Safety and Efficacy of NTX-001 Compared to SOC in Acute Single Peripheral Nerve Injuries

Phase 2a, Multicenter, Randomized, Patient and Evaluator Blinded, Controlled Study Evaluating the Safety and Efficacy of NTX-001 Compared to SOC in the Treatment of Acute Single Transected Peripheral Nerve Injury Occurring Below the Distal Border of the Brachial Plexus Requiring Surgical Repair.

NTX-001 is a single use surgical product intended for use in conjunction with standard suture neurorrhaphy of severed nerves in patients between 16 and 80 years of age.

NTX-001 (Product) is a surgical product that consists of an active solution (drug), an isolation chamber medical device (chamber or device) and two (2) other sterile solutions.

NTX-001 has been developed as a surgical product to be used in conjunction with standard suture neurorrhaphy of a severed nerve. Use of NTX-001 is intended to safely accelerate the often slow and diminished return of function in repaired nerves. It often takes months and/or years to determine if function will be restored. By that point, restoration is often incomplete and can result in lifelong motor and/or sensory deficits. By reconnecting (PEG-fusion) a substantial number of axons within a severed nerve, the degeneration-regeneration cycle and subsequent atrophy may be reduced or even prevented for those axons and their targets, respectively. NTX-001 (PEG-fusion) has the potential to avoid the consequences of protracted denervation of distal target tissues by eliminating the period of total denervation thus reducing the time to stable recovery and providing greater innervation to affected tissues.

Inclusion Criteria:

• The subject is at least 12 years of age and not older than 80.
• The subject has sustained a confirmed (intra-op assessment) single transected peripheral nerve injury.
• The subject's nerve injury is classified as Sunderland's Fourth and Fifth Degree (Class III)
• The subject's nerve injury is amenable to minimal or acceptable tension, in direct, end-to-end repair.
• The surgical repair will occur within 48 hours of injury.

Exclusion Criteria:

• The subject has a PNI with a segmental loss (gap) that cannot be repaired with minimal or acceptable tension.
• Other treatments known to affect the growth and/or physiology of the neural and vascular system.
• The nerve injury has vascular damage that cannot be repaired to provide adequate perfusion of the injured site.
• The subject is pregnant and/or is breastfeeding.
• The subject has a significant medical comorbidity precluding immediate repair.