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. In October 2025, the company 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 technology for benign and malignant tumors in women's health and interventional oncology. Its core product, the FDA-cleared and CE-marked ProSense® System, utilizes liquid nitrogen to destroy tumors by freezing them, offering a less invasive alternative to surgical removal. The company serves markets across several European and East Asian countries, Brazil, India, and the United States, operating within the medical devices and medical treatment & therapeutics sectors.

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 marks a major advancement in minimally invasive care for breast cancer, validating the clinical efficacy and safety of the ProSense system and opening up a new market segment 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, marking a significant development in minimally invasive care.

What new patent was granted to IceCure Medical in September 2025?

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

What regulatory approval did IceCure Medical receive in Israel in September 2025?

In September 2025, IceCure Medical received regulatory approval in Israel for its next-generation XSense™ Cryoablation System for breast cancer and other indications.

What were the findings from the independent THERMAC Trial featuring IceCure's ProSense® in breast cancer, published in September 2025?

In September 2025, two new 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.

What were the key results presented at the European Society of Breast Imaging Congress in September 2025 regarding IceCure's ProSense®?

In September 2025, IceCure's ProSense® was featured at the European Society of Breast Imaging Congress, where positive results from five independent studies were presented, focusing on unlocking de-escalation of care in breast cancer.