2422766
Cooperative Agreement
Overview
Grant Description
SBIR Phase II: Scalable manufacturing of supramolecular polymers for regenerative medicine.
The broader impact of this Small Business Innovation Research (SBIR) Phase II project is to develop a synthetic bone graft that enables safer, simpler, and lower-cost spinal fusion surgery.
The success of this technology would reinforce the United States' competitive advantage and leadership position in the $12B global spinal implant market.
The bone graft implant consists of a novel nanotechnology which introduces a new approach for regenerative medicine.
This technology requires the development of new manufacturing methods, as standard approaches are not sufficient for larger scale production.
This project directly addresses the manufacturing challenges in producing this implant, and the knowledge generated can accelerate the clinical development of other similar therapies.
This project will serve as a model for other novel forms of matter requiring unique manufacturing and processing methods.
Since the technology used in the implant has deep roots in academic research, this project also serves as a model for academia-industry collaboration.
The proposed project will develop methods for manufacturing a new spine implant technology at large scales, which will enable its translation to clinical trials.
First, the active ingredient in the implant, which has novel chemical properties, will be manufactured at large scales in conditions appropriate for use in human patients.
The active ingredient is a supramolecular polymer held together by non-covalent bonds, which are sensitive to manufacturing and processing steps, akin to protein misfolding.
Spectroscopic and microscopy techniques will be used to ensure that the correct structures and function are maintained as manufacturing is scaled up.
Second, the active ingredient will be combined with other supporting materials to create a formulation that surgeons can easily handle and place into the spine.
Manufacturing methods will be developed to address the challenge of processing and freeze-drying viscous solutions at large scale.
Furthermore, the biocompatibility of the spine implants will be established to ensure the manufacturing methods are safe for human use.
The final deliverable of this project is a packaged and sterilized implant, manufactured at scale and under conditions appropriate for clinical use in humans.
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 of this Small Business Innovation Research (SBIR) Phase II project is to develop a synthetic bone graft that enables safer, simpler, and lower-cost spinal fusion surgery.
The success of this technology would reinforce the United States' competitive advantage and leadership position in the $12B global spinal implant market.
The bone graft implant consists of a novel nanotechnology which introduces a new approach for regenerative medicine.
This technology requires the development of new manufacturing methods, as standard approaches are not sufficient for larger scale production.
This project directly addresses the manufacturing challenges in producing this implant, and the knowledge generated can accelerate the clinical development of other similar therapies.
This project will serve as a model for other novel forms of matter requiring unique manufacturing and processing methods.
Since the technology used in the implant has deep roots in academic research, this project also serves as a model for academia-industry collaboration.
The proposed project will develop methods for manufacturing a new spine implant technology at large scales, which will enable its translation to clinical trials.
First, the active ingredient in the implant, which has novel chemical properties, will be manufactured at large scales in conditions appropriate for use in human patients.
The active ingredient is a supramolecular polymer held together by non-covalent bonds, which are sensitive to manufacturing and processing steps, akin to protein misfolding.
Spectroscopic and microscopy techniques will be used to ensure that the correct structures and function are maintained as manufacturing is scaled up.
Second, the active ingredient will be combined with other supporting materials to create a formulation that surgeons can easily handle and place into the spine.
Manufacturing methods will be developed to address the challenge of processing and freeze-drying viscous solutions at large scale.
Furthermore, the biocompatibility of the spine implants will be established to ensure the manufacturing methods are safe for human use.
The final deliverable of this project is a packaged and sterilized implant, manufactured at scale and under conditions appropriate for clinical use in humans.
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
Chicago,
Illinois
60607-1156
United States
Geographic Scope
Single Zip Code
Amphix Bio was awarded
Cooperative Agreement 2422766
worth $1,000,000
from National Science Foundation in September 2024 with work to be completed primarily in Chicago Illinois 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: Scalable Manufacturing of Supramolecular Polymers for Regenerative Medicine
Abstract
The broader impact of this Small Business Innovation Research (SBIR) Phase II project is to develop a synthetic bone graft that enables safer, simpler, and lower-cost spinal fusion surgery. The success of this technology would reinforce the United States’ competitive advantage and leadership position in the $12B global spinal implant market. The bone graft implant consists of a novel nanotechnology which introduces a new approach for regenerative medicine. This technology requires the development of new manufacturing methods, as standard approaches are not sufficient for larger scale production. This project directly addresses the manufacturing challenges in producing this implant, and the knowledge generated can accelerate the clinical development of other similar therapies. This project will serve as a model for other novel forms of matter requiring unique manufacturing and processing methods. Since the technology used in the implant has deep roots in academic research, this project also serves as a model for academia-industry collaboration.
The proposed project will develop methods for manufacturing a new spine implant technology at large scales, which will enable its translation to clinical trials. First, the active ingredient in the implant, which has novel chemical properties, will be manufactured at large scales in conditions appropriate for use in human patients. The active ingredient is a supramolecular polymer held together by non-covalent bonds, which are sensitive to manufacturing and processing steps, akin to protein misfolding. Spectroscopic and microscopy techniques will be used to ensure that the correct structures and function are maintained as manufacturing is scaled up. Second, the active ingredient will be combined with other supporting materials to create a formulation that surgeons can easily handle and place into the spine. Manufacturing methods will be developed to address the challenge of processing and freeze-drying viscous solutions at large scale. Furthermore, the biocompatibility of the spine implants will be established to ensure the manufacturing methods are safe for human use. The final deliverable of this project is a packaged and sterilized implant, manufactured at scale and under conditions appropriate for clinical use in humans.
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
PT
Solicitation Number
NSF 23-516
Status
(Ongoing)
Last Modified 9/25/24
Period of Performance
9/15/24
Start Date
8/31/26
End Date
Funding Split
$1.0M
Federal Obligation
$0.0
Non-Federal Obligation
$1.0M
Total Obligated
Activity Timeline
Additional Detail
Award ID FAIN
2422766
SAI Number
None
Award ID URI
SAI EXEMPT
Awardee Classifications
Small Business
Awarding Office
491503 TRANSLATIONAL IMPACTS
Funding Office
491503 TRANSLATIONAL IMPACTS
Awardee UEI
G57NNUM46SJ3
Awardee CAGE
8F6R5
Performance District
IL-07
Senators
Richard Durbin
Tammy Duckworth
Tammy Duckworth
Modified: 9/25/24