Core Points - IceCure Medical has received U.S. FDA marketing authorization for ProSense Cryoablation for the local treatment of low-risk breast cancer in women aged 70 and above when combined with Endocrine Therapy [3] Group 1 - The conference call was held to discuss the FDA's marketing authorization for ProSense Cryoablation [3] - Participants in the call included IceCure Medical's CEO Eyal Shamir and VP of Sales, North America, Shad Good [3] - The company believes that ProSense will be the only Cryoablation System approved in the U.S. for early-stage breast cancer in the foreseeable future [5]

PresentationGood morning, and thank you for standing by. [Operator Instructions] Please be advised that today's conference call is being recorded. I would now like to turn the conference over to Michael Polyviou. Please go ahead.Michael PolyviouEVC Group Inc. Thank you, Sarah, and welcome to IceCure Medical's conference call to discuss the company's receipt of the U.S. Food and Drug Administration's marketing authorization for ProSense Cryoablation in a specific indication for the local treatment of low-ris ...

Key Takeaways ICCM gains FDA authorization to market ProSense for low-risk breast cancer in U.S. women aged 70 .The approval, backed by ICE3 trial data, validates ICCM's ProSense as a minimally invasive alternative.ICCM's clearance opens U.S. sales, strengthens market edge, and supports faster revenue and adoption growth.IceCure Medical (ICCM) recently received FDA marketing authorization for its ProSense cryoablation system, marking the first approval for a minimally invasive treatment of low-risk breast c ...

Summary of IceCure Medical's Conference Call Company and Industry - **Company**: IceCure Medical Ltd - **Industry**: Medical Devices, specifically focused on breast cancer treatment Core Points and Arguments 1. **FDA Marketing Authorization**: IceCure Medical received FDA marketing authorization for the ProSense cryoablation system for local treatment of low-risk breast cancer in women aged 70 and above when combined with endocrine therapy [2][6] 2. **Target Population**: The approved indication covers approximately 46,000 women in the U.S. annually, specifically those with biologically low-risk tumors up to 1.5 centimeters who are not suitable for surgery [6][7] 3. **Innovative Treatment**: ProSense is the first and only medical device approved for breast cancer treatment that offers a minimally invasive outpatient procedure, which destroys tumors by freezing without removing breast tissue [7][8] 4. **Clinical Validation**: The FDA's decision was supported by data from the ICE3 study, showing outcomes comparable to traditional lumpectomy without surgery [7][10] 5. **Market Positioning**: The marketing authorization positions ProSense to set a new standard of care for eligible patient populations in the U.S. and reflects IceCure's commitment to improving women's quality of life globally [3][8] 6. **Reimbursement Strategy**: Procedures conducted through the post-market study will be eligible for CPT III reimbursement, which covers $3,800 of facility costs, potentially accelerating adoption across the U.S. [10][4] 7. **Global Expansion**: The FDA authorization is expected to have a global impact, facilitating regulatory submissions in other countries, including Japan and the European Union [11][12] Additional Important Content 1. **Post-Market Surveillance Study**: IceCure plans to conduct a post-market study involving approximately 400 patients across 30 sites, which will also serve as commercial sites for treatment [10][17] 2. **Future Capital Needs**: The company successfully raised $10 million in a rights offering to fund short-term commercialization and the post-market study [31] 3. **Go-to-Market Strategy**: IceCure's strategy includes expanding the U.S. sales team in 2026 and engaging with professional medical societies to ensure cryoablation is included in treatment guidelines [9][34] 4. **Potential for Off-Label Use**: Physicians may treat patients under 70 as off-label, particularly those who are non-candidates for surgery due to comorbidities [36][37] 5. **Upcoming Events**: The CFO will meet investors in Los Angeles and attend the Maxim Growth Conference in New York City later in October [39]

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 a ...

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 ...

Accessibility StatementSkip Navigation 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. LucÃa 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; se ...

Core Insights - IceCure Medical Ltd. showcased its ProSense® cryoablation technology at the CIRSE Annual Meeting, highlighting its potential in treating breast cancer and endometriosis [1][2][3] Company Participation and Technology - The company hosted numerous medical practitioners at its booth, featuring live demonstrations of ProSense®, which utilizes liquid nitrogen for cryoablation [1][2] - ProSense® is positioned as a minimally invasive alternative to surgical tumor removal, particularly for breast cancer patients [5][7] Clinical Studies and Findings - The PRECICE trial, led by Dr. Franco Orsi, is using ProSense® to treat 234 patients with early-stage breast cancer, indicating a broader patient demographic than previous studies [3][4] - A study presented by Dr. Sofia Baldi Giorgi found that cryoablation combined with hormonal therapy significantly reduced tumor size in surgery-ineligible patients [3][4] - Another study indicated that ProSense® is a safe and effective alternative for elderly patients with small HR+/HER2- breast cancers, with a median age of 86 years [4] - Research on abdominal wall endometriosis showed significant pain relief and treatment efficacy using ProSense®, with pain scores dropping from an average of 8 to 1 on a scale of 1 to 10 [4] Market Position and Future Outlook - IceCure Medical is focused on expanding the use of its cryoablation technology across various cancer types, including breast, kidney, lung, and liver cancers [5][7] - The ProSense® system is designed to enhance patient recovery, reduce pain, and minimize surgical risks, making it suitable for office-based procedures [6][7]

Core Insights - IceCure Medical has received regulatory approval for its XSense™ System with Cryoprobes, aimed at enhancing cryoprobe extraction and reducing tissue trauma risk, which leads to lower costs and improved patient experience [1][2] - The new cryoprobe technology integrates a heater, temperature sensor, and controlled gas pulses for precise temperature management during extraction, making it versatile for various clinical scenarios [2] Company Overview - IceCure Medical specializes in minimally-invasive cryoablation technology that destroys tumors by freezing, providing an alternative to surgical tumor removal [1][5] - The company's flagship products, ProSense® and XSense™ systems, utilize liquid nitrogen to create large lethal zones for effective tumor destruction in various types of lesions, including breast, kidney, lung, and liver [3][5] Product Benefits - IceCure's cryoablation systems enhance patient and provider value by accelerating recovery, reducing pain, and minimizing surgical risks and complications [4] - The design of the ProSense® and XSense™ systems allows for fast and convenient office-based procedures, particularly for breast tumors [4]

Core Viewpoint - IceCure Medical has received regulatory approval for its next-generation cryoablation system, XSense™, in Israel, enhancing its position in the minimally invasive treatment market for tumors [1][3]. Regulatory Approvals - The XSense™ system and its cryoprobes have been approved in Israel for a wide range of indications, including gynecology, oncology, and general surgery, similar to the approvals already granted to the ProSense system [1][3]. - As of mid-2024, XSense™ has also received regulatory clearance from the U.S. FDA for all indications for which ProSense has been approved [2]. Technology and Benefits - IceCure's cryoablation systems utilize liquid nitrogen to create large lethal zones for effective tumor destruction, applicable to both benign and malignant lesions, including those in the breast, kidney, lung, and liver [4][6]. - The systems are designed to enhance patient and provider value by accelerating recovery, reducing pain, and minimizing surgical risks and complications, making them suitable for office-based procedures [5][6]. Market Position and Future Outlook - The CEO of IceCure Medical emphasized that the latest regulatory approval reinforces the company's leadership in liquid-nitrogen-based cryoablation and supports the commercial adoption of cryoablation for breast cancer treatment [3]. - The company aims to leverage the growing body of evidence supporting cryoablation as a minimally invasive option to de-escalate cancer care and reduce treatment costs [3].