Novian Health is bringing laser tumor therapy to market for early stage cancerous and benign breast tumors.
In Europe, Novian has received a CE Mark for treatment of malignant and benign breast tumors. Post marketing clinical follow up will commence coincident with commercial launch.
In the U.S., Novilase is FDA 510(k) cleared for treatment of benign breast tumors and soft tissue ablation. A post-marketing registry comprising benign breast tumors is ongoing with patients being treated at centers in the U.S. and soon Europe.
Novian Health will conduct the BR-003 confirmatory trial to collect data in support of U.S. marketing clearance for focal destruction of malignant tumors of the breast.