Who is a candidate?

Novilase Breast Therapy is intended for the treatment of benign fibroadenoma of the breast, with tumors sizes up to 2.0 cm.

Novilase is indicated for patients who fit the following criteria:

• Females ages 15 and older
• Breast tumors detected by physical examination or by imaging techniques, such as mammogram or ultrasound.  The tumor must be well defined on a mammogram or ultrasound
• Definitive histological diagnosis of benignity, i.e. fibroadenomas
• Only tumors that do not exceed 2.0 cm in diameter and measure at least 0.5 cm away from the skin should be considered for treatment
• Women with single or multiple benign lesions

Novilase is not indicated for patients who fit the following criteria:

• Pregnant or lactating women and women with uncorrectable coagulopathy
• Tumors that cannot be clearly visualized by mammography or ultrasound
• Tumors with equivocal histology, i.e. cystosarcoma, phylloides, atypia, or in-situ carcinoma.
• Women with significant concomitant diseases that could interfere with data analysis
• Women with physical or psychological disorders within the last five years that may be life threatening