IceCure Medical has received US Food and Drug Administration (FDA) marketing authorisation for its ProSense cryoablation system to treat breast cancer.
The FDA’s approval requires IceCure to conduct a post-market surveillance study involving around 400 patients across 30 sites to gather additional data.
Go deeper with GlobalData
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
Combined with adjuvant endocrine therapy, the treatment is indicated for women aged 70 and above with early-stage, low-risk breast tumours.
The cryoablation procedure involves inserting a cryoprobe into the tumour under local anaesthesia, guided by ultrasound imaging.
Liquid nitrogen is used to freeze and destroy the tumour.
The process typically takes 30–45 minutes and allows patients to return to normal activities within 24 hours, with median recovery spanning one day.
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalDataIceCure CEO Eyal Shamir said: “We are excited to add a minimally invasive choice around breast cancer treatments and to offer patients an effective, outpatient procedure.
“With the ProSense Cryoablation System, we are giving women with low-risk, early-stage breast cancer the choice to freeze their cancer, not their lives, through an effective treatment that minimises recovery time, and minimal cosmetic changes to the breast.”
The FDA’s decision was informed by data from IceCure’s ICE3 trial involving 194 patients aged 60 and above, published in the Annals of Surgical Oncology.
The trial showed a 3.1% local recurrence rate of breast cancer within five years for those treated with cryoablation and endocrine therapy.
Adverse effects observed included swelling, bruising and mild postoperative pain, all of which were resolved without lasting impacts.
IceCure said that its ProSense system offers a minimally invasive alternative for patients, preserving breast shape and requiring no reconstruction.
Real-time ultrasound monitoring during the procedure helps ensure accuracy and prevents damage to surrounding tissues.
Last year, the company received a favourable recommendation from the FDA’s Medical Device Advisory Committee Panel for its ProSense system.
