chart of timeline of amendments to 2322411

Additional Detail

Award ID FAIN
2322411
SAI Number
None
Award ID URI
SAI EXEMPT
Awardee Classifications
Small Business
Awarding Office
491503 TRANSLATIONAL IMPACTS
Funding Office
491503 TRANSLATIONAL IMPACTS
Awardee UEI
WFM9DG3MY7L8
Awardee CAGE
8TMC3
Performance District
AZ-07
Senators
Kyrsten Sinema
Mark Kelly

Budget Funding

Federal Account Budget Subfunction Object Class Total Percentage
Research and Related Activities, National Science Foundation (049-0100) General science and basic research Grants, subsidies, and contributions (41.0) $273,563 100%
Modified: 10/6/23