A Feasibility Safety Study of Benign Centrally-Located Intracranial Tumors in Pediatric and Young Adult Subjects

The goal of this prospective, non-randomized, single-arm, feasibility study is to develop
data to evaluate the safety and feasibility of ExAblate 4000 treatment of benign intracranial
tumors which require clinical intervention in pediatric and young adult subjects.

Indication of Use: Ablation of benign intracranial tumors in children and young adults which
are ExAblate accessible.

This is a feasibility study intended to collect data for use in the development of future
studies. As such, no formal statistical hypothesis or hypothesis testing is proposed. The
purpose of this study is to evaluate the safety and feasibility of managing benign brain
tumor size using ExAblate 4000 treatment of progressing benign intracranial tumors which
require clinical intervention in pediatric and young adult subjects.

Inclusion Criteria:

- Subjects with benign (WHO grade I) centrally located intracranial tumors which require
clinical intervention and are known to carry minimal hemorrhage risk

- Minimum head circumference will be 52cm

- Subjects should be on a stable dose of all condition-related medications for 30 days
prior to study entry as determine by medical records

Exclusion Criteria:

- Subjects who are taking human growth hormone (hGH), also known as somatotropin

- Subjects with standard contraindications for MR imaging such as non-MRI compatible
implanted metallic devices including vagus nerve stimulator, responsive
neurostimulator, cardiac pacemakers, non-metallic shunts, size limitations, etc.

- Subjects with suicidal ideation or previous suicide attempt within the past year

- Subjects with malignant brain tumors, or the presence of any ambiguous clinical
features that could imply a malignant potential to the tumor, or for which a biopsy is
necessary

- Subjects for whom histopathology is important for ongoing management

- Subjects who are unwilling or unable to undergo general anesthesia