American Breast Laser Ablation Therapy Evaluation

ABLATE is a prospective, observational multi-center tracking database which will evaluate
clinical outcomes from patients undergoing Novilase for benign breast conditions (i.e.
fibroadenomas, papillomas, etc). Data captured will assess the potential advantages and
disadvantages of the procedure as compared with lumpectomy. Tumor characteristics, equipment
used, complications, patient satisfaction and cosmesis ratings will also be tracked.

Inclusion Criteria:

- Diagnosis confirmed by needle core biopsy

- Tumors detected either by physical exam or imaging

- Tumors do not exceed 2 cm in diameter and measure at least 0.5 cm away from the skin
and chest wall

- Single, multiple and/or bilateral tumors

- Patient has given consent prior to being treated with Novilase™

Exclusion Criteria:

- Patient is pregnant or lactating

- Hypercellularity suggestive of phyllodes

- Atypia

- Equivocal pathology report (e.g., discordance between radiographic and microscopic
results)

- Fibroadenomas with stromal solidarity