Other Tumor Indications
Ablation of tumors in other soft tissue sites
ExploratoryActive
Key Facts
Indication
Ablation of tumors in other soft tissue sites
Phase
Exploratory
Status
Active
Company
About Novian Health
Novian Health is a medical device innovator developing the Novilase Interstitial Laser System for the thermal ablation of tumors, with a primary focus on breast cancer and benign breast tumors. The technology has achieved CE Mark approval in Europe for both malignant and benign indications and holds FDA 510(k) clearance in the U.S. for benign tumors and soft tissue ablation, with Breakthrough Device designation for malignant breast tumors. The company is preparing for a pivotal U.S. trial (BR-003) to support FDA marketing clearance for the malignant indication while building commercial and clinical evidence through post-market registries.
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