Imricor Medical Systems (ASX:IMR) used its full-year FY2025 results call to frame the year as a transition from “proven to ready,” highlighting regulatory milestones in Europe, expanding clinical activity in both Europe and the U.S., and building commercial infrastructure ahead of broader rollouts. Management reiterated the company’s focus on MRI-guided cardiac ablation, aiming to move procedures from traditional X-ray cath labs to MRI environments where physicians can see soft tissue and lesion formation during interventions.
FY2025 milestones: regulatory progress and clinical “firsts”
Chief Executive Officer Steve Wedan said FY2025 delivered progress across three dimensions: regulatory and clinical process, commercial readiness, and balance sheet strength.
Wedan also emphasized a clinical milestone at Amsterdam University Medical Centers: the first-in-human ischemic ventricular tachycardia (VT) ablation under real-time MRI guidance. He said the procedure included multiple first-in-human achievements and argued the case is a reference point for electrophysiology, particularly because outcomes and efficiency for VT remain “very disappointing” under conventional X-ray guidance.
U.S. pathway: 510(k) clearances and trial site expansion
Wedan said the company completed a large human factors study across its products, involving physician-led teams from roughly 20 U.S. hospitals, to support FDA approval efforts. He noted that NorthStar and the Vision-MR diagnostic catheter were submitted for 510(k) clearance and have since been cleared by the FDA in January.
On the clinical side, Wedan said the company expanded its VISABL-AFL trial, which supports FDA approval of the ablation catheter and generator. The University of Virginia was added as a second U.S. site, followed by Virginia Commonwealth University and Oklahoma Heart Institute. He said the company was progressing toward first procedures at each site.
During Q&A, Wedan said the VISABL-AFL trial target is 92 procedures. He explained the trial began with four sites (three in Europe and one in the U.S. at Johns Hopkins University) and that adding U.S. sites was intended to accelerate enrollment after “disappointing” enrollment rates in Europe. He also said protocol changes were made to allow more patients to qualify, describing the balancing act between regulatory trial requirements and common medical practice. Wedan added that increased U.S. enrollment would provide additional U.S. data for the FDA, reiterating management’s expectation to have “the entire platform approved in this calendar year.”
Commercial readiness: Europe pipeline growth, platform compatibility, Middle East setup
Wedan said the company completed integration and testing of NorthStar on the Philips MRI platform, which he said “unlocks Philips sites,” and trained a European sales team hired in July. He said these efforts helped expand the European customer pipeline from 7 to 40 by year-end.
In the Middle East, Wedan said construction began on two ICMR labs in Saudi Arabia and that the company supported an accredited ICMR summit in Riyadh attended by close to 100 doctors, alongside a key opinion leader from Amsterdam.
In later remarks and Q&A, Wedan said platform compatibility matters because hospitals typically do not switch MRI vendors easily. He said Philips integration also supports Middle East expansion, which he described as “pretty heavily weighted toward the Philips platform,” and noted GE integration was progressing but “not quite ready yet.” He said the company expected flutter volumes to “step up quite nicely” through the rest of the calendar year, while also noting site activations require planning and budgeting and therefore take time.
Financial results: lower revenue, higher investment, stronger cash position
Chief Financial Officer Jon addressed financial performance, noting all figures were in U.S. dollars. Total revenue for FY2025 was $292,000, down from $959,000 in the prior year. Consumable revenue was $171,000, down 63% year over year. Jon attributed the decline to the prior year including an initial sale of consumables to a distribution partner in the Middle East and to continued enrollment of European sites in the VISABL-AFL trial, which he said included procedures that were not revenue-generating in the short term.
Costs and non-R&D expenses increased by $2.8 million versus the prior year, reflecting renewed investment in the European sales team and commercial support functions ahead of revenue growth and preparation for a U.S. launch. R&D spending increased by $3 million, driven primarily by staffing to support multiple concurrent development programs and regulatory initiatives, including investments related to the VISABL-AFL trial and the VISABL-VT trial, which commenced enrollment during the year.
Net loss was $25.3 million, a 15% improvement from the prior year, which Jon said was primarily due to a lower fair value change recognized in the current year. On an adjusted basis excluding fair value changes and foreign exchange gains, the underlying net loss was $20.99 million, up 33% compared to the prior year’s adjusted net loss of $15.75 million.
Jon said the company ended the year with $40.8 million of cash and marketable securities. Operating cash outflow was approximately $19 million, up $3.5 million, which he attributed to increased investment in commercial development, clinical research, and regulatory affairs, as well as ongoing approval processes. He added that marketable securities consisted of short-term U.S. Treasury bills expected to convert to cash in the first half of 2026.
NorthStar strategy, VT expansion, and near-term catalysts
Management repeatedly highlighted NorthStar as a central commercialization driver. In Q&A, Wedan said the U.S. sales and marketing team was preparing a “proper launch” now that NorthStar is cleared, adding that inbound interest had already begun, particularly from pediatric hospitals. Asked about pricing, he said the company has established an approach that will be market-tested with early adopters, and described NorthStar as a platform capable of supporting multiple “frameworks” beyond electrophysiology, including diagnostic catheterization and structural heart applications.
On VT, Wedan described MRI guidance as a way to reduce reliance on intracardiac echo and separate mapping catheters, potentially improving workflow and economics. He said the VISABL-VT trial is not expected to be linear, with additional time needed for site setup followed by faster execution. He told investors the company had targeted six high-volume VT sites with prominent key opinion leaders and that, after the first-in-human case in Amsterdam, three sites were active with three more identified.
Wedan also outlined near-term milestones, including ongoing 510(k) progress, PMA module submissions (with modules one and two submitted and module three nearing submission), additional clinical milestones, new site activations, and Middle East first procedures and expansion. He also said the company continued R&D in pulsed field ablation with the intention of bringing that modality to the ICMR lab.
About Imricor Medical Systems (ASX:IMR)
Imricor Medical Systems, Inc, a medical device company, designs, manufactures, sells, and distributes magnetic resonance imaging (MRI) compatible products for cardiac catheter ablation procedures in the United States. The company's principal product includes the Advantage-MR EP Recorder/Stimulator system, an EP recording system and cardiac stimulator. Its products also include Vision-MR Ablation Catheter, which is used as an indication for treating type I atrial flutter; and Vision-MR Dispersive Electrode that is used to minimize eddy currents induced on the conductive pads during MR scanning.
