Welcome to our dedicated page for IceCure Medical news (Ticker: ICCM), a resource for investors and traders seeking the latest updates and insights on IceCure Medical stock.
IceCure Medical Ltd. develops and markets liquid-nitrogen-based cryoablation systems for minimally invasive tumor destruction. Its flagship ProSense® system is used for benign and cancerous lesions, with company updates centered on breast, kidney, bone and lung cancer indications and on markets where the device is cleared or approved, including the United States, Europe and Asia.
News about ICCM commonly covers ProSense commercialization, FDA-related breast cancer developments, post-market study activity, clinical evidence such as the ICESECRET kidney cancer study, medical-conference presentations, financial and operating results, and governance changes. The company’s updates also address physician training, reimbursement context and shareholder matters tied to its ordinary shares.
IceCure Medical (ICCM) received Class III medical device approval from China’s National Medical Products Administration (NMPA) for its ProSense® cryoablation system and associated cryoprobes. This approval allows ProSense® to be marketed in China in line with the granted registration.
The company describes the NMPA decision as an important regulatory milestone that strengthens its global regulatory position and expands the markets where ProSense® may be commercialized. ProSense®, IceCure’s flagship liquid-nitrogen-based cryoablation system, is designed as a minimally invasive option to surgical tumor removal and is already marketed for cleared and approved indications in the U.S., Europe, and Asia.
IceCure Medical (Nasdaq: ICCM) signed an exclusive distribution agreement with Scovas Medical for its ProSense® cryoablation systems in the Netherlands, covering breast cancer and interventional oncology. Scovas will initially act as exclusive distributor, with a view to negotiating a longer-term agreement subject to both parties.
According to IceCure, the deal supports market development and clinical education in a country with strong interventional radiology expertise. The Netherlands-hosted, independent multicenter randomized THERMAC trial has advanced to Phase III focusing on cryoablation, after earlier data showed ProSense® achieved the highest complete ablation rate among evaluated thermal ablation techniques, with a 94% success rate, 0% complication rate and 100% treatment tolerance without general anesthesia.
IceCure Medical (NASDAQ: ICCM) reported that the Institutional Review Board of West Cancer Center & Research Institute in Germantown, Tennessee has approved the Company’s post-marketing ChoICE Study evaluating ProSense® cryoablation for the local treatment of low-risk breast cancer, enabling patient enrollment in the coming weeks.
ProSense® is the first and only device with U.S. FDA marketing authorization for local treatment of low-risk breast cancer with endocrine therapy in women aged 70 and above. Prior ICE3 trial results showed a 3.1% local recurrence rate and very high cosmetic satisfaction among patients and physicians, which supported this authorization.
IceCure Medical (NASDAQ: ICCM) highlighted two new peer-reviewed U.S. publications supporting the role of its ProSense® cryoablation system in breast cancer treatment de-escalation. One review in Clinical Breast Cancer discusses clinical evidence, procedural aspects and ProSense®'s FDA marketing authorization, its inclusion in updated American Society of Breast Surgeons guidelines, and five-year ICE3 trial outcomes showing a 3.1% IBTR rate in selected patients.
A second article in the Journal of Breast Imaging addresses cryoablation of axillary lymph node metastases for breast cancer patients who are poor surgical candidates or decline surgery, reporting high technical success and low complication rates in both curative and palliative settings, and broadening discussion beyond primary tumors to regional nodal disease.
IceCure Medical (NASDAQ: ICCM) reported first-half 2026 revenue of $1.8 million, up about 45% from $1.25 million in 2025, driven by higher ProSense® system and disposable probe sales. Gross profit rose to $548,000. The active U.S. commercial installed base grew approximately 70% following FDA clearance, reflecting increased physician adoption and procedure volumes.
Net loss widened to $8.8 million versus $7.0 million a year earlier, as research and development, sales and marketing, and general and administrative expenses all increased. IceCure strengthened its balance sheet through multiple financings, ending June 30, 2026 with about $12.0 million in cash and cash equivalents and shareholders’ equity of $11.9 million. The Company continued to invest in its U.S. sales force and advanced its FDA-approved post-marketing CHoICE Study, while clinical visibility was supported by guideline inclusion, peer-reviewed publications, and five-year kidney cancer data.
IceCure Medical (Nasdaq: ICCM) announced that Adventist Health Glendale in California has signed an agreement and received Institutional Review Board (IRB) approval to become the first U.S. clinical site able to enroll patients in the post-marketing ChoICE Study of ProSense® for local treatment of low-risk breast cancer, following FDA marketing authorization in October 2025.
According to IceCure Medical, the ChoICE Study is planned to enroll up to 400 patients across multiple U.S. sites to collect real-world data that may support clinical adoption and broader access. The Adventist Health Glendale site will be led by breast surgeon Dr. Dennis Holmes, MD, FACS, described as a recognized authority and leading researcher in breast cancer cryoablation, with a focus on minimally invasive options for carefully selected, typically older patients with low-risk, early-stage disease.
IceCure Medical (NASDAQ: ICCM) announced it will release its financial and operational results for the six months ended June 30, 2026 before the Nasdaq Stock Market opens on Wednesday, August 12, 2026.
Management will review these results and discuss other corporate developments on a conference call and live webcast at 10:00 a.m. EDT the same day. U.S. investors can join by dialing 1-888-407-2553, while Israel and international participants can dial +972-3-918-0696. A live webcast will be available at https://www.veidan-conferencing.com/icecure-investors, and a recording will later be accessible at ir.icecure-medical.com.
IceCure Medical (Nasdaq: ICCM) reported that the Society of Interventional Oncology (SIO) has submitted a formal petition to the NCCN Breast Cancer Guidelines Panel to include percutaneous cryoablation without surgical excision as a Category 2B treatment option for selected patients with low-risk, early-stage breast cancer.
The petition proposes cryoablation as an alternative to breast-conserving surgery for women aged 70+ meeting strict clinical criteria, and for patients aged 50–69 who are poor surgical candidates or decline surgery when combined with radiation and endocrine therapy. SIO cites the FDA’s October 2025 marketing authorization of IceCure’s ProSense system, the first device cleared for local treatment of biologically low-risk breast cancer in women 70+ with tumors ≤1.5 cm receiving adjuvant endocrine therapy. According to IceCure, potential NCCN inclusion could raise clinical awareness and influence future reimbursement discussions.
IceCure Medical (Nasdaq: ICCM) has initiated its post-marketing ChoICE Study in the U.S. by signing an agreement with West Cancer Center & Research Institute in Germantown, Tennessee as the first clinical site. The study evaluates the ProSense® cryoablation system for treating low-risk breast cancer following U.S. FDA marketing authorization granted in October 2025.
The ChoICE Study is planned to enroll up to 400 patients across 30 U.S. sites, collecting real-world data to support clinical adoption and access for eligible patients. The West Cancer Center site will be led by breast surgical oncologist Dr. Richard Gilmore at the Margaret West Comprehensive Breast Center.
IceCure Medical (NASDAQ: ICCM) reported expanding commercial adoption of its ProSense™ cryoablation system in Brazil following FDA marketing authorization for early-stage, low-risk breast cancer.
ProSense™ has ANVISA approval, commercial procedures are being performed in multiple tumor types, and two large independent breast cancer cryoablation studies (750 patients in Brazil, 900 in France) are underway or planned.