Imricor Medical Systems (IMR) H2 2025 earnings summary

Executive summary

• Achieved CE mark approval for second-generation ablation catheter, NorthStar 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 PFA ablations and first-in-human ischemic VT ablation under real-time MRI guidance, validating the technology and expanding clinical leadership.

• Expanded clinical trial footprint in the U.S. and Europe, with new hospital sites, protocol modifications, and regulatory submissions to accelerate enrollment.

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

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

Financial highlights

• FY 2025 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.

• R&D spend increased by $3M, driven by staffing and clinical trial investments.

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.

• Anticipates FDA approval for U.S. commercial release of platform technology and further 510(k) submissions, with new site activations in the U.S., ANZ, Nordics, and Middle East within 6-12 months.

• Key value drivers include regulatory clearances, trial enrollment, new site activations, pipeline conversion, and NorthStar commercialization.

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

• VISABL-VT trial progressing with high-volume sites and rapid enrollment anticipated.