Imricor Medical Systems (ASX: IMR) has announced Oklahoma Heart Institute (OHI) as the fourth U.S. site for its VISABL-AFL clinical trial, supporting FDA approval for the company’s MRI-guided ablation products. Procedures at the Oklahoma facility are expected to commence in March, with the site addition positioned to accelerate patient recruitment and compress the timeline to potential U.S. commercialisation.
The Imricor VISABL-AFL trial expansion brings OHI alongside three existing U.S. institutions: University of Virginia Health, Virginia Commonwealth University Health, and Johns Hopkins University. Dr. Edward T. Martin, Director of Cardiovascular Magnetic Resonance Imaging at OHI and a Master of the Society for Cardiovascular Magnetic Resonance (MSCMR), will serve as Principal Investigator.
Oklahoma Heart Institute Joins Elite Trial Network
The addition of Oklahoma Heart Institute marks a strategic milestone in Imricor’s U.S. clinical trial programme, bringing the total number of American sites to four. The participating institutions now include:
- University of Virginia Health
- Virginia Commonwealth University Health
- Johns Hopkins University
- Oklahoma Heart Institute
Dr. Martin brings 30 years of cardiac MRI experience to the trial. “I have been involved with the imaging aspect of cardiac MRI for the last 30 years, and I have seen and participated in many exciting technological advances over that time,” he stated. “I am extremely excited to see the advancements in hardware, software and catheter development that allow expansion of cardiac MRI into interventional electrophysiology and am eager to get started with the project.”
The trial is positioned to benefit from increased U.S. enrolment capacity, which management expects will support more efficient patient recruitment and accelerate the FDA approval process.
Why Cardiology-Owned MRI Infrastructure Matters
Oklahoma Heart Institute operates as a specialty hospital with established cardiology-owned cardiac MRI facilities, a structural advantage that differentiates it from traditional hospital MRI models. When cardiology departments own and control MRI infrastructure rather than radiology departments, several operational barriers to procedure adoption are reduced.
In conventional hospital settings, MRI suites are typically managed by radiology departments, requiring cross-departmental coordination for interventional cardiology procedures. This structure can create scheduling conflicts and slow implementation of new technologies. Cardiology ownership eliminates these organisational complexities, allowing cardiologists to make clinical decisions about MRI usage without navigating inter-departmental negotiations.
For investors, this ownership model represents a scalable commercial pathway with lower hospital capital expenditure requirements. Imricor has identified multiple U.S. hospitals with existing cardiology-owned MRI infrastructure, which management believes offers a favourable route to faster market adoption. The company’s ability to target facilities with existing MRI assets reduces the capital barrier to entry, a key de-risking factor for commercial expansion.
Accelerating the FDA Approval Timeline
The addition of OHI as a fourth U.S. enrolling site is expected to accelerate patient recruitment for VISABL-AFL. Faster recruitment translates directly into a compressed timeline to trial completion and subsequent FDA submission.
The expanded U.S. capacity also allows European trial sites to complete their participation sooner and return to revenue-generating clinical activity, providing dual benefits: trial efficiency and European commercial continuity.
With procedures at Oklahoma Heart Institute expected to commence in March, the site will begin contributing to trial data in the current quarter.
What is Interventional Cardiac MRI?
Interventional cardiac MRI (iCMR) represents a significant departure from traditional cardiac ablation procedures, which rely on x-ray fluoroscopy guidance. X-ray imaging provides limited soft tissue detail, making it difficult for physicians to visualise the precise cardiac structures being treated during ablation procedures.
MRI-guided ablation offers superior imaging capabilities, allowing physicians to see the exact heart tissue being treated in real-time. This includes visualisation of arrhythmia-causing characteristics such as fibrosis, which are difficult to detect with x-ray guidance. The ability to visualise ablation effects as they occur may improve success rates and reduce the need for repeat procedures.
Dr. Edward Martin’s Clinical Perspective
“I think cardiac MRI has the potential to aid in ablation success.”
For hospitals and healthcare systems, the potential for improved patient outcomes creates a compelling value proposition despite initial setup costs. If iCMR delivers measurably better clinical results, the technology could shift standard-of-care practices in cardiac ablation.
Strategic Implications for Investors
The fourth site addition represents meaningful progress within Imricor’s broader FDA approval journey. Management’s identification of cardiology-owned MRI infrastructure as a commercial strategy provides visibility into the company’s U.S. market penetration plan beyond clinical trial completion.
The current trial site network positions Imricor to recruit patients across multiple geographies while maintaining institutional credibility through partnerships with leading academic medical centres.
| Site | Location | Status |
|---|---|---|
| University of Virginia Health | Virginia, USA | Enrolled |
| Virginia Commonwealth University Health | Virginia, USA | Enrolled |
| Johns Hopkins University | Maryland, USA | Enrolled |
| Oklahoma Heart Institute | Oklahoma, USA | Newly Enrolled |
The dual-geography benefit of increased U.S. enrolment capacity extends beyond trial efficiency. European sites that complete their participation can return to commercial procedures, maintaining revenue generation while the U.S. regulatory process continues. This operational flexibility reduces the financial opportunity cost of trial participation for European institutions.
CEO Perspective
Steve Wedan, Imricor’s Chair and CEO, emphasised the strategic value of the cardiology-led infrastructure model at Oklahoma Heart Institute.
CEO Steve Wedan on Oklahoma Heart Institute
“Oklahoma Heart Institute represents a highly sophisticated cardiology-led model of care, with the clinical vision and infrastructure already in place to support advanced MRI-guided procedures. The fact that cardiology owns and operates their MRI system creates a streamlined environment for innovation, reducing organisational complexity while enabling physicians to focus on delivering the best possible outcomes for patients.”
Wedan also highlighted Dr. Martin’s standing in the cardiovascular MR community: “Dr. Martin is a worldwide cardiovascular MR leader, and we are delighted to welcome him and his team at the Oklahoma Heart Institute to VISABL-AFL. We look forward to working closely with them as we advance the trial efficiently and continue building momentum toward FDA approval.”
Forward Momentum in the FDA Pathway
With four U.S. sites now enrolled and procedures at Oklahoma Heart Institute scheduled to commence in March, Imricor has established operational capacity to accelerate patient recruitment across multiple centres. The company’s strategic focus on cardiology-owned MRI infrastructure provides a replicable model for commercial expansion post-approval, targeting facilities where organisational barriers to adoption are minimised.
Each site addition reduces execution risk and compresses the timeline to Imricor’s most significant near-term catalyst: U.S. FDA approval. For investors tracking the company’s progress, the Oklahoma Heart Institute announcement represents incremental validation of both the clinical trial strategy and the commercial pathway management is constructing for post-approval market entry.
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