RNS® System Epilepsy PAS

NeuroPace, Inc. is sponsoring a post-approval study (PAS) of the RNS System device. The RNS
System is the first FDA-approved closed loop responsive neurostimulator designed to reduce
the frequency of seizures in individuals with partial onset seizures.

The RNS System Epilepsy PAS is a 5 year, non-randomized, open-label, multi-center prospective
observational study. Data regarding safety and efficacy are collected at enrollment and
periodically throughout the 5-year study.

The study is designed to assess the long-term safety and effectiveness of the RNS System as
an adjunctive therapy in reducing the frequency of seizures in individuals 18 years of age or
older with partial onset seizures who have undergone diagnostic testing that localized no
more than 2 epileptogenic foci, are refractory to two or more antiepileptic medications, and
currently have frequent and disabling seizures (motor partial seizures, complex partial
seizures and/or secondarily generalized seizures).

Data from the RNS System Epilepsy PAS will be used to calculate long-term SAE rates, median
percent change in seizure frequency (from pre-implant retrospective data), as well as other
safety and effectiveness endpoints.

Inclusion Criteria:

- Subject is 18 years of age or older

- Subject has frequent, disabling seizures (SPS-motor, CPS, and/or secondarily
generalized seizures)

- Subject has failed treatment with a minimum of 2 AEDs

- Subject has undergone diagnostic testing that has identified no more than 2
epileptogenic foci

- Subject or legal guardian is able to provide appropriate consent to participate

- Subject is able to maintain a seizure diary alone or with the assistance of a
competent individual

- Subject is able to attend clinic appointments in accordance with the study schedule

Exclusion Criteria:

- Subject was diagnosed with primarily generalized seizures

- Subject is participating in a therapeutic investigational drug or device study

- Subject has an implanted medical device that delivers electrical energy to the brain

- Subject was treated with a VNS within the last three months (90 days)

- Subject requires MR imaging

- Subject is pregnant