Icecure Medical Ltd. Stock Price, News & Analysis

IceCure (NASDAQ: ICCM) reported that four independent abstracts featuring its ProSense cryoablation system were presented at RSNA 2025 (Nov 30–Dec 4, 2025).

Key data from three studies covering 263 patients include: 100% success for luminal cancers ≤2.5 cm, complete necrosis 81.2% in a 73‑patient cohort, Cryoablation+HT tumor reduction 83.3% (mean 13.6 mm) versus HT‑only 42.1%, and CEM showing NPV and sensitivity 100% for cryoablation assessment. The company noted growing adoption following the FDA marketing approval for low‑risk breast cancer.

IceCure Medical (Nasdaq: ICCM) presented ProSense® liquid-nitrogen single‑probe cryoablation data and training at CIRSE 2025 in Barcelona, highlighting independent clinical studies and hands‑on sessions for interventional radiologists.

Key items: PRECICE will treat 234 Luminal A/B patients >50; a prospective series reported outcomes for 55 elderly HR+/HER2- patients (median age 86); a cohort of 39 inoperable malignant lesions showed efficacy in small, low‑grade HR+ unifocal IDC; an AWE study reported pain scores falling from 8 to 1 and MRI necrosis/resolution in 95% of cases.

IceCure (NASDAQ: ICCM) received a Notice of Allowance in China for a patent titled "Cryogen Flow Control" on Dec 5, 2025, covering temperature regulation for its next-generation XSense cryoablation system and probes.

The invention builds on prior intellectual property wins, with the same patent granted in Japan and pending in the EU, U.S., and other markets, and contributes to IceCure's stated 55 patents granted and allowed globally. The technology aims to use sensor-driven flow control to maintain distal tip temperatures, improve efficacy and tissue safety, and support navigation/mapping features. IceCure notes its ProSense cryoablation system has FDA marketing authorization for local treatment of low-risk breast cancer in specified patients.

IceCure (NASDAQ: ICCM) reported results for the nine months ended September 30, 2025 and highlighted a landmark FDA marketing authorization (Oct 2025) for ProSense® for low-risk breast cancer in patients ≥70 with tumors ≤1.5 cm.

Key operational notes: planned commercial rollout to 30 U.S. sites with a ~400-patient post-market study, Switzerland regulatory clearance, reimbursement under CPT III (facility portion ~$3,800, rising to >$4,000 Jan 2026), and patent notices for XSense™ in U.S./Japan.

Financials: nine-month revenue of $2.1M, gross margin 30%, net loss $10.8M, and cash of approximately $10.0M as of Sept 30, 2025.

IceCure (NASDAQ: ICCM) announced that Swissmedic approved its ProSense® cryoablation system and cryoprobes for treating malignant or benign tissue of the breast, lung, liver, kidney and musculoskeletal (bone), including palliative interventions. The approval, announced November 18, 2025, matches ProSense® indications already approved in the European Union.

The company said this Swiss registration complements recent U.S. FDA marketing authorization for ProSense® in low-risk breast cancer and supports IceCure's commercial expansion in Europe. The release notes Switzerland's large healthcare market, citing a KOF estimate of a $120 billion healthcare market in 2023 and healthcare spending near 12% of GDP.

IceCure Medical (Nasdaq: ICCM) received a Nasdaq written notice on Nov 14, 2025 for noncompliance with the $1.00 minimum bid price requirement under Nasdaq Listing Rule 5550(a)(2).

Nasdaq granted a 180-calendar-day cure period ending May 11, 2026. The company can regain compliance if its closing bid is at least $1.00 for 10 consecutive business days. The notice does not affect current listing or trading during the cure period. If compliance is not regained, the company may request a second 180-day period only if it meets market value of publicly held shares and other listing standards (except the minimum bid), but failure to cure can lead to Nasdaq delisting.

IceCure Medical (Nasdaq: ICCM) will report its financial and operating results for the nine months ended September 30, 2025 on Wednesday, November 19, 2025 before the Nasdaq opens.

The company will host a conference call and webcast to discuss results and corporate developments at 10:00 a.m. EST the same day. Dial-in numbers are provided for US and Israel/international participants, and a live webcast plus a recording will be available via the company links.

IceCure (NASDAQ: ICCM) promoted Shay Levav to Chief Operating Officer on Nov 10, 2025 as the company prepares to scale U.S. commercial efforts following FDA marketing clearance for ProSense® for low‑risk breast cancer in Oct 2025.

Levav will continue to lead Regulatory Affairs, Quality Assurance, and Clinical Affairs, roles he has held since 2020, and management says his experience through the ProSense® clinical and regulatory process will support operational execution as U.S. market traction increases.

IceCure (NASDAQ: ICCM) announced publication of an independent PLOS One study (Nov 3, 2025) reporting long‑term outcomes for stage I non‑small cell lung cancer (tumors ≥2.0 cm) treated with stereotactic body radiation therapy (SBRT) followed by IceCure's cryoablation system.

Key results: 5‑year local control 93%, 5‑year overall survival 74% (vs published SBRT alone 41%–52%), 5‑year disease‑specific survival 92%, median follow‑up 74 months, sample size 64, and no treatment‑related mortality; most frequent complication pneumothorax (CTCAE grade 2) at 40%.