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Imricor (ASX: $IMR) receives approval for commercialization in saudi arabia

Imricor receives Medical Device Marketing Authorization from Saudi Food & Drug Authority


Imricor Medical Systems, Inc. (ASX: $IMR) has obtained Medical Device Marketing Authorization from the Saudi Food & Drug Authority, allowing the company to commence commercialization efforts in the Kingdom of Saudi Arabia (KSA) through its exclusive distributor, Al Faisaliah Medical Systems (FMS). With nearly 50,000 cardiac ablation procedures performed annually in KSA and the expected growth as part of Saudi Vision 2030's Health Sector Transformation Program, this approval marks a significant milestone for Imricor's expansion and growth in strategic markets.

Executive Commentary on Saudi Arabia Approval


Imricor's Chair and CEO, Steve Wedan, expressed his excitement about the SFDA approval, highlighting the upcoming Arab Health Medical Expo as an opportune time for the company to launch its products and expand its business across KSA. He emphasized the significance of this milestone in realizing the company's vision to deliver real-time iCMR ablations to patients and physicians worldwide. Additionally, FMS, Subsidiary of Tibbiyah Holding Company CEO, Alaa Ameen, conveyed his confidence in the state-of-the-art technology adding value to patient outcomes and aligning with the goals of Saudi Vision 2030 to establish the best cardiac Centres in the Middle East region.

Summary of Imricor's Saudi Arabia Approval


Imricor (ASX: $IMR) has received Medical Device Marketing Authorization from the Saudi Food & Drug Authority, enabling the company to initiate commercialization efforts in the Kingdom of Saudi Arabia (KSA) through its exclusive distributor, Al Faisaliah Medical Systems (FMS). With the KSA market performing nearly 50,000 cardiac ablation procedures annually and the expected growth as part of Saudi Vision 2030's Health Sector Transformation Program, this approval marks a significant milestone for Imricor's expansion and growth in strategic markets. The company's Chair and CEO, Steve Wedan, expressed enthusiasm for the upcoming launch of products in KSA, while FMS, Subsidiary of Tibbiyah Holding Company CEO, Alaa Ameen, highlighted the technology's potential to enhance patient outcomes and align with the goals of Saudi Vision 2030. This approval strategically positions Imricor in the Middle East as the second region for commercialization, reflecting the company's commitment to delivering innovative solutions in cardiac ablation procedures.

Sourcehttps://announcements.asx.com.au/asxpdf/20240111/pdf/05zbw92zs9x4h4.pdf

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