Quarterly Revenue Growth
Reported revenue growth of 26% year-over-year for Q1 2026, driven by new system placements and increased sales of disposable probes.
Strong North America and U.S. Performance
North America sales increased 84% and U.S. sales grew 31% in Q1, reflecting accelerating commercial momentum after FDA clearance.
Increase in Active U.S. Accounts
Active U.S. account base rose from 13 to 19 following FDA approval, a 46% increase compared to the pre‑approval active account level.
FDA Clearance and Global Impact
FDA clearance for low‑risk early breast cancer secured (key validation milestone); clearance is driving higher international interest across Europe, Asia and the Americas and stronger physician engagement at major conferences.
Choice Post‑Market Study Approval
Choice post‑market study received FDA approval in Q1 and will include 30 clinical/commercial hybrid U.S. sites (about half of current active sites intend to participate), expected to accelerate adoption and generate additional clinical data.
Reimbursement Progress
Procedures already supported by an established CPT facility code covering about $4,000; company plans to submit for a CPT‑1 physician reimbursement code in June (decision expected early 2027) and has applied for transitional pass‑through payment that could add roughly $9,000 if qualified.
Commercial Scale-Up Plans
Company is expanding its U.S. commercial organization (hiring sales reps) to increase footprint; strong lead generation at recent conferences and a robust pipeline provide visibility into further system sales and installations across 2026 and into early 2027.
Clinical Validation and Physician Support
Growing independent clinical research and investigator‑initiated studies (including ICE3 data) plus the 2026 American Society of Breast Surgeons resource guide recommending cryoablation for select low‑risk patients reinforce clinical acceptance; investigator feedback (Dr. Fine) reports encouraging outcomes and high physician interest.
Regulatory Progress in Other Markets
Engagement with Health Canada (amendment submitted in March; company expects a decision prior to year‑end) and active progress toward PMDA submission in Japan via partner, indicating parallel international expansion efforts.