Financial Data and Key Metrics Changes - Product sales in North America increased by 42% year-over-year, contributing to an overall product sales increase of 8% to $3.19 million for the twelve months ended December 31, 2024, compared to $2.96 million for the same period in 2023 [10][17] - Total revenue rose slightly to $3.29 million for the twelve months ended December 31, 2024, from $3.23 million in 2023, driven by increased product sales [17] - Gross profit increased by 12% to $1.45 million, with gross margin improving to 44% from 40% year-over-year [18] - Net loss increased by 5% to $15.32 million or $0.30 per share during the twelve months ended December 31, 2024, compared to a net loss of $14.65 million or $0.32 per share for the same period last year [20] Business Line Data and Key Metrics Changes - The growth in sales was primarily driven by the adoption of ProSense cryoablation across various indications, particularly in breast cancer, with 33 investigator-initiated studies presented in 2024 [10][12] - Non-GAAP gross profit from product sales increased by 32% to $1.35 million, with non-GAAP gross margin rising to 42% from 35% year-over-year [18] Market Data and Key Metrics Changes - The company noted sales momentum in Europe, Japan, and other parts of Asia, indicating a growing international presence [10] - The company is awaiting FDA approval for ProSense, which is expected to enhance sales momentum in the U.S. market [12][14] Company Strategy and Development Direction - The company is focused on innovation and patenting new technologies, including the next-generation cryoablation system, XSEN, which is already FDA cleared for the same indication as ProSense [16] - A soft launch of XSEN is planned for early next year, with the intention of eventually replacing ProSense as the flagship product [41][42] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the FDA's decision on ProSense, citing a favorable recommendation from the FDA Medical Device Advisory Committee [14] - The company is actively engaged with the FDA and believes that the approval process is progressing, despite delays [31][32] Other Important Information - The company raised $2.6 million in net proceeds from the sale of ordinary shares between January 13, 2025, and March 24, 2025 [20] - The company continues to manage costs diligently while prioritizing investments in marketing, sales, and research and development [21] Q&A Session Summary Question: Update on ProSense cryoablation procedures and US commercial efforts - Management confirmed ongoing activities at major hospitals like Emory, UCLA, and Mayo Clinic, with a focused sales team in the U.S. awaiting FDA approval [24][27] Question: Timing of FDA approval and sales hiring - Management indicated that delays are due to the evolving situation at the FDA, but they remain engaged and hopeful for a favorable decision [31][34] Question: Update on regulatory filing in Japan - Management stated that Terumo Corporation plans to submit a regulatory filing in Japan in the second semester of 2025 [36] Question: Dynamic between XSEN and ProSense - Management clarified that XSEN is intended to replace ProSense in the long run, with a soft launch planned for 2026 [41][45]

IceCure Medical Ltd. (ICCM) Q4 2024 Earnings Conference Call March 27, 2025 10:00 AM ET Company Participants Conference Call Operator - Call ModeratorMichael Poivieu - Conference Call HostEyal Shamir - CEO, IceCure MedicalRonan Zimmerman - CFO and Chief Operating Officer, IceCure MedicalEduardo (on behalf of Yi Chen) - Representative, HC Wainwright Conference Call Participants Kemp Dolliver - Analyst, Brookline Capital MarketsAnthony Vendetti - Analyst, Maxim Group Conference Call Operator Good morning, and ...

Product Development and Regulatory Approvals - IceCure Medical's lead product, the ProSense system, is a cryoablation technology for treating tumors, with regulatory approval in 15 countries including the U.S. and China[19]. - The company has received 510(k) regulatory clearance for its next-generation XSense system, which is designed to be more efficient and user-friendly than the ProSense system[17]. - IceCure is developing the MSense system, a multi-probe system aimed at treating multiple and larger tumors, which is still in the research phase[17]. - As of December 31, 2024, IceCure's products are cleared for various tumor treatments but still require separate FDA approval for malignant breast tumors[18]. - Regulatory developments in the U.S. and other countries are critical for IceCure's ability to market and sell its products, impacting future growth[25]. Financial Condition and Concerns - The company has incurred significant operating losses since inception and anticipates continued losses for the foreseeable future, indicating a need for substantial additional funding[38]. - IceCure's management has expressed concerns about the company's ability to continue as a going concern due to its financial condition[38]. Market Competition and Dependency - The company is highly dependent on successful regulatory clearances and marketing of its cryoablation systems, including ProSense, XSense, and future MSense systems[38]. - The company faces intense competition in the medical device market, which may hinder its ability to effectively compete[38]. Shareholder Control - IceCure's principal shareholders, officers, and directors own approximately 47.6% of the Ordinary Shares, allowing them significant control over shareholder matters[41].

Expecting FDA decision on marketing authorization for early-stage low risk breast cancer with endocrine therapyPositive ProSense® results were reported through 33 peer-reviewed journals and medical conferences during 2024Conference call to be held today at 10:00 am Eastern TimeCAESAREA, Israel, March 27, 2025 /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 ...

Interim Data confirm ProSense® cryoablation is highly effective for kidney tumors ≤3 cm and a safe procedure for kidney tumors ≤5 cm in people ineligible for surgery CAESAREA, Israel, March 24, 2025 /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 interim results from the Company's ICESECRET study of cry ...

CAESAREA, Israel, March 21, 2025 /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 it will issue a press release with its financial and operational results as of and for the twelve months ended December 31, 2024 before the Nasdaq Stock Market opens on Thursday, March 27, 2025. The Company will also discus ...

IceCure working in close collaboration with FDA towards De Novo decisionCAESAREA, Israel, March 20, 2025 /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 is in continued discussions with the U.S. Food and Drug Administration ("FDA") regarding its De Novo marketing authorization request for ProSense® in ear ...

IceCure exhibited at the prestigious event in Vienna, Austria attended by oncologists, breast surgeons An abstract on ICE3 study results by Dr. Richard Fine was accepted and included in the poster presentation gallery An independent study by Dr. Ava Kwong evaluated expanding the ICE3 study population to include triple negative breast cancer and younger patients Four additional independent abstracts were presented at the conference and all six will be published in the scientific journal—The BreastCAESAREA, ...

This latest IP win rounds out protection for the cryogenic pump in major global market following grants for the same patent in the U.S., Europe and JapanCAESAREA, Israel, March 17, 2025 /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 S ...

Independent study published in Gland Surgery and conducted at Kameda Medical Center in Japan by ProSense® users including Dr. Kizuki Matsumoto and Dr. Eisuke Fukuma Patients who underwent cryoablation compared to breast-conserving therapy (BCT) reported significantly higher satisfaction (71.0±18.6 vs. 56.3±16.5) in the primary outcome with a mean follow-up of 4.2 and 4.0 years, respectively Data support continued move toward de-escalation of breast cancer treatment from BCT (lumpectomy) to nonsurgical opt ...