Record 4(th) quarter and full year sales of $1.3 million and $3.4 million, respectively

Strong commercial momentum for ProSense$(R)$ in the U.S. and globally following FDA clearance in low-risk breast cancer and medical society recommendations

30 hybrid commercial-clinical sites to be added for FDA approved post-marketing study in addition to growing pipeline of potential commercial customers

IceCure Applies to Expand Regulatory Approval in Canada for ProSense(R) Cryoablation to Include the Treatment of Low-Risk Breast Cancer

Conference call to be held today at 11:00 am Eastern Time

CAESAREA, Israel, March 17, 2026 /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 option to surgical tumor removal, today reported record sales as of and for the twelve months ended December 31, 2025 as well as recent commercial and clinical updates.

Three significant events are expected to drive commercial adoption of ProSense(R):

   -- The American Society of Breast Surgeons' ("ASBrS") updated 2026 "Resource 
      Guide on the Use of Transcutaneous and Percutaneous Ablation for the 
      Treatment of Benign and Malignant Tumors of the Breast" recommends 
      cryoablation as an option for selected patients with biologically 
      low-risk early-stage breast cancer. The updated guidance represents an 
      important step toward broader clinical adoption of IceCure's ProSense(R) 
      cryoablation system. 
 
   -- The U.S. Food and Drug Administration ("FDA") approved the study design 
      for IceCure's post-marketing study for ProSense(R) in the treatment of 
      low-risk breast cancer. Patient enrollment for the "ChoICE" study is 
      expected to commence by the second half of 2026, with at least 80 
      patients enrolled in the first year of the study. The ChoICE study is 
      expected to enroll and treat 400 patients within 36 months across 30 
      clinical sites in the U.S. which can be used commercially. 
 
   -- On March 16, 2026, the Company submitted a Class III amendment 
      application to Health Canada seeking to expand its current regulatory 
      approval to include the use of the ProSense(R) cryoablation system for 
      the treatment of early-stage, low-risk invasive breast cancer in patients 
      aged 60 years and older. The application is supported by data from 
      IceCure's ICE3 clinical study, the largest study of its kind, which 
      served as the basis for the FDA's marketing clearance of ProSense(R) in 
      the treatment of low-risk breast cancer. Under the proposed indication in 
      Canada, up to 7,130 number of women would be eligible for breast cancer 
      cryoablation. A decision is expected during the second half of 2026, 
      subject to the agency's standard review procedures and potential 
      follow-up questions. 

"2025 was a pivotal year for IceCure. Following the FDA's clearance for cryoablation of low-risk breast cancer in October, we had record sales in the fourth quarter and fiscal year, which were driven by growing global adoption of ProSense(R). We believe we are just at the beginning of this favorable trend," stated Eyal Shamir, Chief Executive Officer of IceCure. " The recent ASBrS recommendation issued in March 2026, supports cryoablation as a treatment option and represents powerful validation of our technology and its role in modern breast cancer care. We are seeing increasing interest from physicians, hospitals, and patients around the world, and we believe these milestones position IceCure to accelerate adoption, expand installations, and continue advancing our mission of providing a minimally invasive alternative that improves outcomes and patient quality of life."

Shad Good, IceCure's VP of Sales North America, added, "Momentum in the U.S. market continues to build as three important factors have converged: FDA clearance of ProSense(R), reimbursement, and new professional society guidelines supporting cryoablation for selected breast cancer patients. We are seeing a clear uptick in engagement from hospitals and clinics, increased cryoprobe orders from existing customers, and a growing pipeline of new sites evaluating the system. With plans to expand our commercial infrastructure and launch our post-marketing study across 30 clinical sites, we believe we are well positioned to significantly broaden access to ProSense(R) and drive meaningful commercial growth in North America."

Upcoming Catalysts

   -- Further commercial momentum and conversion of sales pipeline into signed 
      contracts and installed systems expected in North America and globally. 
      - Organic demand from patients and doctors is further advanced by 
      positive word-of-mouth and media coverage, as seen in a recent news 
      segment featuring a new ProSense(R) installation at Thomas Hospital in 
      Alabama.- Physician-focused outreach at the leading U.S.-based breast 
      cancer conferences in April 2026--the ASBrS Annual Meeting and the 
      Society of Breast Imaging Symposium--is expected to result in a more 
      immediate response from doctors, due to FDA clearance and medical society 
      recommendations. 
 
   -- Expected to on-board 30 hybrid commercial-clinical sites across the U.S. 
      are expected to open following the FDA's recent approval of IceCure's 
      ChoICE post-marketing study protocol. These 30 planned sites, while 
      treating study participants, will also be active commercial sites where 
      any appropriate patient seeking treatment with ProSense(R) cryoablation 
      may be treated. Both clinical study and commercial procedures will be 
      eligible for CPT III reimbursement. Several potential customers in 
      IceCure's U.S. pipeline have indicated they would move forward with 
      purchase and installations upon the FDA's approval of the post-marketing 
      study protocol. 
 
   -- Expanded reimbursement coverage is expected for low-risk breast cancer 
      procedures following FDA marketing clearance and the new ASBrS guidelines 
      which recommend cryoablation for select patients. ProSense(R) currently 
      has reimbursement under the CPT III code which covers $4,000 of facility 
      costs, and this may increase by up to an additional $900in early 2027 if 
      the Company's submission for Transitional Pass-Through ("TPT") payment is 
      approved later this year. IceCure also plans to submit for CPT I code 
      reimbursement in the second quarter of this year, and expects a response 
      by early 2027, with CPT I expected to go effective in early 2028. 
 
   -- More regulatory submissions are expected. IceCure's distributor in Japan, 
      Terumo Corporation, is expected to file for regulatory approval for 
      ProSense(R) in the treatment of breast cancer in the first half of 2026. 

Additional Recent Operational and Clinical Highlights

   -- 2025 marked an all-time sales record in Europe, reflecting strong demand 
      and expanded market presence - The FDA's marketing clearance in the U.S. 
      for low-risk breast cancer had a direct positive influence on European 
      markets, as expected. Regulatory validation in the U.S. increased 
      confidence and adoption internationally, especially in Europe. In markets 
      where IceCure already had activity, the Company saw expanded usage 
      including new clinical applications, particularly in breast cancer, 
      beyond interventional oncology. 
 
   -- Recent installations of ProSense(R) in the U.S. range from small clinics, 
      to mid-sized hospitals, to a globally recognized prestigious hospitals 
      network-- A hospital network that is widely regarded as the leading 
      hospital in the U.S. and one of the top in the world now has ProSense(R) 
      installations at two of its larger sites and is expected to purchase 
      additional ProSense(R) systems. A major university teaching hospital in 
      the southern U.S. recently purchased ProSense(R). These are two examples 
      representing the profile of potential customers in IceCure's pipeline. 
 
   -- Thomas Hospital of Infirmary Health, the largest not-for-profit, 
      non-governmental healthcare system in Alabama, purchased and installed 
      ProSense(R) - The first breast cancer cryoablation procedures in the 
      state of Alabama were performed at Thomas Hospital with ProSense(R). A 
      local CBS news affiliate station aired an engaging news segment regarding 
      a 90 year-old patient who was treated for low-risk breast cancer with 
      ProSense(R) and walked out 30 minutes later to continue her active day. 
      See the segment HERE. The hospital's purchase was made possible by 
      the Thomas Hospital Foundation, a nonprofit organization dedicated to 
      supporting Thomas Hospital to access state-of-the-art medical technology 
      to offer innovative and compassionate care for their patients. IceCure is 
      currently in talks with numerous regional hospitals across the U.S. with 
      a profile similar to Thomas Hospital. 
 
   -- Shero Imaging, a St. Louis, Missouri based privately owned and operated 
      clinic, is the first clinic in the state to offer breast cancer 
      cryoablation with ProSense(R) - Shero Imaging is an example of how an 
      advanced breast imaging center can grow beyond diagnostics into treatment 
      with ProSense(R). IceCure estimates that there are approximately 8,700 
      breast imaging facilities in the U.S., with 3,000 to 4,000 of them being 
      privately owned and 800 -- 1,500 dedicated women's breast imaging centers, 
      similar to Shero. 
 
   -- During 2025, ProSense(R) was featured in a record number of peer-reviewed 
      publications and conference presentations - 16 principal investigators 
      presented at 10 conferences across the globe including the U.S., Europe, 
      and Asia, covering indications including breast, musculoskeletal and 
      kidney cancer. 
 

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March 17, 2026 08:30 ET (12:30 GMT)