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Novian Health passes CE Mark for groundbreaking laser Novilase Breast Therapy
16 July 2019 -

Medical device company Novian Health Inc said on Tuesday that it has received the CE Mark approval for its Novilase Breast Therapy, a minimally invasive procedure that uses laser induced heat for focal destruction of breast tumours up to two centimetres in size.

Following the CE Mark approval , the company can commercialise its technology in the European Union (EU) and Switzerland, giving women an alternative to surgery for early-stage breast cancer and benign breast tumours (fibroadenomas), the most common type of solid breast tumor (typically benign), affecting 10% of all women.

Novilase Breast Therapy, the company's minimally invasive procedure, requires local anesthesia. Two small probes are inserted into the breast and guided to the tumour by ultrasound imaging. One probe uses heat to destroy the tumour while the other monitors the procedure through temperature. The treatment takes about 30 minutes.

A recent study conducted in the US and UK showed that more than 90% of malignant breast tumours were completely destroyed during one Novilase procedure. In addition, patients in the trial reported better health-related quality of life outcomes compared to lumpectomy surgery, said the company.

In conjunction, the company has received the ISO:13485:2016 certification for its quality management system.

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