NTX-001 to Repair Peripheral Nerve Transection(s)

Inclusion Criteria

• •Inclusion:
• •1\. The patient has clinical evidence of a peripheral nerve transection from conditions or interventions that has or may result in motor and/or sensory impairment and requires surgical treatment.
• •Exclusion:
• •1. Patients whose nerve repair will occur greater than 48 hours after nerve transection.
• •2. Patients requiring repair of the intracranial portion of any nerve.
• •3. Patients requiring a nerve repair involving an allograft or conduit.
• •4. Patients expected to show signs of spontaneous recovery by 12 months (e.g., Bell's palsy).
• •5. Patients who, in the judgement of the investigator, are not likely to demonstrate meaningful recovery within a reasonable time frame during follow-up due to significant muscle atrophy or other morbidity.
• •6. The patient has documented history or clinical signs of any condition where NTX-001 might not prove beneficial (e.g., systemic neuromuscular disease, systemic neurological deficit, or other treatments known to affect the growth and/or physiology of the neural and vascular system).
• •7. The patient has a known allergy to polyethylene glycol (PEG) or human grade silicone.