Industry Press Releases

Novian Health Achieves CE Mark for Novilase Breast Treatment

Wednesday, Jul 17, 2019

Novian Health Inc. Announces CE Mark Approval for Novilase® Breast Treatment, a Minimally Invasive Procedure That Uses Laser-Induced Heat for Destruction focal breast tumors up to 2 cm (cm) in size. CE Mark approval allows Novian Health to commercialize its technology in the European Union (EU) and Switzerland, providing women with an alternative to surgery for early-stage breast cancer and benign breast tumors ( fibroadenomas).

"CE marking is a major milestone for Novian Health, as Novilase is the first approved thermal ablation device for the treatment of malignant breast tumors," said Henry Appelbaum , CEO of Novian Health. "Laser therapy can help women avoid the trauma and risks of surgery. We are pleased to have the opportunity to offer this option to women in the EU. "

Minimally invasive procedure, Novilase breast treatment only requires 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 controls the procedure via temperature. The treatment lasts less than 30 minutes, and its success is confirmed by follow-up imaging.

A recent study in the United States and the United Kingdom has shown that more than 90 percent of malignant breast tumors have been completely destroyed in a single Novilase procedure. In addition, patients in the study reported better health-related quality of life outcomes compared to lumpectomy surgery. No serious side effects have been reported.

"Novilase is an important new treatment option for women with malignant and benign breast tumors who wish to benefit from less invasive treatment, faster recovery, and better esthetic results," said the surgeon. breast Michael Shere, MD, British chief investigator in the Novilase study. "Up to 25 percent of women who undergo a lumpectomy need additional surgery, as long as the tumor has not been completely removed. Based on data from our clinical study, Novilase may reduce the rate of new procedures for patients, allowing them to recover more quickly, or to move more quickly to additional treatments such as radiation or chemotherapy. "

In the United States, Novilase has been approved as an alternative to surgery for the treatment of fibroadenomas. The FDA has approved an Investigational Device Exemption (IDE) for Conducting a Confirmatory Study (BR-003) to Collect Data to Support a Commercialization Application for Focal Tumor Destruction malignant breast. On-site researchers in the United States and Europe will participate in the BR-003 study .

In addition to obtaining CE Mark approval, Novian Health has also achieved ISO: 13485: 2016 certification for its quality management system. To achieve this certification, Novian has had to demonstrate its ability to provide its products and related services in a manner that consistently meets customer and regulatory requirements.

Cancer tumors, which are cancerous and non-cancerous, are one of the most serious health problems facing women today. Breast cancer is the most common cancer among women worldwide, with an annual incidence of 404,920 in the EU . More than two-thirds of newly diagnosed breast cancers are detected when tumors are less than 2 cm.

Adenofibromas are the most common type of solid breast tumor (usually benign), and affect an estimated 10 percent of women.

About Novian Health Inc.
Headquartered in Chicago and headquartered in Evry, France , Novian Health Inc. is a privately held specialty medical device company with patented technology for the treatment of tumors through interstitial laser therapy. For more information, please contact (312) 266-7200 or visit the website: .

Contact: Liz Dowling , Phone (415) 388-2794
Dowling & Dennis Public Relations



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