Novilase
Commercial- Indications
- Benign breast tumors, Breast cancer
Company intelligence / Profile preview
Novian Health’s image-guided laser system, Novilase, is CE Marked and commercialized in Europe for both malignant and benign breast tumor ablation. In the US, it is FDA-cleared for benign indications with a pivotal trial underway to support approval for focal destruction of early-stage malignant breast cancer. Published multicenter data show promising results as a minimally invasive alternative to surgery with advantages such as minimal scarring and faster recovery. The company has also received Breakthrough Device designation from the FDA.
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