Cryoablation Shown As Viable Alternative To Lumpectomy For Early Stage Breast Cancer

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New research published in the Annals of Surgical Oncology demonstrates efficacy of Sanarus Technologies' Visica® 2 Treatment System for the treatment of certain breast cancers.

Sanarus Technologies, developers of a patented proprietary cryoablation system, today announced publication of a groundbreaking study that shows freezing early stage breast cancer tumors is a safe and effective treatment option for select patients.

Results from the ACOSOG Z1072 breast cancer study published in the Annals of Surgical Oncology showed that image-guided cryoablation with the Visica® 2 Treatment System was 100% effective for complete ablation of invasive ductal breast cancer tumors <1cm and cryoablation was successful for the target lesion in 92% of patients.

Funded by the National Cancer Institute and sponsored by the Alliance for Clinical Trials in Oncology, the 5-year multicenter study measured the rates of complete tumor ablation in breast cancer patients treated with cryoablation. Patients enrolled in the study agreed to undergo surgery after cryoablation, so that tumor-adjacent tissue could be evaluated by the pathologist for the presence of any remaining tumor.

BJ Hardman, chairman and CEO of Sanarus Technologies added, "We are thrilled with the results of this landmark breast cancer study. We want to thank the National Cancer Institute for their financial support and for selecting our Visica 2 Treatment System as the exclusive device used for the study, the Alliance for their hard work and dedication in completing the study during the five years of effort, and the women who chose to participate in this trial.”

Cryoablation—also referred to as percutaneous cryoablation or cryotherapy—is a minimally invasive treatment that uses extreme cold to freeze and destroy diseased tissue, including cancer cells. Nonsurgical methods of tissue freezing are used topically to remove skin lesions, and percutaneously (through the skin) to treat cancers of the prostate, liver, lung and kidney, as well as certain cancers that have metastasized.

Tumor freezing has been used for many years for the treatment of noncancerous breast tumors e.g., fibroadenomas; however, data gleaned from this study confirms that cryoablation is a safe and effective treatment for certain types of breast cancer.

A second clinical trial, Freezing Instead of Resection Of Small Breast Tumors (FROST), will begin enrolling patients this year. The FROST Trial examines the use of cryoablation as an alternative to surgical resection for the management of primary early stage invasive breast cancer. The trial will recruit 200 female patients, 50+ years of age, at 20 locations and will provide follow-up results for five years. Unlike the Z1072 Trial, the ablation tumors will not be resected. Cryoablation will be done with the Visica 2 Treatment System.

Developed in 2007 by Sanarus Technologies, the Visica 2 Treatment System is a patented, FDA-cleared image-guided cryoablation device for the treatment of breast tumors. During the Visica® Procedure, liquid nitrogen is circulated through a hollow tube at therapeutic freezing temperatures to targeted tissue. The tube is inserted into the mass under ultrasound guidance to ensure that an ice ball engulfs the tumor. Freezing kills the tumor cells, which are then reabsorbed by the body. The procedure generally takes about 30 minutes and is done under local anesthesia in a physician’s office or outpatient setting.

Discomfort following the procedure is mild, with most patients resuming normal activity relatively quickly. In contrast to lumpectomy, the potential for scarring or change in the shape of the breast is minimal. The tumor lump gradually resolves over a period of several months.

"Sanarus is the clear leader in the field of transformative breast tumor ablation and we are dedicated to improving treatment and quality of life for women diagnosed with a breast tumor," said Ms. Hardman. “We will continue to focus our efforts on offering clinically proven solutions for patients with benign tumors or breast cancer.”

View ACOSOG Z1072 study results here:

About Sanarus Technologies
In 2001, the Visica Treatment System was the first system available for cryoablation of breast tumors. Since then, our system has been used to successfully treat thousands of patients. The System is FDA-cleared for the ablation of cancerous or malignant tissue and benign tumors. At Sanarus, we pride ourselves in pioneering minimally invasive breast care solutions and are the industry leader for the ablation of both benign tumors and breast cancer. We are a majority woman-owned business, headquartered in Pleasanton, CA, and all of our products are manufactured in the USA. Find out more at

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Karen Hambly
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