Novian Health
Novian Health develops image-guided laser therapies for tumors, offering minimally invasive alternatives to surgery, primarily for breast tumors, with regulatory approvals in Europe and the U.S.
Company Overview
Novian Health focuses on developing image-guided laser tumor therapies. It provides minimally invasive alternatives to surgery for treating both cancerous and non-cancerous breast tumors. By leveraging advanced laser technology, Novian Health aims to offer less invasive and more precise treatment options.
Services
Novian Health offers treatments for malignant and benign breast tumors using its FDA 510(k) cleared Novilase Interstitial Laser System. This system has been granted Breakthrough Device designation by the FDA for its innovative approach to the focal destruction of malignant breast tumors. The company also conducts a post-marketing registry for benign breast tumors in both the U.S. and Europe, aiming to further validate the efficacy and safety of its treatments.
Regulatory Approvals
Novian Health has received significant regulatory approvals, underscoring its commitment to safety and efficacy. In Europe, the company received a CE Mark for the treatment of malignant and benign breast tumors. In the United States, its Novilase Interstitial Laser System has been granted Breakthrough Device designation by the FDA and is FDA 510(k) cleared for the treatment of benign breast tumors and soft tissue ablation.
Global Presence
Novian Health is headquartered in Chicago, Illinois, and operates a manufacturing facility in Tonganoxie, Kansas. The company also has an international presence with a subsidiary located in Evry, France. This global footprint allows Novian Health to serve a broader patient population and collaborate with leading healthcare providers across different regions.