CAESAREA, Israel, Sept. 15, 2025 – IceCure Medical Ltd. (NASDAQ: ICCM), a pioneer in minimally invasive cryoablation therapies, today announced that its next-generation single cryoprobe cryoablation system, XSense™, has received regulatory approval from Israel’s Ministry of Health (AMAR). This marks a major expansion in the company’s portfolio, adding broad treatment indications in gynecology, oncology, and general surgery, including the treatment of breast cancer.
Science Significance
The XSense™ system utilizes IceCure’s proprietary liquid-nitrogen-based cryoablation platform, offering precise and effective destruction of benign and malignant tumors through freezing. By creating large lethal zones, XSense™ allows clinicians to treat a wide variety of tumors—including breast, kidney, lung, and liver lesions—without open surgery. The new approval expands opportunities for minimally invasive oncology and surgical applications, supporting growing evidence of cryoablation’s value in tumor management.
Regulatory Significance
The AMAR approval validates IceCure’s next-generation technology in its home market of Israel. XSense™ and its cryoprobes had already received U.S. FDA clearance in 2024 for the same indications approved for the company’s flagship ProSense® system. The dual recognition from U.S. and Israeli regulators strengthens IceCure’s regulatory credibility and positions the technology for additional global submissions.
Business Significance
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Eyal Shamir, CEO of IceCure Medical, emphasized that the new approval reinforces the company’s leadership in cryoablation:
“This latest approval reaffirms IceCure’s leadership in liquid-nitrogen cryoablation, expanding commercial opportunities across multiple therapeutic areas while addressing the cost pressures faced by healthcare systems.”
With Israel’s approval, IceCure is now positioned to accelerate adoption of XSense™ in domestic hospitals and clinics, while supporting expanded commercialization efforts globally. The minimally invasive, office-based nature of cryoablation also opens pathways for payer acceptance and broader reimbursement.
By demonstrating clinically relevant preclinical efficacy, Silexion strengthens its standing with investors, prospective partners, and regulatory authorities — an important step as it advances toward pivotal trials.
Patients’ Significance
For patients, XSense™ offers an alternative to invasive surgical tumor removal, minimizing pain, recovery times, and hospital stays. The approval for breast cancer treatment is particularly notable, providing a minimally invasive option that could reduce mastectomy rates and improve quality of life. By extending indications across oncology and gynecology, XSense™ supports better patient-centered care with reduced procedural risks.
Policy Significance
This approval aligns with Israel’s broader healthcare innovation policy, which emphasizes faster adoption of advanced, cost-effective, and less invasive treatment technologies. Cryoablation procedures can potentially lower national healthcare expenditures by reducing operating room demand, hospital bed occupancy, and surgical complications. The decision also strengthens Israel’s position as a hub for medtech innovation and regulatory agility.
Transaction Highlights
IceCure has secured regulatory approval from Israel’s Ministry of Health (AMAR) for its next-generation XSense™ cryoablation system and cryoprobes, expanding indications across oncology, gynecology, ENT, thoracic surgery, dermatology, neurology, proctology, and urology. The approval includes treatment for benign and malignant breast tumors, a milestone expected to accelerate adoption of minimally invasive cancer care. Notably, XSense™ is already FDA-cleared in the United States for all ProSense® indications, underscoring strong regulatory momentum worldwide. By enabling office-based, minimally invasive procedures that reduce recovery times, surgical risks, and treatment costs, the XSense™ system offers significant clinical and economic advantages. Its portable design and reliance on liquid nitrogen enhance practicality across healthcare settings, positioning IceCure to strengthen its market presence in Israel and expand global commercialization.
Source: IceCure Medical Press Release
