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Controlled Gradient Release of Biologics: Enhanced Nerve Conduit for Long‐Gap Injury Repair

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41NS130907-01
Agency Tracking Number: R41NS130907
Amount: $422,015.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: 106
Solicitation Number: PA21-262
Solicitation Year: 2021
Award Year: 2023
Award Start Date (Proposal Award Date): 2023-08-01
Award End Date (Contract End Date): 2025-07-31
Small Business Information
Sudbury, MA 01776-1360
United States
DUNS: 118584278
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (713) 743-0624
Business Contact
Phone: (617) 752-2475
Research Institution
HOUSTON, TX 77204-2610
United States

 Nonprofit College or University

Project Summary / Abstract
Nerve injuries arising from trauma, disease, or as a surgical necessity, lead most often to permanent loss of
some or all functions mediated by the injured nerves. 50,000 peripheral nerve procedures are performed every
year in the US, and 300,000 across Europe. After complete transection of a nerve, the optimal clinical
procedure for nerve repair remains the surgical end-to-end reattachment of the injured nerve, aligning the ends
into as close to their original apposition as possible and without tension. This approach offers the best
possibility for efficient and effective axonal regeneration and functional recovery. For cases in which there is
damage that results in a gap that is too long for tensionless end-to-end repair, nerve grafts are used to support
the regeneration of axons. The degree of recovery of function with grafts decreases precipitously with
increases in either/both gap-length and the distance from the injury to the target tissues. Treatments that can
enhance the number of axons growing, the speed of their growth, and the gap-length they can span are
needed. The academic PI has identified a combination of growth factors that significantly and clinically-
meaningfully enhances each of these characteristics and can be encapsulated in polymer beads to enable
incorporation into grafts for extended-duration of release. The academic PI has demonstrated efficacy of this
system in a large animal model. This project aims to develop the fabrication procedures for growth factor
encapsulation and impregnation into nerve conduit grafts that could be used clinically. The goals include in
vitro and in vivo assessment of the fabricated grafts to validate that they remain effective. This work is
necessary to determine the commercial viability of the lab-proven technology.

* Information listed above is at the time of submission. *

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