Imricor Medical Systems (IMR) investor relations material

Executive summary

• Achieved CE Mark approval for second-generation ablation catheter, NorthStar MRI-native 3D mapping system, and capital equipment in Europe under EU MDR.

• Performed world-first in vivo PFA ablations and first-in-human ischemic VT ablation under real-time MRI guidance, validating the technology and field.

• Expanded clinical trial footprint in the US and Europe, with new hospital sites, regulatory submissions, and VISABL-AFL trial expansion.

• Commercial readiness advanced with Philips MRI platform integration, European sales team expansion, and customer pipeline growth from 7 to 40 sites.

• Strengthened leadership and board to support commercialization and growth.

Financial highlights

• FY 2025 revenue was $292,000, down from $959,000 year-over-year, mainly due to non-revenue-generating clinical trial procedures.

• Consumable device sales fell 63% to $171,000; equipment revenues also declined.

• Operating cash outflow was $19 million, up $3.5 million from the prior year, reflecting increased investment in commercial and regulatory activities.

• Net loss before tax was $25.3 million, a 15% improvement from the prior year, but adjusted net loss rose 33% to $20.99 million.

• Cash and marketable securities totaled $40.8 million at year-end.

Outlook and guidance

• Positioned to scale commercially in Europe, Middle East, and soon the U.S. as regulatory approvals progress.

• Anticipates FDA approval for U.S. commercial release of platform technology and further 510(k) submissions in the next 3–6 months.

• Expects acceleration in consumable revenues and capital sales as clinical trial sites convert to commercial use.

• New site activations expected in the US, ANZ, Nordics, and Middle East within 6–12 months.

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