FDA decision on marketing authorization expected in the first quarter of 2025CAESAREA, Israel, Nov. 8, 2024 /PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure", "IceCure Medical" or the "Company"), developer of minimally-invasive cryoablation technology that destroys tumors by freezing as an alternative to surgical tumor removal, announced the U.S. Food and Drug Administration's ("FDA") Medical Device Advisory Committee Panel's (the "Advisory Panel") favorable recommendation with 9 panelists voti ...

Comments from key stakeholders, including doctors, nurses, researchers, and breast cancer patients, are available on FDA website FDA Advisory Panel providing recommendations and vote on information concerning the benefit-risk profile for a De Novo marketing submission of the IceCure ProSense® Cryoablation System in earlystage low risk breast cancer scheduled for November 7, 2024 CAESAREA, Israel, Oct. 29, 2024 /PRNewswire/ -- IceCure Medical Ltd. (NASDAQ: ICCM) ('IceCure', 'IceCure Medical' or the 'Company' ...

Innovative cryogenic system connector technology designed to improve usability and maintain the integrity of cryogen used in the cryoablation procedure CAESAREA, Israel, Oct. 21, 2024 /PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure", "IceCure Medical" or the "Company"), developer of minimally-invasive cryoablation technology that destroys tumors by freezing as an alternative to surgical tumor removal, today announced it has received a Notice of Allowance for its invention titled "Cryogenic Sys ...

Liquid nitrogen- (LN2) based ProSense® found to have favorable safety compared to argon-based cryoablation systems, as well as being more cost effective and easier to manage Independent study conducted at the European Institute of Oncology (IEO) demonstrates interventional radiology use cases for ProSense® for indications that are approved in various markets across the world CAESAREA, Israel, Sept. 16, 2024 /PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure", "IceCure Medical" or the "Company"), ...

Public forum to evaluate ProSense® cryoablation as a minimally invasive alternative to lumpectomy for an estimated 70,000 women diagnosed in U.S. annually with early-stage low risk breast cancer FDA decision regarding marketing authorization of ProSense® expected by early 2025 CAESAREA, Israel, Sept. 12, 2024 /PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure", "IceCure Medical" or the "Company"), developer of minimally-invasive cryoablation technology that destroys tumors by freezing as an alter ...

Company presentation to focus on how IceCure's industry-leading ProSense® enables non-surgical treatment of benign and cancerous tumors and upcoming near-term regulatory and operating catalysts CAESAREA, Israel, Sept. 4, 2024 /PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure", "IceCure Medical" or the "Company"), developer of minimally-invasive cryoablation technology that destroys tumors by freezing as an alternative to surgical tumor removal, today announced that the Company's Chief Executive ...

Financial Data and Key Metrics - ProSense systems and disposable probes sales increased by 20% YoY to $1.65 million for the six months ended June 30, 2024, compared to $1.37 million in the same period last year [10] - Total revenues grew by 6.5% to $1.75 million for the six months ended June 30, 2024, compared to $1.65 million in the same period last year, driven by higher sales in Europe, the US, Japan, and other Asian territories, partially offset by a decrease in China [10] - Gross profit increased to $799,000 for the six months ended June 30, 2024, compared to $754,000 in the same period last year, with gross margin remaining consistent at 46% [11] - Non-GAAP gross profit increased by 46% to $699,000 for the six months ended June 30, 2024, compared to $480,000 in the same period last year, with non-GAAP gross margin growing to 42% from 35% [11] - Total operating expenses decreased to $7.68 million for the six months ended June 30, 2024, compared to $8.8 million in the same period last year, primarily due to reductions in R&D and general administrative expenses [12] - Net loss narrowed to $6.7 million or $0.14 per share for the six months ended June 30, 2024, compared to a net loss of $7.66 million or $0.17 per share in the same period last year [12] - Cash and cash equivalents were approximately $10.5 million as of June 30, 2024, and $10.3 million as of July 31, 2024 [13] Business Line Data and Key Metrics - ProSense systems and disposable probes sales growth was driven by higher demand in Europe, the US, Japan, and other Asian territories, with a notable decrease in sales in China [10] - The company continues to see excellent clinical results from independent studies in Europe, particularly in breast cancer treatment, with promising results presented at the 32nd Annual Meeting of the Japanese Breast Cancer Society [8] - Terumo, the company's distribution partner in Japan, plans to file for regulatory approval of ProSense for early-stage low-risk breast cancer with endocrine therapy in Q1 2025 [8] Market Data and Key Metrics - The FDA will convene a public medical device advisory panel later in 2024 to review ProSense for early-stage breast cancer treatment, highlighting the public health importance of providing a minimally invasive alternative to surgery [6] - The company expects strong demand for cryoablation to treat early-stage low-risk breast cancer, supported by a reimbursement code for facility expenses of $3,600 and potential additional reimbursement for physician expenses post-FDA approval [7] - In Japan, Terumo's regulatory filing for ProSense is expected in Q1 2025, with the company leveraging ICE3 trial data and working closely with regulatory teams and KOLs [17] Company Strategy and Industry Competition - The company is focused on advancing regulatory, marketing, and commercial strategies, with plans to be highly visible at medical conferences in the US and Europe to engage with interventional radiologists, breast radiologists, and breast surgeons [8] - The company believes that the FDA advisory panel's transparent and public forum will raise awareness of ProSense as a nonsurgical option, potentially leading to rapid adoption in the US if marketing authorization is granted [7] - The company is leveraging independent studies and clinical data from around the world to support its regulatory efforts, particularly in the US and Japan [8][17] Management Commentary on Operating Environment and Future Outlook - Management highlighted the growing demand for ProSense, driven by physician engagement and upcoming catalysts, including the interim analysis of the ICESECRET kidney cancer trial expected in December 2024 [5] - The company is optimistic about the potential for FDA approval of ProSense for early-stage breast cancer, with a detailed commercialization plan in place for the US market post-approval [15][16] - Management noted the importance of independent studies and the consistent positive data from these studies, which they believe will support the company's regulatory and commercial objectives [22][23] Other Important Information - The company raised $5.035 million in gross proceeds from the sale of ordinary shares under its ATM facility during the first half of 2024, positioning it to execute major upcoming catalysts, including the FDA advisory panel and potential marketing clearance decision [13] - The company's CEO, Eyal Shamir, will participate in the H.C. Wainwright's Annual Global Investment Conference and Lake Street's Annual Best Ideas Growth Conference in September 2024 to provide an overview of the company's story and opportunities [14] Q&A Session Summary Question: Commercialization plan post-FDA approval in the US [15] - The company has a detailed five-year commercialization plan, including targeting key societies, KOL development, and strategic hires to support expected growth [16] Question: Plans and expectations in Japan [17] - Terumo is expected to file for PMDA approval in Q1 2025, with the company leveraging ICE3 trial data and working closely with regulatory teams and KOLs in Japan [17] Question: Sales performance in China [19] - Sales in China are inconsistent due to market complexities, but the company remains optimistic about future performance in the region [19] Question: Leveraging ICESECRET data in the US [20] - The company is currently focused on breast cancer in the US but plans to leverage ICESECRET data in other regions, including Europe, Southeast Asia, and South America [20] Question: Independent breast cancer studies and broader applicability of ProSense [22] - Management views independent studies positively, noting that KOLs see potential in cryoablation and choose their own patient groups for studies, which provides consistent and promising data [22] Question: Highlighting specific independent studies [23] - Most of the 15 ongoing independent studies focus on breast cancer, with the company optimistic about the results but unable to provide specific details as the studies are independent [23] Question: Details on the FDA advisory committee meeting [25][26] - The company expects to receive the date for the advisory committee meeting shortly and will announce details via press release. The committee is expected to include breast surgeons, breast radiologists, oncologists, and regulatory experts [26][27]

IceCure Medical Ltd. (ICCM) came out with a quarterly loss of $0.06 per share versus the Zacks Consensus Estimate of a loss of $0.07. This compares to loss of $0.09 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of 14.29%. A quarter ago, it was expected that this company would post a loss of $0.08 per share when it actually produced a loss of $0.08, delivering no surprise. Over the last four quarters, the company has surpassed ...

Exhibit 99.1 | --- | --- | --- | --- | --- | |--------|-------|-------|-------|----------------------| | | | | | As of December 31, | | ASSETS | | | 2024 | 2023 | As of June 30, The accompanying notes are an integral part of the consolidated financial statements. ICECURE MEDICAL LTD. UNAUDITED INTERIM CONDENSED CONSOLIDATED BALANCE SHEET (U.S. dollars in thousands, except share data and per share data) | --- | --- | --- | |------------------------------------------------------------------------------------- ...

After a median follow-up of 16 months, the complete ablation rate in Luminal A and B breast cancer tumors ≤ 25mm was 100% Study concluded that most non-surgical patients with early-stage breast cancer accepted cryoablation when the treatment was offered and that cryoablation is a safe, effective alternative to surgery and well-tolerated as an out-patient procedure CAESAREA, Israel, Aug. 14, 2024 /PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure", "IceCure Medical" or the "Company"), developer of ...