• The second module for Imricor’s premarket approval products has been submitted to the US FDA
• Module two comprises manufacturing processes across seven devices and has been submitted within expected timelines
• Imricor’s 3D mapping and guidance system NorthStar will be submitted next under the 510(k) process

Special Report: Imricor Medical Systems has announced another key milestone towards US regulatory approval for its devices with submission of a second premarket approval module for FDA review.

Imricor Medical Systems (ASX:IMR) – which has developed the world’s only MRI-compatible devices for cardiac ablations – said the second module, focused on quality manufacturing processes, is significant and surrounds seven products in total.

Imricor said six of these are the company’s products, which are undergoing the US Food and Drug Administration’s (FDA’s) premarket approval (PMA) process, with an additional third-party product it will distribute.

The company said the second module includes items such as design controls, receipt, inspection and storage of raw materials, build procedures, process validation, part and device traceability, along with the applicable quality management systems.

Imricor is executing a modular review process with the FDA, whereby modules covering various aspects of the company’s products are submitted and reviewed serially, with the goal of achieving a more streamlined review process.

Preparation for third PMA module and NorthStar 510(k) application underway

Imricor said its team is also working on the third PMA module for its devices, as well as the 510(k) FDA application for its NorthStar mapping system, which is slated for submission next.

The company is following a 510(k) pathway for NorthStar, which involves a shorter review cycle.

Imricor said it expects to have NorthStar commercially available in the US market in early Q3.

The commercial launch in Europe of NorthStar is expected around the middle of the year, following a recent submission for CE Mark approval.

The company recently announced its second-generation Vision-MR Ablation Catheter had received CE mark certification under new European Medical Device Regulation.

Working to improve arrhytmia treatments

IMR is working to improve 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 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 kick off a pivotal VISABL-VT clinical trial for its second indication, ventricular tachycardia (VT).

On track with module submission timelines

Imricor’s chair and CEO Steve Wedan said an internal deadline for the manufacturing module will be submitted by the end of February.

“Again, I commend our Regulatory team, as well as our Quality and Manufacturing teams for this tremendous milestone,” he said.

“It is difficult to convey how much work is involved due to the number of devices for which we are seeking approval simultaneously.

“We are now one step closer to getting the entire platform of technology on the market in the US.”

Wedan said the company looked forward to working closely with the FDA as it continues towards full submission and market entry.

“The company remains on track for the submission of the remaining modules in line with its planned timeline and will continue to update the market on further developments,” he added.

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.