NOVILASE® BREAST THERAPY
The Novilase® Laser Therapy System is an innovative medical device designed for the focal destruction of tumors, offering a less invasive alternative to surgery. It has earned recognition as a Breakthrough Device by the U.S. FDA for malignant breast tumors specifically. Moreover, it holds FDA clearance for treating benign breast tumors and conducting soft tissue ablation. It is undergoing evaluation in a pivotal clinical trial (BR-003) for focal destruction of small breast cancers. In Europe and the UK, Novilase carries a CE Mark for the focal destruction of malignant and benign breast tumors, making it the first thermal ablation device approved for early-stage breast cancer.
This thermal laser ablation procedure employs ultrasound imaging guidance and local anesthesia, eliminating the need for general anesthesia. It can be performed in a breast center procedure room rather than an operating room. The procedure involves placing two small probes under ultrasound or x-ray imaging guidance into the breast—one probe to deliver the necessary laser energy for tumor destruction and another to monitor and control the ablation process in real time with multiple temperature sensors.
Physicians experienced in image-guided procedures, such as breast surgeons and radiologists, are qualified to perform the Novilase procedure.