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Novel laser therapy system could dramatically change the landscape of early-stage breast cancer treatment
CHICAGO, IL., December 6, 2022 – Novian Health has received Frost & Sullivan’s 2022 European New Product Innovation Award in the breast tumor ablation industry for its Novilase® Breast Therapy system. Novilase, a minimally invasive procedure that uses laser ablation to destroy tumors as an alternative to surgery, has the potential to make “the treatment of breast cancer much simpler and more effective, with significantly lower side effects,” according to Frost & Sullivan’s evaluation.
“This quick, percutaneous, and ultrasound-guided procedure needs only local anesthesia, offers minimal scarring, and ensures lower pain and fatigue and quicker recovery for the patients,” said Debarati Sengupta, Senior Industry Analyst at Frost & Sullivan. “It facilitates a paradigmatic shift in the perception of breast tumor treatment, putting the patients’ minds at ease.”
Novilase is a thermal ablation device that uses laser heat to destroy tumor cells without lumpectomy surgery. The intended use is for the focal destruction of malignant and benign tumors of the breast up to 20 mm; for general surgery procedures including incision, excision, and ablation of soft tissues; and coagulative necrosis and interstitial laser coagulation of soft tissues.
It is the first thermal ablation device to receive CE Mark approval in the European Union (EU) and Switzerland for the treatment of both malignant tumors and fibroadenomas (benign breast tumors).
“Laser therapy can help patients avoid the trauma and risks of breast cancer surgery,” said Henry Appelbaum, president and CEO of Novian Health. “The Novian Health team is proud to receive this award as we begin to offer the benefits of this game-changing technology to breast cancer patients in Europe.”
Novilase is already cleared in the U.S. for the treatment of fibroadenomas, and in 2021 it was granted Breakthrough Device designation from the U.S. Food & Drug Administration for its proposed use in focal destruction of malignant breast tumors. In addition, FDA granted an investigational device exemption for Novian Health’s pivotal study (BR-003), with enrollment anticipated to start shortly with study completion by 2024.
How Novilase Works
Every year, more than 275,000 women in the U.S., half a million in Europe, and 2 million worldwide are diagnosed with breast cancer. About two-thirds of early-stage breast cancer patients and their doctors will surgically remove the tumors in a breast-conserving procedure called a lumpectomy. This leaves a scar and can change the shape of a woman’s breast — and as many as 25% 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, 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.
The entire procedure takes 15 to 30 minutes and does not require general anesthesia, unlike a lumpectomy. 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 malignant tumor by MR imaging, patients will 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 focally destroyed the tumor in 98% of patients. For tumors up to 20 mm 91% were destroyed. In addition, patients in the trial reported better health-related quality of life outcomes than lumpectomy surgery.
“Besides the improved quality of life for the patients, this interstitial laser therapy is significantly more cost-effective than standard breast cancer surgery, as it eliminates the need for hospital stays. The high efficacy and significantly lower chances of repeated excision also drive adoption,” said Sengupta.
About the Frost & Sullivan Awards
Frost & Sullivan, a global market intelligence firm, applies a rigorous analytical process to evaluate multiple nominees for each award category before determining the final award recipient. The process involves a detailed evaluation of best practices criteria across two dimensions for each nominated Company.
ABOUT NOVIAN HEALTH INC.
Based in Chicago, with a subsidiary in Evry, France, Novian Health Inc. is a privately held medical device company with proprietary technology for focal destruction of tumors using Interstitial Laser Therapy. For more information, call (312) 266-7200 or access www.novianhealth.com.