Tolerability and Feasibility Pilot Clinical Study of a Large-Diameter Nerve Cap for Protecting and Preserving Terminated Nerve Ends

Inclusion Criteria: Potential Subjects MUST:

1. Sign and date an IRB-approved written Informed Consent Form prior to initiation ofany study procedures;

2. Be an adult male or female ≥ 18 and ≤ 80 years of age;

3. Present for surgery with either:

4. Limb trauma and/or planned amputation of a limb and be candidates who areplanned for a secondary nerve surgery such as Targeted Muscle Reinnervation (TMR) or Regenerative Peripheral Nerve Interface (RPNI) procedures within 6-12months from time of amputation, or;

5. A previous amputation and be undergoing surgery to address nerve ends;

6. Have at least one nerve end measuring greater than 4 mm and less than 7 mm indiameter after debridement and hemostasis of the proximal nerve stump;

7. Have sufficient soft tissue available to be adequately covered by the Axoguard NerveCap;

8. Be willing and able to comply with all aspects of the treatment and follow-upassessments and to return for all required study visits throughout the studyduration.

Exclusion Criteria: Potential Subjects MUST NOT:

1. Currently undergoing or are expected to undergo treatment with chemotherapy,radiation therapy, or other known treatment that affects the growth of neural and/orvascular tissues;

2. Have signs and symptoms of chemotherapy-induced peripheral neuropathy from previouschemotherapy;

3. Be immunosuppressed or have planned immunosuppressive therapy during the duration ofthe study;

4. Current uncontrolled local or systemic infection as indicated by positive bloodculture or other pathological indicators of infection;

5. Be contraindicated for soft tissue implants. This includes but is not limited to anypathology that would limit the blood supply to the target area or otherwisecompromise healing;

6. Have a life expectancy of less than 15-months;

7. Have a history of or be planning to undergo radiotherapy in the area of theend-neuroma;

8. Have bony exostosis of the affected limb that is not treated at the time of nervecap placement;

9. Have uncontrolled Type 1 or Type 2 Diabetes Mellitus with HbA1c of 8% or greater orthose with diabetic neuropathy in the target area or proximal to the amputationsite;

10. Have a history of idiopathic neuropathy/radiculopathy, known sciatica or chronicback pain;

11. Documented history of centralized nerve pain that does not respond to a peripheralnerve block in the affected limb;

12. Have a known allergy to anesthetic agents;

13. Have a known sensitivity to porcine-derived products;

14. Be currently enrolled or have been enrolled in another interventional clinicalresearch study within the past 30 days (at time of consent); or

15. Be deemed unsuitable for inclusion in the study at the discretion of theinvestigator.