IceCure Medical, a developer of minimally invasive cryoablation technology for tumor destruction, has announced the publication of an independent investigator-initiated study evaluating its ProSense system for the treatment of non-cancerous breast tumours, known as fibroadenomas.

The study, titled “Cryoablation for fibroadenoma with liquid nitrogen-based system: A retrospective analysis of prospectively collected data,” was published in the peer-reviewed journal PLOS One.

Fibroadenomas are the most common benign breast lesions identified through core needle biopsy, with up to 10 percent of women experiencing the condition during their lifetime, according to the Cleveland Clinic. Surgical excision remains the standard of care, particularly for larger or symptomatic lesions. IceCure estimates that cryoablation could potentially address approximately 63,000 fibroadenoma excision cases annually in the United States.

The study was conducted at the Premier Med Healthcare Training and Research Institute in Hungary and led by Dr Teodora Filipov and Dr Pál Ákos Deák. Investigators concluded that cryoablation using a liquid nitrogen-based system, specifically ProSense, demonstrated strong safety and effectiveness outcomes. Median tumour volume reduction reached 80.6 percent at approximately six months and 92.9 percent at one year post-treatment. The study also found that sequential cryoprobe relocations—permitted up to three times per patient per procedure—maintained safety and efficacy while enabling complete treatment of larger or multifocal lesions.

Eyal Shamir, Chief Executive Officer of IceCure, said the publication reinforces the clinical value of ProSense cryoablation and could contribute to potential updates in treatment guidelines for non-cancerous breast tumors by medical societies, including the American Society of Breast Surgeons.

IceCure believes the findings support the growing adoption of minimally invasive cryoablation as an alternative to surgical excision, particularly for patients seeking reduced scarring and shorter procedure times.