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.

Novilase Interstitial Laser System: An image-guided (ultrasound), percutaneous thermal ablation platform using parametrically controlled laser energy to destroy tumors.

Novian competes in the tumor ablation space against other energy-based modalities (e.g., radiofrequency, cryoablation, microwave) from companies like Medtronic, Boston Scientific, and AngioDynamics. Its primary competition is the entrenched standard of care: surgical lumpectomy.