ICCM · IceCure Medical Ltd

IceCure’s Q1 2026 results reflect a pivotal inflection point driven by FDA clearance for ProSense® in low-risk breast cancer at the end of 2025. Revenue growth of 26% — with U.S. sales up 31% and North America up 84% — demonstrates rapid commercialization momentum, validated by a 46% increase in active U.S. accounts to 19, including new installations at Thomas Hospital and SHERO Imaging. Gross margin expanded to 32%, suggesting improving operational leverage despite higher cost of revenues, likely tied to scaling production and favorable probe/system mix. The $2.21 million R&D spend — up 33% year-over-year — was largely directed toward the FDA-approved ChoICE post-marketing study, now enrolling across 30 U.S. hybrid clinical/commercial sites; this trial is explicitly positioned to accelerate both adoption and reimbursement. Sales and marketing expenses declined 17% year-over-year due to reduced regulatory consulting fees, though management expects them to rise through 2026 as the company expands its U.S. sales footprint to eight regions. Net loss widened to $4.27 million, consistent with strategic investment: operating expenses rose 17% overall, led by R&D and G&A (the latter impacted by USD/ILS exchange rate fluctuations). Critically, the American Society of Breast Surgeons’ updated clinical guideline endorsing cryoablation provides durable, third-party validation that de-risks future payer coverage decisions. With $8.1 million in cash and no debt, IceCure retains runway to execute on its U.S. commercial plan, though continued financing will be needed to sustain the current investment pace beyond 2026.