Financial Data and Key Metrics Changes - For the six months ended June 30, 2022, revenue decreased by 27% to $1.5 million, compared to $2.1 million in the first half of last year, primarily due to reduced revenue recognition from distribution agreements and decreased sales in Asia due to COVID-19 impacts [24][30] - Gross profit was approximately $800,000 with a gross margin of approximately 54%, down from approximately $1.2 million and 58% respectively in the same period of 2021 [26] - Net loss increased to approximately $9 million or $0.24 per share, compared to a net loss of approximately $3.8 million or $0.16 per share for the same period last year [30] Business Line Data and Key Metrics Changes - The company signed an exclusive distribution agreement in Mainland China for IceSense3, with a minimum purchase target of $3.5 million over the first three years [10][13] - ProSense systems were sold and installed in several clinics worldwide, including the U.S., Turkey, and Poland, with expectations for increased installations based on commercial interest [15][16] Market Data and Key Metrics Changes - The healthcare market in China is expected to reach $2.3 trillion by 2030, driven by government investments in healthcare infrastructure [12] - The company is actively expanding its regulatory landscape, with applications filed in Brazil and Canada for the ProSense system [17][18] Company Strategy and Development Direction - The company aims to expand its regulatory and commercial strategies, focusing on the adoption of its minimally-invasive cryoablation technology [5][21] - Management highlighted the importance of the distribution agreement with Medtronic as a strategic milestone for market penetration in China [11] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future revenue growth driven by increased installations and sales of ProSense systems [21] - The management team is focused on advancing regulatory approvals and expanding clinical applications, with expectations for revenue recognition from the new distribution agreement in the second half of 2022 [14][21] Other Important Information - The company participated in 10 conferences and events during the second quarter, showcasing its technology and gaining traction within the medical community [19][20] - The ICE3 clinical trial is expected to provide final results by the end of 2023 or early 2024, which could further validate the technology [34] Q&A Session Summary Question: Can you share updated patient follow-up data from the trial? - By June 2022, 82 patients had completed the trial with follow-ups of up to five years, with a local recurrence rate of 2.06% [75][78] Question: Is this a reasonable run rate to think about for the full year? - The company believes that spending levels will remain consistent with the first half of the year, indicating a flexible budget to accommodate necessary changes [81] Question: What are the differences in breast cancer patients seen by the company versus breast surgeons? - The patients seen are largely the same, with collaboration between the company and breast surgeons in the ICE3 trial [82] Question: What is the regulatory strategy for FDA submissions? - The first indication planned for submission is for low-risk early-stage T1 invasive breast cancer, based on interim results [85]

Financial Data and Key Metrics Changes - Revenue for Q1 2022 decreased by 48% to approximately $0.75 million compared to $1.4 million in Q1 2021, primarily due to decreased revenue recognition from the distribution agreement with Terumo and a decline in sales in the Asia region impacted by COVID surges [17][24] - Gross profit was approximately $0.44 million for Q1 2022, down from approximately $0.94 million in the same period last year, with a gross margin of approximately 58% compared to 65% in Q1 2021 [18] - Net loss for Q1 2022 increased to approximately $4.4 million, or $0.12 per share, compared to a net loss of approximately $1.4 million, or $0.07 per share, for the same period last year [24] Business Line Data and Key Metrics Changes - Sales in the U.S. increased in Q1 2022, with ProSense receiving positive feedback at major oncology conferences [9] - The company has installed several new ProSense systems globally, indicating a strong commercial presence in 20 countries [7][8] Market Data and Key Metrics Changes - The decrease in revenue recognition from the Terumo distribution agreement was a significant factor in the overall revenue decline, particularly affecting markets in Japan, Singapore, and Thailand [17][66] - The company expects to have probe approval in China by September or October 2022, despite COVID-related delays [41] Company Strategy and Development Direction - The company is focused on obtaining FDA approval for ProSense in early-stage breast cancer, with plans for a De Novo classification and a sprint discussion with the FDA [13][38] - IceCure aims to expand its commercialization efforts and enhance its clinical applications with its cryoablation technology [3][16] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about future revenue growth due to international distribution agreements and increased sales efforts [16] - The company is working closely with the FDA and expects to finalize its submission for early-stage breast cancer treatment by early 2024 [59] Other Important Information - Research and development expenses increased to $2.4 million in Q1 2022, attributed to the acceleration of the next-generation single-probe system development [19][20] - Selling, marketing, general, and administrative expenses rose to $2.5 million, reflecting the company's expanding commercialization efforts [22] Q&A Session Summary Question: Update on FDA submission and timeline - Management confirmed ongoing discussions with the FDA and plans to submit for clearance for cryoablation of early-stage breast cancer operations who are high risk for surgery [36][38] Question: Impact of COVID on NMPA clearance in China - Management expects probe approval by September or October 2022, with minimal delays anticipated due to COVID lockdowns [41] Question: Operating expenses outlook - Operating expenses are expected to remain at current levels due to accelerated R&D efforts [42][43] Question: Receptiveness to cryoablation among colleagues - There is significant excitement and recognition of cryoablation as a viable alternative to surgery among medical professionals [45][48] Question: Timeline for registry implementation - The goal is to start the registry towards the end of summer or beginning of fall 2022 [73] Question: Ongoing NASDAQ listing costs - Management indicated that NASDAQ-related costs are expected to remain elevated due to rising insurance costs [74]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 20-F ☐ REGISTRATION STATEMENT PURSUANTTO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission ...