Skip to main content

AI assistant

Sign in to chat with this filing

The assistant answers questions, extracts KPIs, and summarises risk factors directly from the filing text.

IMRICOR MEDICAL SYSTEMS INC. Capital/Financing Update 2023

Apr 10, 2023

65123_rns_2023-04-10_62a730ef-8249-4674-88f6-f09a102f2482.pdf

Capital/Financing Update

Open in viewer

Opens in your device viewer

==> picture [114 x 23] intentionally omitted <==

IMRICOR ESTABLISHES FIRST ICMR SITE IN SWITZERLAND

Highlights:

  • University Hospital Lausanne (CHUV), widely considered one of the best hospitals in the world, becomes first site to establish an iCMR lab with Imricor in Lausanne, Switzerland

  • Site will be a Centre of Excellence for Imricor, with physicians from other hospitals able to visit, be trained on real-time iCMR cardiac ablations and other future interventions, as the number of active sites across Europe continues to grow

  • CHUV is expected to participate in the global VISABL-AFL trial supporting US FDA approval of Imricor’s platform of products with process underway

  • With CHUV establishing an iCMR lab in Switzerland, Imricor now has a presence in eight European countries: Germany, the Netherlands, Hungary, France, Italy, Greece, Croatia, and Switzerland

10 April 2023 – Minneapolis, MN United States ( 11 April 2023 – Melbourne, Australia) – 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.

Widely considered one of the best hospitals in the world, CHUV is the first site to establish an iCMR lab with Imricor in Switzerland. The site will be a Centre of Excellence for Imricor, where physicians from other hospitals can visit and be trained on real-time iCMR cardiac ablations and other future interventions, as the number of active sites across Europe continues to grow.

The process is underway for CHUV to participate in the global VISABL-AFL trial supporting US FDA approval of Imricor’s platform of products.

Professor Juerg Schwitter, MD, Director Cardiac MR Center, Staff of Cardiology and Member of the Faculty of Biology and Medicine at CHUV commented:Here at the University Hospital Lausanne, the CHUV, we are proud to be among the 15 best ranked hospitals worldwide since several years in series (according the Newsweek Magazine) – and we are constantly preparing the future. Therefore, we will launch our fully dedicated iCMR centre this summer as a research and training centre. We will start with electrophysiological interventions and will then also expand to other cardiovascular interventions to treat structural heart diseases, evaluate the pulmonary circulation, complement diagnostics with actively guided myocardial biopsies, and to treat peripheral arterial disease.

“Many years ago in San Francisco, we did pioneering work on coronary artery disease detection by MRI. Now ischemia diagnostics by MRI is in all international guidelines. Similarly, pacemakers and defibrillators were not compatible with MRI 10 years ago. We started a collaboration with industry, and now all leading device manufactures offer a full spectrum of devices, all MRI compatible, reaching market shares up to 100%.

“I believe strongly, that this evolution will also happen to the iCMR field, as it allows for high precision interventions, where we expect higher success rate, lower relapse rate and less

Imricor Medical Systems, Inc. (ASX: IMR) | ARBN 633 106 019

400 Gateway Blvd. | Burnsville, Minnesota 55337 USA | +1 952.818.8400 | imricor.com

==> picture [114 x 23] intentionally omitted <==

complications compared to conventional techniques, and all these advantages go without radiation exposure and potentially shorter interventions times.”

Imricor has had a Collaboration Agreement in place with CHUV since 2019, but construction of the new cardiology-owned iCMR lab was delayed through the pandemic. Under the terms of the Collaboration Agreement, Imricor and CHUV will develop and test new technologies for iCMR applications, such as AI applications for Imricor’s NorthStar 3D mapping system, new MRI imaging sequences to support iCMR procedures such as for Pulsed Field Ablation (PFA) of atrial fibrillation, and training platforms for visiting physicians and medical teams.

Imricor’s Chair and CEO, Steve Wedan, commented:We are very excited to open the new cardiology-owned iCMR facility at the world-class CHUV in Lausanne. We believe this very important site will be an incubator for new iCMR technologies, and a catalyst for new iCMR adoption across Switzerland and all of Europe. We couldn’t be more thrilled than to work so closely with Professor Schwitter and the great team at CHUV.”

ENDS

Authorised for release by Steve Wedan, Executive Chair, President, and CEO.

Media and Investor Relations Contact:

Simon Hinsley [email protected] +61 401 909 653

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 real-time iCMR cardiac 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 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 realtime 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

Imricor Medical Systems, Inc. (ASX: IMR) | ARBN 633 106 019

400 Gateway Blvd. | Burnsville, Minnesota 55337 USA | +1 952.818.8400 | imricor.com

==> picture [114 x 23] intentionally omitted <==

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.

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.

Imricor Medical Systems, Inc. (ASX: IMR) | ARBN 633 106 019

400 Gateway Blvd. | Burnsville, Minnesota 55337 USA | +1 952.818.8400 | imricor.com