Breast Surgeons Show Strong Support for IceCure's ProSense® at ASBrS 2025 After FDA Progress

Surgeons Enthusiastically Embrace IceCure's ProSense® at ASBrS 2025

IceCure Medical Ltd., a pioneer in the realm of cryoablation technology for tumor treatment, noted a significant surge of interest at the recent American Society of Breast Surgeons (ASBrS) 2025 Annual Meeting held in Las Vegas from April 30 to May 4. The excitement is largely rooted in recent favorable developments from the U.S. Food and Drug Administration (FDA) concerning IceCure's ProSense® system.

The ProSense® Cryoablation System represents a groundbreaking approach in breast cancer treatment, allowing for tumor destruction through freezing as a viable alternative to traditional surgical methods. Eyal Shamir, CEO of IceCure, expressed his enthusiasm regarding the event, noting how numerous surgeons approached their booth to inquire about participating in a scheduled post-market study designed to assess the effectiveness of ProSense® post-approval.

At the ASBrS meeting, ProSense® not only captured attention through its display and hands-on demonstrations but was also included in important discussions led by industry thought leaders. Notably, the technology's potential was highlighted in the Presidential Address and the Best Papers of 2024 segment, which underscored the role of cryoablation in providing patients with more treatment options for early-stage breast cancer.

Among the activities IceCure conducted at the conference was sponsoring and leading a pre-conference ultrasound course, where attendees received comprehensive hands-on training with the ProSense® system. Additionally, an Expert Booth meeting was hosted, titled "The Future of Cryoablation in Breast Cancer: A Focus on the Patient Journey," featuring insights from leading figures like Dr. Nathalie Johnson and Dr. Richard Fine.

The interaction between surgeons and the IceCure team suggested a promising future for the cryoablation method, as many expressed eagerness to integrate ProSense® into their practices once marketing authorization is confirmed. This wave of interest aligns with the encouraging remarks within the ASBrS Presidential Address, which advocated for breast surgeons to be proficient in all therapeutic modalities, including minimally invasive techniques like cryoablation.

In a noteworthy announcement on April 30, IceCure reported a fruitful meeting with the FDA’s Center for Devices and Radiological Health regarding its De Novo marketing authorization request for ProSense® aimed at treating early-stage low-risk breast cancer, specifically for women aged 70 and older. Ahead of marketing approval, the FDA has requested that IceCure carry out a study to gather additional data related to this indication, which is expected to include over 400 patients across 25 sites.

The Promise of ProSense®

The unique approach of the ProSense® Cryoablation System ensures the cold temperature generated by liquid nitrogen can effectively create substantial lethal zones necessary for tumor destruction in various lesions, including those found in the breast, kidney, lung, and liver. Its minimally invasive nature not only enhances recovery times for patients but also significantly reduces pain and the risk of complications that often accompany conventional surgeries.

As IceCure Medical forges forward, the anticipation of receiving FDA's final marketing authorization indicates a pivotal shift in breast cancer treatments. The numerous interactions at ASBrS 2025 demonstrate that the medical community is collectively moving towards integrating innovative solutions like cryoablation into standard care protocols. IceCure is committed to facilitating this transition, underscoring its belief that ProSense® can empower women facing early-stage breast cancer with more treatment choices while ensuring a safer, more patient-friendly approach to care.