Evaluation of NEUROCAP® In the Treatment of Symptomatic Neuroma

1. Device description NEUROCAP®, a bioresorbable nerve capping device based upon the
NEUROLAC® nerve guide, is indicated to protect a peripheral nerve end and to separate
the nerve from surrounding environment to reduce the development of a symptomatic
neuroma. NEUROCAP® is composed of the same biocompatible, bioresorbable copolyester
composing the NEUROLAC® nerve guide, Poly(68/32[15/85 D/L] Lactide-Ԑ-Caprolactone)
(PLCL).

2. Objective This post-market surveillance study is conducted to provide post market
surveillance information regarding long-term performance and ease of use of the
Polyganics nerve capping device (NEUROCAP®) for reduction of the development of
peripheral symptomatic end-neuroma.

3. Study design This post-market surveillance study consists of a cohort study to provide
post market surveillance information regarding long-term performance and ease of use of
the NEUROCAP® for reduction of the development of peripheral symptomatic end-neuroma in
the upper and lower extremity. Sub analyses will be performed regarding demographics and
medical background.

Inclusion Criteria:

1. Subjects who are able to provide a written informed consent prior to participating in
the clinical investigation.

2. Subjects who are able to comply with the follow-up or other requirements.

3. Subjects who are ≥ 18 years old.

4. Subjects with a diagnosis of peripheral symptomatic (end-) neuroma in the upper limb.

5. Subjects with a positive Tinel's sign.

6. Symptomatic neuroma confirmed by pain relief following a 10min ± 2min nerve block with
Xylocaine (Lidocaine) - Pain relief defined as minimally 50% reduction in VAS
questionnaire score.

7. Subjects that are indicated for surgery to treat symptomatic neuroma.

Exclusion Criteria:

1. Subjects who do not complete the informed consent.

2. Subjects who are not willing to follow post-surgery protocols (e.g. avoiding pressure
on the implant zone or immobilization).

3. Subjects who are unable to comply with the follow-up or other requirements and/or have
a life expectancy of less than 24 months.

4. Subjects with congenital neuropathy.

5. Insufficient amount of soft tissue to cover the investigational device, as assessed by
the surgeon. Use of the device over a joint is advised against.

6. Subjects who have had historical radiotherapy in the area of the (end-) neuroma.

7. Subjects who have a known allergy to anesthetic agent or bioresorbable copolyester
Poly(68/32[15/85 D/L] Lactide-ε-Caprolactone) (PLCL).

8. Proximal nerve end > 8mm.

9. Pregnancy.