Novian Health Inc. announced that it has obtained the CE Mark approval for its Novilase® Breast Therapy, a minimally invasive procedure that uses laser induced heat for focal destruction of breast tumors up to 2 centimeters (cm) in size. The CE Mark approval allows Novian Health to commercialize its technology in the European Union (EU) and Switzerland, giving women an alternative to surgery for early-stage breast cancer and benign breast tumors (fibroadenomas).
“The CE Mark is a significant milestone for Novian Health, as Novilase is the first thermal ablation device approved for treatment of malignant breast tumors,” said Henry Appelbaum, president and CEO of Novian Health. “Laser therapy can help women to avoid the trauma and risks of surgery. We’re thrilled to have the opportunity to bring this option to women in the EU.”
A minimally invasive procedure, Novilase Breast Therapy requires only local anesthesia. Two small probes are inserted into the breast and guided to the tumor by ultrasound imaging. One probe uses heat to destroy the tumor while the other monitors the procedure through temperature. The treatment takes less than 30 minutes and its success is confirmed by follow-up imaging.
A recent study conducted in the U.S. and U.K. showed that more than 90 percent of malignant breast tumors 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. No serious adverse events were reported.
“Novilase represents a major paradigm shift in how we treat early-stage breast cancer, effectively replacing the traditional lumpectomy,” said surgeon Barbara Schwartzberg, principal investigator of the Novilase study. “Using laser technology to treat breast tumors is less invasive, less painful, and produces better cosmetic results, in addition to being significantly less expensive. Compared to surgery, it’s simply a better technique all around.”
In the United States, Novilase has been cleared as an alternative to surgery for the treatment of fibroadenomas. The FDA approved an investigational device exemption (IDE) to conduct a confirmatory study (BR-003) to gather data to support a marketing application for focal destruction of malignant breast tumors. Investigators at U.S. and European sites will participate in the BR-003 study.
“I’m confident the existing data, combined with the results of the forthcoming BR-003 study, will be enough to support moving forward with laser ablation therapy for women with early-stage breast cancer in the United States,” said Dr. Schwartzberg.
In addition to obtaining the CE Mark approval, Novian Health also received ISO:13485:2016 certification for its quality management system. To earn the certification, Novian had to demonstrate its ability to provide its products and related services in a way that consistently meets customer and applicable regulatory requirements.
Breast tumors, both cancerous and non-cancerous, are one of the most serious health problems facing women today. Breast cancer is the most common cancer in women worldwide, with an annual incidence of 404,920 in the EU. More than two-thirds of newly diagnosed breast cancers are found when tumors are smaller than 2 cm.
Fibroadenomas are the most common type of solid breast tumor (typically benign), affecting an estimated 10 percent of all women.