THE COMPANY A. History and Development of the Company. We are an Israeli corporation based in Caesarea, Israel and were incorporated in Israel in 2006. On February 2, 2011, we became a public company in Israel and our shares were listed for trade on the TASE. On August 26, 2021, our shares were listed for trade on Nasdaq under the symbol “ICCM.” On July 24, 2023, we delisted our Ordinary Shares from the TASE. Our principal executive offices are located at 7 Ha’Eshel St., PO Box 3163, Caesarea, 3079504 Israel. Our telephone number in Israel is +972-4-6230333. Our website address is http://www.icecure-medical.com. The information contained on our website or available through our website is not incorporated by reference into and should not be considered a part of this annual report on Form 20-F, and the reference to our website in this annual report on Form 20-F is an inactive textual reference only. IceCure Medical Inc. is our agent in the United States, and its address is 10 W Prospect Street, Suite 401, Nanuet, New York 10954. We are an “emerging growth company,” as defined in Section 2(a) of the Securities Act of 1933, as amended, or the Securities Act, as modified by the JOBS Act. As such, we are eligible to, and intend to, take advantage of certain exemptions from various reporting requirements applicable to other public companies that are not “emerging growth companies” such as not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act of 2002, or the Sarbanes-Oxley Act. We could remain an “emerging growth company” for up to five years, or until the earliest of (a) the last day of the first fiscal year in which our annual gross revenues exceeds $1.235 billion, (b) the date that we become a “large accelerated filer” as defined in Rule 12b-2 under the U.S. Securities Exchange Act of 1934, as amended, or the Exchange Act, which would occur if the market value of our Ordinary Shares that is held by non-affiliates exceeds $700 million as of the last business day of our most recently completed second fiscal quarter, or (c) the date on which we have issued more than $1 billion in nonconvertible debt during the preceding three-year period. The SEC maintains an internet site, http://www.sec.gov that contains reports, proxy and information statements, and other information regarding issuers that file electronically with the SEC. Our internet address is https://www.icecure-medical.com. The information on that website is not part of this Annual Report and is not incorporated by reference herein. We are a foreign private issuer as defined by the rules under the Securities Act and the Exchange Act. Our status as a foreign private issuer also exempts us from compliance with certain laws and regulations of the SEC and certain regulations of the Nasdaq Stock Market, including the proxy rules, the short-swing profits recapture rules, and certain governance requirements such as independent director oversight of the nomination of directors and executive compensation. In addition, we are not required to file annual, quarterly and current reports and financial statements with the SEC as frequently or as promptly as U.S. domestic companies registered under the Exchange Act. 47 In 2024 and 2025, our capital expenditures amounted to $71 thousand and $36 thousand, respectively. Our current capital expenditures are primarily for manufacturing facility and equipment, computers, software, research and development equipment and office improvements substantially all in Israel, and we expect to finance these expenditures primarily from cash on hand. B. Business Overview. We are a commercial stage medical device company focusing on the research and development of cryoablation systems, disposables based on LN2 for treating tumors. Cryoablation is the process by which benign and malignant tumors, nerves or other tissues are ablated (destroyed) through freezing such tumors while in a patient’s body. Our proprietary cryoablation technology is a minimally invasive alternative to surgical intervention, for tumors including those found in the breast, lungs, kidneys, bones, tissues and other indications, as well as for nerve ablation for pain management and the treatment of other conditions such as endometriosis. Our lead commercial cryoablation product is the ProSense system, as pictured below, and the associated CryoProbes. The ProSense system has received marketing authorization from the FDA 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. Alongside our continued efforts at improving our core technology, including our flagship product, the ProSense system, which has received FDA marketing authorization for patients with low risk breast cancer when combined with adjuvant endocrine therapy for women aged 70 and over, we are also focused on new product developments. This includes our XSense system with CryoProbes for which we have received 510(k) regulatory clearance from the FDA. We believe that the XSense system with CryoProbes can serve as a platform that will allow us to develop other unique CryoProbes and catheters and expand our clinical applications, and that it is also more efficient, intuitive and user friendly. Our pipeline also includes MSense which could enable the treatment of multiple and larger tumors (see “Item 4.B. Business Overview – Our Products – Research and Development” for additional information). 48 We believe that obtaining regulatory approval for our existing and next-generation products for specific indications will help us grow our business. As of December 31, 2025, in the United States, we have a broad range of regulatory approvals for our systems to be used as a cryosurgical tool in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery, ENT, gynecology, oncology, proctology and urology. In the United States our products are cleared as a “single family” known as the “IceCure Family,” which includes the IceSense3, ProSense, XSense, and MSense cryoablation systems, the latter of which has not been commercialized. Although our existing, “IceCure Family” systems have regulatory clearance from the FDA for commercialization in the United States, only ProSense has received FDA marketing authorization for the treatment of early-stage, biologically low-risk breast cancer in a defined patient population, while our other systems have not yet received FDA clearance or authorization for the treatment of malignant breast tumors and would require separate regulatory approval or authorization for such indications. The FDA classifies medical devices into one of three classes (Class I, Class II, or Class III) depending on their level of risk and the types of controls that are necessary to ensure device safety and effectiveness. The class assignment is a factor in determining the type of premarketing submission or application, if any, that will be required before marketing products in the United States. On October 18, 2022, we requested that De Novo classification would be granted for our ProSense system for breast cancer indication. Because of this De Novo classification request, we would be required to accept special controls imposed by the FDA, mainly on the production process and post-market monitoring. This De Novo classification request regulatory filing with the FDA for marketing authorization was based on our ICE3 clinical trial interim analysis of ProSense for the indication of early-stage (Luminal A T1 invasive) low-risk breast cancer in patients who are at high risk to surgery (not suitable for surgical alternatives). On September 20, 2023, we received notice that the FDA denied our De Novo classification request and on November 15, 2023 we filed a request with the FDA for supervisory review under 21 CFR 10.75. On January 30, 2024, we announced that the FDA responded affirmatively to our request and determined that there is sufficient basis to reopen the De Novo file if we submit the full 5-year dataset from our ICE3 trial. On March 15, 2024, the last patient in the ICE3 trial concluded her 5 year-follow-up. 96.39% of the patients from the study were local recurrence-free with no significant device-related adverse events or complications reported. Having compiled and submitted the dataset and comparative analysis of the ICE3 results versus the data from the LUMINA study, the FDA convened a medical device advisory committee panel, or the Advisory Panel, to review the De Novo marketing authorization request for ProSense on November 7, 2024, the decision about which is expected to be delivered by the FDA after the first quarter of 2025. The Advisory Panel included breast surgeons, interventional radiologists, breast oncologists, and representatives from the patient, consumer, and regulatory communities. The purpose of the Advisory Panel was for the FDA to obtain independent non-binding expert advice on scientific, technical and policy matters related to the potential granting of marketing authorization of ProSense for treating patients with early-stage low risk invasive breast cancer with cryoablation and adjuvant endocrine therapy. The majority of panelists voted that the benefits of ProSense outweigh the risks when used according to the proposed indications for the treatment of patients with early-stage low risk invasive breast cancer with cryoablation and adjuvant endocrine therapy. The Advisory Panel’s favorable vote was based on the comprehensive body of data available on ProSense as a treatment for early-stage low risk breast cancer, including results from the ICE3 study compared with data from the current standard of care, lumpectomy, as well as testimonials and input from a broad range of key stakeholders, including women with breast cancer and their family members, patient advocacy groups, doctors, nurses and researchers. On October 3, 2025, ProSense received FDA marketing authorization for the treatment of biologically low-risk breast cancer in women aged 70 and above who receive adjuvant endocrine therapy for such breast cancer. See “Item 4.B. Business Overview – Government Regulation” and “Item 4.B. Business Overview – Malignant Breast Tumors” for additional information. In October 2025, we received FDA marketing authorization for our ProSense system for the treatment of low-risk breast cancer in women aged 70 and above. In March 2026, the American Society of Breast Surgeons, or the ASBrS, updated their resource guides to support cryoablation as an additional option to surgery. Other key steps to gaining market acceptance depends on obtaining CPT I codes for cryoablation for breast cancer (with the support of the ASBrS), negotiating medical coverage for our systems from medical insurers and collaborating with a major distributor of medical devices. (see ““Item 4.B. Business Overview – Government Regulation – FDA Regulation of Medical Devices” and “Item 3.D. Risk Factors – Risks Related to Product Development and Regulatory Approval”” for additional information). 49 In addition, there is significant competition in the medical devices and cancer treatment market. Some of our competitors possess significant market share, reputation, and longevity within the industry and have greater brand recognition and financial and human resources than us. They also have more experience and capabilities in researching and developing testing devices, obtaining and maintaining regulatory clearances, manufacturing and marketing those products and other requirements, than us. Their dominant market positions and significant control over the market could significantly limit our ability to introduce or effectively market and generate sales and capture market share. To date, we have incurred significant operating losses, generated minimal revenues from product sales, and as of December 31, 2025 and 2024, our accumulated deficit was $120.4 million and $105.4 million, respectively. We expect that we will need to raise substantial additional funding in the future (see “Item 3.D. Risk Factors – Risks Related to Our Financial Condition and Capital Requirements”). In the United States, European Union, Switzerland, Canada, China, Singapore, India, Hong Kong, Russia, Thailand, Taiwan, South Africa, Mexico, Australia, Israel, Costa Rica, Turkey, and Brazil we have regulatory approvals for either our ProSense or our IceSense3 systems, or, in certain countries, both products (see “Item 4.B. Business Overview – Our Products – Regulatory Approvals” for additional information). In the United States and in Israel, we have regulatory approval for the XSense system with CryoProbes for all the indications for which ProSense has already received the requisite FDA clearance. In addition, in order to generate significant revenue, we are applying for additional regulatory approvals for our products for specific indications in countries where we already have general regulatory approvals. For example, we filed a submission for regulatory approval for the ProSense with CryoProbes in China with the National Medical Products Administration, or the NMPA, in January 2025. In these countries, we are seeking regulatory approval for the treatment of specific tumors, including those found in the breast, lungs, kidneys and bones. In addition, we are seeking regulatory approvals for our systems in other countries where we believe that there is significant potential for sales of our products. In March 2023, the NMPA approved the IceSense3 disposable CryoProbes for commercial use, to be used in combination with our IceSense3 system. This approval enables us to market our disposable IceSense3 CryoProbes for commercial procedures. In September 2025, the Medical Device Division of the Israeli Ministry of Health, or the AMAR, approved our XSense system with CryoProbes for commercial use across multiple indications including in gynecology, oncology and general surgery. The procedure using our cryoablation systems begins with the introduction of our proprietary disposable probes, through a small pea-sized incision in the skin, into the tumor while the patient is under local anesthesia and/or sedation. The probe is guided by high-resolution ultrasound (for breast tumors) or computed tomography, or CT (for other indications). For some indications guiding needles (introducers) are used to guide the probe to the tumor. Once the probe is in place, LN2 is introduced into the probe in a closed-loop circuit, so that LN2 does not enter the body, and creates a freezing zone around the tip of the probe. During the freeze cycle, an ice ball forms in the freezing zone and encompasses the tumor, ablating the cancer or benign tumor. The ice ball form can be monitored by the physician using ultrasound or CT in order to avoid causing damage to the healthy tissue surrounding the tumor. Several minutes after the procedure is completed, the ice ball thaws and, as a result thereof, there is no need for surgical removal of the dead tumor tissue as the dead tissue is naturally absorbed by the body. The entire cryoablation procedure of freeze-thaw-freeze with our ProSense system generally takes between 15 to 40 minutes, the precise time depending on the size, type and location of the tumor. The same system configuration can be used for and was designed to treat both malignant and non-malignant tumors. However, there is usually a different configuration for the probe handle between the systems used to treat breast tumors (with a primarily straight handle) and used to treat other indications (with a 90-degrees handle) due to the different imaging devices that are used in each instance (see “Item 4.B. Business – Our Products” for additional information). Pictured below is our system forming an ice ball (which in practice forms around the tissue within the body) in ultrasound gel. As a minimally invasive alternative to surgery, cryoablation is much less traumatic than open surgery, and, based on current data, we believe this treatment is more affordable, entails less risk and generally results in fewer side effects and complications than open surgery. On the patient side, following procedures with our cryoablation technology, patients usually can resume normal activities within 24 hours after the procedure. In addition, the use of our technology in breast procedures eliminates the need for a post-procedure reconstruction surgery. Moreover, our procedure eliminates the need for re-excision following a lumpectomy for breast cancer, which ranges between 14% to 20% of initial lumpectomies. This data is indicated in a study published on February 21, 2019 by Liska Havel, Himani Naik, Luis Ramirez et al titled “Impact of the SSO-ASTRO Margin Guideline on Rates of Re-excision After Lumpectomy for Breast Cancer: A Meta-analysis,” and a study published on May 20, 2020, in the Journal of Clinical Oncology by Mariana Chavez-MacGregor, Xiudong Lei, Nina Tamirisa. Abigail Suzanne Caudle, Sharon H. Giordano entitled “Re-excision rates among older breast cancer patients undergoing breast-conserving surgery, or BCS, Impact of the SSO-ASTRO consensus guideline on margins”. On the health provider side, procedures with our cryoablation technology for breast tumors may be carried out in a clinic, while treatment for other indications can generally be carried out as an outpatient procedure, in a CT room. As a result, the potential profit margins for health care providers and payors are greater than most of the current surgical procedures that are conducted in the operating room, which entail additional and expensive cost elements for the operating room and its staff. In addition, we believe that our LN2-based technology provides patients, medical service providers, physicians and insurers with advantages versus our competitors, especially those using heat to treat tumors, also known as thermal ablation (otherwise known as heat ablation). For example, the freezing effect on tissue from cryoablation results in less pain, and accordingly less anesthesia (which also reduces costs). A study published on April 8, 2021 by Elles M.F. van de Voort et al titled “Thermal Ablation as an Alternative for Surgical Resection of Small (≤2 cm) Breast Cancers: A Meta-Analysis” suggested that cryoablation has the lowest complication rate among breast cancer tumor procedures and the advantage of an analgesic effect. In addition, in comparison to the treatment of tumors with heat, when treating a tumor with cryoablation, the freezing does not cause evaporation of the treated tissue and therefore provides the physician conducting the treatment with a clearer view of the tissue, which we believe enables the physician to carry out the procedure more accurately with a precise view of the tumor and the treated area. 50 According to an investigator-led randomized phase II study on post-menopausal patients with CT1N0 breast cancer, which compared cryoablation with RFA and MWA, cryoablation achieved complete ablation rate of 94% while other ablative techniques had lower success rates. For those who underwent RFA and MWA, the complete ablation rates were 33% and 72% respectively. On September 28, 2023, an independent study, overseen and conducted at the Breast Center of Excellence and the Department of Surgery, School of Medicine at Texas Tech University Health Sciences Center, was published called “Cryoablation Allows the Ultimate De-escalation of Surgical Therapy for Select Breast Cancer Patients” in the Annals of Surgical Oncology. The study’s authors concluded that the success of the clinical trial analyzed in the paper showed that cryoablation is as effective as surgical resection for early-stage, low-risk tumors, is a superior alternative financially. Furthermore, they concluded, the two multi-institutional studies on cryoablation by Simmons et al. on ACOSOG Z-1072 and Fine et al. on ICE3 have shown that cryoablation ensures surgical de-escalation for small, early-stage, low-risk breast cancers. On October 17, 2023, a paper called “Cryoablation Therapy for Early-Stage Breast Cancer: Evidence and Rationale”, co-authored by Robert C.Ward, MD and Alexander B. Sevrukov, MD, was published in the Journal of Breast Imaging. The paper describes the efficacy of less aggressive and invasive treatment of early-stage breast cancer of patients who have small, lower-risk tumors. Furthermore, it highlights the faster recovery, improved cosmetics and that it has advantage of being administered under local anesthesia. On November 22, 2023, a study was published called “Piezo1 facilitates optimal T cell activation during tumor challenge” in Oncolmmunology. The study explored the role of the Piezo1 protein in regulating T-cell tumor immune-mediated rejection of soft tissue tumors through cryoablation. The data from the study show that cryoablation induces immune rejection by enhancing CD8+ T cell activation. Increased activation and responsiveness, leading to a more robust immune response against abnormal cells, was detected up to 2 weeks after cryoablation, displayed as an increase in CD25 and interferon gamma expression on CD8+ T cells. We believe that cryoablation has already started to be recognized for its true potential, and that it represents the future of treatment for certain benign and malignant tumors. Our ongoing business strategy, as further detailed below, is focused on helping us overcome certain factors that have limited our ability to generate significant revenues, including, but not limited to, obtaining additional regulatory clearance, obtaining support of key opinion leaders and leading medical associations for the use of cryoablation (and specifically, our systems) for the treatment of tumors and other indications. In recent years, and in part due to our efforts and accomplishments, cryoablation of malignant breast tumors has been recognized for its vast potential. For example, following preliminary results of our ICE3 trial, which we presented at the yearly conference of the ASBrS in May 2018, and at the yearly Radiological Society of North America, or RSNA, conference in October 2018, the ASBrS, which, among other things, sets resource guides for breast cancer treatment, updated its resource guide on performing cryoablation procedures on breast malignant tumors in their early stages. While not cited by the ASBrS, based on our discussions with the ASBrS, we believe that the results of our study were a factor in the ASBrS decision to update its resource guide. (see “Item 4.B. Business Overview – Our Lead Indication and Market Opportunity – Primary Indication – Breast Tumors – Malignant Breast Tumors – Multi-Site Clinical Trial of the Cryoablation System ICE3 Study – United States” for additional information). 51 In January 2026, the ASBrS announced a proposed update to its "Resource Guide on the Use of Transcutaneous and Percutaneous Ablation for the Treatment of Benign and Malignant Tumors of the Breast," which, if finalized, would include cryoablation as a recommended treatment option for low-risk breast cancer in patients aged 70 and above with biologically low-risk tumors measuring 1.5 cm or less who are treated with adjuvant endocrine therapy, as well as for small benign breast tumors such as fibroadenomas. In March 2026, the ASBrS updated its resource guide, becoming the first medical society to include cryoablation in its treatment resource guide for breast cancer. We believe this update in the ASBrS resource guide will support broader physician adoption, expand reimbursement coverage, and accelerate commercial adoption of cryoablation as a standard-of-care treatment option. Revenues and Growth Strategy Our strategic objective is to be the leader in the field of cryoablation treatment for benign and malignant breast tumors and other interventional oncology indications. Using our innovative ProSense LN2 cryoablation system (and, in the future, potentially using our next generation systems) and propriety disposable probes and introducers, we intend to create a recurring revenues stream by selling single use probes to the users of our ProSense system. For tumors which are not in the breast, we also sell a disposable (single use) introducer which is used to assist with navigating the probe to the tumor. Our revenues are based on a number of business models, which include: ● the sale of our systems and disposables to distributors and/or end users; ● placing the system and attaining end user commitments to purchase a minimum number of disposable probes per month; and ● providing service and maintenance for our systems. In our models, although we may sell a fixed number of systems over a period of time, the sales of the disposables are tied to the number of procedures conducted (similar to the razor/razor-blade model), and therefore, we expect to sell an increasing number of disposables as the number of procedures increases. In order to generate significant revenues, we believe that we need to achieve each of the following milestones: (i) having received FDA marketing authorization for commercialization of our products for the use of ProSense for the local treatment of low-risk breast cancer in women aged 70 and above in October 2025 and since the March 2026 update to the ASBrS resource guide now includes cryoablation as a recommended treatment option for low-risk breast cancer, we are now focused on obtaining regulatory approvals in additional jurisdictions where we currently have no regulatory approvals to market our products, (ii) expanding recommendations for the use of our products in guidelines of medical associations, such as the Society of Breast Imagine, or SBI, and others, (iii) obtaining category I CPT code and coverage for our products, (iv) extracting the most out of our category CPT III code and apply additional payment such as Transitional Pass-Through Payment, or TPT, and (v) negotiating reimbursement with government and private insurers and payers. We believe that reaching these milestones, while focusing on our business growth strategy, will help us achieve greater revenues. Our growth strategy includes the following actions: ● Obtaining regulatory approval for our ProSense and other future systems in countries within which we do not currently have regulatory approval as well as obtaining regulatory approvals for additional indications in countries within which we already have certain approvals. 52 ● Obtaining clinical data (by conducting both sponsored and independent clinical trials for our systems) and by gaining the support of these key opinion leaders. ● Expanding our distribution network for further commercialization, which may include distribution and/or license agreements or other forms of collaborative agreements. ● Obtaining the relevant approvals to allow for reimbursement to end-users of our systems. ● Having cryoablation treatment included in the recommendation guidelines as a valid treatment option of certain medical associations, such as the ASBrS. ● Continuing research and development efforts aimed at developing our new products. We believe that completing development of our new products and obtaining regulatory approval to commercialize our new products for a variety of indications, in the United States is necessary in order for us to grow our business. ● Continuing our efforts to obtain regulatory approval for our XSense system with CryoProbes so that we are able to commercialize it for a variety of indications so that we can grow our business. ● Obtaining guidelines from relevant professional societies in the geographic territories we operate or plan to operate. ● Obtaining CPT I coding and broad reimbursement coverage for cryoablation procedures in the United States, and seeking equivalent reimbursement recognition in other key territories where we operate or intend to operate, including through engagement with government and private insurers and payers; ● Expanding utilization and use of our products for breast cancer treatment by commercial sales and clinical studies around the world. Our Lead Indication and Market Opportunity Our lead indication is breast tumors. There are generally two types of breast tumors: those that are non-cancerous, or benign, and those that are cancerous, or malignant. Primary Indication Breast Tumors The national expenditure involved in treating breast tumors (both for benign and malignant tumors), based on the National Cancer Institute increases each year. Thus, in 2015, the cost of treating breast cancer was approximately $26.8 billion in the United States – higher than any other type of cancer. This cost increased to $29.8 billion in 2020. Individual costs vary, depending on the stage of the malignancy and treatment options selected. Benign Breast Tumors The majority of breast tumors are benign (non-cancerous), and are generally not life-threatening compared to breast cancer. Fibroadenomas is a common type of benign breast tumors. They are solid benign (noncancerous) tumors common among women of various ages. Fibroadenoma tumors range in size and on average can be located anywhere in the breast, from the size of a marble to up to 2.5 centimeters in diameter, and tend to grow during pregnancy and breastfeeding. According to scientific publications from recent years, 10% of all women in the world suffer from fibroadenomas, and the phenomenon is particularly common among women under the age of 30 (80% of breast biopsies for women of these ages identify benign tumors). Many physicians and oncologists recommend removal of benign tumors for a variety of reasons, including: concerns that the tumor will increase in size, pain and due to concerns that the existence of a benign breast lump will make it difficult to manually discover breast cancer in the future. However, the vast majority of benign tumors are left untreated for reasons including cost and undesirable cosmetic outcomes, the latter of which, is generally not caused by treatment with our ProSense system. 53 Clinical Trial in Fibroadenoma (Benign Breast Tumors) We sponsored and completed a prospective clinical trial in benign breast tumors in the Czech Republic, Israel and Germany. Between April 2009 and September 2012, data was collected from 60 procedures that were performed across four clinical sites located in Czech Republic, Israel and Germany (two sites). The IceSense3 was used to conduct the cryoablation procedures. The primary endpoint was to create an ice ball which would successfully engulf the entire tumor, as seen using ultrasound imaging. Our inclusion criteria were patients over 18 years old with core biopsy-proven breast fibroadenoma between 0.5 cm and 3.0 cm. The expected probability of success was 88%. At the one-year follow-up, in 93% of the cases, the fibroadenomas no longer existed. A June 2015 publication highlighting the data concluded that cryoablation of the fibroadenoma using a LN2 system demonstrated meaningful reduction in volume, palpability, pain and an improvement in cosmetic results from the procedure. No serious adverse events related to the IceSense3 system occurred during the clinical trial. In March 2026, an independent study evaluating ProSense for the treatment of fibroadenomas was published in the peer-reviewed journal PLOS One. The study, conducted at the Premier Med Healthcare, Training, and Research Institute in Hungary, evaluated the use of cryoablation with a liquid nitrogen-based system, specifically ProSense, and found it to be safe and effective, demonstrating a median volume reduction of 80.6% at approximately six months and 92.9% at one-year post-treatment. The study further found that sequential cryoprobe relocations preserve safety and efficacy, with ProSense cryoprobes relocatable up to three times per patient per procedure, enabling complete ablation coverage of large or multifocal lesions. This independent study is believed to be the first to evaluate larger lesions and employ multiple cryoprobe relocations. Malignant Breast Tumors According to recent estimates from the American Breast Cancer Foundation’s publications, breast cancer is the most commonly diagnosed cancer among American women except for skin cancers. Of the diagnosed breast cancers, it is estimated by the American Cancer Society that 73% of breast cancers are low-risk, while according to the American Society of Clinical Oncology, localized breast cancer accounts for 63% of total breast cancer incidence. In 2025, according to the American Cancer Society, it is estimated that there will be a total of 382,640 new cases of invasive breast cancer and ductal carcinoma in situ, or DCIS, in the United States in 2026. Furthermore, it is estimated that 42,140 women will die of breast cancer in 2026. It is further estimated that breast cancer is the second leading cause of cancer-related death in women. Additionally, the American Cancer Society reported that the average risk of a woman in the United States of developing breast cancer during her lifetime is approximately 13%, which means that there is a one in eight chance that a woman will develop breast cancer in her lifetime. A study conducted by the American Association for Cancer Research suggests that the number of breast cancer patients may increase by 50% by 2030 compared to 2011 estimates, which shows a significant long-term market growth potential. Traditional treatment options for malignant breast tumors include surgery, radiation, and systemic chemotherapy. Concerning the surgical path, most breast cancer cases will require to have some type of surgery to remove the tumor. Surgical treatment often entails either breast-conserving surgery, or breast-conserving surgery (BCS or lumpectomy), in which only the part of the breast containing the cancer is removed, or mastectomy, in which the entire breast is removed, including all of the breast tissue and sometimes also nearby tissue. Clinical Trials in Cancerous (Malignant) Breast Tumors We completed our sponsorship of a clinical trial in cancerous breast tumors in the United States in March 2024. Our systems and probes are being used in three clinical studies initiated by investigators for malignant breast tumors in Japan, Hong Kong and China, and the Netherlands. Based on data presented from the Kameda Medical Center in Kamogawa, Japan, since May 2012, more than 650 procedures for breast cancer have been performed at the Center using our cryoablation system. 54 Multi-Site Clinical Trial of the Cryoablation System ICE3 Study – United States In May 2014, we initiated a multi-site clinical trial in the United States, which included participation of 19 sites across the U.S., including Columbia University/NY Presbyterian Hospital and Mount Sinai Beth Israel. The ICE3 trial was intended to expand the clinical base for using our cryoablation system for treating low-risk, small breast cancer tumors (up to 1.5 centimeters). The primary goal of ICE3 was to assess the effectiveness by the breast tumors local recurrence rates in patients who undergo cryoablation without excision for a follow-up period of five years. The inclusion criteria were patients over 65 years old with core biopsy-proven invasive ductal carcinoma with unifocal primary disease, tumor size 1.5 cm or less, Nottingham grade 1-2, estrogen and/or progesterone receptor positive and HER2 negative and breast size adequate for safe cryoablation. ICE3 is the largest controlled multi-center clinical trial ever performed for liquid nitrogen based cryoablation of small, low-risk, early-stage malignant breast tumors without subsequently removing them. In February 2019, the last patient was recruited. In total, 211 patients were recruited to the ICE3 trial, 206 of whom have enrolled, and 194 undergone Cryoablation according to the study protocol. On October 18, 2022, we submitted a De Novo classification request regulatory filing with the FDA for marketing authorization based on our ICE3 clinical trial interim analysis of ProSense for the indication of early-stage (Luminal A T1 invasive) low-risk breast cancer in patients who are at high risk to surgery (not suitable for surgical alternatives), the demographic of which comprises of approximately 43,000 women in the United States annually. On September 20, 2023, we received notice that the FDA denied our De Novo classification request and on November 15, 2023, we filed a request with the FDA for supervisory review under 21 CFR 10.75. On January 30, 2024, we announced that the FDA responded affirmatively to our request and the FDA determined that there is sufficient basis to reopen the De Novo file if we submit the full 5-year dataset from our ICE3 trial. On March 15, 2024, the last patient in the ICE3 trial concluded her 5 year-follow-up. 96.39% of the patients from the study were local recurrence-free with no significant device-related adverse events or complications reported. Having compiled and submitted the dataset and comparative analysis of the ICE3 results versus the data from the LUMINA study, the FDA convened the Advisory Panel to review the De Novo marketing authorization request for ProSense on November 7, 2024. The Advisory Panel included breast surgeons, interventional radiologists, breast oncologists, and representatives from the patient, consumer, and regulatory communities. The purpose of the Advisory Panel was for the FDA to obtain independent non-binding expert advice on scientific, technical and policy matters related to the potential granting of marketing authorization of ProSense for treating patients with early-stage low risk invasive breast cancer with cryoablation and adjuvant endocrine therapy. The majority of panelists voted that the benefits of ProSense outweigh the risks when used according to the proposed indications for the treatment of patients with early-stage low risk invasive breast cancer with cryoablation and adjuvant endocrine therapy. The Advisory Panel’s favorable vote was based on the comprehensive body of data available on ProSense as a treatment for early-stage low risk breast cancer, including results from the ICE3 study compared with data from the current standard of care, lumpectomy, as well as testimonials and input from a broad range of key stakeholders, including women with breast cancer and their family members, patient advocacy groups, doctors, nurses and researchers. On October 3, 2025, ProSense received FDA marketing authorization for the treatment of biologically low-risk breast cancer in women aged 70 and above who receive adjuvant endocrine therapy for such breast cancer. The total group of Luminal A breast cancer for women in all ages, is estimated at 144,000 cases annually in the United States. We estimate that our potential market size in the U.S. is 47,245 patients. In the future, we intend to explore additional subgroups that are part of the total group of Luminal A breast cancer. Data suggests the use of ProSense cryoablation in breast procedures eliminates the risk of re-excision (a second surgery). Between 14% - 20% of breast cancer surgeries result in re-excision due to the practice of requiring a margin of normal breast tissue beyond the involved malignant tissue. This is associated with greater morbidity, patient anxiety, poorer cosmetic outcomes, and increased cost. 55 In September 2024, an article titled “Cryoablation Without Excision for Early–Stage Breast Cancer: ICE3 Trial 5–Year Follow–Up on Ipsilateral Breast Tumor Recurrence,” presenting the results of IceCure’s ICE3 trial, the largest controlled multicenter clinical trial ever completed in the United States for LN2-based cryoablation of small, low-risk, early-stage malignant breast tumors as an alternative to surgery. The lead author of the study is Dr. Richard Fine, an ICE3 Investigator, who co-authored the publication with 24 doctors who are ProSense users, including co-primary investigator, Dr. Kenneth Tomkovich. 194 eligible patients received successful treatment and were included in the final results for analysis. The mean age was 74.9 years with a mean tumor size of 7.4 mm traverse and 8.1 mm sagittal. Of the 124 patients who received cryoablation and endocrine therapy, the recurrence free rate was 96.3%. Independent Study of Cryoablation Systems – United States An independent study, the largest multi-institutional study of women ineligible for prospective clinical trials due to patient of tumor characteristics, was published in the American Journal of Roentgenology under the title “Cryoablation of Primary Breast Cancer in Patients Ineligible for Clinical Trials: A Multi-Institutional Study”. The independent study evaluated 112 patients with a median age of 71. ProSense was one of four different cryoablation systems used for procedures performed at seven U.S. institutions by seven different radiologists. The recurrence-free rates were 94.7%, 87.8%, and 81.8%, at one, two, and three years, respectively, when accounting for death, including from comorbidities, as a competing risk. Treatment with cryoablation had a low frequency of adverse events and a high frequency of procedures were technically successful. Independent Clinical Trial of the Cryoablation System – Japan Since May 2012, an independent clinical trial has been ongoing at the Kameda Medical Center in Kamogawa, Japan using our IceSense3 cryoablation system. So far, over 650 cryoablation procedures have been conducted using our cryoablation system (in addition to approximately 80 additional procedures with a different system). According to information reported on the International Cryosurgery Society Convention, which was held in September 2019, in 304 of the 400 patients who were treated with cryoablation between 2006 and 2019, the recurrence rate of breast cancer was lower than 1%. The inclusion criteria were patients with histologically-proven breast cancer at stage 0 (TisN0M0) or stage 1 (T1N0M0) with tumor mass and lesion (including the progress within intraductal component) less than 1.0 cm. The primary endpoints were comparing the tumor necrosis rate, cosmetic results of the procedure, clarity of imaging, safety and therapeutic effects of IceSense3 versus a competing cryoablation device. In addition, since May 2018, an independent investigator initiated clinical trial in Japan at the St. Marianna University School of Medicine Department of Mammary Gland and Endocrine Surgery using our ProSense system. The trial’s purpose was conducted in breast cancer tumors of up to 1.5 cm (in their early stages). The inclusion criteria were patients with histologically-proven breast cancer at stage 0 (TisN0M0) or stage 1 (T1N0M0), between the age of 20 and 85 years, HER2 protein expression-negative status, Ki-67 positivity of ≤ 20% and lesion spread of 1.5 cm or less. The trial was completed after the enrollment of seven patients, in which pathology was confirmed using a vacuum-assisted biopsy. In all seven patients, there was no evidence of malignant cells, and following a monitoring period of two years, all seven patients remain disease free with no clinical and imaging evidence. The primary endpoint of this clinical trial was to expand the clinical knowledge of cryoablation of cancerous breast tumors and enable to implement this technology at the St. Marianna University Hospital as a routine procedure. Based on these results, the trial received approval from the hospital to offer cryoablation for breast cancer in a commercial setting. In April 2024, data from an independent study performed in Japan were published in an article titled “Percutaneous ultrasound-guided cryoablation for early-stage primary breast cancer: a follow-up study in Japan” in the journal Beast Cancer. Eighteen early-stage breast cancer patients, with a mean age of 59.0 and a mean tumor size of 9.8mm underwent treatment with ProSense and were followed for a mean of 44.3 months. No patient had local recurrence or distant metastasis in the 5 year follow up, no serious adverse events were reported and patient satisfaction was high. In March 2025, data from an independent study performed in Japan were published in an article titled “Post-treatment patient satisfaction in early-stage breast cancer: Comparison of cryoablation versus breast conservation therapy using BREAST-Q” in the peer reviewed journal Gland Surgery. The study was conducted at the Breast Center at Kameda Medical Center in Chiba, Japan. A total of 147 breast cancer patients underwent cryoablation with ProSense. Those who underwent cryoablation reported a significantly higher satisfaction with the primary outcome (Satisfaction with Breasts component of the BREAD-Q questineer) compared to breast-conserving therapy (71.0±18.6 vs. 56.3±16.5). At the Japanese Breast Cancer Society Annual Meeting in July 2025, updated clinical data presented by Dr. Takeo Takahashi reported that, based on expanded experience from 2006 through September 2024, over 600 women treated with cryoablation demonstrated an approximately 99% recurrence-free rate. 56 Independent Clinical Trial of the Cryoablation System –Hong Kong and China Since November 2018, an independent clinical trial has been ongoing at the Queen Mary Medical Center in Hong Kong and at Hong Kong-Shenzhen University Hospital in China. According to information disclosed by the primary investigator, treatments using our ProSense cryoablation system has been performed to date in 20 patients, out of an expected total patient pool of 150, in which each patient underwent an excision after the cryoablation to examine the ablated area by pathology. Following the first phase, the remaining patients are expected to be monitored according to the standard of care without excision. The purpose of this clinical trial is to expand the clinical knowledge of cryoablation of cancerous breast tumors. The primary endpoints were to demonstrate cryosurgery’s efficacy in ablating small breast cancers, safety with low morbidity and the use of PET/MRI as an effective imaging modality to assess post-treatment responses. The inclusion criteria were patients between 18 and 70 years old with core biopsy-proven T0/T1a and b breast cancer or ductal carcinoma in situ. Independent Study of the Cryoablation System – Spain In October 2023, we announced that University Hospital Lucus Augusti, in Lugo, Spain, conducted a study of ProSense for the cryoablation treatment of 31 patients for early-stage breast cancer patients. After a median follow-up of 10 months, cancer progression was observed only in one out of 31 patients, or a 96.8% success rate, that the lead radiologist cited as being evidence that our ProSense system is a safe and effective outpatient procedure for breast cancer. In August 2024, we announced that University Hospital Lucus Augusti published an independent study titled “Acceptance and results of cryoablation for the treatment of early breast cancer in non-surgical patients” in the British Journal of Radiology. In evaluating the acceptance of percutaneous cryoablation treatment by patients with early-stage breast cancer who choose not to have surgery, 43 of the 45 patients offered cryoablation with ProSense, or 95.6% accepted. 36 of these, representing 39 malignant tumors (median size 24mm), proceeded to undergo cryoablation. Independent Study of the Cryoablation System – Italy ProSense is approved in Italy for numerous indications, including breast cancer. In February 2024, we announced new data from a preliminary independent breast cancer study conducted by Dr. Federica di Naro of Azienda Ospedaliero-Universitaria Careggi. The results were recently published in an article titled “Cryoablation for Treatment of Early-Stage Breast Cancer: Efficacy and Quality of Life Assessment” in the Clinical breast cancer journal. Ultrasound-guided cryoablation using ProSense® was performed on 39 tumors (36 women) between the ages of 60 to 94 who had biopsy-proven malignant lesions and were deemed inoperable due to factors such as advanced age and comorbidities or who refused surgery. Patients were monitored at one, three, six- and 12-months post-procedure, at which time the tumor size reduction rate was evaluated by ultrasound. At 12 months post-procedure, the effectiveness of the procedure was further evaluated by core needle biopsy on the post-procedural scar (inside the breast at the site of the tumor) and contrast enhanced mammography (CEM) to determine the presence or absence of residual tumoral cells and the effectiveness of cryoablation. No device-related unexpected adverse events were reported. The median breast cancer tumor size reduction rates reported in the study were 27.8%, 60.9% and 100.0% at one, three, and six, months post procedure respectively. The 39 BCs were early-stage luminal A or B, invasive ductal carcinoma, or IDC, or IDC + DCIS. Complete ablation rates for tumors ≤ 15 mm and > 15 mm were 100% and 84.6%, respectively. Cryoablation positively impacted patient Quality of Life, including physical, social, emotional, and functional well-being; anxiety and depression; physical and mental measures, as assessed using validated questionnaires, including VAS (pain), FACT-B (breast cancer–specific quality of life), HADS (anxiety and depression), and SF-36 (general health-related quality of life). 57 Independent Study of the Cryoablation System – Germany An independent study on ProSense, led by Professor Thomas Vogl at the Institute of Radiology and Nuclear Medicine, University Hospital Frankfurt, at Goethe University in Germany, titled “CT-Guided Percutaneous Cryoablation of Breast Cancer: A Single-Center Experience” was published in Cancers. The independent study retrospectively evaluated the efficacy and safety of the system. Patients were treated in out-patient settings with curative intention for non-metastatic patients, while patients with metastases were treated to achieve local tumor control. 45 patients, with a mean age of 55, with 56 tumors, including 11 patients with recurrent tumors and 21 patients with metastatic disease, were observed at three, six, nine, and 12 months, respectively, and after the first year were followed up biannually. There were four cases of local tumor progression, representing a rate of 8.9%. There were no complications observed in any of the 56 ablations and initial complete ablation was achieved in 100% of cases. Independent Study of the Treatment of Breast Cancer with Percutaneous Thermal Ablation – the Netherlands An independent study initiated in March 2021 in the Netherlands aimed to assess the efficacy of RFA, MWA, and cryoablation in achieving complete tumor ablation for early-stage breast cancer patients with minimal ductal carcinoma in situ (≤ 25% of the tumor). The study was designed to inform a potential randomized phase III trial comparing thermal ablation to surgery. Cryoablation met the minimum efficacy requirements, with a 94% success rate, 0% complication rate, and 100% treatment tolerance, making it the choice for the phase III study. In contrast, MWA had a 62% efficacy and a 44% complication rate, while RFA showed the lowest efficacy at 33%. Cryoablation also demonstrated superior cosmetic outcomes and patient satisfaction compared to surgery, with the best results reported on relevant questionnaires. In September 2025, two peer-reviewed publications from this independent study further reported that patients treated with cryoablation demonstrated high satisfaction rates, with 95% of patients reporting satisfaction with thermal ablation, and that ProSense cryoablation achieved the highest complete tumor ablation rate among the evaluated thermal ablation modalities. In September 2025, we announced that University Hospital Lucus Augusti published two peer-reviewed articles reporting results of the independent randomized phase II THERMAC trial; one titled “Cosmetic outcome and patient satisfaction following percutaneous thermal ablation of early-stage breast cancer; results of an open label randomized phase 2 trial” in the European Journal of Surgical Oncology), and the other titled “In conclusion, cryoablation is the preferred technique for comparison with surgery in a future phase III trial” in Radiology. The THERMAC trial compared RFA, MWA, and cryoablation with ProSense® in patients with early-stage breast cancer. Based on the Phase II results, the investigators concluded that cryoablation is the preferred technique for comparison with surgery in a future Phase III trial. The European Journal of Surgical Oncology publication reported favorable cosmetic outcomes and high patient satisfaction following percutaneous thermal ablation. Median cosmetic outcome was rated good after thermal ablation and intermediate after surgery (1.6 vs. 1.8; P = 0.07). In addition, 95% of patients were satisfied or very satisfied, and 91% indicated they would prefer thermal ablation over surgery. The Radiology publication reported that cryoablation with ProSense achieved the highest complete ablation rate with no complications among the modalities evaluated and was associated with zero cases requiring oncoplastic surgery, compared to two cases (40%) in the RFA group and two cases (11%) in the MWA group. Independent Study of the Treatment of Breast Cancer with Percutaneous Thermal Ablation – Brazil Dr. Vanessa Sanvido, currently leading a clinical study of cryoablation for breast tumors at the Hospital do Coracao (Hcor), Brazil, with the objective to assess the effectiveness of cryoablation with ProSense for early breast cancer. Women with invasive breast cancer (N0, M0) ≤2.5 treated with cryoablation, followed by surgery 14-28 days post-cryoablation will be followed for by mammogram, ultrasound and/or MRI Other Clinical Indications We are targeting other tissue tumor ablation for our ProSense system, in organs such as: lungs, kidneys, bones and other organs. Our approach to these indications is to collaborate with hospitals and doctors to conduct clinical trials in order to gain additional information regarding the potential of our products to treat certain diseases. While our cryoablation products have been approved by various regulatory agencies for variety of oncology and surgical uses, we will need to validate our products in specific indications, and in certain situations in order to obtain specific regulatory approvals, and/or to collect medical data, which will be required in order to successfully market our products for these indications. 58 Lung Cancer The American Cancer Society has estimated that in 2026, approximately 229,410 new cases of lung cancer will be diagnosed in the United States while an estimated of 124,990 patients will die of such cancers in the United States during 2026. Lung Cancer Clinical Trial – Japan Since November 2013, an independent clinical trial in cryoablation of lung tumors in non-small cell carcinoma or metastatic lesions has been ongoing at the Kameda Medical Center in Kamogawa, Japan using our cryoablation system. In 2019, this study migrated to the Kashiwa Kusei General Hospital. Based on data provided to us, this trial is an ongoing trial, and to date, more than 435 procedures have been performed using our cryoablation system. In November 2020, the lead investigator for the trial published the results in a peer reviewed article in the European Journal of Radiology and in July 2022 in the Clinics In Oncology journal. The results of the 2020 published article covered the cryoablation treatments in 101 patients during the years 2013 through 2019. The patients with T1N0MO non-small cell lung cancer, or NSCLC, in this review were divided into four categories based on the size of maximum tumor diameter, as follows: (1) group 1: tumor size up to 0.9 cm; (2) group 2: tumor size between 1 and 1.2 cm; (3) group 3: tumor size between 1.3 and 1.7 cm; and (4) group 4: tumor size larger than 1.8 cm. Ten patients experienced local recurrences. There were no recurrences in groups 1 or 2 (0%). There was one recurrence in group 3 (4%) and nine in group 4 (33%), indicating local control to be better in smaller tumors (p<0.001). The 3-year recurrence-free survival rates were: 86% in group 1; 97% in group 2; 93% in group 3; and 53% in group 4, indicating survival to be better in smaller tumors (p<0.001). There were no serious adverse events reported. The results of the 2022 publication covered a different group of 68 patients with metastatic lung cancer during the same period of time. The three-year local control rate was 73% for all tumors and 96% and 46% in tumors <2.2 cm and ≥ 2.2 cm, respectively. Local control was not different in tumors <2.2 cm between carcinoma and sarcoma (p=0.43). Sarcoma showed significantly poorer local control than carcinoma in tumors ≥ 2.2 cm, of which three-year local control rate was 18% and 62%, respectively (p<0.001). The incidence of pneumothorax was 25%. While the average preserved pulmonary function was 98 ± 6% after cryoablation for one tumor, the treatment for multiple tumors was associated with significantly lower preservation of pulmonary function (p=0.002). It was concluded that cryoablation using liquid nitrogen would be one of the treatment methods for metastatic lung cancers <2.2 cm. The results of the trial, as disclosed in the published article, were that the treatment of tumors in groups 1 and 2 through cryoablation and LN2 and local control of the tumor and the lack recurrence of the cancer was more effective than in groups 3 and 4. As part of the trial, tumors treated in groups 1 and 2 did not have local recurrence, while in groups 3 and 4, 4% and 33%, respectively, of the tumors had local recurrence. The 3-year recurrence-free survival rates were: 86% in group 1; 97% in group 2; 92% in group 3; and 53% group 4, indicating the survival to be better in smaller tumors (p < 0.001). No patient had treatment-related mortality. The most frequent complication was pneumothorax, with a rate of 24%, while the decrease of pulmonary function was just 3%. The peer reviewed publication also highlighted that the use of cryoablation treatment with only one needle for the majority of the patients in the trial represented an advantage in comparison to systems that use argon gas, which usually requires the use of 2-3 needles for a procedure on the same tumors size. We believe that the publication of the results of the trial in a peer reviewed publication raises the validity of using our products for the treatment of lung tumors. In November 2025, additional clinical results were reported for a retrospective observational study published in the peer-reviewed journal PLOS One evaluating the combination of stereotactic body radiation therapy, or SBRT, followed by cryoablation, 2-3 weeks after, using our system in patients with stage I NSCLC with tumors ≥ 2 cm. Follow-up included CT scans every 3 or 4 months for three years and at least every six months thereafter. This study, which included 64 patients with a mean tumor diameter of 2.7 ± 0.5 cm and a median follow-up of 74 months, showed a five-year local control rate of 93%, overall survival rate of 74%, and disease-specific survival of 92%. The results are better than those reported for SBRT alone and comparable to the standard treatment (surgery), in similar populations, where the five-year overall survival was 41%-52% and 82% or 67%, respectively. There were no treatment-related deaths, and the most frequent complication was pneumothorax (CTCAE grade 2, 40%). Pulmonary function, up to 6 months after treatment decrease (FEV1 1.8 ± 0.6 vs. 1.7 ± 0.5 L, P < 0.001), comparable to that after SBRT alone. These outcomes align with findings from previous independent studies and suggest that SBRT plus cryoablation may extend long-term survival in select patients with inoperable stage I NSCLC. 59 Independent Study of the Cryoablation System – Italy An independent study led by Dr. Franco Orsi, director of interventional radiology at the European Institute of Oncology in Milan, titled “Liquid Nitrogen-Based Cryoablation: Complication Rates for Lung, Bone and Soft Tissue Tumors” was published by Oxford University Press. The study assessed the complication rate both during and 24 hours after treatment with IceCure’s cryoablation system in 85 patients who were treated for 96 lesions (tumors), 36.4% of which were lesions in bones, 18.8% in lungs, and 44.8% in soft tissue. The primary technical success rate, defined as complete tumor coverage, was 97.7% (83 of 85 patients). Patients with benign and malignant tumors were treated for either curative or palliative intent. Minor complications resolved themselves without intervention or merely required simple interventions such as drainage. The study concluded that cryoablation using an LN2-based system, is safe across various tumor sizes and locations, with only minor complications observed. Kidney Tumors The American Cancer Society has estimated that in 2026, approximately 80,450 new cases of kidney and cancer will be diagnosed in the United States, while an estimated of 15,160 patients will die of such cancers in the United States during 2026. Globally, there were more than 434,840 new cases of kidney cancer in 2022 and about 155,953 deaths according to World Cancer Research Fund International. According to an article published in European Radiology in 2023, the cost of cryoablation of a kidney is about 77% of the cost of an open kidney surgery, also known as an open partial nephrectomy. Protocatechuic aldehyde yields a comparable health benefit at lower costs compared to open partial nephrectomy, making protocatechuic aldehyde the more dominant and cost-effective treatment. Kidney Tumors Clinical Trials In 2012, a clinical trial called ICESECRET (NCT02399124) Post Marketing Surveillance for PROSENSE™ a Cryotherapy Treatment of Renal Cell Carcinoma was initiated at Bnei Zion Medical Center in Haifa, Israel, in collaboration with the Shamir/Assaf Harofeh Medical Center in Be’er Ya’akov, Israel. Procedures were performed using our ProSense system for freezing and ablating kidney tumors. According to the American Journal of Roentgenology, small renal masses, which may be malignant or benign tumors in the kidney, have been rising in incidence over the past two decades. In November 2023, we announced that a study titled “Single-Probe Percutaneous Cryoablation with Liquid Nitrogen for the Treatment of T1a Renal Tumors” was published in Cancers and demonstrated the safety and efficacy of ProSense® in treating malignant small renal masses. The Study was authored by eight physicians in France, including interventional radiologists and urologists from Curie Institute, Paris, Nîmes University Hospital (University of Montpellier), Nîmes, and Carémeau University Hospital, Nîmes. The objective of this retrospective study was to address the challenges of managing small renal masses, including recurrence rates, by exploring the safety and efficiency of single-probe percutaneous cryoablation as a potential solution. The causes of partial tumor response and persistent tumor residue after a T1a renal cryoablation procedure were assessed. A total of 25 patients underwent cryoablation for 26 T1a renal tumors with a median tumor size of 25.3 mm (20 to 30.7 mm) and a median RENAL nephrometry score, indicating tumor complexity, of 7 (5 to 9). The main findings of the study were as follows: ● Disease-free survival rate was 92% (23 out of 25) at a median follow-up of 26 and a half months. 60 ● Recurrent lesions were treated again using cryoablation, achieving a secondary local control rate of 100%. ● No patients died. ● No major complications arose. ● 92.4% of patients (N= 24) were discharged the day after surgery. In December 2024, we announced that in the interim analysis of our ICESECRET study of cryoablation for patients with small renal masses who cannot be offered kidney preserving surgery, there was an 88.7% recurrence-free rate. In 91 patients, 82% of the patient group, no tumor recurrence was observed. Following an additional cryoablation for the same tumor in 13 patients, the success rate was 83.8%, with a mean follow-up time of 39.6 months. In patients without a history of kidney cancer with one tumor of less than 3cm, the success rate was 88.7%. Renal function was preserved with no significant change in creatinine and hemoglobin levels relative to the baseline. In March 2025, interim results from the ICESECRET study were presented at the European Association of Urology Annual Congress in Madrid by Dr. Nasir Said. The presentation included data from 111 patients (mean age of 69 years), of whom 84.2% had comorbidities with a mean follow-up of approximately 3.4 years and reported an approximately 88.7% recurrence-free rate for tumors measuring up to 3 cm, with a favorable safety profile consisting predominantly of mild adverse events. In February 2026, we announced the successful completion of the five-year follow-up in the ICESECRET kidney cancer cryoablation study. We expect to report a final analysis in the second quarter of 2026. Endometriosis In April 2023, we announced that our ProSense system was used in a single-site study conducted at the Sorbonne University Department of Interventional Radiology and Oncology at Tenon Hospital in Paris. The study was conducted by Francois H. Cornelis, MD. Cryoprobes used in the study were of two types: our ProSense CryoProbe and Varian’s V-probe. The purpose of the study was to retrospectively evaluate the pain-free survival of percutaneous (minimally invasive, through the skin) image-guided cryoablation of symptomatic extraperitoneal endometriosis, or the EE. 42 patients with a total of 47 lesions were treated. Patients were made aware that cryoablation was offered as a minimally invasive alternative to surgery, and that a surgical procedure may be performed if cryoablation failed. According to the published study, the therapeutic options thus far to avoid the progression of endometriosis and reduce symptoms have been limited to hormonal agents and wide surgical excision. During the last decades, minimally invasive techniques such as cryoablation have been suggested as a promising option to treat abdominal wall endometriosis with satisfactory outcomes and low morbidity. Based on the following study outcome data, the study concluded that percutaneous cryoablation is a safe and effective procedure that significantly reduces pain and obtains local control of EE. The median follow-up was 13.5 months after cryoablation. The study’s conclusions included: ● Efficacy rate of cryoablation to avoid secondary surgery was 92.8% per patient and 93.6% per nodule treated. ● Median pain-free survival rates were 93.75% at 6 months and 82.72% after 12 months, 24 months, and 36 months. ● Pain decreased from a median of 8/10 on the visual analogue scale to 0/10 at the last follow-up (P < 0.0001). ● 4 patients had an adverse event in the days following the procedure, 1 patient had a severe adverse event. 61 On February 29, 2024, results from an independent study conducted at Nîmes University Hospital titled “Beyond Pain: Cryoablation of Endometriotic Nodules Using Liquid Nitrogen” were presented at the European Congress of Radiology. Seven women, between the ages of 30-45, with endometriosis in the abdominal wall and para-diaphragmatic areas were treated with ProSense cryoablation. MRI assessments, one month following the procedures, showed that hemorrhagic signals had been eliminated from and that necrotic changes developed. In June 2025, we announced that a study titled "Efficacy and Safety of Percutaneous Single-Probe Cryoablation Using Liquid Nitrogen in the Treatment of Abdominal Wall Endometriosis" from Nîmes University Hospital in Nîmes, France, was published in the Journal of Personalized Medicine. The study, which enrolled 14 patients with a total of 23 AWE lesions, reported substantial pain relief, from a median pain scores of 8/10 (range: 6–10) pre-treatment to 0/10 (range: 0–2) at 3-month follow-up (p < 0.0001). MRI confirmed high procedural efficacy, demonstrating complete coverage of the ablation zone and disappearance of hemorrhagic inclusions in all cases. The retreatment rate was 14% (two patients), both of whom achieved satisfactory outcomes following repeat treatment with the same modality. The procedure was safe, with no peri- or post-procedural complications reported and and cosmetic outcomeswere escellent, with no visible scars. The resuls of this independent study on abdominal wall endometriosis was presented were presented by Prof. Julien Frandon at the Cardiovascular and Interventional Radiology Society of Europe Annual Meeting in Septembet 2026. In September 2025, at the Cardiovascular and Interventional Radiology Society of Europe Annual Meeting, an independent study on abdominal wall endometriosis was presented by Prof. Julien Frandon of Nîmes University Hospital. The study reported that ProSense cryoablation was associated with significant pain reduction, with mean pain scores decreasing from 8 on a 1 to 10 scale prior to the procedure to approximately 1 following the procedure, and MRI findings showed resolution of hemorrhagic signals and necrotic changes in approximately 95% of treated cases. These results further support the potential of percutaneous cryoablation as a minimally invasive option for patients with symptomatic abdominal wall endometriosis. Our Products Existing Products Our ProSense system is our second-generation cryoablation system comprised of two main parts, the main cryoablation system, our unique disposable probe, and the associated disposable introducer (guiding needle), which is used for procedures which are not in the breast. Our first product, the IceSense3 was initially designed for cryoablation of breast tumors. After identifying a number of additional possible applications for the use of our technology, such as treating lungs, kidneys, bones and other possible applications, in 2016 we launched our ProSense system as well as associated disposables (which, as shown below, are inserted into the body to conduct the freezing process). Currently, we sell ProSense in all territories in which we have regulatory approval, with the exception of China where we sell the IceSense3. In 2024, we completed the development stage of our XSense system, a more advanced system that may potentially enable the use of thinner cryoprobes and flexible probes (catheters). These capabilities may potentially enable us to expand into clinical applications such as atrial fibrillation, renal denervation and through further regulatory approvals. 62 The following illustration demonstrates the course of the cryoablation procedure with our ProSense system in an ultrasound of the breast: Research and Development We are currently commercializing our single probe ProSense system and its disposables and have completed the development of our XSense system. In addition, we are also focusing on developing our next generation MSense system. We started development of our first-generation system for technical proof concept process and evaluation of clinical application in 2006. In the beginning of 2009, we started to develop our IceSense3 system, which was later improved and replaced by the ProSense. Both the IceSense3 and ProSense are commercially available systems which include technical modifications to our first-generation system in order to perform clinical procedures. We started developing what was previously known as the MSense system in 2016, but did not commercialize it. As of March 17, 2026, we are in the initial stages of developing the MSense. 63 We intend to commercialize our next generation systems, which will be our third-generation systems, subject to regulatory approvals. Our strategy is to make our next generation systems more capable, efficient and user-friendly in several aspects. The physical size of the system will have a smaller footprint, which is an important factor in CT rooms and clinics. Since our next generation MSense system will have more than one probe, it will have freezing capabilities that both our current and next generation systems do not have, such as the ability to treat regular-sized or larger tumors in more than one location simultaneously. We believe that our next generation MSense system will help us to increase our ability to penetrate the non-breast tumors market more easily and allow us to offer a more innovative product. In the United States, we received 510(k) clearance for the XSense system with CryoProbes in June 2024 for all the indications for which ProSense has already received the requisite FDA clearance. We currently expect to submit an application for Medical Device Regulation, or MDR) approval for the XSense system with CryoProbes by the second half of 2026. Even if we complete development as planned, we do not yet know if and when we will begin to commercialize these systems or whether commercialization of such systems will lead to us generating increased revenue. Regulatory Approvals We have received a broad range of regulatory approvals for ProSense in the United States, Canada, European Union, Switzerland, China (IceSense3 system and CryoProbes only), Singapore, Hong Kong, Mexico, Australia, Israel, Colombia, Costa Rica, India, Thailand, Russia, South Africa, Taiwan, Brazil, Turkey, and Israel. Moreover, we are pursuing additional regulatory approvals in other indications in existing countries and in other countries where we believe that there is significant potential for sales. For example, we have made submissions for regulatory approval in China (for our ProSense system, which is an upgrade to the already approved IceSense3) and the United States (for specific approval for breast cancer). We market our ProSense for a specific indication per the rules and medical device classification in the specific territory. United States In the United States, we received from the FDA 510(k) clearance for our IceSense3, ProSense and MSense and the related disposables. On December 10, 2007, we received initial 510(k) clearance for our IceSense3 system for ablation indications specific to urology, oncology, dermatology, gynecology, general surgery, thoracic surgery and proctology. On November 29, 2010, we received 510(k) clearance for our IceSense3 system for the ablation of breast fibroadenomas under general surgery. On December 20, 2019, we received 510(k) clearance to allow us to market and sell our IceCure family (which includes Icesense3, ProSense and MSense) systems for the treatment of breast fibroadenomas, prostate and kidney tissue, liver metastases, tumors, skin lesions, and other indications, and treat our products as “one family of products,” which means that any additional approval given by the FDA in relation to the family of products will apply automatically to the “family” as one product, without the need for FDA approval for each separate system; provided, however, that we expect to require individual approvals for our products from the FDA if we seek marketing approval for a new specific indication, as is the case for the use of these products for breast cancer. On December 31, 2020, we submitted a pre-submission package to the FDA for approval of breast cancer indication, based on our ICE3 trial interim results for our IceCure family systems. As part of the pre-submission package, we requested that we receive approval for this indication through the 510(k) submission pathway or De Novo classification. There can be no guarantee that the FDA approves the use of any of our products for the treatment of this indication, and an approval could be given on a narrower indication than requested, or, even if approval is given to market our products, there can be no guarantee that the approval is given via the 510(k) pathway or De Novo classification, which could result in additional costs and a longer timeline until we receive any such approval. If we do not receive approval via the 510(k) pathway or De Novo classification, we may seek to receive a PMA (see “Item 4.B. Business Overview–- Government Regulation – PMA Pathway” for additional information). 64 On March 31, 2021, we were granted Breakthrough Device Designation, or BDD, from the FDA for our ProSense system, for treatment for various indications, including for use in the treatment of patients with T1 invasive breast cancer and/or patients not suitable for surgical alternatives for the treatment of breast cancer. In addition, on November 24, 2021, we submitted a pre-submission package to the FDA in which we proposed an intended use for early-stage breast cancer and high risk to surgery for our ProSense system and requested a De Novo classification. Since we were granted BDD for our ProSense system, the pre-submission package included a request for a sprint discussion under FDA procedures. On October 18, 2022, we submitted a De Novo Classification Request regulatory filing with the FDA for marketing authorization based on our ICE3 clinical trial interim analysis of ProSense for the indication of early-stage (Luminal A T1 invasive) low-risk breast cancer in patients who are at high risk to surgery (not suitable for surgical alternatives), representing approximately 43,000 women in the United States annually. The specific indication filed is based on interim data from our ICE3 trial and is in accordance with discussions we have had with the FDA, which granted ProSense BDD on March 31, 2021, enabling closer communications regarding our regulatory filing. Following subsequent interactions with the FDA, including submission of the full five-year ICE3 dataset, ProSense received FDA marketing authorization on October 3, 2025, for the treatment of biologically low-risk breast cancer in women aged 70 and above who receive adjuvant endocrine therapy. On November 1, 2022, the CMS assigned payment to our ProSense breast cancer cryoablation procedures. The procedures were assigned as CPT Category III code 0581T to ambulatory payment classification 5091, Level 1 Breast/Lymphatic Surgery and Related Procedures. This payment assignment for the procedure went into effect on January 1, 2023, opening the potential for facilities to be paid, on a case-by-case basis, for these procedures subject to our receipt of FDA marketing authorization of ProSense for breast cancer. Under the temporary CPT Category III code, the ProSense procedure is priced for coverage by the CMS at approximately $4,000 for the facility fee alone. Additional coverage, including payment for the physician, is expected upon following our submission of an application for a permanent CPT Category I, or CAT I, code, which we currently expect to submit by June 2026, with a potential effective date of January 2028. Canada In July 2023 we announced that Health Canada, the Canadian government’s regulatory agency, approved IceCure’s ProSense System, disposable CryoProbes, and introducers as cryosurgical tools for indications including: tumors (ablation of benign and malignant tumors of the lung, liver, kidneys, and musculoskeletal system, and benign tumors of the breast); general surgery; palliative intervention; and other surgeries. The European Union In Europe, we received Conformitè Europëenne, or CE, mark approval for our ProSense cryoablation system and its disposables with indications for use as a cryosurgical tool in the fields of general surgery, dermatology, thoracic surgery, gynecology, oncology, proctology and urology, which enable us to sell our ProSense in order to perform procedures in the indications we aim to such as breast cancer, kidney, lung, bone and other indications. Switzerland In November 2025, we announced that Swissmedic, Switzerland’s regulatory authority for medical devices, granted regulatory approval for our ProSense cryoablation system and its disposable CryoProbes for indications including breast, lung, liver, and kidney cancer. This approval permits the commercial marketing and clinical use of ProSense for such indications in Switzerland. 65 Russia In 2020, we received regulatory approvals to market and distribute ProSense and disposables in Russia for use of our products in the treatment of benign and cancerous tumor cells through freezing in a number of organs, such as kidneys, lungs, liver and bones. Asia and Africa In Singapore, Hong Kong and South Africa, our ProSense system has specific approval for cryoablation of benign and malignant tumors in the breast, lung, bone and liver. China In China, the IceSense3 system has NMPA approval. We have received an additional five-year renewal up to June 3, 2026. On March 28, 2023, we announced that the NMPA approved our IceSense3 disposable CryoProbes for commercial use, to be used in combination with our IceSense3 system. This approval will allow us to sell our disposable IceSense3 CryoProbes for commercial procedures. In January 2025, we filed a submission for regulatory approval of our ProSense and CryoProbes in China with the NMPA. Japan In Japan, our ProSense and disposables are not yet approved by the Japanese regulatory authority, the Pharmaceuticals and Medical Devices Agency, or PMDA. We started to sell our products in Japan as “experimental products” under “private doctor importation” licenses in low quantities. Currently, without approval from the PMDA, we are only able to sell a limited number of ProSense systems and disposables under “private doctor importation” licenses. Following our distribution agreement with Terumo, Terumo will be responsible and bare all costs of obtaining regulatory approval for breast cancer from the PMDA to sell our products in Japan. We expect that Terumo will submit a regulatory request for breast cancer indication for our ProSense system in the second half of 2026. Thailand In Thailand, our products have the Ministry of Public Health approval for our ProSense system and associated disposables to treat malignant breast tumors and other intended uses. Israel In Israel, we have received the AMAR authorization for use of our freezing technology for freezing of benign and malignant tumors, including and among others, breast, lungs, bones, kidney and other indications which enables us to market our products and will allow doctors in Israel to use our product for those indications listed above. In September 2025, the AMAR approved our XSense system with CryoProbes for commercial use across multiple indications including in gynecology, oncology and general surgery. 66 Taiwan In 2020, we received regulatory approvals to market and distribute ProSense and disposables in Taiwan for use of our products in the treatment of benign and cancerous tumor cells through freezing in a number of organs, such as kidneys, lungs, liver and bones. India In 2020, we received regulatory approval to commercialize our disposables in India, where our systems themselves do not require regulatory approval before commercialization. In February 2020 we received regulatory approval in India for our CryoProbes. In November 2023, CDSCO granted approval for our ProSense System. Brazil In 2023 we announced that our ProSense System received regulatory approval as a Class III device from the Brazilian Health Regulatory Agency, or ANVISA. Applications for both the ProSense System and its disposable CryoProbes and introducers were submitted to ANVISA by IceCure’s distributor in Brazil, Ktrfios Importação e Exportação LTDA, or Ktrfios. ProSense’s indications approved by ANVISA are oncology, which includes the ablation of benign and malignant tissues in the breast, prostate, kidney, lung, liver, musculoskeletal, and skin tissue, as well as for palliative intervention and other indications. Healthcare providers are cleared to conduct procedures with ProSense, its introducers and disposable probes, and Ktrfios is cleared to both market and sell ProSense’s introducers and disposable probes. ANVISA has requested that the CryoProbes also be submitted by Ktfrios for regulatory approval as a Class III device. The introducers remain a Class II device and do not require an additional regulatory submission. The probes received Class III device clearance in April 2024. Mexico Our ProSense system has regulatory approval from the Comisión Federal para la Protección contra Riesgos Sanitarios in Mexico. We are in the process of applying for a renewal of regulatory approval for our disposables in Mexico. Commercialization We began selling our IceSense3 and disposable probes in small quantities, for cryoablation of fibroadenoma in the United States in 2011. As of 2012, we began selling all of our products (IceSense3, ProSense and disposables) in the United States and other countries, with sales generated primarily by our sponsored ICE3 trial and independent clinical trials not sponsored by us. Following limited commercialization efforts that took place during our research and development phase, in 2018 and 2019, we started to increase our commercial efforts to sell our products to distributors and end users in the United States, Europe and Asia. Since then, we continued our commercialization efforts and intend to continue to commercialize our products during 2026 and beyond. As part of our strategy of raising awareness for our products and proprietary technologies within the medical community, although no formal agreement exists, in light of the ASBrS’s importance in our industry, we are operating in the United States with them as the leading organization and also with other organizations, such as the SIR, SIO, Society of Breast Imaging, and others that sets guidelines for breast cancer treatment. In March 2026, the ASBrS updated its treatment resource guide to include cryoablation as a recommended option for the treatment of low-risk breast cancer in patients aged 70 and above. We are also continually seeking to collaborate with additional societies like CIRSE, ECIO, EUSOBI who represent the EU relevant societies. We are seeing growing demand from key societies seeking to expand the breast cancer cryoablation course and education program to offer their members. on top of that. We are Expanding collaboration with key opinion leaders in additional territories such as China, Italy, France, Spain, India, Brazil, Hong Kong, Japan and Germany in order to create awareness, offer observing live procedures to train new users globally and collect clinical evidence for our technology in such territories. 67 Our customers in the United States are hospitals, interventional radiological centers, ambulatory centers and private clinics that purchase, lease or loan the ProSense system and buy the disposables directly from us. In certain instances, we place our ProSense system in hospitals and clinics and our customers in turn commit to purchasing a minimum number of probes per year for an extended period. In other territories, excluding Japan, where we sell directly to medical facilities, we sell our products to distributors who sell medical products and procedures in our field of activity. The primary users of our products are breast surgeons, breast radiologists, and interventional radiologists. As we sell and place more cryoablation systems, we anticipate the volume of sales of our probes will materially increase as we engage in a razor/razor blades sales model (see “Item 4.B. Business Overview – Revenues and Growth Strategy” for additional information). We currently have distribution agreements in Japan, Mainland China, Italy, France, Spain, Hong Kong, , Poland, Turkey, India, Brazil, Portugal, Romania , Germany, Switzerland, Greece, South Africa and other countries. We are reviewing new opportunities for collaboration with distributors across Europe as well. Below are the countries where we currently have distribution agreements. United States In the United States, we are working with leading breast surgeons and breast radiologists in order to initiate collaborations in the field of freezing malignant breast tumors. At the Radiological Society of North America, or RSNA, conference held in 2018, our freezing technology was declared one of 15 groundbreaking solutions in this field. In 2021 and 2022, our technology was also presented at the RSNA conference. Specifically, in 2021, interim data from the ICE3 clinical trial was presented and selected to be featured in a daily bulletin by RSNA. At the 2022 conference, the ProSense was featured in a poster presentation titled “To Freeze Or Not To Freeze? That Is The Question: Cryoablation For The Treatment Of Breast Cancer” by Kenneth Tomkovich, MD, Co-Primary investigator for IceCure’s ICE3 clinical trial, and Diagnostic and Interventional Radiologist with Princeton Radiology, CentraState Medical Center, and Penn Princeton Medical Center in Princeton, New Jersey. In the United States, unlike in other territories, as described below, we are entering a consolidated market and, in addition to our existing growth strategy, we will need to refine our marketing approach in order to generate significant revenue. In addition to our distribution agreements and other aspects of our product revenues and growth strategies, as described below, commercialization of our products is also highly dependent on the receipt of Current Procedural Terminology, or CPT, characterization in the United States. On July 2, 2019, our application for a CPT category III codes (0581T) describing the use of cryoablation for treating cancerous breast tumors was approved by the American Medical Association. On November 1, 2022, the CMS assigned payment to our ProSense breast cancer cryoablation procedures. The procedures were assigned as CPT Category III code 0581T to ambulatory payment classification 5091, Level 1 Breast/Lymphatic Surgery and Related Procedures. This payment assignment for the procedure went into effect on January 1, 2023, opening the potential for facilities to be paid, on a case-by-case basis, for these procedures subject to our receipt of FDA marketing authorization of ProSense for breast cancer. Under the temporary CPT Category III code, the ProSense procedure is priced for coverage by the CMS at approximately $4,000 for the facility fee alone. Additional coverage, including payment for the physician, is expected following our submission of an application for a permanent CPT Category I code, which we currently expect to submit by June 2026, with a potential effective date of January 2028. We are currently pursuing the establishment of additional CAT I codes for breast cancer cryoablation, which is required in order to make procedures with our products eligible for reimbursement from insurance companies in the United States. Even if we are successful in obtaining approval for our products for entry into additional CPT I category codes, these changes generally take over 24 months to go into effect, usually at the start of a new calendar year. 68 In order to cause our products to receive entry into additional CPT I categories, we intend to work with the ASBrS and conduct registry trials to collect additional data that we believe will support the use of our system and technology as a viable treatment option for breast cancer. We believe that by conducting such trials and collecting such data, which will result in increased use of our products, and potentially additional publications regarding their use, the ASBrS may amend its resource guide and enable our treatment system to receive CPT I approval, which could enable medical providers to receive appropriate reimbursement for treatment through our systems. At this time, it is unlikely that our ProSense (or any future system) will be eligible for rebates from insurance companies and other third-party payers without specific regulatory approvals for specific indications. Specific indications such as kidney cancer, liver cancer, bone tumors (under cryoanalgesia) have CPT I codes and reimbursement in a level of US$ 5,000-$9,000 per case. At this time, we have yet to initiate any marketing efforts for these indications. Terumo Japan In August 2019, we entered into an exclusive distribution agreement, or the Terumo Japan Agreement, for licensing, registration, import, marketing, sale, promotion and distribution of our ProSense system and its disposable products with breast tumors, with a leading global medical company, Terumo Corporation, or Terumo, in Japan and Singapore; provided, however, that with respect to the exclusivity clause, (i) we shall continue to have the ability to sell our system and disposables in Japan until Terumo obtains regulatory permit for marketing and distribution of our ProSense system and (ii) notwithstanding the foregoing, the exclusivity condition shall continue in force only for so long as Terumo purchases a minimum agreed upon number of products during the term of the Terumo Japan Agreement. We believe that the Terumo Japan Agreement will accelerate the commercialization of our ProSense system and associated disposables to treat malignant breast tumors in Japan and Singapore. The Terumo Japan Agreement requires Terumo to obtain necessary regulatory permits for marketing and distribution in Japan and obtaining reimbursement approvals. In Singapore, we have received the applicable regulatory approvals for our products; however, in February 2023, Termuo notified us that they suspended their distribution activities in Singapore with effect from March 31, 2023. The Terumo Japan Agreement is for an initial term of five years from the date of receipt of regulatory approvals for the sale of the Company’s products in Japan and is automatically extended for additional terms of five years each, unless a party notifies the other party of its intention to terminate the Terumo Japan Agreement at least one year prior to the end of the term, or at any time upon the mutual agreement of the parties in writing. A party shall have the right to terminate the Terumo Japan Agreement upon a breach of a material provision of the Terumo Japan Agreement by the other party or upon the insolvency of such other party, subject to certain conditions. In addition, the Terumo Japan Agreement may be terminated by either party under certain terms, including the option of revocation by the Company if Terumo does not purchase at least 60% of the minimum quantities defined in the Terumo Japan Agreement for the purchase of products and if Terumo fails to obtain the regulatory approvals on the dates stipulated in the Terumo Japan Agreement. In some cases, upon revocation or termination of the agreement, Terumo will assign to the Company the regulatory filings and regulatory approvals for the marketing and distribution of the ProSense system in Japan. The minimum aggregate consideration that Terumo owes us under the Terumo Japan Agreement is approximately $13.2 million, of which, as of the date of this annual report on Form 20-F, we have received $4 million as proceeds for distribution rights, knowledge sharing, the first purchase order, and another $708 thousand for the sale of our products and services. Pursuant to the Terumo Japan Agreement, we recognized revenues of $274 thousand in 2023, representing the final recognition of revenues under the agreement, with no further revenues recognized in 2024 or 2025. Terumo Thailand In December 2020, we entered into an exclusive distribution agreement with Terumo Thailand (an affiliate of Terumo), or the Terumo Thailand Agreement, for licensing, registration, import, marketing, sale, promotion and distribution of ProSense system and its disposables, in Thailand. The exclusivity condition shall continue in force only for so long as Terumo Thailand purchases a minimum agreed upon number of products during the term of the agreement. The distribution agreement is intended to accelerate the commercialization of our ProSense system and associated disposables to treat malignant and benign tumors in the breast, kidney, lung and other applications in Thailand. The agreement requires Terumo Thailand to obtain necessary regulatory permit for marketing and distribution in Thailand. 69 The Terumo Thailand Agreement is for an initial term of six years and is automatically extended for additional terms of six years each, unless a party notifies the other party of its intention to terminate the Terumo Thailand Agreement at least one year prior to the end of the term, or at any time upon the mutual agreement of the parties in writing. A party shall have the right to terminate the Terumo Thailand Agreement upon a breach of a material provision of the Terumo Thailand Agreement by the other party or upon the insolvency of such other party, subject to certain conditions. In addition, the Terumo Thailand Agreement may be terminated by either party under certain terms, including the option of revocation by the Company if Terumo does not purchase at least 60% of the minimum quantities defined in the Terumo Thailand Agreement for the purchase of products, and the option of revocation by Terumo Thailand if the Company discontinues its business relating to the ProSense system and its disposables or does not bring action with respect to an infringement of the exclusive distribution right within a reasonable time frame. To date, we have received up-front payments in a total aggregate amount of $450,000 under the Terumo Thailand Agreement. The minimal aggregate consideration that Terumo Thailand owes us under the agreement is approximately $7.2 million, of which $450,000 is to be paid in three equal installments of $150,000 for the sole distribution rights, transferring the regulatory approval from our regulatory agent to Terumo Thailand and knowledge sharing and $329,000 for the first purchase order. In 2021, we received $498,000 in furtherance of the first purchase order. In 2024 and 2025 we received $11,000 and $4,000 in orders, respectively. As of March 17, 2026, Terumo Thailand has not purchased the minimum quantities pursuant to the Terumo Thailand Agreement. We are currently evaluating our commercial activities in Thailand. Mainland China On June 12, 2022, we signed an exclusive distribution agreement for the IceSense3 and disposable probes with Shanghai Medtronic Zhikang and Beijing Turing. Pursuant to the agreement, Shanghai Medtronic Zhikang served as the exclusive distributor of the IceSense3 and its disposable probes in mainland China for an initial period of three years, with minimum purchase targets of $3.5 million for this period. While Shanghai Medtronic Zhikang was responsible for conducting all marketing, sales, and certain professional training, Beijing Turing was responsible for the import, installation, and after-sales service of IceSense3 systems in mainland China. Shanghai Medtronic Zhikang did not fulfil its minimum purchase target of $3.5 million by April 30, 2025, and as a result, the distribution agreement expired in accordance with its terms. We currently sell our products in China through Beijing Turing. Furthermore, pursuant to our arrangements with Beijing Turing, we remain responsible for obtaining and maintaining any and all regulatory approvals in mainland China required for marketing, promotion, distribution, sale and use of the products issued by the NMPA, its local branches or any other government authorities. We have already obtained regulatory approvals for the IceSense3/ProSense system and for the disposable IceSense3/ProSense CryoProbes for commercial procedures. In January 2025, we filed a submission for regulatory approval of ProSense and CryoProbes in China with the NMPA. 70 India As of March 17, 2026, we have two distribution partners in India, Novomed Ltd covering Maharashtra and certain territories in the north region of India and EMT Electronics Manufacturing Technologies Ltd covering certain states in the south region of India. The agreement with EMT Electronics Manufacturing Technologies Ltd. is scheduled to expire on March 31, 2026, and we currently do not expect to extend the agreement upon its expiration. Our ProSense system is installed in certain Tata Medical Center locations in Mumbai and other locations across India, a renowned hospital for oncology in India. Brazil In June 2021, we entered into an exclusive distribution agreement for the sale, marketing and distribution of our products in Brazil with Ktrfios. With ANVISA regulatory approval granted in October 2023, we are collaborating with key hospitals and key opinion leaders with a view to expanding the use of our technology in Brazil. Intellectual Property Our intellectual property portfolio consists of 46 issued patents (16 in the United States, 19 in Europe, 3 in Great Britain, 3 in China, and 5 in Japan), as further detailed in the table below. Patent No. Application No. Title Type of Patent Application Type of Patent Protection Expiration Date Country PCT No. 7967815 12/731,219 Cryosurgical Instrument with Enhanced Heat Transfer Utility patent Machine 03/25/2030 US PCT/US2011/025663 2549941 Utility patent Machine 02/22/2031 France 602011054052.1 Utility patent Machine 02/22/2031 Germany 2549941 11715783.4 Utility patent Machine 02/22/2031 Europe 7967814 12/700,761 Cryoprobe with Vibrating Mechanism Utility patent Machine 02/05/2030 US N/A 8162812 12/722,845 Combined Cryotherapy and Brachytherapy Device and Method Utility patent Machine and Process 03/12/2030 US N/A 71 7938822 12/778,172 Heating and Cooling of Cryosurgical Instrument Using a Single Cryogen Utility patent Machine 05/12/2030 US PCT/US2011/031722 2533716 11725226.2 Utility patent Machine 09/14/2031 Europe 8080005 12/846,047 Closed Loop Cryosurgical Pressure and Flow Regulated System Utility patent Machine 07/29/2030 US N/A 103402449 201180068737.1 Cryosurgical Instrument with Redirected Flow Utility patent Machine 12/29/2031 China PCT/US2011/067858 EP2683315 2683315 Utility patent Machine 12/29/2031 Great Britain 2683315 Utility patent Machine 12/29/2031 France 602011031296.0 Utility patent Machine 12/29/2031 Germany 502016000113273 Utility patent Machine 12/29/2031 Italy 2683315 11819145.1 Utility patent Machine 12/29/2031 Europe 7425211 11/462,244 Cryogenic Probe for Treating Large Volume of Tissue Utility patent Machine 11/24/2026 US N/A 7803154 11/832,778 Cryogenic Probe for Treating Large Volume of Tissue Utility patent Machine 04/19/2027 US N/A 8709005 13/232,203 Utility patent Machine 04/14/2032 US EP2696785 2696785 Coiled Heat Exchanger for Cryosurgical Instrument Utility patent Machine 09/14/2031 Great Britain PCT/US2011/051529 2696785 Utility patent Machine 09/14/2031 France 602011031962.0 Utility patent Machine 09/14/2031 Germany 502016000122670 Utility patent Machine 09/14/2031 Italy 9050075 14/133980 Utility patent Machine 09/14/2031 US 2696785 11760933.9 Utility patent Machine 09/14/2031 Europe 72 8906004 14/204,175 Phase Separation of Cryogen in Cryosurgical Instrument Utility patent Machine 09/14/2031 US N/A 9039689 14/547,483 Phase Separation of Cryogen in Cryosurgical Instrument Utility patent Machine 09/14/2031 US N/A 11633224 16-785,686 Cryogen Pump Utility patent Machine and process 06/26/2041 US N/A 7219498 2021-12530 Cryogen Pump Utility patent Machine and process 01/28/2041 Japan N/A EP3868320 21151413.8 Cryogen Pump Utility patent Machine and process 01/13/2041 Europe N/A 21151413.8 Cryogen Pump Utility patent Machine and process 01/13/2041 France N/A 21151413.8 Cryogen Pump Utility patent Machine and process 01/13/2041 Germany N/A 21151413.8 Cryogen Pump Utility patent Machine and process 01/13/2041 Italy N/A 21151413.8 Cryogen Pump Utility patent Machine and process 01/13/2041 Switzerland N/A 21151413.8 Cryogen Pump Utility patent Machine and process 01/13/2041 The Netherlands N/A 21151413.8 Cryogen Pump Utility patent Machine and process 01/13/2041 Turkey N/A 21151413.8 Cryogen Pump Utility patent Machine and process 01/13/2041 UK N/A ES2919851T3 21151413.8 Cryogen Pump Utility patent Machine and process 01/13/2041 Spain N/A 7465002 2022-91916 Cryogen flow control Utility patent Machine and process 06/06/2042 Japan N/A 12167880 18/184-693 Cryogen Pump Utility patent Machine and process 02/17/2040 U.S. N/A 12215811 17/866-614 Cryogenic System Connector Utility patent Machine and process 09/25/2042 U.S. N/A 4309604 23180921.1 Unitary Patent* Machine and process 06/22/2043 Europe* 7612237 2023115854 Cryogenic System Connector Utility patent Machine and process 07/14/2043 Japan N/A 12426934 17681868 Cryogen flow control Utility patent Machine and process 12/25/2047 U.S. N\A 116650093 202210632514.3 Cryogen flow control Utility patent Machine and process 06/06/2042 China N\A 7612233 23088275A Cryogenic System with Multiple Immersion Pumps Utility patent Machine and process 05/30/2043 Japan N/A 113243983 202110145919 Cryogen Pump Utility patent Machine and process 02/02/2041 China N/A 12527613 18464309 CRYOPROBE Utility patent Machine and process 04/27/2044 U.S. N/A 7785142 2024155459 CRYOPROBE Utility patent Machine and process 09/10/2044 Japan N/A * A unitary patent is a single EU patent that is registered as having "unitary effect" and provides uniform protection across all participating EU member states (currently 18 states). 73 Our intellectual property covers our technological platform, as well as innovative developments that will be used in our future products. 14 patents are not currently used by us for the development of our current and future technology and products and the expiry has not affected our business. In addition, to our patent portfolio, we have the following issued trademarks. We also have a number of other trademarks in the United Kingdom that we intend on abandoning. Registration No. Application No. Expiration Date Country Mark Renewal Due Date 4063706 77/615,741 N/A US ICECURE® 11/29/2030 (20 year) 4146269 85/430,438 N/A US ICECURE LOGO 05/22/2031 (20 year) 017884253 04/04/2018 N/A Europe ICECURE LOGO 04/04/2028 (10 year) 5251758 86/790,477 N/A US PROSENSE® 07/25/2026 (5 year) 017884265 17884265 N/A Europe PROSENSE® 04/04/2028 (10 year) 27566828 27566828 N/A China PROSENSE 02/06/2029 (10 year) 27566823 27566823 N/A China PROSENSE (CHINESE) 11/13/2027 (10 year) 010241305 010241305 N/A Europe ICECURE 09/05/2031 (10 year) 010241297 010241297 N/A Europe ICESENSE3 09/05/2031 (10 year) 010241263 010241263 N/A Europe ICESENSE 09/05/2031 (10 year) 018042365 018042365 N/A Europe ICECURE (NEW LOGO) 03/28/2029 (10 year) 6301784 2019-125291 N/A Japan PROSENSE 10/08/2030 (10 year) 6301783 2019-125290 N/A Japan ICECURE (ENGLISH) 10/08/2030 (10 year) 6301782 2019-125289 N/A Japan ICECURE (Logo) 10/08/2030 (10 year) Allowed 90857406 N/A US ICECURE (New Logo) Not yet registered Allowed 97544323 N/A US XSENSE Not yet registered Allowed 97544323 N/A US MSENSE Not yet registered 019031536 MEKW16EU N/A Europe XSENSE 05/23/2034 019031469 MEKW17EU N/A Europe MSENSE 05/23/2034 Production and Manufacturing The majority of the manufacturing of the ProSense system’s components is outsourced, and we complete the final assembly and testing in our facility in Israel. The majority of the manufacturing of our disposables, including sterilization and packaging, is outsourced. We conduct the final tests at our facility. The various components of our ProSense and probes are purchased and manufactured by several vendors and subcontractors. We are engaged with approximately 80 suppliers of components for our ProSense system and its disposables. The primary suppliers for our ProSense system and disposables are M. Shoham LTD, J.H. Avidan LTD and Concept Group LLC. We consistently monitor our inventory levels, manufacturing and distribution capabilities, and maintain recovery plans to address potential disruptions that we may encounter. In the future, as we scale up our sales and production further, we may implement a turnkey operation with select manufacturers for our probes. 74 We enter into quality agreements with our vendors and subcontractors. Pursuant to such agreements, we and the subcontractor will provide the parts and raw materials, components and/or perform the assembly of such components and/or service in accordance with specific terms of the mutually agreed work instructions and purchase orders. The agreements define the responsibilities of each party and the regulatory and compliance requirements that apply and contain industry-standard terms and guidelines. We entered into agreements with three contract manufacturers for the production of our XSense consoles and for the production of CryoProbes, pursuant to which the subcontractors shall be responsible for purchasing the components and raw materials, in a full turnkey model, in accordance with our specifications and work instructions. The engagements and quality agreements with these contract manufacturers set out the responsibilities of the parties and the applicable regulatory and compliance requirements and industry-standard terms and guidelines. Competition The medical device and tumor treatment industry is characterized by rapidly advancing technologies, intense competition and a strong emphasis on proprietary products. Cryoablation is an alternative approach to surgically removing tumors and/or to heat ablation of tumors, such as RFA, MWA and high intensity focused ultrasound. We encounter significant competition across our product lines in each market in which we sell our products from various companies, some of which may have greater financial and marketing resources than we do. We also face competition from non-medical device companies, as pharmaceutical companies, which may offer alternative therapies and treatments. We believe that the ability of our products and services to deliver rapid minimally-invasive treatments in-office or ambulatory hospital settings serves as a key competitive advantage versus surgical and other tumor treatment solutions. In the current environment of managed care, with economically-motivated buyers, consolidation among healthcare providers, increased competition and declining reimbursement rates, we have been increasingly required to compete on the basis of price, value, reliability and efficiency, which we believe we have been able to do and hope to continue to do. We believe that our cryoablation technology, and especially our LN2-based technology, has advantages over heat ablation technologies for breast tumors, which include, but are not limited to the below competitive advantages relative to heat ablation technologies. ● Pain: Because of the freezing effect on tissue, our procedure is less painful than heat ablation. ● Anesthesia: Due to the lower amount of pain that is generally caused by procedures from cryoablation, patients generally require less anesthesia. ● Accuracy: Image guided visualization of the cryoablation ice ball is clearer than heat ablation as the freezing does not cause evaporation, thereby allowing the cryoablation to be more accurate than thermal heat ablation. It is also safer as the boundaries of the treated area are clear under imaging with less risk of affecting healthy tissue during the ablation time. We believe that our direct competitors for cryoablation of malignant breast tumors are Sanarus Medical, Inc. which is part of Hologic Inc., which to the best of our knowledge is not active, Galil Medical Ltd., a subsidiary of Boston Scientific Corporation and EndoCare, Inc., a subsidiary of Siemens Healthineers. For tumors in other organs, other alternatives to surgical removal or cryoablation are available, such as thermal ablation, (including RFA, MVA and high intensity focused ultrasound). Our primary direct competitors also include other cryoablation companies, such as Galil Medical Ltd., part of Boston Scientific Corporation, EndoCare, Inc., part of Siemens Healthineers AG, Hygea Medical Technology Co. Ltd., and Beijing Sunshine Yibang Medical Technology Co., Ltd (the latter two of which operate mainly in China) for interventional radiology. Hygea Medical Technology Co. Ltd. is a company that also uses LN2-based technology. Unlike these competitors who have a multi probe system in the market, we are still developing our MSense system. Despite this, we believe that our LN2-based cryoablation technology is superior to those of our competitors, including Galil Medical and EndoCare, for a variety of reasons, including the following: ● our cryoablation LN2 technology allows deeper freezing temperatures, in the range of -150° to -170° Celsius, which results in faster and more efficient destruction of the tumor cells; 75 ● our LN2 technology allows us to achieve lower temperatures faster, potentially leading to shorter procedures; ● our effective ablating zone for one probe is greater than that of technologies utilizing argon-based technology probes (we are able to use one probe, while argon-based technologies need more than one probe to create the same killing zone, at the same time); ● using one probe in our technology is more cost-effective, less complicated, and easier to use for most physicians. ● the price of argon gas is significantly higher and less available in some territories than LN2 which makes our procedures more cost-effective. ● Argon gas is stored in 4,500 PSI (6,000 PSI in the United States only) gas balloons, which potentially creates a risk of explosion, whereas our LN2 is stored in low-pressure containers, which present less risk. The European authorities have issued a new directive forbidding patients from being in the same room as Argon gas balloons for safety reasons. Argon gas supply in large balloons (70 L) requires 2-3 balloons per average procedure, making it difficult to handle and store. LN2 is supplied by small 25L and 2 L Dewars (for ProSense) and is easy to handle, allowing for office-based procedures. We believe that these technological advantages will enable us to compete effectively with our competitors. In addition, we believe that by completing the development and initiating commercialization of our next generation XSense and future MSense systems, we will be able to compete even more effectively with our competitors. Government Regulation Our products and business are subject to extensive federal, state, local and foreign laws and regulations, including those relating to the protection of the environment, health and safety and our failure to comply with applicable requirements could harm our business. Some of the pertinent laws have not been definitively interpreted by the regulatory authorities or the courts, and their provisions are open to a variety of subjective interpretations. In addition, these laws and their interpretations are subject to change, or new laws may be enacted. Both federal and state governmental agencies continue to subject the healthcare industry to intense regulatory scrutiny, including heightened civil and criminal enforcement efforts. As indicated by work plans and reports issued by these agencies, the federal government will continue to scrutinize, among other things, the billing practices of healthcare providers and the marketing of healthcare products. We believe that we have structured our business operations and relationships with our distributors and customers to comply with all applicable legal requirements. However, it is possible that governmental entities or other third parties could interpret these laws differently and assert otherwise. In addition, because there is a risk that our products are used off label, we believe we are subject to increased risk of prosecution under these laws and by these entities even if we believe we are acting appropriately. We discuss below the statutes and regulations that are most relevant to our business and most frequently cited in enforcement actions. FDA Regulation of Medical Devices The Federal Food, Drug and Cosmetic Act, or FDCA, and FDA regulations establish a comprehensive system for the regulation of medical devices intended for human use. Our products include medical devices that are subject to these regulations, as well as other federal, state, local and foreign, laws and regulations. The FDA is responsible for enforcing the laws and regulations governing medical devices in the United States. 76 The FDA classifies medical devices into one of three classes (Class I, Class II, or Class III) depending on their level of risk and the types of controls that are necessary to ensure device safety and effectiveness. The class assignment is a factor in determining the type of premarketing submission or application, if any, that will be required before marketing in the United States. ● Class I devices present a low risk and are not life-sustaining or life-supporting. The majority of Class I devices are subject only to “general controls” (e.g., prohibition against adulteration and misbranding, registration and listing, good manufacturing practices, labeling, and adverse event reporting. General controls are baseline requirements that apply to all classes of medical devices.) ● Class II devices present a moderate risk and are devices for which general controls alone are not sufficient to provide a reasonable assurance of safety and effectiveness. Devices in Class II are subject to both general controls and “special controls” (e.g., special labeling, compliance with performance standards, and post market surveillance. Unless exempted, Class II devices typically require FDA clearance before marketing, through the premarket notification (510(k) process.) ● Class III devices present the highest risk. These devices generally are life-sustaining, life-supporting, or for a use that is of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury. Class III devices are devices for which general controls, by themselves, are insufficient and for which there is insufficient information to determine that application of special controls would provide a reasonable assurance of safety and effectiveness. Class III devices are subject to general controls and typically require FDA approval of a premarket approval, or PMA, application before marketing. Unless it is exempt from premarket review requirements, a medical device must receive marketing authorization from the FDA prior to being commercially marketed, distributed or sold in the United States. The most common pathways for obtaining marketing authorization are 510(k) clearance and PMA. All of our medical device products sold in the United States are subject to regulation as medical devices under the FDCA, as implemented and enforced by the FDA. The FDA governs the following activities that we perform or that are performed on our behalf, to ensure that medical products we manufacture, promote and distribute domestically or export internationally are safe and effective for their intended uses: ● product design, preclinical and clinical development and manufacture; ● product premarket clearance and approval; ● product safety, testing, labeling and storage; ● record keeping procedures; ● product marketing, sales and distribution; and ● post-marketing surveillance, complaint handling, medical device reporting, reporting of deaths, serious injuries or device malfunctions and repair or recall of products. 510(k) Pathway The 510(k) review process compares a new device to a legally marketed device. Through the 510(k) process, the FDA determines whether a new medical device is “substantially equivalent” to a legally marketed device (i.e., predicate device) that is not subject to PMA requirements. “Substantial equivalence” means that the proposed device has the same intended use as the predicate device, and the same or similar technological characteristics, or if there are differences in technological characteristics, the differences do not raise different questions of safety and effectiveness as compared to the predicate, and the information submitted in the 510(k) application demonstrates that the proposed device is as safe and effective as the predicate device. 77 To obtain 510(k) clearance, a company must submit a 510(k) application, containing sufficient information and data to demonstrate that its proposed device is substantially equivalent to a legally marketed predicate device. These data generally include non-clinical performance testing (e.g., software validation, animal testing electrical safety testing), but may also include clinical data. Typically, it takes three to twelve months for the FDA to complete its review of a 510(k) submission; however, it can take significantly longer and clearance is never assured. During its review of a 510(k) application, the FDA may request additional information, including clinical data, which may significantly prolong the review process. After completing its review of a 510(k) application, the FDA may issue an order, in the form of a letter, that finds the device to be either (i) substantially equivalent and states that the device can be marketed in the United States, or (ii) not substantially equivalent and states that device cannot be marketed in the United States. If the FDA determines that the device is “not substantially equivalent” to a previously cleared device, the device is automatically designated as a Class III device. The device sponsor must then fulfill more rigorous PMA requirements, or can request a risk-based classification determination for the device in accordance with the “de novo” process, which is a route to market for novel medical devices that are low to moderate risk and are not substantially equivalent to a predicate device. After a device receives 510(k) clearance or de novo classification, any modification that could significantly affect the safety or effectiveness of the device, or that would constitute a major change in its intended use, including significant modifications to any of our products or procedures, requires submission and clearance of a new 510(k) application or de novo classification or approval of a PMA. The FDA relies on each manufacturer to make and document this determination initially, but the FDA can review any such decision and can disagree with a manufacturer’s determination. Modifications meeting certain conditions may be candidates for a streamlined FDA review known as Special 510(k) review, which the FDA intends to process within 30 days of receipt. If a device modification requires the submission of a 510(k) application, but the modification does not affect the intended use of the device or alter the fundamental technology of the device, then summary information that results from the design control process associated with the cleared device can serve as the basis for clearing the application. A Special 510(k) allows a manufacturer to declare conformity to design controls without providing new data. When a modification involves a change in material, the nature of the “new” material will determine whether a traditional or Special 510(k) is necessary. An Abbreviated 510(k) is another type of 510(k) process that is intended to streamline the review of data through the reliance on one or more FDA-recognized consensus standards, special controls established by regulation, or FDA guidance documents. In most cases, an Abbreviated 510(k) includes one or more declarations of conformity to an FDA-recognized consensus standard. We may also make minor product enhancements that we believe do not require new 510(k) clearances. If the FDA disagrees with our determination regarding whether a new 510(k) clearance was required for these modifications, we may need to cease marketing and/or recall the modified device. The FDA may also subject us to other enforcement actions, including, but not limited to, issuing a warning letter or untitled letter to us, seizing our products, imposing civil penalties, or initiating criminal prosecution. De Novo Pathway Medical device types that the FDA has not previously classified as Class I, II, or III are automatically classified as Class III regardless of the level of risk they pose. The Food and Drug Administration Modernization Act of 1997 established a new route to market for low to moderate risk medical devices that are automatically placed into Class III due to the absence of a predicate device, called the “Request for Evaluation of Automatic Class III Designation,” or the de novo classification procedure. This procedure allows a manufacturer whose novel device is automatically classified as Class III to request down-classification of its medical device into Class I or Class II on the basis that the device presents low or moderate risk, rather than requiring the submission and approval of a PMA application. Prior to the enactment of the Food and Drug Administration Safety and Innovation Act, or FDASIA, in July 2012, a medical device could only be eligible for de novo classification if the manufacturer first submitted a 510(k) premarket notification and received a determination from the FDA that the device was not substantially equivalent. FDASIA streamlined the de novo classification pathway by permitting manufacturers to request de novo classification directly without first submitting a 510(k) premarket notification to the FDA and receiving a not substantially equivalent determination. We originally obtained marketing authorization for our system using the de novo classification process after receiving a not substantially equivalent determination following the submission of a 510(k) premarket notification. We have subsequently used the 510(k) clearance process to obtain authorization from the FDA for changes to our marketed system. 78 PMA Pathway Unlike the comparative standard of the 510(k) pathway and the De Novo Pathway, the PMA process requires an independent demonstration of the safety and effectiveness of a device. PMA is the most stringent type of device marketing application required by the FDA. PMA is based on a determination by the FDA that the PMA contains sufficient valid scientific evidence to ensure that the device is safe and effective for its intended use(s). A PMA application generally includes extensive information about the device including the results of clinical testing conducted on the device and a detailed description of the manufacturing process. After a PMA application is accepted for review, the FDA begins an in-depth review of the submitted information. FDA regulations provide 180 days to review the PMA and make a determination; however, in reality, the review time is normally longer (e.g., one to three years). During this review period, the FDA may request additional information or clarification of information already provided. In addition, during the review period, an advisory panel of experts from outside the FDA may be convened to review and evaluate the data supporting the application and provide recommendations to the FDA as to whether the data provide a reasonable assurance that the device is safe and effective for its intended use. The FDA generally will conduct a preapproval inspection of the manufacturing facility to ensure compliance with Quality System Regulation, or QSR, which imposes comprehensive development, testing, control, documentation and other quality assurance requirements for the design and manufacturing of a medical device. Based on its review, the FDA may (i) issue an order approving the PMA, (ii) issue a letter stating the PMA is “approvable” (e.g., minor additional information is needed), (iii) issue a letter stating the PMA is “not approvable,” or (iv) issue an order denying PMA. A company may not market a device subject to PMA review until the FDA issues an order approving the PMA. As part of a PMA, the FDA may impose post-approval conditions intended to ensure the continued safety and effectiveness of the device including, among other things, restrictions on labeling, promotion, sale and distribution, and requiring the collection of additional clinical data. Failure to comply with the conditions of approval can result in materially adverse enforcement action, including withdrawal of the approval. Most modifications to a device having completed PMA, including changes to the design, labeling, or manufacturing process, require prior approval before being implemented. Prior approval is obtained through submission of a PMA supplement. The type of information required to support a PMA supplement and the FDA’s time for review of a PMA supplement vary depending on the nature of the modification. Breakthrough Devices Program The goal of the BDP is to provide patients and health care providers with timely access to these medical devices by speeding up their development, assessment, and review, while preserving the statutory standards for premarket approval, 510(k) clearance, and De Novo marketing authorization, consistent with the FDA’s mission to protect and promote public health. The Breakthrough Devices Program offers manufacturers an opportunity to interact with the FDA’s experts through several different program options to efficiently address topics as they arise during the premarket review phase, which can help manufacturers receive feedback from the FDA and identify areas of agreement in a timely way. Manufacturers can also expect prioritized review of their submission. On November 15, 2021, the CMS announced the repeal of a proposed rule that would have provided a new Medicare coverage pathway in efforts to bring new and innovative technologies to beneficiaries sooner, start the process of accelerating the coverage of new, innovative breakthrough devices to Medicare beneficiaries and provide a four-year provisional reimbursement coverage period. We are working to understand current Medicare requirements and polices for coverage, coding and payment of breakthrough devices and how our ProSense system will be treated as a result of this rule repeal. CMS has stated that they are considering other coverage pathways for breakthrough devices, however no timeline for such other pathways has been announced. We expect that we will still be required to apply for CPT I codes under regular approval procedures in order to receive reimbursement. 79 Clinical Trials A clinical trial is typically required to support a PMA application or de novo classification, and is sometimes required for a 510(k) pre-market notification. Clinical trials of medical devices in the United States are governed by the FDA’s Investigational Device Exemption, or IDE, regulation. This regulation places significant responsibility on the sponsor of the clinical study including, but not limited to, choosing qualified investigators, monitoring the trial, submitting required reports, maintaining required records, and assuring investigators obtain informed consent, comply with the study protocol, control the disposition of the investigational device, submit required reports, etc. Clinical trials of significant risk devices (e.g., implants, devices used in supporting or sustaining human life, devices of substantial importance in diagnosing, curing, mitigating or treating disease or otherwise preventing impairment of human health) require FDA and Institutional Review Board, or IRB, approvals prior to starting the trial. FDA approval is obtained through submission of an Investigational Device Exemption, or IDE, application. Clinical trials of non-significant risk, or NSR, devices, (i.e., devices that do not meet the regulatory definition of a significant risk device) only require IRB approval before starting. The clinical trial sponsor is responsible for making the initial determination of whether a clinical study is significant risk or NSR; however, IRB and/or FDA reviewer may review this decision and disagree with the determination. An IDE application must be supported by appropriate data, such as performance data, animal and laboratory testing results, showing that it is safe to evaluate the device in humans and that the clinical study protocol is scientifically sound. There is no assurance that submission of an IDE will result in the ability to commence clinical trials. Additionally, after a trial begins, the FDA may place it on hold or terminate it if, among other reasons, it concludes that the clinical subjects are exposed to an unacceptable health risk. As noted above, the FDA may require a company to collect clinical data on a device in the post-market setting. The collection of such data may be required as a condition of PMA. The FDA also has the authority to order, via a letter, a post-market surveillance study for certain devices at any time after they have been cleared or approved. Even if a trial is completed, the results of clinical testing may not adequately demonstrate the safety and efficacy of the device or may otherwise not be sufficient to obtain FDA clearance or approval to market the product in the United States. Similarly, in Europe the clinical study must be approved by a local ethics committee and in some cases, including studies with high-risk devices, by the ministry of health in the applicable country. Pervasive and Continuing FDA Regulation After a device is placed on the market, regardless of its classification or premarket pathway, numerous additional FDA requirements generally apply. These include, but are not limited to: ● establishment registration and device listing requirements; ● QSR, which governs the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of finished devices; ● labeling requirements, which mandate the inclusion of certain content in device labels and labeling, and generally require the label and package of medical devices to include a unique device identifier, and which also prohibit the promotion of products for uncleared or unapproved, i.e., “off-label,” uses; ● medical device reporting regulation, which requires that manufacturers and importers report to the FDA if their device may have caused or contributed to a death or serious injury or malfunctioned in a way that would likely cause or contribute to a death or serious injury if it were to recur; and ● reports of Corrections and Removals regulation, which requires that manufacturers and importers report to the FDA recalls (i.e., corrections or removals) if undertaken to reduce a risk to health posed by the device or to remedy a violation of the FDCA that may present a risk to health; manufacturers and importers must keep records of recalls that they determine to be not reportable. 80 The FDA enforces these requirements by inspection and market surveillance. Failure to comply with applicable regulatory requirements can result in an enforcement action by the FDA, which may include, but is not limited to, the following sanctions: ● untitled letters or warning letters; ● fines, injunctions and civil penalties; ● recall or seizure of our products; ● operating restrictions, partial suspension or total shutdown of production; ● refusing our request for 510(k) clearance or premarket approval of new products; ● withdrawing 510(k) clearance or premarket approvals that are already granted; and ● criminal prosecution. We are subject to unannounced device inspections by the FDA, as well as other regulatory agencies overseeing the implementation of and compliance with applicable state public health regulations. These inspections may include our suppliers’ facilities. We cannot assure that we have adequately complied with all regulatory requirements or that one or more of the referenced sanctions will not be applied to us as a result of a failure to comply. International Regulation International sales of medical devices are subject to foreign government regulations, which vary substantially from country to country. In order to market our products in other countries, we must obtain regulatory approvals and comply with extensive safety and quality regulations in other countries. The time required to obtain approval by a foreign country may be longer or shorter than that required for FDA clearance or approval, and the requirements may differ. The European Union/European Economic Area, or the EU/EEA, requires a CE conformity mark in order to market medical devices. Many other countries, such as Australia, India, New Zealand, Pakistan and Sri Lanka, accept CE or FDA clearance or approval, although others, such as Brazil, Canada, China and Japan require separate regulatory filings. In the EU and the EEA, devices are required to comply with the essential requirements of the EU Medical Devices Directive being replaced by MDR 2017/745 which allowed the marketing of medical devices in the EU, under MDD until May 26, 2024. Compliance with these requirements entitled us to affix the CE conformity mark to our medical devices, without which they cannot be commercialized in the EU and EEA. To demonstrate compliance with the essential requirements and obtain the right to affix the CE conformity mark we must undergo a conformity assessment procedure, which varies according to the type of medical device and its classification. Except for low-risk medical devices (Class I), where the manufacturer can issue a CE Declaration of Conformity based on a self-assessment of the conformity of its products with the essential requirements of the Medical Devices Directive, a conformity assessment procedure requires the intervention of a Notified Body, which is an organization accredited at the European Commission to conduct conformity assessments. The Notified Body would typically audit and examine the quality system for the manufacture, design and final inspection of our devices before issuing a certification demonstrating compliance with the essential requirements. Based on this certification we can draw up a CE Declaration of Conformity which allows us to affix the CE Mark to our products. On April 5, 2017, the European Parliament passed the Medical Devices Regulation, which repeals and replaces the EU Medical Devices Directive. Unlike directives, which must be implemented into the national laws of the EEA member states, the regulations would be directly applicable (i.e., without the need for adoption of EEA member State laws implementing them) in all EEA member states and are intended to eliminate current differences in the regulation of medical devices among EEA member States. The Medical Devices Regulation, among other things, is intended to establish a uniform, transparent, predictable and sustainable regulatory framework across the EEA for medical devices and in vitro diagnostic devices and ensure a high level of safety and health while supporting innovation. 81 The MDR, which became effective on May 26, 2021, does the following: ● strengthen the rules on placing devices on the market and reinforce surveillance once they are available; ● establish explicit provisions on manufacturers’ responsibilities for the follow-up of the quality, performance and safety of devices placed on the market; ● improve the traceability of medical devices throughout the supply chain to the end-user or patient through a unique identification number; ● set up a central database to provide patients, healthcare professionals and the public with comprehensive information on products available in the EU; and ● strengthen rules for the assessment of certain high-risk devices, such as implants, which may have to undergo an additional check by experts before they are placed on the market. These modifications may have an impact on the way we design and manufacture products and the way we conduct our business in the EEA. We are progressing in our plans to meet the new requirements. Further, the advertising and promotion of our products in the EU and the EEA is subject to the laws of individual EU and EEA member states implementing the EU Medical Devices Directive, Directive 2006/114/EC concerning misleading and comparative advertising, and Directive 2005/29/EC on unfair commercial practices, as well as other EU and EEA member state laws governing the advertising and promotion of medical devices. These laws may limit or restrict the advertising and promotion of our products to the general public and may impose limitations on our promotional activities with healthcare professionals. We are in the process of implementing the new MDR requirements to conform with the European requirements. We have received AMAR approval in Israel. In addition, we received approval from the MedCert Zertifizierungs und Prufungsgsesellschaft fur die Medizin GmbH of Germany, and are entitled to print the CE Mark on our products, after having examined the EU Technical File for each new product. Other Regulatory Matters Manufacturing, sales, promotion and other activities following product approval are also subject to regulation by numerous regulatory authorities in addition to the FDA, including, CMS, other divisions of the Department of Health and Human Services, the Department of Justice, the Consumer Product Safety Commission, the Federal Trade Commission, the Occupational Safety and Health Administration, the Environmental Protection Agency, and state and local governments. If products are made available to authorized users of the Federal Supply Schedule of the General Services Administration, additional laws and requirements apply. Manufacturing, sales, promotion and other activities are also potentially subject to federal and state consumer protection and unfair completion laws. The distribution of medical device products is subject to additional requirements and regulations, including extensive record-keeping, licensing, storage and security requirements intended to prevent the unauthorized sale of medical device products. Third-Party Payors Coverage and Reimbursement Procedures using our products to treat breast cancer are not reimbursed currently by private or governmental third-party payors in the United States. On November 1, 2022, the CMS assigned our ProSense breast cancer cryoablation procedures with CPT Category III code 0581T to ambulatory payment classification 5091, Level 1 Breast/Lymphatic Surgery and Related Procedures. This payment assignment for the procedure went into effect on January 1, 2023, opening the potential for facilities to be paid, on a case-by-case basis, for these procedures subject to our receipt of FDA marketing authorization of ProSense for breast cancer. Under the temporary CPT Category III code, the ProSense procedure is priced for coverage by the CMS at approximately $4,000 for the facility fee alone. The Company may request an extension to the temporary CPT Category III code, which is due to expire on December 31, 2029. Additional coverage, including payment for the physician, is expected following our submission of an application of a permanent CPT CAT I code, which we currently expect to submit by June 2026, with a potential effective date as early as January 2028. 82 We intend to seek reimbursement through private and governmental third-party payors in the future, although significant uncertainty exists as to whether coverage and reimbursement of such procedures will be approved. In both the United States and foreign markets, our ability to expand utilization of the system and to attract commercialization partners depends, in part, on the availability of adequate coverage and reimbursement from third-party payors, including, in the United States, governmental payors such as the Medicare and Medicaid programs, and private health insurers. Medicare is a federally funded program managed by the CMS, through local contractors that administer coverage and reimbursement for certain healthcare items and services furnished to the elderly and disabled. Medicaid is an insurance program for certain categories of patients whose income and assets fall below state defined levels and who are otherwise uninsured, that is both federally and state funded and managed by each state. The federal government sets general guidelines for Medicaid and each state creates specific regulations or other guidelines that govern its individual program. Each payor, whether governmental or private, has its own process and standards for determining whether it will cover and reimburse a procedure or a particular product. Since private payors often rely on the lead of the governmental payors in rendering coverage and reimbursement determinations, achieving favorable CMS coverage and reimbursement is often a significant gating issue for successful introduction of a new product. The competitive position of our systems will depend, in part, upon the extent of coverage and adequate reimbursement for the procedures in which such products are used. Coverage policies and third-party reimbursement rates may change at any time. Even if favorable coverage policies and reimbursement rates are attained for procedures using our products, less favorable coverage policies and reimbursement rates may be implemented in the future. State and federal healthcare reform measures may be adopted in the future, any of which may result in additional reductions in Medicare and other healthcare funding, and otherwise affect the prices we may obtain for any of our products for which we may obtain regulatory approval, or the frequency with which any such products is prescribed or used. In addition, in some foreign countries, the proposed pricing for a medical device must be approved before it may be lawfully marketed. The requirements governing medical device pricing vary widely from country to country. In some countries, we may be required to conduct a clinical study or other studies that compare the cost-effectiveness of any of our product candidates to other available therapies in order to obtain or maintain reimbursement or pricing approval. Historically, products launched in the EU do not follow price structures of the United States and generally tend to be significantly lower. Publication of discounts by third-party payors or authorities may lead to further pressure on the prices or reimbursement levels within the country of publication and other countries. If pricing is set at unsatisfactory levels or if reimbursement of our products is unavailable or limited in scope or amount, our revenues from sales by us or our distributors and the potential profitability of any of our product candidates in those countries could be negatively affected. Other Healthcare Laws and Compliance Requirements Healthcare providers, physicians, and third-party payors will affect the utilization of any products for which we obtain marketing approval. Our future arrangements with healthcare providers and physicians may expose us to broadly applicable fraud and abuse and other healthcare laws and regulations that may constrain the business or financial arrangements and relationships through which we market, sell and distribute any device for which we obtain marketing approval. In the United States, our activities are potentially subject to regulation by various federal, state and local authorities in addition to the FDA, including the CMS, other divisions of the United States Department of Health and Human Services (e.g., the Office of Inspector General), the United States Department of Justice and individual United States Attorney offices within the Department of Justice, and state and local governments. The applicable laws and regulations include the federal Anti-Kickback Statute, the False Claims Act, and the Health Insurance Portability and Accountability Act of 1996, or HIPAA. 83 ● The Anti-Kickback Statute makes it illegal for any person, including a device manufacturer (or a party acting on its behalf), to knowingly and willfully solicit, receive, offer or pay any remuneration, directly or indirectly, in cash or in kind, that is intended to induce or reward referrals, including the purchase, recommendation, or order of a particular device, for which payment may be made under a federal healthcare program, such as Medicare or Medicaid. Violations of this law are punishable by up to five years in prison, criminal fines, administrative civil money penalties and exclusion from participation in federal healthcare programs. In addition, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it. ● The Federal False Claims Act imposes civil penalties, including through civil whistleblower or qui tam actions, against individuals or entities (including manufacturers) for, among other things, knowingly presenting, or causing to be presented false or fraudulent claims for payment by a federal healthcare program or making a false statement or record material to payment of a false claim or avoiding, decreasing or concealing an obligation to pay money to the federal government. Penalties for a False Claims Act violation include three times the actual damages sustained by the government, plus mandatory civil penalties of between $10,957 and $21,916 for each separate false claim and the potential for exclusion from participation in federal healthcare programs. Conduct that violates the False Claims Act also may implicate various federal criminal statutes. The government may deem manufacturers to have “caused” the submission of false or fraudulent claims by, for example, providing inaccurate billing or coding information to customers or promoting a product off-label. Claims which include items or services resulting from a violation of the federal Anti-Kickback Statute also are deemed false or fraudulent claims for purposes of the False Claims Act. Our future marketing and activities relating to the reporting of wholesaler or estimated retail prices for our products and other information affecting federal, state and third-party reimbursement for our products, and the sale and marketing of our product and any future product candidates, are subject to scrutiny under this law. ● HIPAA which imposes criminal and civil liability for executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters and, as amended by the Health Information Technology for Economic and Clinical Health Act, or HITECH, and its implementing regulations, also imposes certain obligations, including contractual terms and technical safeguards, with respect to maintaining the privacy, security and transmission of individually identifiable health information. ● HITECH also created new tiers of civil monetary penalties, amended HIPAA to make civil and criminal penalties directly applicable to business associates, and gave state attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce the federal HIPAA laws and seek attorneys’ fees and costs associated with pursuing federal civil actions. ● The Federal Physician Payments Sunshine Act within the Affordable Care Act, and its implementing regulations, which requires that certain manufacturers of devices and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) to report information related to certain payments or other transfers of value made or distributed to physicians and teaching hospitals, or to entities or individuals at the request of, or designated on behalf of, physicians and teaching hospitals and to report annually certain ownership and investment interests held by physicians and their immediate family members; and ● Analogous state and foreign fraud and abuse laws and regulations, such as anti-kickback and false claims laws, which may apply to sales and marketing arrangements and claims involving healthcare items or services reimbursed by any third party payor, including commercial insurers, and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and often are not preempted by federal laws, thus complicating compliance efforts. Such laws are generally broad and are enforced by various state agencies and private actions. In addition, we may be subject to data privacy and security regulation by both the federal government and the states in which we conduct our business. HIPAA imposes certain requirements relating to the privacy, security and transmission of individually identifiable health information, which are applicable to “business associates”—independent contractors or agents of HIPAA covered entities that receive or obtain protected health information in connection with providing a service on behalf of a covered entity. 84 Current and future legislation In the United States and foreign jurisdictions, there have been a number of legislative and regulatory changes and proposed changes regarding the healthcare system that could prevent or delay marketing approval of our product candidates, restrict or regulate post-approval activities and affect our ability to profitably sell any product candidates for which we obtain marketing approval. We expect that current laws, as well as other healthcare reform measures that may be adopted in the future, may result in more rigorous coverage criteria and in additional downward pressure on the price that we, or any collaborators, may receive for any approved products. U.S. Regulation The Affordable Care Act has had, and is expected to continue to have, a significant impact on the healthcare industry. The Affordable Care Act was designed to expand coverage for the uninsured while at the same time containing overall healthcare costs. With regard to pharmaceutical products, among other things, the Affordable Care Act expanded and increased industry rebates for drugs covered under Medicaid programs and made changes to the coverage requirements under the Medicare prescription drug benefit. There remain judicial, Congressional and executive branch challenges to certain aspects of the Affordable Care Act, and we expect there will be additional challenges and amendments to the Affordable Care Act in the future. While Congress has not passed comprehensive repeal legislation, it has enacted laws that modify certain provisions of the Affordable Care Act such as removing or delaying penalties, starting January 1, 2019, for not complying with the Affordable Care Act’s individual mandate to carry health insurance, delaying the implementation of certain Affordable Care Act-mandated fees, and increasing the point-of-sale discount that is owed by pharmaceutical manufacturers who participate in Medicare Part D. Additionally, on December 15, 2018, a Texas U.S. District Court Judge ruled that the Affordable Care Act is unconstitutional in its entirety because the individual mandate was repealed by Congress. Further, on December 18, 2019, the U.S. Court of Appeals for the 5th Circuit upheld the District Court ruling that the individual mandate was unconstitutional and remanded the case back to the District Court to determine whether the remaining provisions of the Affordable Care Act are invalid as well. On March 2, 2020, the United States Supreme Court granted the petitions for writs of certiorari and on June 17, 2021, decided that the plaintiffs lacked standing to challenge the individual mandate, leaving unresolved the question of whether the mandate is constitutional. We continue to evaluate the effect that the Affordable Care Act has on our business. Other legislative changes have been proposed and adopted in the United States since the Affordable Care Act was enacted. For example, through the process created by the Budget Control Act of 2011, there are automatic reductions of Medicare payments to providers up to 2% per fiscal year, which went into effect in April 2013 and, due to subsequent legislative amendments, will remain in effect through 2030 unless additional Congressional action is taken. However, the CARES Act, which was signed into law in March 2020 and is designed to provide financial support and resources to individuals and businesses affected by the COVID-19 pandemic, suspended the 2% Medicare sequester from May 1, 2020 through December 31, 2020, and extended the sequester by one year, through 2031. In January 2013, President Obama signed into law the American Taxpayer Relief Act of 2012, which, among other things, further reduced Medicare payments to several types of providers and increased the statute of limitations period for the government to recover overpayments to providers from three to five years. In addition, on January 28, 2021, President Biden issued an executive order to initiate a special enrollment period from February 26, 2021 through August 15, 2021 for purposes of obtaining health insurance coverage through the Affordable Care Act marketplace. The executive order also instructed certain governmental agencies to review and reconsider their existing policies and rules that limit access to healthcare, including among others, reexamining Medicaid demonstration projects and waiver programs that include work requirements, and policies that create unnecessary barriers to obtaining access to health insurance coverage through Medicaid or the Affordable Care Act. In addition, on August 16, 2022, President Biden signed the IRA into law, which among other things, extends enhanced subsidies for individuals purchasing health insurance coverage in Affordable Care Act marketplaces through plan year 2025. The IRA also eliminates the “donut hole” under the Medicare Part D program beginning in 2025 by significantly lowering the beneficiary maximum out-of-pocket cost through a newly established manufacturer discount program. Affordable Care Act Additional legislative and regulatory changes and judicial challenges to the Affordable Care Act, its implementing regulations and guidance and its policies, remain possible. 85 It is possible that the Affordable Care Act will be subject to judicial or Congressional challenges in the future. It is unclear how any such challenges and any healthcare reform measures of the Trump administration will impact the Affordable Care Act. In the coming years, additional legislative and regulatory changes could be made to governmental health programs that could significantly impact pharmaceutical companies and the success of our product candidates. At the state level, legislatures have increasingly passed legislation and implemented regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing. The Affordable Care Act, as well as other federal, state and foreign healthcare reform measures that have been and may be adopted in the future, could harm our future revenues. Additional laws and regulations governing international operations Since we further expand our operations outside of the United States, we must dedicate additional resources to comply with numerous laws and regulations in each jurisdiction in which we plan to operate. The Foreign Corrupt Practices Act, or FCPA, prohibits any United States individual or business from paying, offering, authorizing payment or offering of anything of value, directly or indirectly, to any foreign official, political party or candidate for the purpose of influencing any act or decision of the foreign entity in order to assist the individual or business in obtaining or retaining business. The FCPA also obligates companies whose securities are listed in the United States to comply with certain accounting provisions requiring the company to maintain books and records that accurately and fairly reflect all transactions of the corporation, including international subsidiaries, and to devise and maintain an adequate system of internal accounting controls for international operations. Compliance with the FCPA is expensive and difficult, particularly in countries in which corruption is a recognized problem. Certain payments to hospitals in connection with clinical trials and other work have been deemed to be improper payments to government officials and have led to FCPA enforcement actions. Various laws, regulations and executive orders also restrict the use and dissemination outside of the United States, or the sharing with certain non-United States nationals, of information classified for national security purposes, as well as certain products and technical data relating to those products. Our presence outside of the United States, requires dedicating additional resources to comply with these laws, and these laws may preclude us from developing, manufacturing, or selling certain products and product candidates outside of the United States, which could limit our growth potential and increase our development costs. The failure to comply with laws governing international business practices may result in substantial civil and criminal penalties and suspension or debarment from government contracting. The SEC also may suspend or bar issuers from trading securities on the United States exchanges for violations of the FCPA’s accounting provisions. Post-Marketing Regulations Following clearance or approval of a new product, a company and the product are subject to continuing regulation by the FDA and other federal and state regulatory authorities, including, among other things, monitoring and recordkeeping activities, reporting to applicable regulatory authorities of adverse experiences with the product, providing the regulatory authorities with updated safety and efficacy information, product sampling and distribution requirements, and complying with promotion and advertising requirements, which include, among others, standards for direct-to-consumer advertising, restrictions on promoting for uses or in patient populations not described in the product’s approved labeling (known as “off-label use”), limitations on industry-sponsored scientific and educational activities, and requirements for promotional activities involving the internet. Although physicians may prescribe legally available products for off-label uses, manufacturers may not market or promote such off-label uses. Modifications or enhancements to the products or labeling or changes of site of manufacture are often subject to the approval of the FDA and other regulators, which may or may not be received or may result in a lengthy review process. 86 Our research and development efforts were financed in part through royalty-bearing grants from the Israel Innovation Authority, or the IIA. As of December 31, 2025, we have received the aggregate amount of approximately $2.7 million (including accumulated interest) from the IIA for the development of our products. With respect to such grants, we are committed to pay certain royalties up to the total grant amount, including accumulated interest. As of December 31, 2025, we paid approximately $779 thousand. Regardless of any royalty payment, we are further required to comply with the requirements of the Research Law, with respect to those past grants. When a company develops know-how, technology or products using IIA grants, the terms of these grants and the Research Law restrict the transfer of such know-how, and the transfer of manufacturing or manufacturing rights of such products, technologies or know-how outside of Israel, without the prior approval of the IIA. This may restrict our ability to move the production of our products outside of Israel, or to sell intellectual property and other know-how. Further, should we move our production outside of Israel, we may be subject to repayment of 120% or more of the grants. The royalty rate we have undertaken to pay the IIA is 3.5%, and in any event up to the level of the grant, including accumulated interest, being linked to the exchange rate of the U.S. dollar and bearing Libor interest. Starting from the second half of 2017, new directives were introduced, according to which small companies (up to an annual turnover of $70 million) are to pay royalties of 3%. The total sum of royalties, including accumulated interest, we are required to repay the IIA, as of December 31, 2025 was approximately $1.9 million, net, after deducting the sums we paid as royalties to the IIA. C. Organizational Structure. We have three wholly-owned subsidiaries: IceCure Medical Inc., IceCure Medical HK Limited and IceCure (Shanghai) MedTech Co., Ltd., a Chinese company fully owned by the subsidiary in Hong Kong. IceCure Medical Inc. is our wholly-owned subsidiary incorporated in the State of Delaware. IceCure Medical Inc. is engaged in business development, marketing and selling our products in the United States. IceCure Medical HK Limited is our wholly-owned subsidiary incorporated in Hong Kong. IceCure Medical HK Limited serves as a holding company for IceCure (Shanghai) MedTech Co., Ltd. Currently, there is no other activity in IceCure Medical HK. IceCure (Shanghai) MedTech Co., Ltd., a subsidiary fully owned by IceCure Medical HK Limited, started its operations on January 1, 2021, and is engaged in obtaining regulatory approvals, business development, and marketing activities in China. D. Property, Plant and Equipment. Our headquarters are located at 7 Ha’Eshel St., Caesarea, 3079504, Israel, where we currently occupy approximately 879 square meters (approximately 9,461 square feet). We lease our facilities and our lease is due to end in July 2026.