Breast cancer is the most common female malignancy with an annual incidence of approximately 250,000 in the U.S. and 404,000 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 a potential alternative to lumpectomy. Novilase Breast Therapy is performed with ultrasound image guidance, similar to a breast biopsy, under only local anesthetic. It can be performed in a procedure room in a breast center.
Novian Health has received a CE Mark for treatment of breast tumors. Novilase is the first thermal ablation device to receive a CE Mark for treatment of malignant tumors of the breast. It also is U.S. FDA cleared for treatment of benign breast tumors (fibroadenomas). Novilase has been evaluated in multiple clinical trials in the U.S. and Europe. Novian Health will seek regulatory approval for Novilase in other markets as well.