IceCure's ProSense® Showcased at TME Fall Summit: "Take the Lead in Breast Cancer Care" Roundtable Highlighting Cryoablation Advances

Rhea-AI Summary

IceCure (Nasdaq: ICCM) announced that the U.S. Food and Drug Administration granted marketing authorization for ProSense® on October 3, 2025 for local treatment of breast cancer in patients ≥70 years with biologically low-risk tumors ≤1.5 cm treated with adjuvant endocrine therapy, and for patients not suitable for surgery.

The authorization followed IceCure's participation in the TME Fall Summit (Sept 26–27, 2025), where ProSense® drew high interest from a multidisciplinary roundtable of 40+ key opinion leaders and was highlighted in de-escalation sessions and a cryoablation faculty led by Dr. Richard Fine.

Positive

• FDA marketing authorization granted on October 3, 2025 for ProSense
• Roundtable engagement with 40+ KOLs at TME Fall Summit (Sept 26–27, 2025)
• ICE3 investigator Dr. Richard Fine led cryoablation faculty and showcased ICE3 data

Negative

• Authorization limited to patients ≥70 years with tumors ≤1.5 cm and biologically low-risk
• Label includes only patients treated with adjuvant endocrine therapy or those unsuitable for surgery

Insights

Breast oncology commercial strategist

FDA marketing authorization for ProSense® for defined low‑risk breast cancer cohorts and strong KOL interest increase commercial relevance.

IceCure’s regulatory milestone — the FDA marketing authorization on October 3, 2025 for local treatment of breast cancer in patients aged ≥70 with biologically low‑risk tumors ≤1.5 cm and patients unsuitable for surgery — creates a clear commercial pathway for a minimally invasive alternative to surgery. The company demonstrated product capabilities to more than 40 KOLs at the TME Fall Summit and received high clinician interest during the cryoablation faculty led by Dr. Richard Fine, who is associated with the ICE3 trial.

The near‑term commercial opportunity depends on three explicit dependencies: clinician adoption following the Summit engagement, alignment of post‑procedure adjuvant endocrine therapy with the authorization conditions, and offering ProSense® to patients who meet the stated eligibility criteria. Risks include narrow labeled indications (age and tumor size limits) and the need for sustained KOL support to convert interest into routine use.

Watch for concrete, monitorable milestones: institutional adoption decisions or hospital formulary entries, published real‑world use data in the labeled population, and any FDA communications refining use; expect initial uptake signals within the next 6–18 months as centers assess implementation and patient selection.

FDA's marketing authorization for ProSense® for low-risk breast cancer received following the TME Fall Summit—Marketing authorization expected to further drive commercial traction based on the high level of interest received at the roundtable event

CAESAREA, Israel, Oct. 13, 2025 /PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure", "IceCure Medical" or the "Company"), developer of minimally-invasive cryoablation technology that destroys tumors by freezing as an option to surgical tumor removal, today announced its participation at Aptitude Health's TME Take the Lead in Breast Cancer Care Fall Summit 2025, which took place on September 26–27, 2025, in New Orleans, Louisiana. The two-day high-level roundtable convened more than 40 Key Opinion Leaders ("KOLs") from across the U.S. including leading breast surgeons, medical oncologists, and interventional radiologists to advance multidisciplinary care for high-risk and newly diagnosed breast cancer patients.

In the days following the conclusion of the TME Fall Summit, on October 3, 2025, the U.S. Food and Drug Administration ("FDA") granted marketing authorization for ProSense® for the local treatment of breast cancer in patients ≥70 years of age with biologically low-risk tumors ≤1.5 cm in size and treated with adjuvant endocrine therapy, and patients that are not suitable for surgery for breast cancer treatment. 

"We were honored to participate in the TME Fall Summit and engage directly with KOLs from across the U.S.," stated IceCure's Chief Executive Officer, Eyal Shamir. "The inclusion of cryoablation in the de-escalation dialogue underscores the momentum building around less-invasive breast cancer strategies, and ProSense® continues to draw attention as a tool that can reshape the standard of care. The engagement and high level of interest we received from top clinicians is highly encouraging, and we anticipate this interest will translate into clinical adoption now that ProSense® has received the FDA's marketing authorization in the U.S. for low-risk breast cancer in the days following the TME Summit."

The TME summit focused on the evolving paradigm of de-escalation strategies in early and high-risk breast cancer care, with special emphasis on minimally invasive options. Cryoablation was prominently featured during a multidisciplinary de-escalation session illustrating its growing relevance in breast oncology treatment planning.

ProSense® and IceCure received a high level of interest during a cryoablation faculty led by Dr. Richard Fine, a leading investigator of IceCure's ICE3 trail, the largest cryoablation study of its kind in the U.S. Dr. Fine is winner of the 2024 American Society of Breast Surgeons' Scientific Impact Award for his presentation of the ICE3 trial data and lead author of an ICE3 study published in the Annals of Surgical Oncology.

IceCure delivered a product showcase presentation focused on ProSense®'s current capabilities and its potential to provide an unprecedented option for women with low-risk breast cancer.

About ProSense®

The ProSense® Cryoablation System is the first and only medical device to receive FDA marketing authorization for the local treatment of low-risk breast cancer with adjuvant endocrine therapy for women aged 70 and above, including patients who are not suitable for surgical alternatives for breast cancer treatment. A full list of benefits and risks can be found on the Company's website.

ProSense® is a minimally invasive cryosurgical tool that provides the option to destroy tumors by freezing them. The system uniquely harnesses 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.

ProSense® enhances patient and provider value by accelerating recovery, reducing pain, surgical risks, and complications. With its easy, transportable design and liquid nitrogen utilization, ProSense® opens the door to fast and convenient office-based procedures for breast tumors.

About IceCure Medical

IceCure Medical (Nasdaq: ICCM) develops and markets advanced liquid-nitrogen-based cryoablation therapy systems for the destruction of tumors (benign and cancerous) by freezing, with the primary focus areas being breast, kidney, bone and lung cancer. Its minimally invasive technology is a safe and effective option to surgical tumor removal that is easily performed in a relatively short procedure. The Company's flagship ProSense® system is marketed and sold worldwide for the indications cleared and approved to date including in the U.S., Europe and Asia.

Forward Looking Statement

This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and other Federal securities laws. Words such as "expects," "anticipates," "intends," "plans," "believes," "seeks," "estimates" and similar expressions or variations of such words are intended to identify forward-looking statements. For example, IceCure is using forward looking statements in this press release when it discusses: the potential of ProSense to provide an unprecedented option for women with early-stage low-risk breast cancer; that the FDA's marketing authorization for ProSense is expected to further drive commercial traction; and the high level of interest in ProSense received from clinicians translating into clinical adoption. Historical results of scientific research and clinical and preclinical trials do not guarantee that the conclusions of future research or trials will suggest identical or even similar conclusions. Important factors that could cause actual results, developments and business decisions to differ materially from those anticipated in these forward-looking statements include, among others: the Company's planned level of revenues and capital expenditures; the Company's available cash and its ability to obtain additional funding; the Company's ability to market and sell its products; legal and regulatory developments in the United States and other countries; the Company's ability to maintain its relationships with suppliers, distributors and other partners; the Company's ability to maintain or protect the validity of its patents and other intellectual property; the Company's ability to expose and educate medical professionals about its products; political, economic and military instability in the Middle East, specifically in Israel; as well as those factors set forth in the Risk Factors section of the Company's Annual Report on Form 20-F for the year ended December 31, 2024 filed with the SEC on March 27, 2025, and other documents filed with or furnished to the SEC which are available on the SEC's website, www.sec.gov. The Company undertakes no obligation to update these statements for revisions or changes after the date of this release, except as required by law. Information on, or accessible through, the websites mentioned above does not form part of this press release.

IR Contact:

Email: investors@icecure-medical.com

Michael Polyviou

Phone: 732-232-6914

Logo: https://mma.prnewswire.com/media/2319310/IceCure_Medical_Logo.jpg

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SOURCE IceCure Medical

FAQ

What FDA authorization did IceCure (ICCM) receive for ProSense and when?

The FDA granted marketing authorization on October 3, 2025 for ProSense to treat specified low-risk breast cancer patients.

Which patient group is covered by ProSense's FDA authorization (ICCM)?

The authorization covers patients ≥70 years with biologically low-risk tumors ≤1.5 cm treated with adjuvant endocrine therapy, and patients unsuitable for surgery.

How did ProSense perform at the TME Fall Summit referenced by IceCure (ICCM)?

ProSense drew a high level of interest during the Sept 26–27, 2025 summit and was featured in cryoablation sessions attended by 40+ KOLs.

Does the ProSense authorization expand beyond surgical candidates for breast cancer?

Yes; the authorization explicitly includes patients who are not suitable for surgery as an indicated group.

Which investigator and study were highlighted by IceCure (ICCM) at the summit?

Dr. Richard Fine, lead investigator of the U.S. ICE3 trial, led the cryoablation faculty and presented related data.