Ablation Confirmation Study

Prospective, single-arm, multicenter study that will generate clinical data on 100 adult
patients using the NEUWAVE MicroWave Ablation System with AC (Ablation Confirmation) software
in patients undergoing ablation of a soft tissue liver lesion. AC software is a computed
tomography (CT) image processing software package available as an optional feature for use
with the NEUWAVE Microwave Ablation System. AC imports images from CT scanners for display
and processing during ablation procedures to assist physicians in identifying ablation
targets, assessing optimal ablation probe placement, and confirming the adequacy of the
ablation margin.

All ablations will be performed percutaneously by an interventional radiologist while the
patient is under general anesthesia or deep conscious sedation.

Inclusion Criteria:

1. A patient with one liver lesion less than or equal to 5cm undergoing microwave
ablation using the NEUWAVE Microwave Ablation System

2. Intent to use Ablation Confirmation during the procedure

3. Written Informed Consent to voluntarily participate in the study, follow CT scan
schedule, and authorize the transfer of his/her data to the Sponsor

4. Patients greater than or equal to 18 years of age

5. Performance status 0-2 (Eastern Cooperative Oncology Group [ECOG]) classification

6. Functional hepatic reserve based on the Child-Pugh score (Class A or B)

7. Lesion must be visualized by non-contrast enhanced CT scan or the patient must
tolerate contrast and meet institutional guidelines for contrast use based on
glomerular filtration rate (GFR)

Exclusion Criteria:

1. Active bacterial infection or fungal infection on the day of the ablation

2. Patients with implantable pacemakers or other electronic implants

3. Platelet count less than 50,000/mm cubed

4. Patients with uncorrectable coagulopathy at the time of ablation

5. Currently breastfeeding or pregnant (latter confirmed by serum pregnancy test)

6. Physical or psychological condition which would impair study participation

7. ASA (American Society of Anesthesiologists) score of great or equal to 4

8. Cannot safely obtain a 1cm margin

9. Planned use of hydrodissection

10. Systemic administration (intravenous or oral) of steroids, including herbal
supplements, that contain steroids, within 30 days prior to the study ablation
procedure

11. Chemotherapy or radiation therapy, within 30 days prior to the study ablation
procedure

12. INR greater than 1.5