Axonova Medical LLC — Department of Health and Human Services SBIR Phase I: NINDS

Description

ABSTRACT Peripheral nerve injuryPNIis a common consequence of trauma or surgeryand the extent of functional recovery is often unsatisfactoryMoreovera particular challenge is the repair ofmajorPNIdefined as injuries where a large segment of a nerve is losti eandgtcmor more proximal injuriese gbrachial plexus or upper armthat necessitate extremely long distances for axonal regeneration to distal end targetse ghandPatients who experience major PNI face the high probability of a significant residual functional deficiteven following state of the art surgical reconstructionTo address this gap in careAxonova Medical has developed a revolutionary approach using tissue engineered nerve graftsTENGsTENGs are living three dimensional nerve constructs that consist of longitudinally aligned axonal tracts spanning discrete neuronal populationsIn rat and pig models of PNIwe have shown that allogeneic TENGs can circumvent the key limitations of current reconstructive strategiesnotably the ability toaccelerate and direct axon regeneration across the zone of injuryandsustain the regenerative environment of distal nerve structures and receptiveness of target muscles to enable host axons to reinnervate long distance targetsNotablyin an exciting recent studywe found that TENGs serve as aliving scaffoldto promote rapid nerve regeneration and functional restoration in an extremely challenging major nerve gapcmmodel in pigsThe scope of the current proposal is to translate our preclinical protocols to create TENGs using a starting biomass suitable for eventual clinical testing in humansThrough a partnership with RevivicorAxonova will pursue a xenogeneic product development strategy to build TENGs using so calledhumanizedpig neuronsSpecificallyneurons used to generate TENGs will be sourced from Revivicorandapos s custom and proprietary GalSafepigs that are genetically engineered to be non immunogenic when transplanted into humansThese GalSafeTENGs will then be tested in an established xenogeneic PNI repair model using athymicnuderatsand the regenerative efficacy will be compared to benchmarks established using allogeneic TENGsAxonovaandapos s ultimate product will be a combination productGalSafeTENGs encased in a biodegradable wrapthat will be regulated under a Biologics License ApplicationBased on the companyandapos s preclinical dataTENGs not only represent a superior option to current reconstructive strategiesbut a transformativeoff the shelf solution for repair of currently untreatable major PNISuccessful execution of the milestones in this SBIR proposal will accelerate Axonovaandapos s path to clinical testing in humansGalSafeTENGs represent an innovative product and potentially transformative strategy for major PNI repair that can greatly improve the quality of life for hundreds of thousands of patients in the U S alone NARRATIVE Peripheral nerve injuryPNIis a common consequence of trauma or surgeryand the extent of functional recovery is often unsatisfactoryAxonova Medical has developed a revolutionary approach to repair major PNI lesions using tissue engineered nerve grafts that serve as aliving scaffoldto promote rapid nerve regeneration and functional restorationThe scope of the current proposal is to translate our preclinical protocols to create a biological product using a source material suitable for eventual clinical testing in humansAxonovaandapos s tissue engineered nerve grafts represent an innovative product and potentially transformative strategy for major PNI repair that can greatly improve the quality of life for hundreds of thousands of patients in the U S alone