Freezing Cancer With IceCure: ProSense Cryoablation System Receives FDA Marketing Authorization For Early-Stage Breast Cancer Treatment

IceCure Medical Ltd. (NASDAQ:ICCM), the developer of minimally invasive cryoablation technology that destroys tumors by freezing them, was granted marketing authorization from the U.S. Food and Drug Administration (FDA) for its ProSense® cryoablation system for the local treatment of low-risk breast cancer in women aged 70 and older. The system is the first and only cryoablation medical device cleared for this indication for breast cancer treatment, according to the company. 

The company has been granted a De Novo marketing authorization, which is the FDA's pathway for novel medical devices that are low-to-moderate risk and have no marketed equivalent device to use for clearance. The ProSense cryoablation system is indicated for women aged 70 and older with biologically low-risk tumors that are less than 1.5 centimeters in size and treated with adjuvant endocrine therapy, including patients who are not suitable for surgery. The system has already been approved for breast cancer treatment in other countries, including the European Union and Brazil.

Global Breast Cancer Cases Are On The Rise 

IceCure estimates its device can treat approximately 46,000 women annually in the U.S., along with approximately 88,000 additional patients not suitable for surgery. Additionally, there are approximately 63,000 patients with benign breast tumors who can also benefit from cryoablation. The breast cancer market in the U.S. as a whole was valued at $27.5 billion in 2024, and is projected to grow at a CAGR of 9.4% between 2025 and 2034. 

"We expect that the FDA's marketing authorization, the very enthusiastic response from physicians who have had clinical experience with ProSense and the existing reimbursement code, will all combine to drive strong demand for our cryoablation procedure in breast cancer," said Eyal Shamir, Chief Executive Officer of IceCure. "ProSense offers the first new innovation in the treatment of women aged 70 and above with low-risk early-stage breast cancer in decades. We are proud to deliver a significant advancement and enhancement to women's cancer care and quality of life."

Women aged 70 and older are being diagnosed with low-risk breast cancer at an increasing rate due to a number of factors, including advances in mammography screening technology, increased awareness about the need for screenings in healthy older women and longer life expectancy. As women live longer, they have a higher likelihood of developing breast cancer. 

ProSense's Tumor Freezing Power 

IceCure reports that ProSense works by harnessing the power of liquid nitrogen to create large lethal zones for maximum efficacy in tumor destruction in benign and cancerous lesions, including in the breast, kidney, lung and liver.  

Performed by breast surgeons and interventional radiologists, during a ProSense cryoablation procedure, a doctor injects local anesthesia and uses ultrasound imaging to guide a small cryoprobe – a thin hollow needle – into the breast tumor. Once the cryoprobe is placed, liquid nitrogen creates extremely cold temperatures (-170°C) at its tip, which destroys the breast tumor by creating an ice ball around the targeted tissue.

IceCure says ProSense enhances patient and provider value by reducing recovery time and minimizing pain, surgical risks and potential complications. There is minimal scarring from the insertion of the cryoprobe, the breast maintains its shape, the procedure takes approximately 30 to 45 minutes and patients typically return to normal activity within 24 hours. The median recovery time is one day, with a range of zero to eight days, reports the company. 

“You don’t need any kind of cosmetic follow-up, you don’t have a scar, and you don’t have the feeling of having lost part of your breast, because it’s all still there,” shared breast cancer patient and ICE3 trial participant, Pam Dixon, when describing her experience with the ProSense® cryoablation procedure. “There was no pain. It was one of the easiest things I’ve ever done. I don’t remember any limitations on my activity.”

The system itself is easy to use and transport, which IceCure says opens the door to fast and convenient office-based procedures for breast tumors. 

Post-Market Study Kicking Off 

IceCure said the FDA granted the ProSense marketing authorization based on an abundance of data, including the company's ICE3 trial, which it said was the largest clinical trial of its kind for low-risk early-stage breast cancer. As part of the marketing authorization, the FDA is requiring IceCure to conduct a post-market surveillance study to collect additional data. The study will include approximately 400 patients from at least 30 sites, reported the company, noting the established reimbursement code could be used to support claims and reimbursement during the study. At the same time the sites are treating the post-market surveillance study participants, they will also treat any patients independently seeking treatment with ProSense cryoablation. 

What's more, IceCure said that, thanks to the marketing authorization, any other company that wants to file for marketing authorization for breast cancer with a competing cryoablation system will now be required to submit five years of follow-up data, which is a process that can take more than eight years to achieve. It also requires that any other company seeking 510(k) clearance must use a liquid-nitrogen-based system with 10-gauge probes. The company said it is not aware of any other companies conducting a similar breast cryoablation clinical study in the U.S., creating a significant barrier to entry.

Breast cancer among women aged 70 and older is on the rise due to increased life expectancy, and early diagnoses are increasing, driven by improved screenings and greater awareness. Eliminating low-risk tumors can be quick and easy thanks to IceCure’s ProSense cryoablation system. With FDA clearance and a competitive advantage, IceCure is seeking to freeze tumors and warm the hearts of patients and doctors. 

Featured image from Shutterstock.

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