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) 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%.
IceCure (Nasdaq: ICCM) announced that the U.S. Food and Drug Administration granted marketing authorization for ProSense® on October 3, 2025 for local treatment of breast cancer in patients ≥70 years with biologically low-risk tumors ≤1.5 cm treated with adjuvant endocrine therapy, and for patients not suitable for surgery.
The authorization followed IceCure's participation in the TME Fall Summit (Sept 26–27, 2025), where ProSense® drew high interest from a multidisciplinary roundtable of 40+ key opinion leaders and was highlighted in de-escalation sessions and a cryoablation faculty led by Dr. Richard Fine.
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.