Imricor (ASX: $IMR) CE Mark Approval Announcement

Imricor Medical Systems, Inc. (ASX: $IMR) has announced that its Vision-MR Diagnostic Catheter has received CE mark certification under the new European Union Medical Device Regulations (EU MDR). The manufacturing of the Vision-MR Diagnostic Catheter is set to commence in April, and it is expected to replace the second ablation catheter in the kit, thereby improving margins for each procedure. The Company estimates the cost to manufacture the Vision-MR Diagnostic Catheter is approximately 35% less than manufacturing the Vision-MR Ablation Catheter.

Executive Commentary on CE Mark Approval

Imricor's Chair and CEO, Steve Wedan, expressed excitement about the release of the Vision-MR Diagnostic Catheter into the clinical market, highlighting the immediate margin improvements. He acknowledged the significant effort put into adapting Imricor's Quality Management System to comply with the new EU MDR regulations and emphasized the positive validation of years of work across all functions, led by the Quality and Regulatory team. Wedan also mentioned the solid foundation of the quality system under EU MDR, which will be leveraged as the rest of their devices go through the new European regulatory process.

Summary of Imricor's CE Mark Approval

Imricor Medical Systems, Inc. (ASX: $IMR) has successfully obtained CE mark certification for its Vision-MR Diagnostic Catheter, allowing it to be sold in the EU. The approval marks a significant milestone as the Vision-MR Diagnostic Catheter is the first Imricor device to be approved under the new EU MDR regime. The Company anticipates immediate margin improvements with the introduction of the lower-cost diagnostic catheter, which is expected to reduce manufacturing costs by approximately 35%. Imricor's Chair and CEO, Steve Wedan, highlighted the positive validation of their quality system under EU MDR and the potential leverage for future regulatory processes. The approval sets the stage for the Company to enhance its product offerings and expand its market presence in Europe, ultimately aiming to make a meaningful impact on patients, healthcare professionals, and healthcare facilities worldwide.