ProSense Cryoablation Achieves 92.9% Fibroadenoma Reduction, May Shift Treatment Guidelines
An independent study found ProSense cryoablation achieved a median 80.6% fibroadenoma volume reduction at six months and 92.9% at one year using multiple cryoprobe relocations on lesions larger than 4 cm. The FDA-cleared system could address roughly 63,000 US fibroadenoma excisions annually and may inform updated breast tumor treatment guidelines.
1. Study Design and Key Results
The study evaluated ProSense cryoablation in a retrospective analysis of prospectively collected data on non-cancerous breast fibroadenomas, including lesions larger than 4 cm. Investigators performed up to three cryoprobe relocations per procedure and observed a median volume reduction of 80.6% at six months and 92.9% at one year post-cryoablation.
2. Clinical Impact and Patient Benefits
ProSense is FDA-cleared for fibroadenoma treatment and offers minimal scarring, short procedures and office-based convenience. IceCure estimates the technology could replace approximately 63,000 annual US surgical excisions of fibroadenomas, particularly benefiting patients with larger or multifocal lesions seeking less invasive options.
3. Market Outlook and Guideline Adoption
IceCure’s leadership highlights the study’s potential to influence updates in breast tumor treatment guidelines issued by major medical societies, such as the American Society of Breast Surgeons. The positive safety and efficacy data may accelerate ProSense adoption as an alternative to surgical excision in key markets.