Imricor Advances Towards U.S. Market Entry with FDA Submission
Imricor Medical Systems (ASX: IMR) is making steady progress in its regulatory journey, recently submitting the second module of its Premarket Approval (PMA) process to the U.S. Food and Drug Administration (FDA). This marks a significant step toward bringing its MRI-compatible cardiac ablation technology to the U.S. market.
Regulatory Progress: A Key Milestone Achieved
The second PMA module focuses on the design, manufacturing, and quality control processes for seven medical devices. This includes six proprietary products under FDA review, along with a third-party product Imricor plans to distribute. Given the complexity of these approvals, Imricor’s modular approach allows the FDA to assess each aspect in stages, potentially streamlining the overall approval process.
Imricor’s CEO, Steve Wedan, emphasised the substantial effort behind this milestone, crediting the Regulatory, Quality, and Manufacturing teams for keeping the process on track. With this module now submitted, the company remains on schedule to complete the remaining steps in its planned timeline.
NorthStar: A Faster Path to Market
While the PMA process continues, Imricor is also advancing its NorthStar 3D mapping and guidance system, which is following a separate 510(k) approval pathway. Unlike the lengthier PMA process, the 510(k) route is generally faster, as it demonstrates that a new product is substantially equivalent to an already approved device. NorthStar has already been submitted for CE Mark approval in Europe, with a U.S. FDA submission planned next. If all goes as expected, NorthStar could be commercially available in the U.S. by early Q3 2025, with a European launch anticipated around mid-year.
A Leader in MRI-Guided Cardiac Procedures
Imricor is at the forefront of a shift in interventional cardiology, developing MRI-compatible catheters that provide real-time imaging for ablation procedures. Unlike traditional methods that rely on X-ray fluoroscopy, MRI offers superior imaging, potentially leading to better outcomes, faster procedures, and reduced radiation exposure.
The company’s flagship Vision-MR Ablation Catheter is already approved in the EU, Saudi Arabia, and New Zealand for treating atrial flutter, with plans for expanded indications. Meanwhile, regulatory efforts are underway to introduce these products to the U.S. and other key markets.
Strategic Partnerships and Market Expansion
Imricor’s business model revolves around selling its capital equipment and consumable products to hospitals operating Interventional Cardiac MRI (iCMR) labs. These specialized labs integrate MRI technology into cardiac procedures, and Imricor collaborates with major medical imaging companies—Philips, Siemens, and GE HealthCare—to drive adoption. By working with these industry leaders, the company gains access to a broad customer base and supports the establishment of new iCMR labs worldwide.
Looking Ahead
With regulatory milestones on track, a promising new product pipeline, and strong industry partnerships, Imricor is well-positioned for growth. The upcoming FDA decisions will be pivotal in determining the company’s near-term market entry in the U.S. Investors will be watching closely as Imricor progresses through the remaining regulatory steps and prepares for commercial expansion.
