2304269
Cooperative Agreement
Overview
Grant Description
SBIR PHASE II: A NOVEL SUTURING DEVICE -The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is to improve outcomes following orthopedic soft tissue surgeries through the development of a novel stitching technology. Effective stitching is essential for successful outcomes in ligament and tendon surgery. These surgeries require specialized and technically complex stitch techniques and are performed on a regular and routine basis.
More than 1 million ligament and tendon surgeries are performed in the United States each year, with 7.5% requiring one or more revisions due to graft or stitching issues. This innovation utilizes a two-part needle technology in order to improve surgical consistency and reduce surgical times needed for each procedure. The design enables surgical stitching in a novel manner to enable a multitude of patterns based on the individual needs, while reducing the need for surgical revisions by nearly 2/3 and time needed to perform each procedure by 1/3.
This Small Business Innovation Research (SBIR) Phase II project furthers research and development of a novel suturing device for orthopedic ligament and tendon surgical procedures. The two-part needle design is based on integrated knot designs and is used to increase fastening mechanical integrity while reducing surgical variability and durations. The first technical milestone includes design optimization and validation to demonstrate system superiority over the current clinical standard across various anatomies and procedures (ankle, elbow, and knee).
Biomechanical and cadaver models will be indicative of procedural success. The second milestone will develop and test several new embodiments (size and shape) for enabling wider adoption, using a similar methodology. The new design aims to enable system use for new procedures that are currently inaccessible with the current single part needle design configuration. 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.
More than 1 million ligament and tendon surgeries are performed in the United States each year, with 7.5% requiring one or more revisions due to graft or stitching issues. This innovation utilizes a two-part needle technology in order to improve surgical consistency and reduce surgical times needed for each procedure. The design enables surgical stitching in a novel manner to enable a multitude of patterns based on the individual needs, while reducing the need for surgical revisions by nearly 2/3 and time needed to perform each procedure by 1/3.
This Small Business Innovation Research (SBIR) Phase II project furthers research and development of a novel suturing device for orthopedic ligament and tendon surgical procedures. The two-part needle design is based on integrated knot designs and is used to increase fastening mechanical integrity while reducing surgical variability and durations. The first technical milestone includes design optimization and validation to demonstrate system superiority over the current clinical standard across various anatomies and procedures (ankle, elbow, and knee).
Biomechanical and cadaver models will be indicative of procedural success. The second milestone will develop and test several new embodiments (size and shape) for enabling wider adoption, using a similar methodology. The new design aims to enable system use for new procedures that are currently inaccessible with the current single part needle design configuration. 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 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=NSF22552
Grant Program (CFDA)
Awarding / Funding Agency
Place of Performance
Knoxville,
Tennessee
37996-0001
United States
Geographic Scope
Single Zip Code
Related Opportunity
22-552
Winter Innovations was awarded
Cooperative Agreement 2304269
worth $1,000,000
from National Science Foundation in November 2023 with work to be completed primarily in Knoxville Tennessee United States.
The grant
has a duration of 2 years and
was awarded through assistance program 47.084 NSF Technology, Innovation, and Partnerships.
SBIR Details
Research Type
SBIR Phase II
Title
SBIR Phase II: A Novel Suturing Device
Abstract
The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is to improve outcomes following orthopedic soft tissue surgeries through the development of a novel stitching technology. Effective stitching is essential for successful outcomes in ligament and tendon surgery. These surgeries require specialized and technically complex stitch techniques and are performed on a regular and routine basis. More than 1 million ligament and tendon surgeries are performed in the United States each year, with 7.5% requiring one or more revisions due to graft or stitching issues. This innovation utilizes a two-part needle technology in order to improve surgical consistency and reduce surgical times needed for each procedure. The design enables surgical stitching in a novel manner to enable a multitude of patterns based on the individual needs, while reducing the need for surgical revisions by nearly 2/3 and time needed to perform each procedure by 1/3.
This Small Business Innovation Research (SBIR) Phase II project furthers research and development of a novel suturing device for orthopedic ligament and tendon surgical procedures. The two-part needle design is based on integrated knot designs and is used to increase fastening mechanical integrity while reducing surgical variability and durations. The first technical milestone includes design optimization and validation to demonstrate system superiority over the current clinical standard across various anatomies and procedures (ankle, elbow, and knee). Biomechanical and cadaver models will be indicative of procedural success. The second milestone will develop and test several new embodiments (size and shape) for enabling wider adoption, using a similar methodology. The new design aims to enable system use for new procedures that are currently inaccessible with the current single part needle design configuration.
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 22-552
Status
(Ongoing)
Last Modified 11/22/23
Period of Performance
11/15/23
Start Date
10/31/25
End Date
Funding Split
$1.0M
Federal Obligation
$0.0
Non-Federal Obligation
$1.0M
Total Obligated
Activity Timeline
Additional Detail
Award ID FAIN
2304269
SAI Number
None
Award ID URI
SAI EXEMPT
Awardee Classifications
Small Business
Awarding Office
491503 TRANSLATIONAL IMPACTS
Funding Office
491503 TRANSLATIONAL IMPACTS
Awardee UEI
HN59XB7N2JE5
Awardee CAGE
8RTW6
Performance District
TN-02
Senators
Marsha Blackburn
Bill Hagerty
Bill Hagerty
Modified: 11/22/23