Breast cancer is the most common female malignancy with an annual incidence of approximately 250,000 in the U.S. and 330,000 in the EU leading to over 120,000 deaths each year. Early detection is important, and improvements in imaging have allowed even smaller tumors to be detected. This has led to more than half of newly diagnosed breast cancers being detected when they are smaller than 2 cm and sometimes non-palpable.
With the detection of smaller breast tumors, patients and physicians are desirous of a minimally invasive treatment that would avoid the trauma and risks associated with surgery. Novilase is being studied in clinical trials as a potential alternative to lumpectomy.
Novilase Breast Therapy is performed with ultrasound image guidance, similar to a breast biopsy, under local anesthetic. It can be performed as an outpatient procedure in a breast center. Novilase is already approved for the treatment of benign breast tumors in the U.S. and is currently being evaluated as a treatment for breast cancer in several multicenter clinical trials in the U.S., UK and France. Following the clinical trials, Novian Health will seek regulatory approval for Novilase in Europe, the U.S. and other markets.