Imricor Medical Systems (IMR) H2 2025 earnings summary

Executive summary

• Achieved major regulatory milestones, including CE Mark approvals for second-generation ablation catheter, NorthStar MRI-native 3D mapping system, and capital equipment under EU MDR, as well as FDA 510(k) clearance for NorthStar and Vision-MR diagnostic catheter in the U.S.

• Performed world-first in vivo Pulsed Field Ablations and first-in-human ischemic VT ablation under real-time MRI guidance, initiating the VISABL-VT clinical trial and validating the technology.

• Expanded clinical trial footprint and commercial presence in the U.S., Europe, and Middle East, with European customer pipeline growing from 7 to 40 sites and iCMR labs under construction in Saudi Arabia.

• Advanced commercial readiness with NorthStar integration on Philips MRI, European sales team expansion, and Middle East market entry.

• Strengthened leadership, board, and balance sheet with a $44M institutional placement, ending the year with $40.8M in cash and marketable securities.

Financial highlights

• FY25 revenue was $292,000, down from $959,000 in the prior year, mainly due to non-revenue-generating clinical trial procedures and lower consumable sales.

• Operating cash outflow increased to $19M, reflecting higher investment in commercial, clinical, and regulatory activities.

• Net loss for the period was $25.3M, a 15% decrease from the prior year, primarily due to lower fair value changes in liabilities.

• Adjusted net loss (excluding fair value and FX gains) was $20.99M, up 33% year-over-year.

• Cash and marketable securities totaled $40.8M as of December 31, 2025.

Outlook and guidance

• Positioned to convert two decades of development into commercial scale, first in Europe and the Middle East, then the U.S. as approvals are secured.

• Regulatory momentum expected to continue with recent and upcoming FDA clearances and further 510(k) submissions.

• Expects new site activations in the U.S., ANZ, Nordics, and Middle East within 6-12 months.

• VISABL-AFL trial completion and U.S. platform approval targeted for this calendar year.

• Further geographic expansion planned, including additional approvals in the U.S. and Australia.