Novian Health Gains FDA Breakthrough Designation for Breast Therapy

Novian Health Inc. has been granted Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for its Novilase Interstitial Laser System and its proposed indication for use: the focal destruction of malignant breast tumors in adult women who seek a breast conserving procedure.
 
The FDA’s Breakthrough Device program supports the timely development of technologies that have the potential to provide more effective treatment of life-threatening diseases. By obtaining this status, Novian will benefit from an expedited regulatory review process, which may accelerate access to its interstitial laser therapy system in the United States.
 
“Laser therapy can help patients avoid the trauma and risks of breast cancer surgery,” said Henry Appelbaum, president and CEO of Novian Health. “Receiving this designation is a significant milestone that moves us one step closer to offering the benefits of this game-changing technology to breast cancer patients in the U.S.”
 
Novilase is a minimally invasive procedure that uses laser ablation to destroy tumors as an alternative to surgery. The intended use is for the focal destruction of malignant tumors of the breast up to 15 mm; for general surgery procedures including incision, excision, and ablation of soft tissues; and coagulative necrosis and interstitial laser coagulation of soft tissues.
 
Novilase has already been cleared in the United States for the treatment of benign breast tumors, or fibroadenomas. In addition, FDA granted an investigational device exemption for Novian Health’s pivotal study (BR-003), with enrollment anticipated to start in 2022 and study completion in 2023.
 
Novian received CE Mark approval in 2019 to commercialize its technology in the European Union (EU) and Switzerland for the treatment of both malignant tumors and fibroadenomas, making it the first ablation device to have been cleared for malignant breast tumors.
 
More than 275,000 U.S. women and 2 million around the world are diagnosed with breast cancer every year. About two-thirds of early-stage breast cancer patients and their doctors will opt to remove the tumors surgically in a breast-conserving procedure called lumpectomy. This leaves a scar and can change the shape of a woman’s breast—and more than 25 percent of women will need additional surgery because their entire tumors were not removed during the initial surgical procedure.
 
During a Novilase procedure, doctors insert a laser probe directly into the tumor using ultrasound guidance in a manner similar to a breast biopsy. The tumor is then heated by the laser and destroyed. Intra-procedure confirmation of focal destruction is provided by a parallel temperature probe which records temperature at the periphery of the target ablation zone.
 
In contrast to a lumpectomy, which requires an operating room, general anesthesia, and several days of recovery, Novilase can be performed on an outpatient basis using local anesthesia, with minimal pain and a recovery time of hours instead of days. There is minimal scarring and no change in breast shape. Upon confirmation of focal destruction of the target tumor by MR imaging, patients will then proceed with recommended radiation and/or adjuvant therapies.
 
Multiple clinical trials have evaluated Novilase for the treatment of malignant breast tumors. A multi-center trial published in the Annals of Surgical Oncology in 2018 found that, for malignant breast tumors up to 15 mm, Novilase completely destroyed the tumor in 98 percent of patients. In addition, patients in the trial reported better health-related quality of life outcomes compared to lumpectomy surgery.
 
Based in Chicago, with a subsidiary in Evry, France, Novian Health Inc. is a privately held medical device company with proprietary technology for the treatment of tumors using Interstitial Laser Therapy.