IceCure Medical

Company Overview

Snapshot

Founded in January 2006, IceCure Medical operates with 51–200 employees and has raised a total of $71.53 million across 12 funding rounds from 6 investors. The company received FDA marketing authorization in October 2025 for its ProSense® cryoablation system for the treatment of low-risk breast cancer in women aged 70 and above.

Business overview

IceCure Medical is a Health Tech & Life Sciences company focused on transforming healthcare through advanced minimally invasive cryoablation for benign and malignant tumors. Its core product, the FDA-cleared and CE-marked ProSense® System, utilizes liquid nitrogen to generate ultra-cold temperatures to destroy tumors by freezing them. This technology serves the women's health and interventional oncology markets, providing an alternative to surgical removal by enabling a less invasive, outpatient procedure. The company operates within the Medical Devices and Medical Treatment & Therapeutics sectors, targeting healthcare providers globally.

Strategic signal

In October 2025, IceCure Medical received FDA marketing authorization for its ProSense® cryoablation system for the treatment of low-risk breast cancer in women aged 70 and above. This significant regulatory milestone validates the efficacy and safety of ProSense® for a specific patient demographic, signaling a potential expansion of its market reach and adoption within oncology. For investors, this indicates a strong positive trajectory for the company's flagship product and its ability to navigate complex regulatory landscapes, potentially leading to increased commercial opportunities and market share.

Company Intelligence Q&A

What was a key regulatory achievement for IceCure Medical in late 2025?

In October 2025, IceCure Medical received FDA marketing authorization for its ProSense® cryoablation system for the treatment of low-risk breast cancer in women aged 70 and above. This marks a significant development in providing minimally invasive care for this patient group.

What were the findings of the ICE3 clinical trial for IceCure Medical's ProSense® system?

In September 2024, the 5-year results of IceCure's ICE3 trial were published, demonstrating a 96.3% recurrence-free rate for early-stage, low-risk breast cancer patients who underwent ProSense® cryoablation without excision, combined with endocrine therapy.

What recent patent was granted to IceCure Medical?

In September 2025, IceCure Medical was granted a Notice of Allowance for a U.S. Patent for its next-generation XSense™ Cryoprobes, indicating ongoing innovation in its cryoablation technology.

What was the outcome of a study published in the British Journal of Radiology regarding ProSense®?

In September 2024, a study published in the British Journal of Radiology demonstrated that IceCure's ProSense® is a safe procedure with a 97.7% technical success rate in treating tumors of the lung, bone, and soft tissues.

When did IceCure Medical receive regulatory approval for its ProSense® system in Brazil?

In September 2023, IceCure Medical's ProSense® cryoablation system received regulatory approval in Brazil, expanding its international market presence.