Safety and Efficacy of Cryoablation for Metastatic Lung Tumors

ECLIPSE is a treatment, Phase 1 multicenter, prospective, single arm study with patients
serving as their own control. This study is to enroll patients who will undergo cryoablation
of at least 1 metastatic pulmonary tumor that is less than or equal to 3.5 cm. Patients will
be followed to 5 years post their cryoablation procedure.

Cryoablation is the process of destroying tissue by the application of extremely cold
temperatures. Galil Medical Cryoablation Systems are used as a surgical tool in the fields of
general surgery, dermatology (skin), neurology (nerves), chest surgery (including lung),
Ears-Nose-Throat (ENT), gynecology, oncology (cancer), proctology (colon/rectal) and urology
(kidney).

Inclusion Criteria:

- Patient must be at least 18 years old.

- Patient presents with Stage 4 pulmonary metastatic disease with metastatic disease
previously confirmed by prior biopsy or confirmed on imaging with known primary
disease.

- Patient has up to 3 local metastases unilaterally targeted by cryoablation. Maximum of
5 total pulmonary tumors bilaterally.

- Targeted tumor(s) defined as intra pulmonary or pleural with a maximum size of 3.5 cm.

- The target tumor is determined to be in a location where cryoablation is technically
achievable.

- Eastern Cooperative Oncology Group (ECOG) score of 0-2.

- Karnofsky Performance Scale score ≥60.

- Platelet count >50,000/mm3.

- INR less than 1.5.

Exclusion Criteria:

- Patient's primary cancer is lung cancer.

- Patient has had chemotherapy with neutropenia to levels as confirmed by absolute
neutrophil count (ANC) of less than 1000 that produce increase risk for the
cryoablation procedure.

- Patient has evidence of active systemic, pulmonary, or pericardial infection.