Hello and welcome to the Annual Meeting of Stockholders of EBR Systems Inc. Please note that today's meeting is being recorded. It is now my pleasure to turn today's meeting over to Alan Will. Alan, the floor is yours.
Good morning and good afternoon, ladies and gentlemen. My name is Alan Will, and as Executive Chair of EBR Systems Inc, I am pleased to welcome you to the 2025 Annual Meeting of Stockholders, which is being held as a virtual meeting provided by our security registrar, Computershare Investor Services. It is now 4:00 P.M., Wednesday, 21 May 2025, U.S. Pacific Daylight Time, which is 9:00 A.M., Thursday, 22 May 2025, Australian Eastern Standard Time. I note that this is a properly constituted meeting and that a quorum is present. I therefore declare this Annual Meeting of Stockholders of EBR Systems open. I would like to first introduce our President and Chief Executive Officer, John McCutcheon. Our other directors are on the line today as well. They are Karen Drexler, Dr. Bronwyn Evans, Trevor Moody, Dr. Chris Nave, and Dr. David Steinhaus.
Our directors bring a diverse range of expertise and highly complementary skill sets capable of guiding and overseeing the company's product development, commercialization, and growth. Also online today are Gary Doherty, our Chief Financial Officer, and Matt Grahams, CPA and partner from the company's auditor, Deloitte. Mr. Grahams will be available when we move to the Q&A session to answer submitted questions you may have about the conduct of the audit and the auditor's report. I would like to thank my fellow board members, our President and CEO, John McCutcheon, and the entire staff and management at EBR Systems for their continued dedication to work towards the company's success. I will now call upon John to outline our strategic priorities and further update you on EBR's progress over the past 12 months.
Thank you, Alan. Hi, everyone. Pleasure to be speaking with you all and discussing the progress that EBR has made over the past year. Hopefully, you can see the slide year in review. I won't read these line by line, but I'd like to point out that 2024 was a really pivotal year for EBR Systems. Our focus during the year was commercial preparation for this year in anticipation of FDA approval, and then, of course, the progress we made along the FDA approval path. We were thrilled to announce earlier this year that our efforts in 2024 came to fruition, and we were able to get FDA approval and complete our pre-approval inspection of the facility in the late Q1 and in early Q2 of this year.
Very good progress, very exciting times, and we're now transitioning from an R&D research clinical phase company to a commercial company, and pleased to present that to you. Some of the highlights of our investment thesis are that EBR offers a unique solution. There's no competition for what we're doing, no other clinical solution for the patients that are suffering from heart failure that require biventricular pacing or pacing of the left ventricle. These patients are underserved and in high need of our technology. It's a very large market. We estimate that our total available market in the U.S. is $3.6 billion, a very sizable opportunity, and again, one that we have no competition, so it's ours to go after. We did receive approval, FDA approval, as I mentioned.
Early in the year, we had forecasted that the approval would be received on or before April 13th, and we were happy to announce that we received that in the U.S. on April 11th. Quite exciting time for us and for our investors. We also have a lot of great news flow on reimbursement. We have multiple pathways for Medicare reimbursement, both for inpatient and outpatient, and those are moving forward as expected, and we will have those in place by October first of this year. We have a clear commercial strategy in place. Last year, we hired Erik Strandberg as our Chief Commercial Officer. Erik has many, many years of experience in launching new technologies in electrophysiology and in cardiology and is well-suited to bring together the team that we need in order to execute our commercial strategy.
In terms of manufacturing, we also announced that we were able to sign a new lease. We are currently in our original facility in Sunnyvale. Sometime early next year, we will be moving into our larger facility in Santa Clara, not very far from where we reside today. This new manufacturing facility will give us more capacity to expand and fill our demand for product as we grow revenue, and also will give us more capabilities to be more vertically integrated and bring more of the manufacturing operations in-house. I mentioned the $3.6 billion TAM. The pieces of the pie chart here are based on our FDA-approved indications. All of this is the on-label usage of our device as we go to market. There are four buckets here, but I would break them into two different halves. One are the upgrades.
There are leadless upgrades and high-risk upgrades. Leadless are for pacemakers that are in the right ventricle that do not have a lead. We believe this is the fastest-growing part of our market opportunity going forward. What you see here is a static view of 2025-2026 total available market, but in the years forward, that leadless upgrade market will be growing at a very rapid pace, and we see that as our biggest opportunity going forward. On the right hand of the pie chart, you have acute and chronic lead failures, and these are where conventional CRT systems fail, where the coronary sinus lead or the lead going to the left ventricle is no longer functioning, and the only option for these patients is the WiSE leadless CRT system. I mentioned our commercialization strategy is in place.
This is led by Erik Strandberg and bringing together his team. We have the breakthrough device designation, so that's the reimbursement. It gives us the reimbursement opportunity. So we've got the people, we've got the payments there. We're going to have a limited market release, and the quote that we've been saying is, "Go slow to go fast." We'll go out and establish certain KOLs, thought leaders that will do the cases early on, and then they'll be able to help us do peer-to-peer education and expand the word to other sites and centers as we go from the early adopters into more of a broad marketing application later in 2025. Erik has also put together a great commercial team. We'll exit this year with eight territories, which is roughly 16 direct individuals, and then early next year, we'll be expanding that to 12 territories.
This will be the team that completes the limited market release and then is the nucleus for growing the sales team as we expand further beyond that. For reimbursement, we have the NTAP and TPT. These are add-on payments to the conventional pre-existing reimbursement, and this is what allows us to charge a much higher selling price than current CRT systems. A CRT system in the U.S. today goes for roughly $18,000-$20,000. We've calculated our total available market based on a $45,000 selling price. We believe we can actually achieve more than that, but conservatively, we've modeled it at $45,000. This is based on these add-on payments, which again will cover the difference between what we charge and what sites would otherwise get absent these add-on payments. We've also been invited to participate in the TCET program, Transitional Coverage for Emerging Technologies.
This is the first year that CMS has offered this program. We're the only technology that's been invited to participate so far that we're aware of, and this provides more tailwind as we launch and go into Medicare sites or sites that are treating Medicare patients, and it reduces the risk of denying any coverage. This will present a real big opportunity for us going forward. With that, Alan, I'm going to turn it back over to you.
Thank you, John. I will now move on to the formal part of the meeting. The order of business today will follow the Notice of Annual Meeting and Proxy Statement, hereafter referred to as the Notice of Meeting, dated April 11th, 2025, and I propose we take the Notice of Meeting as read. As required by the company's bylaws, a copy of the Register of Stockholders is available for viewing at EBR's place of business in Sunnyvale and at EBR's registered address in Melbourne, Australia. You're encouraged to make arrangement with Brendan Case, EBR's Australian Company Secretary, should you wish to view the register. Voting restrictions are set out in the Notice of Meeting. Where the chair of the meeting has been nominated as the shareholder's proxy, all open and available proxies have been voted in favor of all items.
Please note that only holders of common stock, common stock proxy holders, or authorized company representatives of holders of common stock may vote online at this meeting today. CDI holders will not be able to vote at today's AGM. However, if you lodged a proxy form with the company, then your CDI votes will be represented by CHESS Depository nominees as the common stock shareholder. Voting today will be conducted by way of a poll, and I will shortly open voting for all proposals. Once voting is open, if you're eligible to vote at this meeting, a polling icon will appear on your screen. Selecting this icon will open the list of proposals 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. I now declare voting open on all items of business. Voting on the poll for each motion will remain open until the end of the meeting. The results of the votes received at this meeting and the voting instructions received in advance of the meeting will be released to the Australian Securities Exchange and will be displayed on the company's website. So that security holders can see the full picture of direct and proxy votes received in advance of the meeting, direct and proxy voting for each item will be displayed on the screen while we conduct the business of the meeting today. I appoint Ashley Schultz from Computershare Investor Services as the independent returning officer.
We shall now work through each of the proposals set out in the Notice of the Meeting. Security holders may ask questions by clicking on the message icon, typing your question, and clicking send. May I ask that you please keep your questions related to the resolutions only and as succinct as possible? For those security holders who have this option available to you and who have not already lodged your vote, please vote as each proposal is put to the meeting. As I'm the first person to be considered for reelection as a director of the company, I will hand the chair to John for this item of business.
Thank you, Alan. Proposal 1A is the reelection of Alan Will as a director of the company. In accordance with the requirements of the company's bylaws, Alan retires and offers himself for reelection as a director at this meeting. Information in relation to Alan's background may be found in the Notice of Meeting and on the company's website. The board fully supports the reelection of Alan as a director. Are there any questions or comments in relation to Proposal 1A, which relates to the reelection of Alan Will? I now formally put Proposal 1A to the meeting in accordance with the Notice of the Meeting, and I'll now hand the chair back to Alan.
Thank you, John. The next item of business is the reelection of Mr. Trevor Moody as a director of the company. In accordance with the requirements of the company's bylaws, Trevor retires and offers himself for reelection as a director. Information in relation to Trevor's background may be found in the Notice of Meeting and on the company's website. The board fully supports the reelection of Trevor as a director. Are there any questions or comments in relation to Proposal 1B, which relates to the reelection of Trevor Moody? I now formally put Proposal 1B to the meeting in accordance with the Notice of Meeting. Proposal two. This proposal relates to the ratification and approval of the issuance of securities by the company in September 2024 under an institutional placement. Details in relation to this proposal are set out in the Notice of Meeting.
Are there any questions or comments in relation to this proposal? I now formally put Proposal two to the meeting in accordance with the Notice of Meeting. Proposal three. This item relates to the approval of an amendment to the 2021 Equity Incentive Plan and the issuance of securities under the amended plan, the terms of which are summarized in the Notice of Meeting. Are there any questions or comments in relation to this proposal? I now formally put Proposal three to the meeting in accordance with the Notice of Meeting. Proposal four. The next item of business relates to the grant of options to the President and CEO, John McCutcheon, on the terms and conditions set out in the Notice of Meeting. Are there any questions or comments on Proposal four? I now formally put Proposal four to the meeting in accordance with the Notice of Meeting. Proposal five.
The next four items to be put to the meeting relate to the approval of option grants to four directors of the company. Proposals nine and 10 relate to the issue of options to separate holdings nominated by two directors, Dr. Bronwyn Evans and Dr. Chris Nave. Comprehensive detail in relation to the proposed terms of each of the option grants may be found in the Notice of Meeting. As Proposal five relates to the approval of the grant of options to me, I will hand the chair back to John McCutcheon.
Thank you, Alan. Are there any questions or comments in relation to Proposal five, which relates to the grant of options to Alan Will on the terms and conditions set out in the Notice of the Meeting? I now formally put Proposal five to the meeting in accordance with the Notice of the Meeting. I will now hand the chair back to Alan.
Thank you, John. Proposal six. Are there any questions or comments in relation to Proposal six, which relates to the grant of options to Karen Drexler on the terms and conditions set out in the Notice of Meeting? I now formally put Proposal six to the meeting in accordance with the Notice of Meeting. Proposal seven. Are there any questions or comments in relation to Proposal seven, which relates to the grant of options to Trevor Moody on the terms and conditions set out in the Notice of Meeting? I now formally put Proposal seven to the meeting in accordance with the Notice of Meeting. Proposal eight. Are there any questions or comments in relation to Proposal eight, which relates to the grant of options to Dr. David Steinhaus on the terms and conditions set out in the Notice of Meeting?
I now formally put Proposal eight to the meeting in accordance with the Notice of Meeting. Proposal nine. Are there any questions or comments in relation to Proposal nine, which relates to the grant of options to Dr. Bronwyn Evans in a joint holding with her spouse, Peter Gordon, on the terms and conditions set out in the Notice of Meeting? I now formally put Proposal nine to the meeting in accordance with the Notice of Meeting. Proposal 10. Are there any questions or comments in relation to Proposal 10, which relates to the grant of options to a nominated entity of Dr. Chris Nave on the terms and conditions set out in the Notice of Meeting? I now formally put Proposal 10 to the meeting in accordance with the Notice of Meeting. Proposal 11.
This proposal relates to the approval of an amendment to the company's amended and restated certificate of incorporation as detailed in the Notice of Meeting. Are there any questions or comments in relation to this proposal? I now formally put Proposal 11 to the meeting in accordance with the Notice of Meeting. Stockholders are asked to note that I will shortly close the voting system. For those stockholders who have this option available to you and who intend to vote today, please ensure that your votes are cast. Questions in relation to annual accounts and audit. EBR Systems, being a company incorporated in the state of Delaware in the United States, is not required to meet the Corporations Act requirements to lay before the meeting the annual financial report.
It has, however, been decided for good governance to lay before the meeting the company's 31 December 2024 annual financial statements and reports. In addition, in accordance with the ASX Corporate Governance Council's corporate governance principles and recommendations, Matt Grahams, CPA and partner from the company's auditor, Deloitte, is in attendance and is available to answer questions from security holders relevant to the conduct of the audit and the auditor's report. Are there any questions security holders may have in relation to the annual financial statements and reports or in relation to the company's 2024 audit? I now declare that the 31 December 2024 annual financial statements and reports have been received and considered at the meeting. I will now proceed to close the meeting. I declare that voting by poll is now closed.
On behalf of the directors and staff of the company, I thank you for your attendance at this virtual meeting today. The results of the motions carried at this meeting and the voting instructions received in advance of the meeting will be released to the Australian Securities Exchange and will be accessible on the company's website. Thank you again for your continued support of EBR Systems. I now formally declare this Annual Meeting of Stockholders is closed.
This concludes the meeting. You may now disconnect.