Anthony Vendetti

Eduardo Martinez-Montes

Kemp Dolliver

Yi Chen

Brian Kemp Dolliver

- IceCure Medical Ltd. received **FDA marketing authorization** for its ProSense® cryoablation system for the local treatment of breast cancer in women aged **70 and above** with biologically low-risk tumors \u22641.5 cm in size and treated with adjuvant endocrine therapy.  **[1584371_0001213900-25-096061_ea0260242-6k_icecure.htm:0]** **[1584371_0001213900-25-096061_ea026024201ex99-1_icecure.htm:0]** **[1584371_0001213900-25-096061_ea026024201ex99-2_icecure.htm:0]** 
- ProSense® is the **first and only medical device** to be granted FDA marketing authorization for the local treatment of breast cancer, addressing an estimated **46,000 women annually** in the U.S..  **[1584371_0001213900-25-096061_ea026024201ex99-1_icecure.htm:0]** **[1584371_0001213900-25-096061_ea026024201ex99-2_icecure.htm:0]** **[1584371_0001213900-25-096061_ea026024201ex99-2_icecure.htm:1]** 
- Initial reimbursement for the procedure is available under the CPT III code, covering **$3,800 of facility costs**.  **[1584371_0001213900-25-096061_ea026024201ex99-1_icecure.htm:0]** **[1584371_0001213900-25-096061_ea026024201ex99-1_icecure.htm:1]** 
- The FDA requested IceCure to conduct a **post-market surveillance study** involving approximately 400 patients at 30 sites, although the company is authorized to commence sales immediately.  **[1584371_0001213900-25-096061_ea026024201ex99-1_icecure.htm:0]** **[1584371_0001213900-25-096061_ea026024201ex99-2_icecure.htm:0]** **[1584371_0001213900-25-096061_ea026024201ex99-1_icecure.htm:1]**

IceCure Medical Receives FDA Marketing Authorization for ProSense® Cryoablation

- **IceCure Medical's ProSense® cryoablation system** has received **FDA marketing authorization** for the local treatment of early-stage, low-risk breast cancer in women aged **70 and over**.  **[1584371_20251003LN90154:0]** 
- This marks the **first and only medical device** to be granted FDA marketing authorization for the local treatment of breast cancer, offering a **minimally invasive outpatient procedure** as an alternative to surgical tumor removal.  **[1584371_20251003LN90154:0]** **[1584371_20251003LN90154:1]** 
- The authorization applies to patients aged **70 and above** with biologically low-risk tumors **≤1.5 cm** in size, combined with adjuvant endocrine therapy.  **[1584371_20251003LN90154:0]** 
- The FDA has requested a **post-market surveillance study** to gather additional data, expected to include approximately **400 patients** at **30 sites**.  **[1584371_20251003LN90154:0]**

IceCure Medical's ProSense® Cryoablation System Receives FDA Marketing Authorization

- IceCure Medical (ICCM) received **FDA marketing authorization** for its **ProSense® cryoablation system** for the local treatment of breast cancer in patients **≥70 years of age** with biologically low-risk tumors ≤1.5 cm and treated with adjuvant endocrine therapy.  **[1584371_20251003LN90141:0]** 
- ProSense® is the **first and only medical device** to be granted FDA marketing authorization for this specific indication, which applies to approximately **46,000 women annually** in the U.S..  **[1584371_20251003LN90141:0]** **[1584371_20251003LN90141:1]** 
- Initial reimbursement is available under the CPT III code, covering **$3,800 of facility costs**, with additional reimbursement coverage expected.  **[1584371_20251003LN90141:0]** **[1584371_20251003LN90141:1]** 
- IceCure's U.S. sales and distribution team is prepared to drive sales, and the company can immediately commence ProSense® sales and procedures.  **[1584371_20251003LN90141:0]**

IceCure Medical Receives FDA Marketing Authorization for ProSense® Cryoablation System

- IceCure Medical Ltd. participated in the European Society of Breast Imaging (EUSOBI) Congress 2025 from **September 25-27, 2025**, showcasing its **ProSense\u00ae** cryoablation technology.  **[1584371_0001213900-25-093467_ea025946301ex99-1_icecure.htm:0]** 
- An exclusive workshop on cryoablation for breast cancer, sponsored by IceCure, was **filled to capacity**, indicating significant interest in the ProSense\u00ae system.  **[1584371_0001213900-25-093467_ea025946301ex99-1_icecure.htm:0]** 
- **Five independent investigator studies** presented positive results for ProSense\u00ae in breast cancer cryoablation, supporting its use as a minimally invasive treatment option.  **[1584371_0001213900-25-093467_ea025946301ex99-1_icecure.htm:0]** 
- Key findings from the studies included a **75.8%** cumulative complete response rate and **96.8%** overall disease control rate at 12 months in one study, and a **91.2%** tumor-free rate when cryoablation was combined with hormone therapy in another.  **[1584371_0001213900-25-093467_ea025946301ex99-1_icecure.htm:1]** 
- Studies also reported **excellent short-term outcomes**, such as all patients rating cosmetic outcomes as **5 out of 5** and a mean pain score of **1.6 out of 10** in one study, with no major complications.  **[1584371_0001213900-25-093467_ea025946301ex99-1_icecure.htm:1]**

IceCure Medical's ProSense\u00ae Showcased at European Breast Imaging Congress with Positive Study Results

- IceCure Medical announced the presentation of **positive results from 5 independent studies** on its **ProSense® cryoablation technology for breast cancer** at the European Society of Breast Imaging (EUSOBI) Congress 2025.  **[1584371_20250930LN86952:0]** 
- An exclusive workshop sponsored by IceCure on cryoablation for breast cancer was **filled to capacity**, indicating strong interest in the technology.  **[1584371_20250930LN86952:0]** 
- Studies highlighted ProSense® as a **safe, effective, and minimally invasive alternative to surgery** for early-stage breast cancer, with one study showing a **75.8% cumulative complete response rate** and **96.8% overall disease control rate** at 12 months for cryoablation alone.  **[1584371_20250930LN86952:1]** 
- IceCure's CEO, Eyal Shamir, stated that ProSense® represents the next step in the de-escalation of care for early-stage breast cancer, offering superior cosmetic outcomes and effectiveness comparable to surgery, with the breast cancer indication already approved in the European Union.  **[1584371_20250930LN86952:0]**

IceCure Medical Presents Positive ProSense® Study Results at EUSOBI Congress 2025

- **IceCure Medical Ltd.** has received a **Notice of Allowance** from the U.S. Patent and Trademark Office for its patent titled "**Cryoprobe**".  **[1584371_20250918IO76847:0]** 
- This invention is designed to **improve cryoprobe extraction**, aiming to **reduce the risk of tissue trauma**, lower costs, and enhance patient experience during cryoablation procedures.  **[1584371_20250918IO76847:0]** 
- The new cryoprobe technology is integrated into IceCure's **next-generation XSense™ system**, which recently received **regulatory approval in the U.S. and Israel**.  **[1584371_20250918IO76847:0]**

IceCure Medical Receives U.S. Patent Notice for Next-Generation XSense™ Cryoprobes

- **IceCure Medical Ltd.** received **regulatory approval in Israel** for its **next-generation XSense™ Cryoablation System** on **September 15, 2025**, for breast cancer and a broad range of other indications.  **[1584371_0001213900-25-087437_ea0257350-6k_icecure.htm:0]** **[1584371_0001213900-25-087437_ea025735001ex99-1_icecure.htm:0]** 
- The XSense™ system is now approved in Israel for indications including general surgery, dermatology, neurology, thoracic surgery, ENT, gynecology, oncology (including benign and malignant breast tumors), proctology, and urology.  **[1584371_0001213900-25-087437_ea025735001ex99-1_icecure.htm:0]** 
- This system had previously secured **U.S. FDA clearance as of mid-2024** for all indications already approved for the company's flagship ProSense® system.  **[1584371_0001213900-25-087437_ea025735001ex99-1_icecure.htm:0]** 
- CEO Eyal Shamir stated that this approval **reaffirms IceCure's leadership** in liquid-nitrogen based cryoablation and is expected to support **accelerated commercial adoption**, particularly for breast cancer.  **[1584371_0001213900-25-087437_ea025735001ex99-1_icecure.htm:0]**

IceCure Medical Receives Israeli Regulatory Approval for XSense™ Cryoablation System

- **IceCure Medical Ltd.** received regulatory approval from **Israel's Ministry of Health (AMAR)** on **September 15, 2025**, for its **next-generation single cryoprobe cryoablation system, the XSense™ System and CryoProbes**.  **[1584371_20250915IO73208:0]** 
- This approval covers a **broad range of indications**, including gynecology, oncology (specifically **breast cancer**), and general surgery.  **[1584371_20250915IO73208:0]** 
- The **XSense™ system** had previously received **U.S. Food and Drug Administration (FDA) regulatory clearance** as of **mid-2024** for all indications already approved for the company's ProSense® system.  **[1584371_20250915IO73208:0]**