The proposed use of NTX-001 for transections of upper extremity and facial peripheralnerves, acutely or planned.
For this expanded access program, there is a case-by-case internal review process
conducted by Neuraptive after the respective investigator provides a prospective case
narrative for enrollment consideration.
Allowed Sunderland Classifications are IV degree (Seddon's Class II) and V degree
(Seddon's Class III). If the case is approved, the investigator can move forward.
Patients who are between twelve (12) and eighty (80) years of age and has clinical
evidence of a peripheral nerve transection from conditions or interventions that has or
may result in motor and/or sensory impairment and require surgical treatment. All
peripheral nerve repairs including gap repairs (autografts) will be considered for
enrollment.
Combination Product: NTX-001
One-time use surgical product of three solutions and a device
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.
Orlando Health Orthopedic Institute
Orlando, Florida, United States
Investigator: Karan A Desai, MD
Contact: 321-843-5851
Karan.Desai@orlandohealth.com
Seth Schulman, MD
617-416-4520
seth.schulman@neuraptive.com
Anna Dodds, BS
724-991-4431
anna.dodds@neuraptive.com