NTX-001 is a single use surgical product intended for use in conjunction with standard suture neurorrhaphy of severed nerves in patients between 18 and 80.
The subject has voluntarily agreed to participate in this study and has signed an Institutional Review Board (IRB) approved informed consent form.
The subject is between eighteen (18) and eighty (80) years of age.
The subject has clinical evidence of a Sunderland's 4th degree (Class II) or 5th degree (Class III) nerve transection(s) that has resulted in upper extremity nerve impairment that requires surgical treatment.
Subjects whose nerve repair will occur greater than 48 hours after nerve transection.
Subjects requiring nerve repair involving an autograft, allograft or conduit(s).
Subjects with multiple transected nerve injuries are allowed into the study only if all injuries are amenable to direct repair.
Subjects 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.