Core Insights - The FDA granted marketing authorization for ProSense® for the local treatment of low-risk breast cancer in patients aged 70 and above, following the TME Fall Summit, which is expected to enhance commercial traction due to significant interest from key opinion leaders [2][5]. Company Overview - IceCure Medical Ltd. specializes in minimally-invasive cryoablation technology, which destroys tumors by freezing, providing an alternative to surgical tumor removal [1][8]. - The ProSense® Cryoablation System is the first and only device authorized by the FDA for treating low-risk breast cancer in specific patient demographics, including those unsuitable for surgery [5][6]. Event Participation - IceCure participated in the TME Take the Lead in Breast Cancer Care Fall Summit, which gathered over 40 key opinion leaders to discuss advancements in breast cancer care, particularly focusing on de-escalation strategies and minimally invasive options [1][2]. Clinical Engagement - The company received high interest during a cryoablation faculty session led by Dr. Richard Fine, a prominent investigator in the ICE3 trial, which is the largest cryoablation study in the U.S. [3][4]. - The TME summit highlighted the growing relevance of cryoablation in breast oncology treatment planning, indicating a shift towards less invasive treatment options [2][3]. Product Features - ProSense® utilizes liquid nitrogen to create large lethal zones for effective tumor destruction, enhancing patient recovery by reducing pain and surgical risks [6][7]. - The system is designed for easy transport and can facilitate fast, office-based procedures for breast tumors, making it a convenient option for both patients and providers [7][8].

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]

Core Viewpoint - 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]. Company Summary - IceCure Medical's ProSense Cryoablation is now the only Cryoablation System approved in the U.S. for early-stage breast cancer, positioning it to potentially set a new standard of care for the appropriate patient population [5]. - The conference call included participation from IceCure Medical's CEO Eyal Shamir and VP of Sales, North America, Shad Good, indicating a strong leadership presence in discussing the implications of this authorization [3]. Industry Summary - The marketing authorization from the FDA is a significant milestone for the industry, as it highlights advancements in treatment options for low-risk breast cancer, particularly for older women [3]. - The approval may influence future treatment protocols and standards of care within the oncology sector, especially concerning cryoablation technologies [5].

Core Insights - IceCure Medical (ICCM) has received FDA marketing authorization for its ProSense cryoablation system, the first minimally invasive treatment for low-risk breast cancer in women aged 70 and above, positioning it as an alternative to lumpectomy [1][8] - The approval opens commercial opportunities in the U.S. and validates IceCure's leadership in cryoablation technology, with established reimbursement pathways enhancing adoption prospects [2][4] Company Summary - Following the FDA announcement, ICCM shares rose by 12% in after-market trading, although the stock has seen a year-to-date decline of 12.4% compared to the industry’s 5.2% growth and the S&P 500's 15.2% gain [3] - ICCM's market capitalization stands at $66.2 million, with an expected earnings growth of 26.7% in 2025 [5] Competitive Position - The FDA authorization significantly enhances IceCure's commercial outlook by granting access to the U.S. breast cancer treatment market, establishing a competitive moat against rivals who will face higher clinical data requirements for entry [4][10] - ProSense benefits from a CPT III reimbursement code covering $3,800 of facility costs, with potential for expanded coverage as adoption increases, positioning IceCure for accelerated revenue growth and market penetration [10] Clinical Validation - The FDA's decision was supported by robust clinical data from the ICE3 trial, demonstrating outcomes comparable to traditional surgical methods while offering a quicker, minimally invasive procedure [9] - IceCure plans to conduct a post-market study involving around 400 patients across 30 sites in the U.S. to further validate long-term efficacy, which will also serve as commercial centers for efficient rollout [9] Industry Outlook - The global cryoablation for cancer market was valued at $3.5 billion in 2024 and is projected to grow at a CAGR of 6.1%, reaching $5.8 billion by 2033, driven by rising cancer incidence and an aging population [11][12] - The increasing adoption of cryoablation for smaller tumors is a major driver of market expansion, as it offers fewer side effects compared to traditional treatments [12]

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]

Core Insights - The FDA has granted marketing authorization for ProSense®, a minimally invasive cryoablation treatment for early-stage low-risk breast cancer, marking a significant innovation in breast cancer treatment [1] - ProSense® offers a non-surgical option that destroys tumors by freezing, providing efficacy and safety comparable to standard lumpectomy, along with excellent cosmetic results and high patient satisfaction [1] - The treatment is specifically indicated for women aged 70 and over, with an estimated annual patient population of 46,000 in the U.S. [1] Company Overview - IceCure Medical Ltd. is the developer of the ProSense® technology, which represents the first new innovation in local treatment for early-stage breast cancer in decades [1] - The company is publicly traded on Nasdaq under the ticker ICCM [1] - A conference call is scheduled for October 6, 2025, to discuss the implications of this FDA authorization [1]

Core Insights - IceCure Medical Ltd. has received FDA marketing authorization for its ProSense® cryoablation system, marking a significant advancement in breast cancer treatment [1] - The ProSense® system offers a minimally invasive outpatient procedure as an alternative to traditional lumpectomy [1] - Initial reimbursement under the CPT III code covers $3,800 of facility costs, with expectations for additional reimbursement coverage [1] Company Developments - The ProSense® system is specifically authorized for local treatment of breast cancer in patients aged 70 years with biologically low-risk tumors measuring 1.5 cm, who are treated with adjuvant endocrine therapy [1] - This authorization represents a potential market of approximately 46,000 women annually in the U.S. who may benefit from this treatment option [1] - The U.S. sales and distribution team is prepared to promote ProSense® systems and disposable probes, aiming to support both the medical community and patients [1] Industry Impact - The response from leading U.S. breast surgeons and radiologists has been enthusiastic, indicating strong interest in the new treatment option [1] - A conference call is scheduled for October 6 at 8:30 AM Eastern Time to discuss further details regarding the ProSense® system [1]

Core Insights - IceCure Medical's ProSense® technology is positioned as a minimally invasive alternative for early-stage breast cancer treatment, emphasizing its effectiveness and superior cosmetic outcomes compared to traditional surgical methods [2][4][6]. Company Participation and Events - IceCure Medical participated in the European Society of Breast Imaging (EUSOBI) Congress 2025, where their workshop on cryoablation for breast cancer was filled to capacity, indicating strong interest in their technology [1][2][3]. Research and Clinical Findings - Five abstracts were presented at the EUSOBI Congress, showcasing independent studies on ProSense® for breast cancer cryoablation, highlighting its growing adoption in Europe [1][2][3]. - Dr. Francesca Pugliese received the Young Physician-Scientist Grant for her study on lesion conspicuity imaging as a potential noninvasive biomarker for treatment evaluation, which was selected as one of the top five abstracts [1][3]. ProSense® Technology - ProSense® utilizes liquid nitrogen to create large lethal zones for tumor destruction, applicable to various lesions including breast, kidney, lung, and liver [4][5][6]. - The system is designed to enhance patient and provider value by accelerating recovery, reducing pain, and minimizing surgical risks [5][6]. Clinical Efficacy - At 12 months, the cumulative complete response rate in the cryoablation group was 75.8%, with an overall disease control rate of 96.8%, demonstrating its effectiveness compared to hormone therapy [7]. - In a study comparing cryoablation alone, cryoablation plus hormone therapy, and hormone therapy alone, the combination group showed the highest tumor-free rate at 91.2% [7].

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]