IceCure Medical (ICCM) Investor Update summary

FDA marketing authorization and clinical impact

• ProSense Cryoablation received FDA marketing authorization for local treatment of low-risk, early-stage breast cancer in women aged 70 and above, covering about 46,000 U.S. patients annually and marking the first device of its kind approved 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 ICE3 study data, showing a 3.1% local recurrence rate over five years and only mild, transient adverse events, setting high barriers for competitors.

• A post-market surveillance study will enroll approximately 400 patients at 30 sites, with commercial activities running in parallel.

• Minimum of 80 patients must be treated by end of 2026, with the first patient treated within six months of protocol approval.

Patient experience and procedural details

• The procedure uses a cryoprobe guided by ultrasound to freeze and destroy tumors, performed under local anesthesia and typically lasting 30–45 minutes.

• Patients usually recover within 24 hours, with minimal scarring, no need for breast reconstruction, and destroyed tissue naturally reabsorbed.

• Patient testimonials highlight lack of pain, quick recovery, and preservation of breast appearance.

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.

• Post-market study procedures are eligible for CPT III reimbursement, with $3,800 facility cost coverage.

• Expectation of expanded reimbursement coverage as clinical data and endorsements grow.

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