IceCure Medical

Company Overview

Snapshot

Founded in January 2006, IceCure Medical operates with 51–200 employees. The company has raised a total of $71.53 million across 12 funding rounds from 6 investors. 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.

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, particularly in women's health and interventional oncology. Its core technology is the FDA-cleared and CE-marked ProSense® System, which uses liquid nitrogen to destroy tumors by freezing them, offering a less invasive alternative to surgical removal. The company serves markets globally, including North America, Europe, Asia, and South America, targeting hospitals, surgeons, radiologists, and oncologists within the healthcare provider sector.

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 approval positions ProSense® as the first and only medical device to receive such authorization for local breast cancer treatment, indicating a major advancement in minimally invasive care and opening new market opportunities for the company.

Company Intelligence Q&A

What was a significant 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 ProSense® as the first and only medical device to be granted such authorization for local breast cancer treatment.

What clinical trial results were published in September 2024 regarding ProSense®?

In September 2024, IceCure's ICE3 5-Year Trial Results were published in the peer-reviewed Annals of Surgical Oncology Journal, demonstrating a 96.3% recurrence-free rate for early-stage, low-risk breast cancer patients who underwent ProSense® cryoablation without excision.

What recent patent development did IceCure Medical announce?

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

When did IceCure Medical's ProSense® system receive regulatory approval in Brazil?

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

What was the outcome of the independent THERMAC Trial featuring IceCure's ProSense® in breast cancer, as published in September 2025?

In September 2025, two publications from the independent THERMAC Trial featuring IceCure's ProSense® in breast cancer found that 95% of patients were satisfied with thermal ablation, and ProSense® cryoablation achieved the highest complete ablation rate.