Imricor expands VISABL-VT trial to third European site with world-leading investigators
Imricor Medical Systems (ASX: IMR) has announced that the Imricor VISABL-VT Trial Expansion has progressed with the addition of Na Homolce Hospital in Prague, Czech Republic, as the third participating site following Ethics Committee approval. The trial now spans three European countries: Germany, the Netherlands, and the Czech Republic, each bringing high-profile cardiac electrophysiology expertise to the clinical programme.
The addition of Na Homolce brings two internationally recognised investigators to the trial. Professor Petr Neužil, Head of Cardiology and Director of the Cardiac Arrhythmia Service at Na Homolce, will serve as Principal Investigator. Dr Vivek Reddy, Director of Cardiac Arrhythmia Services for The Mount Sinai Hospital and the Mount Sinai Health System in New York, will also participate at the Prague site. Na Homolce performs up to 3,500 catheterisation procedures annually, positioning it as a high-volume reference centre for cardiac interventions.
The calibre of investigators joining the VISABL-VT trial strengthens the clinical validation pathway for Imricor’s MRI-guided ablation technology. For investors, the involvement of key opinion leaders from premier institutions signals strong clinical community interest and supports future adoption across broader markets.
What is the VISABL-VT trial and why it matters
Ventricular tachycardia (VT) ablations are among the most complex procedures performed by cardiac electrophysiologists worldwide. Despite decades of advances in mapping and ablation technologies, outcomes across VT patient populations remain disappointing, according to management commentary. The VISABL-VT trial evaluates Imricor’s interventional cardiac MRI (iCMR) technology as an alternative to traditional X-ray fluoroscopy guidance.
MRI guidance enables visualisation of arrhythmogenic substrates (abnormal heart tissue that triggers irregular rhythms) that are hidden to conventional imaging modalities. An arrhythmogenic substrate refers to damaged or scarred heart tissue that creates electrical pathways responsible for VT. Identifying and ablating (destroying) these substrates is critical to treatment success, but current imaging methods often fail to provide adequate tissue detail.
Imricor’s technology operates in a radiation-free environment, benefiting both patients and clinical staff who would otherwise be exposed to X-ray radiation during lengthy procedures. The company has positioned atrial flutter procedures as the “steppingstone” for iCMR, with VT ablation representing the next major clinical application and a larger addressable market opportunity.
Key advantages of MRI-guided VT ablation:
- Superior visualisation of arrhythmogenic substrates
- Radiation-free environment for patients and staff
- Potential for shorter procedures through improved imaging
- Potential for improved patient outcomes compared to fluoroscopy-guided approaches
VT ablation represents a more complex and higher-value market opportunity than atrial flutter. Success in the VISABL-VT trial could significantly expand Imricor’s commercial footprint across approved markets.
Trial investigators and participating sites
The VISABL-VT trial now operates across three European sites, each led by recognised authorities in cardiac electrophysiology. The involvement of world-leading doctors provides strategic validation for the technology and establishes reference sites that could influence broader clinical adoption.
| Site | Location | Principal Investigator | Role/Affiliation |
|---|---|---|---|
| Na Homolce Hospital | Prague, Czech Republic | Professor Petr Neužil | Head of Cardiology, Na Homolce |
| Na Homolce Hospital | Prague, Czech Republic | Dr Vivek Reddy | Director, Cardiac Arrhythmia Services, Mount Sinai Health System (New York) |
| Charité | Berlin, Germany | Professor Gerhard Hindricks | — |
| Charité | Berlin, Germany | Dr Felix Hohendanner | — |
| Amsterdam UMC | Amsterdam, Netherlands | Dr Michiel Kemme | — |
Dr Vivek Reddy’s participation is particularly notable given his prominence in translating next-generation rhythm therapies into real-world practice through high-impact clinical programmes and multicentre research. The recruitment of internationally recognised key opinion leaders from premier institutions signals strong clinical community interest and supports the potential for future adoption across global markets.
CEO commentary on trial momentum
Steve Wedan, Chair and CEO, Imricor Medical Systems
“The names of the world-leading doctors from the first three sites participating in VISABL-VT tells you something about how important the transformation is that we are enabling. Following the groundbreaking work performed at Amsterdam UMC last year, we are now expanding into key sites of influence with leading key opinion leaders in the field. I couldn’t be more excited to welcome Professor Petr Neužil and Dr Vivek Reddy, and the world-class team at Na Homolce, to the VISABL-VT study.”
Management commentary emphasised that the difficulties associated with VT ablations and the promise that MRI guidance offers to these procedures are well-known within the clinical community. The expansion into key sites of influence with leading key opinion leaders supports the company’s strategy to bring MRI-guided interventions into mainstream clinical practice.
Imricor’s path to commercialisation
Imricor’s products are currently approved in multiple geographies, with regulatory submissions progressing in others. The VISABL-VT trial builds the clinical evidence base required to support broader commercial adoption in approved markets and strengthen pending regulatory submissions.
Regulatory status:
- Approved: European Union, Kingdom of Saudi Arabia, New Zealand
- In process: US FDA (Food and Drug Administration)
- Planned: Australia and other geographies
The company is a pioneer and world leader in developing MRI-compatible products for cardiac catheter ablation procedures. Its product portfolio includes capital equipment such as the NorthStar Mapping System and the Advantage-MR EP Recorder/Stimulator, alongside single-use devices including ablation catheters, diagnostic catheters, steerable sheaths, and other tools used for cardiac ablations.
Clinical trial progress and key opinion leader endorsement are critical steps toward driving commercial uptake in approved markets and supporting pending regulatory submissions. The involvement of high-profile investigators across European reference sites provides clinical validation that could accelerate adoption timelines.
What to watch next
Investors should monitor several near-term catalysts related to the Imricor VISABL-VT Trial Expansion (ASX: IMR). Enrolment progress across the three sites will indicate the pace of clinical data generation. Potential additional site expansions could broaden the trial’s geographic footprint and investigator network. Any interim clinical data readouts would serve as key value inflection points, particularly if they demonstrate improved outcomes compared to traditional fluoroscopy-guided approaches.
VT ablation represents the next major clinical application following atrial flutter procedures. Management has framed atrial flutter as an important steppingstone for iCMR, with VT positioned as the next significant market opportunity. The expansion into key sites of influence with leading key opinion leaders supports the strategic pathway toward mainstream clinical adoption of MRI-guided cardiac interventions.
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