# Development of Tissue Engineered Neuromuscular Interfaces from GalSafe Neurons.

> **NIH NIH R43** · AXONOVA MEDICAL, LLC · 2022 · $250,421

## Abstract

PROJECT SUMMARY
Major peripheral nerve injury (PNI) is classified as an injury with a long defect (≥3cm) or occurring proximally,
requiring long regenerative distances of the host nerve to distal structures (distal nerve, target muscle, etc.).
These features result in minimal, if any, functional regeneration as the distal nerve and muscle often degenerate
before the host nerve is able to reinnervate these structures due to inherently slow regeneration rates. Since
current standard clinical practices delay repairing nerve injuries until the patient (in cases of polytrauma) or the
injury site is stabilized, functional recovery is often extremely limited. In order to maintain the innervation
capability of nerves and muscles following injury, the team at Axonova Medical has developed a proxy for these
degenerating axons to maintain or “babysit” the distal structures until the host axons are able to reinnervate the
distal targets. This product, the tissue engineered neuromuscular interface (TE-NMI), consists of axon tracts
spanning a discrete population of neurons within a hydrogel column. Notably, the diameter of TE-NMIs is
designed to be on the scale of micrometers, making them easily injectable to facilitate incorporation into current
standard of care practices in the clinic. In pre-clinical rodent studies, TE-NMIs have been seen to extend axons
into distal structures post implantation, resulting in babysitting of distal nerve and muscle, therefore keeping it
receptive to eventual host axon reinnervation.
Previously, laboratory-grade TE-NMIs have been fabricated using primary rat and porcine neurons as well as
human induced pluripotent stem cell (iPSC)-derived neurons. In this study, a clinical product will be developed
and characterized using GalSafe® neurons as the starting biomass. GalSafe® tissue is an FDA-approved
xenogeneic source produced by Revivicor, Inc. Revivicor has genetically engineered swine to produce tissue
lacking a carbohydrate, known as -galactosidase, that is known to play a key role in eliciting an immune
response in humans. GalSafe® neurons are harvested from the spinal cords of GalSafe® swine embryo, and is
the chosen biomass for Axonova’s other product, tissue engineered nerve grafts (TENGs). For this proposal,
initial characterization and a preliminary in vivo study to determine the efficacy of TE-NMIs to promote recovery
in a chronic axotomy model in swine will be carried out. Successful execution of these studies will accelerate
preclinical safety and efficacy studies and will be incorporated in Axonova’s IND application. Overall, TE-NMIs
hold promise in transforming the field of nerve repair by significantly increasing the clinical window for PNI repair.

## Key facts

- **NIH application ID:** 10385405
- **Project number:** 1R43NS125892-01
- **Recipient organization:** AXONOVA MEDICAL, LLC
- **Principal Investigator:** Kritika Katiyar
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $250,421
- **Award type:** 1
- **Project period:** 2022-01-15 → 2023-12-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10385405

## Citation

> US National Institutes of Health, RePORTER application 10385405, Development of Tissue Engineered Neuromuscular Interfaces from GalSafe Neurons. (1R43NS125892-01). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10385405. Licensed CC0.

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