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 leading specialist 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.
Novian Health received U.S. FDA 510(k) clearance for the treatment of benign breast tumors (i.e., fibroadenomas) and ablation of soft tissue.
Recently, a clinical trial evaluating Novilase Breast Therapy for the focal destruction of malignant breast tumors completed enrollment in the U.S. and UK, and a parallel trial remains ongoing in France. A CE Mark is being sought based on these results.
FDA approval for the treatment of malignant breast tumors will be pursued following completion of a confirmatory clinical trial. Other tumor sites and indications are also being explored.
Novilase is a procedure that can be performed in an outpatient setting with only local anesthesia, offering potentially significant advantages over surgery including minimal scarring, quicker recovery times, and less pain or fatigue. Novilase may be performed by physicians (e.g., surgeons and radiologists) with experience in image-guided procedures (e.g., breast biopsies).
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