Novian Health

Novian Health is a medical device company specializing in image-guided laser tumor therapy for breast pathology. The company develops and commercializes the Novilase Interstitial Laser System, a minimally invasive alternative to surgical resection for early-stage malignant and benign breast tumors. The procedure is performed in breast centers using ultrasound imaging guidance, similar to needle biopsy technique. In Europe, the Novilase system has received CE Mark approval for treatment of both malignant and benign breast tumors. In the United States, the FDA has granted Breakthrough Device designation for focal destruction of malignant breast tumors in adult women seeking breast-conserving procedures. The Novilase system is FDA 510(k) cleared for treatment of benign breast tumors and soft tissue ablation. The company is conducting the BR-003 confirmatory trial to support U.S. marketing clearance for malignant tumor indication. A post-marketing registry for benign breast tumor patients is ongoing at treatment centers in the U.S. and Europe. Novian Health's therapeutic platform targets women with breast cancer and benign breast lesions who prefer minimally invasive, breast-preserving options to traditional surgical approaches. The company has received recognition including Product Innovation Awards and selection among top 50 MedTech startups transforming healthcare.