Novian Health is a privately held medical device company based in Chicago with a subsidiary in Evry, France. It has developed the Novilase® Laser System, image-guided treatment that enables physicians to ablate tumors. Novilase Breast Therapy uses parametrically controlled heating to ablate breast tumors with improved outcomes and lower costs versus surgery.
Novian was founded by Dr. Kambiz Dowlat, a former professor of surgery at Rush University Medical Center in Chicago and a pioneer in breast cancer diagnosis and treatment. Early on he recognized that imaging would be able to detect earlier stage tumors and that a minimally invasive alternative to surgery would be beneficial for patients. To his credit, Dr. Dowlat introduced stereotactic core needle biopsy into the U.S. (the most common type of breast biopsy) and developed the initial version of Novilase Breast Therapy. Sadly, Dr. Dowlat passed away on March 17, 2022. He is greatly missed and his Vision continues to drive us forward.
Data from a multicenter trial in the UK and U.S. that evaluated Novilase for ablation of small breast cancers was published in Annals of Surgical Oncology (see article here). A parallel clinical trial is ongoing in France.
In Europe, Novian Health has received a CE Mark for treatment of malignant and benign breast tumors. Novilase is the first thermal ablation device to be approved for focal destruction of breast cancer.
In the U.S., Novian Health has received FDA 510(k) clearance for the treatment of benign breast tumors (i.e., fibroadenomas) and ablation of soft tissue. In addition, IDE approval has been received to launch the BR-003 confirmatory study, which the Company anticipates will support marketing clearance for focal destruction of malignant breast tumors.
Other tumor sites and indications are also being explored.
Novilase is a percutaneous, ultrasound-guided laser procedure that can be performed in a breast center with only local anesthesia, offering potentially significant advantages over surgery including minimal scarring, quicker recovery, and less pain or fatigue. It may be performed by physicians (e.g., surgeons or radiologists) with experience in image-guided breast procedures (e.g., biopsies).
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