Imricor Medical : Appendix 4C - Quarterly Report and Business Update

For personal use only

ASX Announcement

IMRICOR 4Q FY21 QUARTERLY ACTIVITIES REPORT

AND APPENDIX 4C

26 January 2022 - Minneapolis, United States - Imricor Medical Systems, Inc. (Company or Imricor) (ASX:IMR) the global leader in realtime iCMR cardiac ablation products, today releases its Appendix 4C Quarterly Cash Flow Report for the period ending 31 December 2021 and provides an update on its operational performance.

Highlights

• Imricor signed four new purchase agreements across Europe, bringing the total number of sites to fourteen. The four new sites are:

1. Semmelweis University Heart and Vascular Centre in Budapest, establishing its first site in Hungary

1. German Heart Centre Berlin in Berlin, Germany

• 1. Charité Medical University Virchow-Klinikum Campus in Berlin, Germany o Henry Dunant Hospital Centre in Athens, establishing its first site in Greece
• Filed an application for an Investigational Device Exemption (IDE) from the US Food and Drug Administration (FDA)
• Completed a strategic investment in MiRTLE Medical, LLC (MiRTLE), maker of an MRI-compatible12-lead ECG system
• As at 31 December 2021, Imricor maintained a cash balance of approximately
  US$18.516 million

Expanding sites and geographies in line with strategy

During the quarter, Imricor signed four new purchase agreements across Europe, expanding Imricor's total sites to fourteen at year end. Two of the new sites signed are in new markets for Imricor.

Imricor's Chair and CEO, Steve Wedan, said: "We are very pleased to have added four new sites to our network, and to have expanded into Hungary and Greece. We are working to bring these new sites online and look forward to supporting each of them as they commence procedures in 2022."

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

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

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Site expansion across Europe is a key strategic goal for Imricor, as it establishes an installed base for the sale of Imricor's disposable products.

Recommencement of procedures

During the quarter, procedures were performed at four sites: Dresden Heart Centre, Leipzig Heart Centre, Maastricht University Medical Centre, and the Cardiovascular Institute of South Paris.

Strategic Investment in MiRTLE Medical

In the last quarter, Imricor completed a strategic investment (Investment) in MiRTLE Medical, LLC (MiRTLE), maker of an MRI-compatible12-lead ECG system.

Under the terms of the Investment, which closed on 26 November 2021 (US time), Imricor acquired approximately two per cent of the equity in MiRTLE, along with three ECG systems, for US$200,000. The cash purchase price was funded from the Company's existing cash reserves.

Imricor first partnered with MiRTLE in October 2017 with the establishment of a Joint Development Agreement to work on interfacing MiRTLE's 12-lead ECG system with Imricor's Advantage-MR EP Recorder/Stimulator in the MRI environment. On 28 September 2021, Imricor announced the expansion of its relationship with MiRTLE through the establishment of the Sales Distribution Agreement, under the terms of which Imricor is a non-exclusive distributor of MiRTLE's 12-lead ECG system.

In May of 2021 MiRTLE received CE mark certification for their 12-lead ECG system, which allows the system to be sold in European countries that accept CE mark certification.

Executing this strategic investment with MiRTLE further de-risks Imricor's strategic plan to deliver iCMR-based ventricular tachycardia and other ablation procedures for which 12-lead ECG capabilities are important.

Expanding indications

Preclinical studies to support a ventricular tachycardia ablation (VT) clinical trial in Europe were not completed in in the last quarter but are expected to commence in Q1 2022 with no impact on the overall VT clinical trial timing. The VT clinical trial is expected to commence in 2022.

Appendix 4C Cashflow for 4Q FY21

During the quarter ended 31 December 2021 (Q4 2021) net cash outflows from operating activities were US$3.972 million. Receipts from customers during the period were US$0.341 million comprising the sale and rental of capital equipment (US$0.193 million), consumable product sales (US$0.122 million) and the sale of service agreements (US$0.026 million). Revenue and associated cash receipts in Q4 2021 continued to be impacted by the COVID-19 pandemic.

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

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

For personal use only

Payments made in relation to operating costs of US$4.313 million were down compared to the prior quarter of US$5.017 million primarily due to lower cash outflows for raw material purchases and corporate insurance premiums.

Net cash outflows from investing activities were US$0.247 million during Q4 2021, including the cash payment of US$0.200 million for the strategic investment in MiRTLE. Net cash inflows from financing activities were US$0.536 million in the period, largely comprising proceeds from the security purchase plan completed in October 2021.

At 31 December 2021, Imricor maintained a cash balance of US$18.516 million.

Payments made to related parties as described in Item 6.1 on the Appendix 4C were for directors' fees.

ENDS

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

Further Information
Investors:	Investors & Australian Media:
Steve Wedan	Brett Ward
Executive Chair, President and CEO	Senior Advisor, Cato & Clive
Email:[e-mail]	Email:[e-mail]
	Mobile: [phone]

Rest of World Media:	Investors (Australia):
Nick Twohy	Aisha Jabeen
Director of Marketing, Imricor	Advisor, Cato & Clive
Email:[e-mail]	Email:[e-mail]
Phone: [phone]	Phone: [phone]

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

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

For personal use only

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.

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

For personal use only

Rule 4.7B

Appendix 4C

Quarterly cash flow report for entities subject to Listing Rule 4.7B

Name of entity

Imricor Medical Systems, Inc.
ABN	Quarter ended ("current quarter")
633 106 019	31 December 2021

Consolidated statement of cash flows	Current quarter	Year to date (12
			$USD'000	months)
				$USD'000
1.	Cash flows from operating activities
1.1	Receipts from customers	341	1,079
1.2	Payments for
	(a)	research and development	(926)	(3,558)
	(b) product manufacturing and operating	(64)	(1,343)
		costs
	(c)	advertising and marketing	(252)	(955)
	(d)	leased assets	-	-
	(e)	staff costs	(2,263)	(9,427)
	(f) administration and corporate costs	(770)	(3,132)
1.3	Dividends received (see note 3)	-	-
1.4	Interest received	-	17
1.5	Interest and other costs of finance paid	(38)	(178)
1.6	Income taxes paid	-	-
1.7	Government grants and tax incentives	-	-
1.8	Other (provide details if material)	-	-
1.9	Net cash from / (used in) operating	(3,972)	(17,497)
	activities
2.	Cash flows from investing activities
2.1	Payments to acquire or for:
	(a)	entities	-	-
	(b)	businesses	-	-
	(c) property, plant and equipment	(141)	(565)
	(d)	investments	(70)	(70)
	(e)	intellectual property	(36)	(90)
	(f)	other non-current assets	-	-

ASX Listing Rules Appendix 4C (17/07/20)	Page 1
+ See chapter 19 of the ASX Listing Rules for defined terms.