17 January 2024 – Minneapolis, United States – Imricor Medical Systems, Inc. (Company or Imricor) (ASX:IMR) the global leader in real-time iCMR cardiac ablation products, is pleased to announce it has received Medical Device Marketing Authorization (MDMA) from the Saudi Food & Drug Authority (SFDA). MDMA clears the way for Imricor to begin commercialization efforts in the Kingdom of Saudi Arabia (KSA) through, and in cooperation with, Imricor’s exclusive distributor, Al Faisaliah Medical Systems (FMS). FMS is a prominent distributor in KSA, with an impressive track record of success and more than a billion dollars in annual revenue. FMS brings a wealth of expertise and a robust distribution network to ensure seamless market penetration for Imricor’s technology in KSA. Nearly 50,000 cardiac ablation procedures are performed annually in KSA, and that number is expected to grow as part of Saudi Vision 2030’s Health Sector Transformation Program (https://www.vision2030.gov.sa/en/vision-2030/vrp/health-sector-transformation-program/). This milestone underscores Imricor’s progress and commitment to expansion and continued growth in strategic markets. Imricor’s Chair and CEO, Steve Wedan, said: “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 of our vision to deliver real-time iCMR ablations to patients and physicians worldwide.” FMS, Subsidiary of Tibbiyah Holding Company CEO, Alaa Ameen, said: “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.”
21 December 2023 – Minneapolis, United States– Imricor Medical Systems, Inc. (Company or Imricor) (ASX:IMR) the global leader in real-time iCMR cardiac ablation products, is pleased to announce it has entered into a Distribution Agreement with East Agency WWL, Firm of the Holding (East Agency), a prominent distributor in Qatar. Under the terms of this 5-year agreement, East Agency will be the exclusive distributor of Imricor’s products in Qatar. This marks another major achievement for Imricor as it enters a new Middle East country, following the Kingdom of Saudi Arabia earlier this year, bringing the first and only iCMR family of ablation products to healthcare professionals and patients in Qatar. East Agency’s CEO, Mohamed Mekky, said: “We at East Agency are very thrilled to sign a partnership agreement with Imricor. We believe that this partnership will be a game changer in ablation procedures here in Qatar, especially after the great feedback and strong interest in adopting this technology we had from the largest Cardiac Centres here in Doha.” Imricor’s collaboration with East Agency underscores its commitment to expansion and continued growth in strategic markets. Imricor’s Chair and CEO, Steve Wedan, said: “We are extremely pleased to partner with East Agency, and we look forward to offering real-time iCMR cardiac ablations to patients and physicians in Qatar soon. This is just the latest step in growing our global footprint, and we intend to continue expanding in the Middle East with additional countries over time.”
29 November 2023 – Minneapolis, MN United States – Imricor Medical Systems, Inc. (Company or Imricor) (ASX: IMR) is pleased to advise that it has signed a Joint Development Agreement (JDA) with ADIS SA (ADIS) of Lausanne, Switzerland. Under the terms of the JDA, Imricor and ADIS will collaborate to incorporate Artificial Intelligence (AI) modules developed by ADIS within Imricor’s NorthStar 3D mapping system, starting with automatic segmentation of cardiac chambers from MRI images. Automatic segmentation is expected to save time during iCMR procedures. Imricor NorthStar 3D Mapping System In addition, both companies will collaborate to incorporate NorthStar’s user interface into ADIS’s ARTS iCMR procedure simulator platform (ARTS). ARTS is a simulator platform that allows a user to guide Imricor’s Vision-MR Ablation Catheters within a physical tabletop device, as shown below, and view the catheter’s simulated location relative to anatomy derived from real MRI images within the ARTS user interface. Initially, ADIS developed their own user interface for ARTS; however, the JDA paves the way for the ARTS user environment to become the NorthStar user environment. ADIS ARTS simulator with Imricor’s Vision-MR Ablation Catheter Imricor’s Chair and CEO, Steve Wedan, commented: “We have been working with the highly talented people at ADIS for several years and are thrilled to advance our partnership to the next level with this Joint Development Agreement. “One of our primary goals is to leverage ADIS’s extensive expertise in AI development to bring it into NorthStar, such that we can increasingly deliver the power and value of MR imaging to our physicians performing ablations in the iCMR lab with Imricor products. “Another goal of the JDA is to integrate the NorthStar user environment into the ARTS iCMR procedure simulator platform. As we have highlighted in the past, we intend for NorthStar to be the central hub of every procedure performed in the iCMR lab with Imricor catheters. Therefore, it makes sense that NorthStar should be the environment experienced by users simulating those same iCMR procedures. In the end, we want the user experience within the ARTS simulator to be as close as possible to the experience in the real iCMR lab, thereby reducing training time for iCMR procedures, allowing for patient-specific procedure planning and simulation prior to live procedures, and making the initial simulated experience of performing an ablation guided by MRI more easily accessible to more physicians.
At the Cardiology Department of Amsterdam UMC, location AMC, they are doing something groundbreaking. For about a year now, patients with certain cardiac arrhythmias have been able to come here for an innovative treatment: ablation while lying in an MRI-scanner. We visualized how such an interventional Cardiac MRI (iCMR) works. The treatment is done under anaesthesia. Before the patient is put to sleep, they are given an explanation and there is a final check. The team also introduces themselves. There are quite a few people around the patient. More than with a ‘regular’ ablation. To be able to carry out this new form of treatment, various employees work together. Several lab technicians, an anaesthesiologist who provides the anaesthesia, several nurses and two cardiologists. Marco Götte (imaging cardiologist) and Cor Allaart (cardiologist-electrophysiologist) started researching the possibilities of iCMR in patients with cardiac arrhythmias about 10 years ago. In the room where an MRI scanner is located, nothing made of steel, or any other magnetic material, may be used. The MRI scanner itself works like a large, very powerful magnet. But because this method of treatment is new, there is still very little equipment that is suitable. So, they now use, for example, a plastic table. An ablation is done using two catheters. Thin, flexible tubes that go through the groin to the heart for this treatment. At the end of one catheter is a tip that gets hot. This creates the ‘scars’ on the inside of the heart. Below the tip is a kind of reflector that lights up through the MRI scanner. This makes it possible to see exactly where the catheter is on the screen. Everything is monitored with the other catheter. The cardiologist-electrophysiologist controls the catheters and can thus treat the patient externally. Only the cardiologist-electrophysiologist and a nurse are in the MRI scanner room with the patient. The rest of the team is in the control room. They monitor the screens and communicate with the electrophysiologist via headsets. What makes this method of ablation so special and so important is that the team can see what is happening much more precisely. And that the electrophysiologist can steer much more precisely. An MRI can provide images from all sides/directions: for example, a cross-section of the body from the front, from the side and from above. Everything in and around the heart is clearly visible. An X-ray system, with which these treatments are normally done, only gives a 2D image. This treatment is also much nicer for the patient. So, the chance that the patient needs to be treated again is much smaller. For now, only the ‘simple’ cardiac arrhythmias can be treated with the aid of an MRI scanner. This will remain the case in the near future, as the technology isn’t yet ready to perform more complicated procedures. But if all goes well, that will be different in 2 years. Then the new Heart Center at the AMC location will be ready, and a newly developed MRI scanner will also be installed. Especially for these treatments. New special software has also been developed. This will hopefully make it possible in the future to also perform more complicated treatments on the heart. As far as this team is concerned, the road to that goal is clear.
Listen to the Full Podcast Equity Mates Investing co-hosts, Bryce and Ren, interview Imricor Medical Systems (ASX: IMR) CEO, Steve Wedan. In this podcast, Steve talks through Imricor, how he first came across the idea and what has been the founding story to date. Listen to the full podcast here or on Apple.
1 August 2023 – Minneapolis, MN United States – Imricor Medical Systems, Inc. (Company or Imricor) (ASX: IMR), the global leader in real-time iCMR cardiac ablation products, is pleased to announce it has received approval from the Medical Ethics Review Committee, Leiden The Hague Delft (METC LDD) to begin the VISABL-VT trial at Haga Hospital in The Hague, Netherlands. The VISABL-VT trial is a prospective, single-arm, multi-centre investigation of the safety and efficacy of radiofrequency (RF) ablation of ventricular tachycardia (VT) associated with ischemic cardiomyopathy performed with the Vision-MR Ablation Catheter 2.0 in the iCMR environment. The study calls for treating 64 patients and includes a six-month follow-up for each patient. The study is intended to support CE mark certification of the Vision-MR Ablation Catheter 2.0 for treating VT. The first patient to be enrolled in VISABL-VT is identified, and the first procedure is expected to take place in mid-August, upon the return of physicians and medical staff from summer holiday. Imricor’s Chair and CEO, Steve Wedan, commented: “This is an extraordinary milestone for Imricor. “Since founding the Company 17 years ago, the goal has always been to develop technology that enables complex cardiac arrhythmias like ventricular tachycardia (or VT) to be treated utilising real-time 3D MRI (which we call interventional cardiac magnetic resonance, or iCMR) for guidance. We believe real-time 3D MRI imaging can add tremendous value to VT ablations in terms of effectiveness, time savings, and cost – all in an environment that is free of ionising radiation. “Imricor continues to do what no one else has ever done before, and virtually everyone in the Company has worked tirelessly to make this extraordinary milestone possible. I want to especially acknowledge the clinical and regulatory teams led by our Director of Clinical Research, Dr. Katherine Lindborg, PhD, and our VP of Regulatory and Quality, Jennifer Weisz.”
31 July 2023 – Minneapolis, United States – Imricor Medical Systems, Inc. (Company or Imricor) (ASX:IMR) the global leader in real-time iCMR cardiac ablation products, is pleased to announce it has entered into a Distribution Agreement with Al Faisaliah Medical Systems (FMS) Subsidiary of Tibbiyah Holding Company, a prominent distributor in the Kingdom of Saudi Arabia (KSA). Under the terms of this 5-year agreement, FMS will be the exclusive distributor of Imricor’s products in KSA, a country which performs nearly 50,000 cardiac ablation procedures annually. FMS will also obtain and maintain all required regulatory approvals to import and sell Imricor products in Saudi Arabia, a process that is expected to be completed in Q3 2023, with product launch in KSA starting October 1st, 2023. Imricor expects procedures to be completed in the first 12-months of the partnership. This marks a major achievement for Imricor as it enters a new geographical area, bringing the first and only iCMR family of products to healthcare professionals and patients in KSA. Imricor intends to continue to expand into the Middle East region with additional countries expected over time. Imricor’s collaboration with FMS underscores its commitment to expansion and continued growth in strategic markets. Founded in 1973, FMS has an impressive track record of success with more than a billion dollars in revenue annually. FMS brings a wealth of expertise and a robust distribution network to ensure seamless market penetration for Imricor’s technology in KSA. Imricor’s Chair and CEO, Steve Wedan, said: “We are extremely pleased to partner with one of the leading medical device distributors in the Kingdom of Saudi Arabia. FMS is working with multiple hospitals to establish state of the art cardiology centres throughout KSA, and now is a great time for Imricor’s technology to be introduced at these sites, where the iCMR labs will be dedicated cardiology-owned facilities. “As I’ve said in the past, our sales efforts all over the world are focused on establishing dedicated iCMR facilities, and our partnership with FMS is well aligned with this strategic goal, while it also further grows our geographic footprint. FMS, Subsidiary of Tibbiyah Holding Company CEO, Alaa Ameen, said: “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 leader 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 goal with Saudi Vision 2030 to establish the best cardiac Centres in the Middle east region.”
Minneapolis MN (July 11 2023) – Imricor Medical Systems, Inc. (ASX:IMR) Imricor, the global leader in real-time interventional cardiac magnetic resonance (iCMR) ablation products, is pleased announce it has entered into a non-exclusive software distribution agreement with ADAS 3D Medical S.L. (ADAS 3D Medical) a leading developer of imaging solutions for the electrophysiology (EP) market.
April 11 – Imricor Medical Systems, Inc. (Company or Imricor) (ASX:IMR), the global leader in real-time iCMR cardiac ablation products, is pleased to announce that the University Hospital Lausanne (CHUV) in Lausanne, Switzerland has submitted a purchase order to Imricor for the capital equipment required to fit out the CHUV’s new iCMR lab, scheduled to open this July.