Hello and welcome to the Annual Meeting of Stakeholders of Imricor Medical Systems. Please note that today's meeting is being recorded. It is now my pleasure to turn today's meeting over to Steve Wedan. Steve, the floor is yours.
Thank you. I'd like to welcome everyone to the 2025 Annual Meeting of Imricor Medical Systems. My name is Steve Wedan, Imricor's Chair and CEO. During the course of today's meeting, our stakeholders and their proxies will have the opportunity to ask questions and register both if you haven't already done so. CDI holders will also have the opportunity to ask questions but are not entitled to vote at the meeting except as a proxy for CHESS Depository nominees. You can submit your questions at any time during the meeting as outlined in our meeting guide, and I will address these questions throughout the meeting. Voting today will be conducted by way of a poll on all items of business, and I will shortly open voting for all resolutions. Once voting is open, if you're eligible to vote at the meeting, a polling icon will appear on your screen.
Selecting this icon will open up a list of resolutions and present you with voting options. To cast your vote, simply click on the appropriate option. Once you select an option, the vote is automatically recorded. You have the ability to change your vote at any time up until the time I declare voting closed, and I'll provide the meeting with a warning before the closing of the voting. Please also note that there are a number of voting exclusions that apply to the resolutions being put to today's meeting, and these have been outlined in the notice of meeting. I now declare the voting open on all items of business.
I'd like to take a moment to introduce three of my fellow directors, four actually, who are also joining us today: Mark Tibbles, Anita Misal, Peter McGregor, and Jeffrey Layton, as well as our CFO, Jonathan Gut, and Jeff Ostapeic from our audit firm, BDO. Online, we also have our company secretary, Kobe Li. I've been advised that a quorum is present, and therefore I declare this meeting open and authorize to transact business. As you know, we are the global leader in MRI-compatible interventional devices, enabling physicians to fully utilize MRI's superior imaging during and throughout interventional procedures. Our initial focus has been on cardiac ablation, a fast-growing $10 billion annual market. When we started Imricor, developing MRI-compatible devices posed a significant technical barrier.
Only Imricor had the expertise to overcome these barriers, and today we remain the first and only company to deliver a full suite of MRI-compatible ablation tools for clinical use. Achieving our vision meant inventing, developing, and gaining approval for nearly every device required for MRI-guided ablations, built on our proprietary technology and patented technology platform. While others have tried, only Imricor has succeeded, and the goal has always been clear: faster, safer, more effective procedures at a lower cost. Each regulatory approval we gain represents more than a single device. It's an entire platform, multiple consumables, capital equipment, and now our MRI-native mapping and guidance system we call Northstar. We've secured approvals for our ablation devices across Europe and the Middle East, with Northstar approvals expected soon, and we are currently advancing through the U.S. FDA process. The most important news: the technology is already delivering outstanding clinical results.
We are now scaling commercialization globally and unlocking significant value for patients, physicians, hospitals, payers, and investors. Cardiac ablation is just the beginning. New clinical applications are emerging rapidly. An MRI-guided biopsy tool is already in development. Opportunities in renal denervation, structural heart, oncology, neurology, and beyond are also coming into focus. On the software side, Northstar is positioned to become the core navigation platform for MRI-guided interventions, and its future diagnostic use could unlock additional new markets. In 2024, and including the current year so far, we've made excellent progress across many fronts. We gained Saudi FDA approval and signed distributors in both KSA and Qatar. We then followed that with our first sale in the region to our Qatar distributor. We are eagerly awaiting the registration of our third-party partner's RF generator in KSA, and we look forward to further accelerating adoption in the Middle East.
In Europe, we gained CE mark approval under the new, more stringent Medical Device Regulation, or MDR, for which our Vision- MR Diagnostic Catheter, our second-generation Vision- MR Ablation Catheter, which includes two different curve sizes, and our new Advantage-MR EP Recorder/Stimulator system, which incorporates technology updates to match the second-generation ablation catheter. Now we're fully switched over to the MDR environment, which includes our quality system, manufacturing processes, and so on. We've had even a couple of surprise on-site audits from our notified body, for which, of course, the team is always well prepared. We've also seen site activations, or in some cases, reactivations, across Europe, including Amsterdam University Medical Center in the Netherlands, Dubrava University Hospital in Zagreb, Croatia, Lausanne University Hospital in Switzerland, and Semmelweis University's Heart and Vascular Center in Budapest, Hungary.
Now, with our European sales team fully resourced, we are once again building a pipeline of new sites and progressing our expansion across Europe. The anticipated CE mark approval of Northstar is expected to help drive adoption and is in the progression of our VISABL—I'm sorry, is as in the progression of our VISABL- VT trial. Speaking of trials, we advanced and received approvals to start both our VISABL- AFL trial to support U.S. FDA approval and our VISABL- VT trial to support expanded indications in Europe. We then began enrolling in the VISABL- AFL trial, which included the first procedure performed in the United States, while we, in parallel, began submitting modules to the FDA for review. The first module has been approved, and the second module is currently in progress.
Of course, we've commenced the VISABL- VT trial with our first enrolling patient in Amsterdam University Medical Center, a procedure which included two first-in-human experiences of ablating in the ventricle and ablating on the left side of the heart inside the MRI. This was a huge milestone for the field, and we've been very fortunate to be able to partner with dedicated, world-class teams like those from Amsterdam UMC on this important groundbreaking work. Finally, I'd like to say how fortunate we all are at Imricor to partner, in a very real sense, with all of you, our shareholders, as we aim to improve patient care and safety, decrease the cost of healthcare, and provide safer work environments for medical personnel who dedicate their careers to caring for all of us.
What we're doing is important, and the support we've seen from the investment community is vital to that work. That means we're all in this together. With our recent financing of AUD 70 million, we have a balance sheet now that enables us to progress and accelerate towards our mission, and I want to personally thank you all. I'd also like to take a moment to thank and acknowledge the team at Imricor. I'm so fortunate to work with some of the best talent in this field. Living in the Twin Cities, where we do, with medical device giants like Medtronic, Abbott, and Boston Scientific, as well as countless startups, these are people who have choices about where they work.
It is a testament to the significance of what we're doing together that we are all so dedicated to our mission of growing interventional cardiac magnetic resonance to be the standard of care. Ladies and gentlemen, we will now turn to the formal business of the meeting. As I mentioned previously, you may ask questions online during the meeting via the speech bubble icon on your screen, and if eligible to vote at the meeting, you may do so up until the time I close voting by clicking on the polling icon on your screen. If you've already sent in your proxy voting instructions or voted by internet or the telephone before the meeting, your shares have already been voted accordingly. Therefore, stakeholders do not need to vote today unless they are voting for the first time or want to change their previous vote.
Voting is currently open for all items of business, and I will provide you with a warning before I move to close voting. Prior to commencement of the meeting, valid votes have been received representing approximately 32.6% of Imricor's issued capital, or 10,569,840 shares of Class A common stock. As I stated in the proxy statement, I intend to vote all available undirected proxies in favor of all items. Ladies and gentlemen, a copy of the notice of meeting proxy statement, including explanatory memorandum, has been distributed to or made available to all stockholders and CDI holders. If you do not have a copy with you, please be reminded that you can download these documents from the ASX website. I propose that these documents be taken as read.
As required by the bylaws, a copy of the full register of stockholders is available for viewing at Imricor's place of business in Burnsville and Imricor's registered address in Melbourne, Australia. You're encouraged to make prior arrangements with either myself in the U.S. or with Kobe Li, Imricor's Company Secretary in Australia, should you like to view the register. Before we move to the agenda items, I'd like to address questions in relation to the presentation I made or any other business of the company. I'll defer questions on any of the items of business until we come to that particular item. I'll provide you with a moment to ask your questions online. Are there any questions at this time?
Chair, there are no questions at this time.
Thank you. We will move then to the first item of business, the election of Class III Director, Mr. Peter McGregor. I refer stakeholders and CDI holders to the explanatory memorandum for details of Mr. McGregor's background and experience. I ask you to consider and, if thought fit, to pass the resolution as a separate ordinary resolution, that Mr. Peter McGregor, being a director whose appointment as a director expires at the conclusion of the annual meeting of the company and being eligible, offers himself for election to be elected as a Class III Director of the company. Are there any questions in relation to this resolution?
Chair, there are no questions at this time.
Thank you. I'd like to point out that the laws of Delaware, where the company is domiciled, do not provide for a casting of stockholder votes against certain types of resolutions, including the election of directors. As stated in the notice of meeting, the ASX has granted the company an appropriate waiver to enable the company to comply with these laws. The vote required to approve item one is for vote of the holders of a plurality of the voting power of the voting in the stock that is present or represented by proxy at the meeting and entitled to vote on such proposal. Prior to the commencement of the meeting, the company received combined direct and proxy votes as shown on your screen. I now put the resolution to the meeting and ask you to complete your voting.
We'll now move to the next item of business, the election of Class III Director, Dr. Jeffrey Layton. I refer stakeholders and CDI holders to the explanatory memorandum for Dr. Layton's background and experience. I ask you to consider and, if thought fit, to pass the resolution as a separate ordinary resolution, that Dr. Jeffrey Layton, being a director whose appointment as a director expires at the conclusion of the annual meeting of the company and being eligible, offers himself for election to be elected as a Class III Director of the company. Are there any questions in relation to this resolution?
Chair, there are no questions at this time.
Thank you. Prior to the commencement of the meeting, the company received combined direct and proxy votes as shown on your screen. I now put the resolution to the meeting and ask you to complete your voting. We'll now move to the next item of business, the approval of the 2019 Equity Incentive Plan and an increase in reserve shares. I refer stakeholders and CDI holders to the explanatory memorandum for details about this resolution.
I ask you to consider and, if thought fit, to pass this resolution as a separate ordinary resolution, that for the purposes of Section 19.2 of the plan defined below, Exception 13 of ASX Listing Rule 7.2, and for all other purposes, the stakeholders approve: one, the issue of equity shares under the company's 2019 Equity Incentive Plan within three years from the date of passing this resolution as an exception to the ASX Listing Rule 7.1; two, an increase to the aggregate number of shares of Class A common stock that may be issued pursuant to awards under the plan, such that the total of 40,650,000 shares will be reserved for issuance under the plan; and three, consequential amendments to the plan to reflect this increase. Are there any questions in relation to this resolution?
Chair, there are no questions at this time.
Thank you. Prior to the commencement of the meeting, the company received the combined direct and proxy votes as shown on your screen. I now put the resolution to the meeting and ask you to complete your voting. As the next two items involve the proposed grant of options to me, I will hand the chair to Mr. Mark Tibbles, who is the Chair of our Remuneration and Nomination Committee. Mark?
Thanks, Steve. Ladies and gentlemen, the next two items of business relate to the grant of options to Steve Wedan, Chief Executive Officer of the company. Details of this option grant are set out in the explanatory memorandum. I ask you to consider and, if thought fit, to pass this resolution as a separate ordinary resolution, that for the purposes of ASX Listing Rule 10.14 and for all other purposes, approval is given for the company to grant 455,893 options to purchase shares as a long-term incentive to the Chief Executive Officer of the company, Mr. Steve Wedan, under the company's 2019 Equity Incentive Plan, as described in and on the terms and conditions set out in the explanatory memorandum. Are there any questions in relation to this resolution?
Chair, there are no questions at this time.
Thank you, Kobe. Prior to the commencement of the meeting, the company received the combined direct and proxy votes as shown on your screen. I now put the resolution to the meeting and ask you to complete your voting. I ask you to consider and, if thought fit, to pass this resolution as a separate ordinary resolution, that subject to item three being approved for the purposes of ASX Listing Rule 10.14 and for all other purposes, approval is given for the company to grant 500,000 options as a special one-off grant to the Chief Executive Officer of the company, Mr. Steve Wedan, under the plan as described in and on the terms and conditions set out in the explanatory memorandum. Are there any questions in relation to this resolution?
Chair, there are no questions at this time.
Thank you, Kobe. Prior to the commencement of the meeting, the company received combined direct and proxy votes as shown on your screen. I now put the resolution to the meeting and ask you to complete your voting. Thank you, ladies and gentlemen. I will now hand back to Steve to resume as Chair of the meeting.
Thank you, Mark. Thank you. We will now move to the next item of business, the grant of restricted stock award to Non-Executive director, Mr. Peter McGregor. Details of this restricted stock grant are set out in the explanatory memorandum. I ask you to consider and, if thought fit, to pass this resolution as a separate ordinary resolution. That is subject to item one being approved for the purposes of ASX Listing Rule 10.14 and for all other purposes, approval is given to the company to grant a restricted stock award to Mr. Peter McGregor, Non-Executive Director of the company under the plan described in and on the terms and conditions set out in the explanatory memorandum. Are there any questions about this in relation to this resolution?
Chair, there are no questions at this time.
Thank you. Prior to the commencement of the meeting, the company received combined direct and proxy votes as shown on your screen. I now put the resolution to the meeting and ask you to complete your voting. We'll now move to the next item of business, the grant of restricted stock award to Non-Executive director, Ms. Anita Misal. Details of this restricted stock grant are set out in the explanatory memorandum. I ask you to consider and, if thought fit, to pass this resolution as a separate ordinary resolution, that for the purposes of ASX Listing Rule 10.14 and for all of the purposes, approval is given to the company to grant a restricted stock award to Ms. Anita Misal, Non-Executive Director of the company under the plan as described in and on the terms and conditions set out in the explanatory memorandum.
Are there any questions in relation to this resolution?
Chair, there are no questions at this time.
Thank you, Kobe. Prior to the commencement of the meeting, the company received the combined direct and proxy votes as shown on your screen. I now put it to the meeting and ask you to complete your voting. We'll now move to the next item of business, the grant of restricted stock award to Non-Executive Director, Mr. Mark Tibbles. Details of this restricted stock grant are set out in the explanatory memorandum. I ask you to consider and, if thought fit, to pass the following resolution as a separate ordinary resolution, that for the purposes of ASX Listing Rule 10.14 and for all other purposes, approval is given for the company to grant a restricted stock award to Mr. Mark Tibbles, Non-Executive Director of the company under the plan as described in and on the terms and conditions set out in the explanatory memorandum.
Are there any questions in relation to this resolution?
Chair, there are no questions at this time.
Thank you. Prior to the commencement of the meeting, the company received the combined direct and proxy votes as shown on your screen. I will put the resolution to the meeting and ask you to complete your voting. We will now move to the next item of business, ratification and approval of prior issues of CDIs under the placement. Details in relation to this resolution are set out in the explanatory memorandum.
I ask you to consider and, if thought fit, to pass this resolution as a separate ordinary resolution, that for the purposes of ASX Listing Rule 7.4 and for all other purposes, the stockholders ratify and approve the prior allotment and issue of 49,645,391 CHESS Depository Interests, or CDIs, equivalent to 49,645,391 shares of Class A common stock at an issue price of AUD 1.41, I should say, at AUD 1.41 per CDI under the placement to professional and sophisticated investors on the terms and conditions set out in the explanatory memorandum. Are there any questions in relation to this resolution?
Chair, there are no questions at this time.
Thank you, Kobe. Prior to the commencement of the meeting, the company received the combined direct and proxy votes as shown on your screen. I now put the resolution to the meeting and ask you to complete your voting. We'll now move to the final item of business, ratification of the appointment of BDO USA PC as independent registered public accounting firm. Details in relation to this resolution are set out in the explanatory memorandum. I ask you to consider and, if thought fit, to pass this resolution as a separate ordinary resolution, that the stockholders ratify and approve the appointment of BDO USA PC as the company's independent registered public accounting firm for the year ending 31 December 2025. Are there any questions in relation to this resolution?
Chair, there are no questions at this time.
Thank you, Kobe. Prior to the commencement of the meeting, the company received the combined direct and proxy votes as shown on your screen. I will put the resolution to the meeting and ask you to complete your voting. Ladies and gentlemen, that concludes our items of business. Are there any other further questions at this time?
Chair, there are no questions at this time.
I will shortly close the voting system. Please ensure that you have cast your vote on all resolutions. I'll now pause for 90 seconds to allow you time to finalize these votes. Thank you, everyone. Voting is now closed. The voting results will be released to the ASX later today. I thank you for taking the time to join the board and me today. Your ongoing support is greatly appreciated, and we look forward to sharing the next exciting phase of Imricor's journey with you all. Have a good rest of your day.
This concludes the meeting. You may now disconnect.