A Comparative Post-marketing Study of Commercially Available Peripheral Nerve Gap Repair Options

Inclusion Criteria:

- Require primary or secondary nerve injury repair with Hollow Nerve Conduit or AVANCE™
in at least 1 digital nerve;

- Undergo End to End nerve to nerve graft coaptation on both the proximal and distal
portion of the nerve gap in the AVANCE™ group or nerve entubulation in the Hollow
Nerve Conduit group;

- Be willing to comply with all aspects of the treatment and evaluation schedule over a
12 Month duration; and

- Sign and date an IRB-approved written informed consent prior to initiation of any
study procedures, including screening procedures.

Exclusion Criteria:

- Nerve gaps of < 5 mm or > 20 mm;

- Estimated distance of regeneration of >125 mm (distance from injury site to sensory
target)

- Nerve crush or avulsion injuries;

- Incomplete nerve transections;

- Injury requiring replantation of target digit;

- Contralateral digital injuries corresponding to the target digit;

- Nerve injuries in the affected limb proximal to the crease of the wrist;

- End to side nerve repair;

- Injuries with significant vascular damage which may impair adequate perfusion of the
target limb;

- Subjects who are undergoing treatment with chemotherapy, radiation therapy, or other
know treatment which affects the growth of neural and/or vascular system;

- Use of bovine collagen based hollow nerve conduit in a subject with known or suspected
bovine sensitivity;

- Subjects age ≤18 years or ≥70 years;

- History neuropathy, diabetic or any other known neuropathy;

- Secondary nerve repair >12 weeks post initial injury;

- Currently enrolled in another investigational study;

- Expected use of medications during the study that are known to cause peripheral
neuropathy;

- History or Reynaud's or other disorder known to compromise circulation or sensation in
the upper extremity; and

- Any subject who at the discretion of the Investigator is not suitable for inclusion in
the study.