IceCure Medical (ICCM) investor relations material

FDA marketing authorization and clinical impact

• ProSense cryoablation system received FDA marketing authorization for local treatment of early-stage, low-risk breast cancer in women aged 70 and above, covering about 46,000 U.S. patients annually and marking the first device of its kind for this indication.

• The procedure is minimally invasive, outpatient, preserves breast tissue, and offers efficacy and safety comparable to lumpectomy, with excellent cosmetic outcomes and high patient satisfaction.

• FDA approval was based on robust ICE3 study data, showing a 3.1% local recurrence rate over five years in hormone receptor-positive, HER2- patients, and sets high barriers for competitors.

• Most adverse events were mild and resolved without permanent effects; the procedure is monitored in real time to ensure safety.

• FDA requested a post-market surveillance study enrolling approximately 400 patients at 30 sites, with commercial activities running in parallel.

Patient experience and procedural details

• The procedure uses a cryoprobe guided by ultrasound and local anesthesia, lasting 30–45 minutes, with typical recovery within 24 hours.

• No breast tissue is removed, resulting in minimal scarring, no need for reconstruction, and rapid return to normal activities.

• Destroyed tumor tissue is naturally reabsorbed by the body, with adjacent tissue unharmed.

• The system is designed for office-based use, reducing surgical risks and complications.

• Patients report little to no pain and high satisfaction.

Commercial strategy and reimbursement

• Strong interest from patients and physicians, with initial focus on leading cancer centers and physician practices.

• U.S. sales team to expand in 2026 to support broader deployment and drive adoption.

• Engagement with medical societies aims to include cryoablation in treatment guidelines, boosting adoption.

• Procedures in the post-market study are eligible for CPT III reimbursement, with $3,800 facility cost coverage.

• Recent $10 million rights offering funds short-term commercialization and study needs.