Recent Updates
Recently added Catalysts

Processed Nerve Allograft

Phase 3

Peripheral Nerve Discontinuities | Monoclonal antibody | Other |Axogen, Inc.|Last Updated: Jul 12, 2023

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment220
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01809002Comparison of Processed Nerve Allograft and Collagen Nerve Cuffs for Peripheral Nerve RepairPHASE3 COMPLETED 220Jun 1, 2015Aug 30, 2021Jul 12, 202321 United States
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Static Two-Point Discrimination (Pre-defined Mixed Modeling Approach)
Month 12

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.

Static Two-Point Discrimination (Data As-reported)
Up to Month 12

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.

Secondary Endpoints
Response Rate for Recovery of s2PD at Month 12 (Data As-Reported)
Month 12
Percent Recovery to Pre-Injury Baseline (Contralateral Control Value) s2PD at Month 12 (Pre-defined Modeling Approach)
Month 12
Time to Recovery of s2PD (Data As-reported)
Assessed at Month 3, Month 6, Month 9, Month 12 (some patients were seen for their 12-month visit up to 15 calendar months post-op)
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Processed Nerve AllograftEXPERIMENTALProcessed Nerve Allograft
Collagen Nerve CuffACTIVE_COMPARATOR -
Interventions
NameTypeDescription
Processed Nerve Allograft (human)BIOLOGICAL -
Collagen Nerve CuffDEVICEBovine collagen based nerve cuff
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites21

Inclusion Criteria: * Peripheral Nerve Injury Exclusion Criteria: * Peripheral Neuropathy * Allergic to Bovine products such as Bovine Collagen Nerve Cuff

Countries:United States
Unlock Eligibility Criteria