• CE mark approval secured under new more stringent EU MDR framework
• First software-centric product approval globally for Imricor
• Approval received ahead of Company's schedule
• Enables a staged commercial launch across Europe and the Middle East
• Foundation for future growth: NorthStar is considered the central software layer and guidance system for a broad pipeline of existing and future MRI-guided procedures

Imricor Medical Systems, Inc. (ASX: IMR) has received CE Mark certification under the European Union's Medical Device Regulation (EU MDR) for its NorthStar Mapping System (NorthStar). NorthStar is approved as a Class IIa medical device under EU MDR and comprises a computer workstation and a software application, making it Imricor's first commercial software-centric product globally. This milestone significantly strengthens Imricor's position as the market leader in interventional cardiac MRI (iCMR) and broadens the Company's offerings across Europe and the Middle East. Imricor's Chair and CEO, Steve Wedan, commented that achieving CE Mark approval for NorthStar under EU MDR represents a transformative step towards establishing a global platform for MRI-guided interventions. NorthStar's purpose is to transform MR imaging from something analogous to taking a picture with a still camera into something analogous to shooting a live video, which is essential for guiding medical procedures with MRI. The approval was received ahead of the Company's schedule, and it marks the launch of Imricor's software era, with NorthStar growing and expanding to become the central hub of every interventional MRI practice as the company grows and expands interventional MRI applications even beyond cardiac ablations.

Imricor envisions NorthStar growing and expanding to become the central hub of every interventional MRI practice as the company grows and expands interventional MRI applications even beyond cardiac ablations.