Icecure Medical Ltd. Stock Price, News & Analysis

IceCure Medical (Nasdaq: ICCM) announced that management, including CEO Eyal Shamir, will attend the Maxim Growth Summit in New York City on October 22–23, 2025 for one-on-one investor meetings.

The company will present its corporate overview and recent regulatory and commercial progress, notably that its ProSense® cryoablation system received FDA marketing authorization for local treatment of early-stage, low-risk breast cancer in patients aged ≥70 and in women not suitable for surgery. ProSense is positioned as the first new device option for this defined indication in decades and may influence standards of care for the indicated population.

Investors were invited to schedule meetings via Maxim sales representatives or Michael Polyviou at mpolyviou@evcgroup.com.

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.