2432559
Project Grant
Overview
Grant Description
SBIR Phase I: Innovative actuating smart implant device of transverse tibial transport technology for the treatment of diabetic foot ulcers.
The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is a novel implantable therapy paradigm for initiating autologous healing in patients suffering from diabetic foot ulcers (DFUs).
Severe DFUs can result in amputations, resulting in loss of limb and subsequent decline in their quality of life.
The novel proposed treatment paradigm of transverse tibia transport (TTT) aims to stimulate soft tissue growth to offer a new treatment paradigm to current topical or pharmacological treatments.
The system stimulates patients' regenerative mechanisms needed based on mechanical forces to cause neovascularization and circulation restoration to the diseased limb to heal the ulcer.
This system aims to provide an invasive therapy option for approximately 967K US patients suffering from DFU equating to a total addressable market opportunity of $8 billion.
If successful, the system will be used to treat patients with persistent DFUs, with the future potential of expanding indications to treat less severe DFUs, other ischemic limb diseases, pressure sores, and other common non-healing wounds.
This Small Business Innovation Research Phase I project proposes a novel implantable system which leverages distraction osteogenesis as a treatment for diabetic foot ulcers.
The objectives of this Phase 1 project are to complete the design and development of a low profile implantable transverse tibial transport device integrating an active mechanical mechanism that is to transversely distract or retract a cut tibia bone segment in a programmable manner.
The system will be driven using a novel mechanical actuation system that drives the TTT mechanism using a wireless controller.
The first phase will be the feasibility development and testing of the distraction screw mechanism of the TTT implant device and the second phase is the feasibility development and testing of the actuation hardware platform for the implanted system.
Upon completion, the system will be tested using standard mechanical failure measures suitable for commencing future preclinical validation and 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.
The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is a novel implantable therapy paradigm for initiating autologous healing in patients suffering from diabetic foot ulcers (DFUs).
Severe DFUs can result in amputations, resulting in loss of limb and subsequent decline in their quality of life.
The novel proposed treatment paradigm of transverse tibia transport (TTT) aims to stimulate soft tissue growth to offer a new treatment paradigm to current topical or pharmacological treatments.
The system stimulates patients' regenerative mechanisms needed based on mechanical forces to cause neovascularization and circulation restoration to the diseased limb to heal the ulcer.
This system aims to provide an invasive therapy option for approximately 967K US patients suffering from DFU equating to a total addressable market opportunity of $8 billion.
If successful, the system will be used to treat patients with persistent DFUs, with the future potential of expanding indications to treat less severe DFUs, other ischemic limb diseases, pressure sores, and other common non-healing wounds.
This Small Business Innovation Research Phase I project proposes a novel implantable system which leverages distraction osteogenesis as a treatment for diabetic foot ulcers.
The objectives of this Phase 1 project are to complete the design and development of a low profile implantable transverse tibial transport device integrating an active mechanical mechanism that is to transversely distract or retract a cut tibia bone segment in a programmable manner.
The system will be driven using a novel mechanical actuation system that drives the TTT mechanism using a wireless controller.
The first phase will be the feasibility development and testing of the distraction screw mechanism of the TTT implant device and the second phase is the feasibility development and testing of the actuation hardware platform for the implanted system.
Upon completion, the system will be tested using standard mechanical failure measures suitable for commencing future preclinical validation and 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
Lake Forest,
California
92630-8319
United States
Geographic Scope
Single Zip Code
Related Opportunity
Analysis Notes
Amendment Since initial award the total obligations have increased 7% from $275,000 to $295,000.
Biodynamik was awarded
Project Grant 2432559
worth $295,000
from National Science Foundation in December 2024 with work to be completed primarily in Lake Forest California United States.
The grant
has a duration of 8 months 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: Innovative actuating smart implant device of Transverse Tibial Transport technology for the treatment of Diabetic Foot Ulcers
Abstract
The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is a novel implantable therapy paradigm for initiating autologous healing in patients suffering from Diabetic Foot Ulcers (DFUs). Severe DFU’s can result in amputations, resulting in loss of limb and subsequent decline in their quality of life. The novel proposed treatment paradigm of Transverse Tibia Transport (TTT) aims to stimulate soft tissue growth to offer a new treatment paradigm to current topical or pharmacological treatments. The system stimulates patients' regenerative mechanisms needed based on mechanical forces to cause neovascularization and circulation restoration to the diseased limb to heal the ulcer. This system aims to provide an invasive therapy option for approximately 967k US patients suffering from DFU equating to a total addressable market opportunity of $8Billion. If successful, the system will be used to treat patients with persistent DFU’s, with the future potential of expanding indications to treat less severe DFUs, other ischemic limb diseases, pressure sores and other common non-healing wounds.
This Small Business Innovation Research Phase I project proposes a novel implantable system which leverages distraction osteogenesis as a treatment for diabetic foot ulcers. The objectives of this Phase 1 project are to complete the design and development of a low profile implantable Transverse Tibial Transport device integrating an active mechanical mechanism that is to transversely distract or retract a cut tibia bone segment in a programmable manner. The system will be driven using a novel mechanical actuation system that drives the TTT mechanism using a wireless controller. The first phase will be the feasibility development and testing of the distraction screw mechanism of the TTT implant device and the second phase is the feasibility development and testing of the actuation hardware platform for the implanted system. Upon com
Topic Code
MD
Solicitation Number
NSF 23-515
Status
(Complete)
Last Modified 4/17/25
Period of Performance
12/15/24
Start Date
8/31/25
End Date
Funding Split
$295.0K
Federal Obligation
$0.0
Non-Federal Obligation
$295.0K
Total Obligated
Activity Timeline
Transaction History
Modifications to 2432559
Additional Detail
Award ID FAIN
2432559
SAI Number
None
Award ID URI
SAI EXEMPT
Awardee Classifications
Small Business
Awarding Office
491503 TRANSLATIONAL IMPACTS
Funding Office
491503 TRANSLATIONAL IMPACTS
Awardee UEI
DKNUEG9KJ271
Awardee CAGE
None
Performance District
CA-40
Senators
Dianne Feinstein
Alejandro Padilla
Alejandro Padilla
Modified: 4/17/25