Imricor Medical Systems, an ASX-listed developer of MRI-compatible medical devices, has received Medical Marketing Authorisation from the Saudi Food & Drug Authority (SFDA).
The authorisation means Imricor can now begin its commercialisation efforts in the Kingdom of Saudi Arabia through and in cooperation with Imricor’s executive distributor, Al Faisaliah Medical Systems (FMS).
“We are extremely pleased to receive SFDA approval, and the timing is great, with the Arab Health Medical Expo commencing in less than three weeks. We are very excited to launch our products and grow our business across KSA. This is another significant milestone in pursuit our vision to deliver real-time iCMR ablations to patients and physicians worldwide,” said Steve Wedan, chair and CEO of Imircor.
FMS is a leading distributor in Saudi Arabia and boasts more than a billion dollars in annual revenue. It brings a wealth of expertise and a robust distribution network to ensure seamless market penetration for Imricor’s technology in KSA.
“With our partnership with Imricor, we’re extremely excited in bringing the unique Imricor iCMR technology to Saudi cardiac Centres that aim to be worldwide leaders in patient outcomes. I’m confident that this state-of-the-art technology will add value to patient outcomes and meet the expectations of the Saudi cardiac Centres. In Tibbiyah Holding Company, we are doing our best to align our customers’ goals with Saudi Vision 2030 to establish the best cardiac Centres in the Middle east region,” said Alaa Ameen, CEO of FMS’ Subsidiary of Tibbiyah Holding Company.
Nealy 50,000 cardiac ablation procedures are performed annually in Saudi Arabia. That figure is expected to grow as part of Saudi Vision 2030’s Health Sector Transformation Program.
In an ASX announcement, Imricor said the start of its commercialisation efforts in Saudi Arabia is a major milestone that reflects the company’s progress and commitment to expansion and continued growth in strategic markets.
