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Processed Nerve Allograft · 1 trial · 1 indication
Static two-point discrimination (s2PD) is measured by a blinded assessor using a standardized discriminator tool that measures the innervation density and the subject's ability to discern between a single point and two distinct points between 2mm (best case scenario value possible) and 15mm. The failure to respond to stimulus was pre-defined as the worst case scenario value possible (16mm). Missing or incomplete assessments were imputed as the worst case scenario value possible (16mm). Missing or incomplete data was extrapolated using a pre-defined repeated measures mixed modeling approach for calculations in this analysis. This analysis was completed on the Per Protocol population, defined as subjects with at least 6 months follow-up and no major protocol violations.
s2PD is measured by a blinded assessor using a standardized discriminator tool that measures the innervation density and the subject's ability to discern between a single point and two distinct points between 2mm (best case scenario value possible) and 15mm. The failure to respond to stimulus was pre-defined as the worst case scenario value possible (16mm). Missing or incomplete assessments were not imputed. This analysis was completed on the Per Protocol population, defined as subjects with at least 6 months follow-up and no major protocol violations. Data used for this analysis was from 6 months post-surgical follow-up to the date of each subject's latest completed s2PD assessment, whichever came last, assessed up to 12 months.
| Arm | Type | Description |
|---|---|---|
| Processed Nerve Allograft | EXPERIMENTAL | Processed Nerve Allograft |
| Collagen Nerve Cuff | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Processed Nerve Allograft (human) | BIOLOGICAL | - |
| Collagen Nerve Cuff | DEVICE | Bovine collagen based nerve cuff |
Inclusion Criteria: * Peripheral Nerve Injury Exclusion Criteria: * Peripheral Neuropathy * Allergic to Bovine products such as Bovine Collagen Nerve Cuff
Processed Nerve Allograft is used for peripheral nerve discontinuities, which are gaps or injuries in peripheral nerves. It is an investigational therapy being developed to repair these nerve gaps. The product is currently in clinical development and has not been approved by the FDA.
Processed Nerve Allograft is developed by Axogen, Inc., a company traded on the stock exchange under the ticker AXGN. Axogen is conducting clinical trials to evaluate the safety and effectiveness of this therapy for peripheral nerve repair.
Processed Nerve Allograft is in Phase 3 clinical development. It is an investigational product, meaning it has not yet received FDA approval and is still being studied in clinical trials to assess its safety and efficacy for treating peripheral nerve discontinuities.
Processed Nerve Allograft has one completed Phase 3 clinical trial, identified as NCT01809002. This trial compared Processed Nerve Allograft to collagen nerve cuffs for peripheral nerve repair. The study enrolled 220 participants in the United States and was randomized, double-blind, and active-controlled.
Processed Nerve Allograft is a processed nerve graft used to bridge gaps in peripheral nerves. It provides a scaffold that supports nerve regeneration across the injury site. The product is designed to facilitate the repair of peripheral nerve discontinuities by guiding the growth of nerve fibers.