Recently finalized and delivered proposed post market study plan to the FDA; Awaiting marketing authorization decision for ProSense® in women aged 70+ with early-stage low risk breast cancer
Continues to see rising interest in North America for ProSense®
Conference call to be held today at 10:00 am Eastern Time
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 reported financial results as of and for the three months ended March 31, 2025.
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IceCure delivered its proposed post market study plan (the “Plan”) to the U.S. Food and Drug Administration (“FDA”) as a requisite ahead of the FDA's marketing authorization decision for ProSense® in the treatment of early-stage low risk breast cancer when combined with adjuvant endocrine therapy for women aged 70 and over. The FDA's final marketing authorization decision is expected following review and approval of the plan by the FDA's Center for Devices and Radiological Health (“CDRH”).
“During the first quarter, we continued to experience momentum in North America where ProSense® sales grew year-over-year. As this market remains a priority for IceCure, we have worked diligently over the past few weeks to prepare the requested Plan, which we delivered to the FDA in a timely manner. Upon the CDRH's review, we are optimistic about a positive outcome on marketing authorization from the FDA in early-stage low risk breast cancer for women aged 70 and over,” stated IceCure Medical's CEO, Eyal Shamir. “This indication would cover a sizeable population, of approximately 46,000 women in the U.S. annually, that we believe seeks a patient-friendly minimally invasive option.”
“Additionally, we believe that the recent decision by our largest investor and Board member, Mr. Li Haixiang,to provide a $2 million unsecured loan demonstrates his confidence in our technology and ability to successfully deliver a less invasive, patient-centered care option–one which we see women in other countries are already benefitting from,” Shamir concluded.
In addition to the pending FDA decision described above, the Company has several other potential upcoming milestones in 2025:
— Terumo Corporation, IceCure's partner in Japan, is expected to file for regulatory approval of ProSense® for breast cancer in Japan in the second half of 2025
— A response from the regulatory authorities in Israel is expected for the next-generation XSense™
— Additional third-party data on ProSense® are expected to be published in medical journals and presented at prestigious medical conferences
Key Q1 2025 and Recent ProSense® Developments Demonstrate Continued Medical and Commercial Traction Globally Including:
— Strong reception at the American Breast Surgeons Annual Conference (ASBrS) 2025 included IceCure's ICE3 study being named as one of the “Best Papers of 2024” and cryoablation being mentioned favorably during the Presidential Address
— Award winning independent study of ProSense® in breast cancer and hands-on training for breast cryoablation at the Society of Interventional Oncology in Las Vegas
— Publication in Gland Surgery of independent study in Japan reported significantly higher satisfaction among patients who underwent ProSense® cryoablation compared to patients who underwent standard of care surgery
— ProSense® cryoablation featured in six studies presented at the St. Gallen International Breast Cancer Conference in Vienna, Austria
— ICESECRET kidney cancer cryoablation study's interim results demonstrating 88.7% recurrence-free rate presented at the European Association of Urology Conference in Madrid, Spain
— ProSense® featured in 7 key events at the European Conference on Interventional Oncology 2025 in Rotterdam, the Netherlands, including three presentations and a hands-on training
— Two sold-out breast cryoablation courses featured hands-on training with ProSense® at the Society of Breast Imaging 2025 Breast Imaging Symposium in Colorado Spring, Colorado
Financial Results for the Three Months Ended March 31, 2025
Revenue representing sales of ProSense® systems and disposable probes for the three months ended March 31, 2025 was $725,000 compared to $743,000 for the three months ended March 31, 2024. The 2% decrease in sales was primarily due to a decline in sales in Asia, offset by an increase in sales in Europe and North America. Gross profit for the three months ended March 31, 2025 was $218,000 compared to $269,000 for the three months ended March 31, 2024. Gross margin was 30% in the three months ended March 31, 2025 compared to 36% in the three months ended March 31, 2024. The decrease in gross profit and gross margin was attributable to the slight decline in revenue and the change in product mix. GAAP and non-GAAP gross profit and gross margin results were the same for the three months ended March 31, 2025. Revenues and gross profits are expected to continue to be variable quarter-over-quarter as the Company focuses on building commercial scale sales. The Company does not expect a material change in its revenues before receiving FDA marketing authorization decision.
Research and development expenses for the three months ended March 31, 2025 decreased by 15% to$1,664,000 compared to$1,951,000 for the three months ended March 31, 2024. The decrease was primarily due to a reduction in development expenses for the XSense™ System, which received FDA authorization in June 2024, and a decrease in clinical and regulatory costs as the Company concluded the ICE3 study in March 2024. Sales and marketing expenses increased for the three months ended March 31, 2025 by 24% to$1,289,000 compared to$1,038,000 for three months ended March 31, 2024 as the Company focused on increased global marketing to support growing sales and in anticipation of potential marketing authorization for ProSense® in early-stage breast cancer in the U.S. General and administrative expenses for three months ended March 31, 2025 were $922,000 down slightly from$930,000 for three months ended March 31, 2024.
Total operating expense for the three months ended March 31, 2025 was $3,875,000, relatively the same as $3,919,000 for the three months ended March 31, 2024.
Net loss for the three months ended March 31, 2025 narrowed by 0.6% to $3,588,000, or$0.06per share, compared to a net loss of$3,609,000, or$0.08 per share, for the same period last year.
As ofMarch 31, 2025, the Company had cash and cash equivalents, including short-term deposits, of approximately$6.04 million. As of May 27, 2025, the Company had cash and cash equivalents of approximately $6.2 million, which includes a $2 million unsecured bridge loan from Epoch Partner Investments Limited (“Epoch”), the Company's largest shareholder (the “Loan”).TheLoan bears an interest rate equal to a 12-month U.S. Treasury bond on May 17, 2025, to be repaid at the earlier of May 17, 2026 or when the Company raises money in an equity transaction in which Epoch participates, other than through an at-the-market facility and/or an equity line. Between January 13, 2025 and May 27, 2025, the Company raised $2.65 million in net proceeds from the sale of 2,124,429 ordinary shares under its at-the-market offering facility.
Conference call & webcast info:
Wednesday, May 28, 2025, at 10:00 am EDT US: 1-888-407-2553 Israel/International: +972-3-918-0696 A live webcast will be available at: https://Veidan.activetrail.biz/IcecureQ1-2025 A recording of the webcast will be available at: ir.icecure-medical.com/
About ProSense®
The ProSense® Cryoablation System provides a minimally invasive treatment option to destroy tumors by freezing them. The system uniquely harnesses the power of liquid nitrogen to create large lethal zones for maximum efficacy in tumor destruction in benign and cancerous lesions, including breast, kidney, lung, and liver.
ProSense® enhances patient and provider value by accelerating recovery, reducing pain, surgical risks, and complications. With its easy, transportable design and liquid nitrogen utilization, ProSense® opens that door to fast and convenient office-based procedure for breast tumors.
About IceCure Medical
IceCure Medical (NASDAQ: ICCM) develops and markets advanced liquid-nitrogen-based cryoablation therapy systems for the treatment of tumors (benign and cancerous) by freezing, with the primary focus areas being breast, kidney, bone and lung cancer. Its minimally invasive technology is a safe and effective alternative to hospital surgical tumor removal that is easily performed in a relatively short procedure. The Company's flagship ProSense® system is marketed and sold worldwide for the indications cleared and approved to date including in the U.S., Europe, and Asia.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and other Federal securities laws. Words such as “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates” and similar expressions or variations of such words are intended to identify forward-looking statements. For example, IceCure is using forward looking statements in this press release when it discusses: prospective FDA De Novo marketing authorization for ProSense® in the treatment of early-stage low risk breast cancer when combined with adjuvant endocrine therapy for women aged 70 and over; that the FDA's final marketing authorization decision is expected following review and approval of the Company's post market study plan by the CDRH; the Company's optimism about a positive outcome on marketing authorization from the FDA; the Company's belief that the Loan demonstrates Mr. Li Haixiang's confidence in the Company's technology and ability to successfully deliver a less invasive, patient-centered care option; the Company's potential upcoming milestones, including Terumo Corporation's expected filing for regulatory approval of ProSense for breast cancer in Japan, expected regulatory approval in Israel for XSense, and expected additional third-party data on ProSense to be published in medical journals and presented at medical conferences; when it discusses its expectation regarding its revenues; and the prospective repayment of the Loan from Epoch. Historical results of scientific research and clinical and preclinical trials do not guarantee that the conclusions of future research or trials will suggest identical or even similar conclusions. Important factors that could cause actual results, developments and business decisions to differ materially from those anticipated in these forward-looking statements include, among others: the Company's planned level of revenues and capital expenditures; the Company's available cash and its ability to obtain additional funding; the Company's ability to market and sell its products; legal and regulatory developments in the United States and other countries; the Company's ability to maintain its relationships with suppliers, distributors and other partners; the Company's ability to maintain or protect the validity of its patents and other intellectual property; the Company's ability to expose and educate medical professionals about its products; political, economic and military instability in the Middle East, specifically in Israel; as well as those factors set forth in the Risk Factors section of the Company's Annual Report on Form 20-F for the year ended December 31, 2024 filed with the SEC on March 27, 2025, and other documents filed with or furnished to the SEC which are available on the SEC's website, www.sec.gov. The Company undertakes no obligation to update these statements for revisions or changes after the date of this release, except as required by law.
IR Contact:
Email: investors@icecure-medical.com
MichaelPolyviou Phone: 732-232-6914
Todd Kehrli Phone: 310-625-4462
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SOURCE IceCure Medical
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