Heartbeam Inc (BEAT) 2023 Q2 法說會逐字稿

Greetings and welcome to the HeartBeam second-quarter 2023 financial results conference call. (Operator Instructions) As a reminder, this conference is being recorded. At this time, I will turn the call over to HeartBeam's Chief Executive Officer, Branislav Vajdic. Please go ahead, sir.

您好，歡迎參加 HeartBeam 2023 年第二季度財務業績電話會議。 （操作員指示）謹此提醒，本次會議正在錄製中。此時，我會將電話轉給 HeartBeam 的首席執行官 Branislav Vajdic。請繼續，先生。

Thank you, operator, and good afternoon, everyone. I am pleased to welcome you to today's second-quarter 2023 financial results conference call. On today's call, we will be releasing some very important updates about our business and our products.

謝謝接線員，大家下午好。我很高興歡迎您參加今天的 2023 年第二季度財務業績電話會議。在今天的電話會議上，我們將發布一些有關我們的業務和產品的非常重要的更新。

Recently, we completed $26.5 million in funding, which will enable us to execute on upcoming product development, clinical, and regulatory milestones and extends our cash runway into late 2024. With this funding, we took the opportunity to adjust our strategic focus to enable timely delivery of our ambulatory vector electrocardiogram or VECG products, our key future value drivers.

最近，我們完成了2650 萬美元的融資，這將使我們能夠執行即將到來的產品開發、臨床和監管里程碑，並將我們的現金跑道延長到2024 年末。通過這筆資金，我們藉此機會調整了我們的戰略重點，以便及時實現提供我們的動態矢量心電圖或 VECG 產品，這是我們未來的關鍵價值驅動力。

Our first step is to obtain and 510(k) FDA clearance for the HeartBeam AIMIGo VECG device. This application was submitted to the FDA in May, and we will be following this with a second FDA application on the system's ability to synthesize a 12-lead ECG. Given this strategic focus on our AIMIGo system, we withdrew the 510(k) application for our AIMI product, which is a software applied to 12-lead ECG in the emergency department. This will allow us to devote all of our resources and energy to products that are being powered for our 12-lead ECG into the hands of patients and outside of a medical facility.

我們的第一步是獲得 HeartBeam AIMIGo VECG 設備的 510(k) FDA 許可。該申請已於 5 月份提交給 FDA，隨後我們將針對該系統合成 12 導聯心電圖的能力向 FDA 提交第二份申請。鑑於我們對 AIMIGo 系統的戰略重點，我們撤回了 AIMI 產品的 510(k) 申請，該產品是一款應用於急診科 12 導聯心電圖的軟件。這將使我們能夠將所有資源和精力投入到為我們的 12 導聯心電圖提供動力的產品上，並交付到患者手中和醫療機構之外。

We just announced the publication of our first peer-reviewed paper, a foundational study, demonstrating the ability of our VECG platform to detect the presence of coronary artery blockages. The study comparing our 3D VECG approach to conventional standard 12-lead ECG appeared in JACC: Advances, a journal of the American College of Cardiology.

我們剛剛宣布發表第一篇同行評審論文，這是一項基礎研究，展示了我們的 VECG 平台檢測冠狀動脈阻塞是否存在的能力。這項將我們的 3D VECG 方法與傳統標準 12 導聯心電圖進行比較的研究發表在美國心髒病學會期刊《JACC：進展》上。

We also strengthened our Board with the appointment of three respected industry executives, Dr. Michael Jaff, Ken Nelson, and Mark Strome, bringing the number of HeartBeam Board members to eight. We also are excited to report that we recently welcomed to our team Debbie Castillo, PhD, as Vice President of Regulatory Affairs. Debbie is an experienced biomedical engineer and brings more than 12 years' experience in regulatory affairs and quality assurance for medical devices and diagnostics, both with the FDA and the private sector.

我們還任命了三位受人尊敬的行業高管 Michael Jaff 博士、Ken Nelson 和 Mark Strome 來加強我們的董事會，使 HeartBeam 董事會成員人數達到八人。我們還很高興地報告，我們最近歡迎 Debbie Castillo 博士加入我們的團隊，擔任監管事務副總裁。 Debbie 是一位經驗豐富的生物醫學工程師，在 FDA 和私營部門的醫療器械和診斷的監管事務和質量保證方面擁有超過 12 年的經驗。

Finally, we continued to solidify our intellectual property portfolio in the second quarter with a new patent issued by US Patent Office on automated cardiac detection, with HeartBeam AIMIGo. We believe this patent underscores our leadership effort in the ambulatory VECG space.

最後，我們在第二季度繼續鞏固我們的知識產權組合，美國專利局頒發了一項關於自動心臟檢測的新專利 HeartBeam AIMIGo。我們相信這項專利凸顯了我們在動態 VECG 領域的領先地位。

As previously reported, on May 3 of this year, we closed a secondary offering of $25 million, followed by a registered direct offering of $1.5 million for a total of $26.5 million. We worked with Public Ventures as our placement agent. They are a wholly owned subsidiary of MDB Capital Holdings. MDB and Public Ventures have proven to be tremendous strategic partners for HeartBeam.

正如之前報導的，今年 5 月 3 日，我們完成了 2500 萬美元的二次發行，隨後進行了 150 萬美元的註冊直接發行，總計 2650 萬美元。我們與 Public Ventures 合作作為我們的配售代理。他們是 MDB Capital Holdings 的全資子公司。事實證明，MDB 和 Public Ventures 是 HeartBeam 的重要戰略合作夥伴。

Public Ventures is a member-driven investor community with the mission of backing visionary public companies that have potential to become market leaders in their technology category. We continue to work with them as we execute on our strategic plan. And in fact, our involvement with PatentVest, also an MDB entity, is ongoing example how we plan to continue to use their services.

Public Ventures 是一個由成員驅動的投資者社區，其使命是支持有遠見的上市公司，這些公司有潛力成為其技術類別的市場領導者。在執行我們的戰略計劃時，我們將繼續與他們合作。事實上，我們與 PatentVest（也是 MDB 實體）的合作就是我們計劃如何繼續使用他們的服務的一個持續例子。

We believe that we are the leader in the mobile VECG space. And as we build on our global intellectual property portfolio, our work with PatentVest is a tangible example of our commitment. PatentVest is a unified technology, development, and patent law firm focused on creating IP leadership for development-stage technology companies like HeartBeam. And we expect they will support our goal of creating clear leadership in the area of ambulatory VECG cardiac detection.

我們相信我們是移動 VECG 領域的領導者。當我們建立我們的全球知識產權組合時，我們與 PatentVest 的合作就是我們承諾的具體例子。 PatentVest 是一家統一的技術、開發和專利律師事務所，專注於為 HeartBeam 等處於發展階段的技術公司創造知識產權領先地位。我們希望他們能夠支持我們在動態 VECG 心臟檢測領域建立明確領導地位的目標。

I would like now to turn the call over to our President, Dr. Rob Eno, to further discuss our strategic focus and provide product updates. Rob?

我現在想將電話轉給我們的總裁 Rob Eno 博士，進一步討論我們的戰略重點並提供產品更新。搶？

Thank you, Branislav, and thanks to everyone joining us today. We mentioned this last quarter, but I wanted to reiterate the key points. We've refined our strategic focus and are concentrating on our AIMIGo platform, bringing the performance of a 12-lead ECG into patients' hands. We see this platform, which will enable physicians to remotely monitor patients and immediately interpret any concerning cardiac events, as an important value creation path. In addition, we'll be undertaking clinical studies in 2023 and beyond to demonstrate the performance of the HeartBeam AIMIGo platform, which we believe is the most advanced ambulatory cardiac detection platform available.

謝謝你，布拉尼斯拉夫，也感謝今天加入我們的所有人。我們在上個季度提到過這一點，但我想重申一下要點。我們已經完善了我們的戰略重點，並專注於我們的 AIMIGo 平台，將 12 導聯心電圖的性能帶到患者手中。我們認為這個平台將使醫生能夠遠程監控患者並立即解釋任何有關心臟事件，這是一條重要的價值創造途徑。此外，我們將在 2023 年及以後開展臨床研究，以展示 HeartBeam AIMIGo 平台的性能，我們認為該平台是現有的最先進的動態心臟檢測平台。

As Branislav mentioned, the first peer-reviewed study related to our technology was recently published in JACC: Advances. This publication highlighted the capabilities of the technology to detect the presence of a coronary occlusion, the cause of heart attacks, with the same accuracy as a standard 12-lead ECG. It also demonstrated the advantages of putting a baseline recording for comparison in the analysis. This is something that is integral to the HeartBeam technology. But today, when 12-lead ECGs are analyzed, it's not common that a baseline ECG is used for comparison.

正如 Branislav 提到的，第一個與我們的技術相關的同行評審研究最近發表在《JACC：Advances》上。該出版物強調了該技術能夠檢測冠狀動脈閉塞（心髒病發作的原因）的存在，其準確性與標準 12 導聯心電圖相同。它還展示了在分析中進行比較的基線記錄的優點。這是 HeartBeam 技術不可或缺的一部分。但如今，在分析 12 導聯心電圖時，使用基線心電圖進行比較的情況並不常見。

The significance to this study is in demonstrating the potential to provide patients with an easy-to-use system to record a diagnostic quality ECG signal outside of a medical institution, which could improve heart attack detection, speed up access to care, and save lives. We'll be conducting additional studies focused on our 12-lead synthesis and on the performance of the system as a whole. And we believe these studies will be key to driving clinical and patient adoption.

這項研究的意義在於展示了為患者提供易於使用的系統的潛力，該系統可以在醫療機構之外記錄診斷質量的心電圖信號，這可以改善心髒病發作檢測、加快獲得護理的速度並挽救生命。我們將進行更多研究，重點關注 12 導聯合成以及整個系統的性能。我們相信這些研究將是推動臨床和患者採用的關鍵。

Our commercial launch activities will be for the second version of HeartBeam AIMIGo after we obtain FDA clearance for the algorithms that synthesize the 12-lead ECG. I'll describe this in more detail in just a minute. In this year, we're undertaking aggressive pre-commercial efforts to finding the initial market segments for HeartBeam AIMIGo and identifying potential business partners for HeartBeam AIMIGo and other technologies in our portfolio.

在我們獲得 FDA 批准合成 12 導聯心電圖的算法後，我們的商業發布活動將是 HeartBeam AIMIGo 的第二版。我將在一分鐘內更詳細地描述這一點。今年，我們正在積極開展預商業工作，尋找 HeartBeam AIMIGo 的初始細分市場，並為 HeartBeam AIMIGo 和我們產品組合中的其他技術尋找潛在的業務合作夥伴。

And finally, as Branislav mentioned, we'll continue to aggress -- the aggressive development of our intellectual property through our partnership with PatentVest.

最後，正如 Branislav 提到的，我們將繼續積極進取——通過與 PatentVest 的合作，積極開發我們的知識產權。

Turning to our product timelines and updates, we have two planned FDA 510(k) submissions. The first, which we call Version 1, is for the hardware. In other words, obtaining clearance as a 3-lead ECG collection device. Next Version 2, built upon version one and includes the algorithms that take the 3-lead VECG signals and synthesize a 12-lead ECG for physician review.

至於我們的產品時間表和更新，我們有兩項計劃向 FDA 510(k) 提交。第一個版本，我們稱之為版本 1，是針對硬件的。換句話說，獲得了作為 3 導聯心電圖採集設備的許可。下一版本 2 基於版本 1，包含採用 3 導聯 VECG 信號並合成 12 導聯 ECG 供醫生檢查的算法。

In May, we submitted our 510(k) application for Version 1. We've also started the process for Version 2. In June, we submitted a request for a pre-submission meeting to FDA. The pre-sub process is an excellent means to get feedback on key elements of the submission. That pre-sub meeting has been scheduled. It has been scheduled, and we look forward to working closely with FDA on both of these applications.

5 月，我們提交了第 1 版的 510(k) 申請。我們還啟動了第 2 版的流程。6 月，我們向 FDA 提交了召開預提交會議的請求。預分流程是獲得有關提交的關鍵要素的反饋的極好方法。預分會已經安排好了。它已經安排好了，我們期待在這兩項申請上與 FDA 密切合作。

The result of these two submissions, once cleared by FDA, will be a device carried by patients that can synthesize a 12-lead ECG for physician review. We'll focus then on a limited market release, which we estimate in the second half of 2024.

這兩項提交的結果一旦獲得 FDA 批准，將是一種由患者攜帶的設備，可以合成 12 導聯心電圖供醫生審查。然後我們將重點關注有限的市場發布，我們預計將在 2024 年下半年發布。

With the appointment of Debbie Castillo as Vice President of Regulatory Affairs, we've strengthened our team. Debbie is an experienced biomedical engineer with extensive knowledge of the FDA. In addition to her private sector experience, Debbie held various roles at FDA, including Acting Branch Chief, Senior Lead Reviewer, and Lead Scientific Reviewer.

隨著黛比·卡斯蒂略 (Debbie Castillo) 被任命為監管事務副總裁，我們加強了我們的團隊。 Debbie 是一位經驗豐富的生物醫學工程師，對 FDA 有著豐富的了解。除了在私營部門的經驗外，黛比還在 FDA 擔任過各種職務，包括代理分部主任、高級首席審評員和首席科學審評員。

And finally, in an effort to focus on the HeartBeam AIMIGo product, we withdrew our 510(k) application for HeartBeam AIMI. HeartBeam AIMI is focused on emergency room use, which is significantly smaller opportunity than the HeartBeam AIMIGo ambulatory ECG market. This decision will allow the company to focus on the product development, clinical, regulatory, and market preparation efforts for HeartBeam AIMIGo.

最後，為了專注於 HeartBeam AIMIGo 產品，我們撤回了 HeartBeam AIMI 的 510(k) 申請。 HeartBeam AIMI 專注於急診室使用，這比 HeartBeam AIMIGo 動態心電圖市場的機會要小得多。這一決定將使公司能夠專注於 HeartBeam AIMIGo 的產品開發、臨床、監管和市場準備工作。

I'll now turn the call over to Rick Brounstein, Chief Financial Officer, to discuss operational updates and financials.

我現在將把電話轉給首席財務官 Rick Brounstein，討論運營更新和財務情況。

Thank you, Rob. Turning to our financials, I'll now give a brief review of our financial results. So a full breakdown is available in our regulatory filings -- we just filed the 10-Q -- and in the press release that crossed the wire after the close of business today.

謝謝你，羅布。談到我們的財務狀況，我現在將簡要回顧一下我們的財務業績。因此，我們剛剛提交的 10-Q 監管文件以及今天收盤後發布的新聞稿中提供了完整的詳細信息。

General, administrative expenses for the second quarter of 2023 were $1.8 million compared to $1.8 million for the second quarter last year. Our overall G&A expense is flat. Spending is actually down in 2023 compared to 2022. In 2022, we were invested in the commercial team and due to our change in near-term focus in early 2023, we are not currently emphasizing commercial activities. Reduced sales and marketing expense was offset by increased non-cash stock-based compensation of about $0.4 million, resulting primarily from the issuance of employee stock options following the May 2023 financings.

2023 年第二季度的一般管理費用為 180 萬美元，而去年第二季度為 180 萬美元。我們的總體管理及行政費用持平。與 2022 年相比，2023 年的支出實際上有所下降。2022 年，我們對商業團隊進行了投資，由於我們在 2023 年初改變了近期重點，因此我們目前並不強調商業活動。銷售和營銷費用的減少被約 40 萬美元非現金股票薪酬的增加所抵消，這主要是由於 2023 年 5 月融資後發行了員工股票期權。

Research and development expenses for the second quarter of 2023 were $1.5 million compared to $1.7 million for the second quarter of 2022. Our focus on R&D differed in 2022 compared to this quarter. While both consisted largely of product development and regulatory costs, in 2022, our focus was on the development of our platform for our products, working with an outside development organization, LIVMOR and preparing for our first FDA submission.

2023 年第二季度的研發費用為 150 萬美元，而 2022 年第二季度的研發費用為 170 萬美元。與本季度相比，2022 年我們對研發的重點有所不同。雖然兩者主要包括產品開發和監管成本，但到 2022 年，我們的重點是為我們的產品開發平台，與外部開發組織 LIVMOR 合作，並為我們的首次 FDA 提交做準備。

This quarter, our US development team are employees hired from LIVMOR and the focus is fully on HeartBeam AIMIGo. We submitted Version 1 for FDA clearance in May. And at the same time, we continue to use our professional services agreement with Triple Ring.

本季度，我們的美國開發團隊是從 LIVMOR 聘請的員工，重點完全放在 HeartBeam AIMIGo 上。我們於 5 月份提交了版本 1 以獲得 FDA 批准。同時，我們繼續使用與 Triple Ring 的專業服務協議。

Triple Ring represents over 20% of our investment in R&D this quarter ended June 30, 2023, which we are investing in a device cost reduction program. As of June 30, 2023, we have a remaining commitment with them for this project of $0.8 million. In both periods, we also invested in research costs in support of future product pipeline coming from our patented VECG platform technology, which is the basis for our patent portfolio of 10 issued patents.

Triple Ring 占我們截至 2023 年 6 月 30 日的本季度研發投資的 20% 以上，我們正在投資於設備成本降低計劃。截至 2023 年 6 月 30 日，我們對該項目的剩余承諾為 80 萬美元。在這兩個時期，我們還投資了研究成本，以支持來自我們專利 VECG 平台技術的未來產品線，這是我們由 10 項已發布專利組成的專利組合的基礎。

With the current interest rates in short-term markets around 5%, we earned $158,000 in interest income in the second quarter of 2023. And this only for two months as we close the financing in early May. This compared to $10,000 in the second quarter of 2022.

目前短期市場利率約為 5%，我們在 2023 年第二季度獲得了 158,000 美元的利息收入。而這僅持續了兩個月，因為我們在 5 月初結束了融資。相比之下，2022 年第二季度的銷售額為 10,000 美元。

The net loss for the second quarter of 2023 was $3.2 million compared to a net loss of $3.5 million for the second quarter of 2022. We ended the second quarter of 2023 with $21.3 million in cash, cash equivalents and short-term investments compared to $3.6 million as of December 31.

2023 年第二季度的淨虧損為320 萬美元，而2022 年第二季度的淨虧損為350 萬美元。截至2023 年第二季度，我們的現金、現金等價物和短期投資為2130 萬美元，而2022年第二季度的淨虧損為3.6 美元截至 12 月 31 日，已達 100 萬元。

As mentioned in May, we closed common stock financings with net proceeds of approximately $24.3 million. The use of proceeds is planned to last into late 2024, timed to when we expect to have received clearance for our commercial product. We are confident we remain on track.

正如 5 月份提到的，我們完成了普通股融資，淨收益約為 2430 萬美元。所得款項的使用計劃持續到 2024 年末，屆時我們預計我們的商業產品將獲得批准。我們有信心繼續走上正軌。

With regard to our short-term investments, we take a risk-averse approach only investing in short term government-backed money market funds that we are holding to maturity. The approximate $4 million in short-term investments at June 30, 2023, represent such securities with a four- to six-month term. Also of importance in the recent financing is the fact that the 17.7 million shares offered did not include any warrants and our balance sheet, as a result, has a very simple and straightforward capital structure, approximately 26 million shares now outstanding.

關於我們的短期投資，我們採取規避風險的方法，僅投資於我們持有至到期的短期政府支持貨幣市場基金。截至 2023 年 6 月 30 日，短期投資約為 400 萬美元，此類證券的期限為四到六個月。在最近的融資中另一個重要的事實是，所發行的 1770 萬股不包括任何認股權證，因此我們的資產負債表具有非常簡單明了的資本結構，目前已發行約 2600 萬股。

Finally, I'd like to share the results of our recent annual meeting of shareholders. At the event, all proposals passed, which included adding 4 million authorized shares to the 2022 equity incentive plan, reflecting the overall dilute effect of the S-1 financing.

最後，我想分享一下我們最近召開的年度股東大會的結果。會上，所有提案均獲得通過，其中包括在2022年股權激勵計劃中增加400萬股授權股，體現了S-1融資的整體稀釋效應。

I will now turn the call back over to Branislav for his closing thoughts.

現在我將把電話轉回給布拉尼斯拉夫，聽聽他的結束語。

Thank you, Rick. We remain incredibly optimistic for the future of HeartBeam. I would like to summarize the recent efforts in the following categories: financial, strategic focus, and progress and validation. Following our $26.5 million capital raise, we have a strong cash position, providing a run rate to late 2024. We have adjusted our strategic focus to enable timely delivery of HeartBeam's breakthrough ambulatory VECG products, the company's key future value driver. And we are highly focused on executing on our product development, clinical and regulatory milestones.

謝謝你，瑞克。我們對 HeartBeam 的未來仍然非常樂觀。我想總結一下最近在以下幾方面所做的努力：財務、戰略重點、進展和驗證。在籌集2650 萬美元資金後，我們擁有強大的現金狀況，可以保證到2024 年底的運行速度。我們調整了戰略重點，以便能夠及時交付HeartBeam 突破性的動態VECG 產品，這是公司未來的關鍵價值驅動力。我們高度專注於執行我們的產品開發、臨床和監管里程碑。

The key element of this focus is the HeartBeam AIMIGo, a credit-card-size VECG device. In May, we submitted a 510(k) FDA application on Version 1 of our system. And in June, we have submitted a pre-sub request for Version 2 of the system. We are excited about the addition of Debbie Castillo, our new Vice President of Regulatory, as we work with the FDA on these submissions.

這一重點的關鍵要素是 HeartBeam AIMIGo，這是一款信用卡大小的 VECG 設備。 5 月份，我們針對系統版本 1 提交了 510(k) FDA 申請。 6 月份，我們提交了系統版本 2 的預訂閱請求。我們很高興新任監管副總裁 Debbie Castillo 的加入，我們正在與 FDA 合作處理這些申請。

Finally, we have several recent milestones that adds to the validation of the technology and the company. Our foundational clinical study was recently published in JACC: Advances. We added three strong members to the Board of Directors in addition to Debbie Castillo joining our management team. We had an additional patent granted on our automated cardio detection with HeartBeam AIMIGo system.

最後，我們最近有幾個里程碑，增加了技術和公司的驗證。我們的基礎臨床研究最近發表在《JACC：進展》上。除了黛比·卡斯蒂略加入我們的管理團隊之外，我們還為董事會增加了三名強有力的成員。我們還獲得了一項關於使用 HeartBeam AIMIGo 系統進行自動心臟檢測的專利。

I look forward to providing our shareholders with further updates in the near term. I thank you all for attending today. And now the HeartBeam team would like to answer your questions. Operator?

我期待在短期內向我們的股東提供進一步的更新。我感謝大家今天出席。現在 HeartBeam 團隊願意回答您的問題。操作員？

Thank you. We will now be conducting a question-and-answer session. (Operator Instructions)

謝謝。我們現在將進行問答環節。 （操作員說明）

Ben Haynor, Alliance Global Partners.

Ben Haynor，聯盟全球合作夥伴。

Hey, gentlemen. Thanks for taking the questions and congrats on the progress. First off, for me, just -- I know it's early days, but wondering if you've gotten any reaction to the JACC publication. And then maybe you could talk about -- obviously, the performance was solid. Any surprises, positive or negative, with regard to the device to open and/or kind of the human reading that came out in the study?

嘿，先生們。感謝您提出問題並祝賀取得的進展。首先，對我來說，我知道現在還為時過早，但想知道您對 JACC 的出版物是否有任何反應。然後也許你可以談論——顯然，表現很穩定。關於打開設備和/或研究中出現的人類讀數，有什麼驚喜，無論是積極的還是消極的？

Yes, Ben, thank you for your question. Yes, we were actually very fortunate that our publication caused an; editorial as well. This is a sign of a well-received publication, a publication that's very impactful. And indeed, all our associated medical team members as well as some of our potential business partners have noted this as a very significant event for our future acceptance.

是的，本，謝謝你的問題。是的，我們實際上非常幸運，我們的出版物引起了關注；社論也是如此。這是一本廣受歡迎的出版物的標誌，是一本非常有影響力的出版物。事實上，我們所有相關的醫療團隊成員以及我們的一些潛在業務合作夥伴都認為這是我們未來接受的一個非常重要的事件。

The study shows that we have a technology that puts the power of a 12-lead ECG, the standard of care, in patients' pockets, is always with the patient, and that is a huge value for those high-risk patients. So all in all, this is our first publication, extremely well received, and it's only the first one. We have a few of the follow-on publications in the works, and we will continue on that treadmill of publications showing the efficacy of our technology.

研究表明，我們擁有一項技術，可以將 12 導聯心電圖的功能（護理標準）放在患者的口袋中，並始終陪伴在患者身邊，這對於那些高危患者來說具有巨大的價值。總而言之，這是我們的第一篇出版物，非常受歡迎，而且只是第一篇。我們正在準備一些後續出版物，我們將繼續在出版物的跑步機上展示我們技術的功效。

And can you discuss -- well, first off, I guess, maybe any surprises there? And then any -- on the publications that you have in the works, can you share anything about how they might be similar or different to the current study -- the just published study?

你能討論一下——好吧，首先，我想，也許有什麼驚喜？然後，關於您正在發表的出版物，您能否分享一下它們與當前研究（剛剛發表的研究）有何相似或不同之處？

Yes, the future studies will take a bit different angle at our technology. And I cannot really discuss it in many details, but I can tell you that every one of these studies will be like a brick in the wall, so to speak. And at this point, we have a number of patents and a number of applications that we are working on. And again, that cadence coming out of HeartBeam will continue both on the publication front and the IP front.

是的，未來的研究將對我們的技術採取一些不同的角度。我無法真正詳細討論它，但我可以告訴你，可以說，這些研究中的每一項都像牆上的一塊磚。目前，我們擁有多項專利和一些正在開發的應用程序。同樣，HeartBeam 的這種節奏將在出版方面和知識產權方面繼續下去。

Branislav, maybe I'll just add briefly, if you don't mind. Completely agree with all that. I don't think -- and the question of surprises, I don't think there's any surprises. But I think one thing which comes out in the paper, which maybe is less obvious, is the importance of a baseline. So in both the VECG and the 12-lead, the results were a lot better when the baseline was used to compare with the reading.

Branislav，如果您不介意的話，也許我會簡單補充一下。完全同意這一切。我不認為——至於驚喜的問題，我不認為有任何驚喜。但我認為論文中提出的一件事可能不太明顯，那就是基線的重要性。因此，在 VECG 和 12 導聯中，當使用基線與讀數進行比較時，結果要好得多。

What's interesting about that is that's an integral part of our process. We have a baseline when the patient enrolls and we compare that by definition. And when you think about how 12-leads are analyzed today, they're often analyzed in isolation without a baseline. So the top line of the paper is that the VECG performed equal to a 12-lead in both comparison or one at a time, we're always going to have that baseline and sometimes the 12-leads are analyzed in a vacuum. So I think that's a kind of subtle but important point in the study.

有趣的是，這是我們流程中不可或缺的一部分。當患者入組時，我們有一個基線，並根據定義進行比較。當您思考當今如何分析 12 導聯時，您會發現它們通常是在沒有基線的情況下單獨分析的。因此，本文的第一句話是，在兩次比較或一次比較中，VECG 的表現與 12 導聯相同，我們始終會擁有該基線，有時會在真空中分析 12 導聯。所以我認為這是研究中微妙但重要的一點。

Good point. Thank you, Rob.

好點子。謝謝你，羅布。

And then I guess maybe a couple maybe for Rick. On the G&A, it sounded like there's maybe $400,000 that was kind of non-recurring in the quarter. Is that a fair assessment? Or -- what should we kind of think about going forward on the G&A line?

然後我想也許是給里克的幾個。在 G&A 方面，聽起來本季度可能有 40 萬美元是非經常性的。這是一個公平的評價嗎？或者——我們應該如何思考 G&A 業務的未來發展？

Okay. I would say re-occurring but non-cash, right? And indeed, as we've now up to 26, 27 million shares, you'll see, I think, a growing non-cash stock expense. But if you have -- if you go back to 2022, yes, there was $400,000, I would say, of non-recurring SG&A expense that we won't see again for probably until we start getting commercialization -- late 2024 and or so.

好的。我會說重複發生但非現金，對吧？事實上，由於我們現在擁有 26、2700 萬股股票，我認為您會看到非現金股票支出不斷增長。但如果你回到 2022 年，是的，我想說的是，有 40 萬美元的非經常性 SG&A 費用，我們可能不會再看到，直到我們開始商業化——2024 年末左右。

Okay. So there wasn't any -- I may have misheard it. I thought you said $400,000 related to stock-based comp related to the financing.

好的。所以沒有——我可能聽錯了。我以為你說的是​​與融資相關的基於股票的補償 400,000 美元。

No. As a result of the financing, we granted more stock options to people who now had a much lower share in the company.

不會。作為融資的結果，我們向那些現在在公司中所持股份低得多的人授予了更多的股票期權。

Okay. So there wasn't any kind of one-time-ish G&.A expenses associated with the deal?

好的。那麼這筆交易沒有任何一次性的一般管理費用嗎？

No, not in the quarter, no. Anything that was associated with the financing is all just -- ran through stockholders' equity. It didn't go to the P&L.

不，不是在本季度，不。與融資相關的任何事情都只是通過股東權益進行。它沒有進入損益表。

Okay, got it. And then on the cost reduction program with Triple Ring, how's that progressing? Any more color there that you can provide? And that's it for me. Thanks for taking the questions, gentlemen.

好，知道了。那麼 Triple Ring 的成本削減計劃進展如何？您還可以提供更多顏色嗎？對我來說就是這樣。感謝您提出問題，先生們。

Branislav, do you want to handle that one or -- ?

布拉尼斯拉夫，你想處理那個人還是——？

Go ahead, Rick.

來吧，瑞克。

Yeah. Okay. So then it's probably going to be most of the year -- we're doing things to take a basically a prototype-level device that costs over $1,000 and reducing something that -- when we start to get in volumes -- will be in a couple of hundred dollars, right? So there's various pieces that are going on. It's ongoing. We're looking at the [PCV board]. We're looking at some moles that we'll buy and some other things. But it's a dedicated approach now that we look forward to commercialization to be able to produce a -- if you would, the credit card at a reasonable price.

是的。好的。因此，可能會在今年的大部分時間裡 - 我們正在做一些事情，以採用基本上是原型級設備，成本超過 1,000 美元，並減少一些東西 - 當我們開始批量生產時 - 將在幾百塊錢吧？所以有各種各樣的事情正在發生。它正在進行中。我們正在研究 [PCV 板]。我們正在考慮購買一些鼴鼠和其他一些東西。但現在這是一種專門的方法，我們期待商業化能夠以合理的價格生產信用卡——如果你願意的話。

Okay, great. Thanks for the color and thanks for taking the questions.

好的，太好了。感謝您的顏色並感謝您提出問題。

Thank you, Ben.

謝謝你，本。

(Operator Instructions)

（操作員說明）

At this time, we will now take questions from our webcast.

現在，我們將從網絡廣播中回答問題。

The first question asks, you mentioned that you have withdrawn AIMI. Can you tell me more about that decision?

第一個問題，你提到你已經撤回了AIMI。你能告訴我更多關於這個決定的信息嗎？

Let me handle that question. Our strategic focus is on ambulatory devices. AIMI application, while valuable, had a very different market and distribution strategy. As we have seen the opportunity with our AIMIGo ambulatory VECG device and as we make progress and get closer to its market availability, it is important for us to totally focus and take advantage of that huge opportunity.

讓我來解答這個問題。我們的戰略重點是移動設備。 AIMI 應用程序雖然很有價值，但其市場和分銷策略卻截然不同。由於我們看到了 AIMIGo 動態 VECG 設備的機會，並且隨著我們取得進展並接近其上市，對我們來說，完全專注並利用這一巨大機會非常重要。

This market is much larger market, probably 20x or more, than that of the emergency room market. The great need and the key opportunity is to bring the 12-lead VECG to the patients outside of the healthcare institution. Actually, the algorithm that we developed for AIMI, which basically takes the 12-lead ECG and convert it to the VECG and runs analysis on the VECG, is a plan to be included in future generations of AIMIGo as well. So in that sense, we expect to see this technology appear in AIMIGo down the line.

這個市場比急診室市場大得多，可能是急診室市場的 20 倍或更多。巨大的需求和關鍵機遇是將 12 導聯 VECG 帶給醫療機構之外的患者。實際上，我們為 AIMI 開發的算法，基本上採用 12 導聯心電圖並將其轉換為 VECG，並對 VECG 進行分析，這也是包含在未來幾代 AIMIGo 中的計劃。所以從這個意義上說，我們期望看到這項技術最終出現在 AIMIGo 中。

Our second and final webcast question is you are providing only high-level details on the timings of the future FDA submissions and clearances rather than a detailed timeline. You say you're expecting a limited market release in the second half of 2024. Can you provide more context?

我們的第二個也是最後一個網絡廣播問題是，您僅提供有關未來 FDA 提交和批准的時間的高級細節，而不是詳細的時間表。您說預計 2024 年下半年將有有限的市場發布。您能提供更多背景信息嗎？

Yeah, Rob, would you please go ahead?

是的，羅布，請繼續吧？

Yes, the one thing that's clear about regulatory filings and the whole regulatory process is the timing's uncertain. And to a large extent, it's outside of our control when dealing with regulatory agencies. So we're going to continue to update on our progress toward our milestones, things that we've achieved as we did today, talking both about the Version 1 and Version 2 products.

是的，有關監管備案和整個監管流程的一件事是明確的，那就是時間的不確定性。在很大程度上，在與監管機構打交道時，這超出了我們的控制範圍。因此，我們將繼續更新里程碑的進展情況，以及我們今天所取得的成就，同時討論版本 1 和版本 2 產品。

But rather than give estimates on the timing of some of these upcoming intermediate steps, we decided to focus on the key milestone, which is this limited market release of AIMIGo, which happens after the clearance of Version 2 in the second half of 2024. And we'll continue to do that going forward is focus on that ultimate date of market release, but also keep providing updates on the progress and the milestones that we've achieved.

但我們並沒有對即將實施的一些中間步驟的時間進行估計，而是決定將重點放在關鍵的里程碑上，即 AIMIGo 的有限市場發布，它發生在 2024 年下半年版本 2 批准之後。我們將繼續這樣做，重點關注最終的市場發布日期，但也會繼續提供有關進展和我們已實現的里程碑的更新。

I would now like to turn the floor back over to Dr. Vajdic for his closing comments.

我現在想請 Vajdic 博士發表結束語。

Thank you, operator. I would like to thank each of you for joining our earnings conference call today and look forward to continuing to update you on our ongoing progress and growth. If you were unable to answer any of your questions, please reach out to IR firm, MZ Group, who will be more than happy to assist. Thank you again.

謝謝你，接線員。我要感謝大家今天參加我們的收益電話會議，並期待繼續向您通報我們持續取得的進展和增長的最新情況。如果您無法回答任何問題，請聯繫 IR 公司 MZ Group，他們將非常樂意為您提供幫助。再次感謝你。

This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation.

今天的會議到此結束。此時您可以斷開線路。感謝您的參與。