Imricor eyes worldwide expansion with progress on US and EU regulatory approval

Imricor Medical Systems is racing through regulatory initiatives supporting new device approvals in the US and Europe with the US Food and Drug Administration (FDA) completing a review of its first premarket approval (PME) module ahead of schedule.

Imricor has provided an update on regulatory approval in the EU and US. Pic: Getty Images

• Imricor’s US FDA review for its first premarket approval module has been successfully completed ahead of schedule.

• In Europe the Vision-MR Ablation Catheter 2.0 is pending only final certification, following a successful on-site audit

• Imricor said changeover to the more stringent Medical Device Regulations (MDR) in the EU is moving smoothly and faster than expected.

 

Special Report: Imricor Medical Systems is racing through regulatory initiatives supporting new device approvals in the US and Europe with the US Food and Drug Administration (FDA) completing a review of its first premarket approval (PME) module ahead of schedule.

Imricor Medical Systems (ASX:IMR) has provided an update to the market on several regulatory initiatives supporting new device approvals in Europe and the US.

That includes a major milestone towards its approval in the world’s largest healthcare market, receiving notification on September 27 from the FDA that its first PME module was accepted and considered closed.

In late June IMR submitted the first PMA module for FDA review with its submission  covering devices including the Vision-MR ablation catheter 2.0 and RF-5000 ablation generator, irrigation pump, tubing set, and remote control unit.

The module content included preclinical animal study data, biocompatibility  and  sterilisation validation, which IMR said can often be the most difficult topics for review and take the longest, which is why they were submitted first.

Imricor achieves EU regulatory milestones

IMR said its Notified Body, TÜV SÜD, conducted an on-site audit of IMR’s facilities on October 1 and 2 which had several objectives including:

• Medical Device Directive (MDD) and Medical Device Regulation (MDR) adherence surveillance; and
• MDR review for the design controls and manufacturing of the Vision-MR Ablation Catheter 2.0 and Advantage-MR EP Recorder/Stimulatory System.

In summary the audit results were positive, and the company would be recommended for certification to manufacture these products under the new, more stringent MDR regime.

Earlier this year, the MDR technical review of the Vision-MR Ablation Catheter 2.0 was completed successfully, meaning only the final certification was required to start manufacturing and selling the device.

The new 2.0 catheter would be phased in to replace the original Vision-MR Ablation Catheter in the market. Along with the new 2.0 catheter, IMR’s Advantage-MR system must also be approved under MDR.

The first round of that technical review is complete, with Imricor receiving positive feedback on the overall technical documentation from TÜV SÜD.

The company said it would respond to questions by October 18, and the commercial launch of the new MDR Advantage-MR system was expected in Q1 2025, ahead of IMR’s original projections.

The audit and technical review ensured that the company could continue selling devices under the old MDD regime, while it’s closing in on the release of the 2.0 catheter and its transition to MDR compliance.

Improving treatment of arrhythmias

IMR has developed the world's only MRI-compatible devices for cardiac ablations, a procedure that targets and destroys heart cells causing arrhythmias (irregular heartbeats).

Current ablations use X-ray fluoroscopy, which visualises hard structures like ribs but struggles with soft tissue like the heart, leading to long-term lower success rates –  often below 50% – and requiring repeat procedures.

IMR is advancing the shift toward MRI-guided ablations, offering clearer imaging and better outcomes, while also reducing exposure of patients and staff to radiation.

The company is currently undertaking its Vision-MR Ablation of Atrial Flutter (VISABL-AFL) pivotal clinical trial supporting US FDA approval of its products, which it hopes to achieve in 2025.

In Europe, where the company has already received regulatory approval for atrial flutter, it’s about to start the VISABL-VT clinical trial for its second indication, ventricular tachycardia (VT).

‘Everything is coming together nicely worldwide’

Chair and CEO Steve Wedan said technical regulatory information could be a lot for investors to digest but he was reassured that approvals in both Europe and the US were progressing to plan.

“The FDA review process for our first module went very smoothly and in a timeframe that exceeded our own expectations,” he said.

“That’s not to say there won’t be challenges in the other module reviews, but this was a challenging module, and we are very pleased with FDA’s punctuality and efficiency.”

Wedan said IMR was navigating the process of approval for the Vision-MR Ablation Catheter 2.0 under the new MDR regime with success, and with timelines that also exceeded its original expectations.

“Importantly, the 2.0 catheter is the one used in the VISABL-VT and VISABL-AFL trials, so everything is coming together nicely worldwide,” he said.

"It’s hard to overstate how impressive this all is (especially for an industry insider), and it is only possible because of Imricor’s world-class quality and regulatory teams, formed and operating under the equally impressive leadership of our Vice President, Jennifer Weisz.”

This article was developed in collaboration with Imricor Medical Systems, a Stockhead advertiser at the time of publishing.

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.

Originally published as Imricor eyes worldwide expansion with progress on US and EU regulatory approval