24 Nov

Application for FDA Investigational Device Exemption

Imricor Medical Systems, Inc. (ASX: IMR) | ARBN 633 106 019 400 Gateway Blvd. | Burnsville, Minnesota 55337 USA | +1 952.818.8400 | imricor.com ASX Announcement IMRICOR APPLIES FOR FDA INVESTIGATIONAL DEVICE EXEMPTION 23 November 2021 – Minneapolis, United States – Imricor Medical Systems, Inc. ( Company or Imricor ) ( ASX:IMR ) the global leader in realtime iCMR cardiac ablation products, is pleased to announce that it has filed an application for an Investigational Device Exemption (IDE) from the US Food and Drug Administration (FDA). If granted, the IDE will allow Imricor to commence a clinical study aimed at gaining the clinical data to support the approval of several iCMR ablation devices including the Vision-MR Ablation Catheter, Vision-MR Diagnostic Catheter, Vision-MR Dispersive Electrode, Advantage-MR EP Recorder/Stimulator, and the Osypka HAT500 Ablation Generator and Irrigation Pump. Imricor’s Chair and CEO, Steve Wedan, said: “The IDE application marks the next critical step toward FDA approval of Imricor‘s devices for the treatment of cardiac arrhythmias in the iCMR environment. “As such, the application also represents an important milestone in our strategic plan to expand the geographies in which iCMR ablations can be performed and we look forward to working with the FDA as we strive to bring iCMR ablation technology to patients throughout the US.” ENDS Authorised for release by Steve Wedan, Executive Chair, President, and CEO . Imricor Medical Systems, Inc. (ASX: IMR) | ARBN 633 106 019 400 Gateway Blvd. | Burnsville, Minnesota 55337 USA | +1 952.818.8400 | imricor.com Further Information Investors: Investors & Australian Media : Steve Wedan Brett Ward Executive Chair, President and CEO Senior Advis o r , Cato & Cl ive Email: steve.wedan@imricor.com Email: b rett @catoandclive.com Mobile : +61 4 37 994 451 Rest of World Media: Investors (Australia): Nick Twohy Aisha Jabeen Director of Marketing, Imricor Advis o r , Cato & Clive Email: nick.twohy@imricor.com Email: aisha@catoandlcive.com Phone: +1 952 818 8407 Phone: +61 430 563 964 About Imricor Imricor Medical Systems, Inc. (ASX:IMR) is a leading developer of innovative MRI-compatible medical devices which can be used to carry out MRI-guided cardiac catheter ablation procedures. Headquartered in the US, Imricor seeks to make a meaningful impact on patients, healthcare professionals, and healthcare facilities around the world by increasing the success rates and bringing down the overall costs of cardiac catheter ablation procedures. Imricor’s Products Imricor is a pioneer and leader in developing MRI-compatible products for cardiac catheter ablation procedures, and believes it is the first company in the world to bring commercially viable and safe MRI-compatible products to the cardiac catheter ablation market. The Vision-MR Ablation Catheter is the Company’s prime product offering, specifically designed to work under real- time MRI guidance, with the intent of enabling higher success rates along with a faster and safer treatment compared to conventional procedures using x-ray guided catheters. The Vision-MR Ablation Catheter has been approved in the European Union with an indication for treating type 1 atrial flutter. Imricor intends to seek approval for expanded indications in the future. The Company is also in the early stages of pursuing the required regulatory approvals to place its key products on the market in Australia and the U.S. The Company has also obtained approval within the EU for the sale of the Advantage-MR EP Recorder/Stimulator System and its consumable product, the Vision-MR Dispersive Electrode. Imricor sells its capital and consumable products to hospitals and clinics for use in Interventional Cardiac Magnetic Resonance Imaging (iCMR) labs, in which ablation procedures using the Vision-MR Ablation Catheter can be performed. An iCMR lab is an interventional lab that is fitted with MRI equipment for use in cardiac diagnostic and interventional procedures. The installation of iCMR labs is driven primarily by MRI equipment vendors working collaboratively with Imricor. Vendors such as Koninklijke Philips N.V. and Siemens Healthcare GmbH help to target certain sites and support the design and construction of iCMR labs for those sites. Foreign Ownership Restrictions Imricor’s CHESS Depositary Interests ( CDIs ) are issued in reliance on the exemption from registration contained in Regulation S of the US Securities Act of 1933 ( Securities Act ) for offers which are made outside the US. Accordingly, the CDIs have not been, and will not be, registered under the Securities Act or the laws of any state or other jurisdiction in the US. As a result of relying on the Regulation S exemption, the CDIs are ‘restricted securities’ under Rule 144 of the Securities Act. This means that you are unable to sell the CDIs into the US or to a US person for the foreseeable future except in very limited circumstances after the expiration of a restricted period, unless the re-sale of the CDIs is registered under the Securities Act or an exemption is available. To enforce the above transfer restrictions, all CDIs issued bear a ‘FOR US’ designation on the Australian Securities Exchange ( ASX ). This designation restricts any CDIs from being sold on ASX to US persons. However, you are still able to freely transfer your CDIs on ASX to any person other than a US person. In addition, hedging transactions with regard to the CDIs may only be conducted in accordance with the Securities Act. Imricor Medical Systems, Inc. (ASX: IMR) | ARBN 633 106 019 400 Gateway Blvd. | Burnsville, Minnesota 55337 USA | +1 952.818.8400 | imricor.com Forward-Looking Statements This announcement contains or may contain forward-looking statements that are based on the Company’s management’s beliefs, assumptions and expectations and on information currently available to management. All statements that address operating performance, events or developments that we expect or anticipate will occur in the future are forward-looking statements. These include, without limitation, EU commercial market acceptance and EU. sales of our product as well as our expectations with respect to our ability to develop and commercialise new products. Management believes that these forward-looking statements are reasonable when made. You should not place undue reliance on forward-looking statements because they speak only as of the date when made. Imricor does not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Imricor may not actually achieve the plans, projections or expectations disclosed in forward- looking statements. Actual results, developments or events could differ materially from those disclosed in the forward- looking statements.
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