Confirmatory Clinical Evaluation of Novilase® Laser Therapy for Focal Destruction of Malignant Breast Tumors

Inclusion Criteria:

• Females, aged 18 years and older

• Able to give written informed consent herself

• Definitive pathologic diagnosis by needle core biopsy

• Unifocal malignant tumor (T1a-c, N0-1, M0) that does not exceed 15 mm in longestdimension and measures at least 5 mm away from the skin and chest wall, or can bemoved at least 5 mm away from the skin and chest wall by injection of saline orlocal anesthetic

• No more than 10 mm of calcifications confined to the tumor on imaging

• Tumor is well visualized through ultrasound or x-ray mammography imaging andamenable to image-guidance therapy (i.e., a tumor which is well visualized throughimaging can be identified from surrounding breast tissue and does not have marginsobscured by other structures or artifacts on the images)

• Tumor is well visualized on MRI

• Subject with mammographic appearance of overall dense parenchymal tissue may beincluded, as long as a clearly evident marker is present at tumor site

• Tumor with less than 25% intraductal component, as determined by core biopsy

• No clinically significant co-morbidities (e.g., chronic illnesses existingsimultaneously with and usually independent of breast cancer) that affect lifeexpectancy

• Subject weight limited to ≤300 lbs. or ≤136 kg

• Subject agrees to comply with standard of care radiation or adjuvant therapy asprescribed by physician

Exclusion Criteria:

• Subject younger than 18 years of age

• Pregnant or breast-feeding

• Tumor poorly visualized by ultrasound or x-ray mammography imaging

• Contraindications to administration of gadolinium-based contrast agent, including:prior allergic reaction to a gadolinium-based contrast agent, moderate to end-stagekidney disease, and/or acute or chronic severe renal insufficiency (Glomerularfiltration rate (GFR) <30ml/min/1.73 sq. meters)

• Contraindications to MRI according to site guidelines (e.g., cardiac pacemaker,metallic implants)

• History of severe asthma

• Tumor measuring greater than 15 mm in longest dimension

• Microcalcifications that extend beyond target tumor such that overall longestdimension of target tumor and calcifications is longer than 15 mm.

• Advanced stage breast cancer

• Tumors that are lobular neoplasm, metastatic carcinoma to breast, sarcoma, Phyllodestumor, or Paget's disease

• Tumor with only DCIS with microinvasion

• Extensive intraductal component in lesion (i.e., >25%) as determined by core biopsy

• Subject who is known to be BRCA positive

• Tumor that is ER/PR/HER2 negative (TNBC)

• Inability to lie in prone or supine position for one hour

• Subject who is currently participating in another investigational treatment, deviceor drug study through follow up that would interfere with this trial

• Subject without a definitive HER2 test according to ASCO/CAP guidelines