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

> **NIH NIH R41** · PIONEER NEUROTECH INC. · 2024 · $214,532

## Abstract

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.

## Key facts

- **NIH application ID:** 10891347
- **Project number:** 5R41NS130907-02
- **Recipient organization:** PIONEER NEUROTECH INC.
- **Principal Investigator:** Mario Ignacio Romero-Ortega
- **Activity code:** R41 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $214,532
- **Award type:** 5
- **Project period:** 2023-08-01 → 2025-12-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10891347

## Citation

> US National Institutes of Health, RePORTER application 10891347, Controlled Gradient Release of Biologics: Enhanced Nerve Conduit for Long‐Gap Injury Repair (5R41NS130907-02). Retrieved via AI Analytics 2026-06-01 from https://api.ai-analytics.org/grant/nih/10891347. Licensed CC0.

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