Icecure Medical Ltd. Stock Price, News & Analysis

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.

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.