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 (Nasdaq: ICCM) announced on October 3, 2025 that the FDA granted marketing authorization for ProSense® cryoablation for local treatment of early-stage, biologically low-risk breast cancer in women aged ≥70 with tumors ≤1.5 cm, when combined with adjuvant endocrine therapy. The authorization cites supporting data including the ICE3 trial (194 patients) showing a 3.1% 5‑year local recurrence rate. The FDA requested a post‑market study of ~400 patients at 30 sites. IceCure will hold a webcast on October 6, 2025 at 8:30 AM ET.
IceCure (Nasdaq: ICCM) announced FDA marketing authorization (De Novo) on Oct 3, 2025 for its ProSense® cryoablation system to treat biologically low‑risk breast cancer in women ≥70 with tumors ≤1.5 cm, representing ~46,000 U.S. patients annually. The authorization permits immediate commercial sales and establishes a CPT III reimbursement pathway covering $3,800 of facility costs. The FDA required a post‑market surveillance study of ~400 patients at 30 sites; those sites may also serve commercial patients. FDA set a 5‑year follow‑up data expectation for competitors seeking 510(k) clearance. A company webcast is scheduled for Oct 6, 2025 at 8:30 AM ET.
IceCure Medical (NASDAQ:ICCM) showcased significant progress for its ProSense® cryoablation technology at the European Society of Breast Imaging Congress 2025. The company presented 5 independent studies demonstrating the effectiveness of ProSense® in breast cancer treatment.
Key highlights include Dr. Francesca Pugliese's award-winning study on post-procedure imaging biomarkers, showing 100% sensitivity in treatment evaluation. A major study of 101 patients revealed a 75.8% complete response rate and 96.8% disease control rate at 12 months. Another significant study demonstrated 91.2% tumor-free rate when combining cryoablation with hormone therapy.
The technology's success in early-stage breast cancer treatment was further validated through multiple studies showing excellent safety profiles and superior cosmetic outcomes, positioning ProSense® as a promising minimally-invasive alternative to surgery.
IceCure Medical (NASDAQ:ICCM) showcased its ProSense® cryoablation technology at the CIRSE 2025 Annual Meeting in Barcelona, featuring 4 independent clinical studies demonstrating positive results. The presentations included 3 studies on breast cancer and 1 on endometriosis, highlighting ProSense's effectiveness as a minimally-invasive tumor treatment alternative.
Key findings included successful outcomes in elderly breast cancer patients, with Institut Curie's study showing safety and efficacy in patients aged 75-94 years. Another study demonstrated significant tumor size reduction when combining cryoablation with hormonal therapy. The endometriosis study revealed remarkable pain reduction from a mean score of 8 to 1, with 95% success rate in MRI-confirmed cases.
The conference featured 3 hands-on training sessions and presentations from 5 Key Opinion Leaders, underlining growing interest from interventional radiologists in breast cancer care.
IceCure Medical (NASDAQ: ICCM) has received a Notice of Allowance from the U.S. Patent and Trademark Office for its next-generation XSense™ cryoprobe technology. The innovation enhances the company's liquid-nitrogen-based cryoablation platform, which is used for tumor destruction through freezing as an alternative to surgical removal.
The patented technology features a novel extraction method incorporating a heater, temperature sensor, and controlled gas pulses in the cryoprobe's tip. This advancement enables precise temperature management during probe extraction, reducing tissue trauma risk. The XSense™ System with Cryoprobes has already secured regulatory approval in both the U.S. and Israel.
IceCure Medical (NASDAQ: ICCM) has received regulatory approval from Israel's Ministry of Health for its next-generation XSense™ cryoablation system. The system, which uses liquid-nitrogen based technology to destroy tumors by freezing, has been approved for multiple indications including breast cancer, gynecology, oncology, and general surgery.
The XSense™ System and CryoProbes had previously received FDA clearance in mid-2024 for all indications currently approved for the company's ProSense® system. This minimally invasive treatment option aims to reduce cancer care costs, accelerate patient recovery, and provide an alternative to surgical tumor removal.
IceCure Medical (NASDAQ: ICCM) announced two significant publications from the independent THERMAC Trial evaluating its ProSense® cryoablation system in breast cancer treatment. The trial, conducted in the Netherlands, compared different thermal ablation methods for early-stage breast cancer.
The first study, published in the European Journal of Surgical Oncology, revealed that 95% of patients were satisfied with thermal ablation, with 91% preferring it over surgery. The second publication in Radiology demonstrated that ProSense® achieved the highest complete ablation rate among alternatives, with no complications.
Key findings showed that 94% of thermal ablation cases were rated good or excellent compared to 80% for surgery. ProSense® required no oncoplastic surgery, while other methods needed additional interventions. The successful phase II results led investigators to select cryoablation as the preferred technique for a future phase III trial comparing it with surgery.
IceCure Medical (NASDAQ: ICCM) reported promising results from an independent study evaluating its ProSense® cryoablation system for treating abdominal wall endometriosis (AWE). The study, conducted at Nîmes University Hospital in France, demonstrated significant pain reduction in patients, with median pain scores dropping from 8/10 to 0/10 at 3-month follow-up.
The study included 14 patients with 23 AWE lesions treated between September 2022 and April 2025. Key outcomes showed complete ablation zone coverage, median procedural time of 93 minutes, and no complications. Only 14% of patients required retreatment. ProSense® is FDA-cleared and EU-approved for gynecological indications, targeting a market of approximately 190 million women globally affected by endometriosis.
IceCure Medical (NASDAQ: ICCM) reported financial results for H1 2025, highlighting progress toward FDA marketing authorization for ProSense® in treating early-stage breast cancer in women aged 70+. The company submitted a Post-Market Study plan to FDA, with approval expected by year-end 2025.
Financial highlights include revenue of $1.25M (down from $1.75M in H1 2024), and a successful $10M over-subscribed rights offering. The company reported a net loss of $6.95M ($0.12 per share) and held cash and equivalents of $5.38M as of June 30, 2025.
Clinical developments include strong data from independent studies, with a Japanese study showing 99% recurrence-free rate in over 600 women. The company expects several upcoming milestones, including Terumo's regulatory filing in Japan and XSense™ system approval in Israel.
IceCure Medical (NASDAQ: ICCM), a developer of minimally-invasive cryoablation technology for tumor treatment, will release its financial and operational results for H1 2025 before market open on August 13, 2025.
The company will host a conference call and webcast at 11:00 AM EDT on the same day to discuss the results and corporate developments. Investors can access the call via US toll-free number (1-888-407-2553) or international number (+972-3-918-0696), with a live webcast available through the company's website.