Breast cancer is the most prevalent form of cancer among females, affecting around 250,000 individuals in the U.S. and 330,000 in the EU annually, resulting in over 120,000 deaths yearly. Early detection is crucial, and advancements in imaging have made it possible to identify even smaller tumors. As a result, more than half of newly diagnosed breast cancers are now detected when smaller than 2 cm and sometimes not detectable through touch.
Given the detection of small breast tumors, patients and physicians have been seeking less invasive treatment options. The Novilase procedure offers a less invasive approach that reduces the trauma and risks associated with surgery.
Novilase Laser Therapy utilizes ultrasound imaging guidance, similar to a breast biopsy, and requires only local anesthesia. This procedure can be performed in a breast center procedure room, providing a convenient and efficient option for patients.
After successful clinical trials in the USA, UK, and France, Novilase obtained a CE Mark for the focal destruction of both malignant and benign breast tumors, making it the first thermal ablation device approved for treating breast cancer. A confirmatory pivotal study is currently underway, aiming to secure market clearance in the USA, with participation from leading breast cancer centers in the USA, UK, Germany, Switzerland, and Israel.