NOVIAN HEALTH is a LEADING COMPANY IN IMAGE-GUIDED LASER TUMOR THERAPY
Its vision is to establish laser therapy as a treatment alternative to surgery for tumors, benefiting the patient. Currently Novian Health is focused on providing women with a minimally invasive alternative to surgery for cancerous and non-cancerous breast tumors. The Novilase laser procedure is performed in a breast center with ultrasound imaging guidance in a manner similar to a breast biopsy.
Other indications are also being explored.
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., FDA has granted Breakthrough Device designation to the Novilase Interstitial Laser System for the proposed indication for use: the focal destruction of malignant breast tumors in adult women who seek a breast conserving procedure. 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.
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.
