IceCure Medical

ICCM

Market cap $49M

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.

IceCure recently achieved a significant milestone—ProSense® Cryoablation system became the first and only medical device to be granted FDA marketing authorization for the local treatment of breast cancer CAESAREA, Israel , Oct. 9, 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 that members of the Company's management, including Eyal Shamir, Chief Executive Officer, will be participating in Maxim's Growth Summit held in New York City on October 22 nd and 23rd, 2025.

IceCure Medical Ltd - Special Call Company Participants Eyal Shamir - CEO & Director Shad Good Ronen Tsimerman - CFO & COO Conference Call Participants Michael Polyviou - EVC Group Inc. Anthony Vendetti - Maxim Group LLC, Research Division Brian Kemp Dolliver - Brookline Capital Markets, LLC, Research Division Presentation Operator Good morning, and thank you for standing by. [Operator Instructions] Please be advised that today's conference call is being recorded.

IceCure Medical shares surge after FDA clears ProSense, marking the first minimally invasive breast cancer treatment for women aged 70 and above.

ProSense ® cryoablation offers the choice of  a minimally invasive outpatient procedure that destroys tumors by freezing without surgical removal of breast tissue  First new innovation in the local treatment of early-stage, low-risk breast cancer in decades  and only medical device to be granted FDA marketing authorization for breast cancer treatment  Offers efficacy and safety similar to standard of care lumpectomy, with excellent cosmetic results and patient satisfaction Company conference call to be held at Monday, October 6 at 8:30 AM Eastern Time CAESAREA, Israel , Oct. 3, 2025 /PRNewswire/ -- The U.S. Food and Drug Administration ("FDA") has granted marketing authorization for ProSense®, a minimally invasive cryoablation treatment for patients with early-stage low risk breast cancer when combined with adjuvant endocrine therapy for women aged 70 and over, an estimated population of 46,000 women annually in the U.S. The announcement was made on October 3, 2025, by IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure", "IceCure Medical" or the "Company"), the developer of minimally invasive cryoablation technology that destroys tumors by freezing as an option to surgical tumor removal.

ProSense® is the first and only medical device to be granted FDA marketing authorization for the local treatment of breast cancer Major advancement and new paradigm in breast cancer care as a simple, minimally invasive out-patient procedure Initial reimbursement under the CPT III code which covers $3,800 of facility costs, with additional reimbursement coverage expected U.S. sales and distribution team ready to drive sales of ProSense® systems and disposable probes—supporting medical community and patients looking for a new minimally invasive option to lumpectomy  Enthusiastic response f rom top U.S. breast surgeons and radiologists Conference call to be held Monday, October 6 at 8:30AM Eastern Time CAESAREA, Israel , Oct. 3, 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 that the U.S. Food and Drug Administration ("FDA") has granted marketing authorization to IceCure's De Novo application for the ProSense® cryoablation system 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, representing approximately 46,000 women annually in the U.S. The authorized indication includes patients that are not suitable for surgery for breast cancer treatment.

IceCure's exclusive workshop was filled to capacity – Unlocking De-Escalation of Care: Cryoablation for Breast Cancer led by Key Opinion Leaders Dr. Federica Di Naro  and Dr. Lucía Graña-Lopez  5 abstracts presented from doctors using ProSense® for breast cancer cryoablation in Europe Dr. Francesca Pugliese awarded Young Physician-Scientist Grant for her study on post-procedure lesion conspicuity imaging as potential noninvasive biomarker for treatment evaluation; selected as one of the top 5 abstracts   CAESAREA, Israel , Sept. 30, 2025 /PRNewswire/ -- IceCure Medical Ltd.

Presentations from 5 Key Opinion Leaders on ProSense® cryoablation including 3 independent studies on breast cancer and 1 on endometriosis    3 hands-on training sessions for doctors interested in using ProSense® were very well attended Dedicated CIRSE focus session on the breast shows the growing interest from interventional radiologists to expand their practice to include care for breast cancer patients CAESAREA, Israel , Sept. 22, 2025 /PRNewswire/ -- IceCure Medical Ltd.

The invention is designed to improve cryoprobe extraction, further reducing risk of tissue trauma, leading to lower costs and improved patient experience XSense™ System with Cryoprobes recently received regulatory approval in the U.S. and Israel CAESAREA, Israel , Sept. 18, 2025 /PRNewswire/ -- IceCure Medical Ltd.

Approved for a broad range of indications including in gynecology, oncology and general surgery CAESAREA, Israel , Sept. 15, 2025 /PRNewswire/ -- IceCure Medical Ltd.