• Received regulatory approval for NorthStar and 2nd generation ablation catheter and capital equipment in Europe
• Submitted NorthStar 510(k) Premarket Notification to US FDA, approval expected in CY 2025
• Multiple capital equipment and consumable devices on track for submission and approval by end of 2025 or early 2026

Imricor Medical Systems, Inc. (ASX: IMR) has provided an update on its regulatory and commercial progress across Europe and the United States. In Europe, the company has now received regulatory approval for NorthStar, as well as its 2nd generation ablation catheter and 2nd generation capital equipment, all under the new European Medical Device Regulation (EU-MDR). Imricor is currently phasing out the 1st generation devices and has commenced the commercial launch of the 2nd generation products from July 1st 2025. The company's investments in sales and marketing are beginning to pay off, with the number of hospitals in the active European pipeline increasing from 7 to 26 over the past six months. In the US, Imricor has submitted the NorthStar 510(k) Premarket Notification to the FDA, with approval still expected in CY 2025. This will mark the commercial entry point for Imricor in the US and enable the company's sales team to initiate site engagement and pipeline development. Multiple pieces of capital equipment and various consumable devices remain on track for submission and approval by the end of the calendar year or shortly into next year. However, the company has faced some delays in the PMA approval process for the ablation catheter and RF generator, with the reviewer of the 2nd PMA module no longer being with the agency and a new reviewer appointed. Additionally, the VISABL-AFL clinical trial enrolment has been slower than anticipated during the summer months in the US and Europe, but is expected to ramp up again. Despite these delays, Imricor believes the strategic choice to prioritize NorthStar approval and commercialization ahead of the ablation catheter will not have a material impact on the company's commercial trajectory, as the natural sales cycle is expected to align well with the anticipated PMA approval timeline for the catheter and generator.

Imricor expects NorthStar approval and capital equipment sales activities to begin by the end of CY 2025, which will support an uninterrupted path to revenue generation and scaling in the US.