Feasibility Study on LITT for Medical Refractory Epilepsy

Monteris is sponsoring this multicenter, open-label, prospective feasibility study to
characterize the performance of laser interstitial thermal therapy (LITT) using the Monteris
NeuroBlate System for the treatment of drug-refractory medial temporal lobe epilepsy in
subjects who are candidates for LITT surgery.

The NeuroBlate System uses precise, high-intensity laser light to initiate necrosis of
abnormal brain tissue through thermal ablation while limiting injury to healthy tissue.
Unlike traditional brain surgery, LITT does not require a large opening in the skull.

Subjects who meet the study eligibility criteria and sign the informed consent form will
undergo the LITT procedure. Subjects, or their caregivers, are required to keep a seizure
diary throughout the study, beginning after surgery. The study will monitor and record
subjects' seizure frequency, antiepileptic medications, and physical and emotional health.

Subjects treated with NeuroBlate will have 2 years of follow-up. Throughout study
participation, the study investigator will continuously monitor and document both
effectiveness and safety data at study appointments.

Relevant Inclusion Criteria are listed below

- Diagnosis of unilateral medial temporal lobe epilepsy (MTLE) confirmed clinically and
with either (1) ictal scalp recording and MRI evidence of mesial temporal sclerosis or
(2) intracranial ictal onset consistent with hippocampal origin

- Averages 1 or more complex partial seizures or secondary generalized seizures
compatible with MTLE per month

- On stable antiepileptic medications

- Meets the criteria for a medial temporal lobe resection and is a candidate for LITT

- 18 years or older at the time of consent

Relevant Exclusion Criteria are listed below

- Previous diagnosis of psychogenic/non-epileptic seizures

- Previous diagnosis of primary generalized seizures

- IQ less than 70

- Subject has a MRI-incompatible implanted electronic device or any metallic prosthesis
or implant for which brain MRI is contraindicated