Heartbeam Inc (BEAT) 2024 Q2 法說會逐字稿

Greetings, and welcome to the HeartBeam second-quarter 2024 earnings conference call. (Operator Instructions) As a reminder, this conference is being recorded.

您好，歡迎參加 HeartBeam 2024 年第二季財報電話會議。（操作員指示）謹此提醒，本次會議正在錄製中。

Before we begin the formal presentation, I would like to remind everyone that statements made on the call and webcast may include predictions, estimates or other information that might be considered forward-looking. While these forward-looking statements represent our current judgment on what the future holds, they are subject to risks and uncertainties that could cause actual results to differ materially. You are cautioned not to place undue reliance on these forward-looking statements, which reflect our opinions only as of the date of this presentation.

在我們開始正式演示之前，我想提醒大家，電話會議和網路廣播中的陳述可能包括預測、估計或其他可能被視為前瞻性的資訊。雖然這些前瞻性陳述代表了我們目前對未來的判斷，但它們受到風險和不確定性的影響，可能導致實際結果出現重大差異。請您注意不要過度依賴這些前瞻性陳述，這些陳述僅反映我們截至本簡報發布之日的觀點。

Please keep in mind that we are not obligating ourselves to revise or publicly release the results of any revision to these forward-looking statements in light of new information or future events. Throughout today's discussion, we will attempt to present some important facts relating to our business that may affect our predictions. You should also review our most recent Form 10-K and Form 10-Q for a more complete discussion of these factors and other risks, particularly under the heading Risk Factors. A press release detailing these results crossed the wire this afternoon and is available in the Investor Relations section of our website, heartbeam.com.

請記住，我們沒有義務根據新資訊或未來事件修改或公開發布這些前瞻性陳述的任何修改結果。在今天的討論中，我們將嘗試提出一些與我們的業務相關、可能影響我們的預測的重要事實。您還應該查看我們最新的表格 10-K 和表格 10-Q，以更完整地討論這些因素和其他風險，特別是在風險因素標題下。今天下午詳細介紹了這些結果的新聞稿已透過我們網站 heartbeam.com 的投資者關係部分發布。

Your host today Branislav Vajdic, Chief Executive Officer and Founder; Rob Eno, President; and Ravi Malhotra, Senior Director and Corporate Controller, will present results of operations for the second quarter ended June 30, 2024. At this time, I will turn the call over to HeartBeam's Chief Executive Officer, Branislav Vajdic. Please go ahead.

今天的主持人是執行長兼創辦人 Branislav Vajdic；羅布·伊諾，總裁；資深董事兼公司財務總監 Ravi Malhotra 將介紹截至 2024 年 6 月 30 日的第二季營運表現。此時，我會將電話轉給 HeartBeam 的執行長 Branislav Vajdic。請繼續。

Thank you, operator. I'd like to start by reminding you of the vision for HeartBeam's unique technology. HeartBeam is developing AIMIGo, a credit card sized, cable-free cardiac monitoring device that will be capable of producing a 12-Lead ECG by leveraging the company's core vector technology, which captures 360-degree signals of the heart's electrical activity.

謝謝你，接線生。首先我想提醒您 HeartBeam 獨特技術的願景。HeartBeam 正在開發 AIMIGo，這是一種信用卡大小的無電纜心臟監測設備，能夠利用該公司的核心向量技術產生 12 導聯心電圖，捕捉心臟電活動的 360 度訊號。

AIMIGo has the potential to create new applications for patients and physicians, specifically heart attack detection upon symptom onset, identification of complex arrhythmias that existing variables cannot detect, and the opportunity to monitor chronic conditions such as heart failure and to be used prevention and screening through the use of AI.

AIMIGo 有潛力為患者和醫生創造新的應用，特別是症狀出現時的心臟病發作檢測、現有變量無法檢測到的複雜心律失常的識別，以及監測心臟衰竭等慢性疾病的機會，並通過以下方式進行預防和篩檢：人工智慧的使用。

In addition, HeartBeam's has broad IP protection on its core technology on novel form factors. These include: implementing our vector technology on extended wear cardiac monitor or a mobile cardiac telemetry device, bringing on-demand 12-lead ECG technology to establish market with reimbursement, and novel watch form factor that will combine a continuous monitor and a 12-lead on-demand wrist worn device.

此外，HeartBeam 的新穎外形核心技術擁有廣泛的智慧財產權保護。其中包括：在長期佩戴心臟監視器或移動心臟遙測設備上實施我們的向量技術，引入按需12 導聯心電圖技術來建立可報銷的市場，以及將連續監視器和12 導聯結合在一起的新型手錶外形按需手腕佩戴裝置。

As we have mentioned previously, 12-lead ECG is one of the most commonly performed diagnostic tests and is the standard of care in hospitals and clinics. There are many ECG technologies that can be used by patients or consumers at home. You can see a couple of them on this slide.

正如我們之前提到的，12 導程心電圖是最常用的診斷測試之一，也是醫院和診所的護理標準。有許多心電圖技術可供患者或消費者在家中使用。您可以在這張投影片上看到其中的幾個。

They are not 12-lead ECGs. Instead, there are 1-lead, 3-lead or 6-lead devices. This is adequate, perhaps for detecting many arrhythmias, but is not sufficient to detect heart attack or complex arrhythmias. In contrast, HeartBeam AIMIGo is an easy-to-use cable-free credit card size system that synthesizes the 12-lead ECG.

它們不是 12 導程心電圖。相反，有 1 導聯、3 導聯或 6 導聯設備。這或許足以檢測許多心律不整，但不足以檢測心臟病發作或複雜的心律不整。相較之下，HeartBeam AIMIGo 是一種易於使用的無線信用卡大小的系統，可合成 12 導程心電圖。

The key aim of the HeartBeam technology is to quickly and accurately help clinicians identify the full range of cardiac conditions, including the heart attack outside of a medical institution. Today, patients experiencing heart attacks delay seeking care on an average of three to four hours, which can lead to death and to serious and costly complications such as heart failure.

HeartBeam 技術的主要目標是快速且準確地幫助臨床醫生識別各種心臟疾病，包括醫療機構外的心臟病發作。如今，心臟病發作的患者平均會延遲三到四個小時就醫，這可能導致死亡以及心臟衰竭等嚴重且代價高昂的併發症。

Next, we would like to share a video that demonstrates how easy it will be for patients to use AIMIGo in the real world. Please note that those of you who are dialed into this call by phone will not hear the audio. So you will be experiencing approximately 50 seconds of silence. (video playing) And now I will turn the call over to HeartBeam President, Rob Eno.

接下來，我們想分享一段視頻，展示患者在現實世界中使用 AIMIGo 是多麼容易。請注意，透過電話撥入此呼叫的人將聽不到音訊。因此，您將經歷大約 50 秒的沉默。（影片播放）現在我將把電話轉給 HeartBeam 總裁 Rob Eno。

Thank you, Branislav. HeartBeam technology has the potential to transform a large number of markets. Initially, we'll focus on the detection of arrhythmias with AIMIGo, where its 12-lead capabilities and advanced AI could outperform existing ambulatory cardiac ECGs. Expansion into heart attack detection where 12-lead is needed, accesses the 20 million patients with coronary artery disease and is a $12 billion opportunity.

謝謝你，布拉尼斯拉夫。HeartBeam 技術具有改變大量市場的潛力。最初，我們將重點放在使用 AIMIGo 檢測心律不整，其 12 導聯功能和先進的人工智慧可能優於現有的動態心臟心電圖。擴展到需要 12 導聯的心臟病發作檢測領域，涵蓋 2000 萬冠狀動脈疾病患者，這是一個價值 120 億美元的機會。

Incorporating our proprietary technology into the patch market, access is a market with established reimbursement that's estimated to grow to $4.8 billion in 2030. Over time, HeartBeam's technology plus AI can move into monitoring for the management of chronic conditions such as heart failure and chronic kidney disease where 12-lead ECG, coupled with deep learning algorithms could provide valuable insights.

將我們的專有技術融入補丁市場後，Access 市場建立了報銷機制，預計到 2030 年將成長到 48 億美元。隨著時間的推移，HeartBeam 的技術加上人工智慧可以進入心臟衰竭和慢性腎臟病等慢性疾病管理的監測領域，其中 12 導程心電圖與深度學習演算法可以提供有價值的見解。

And ultimately, a simple, easy-to-use 12-lead device with predictive algorithms could be a prevention and screening tool for an even larger set of patients. More than 120 million Americans have some form of heart disease.

最終，具有預測演算法的簡單、易於使用的 12 導聯設備可以成為更多患者的預防和篩檢工具。超過 1.2 億美國人患有某種形式的心臟病。

We're incredibly excited about the long-term potential of the technology. And in addition, we're making steady progress on our near-term milestones.

我們對該技術的長期潛力感到非常興奮。此外，我們在近期里程碑方面正在穩步取得進展。

Our initial clearance for the AIMIGo system will be a major milestone for the company and is important for several reasons. To start, we anticipate this will be the first patient-held device leveraging vector technology to be cleared by the FDA. Also, this clearance will be the basis for further FDA submissions for HeartBeam, so it's the cornerstone of our efforts.

我們對 AIMIGo 系統的初步批准將是公司的一個重要里程碑，其重要性有幾個原因。首先，我們預計這將是 FDA 批准的第一個利用向量技術的患者手持設備。此外，這項許可將成為進一步向 FDA 提交 HeartBeam 申請的基礎，因此它是我們努力的基石。

The vector approaches an excellent platform for AI algorithms. In the longer run, we believe that applying AI algorithms on top of the rich 360-degree signals could result in unsurpassed predictive and diagnostic capabilities.

該向量為人工智慧演算法提供了一個優秀的平台。從長遠來看，我們相信在豐富的 360 度訊號之上應用人工智慧演算法可能會帶來無與倫比的預測和診斷能力。

Our 510(k) submission for the AIMIGo system is an active review by the agency. We're in the substantial review phase of answering questions posed by the FDA on this submission. We have successfully resolved the vast majority of the questions the FDA has asked. Since our last update, the FDA requested additional information, which we're in the process of providing.

我們針對 AIMIGo 系統提交的 510(k) 申請是該機構的積極審查。我們正處於回答 FDA 對此提交的問題的實質審查階段。我們已經成功解決了 FDA 提出的絕大多數問題。自我們上次更新以來，FDA 要求提供更多信息，我們正在提供這些信息。

The company is working with the FDA to address the small number of remaining questions. We continue to be engaged in productive discussions with the agency, and we believe that we're progressing toward clearance. The company continues to plan for a limited launch of AIMIGo by the end of 2024, which will provide us with valuable feedback on the user experience and functionality of the system in a real-world setting.

該公司正在與 FDA 合作解決少數剩餘問題。我們將繼續與該機構進行富有成效的討論，我們相信我們正在朝著批准的方向取得進展。該公司繼續計劃在 2024 年底之前有限推出 AIMIGo，這將為我們提供有關係統在現實環境中的用戶體驗和功能的寶貴反饋。

We continue to make significant progress on other fronts. We're preparing materials for our second FDA 510(k) submission on the algorithms that convert the 360-degree signals captured by the AIMIGo system into a synthesized 12-lead ECG.

我們繼續在其他方面取得重大進展。我們正在為第二次 FDA 510(k) 提交準備資料，該資料涉及將 AIMIGo 系統捕獲的 360 度訊號轉換為合成 12 導聯心電圖的演算法。

On June 20, we completed enrollment in VALID-ECG, the 198-patient trial comparing simultaneously placed AIMIGo and 12-lead ECGs. We completed enrollment in just three months, which is extremely fast for a study of this size. The data are currently being analyzed.

6 月 20 日，我們完成了 VALID-ECG 的入組，該試驗有 198 名患者參與，比較同時放置的 AIMIGo 和 12 導程心電圖。我們只花了三個月就完成了註冊，對於這種規模的研究來說，這是非常快的。目前正在分析數據。

VALID-ECG will be the basis of the 12-lead synthesis submission, and we anticipate filing this submission soon after we receive clearance for the AIMIGo system. Prior to enrolling VALID-ECG, we conducted an 80-patient pilot study utilizing the same protocol. That study has been accepted for presentation at the American Heart Association meeting in November.

VALID-ECG 將作為 12 導程綜合提交的基礎，我們預計在收到 AIMIGo 系統的許可後不久就會提交此提交。在招募 VALID-ECG 之前，我們利用相同的方案進行了 80 名患者的試驗研究。該研究已被接受在 11 月的美國心臟協會會議上發表。

We've also made great progress on our AI program. In Q2, there were scientific presentations at two top electrophysiology conferences that demonstrate the ability of HeartBeam's AI to detect atrial flutter, an important arrhythmia that's difficult to identify with a single read ECG. These studies demonstrated that HeartBeam's AI algorithm applied to vector cardiography or VCG, greatly outperformed AI on a single lead ECG.

我們的人工智慧專案也取得了很大進展。第二季度，在兩個頂級電生理學會議上進行了科學演講，展示了HeartBeam 的AI 檢測心房撲動的能力，心房撲動是一種重要的心律失常，很難通過單次讀取的心電圖來識別。這些研究表明，HeartBeam 的人工智慧演算法應用於向量心電圖或 VCG，在單導聯心電圖上的表現大大優於人工智慧。

Also, HeartBeam's AI algorithm applied to VCG outperformed both an expert panel of electrophysiologists reviewing single lead ECGs and impressively an expert panel reviewing 12-lead ECGs with a statistically significant improvement in the detection of atrial flutter cases.

此外，應用於VCG 的HeartBeam 人工智慧演算法的性能優於審查單導聯心電圖的電生理學家專家小組和審查12 導聯心電圖的專家小組，在心房撲動病例的檢測方面具有統計學上的顯著改進。

The development of the AI algorithms has progressed. We're getting close to freezing our multiple AI models powering HeartBeam AI that once cleared by the FDA will provide a comprehensive set of diagnostic suggestions. This powerful AI-based tool, combined with the 12-lead ECG provided to the cardiologist will make, we believe, an offering beyond anything that's available in patient obtained ECGs, both in terms of diagnosis covered and diagnostic accuracy.

人工智慧演算法的開發取得了進展。我們即將凍結為 HeartBeam AI 提供支援的多個 AI 模型，一旦獲得 FDA 批准，將提供一套全面的診斷建議。我們相信，這種基於人工智慧的強大工具與提供給心臟病專家的 12 導程心電圖相結合，無論是在診斷覆蓋範圍還是診斷準確性方面，都將提供超越患者獲得的心電圖的任何可用產品。

We've gained significant experience with AIMIGo and believe that technology is derisked. We've conducted multiple clinical studies enrolling more than 500 patients. These include the VALID-ECG study described previously, as well as the 80-patient pilot study.

我們在 AIMIGo 方面獲得了豐富的經驗，並相信該技術沒有風險。我們進行了多項臨床研究，招募了 500 多名患者。其中包括前面描述的 VALID-ECG 研究，以及 80 名患者的試驗研究。

We've previously discussed the study published last year in JAK Advances, demonstrating equivalent to 12-lead ECG in detecting coronary occlusions and also showing a significant improvement in accuracy when comparing the HeartBeam approach with a baseline reporting to a single 12-lead ECG, which is often the case in an emergency room.

我們先前討論過去年在JAK Advances 上發表的研究，該研究證明在檢測冠狀動脈閉塞方面與12 導聯心電圖相當，並且在將HeartBeam 方法與單個12 導聯心電圖的基線報告進行比較時，還顯示出準確性的顯著提高。

We've completed another study on the performance of our ECG technology together with symptoms and patient history compared to the standard of care. These results also will be presented at the American Heart Association meeting in November, along with the results of the 12-lead synthesis pilot study mentioned area. So a total of two presentations at this strategic scientific conference later this year.

我們已經完成了另一項研究，內容涉及心電圖技術的表現以及與護理標準相比的症狀和患者病史。這些結果也將與上述領域的 12 導聯合成試驗研究的結果一起在 11 月的美國心臟協會會議上公佈。因此，今年稍後的戰略科學會議上總共有兩場演講。

Beyond the clinical protocols, we have usability experience in a real-world setting with over 7,500 recordings for more than 250 patients, providing us with strong confidence in the systems functionality. I'd now like to hand the call over to our Corporate Controller, Ravi Malhotra to present selected financials.

除了臨床方案之外，我們還擁有實際環境中的可用性經驗，為 250 多名患者記錄了 7,500 多個記錄，這使我們對系統功能充滿信心。現在我想將電話轉交給我們的公司財務總監拉維·馬爾霍特拉 (Ravi Malhotra)，以介紹選定的財務數據。

Thank you, Rob. I'll now give a brief overview of our financial results. A full breakdown is available in our regulatory filings and in the press release that crossed the wire after market close today.

謝謝你，羅布。現在我將簡要概述我們的財務表現。我們的監管文件和今天收盤後發布的新聞稿中提供了完整的詳細資訊。

General and administrative expenses for the second quarter of 2024 were $2.2 million compared to $1.8 million for the second quarter of 2023. The increase in G&A expense is primarily related to noncash stock-based companion expense associated with additional awards, which the company granted since June 30, 2023, and also higher consulting costs, primarily offset by lower legal costs in the current period.

2024 年第二季的一般及管理費用為 220 萬美元，而 2023 年第二季為 180 萬美元。一般及行政費用的增加主要與與本公司自 2023 年 6 月 30 日以來授予的額外獎勵相關的非現金股票伴隨費用以及較高的諮詢成本有關，但主要被本期較低的法律成本所抵銷。

Research and development expenses for the second quarter of 2024 were $2.8 million compared to $1.5 million for the second quarter of 2023. The increase in R&D expense is primarily related to an increase in headcount, increase of clinical and AI-related costs and increase in consulting spend, which is offset by a decrease in product development consulting cost spending, primarily driven by completion of milestone projects in the prior period.

2024 年第二季的研發費用為 280 萬美元，而 2023 年第二季的研發費用為 150 萬美元。研發費用的增加主要與人員數量的增加、臨床和人工智慧相關成本的增加以及諮詢支出的增加有關，但產品開發諮詢成本支出的減少抵消了這一增加，這主要是由於完成了里程碑項目所致。

Net loss for the second quarter of 2024 was $5 million compared to a net loss of $3.2 million for the second quarter of 2023. We ended the quarter with approximately $9.2 million in cash and cash equivalents as we close to carefully manage spending. I will now turn the call back to Branislav for closing thoughts.

2024 年第二季的淨虧損為 500 萬美元，而 2023 年第二季的淨虧損為 320 萬美元。隨著我們接近謹慎管理支出，本季末我們擁有約 920 萬美元的現金和現金等價物。我現在將把電話轉回給布拉尼斯拉夫，以供結束思考。

In conclusion, we remain extremely excited about the potential at HeartBeam and progress. AIMIGo will be smallest, easiest to use, and first cable-free 12-lead ECG device enabled by HeartBeam's unique IP-protected vector technology.

總之，我們對 HeartBeam 的潛力和進展仍然感到非常興奮。AIMIGo 將是體積最小、最容易使用的首款無線 12 導程 ECG 設備，採用 HeartBeam 獨特的 IP 保護向量技術。

It has the potential to disrupt numerous large markets and clinical applications, starting with the ability to detect complex arrhythmias, expanding to heart attack detection and then to monitor it for complex diseases such as heart failure. Ultimately, we believe that the combination of the small form factor, powerful 360-degree ECG technology and advanced AI algorithms will have significant applications in prediction and screening of cardiac conditions.

它有可能顛覆眾多大型市場和臨床應用，從檢測複雜心律不整的能力開始，擴展到心臟病發作檢測，然後監測心臟衰竭等複雜疾病。最終，我們相信，小巧的外形、強大的 360 度心電圖技術和先進的人工智慧演算法的結合將在心臟疾病的預測和篩檢方面具有重要的應用。

We continue to make progress towards key regulatory and clinical milestones. Our initial 510(k) application for the AIMIGo system is under active FDA review with productive discussions underway. The company is working with the FDA to address the small number of remaining questions. We believe that we are progressing toward clearance.

我們繼續在關鍵的監管和臨床里程碑方面取得進展。我們針對 AIMIGo 系統的初始 510(k) 申請正在接受 FDA 的積極審查，並正在進行富有成效的討論。該公司正在與 FDA 合作解決少數剩餘問題。我們相信我們正在朝著清關邁進。

We anticipate a limited launch by the end of the year, focused on the AIMIGo system, which will provide the company with valuable feedback on the user experience and functionality of the system in a real-world setting. We are preparing materials for our second FDA submission that will be a 510(k) submission on the algorithms that convert the vector signal captured by our AIMIGo system into a synthesized VALID-ECG.

我們預計將在今年年底前推出有限的產品，重點是 AIMIGo 系統，這將為公司提供有關係統在現實環境中的用戶體驗和功能的寶貴反饋。我們正在為第二次 FDA 提交準備資料，該提交將是關於將我們的 AIMIGo 系統捕獲的向量訊號轉換為合成的有效心電圖的演算法的 510(k) 提交。

We have completed enrollment in the VALID-ECG study and anticipate submitting the 510(k) application soon after the clearance of AIMIGo system. We presented positive new data on our deep learning algorithm HeartBeam AI, demonstrating excellent performance in detecting atrial flutter, even outperforming a panel of three electrophysiologists reviewing 12-lead ECG. We are working to freeze the algorithms in preparation for a clinical study to demonstrate the performance of our AI algorithms.

我們已經完成了 VALID-ECG 研究的註冊，並預計在 AIMIGo 系統獲得批准後不久提交 510(k) 申請。我們提供了關於深度學習演算法 HeartBeam AI 的積極新數據，展示了在檢測心房撲動方面的出色性能，甚至超過了由三名電生理學家組成的小組審查 12 導聯心電圖。我們正在努力凍結演算法，為臨床研究做準備，以展示我們的人工智慧演算法的性能。

We ended the quarter with approximately $9.2 million in cash and cash equivalents, enabling the company to execute on upcoming clinical and regulatory milestones. I look forward to providing our shareholders with further updates in the near term. I thank you all for attending. And now, the HeartBeam team would like to answer your questions. Operator?

本季結束時，我們擁有約 920 萬美元的現金和現金等價物，使公司能夠執行即將到來的臨床和監管里程碑。我期待在短期內向我們的股東提供進一步的更新。我感謝大家的出席。現在，HeartBeam 團隊願意回答您的問題。操作員？

(Operator Instructions)

（操作員說明）

Our first webcast question. Can you just provide some more detail on the timing of the FDA clearance?

我們的第一個網路廣播問題。您能否提供有關 FDA 批准時間的更多細節？

Yes. Let me comment on that. We are under active review with the FDA, and we really can't give any more details than what we said in the call and in our earnings materials. To reiterate, we have successfully resolved the vast majority of the questions the FDA has asked. And last quarter, FDA requested additional information, which we are now in the process of providing.

是的。讓我對此發表評論。我們正在接受 FDA 的積極審查，除了我們在電話會議和盈利材料中所說的內容外，我們確實無法提供更多細節。重申一下，我們已經成功解決了 FDA 提出的絕大多數問題。上個季度，FDA 要求提供更多信息，我們現在正在提供這些資訊。

We are engaged in productive discussions with the FDA and believe that we are progressing towards clearance. We still anticipate a limited launch before end of the year. Again, this will provide us with valuable feedback on the user experience as well as functionality of the system in the real-world setting, extremely valuable to us.

我們正在與 FDA 進行富有成效的討論，並相信我們正在朝著批准的方向取得進展。我們仍然預計在今年年底前推出有限的產品。同樣，這將為我們提供有關用戶體驗以及系統在現實環境中的功能的寶貴回饋，這對我們來說非常有價值。

Thank you. Let's see. Our next question. You showed market sizes for HeartBeam's technology. Can you explain just where you're going with those?

謝謝。讓我們來看看。我們的下一個問題。您展示了 HeartBeam 技術的市場規模。你能解釋一下你要用這些東西去哪裡嗎？

Rob?

搶？

Sure. Yes, thanks. That was a new framework. So I can elaborate. The main point there really is to show that HeartBeam's technology, which, again, is a credit card-sized cable-free device that produces a 12-lead ECG can have a wide range of applications. So it's a progression. We're starting with what we call symptom-driven diagnosis, which is arrhythmia, then moving on to ischemia and heart attack detection.

當然。是的，謝謝。那是一個新的框架。所以我可以詳細說明。這裡的要點實際上是要表明 HeartBeam 的技術（同樣是信用卡大小的無電纜設備，可產生 12 導聯心電圖）可以具有廣泛的應用。所以這是一個進步。我們從所謂的症狀驅動診斷開始，即心律不整，然後轉向缺血和心臟病發作檢測。

We also have the ability to incorporate the technology into an extended wear patch monitor that can provide for on-demand 12-week capabilities. And with both that form factor and with AIMIGo itself, we think that could move us into monitoring for patients with chronic conditions like heart failure and chronic kidney disease.

我們還能夠將該技術整合到可按需提供 12 週功能的長戴貼片監視器。憑藉這種外形尺寸和 AIMIGo 本身，我們認為這可以促使我們監測患有心臟衰竭和慢性腎臟病等慢性疾病的患者。

And then ultimately, beyond that, we think that patients taking frequent 12-lead ECGs over time, especially when combined with AI algorithms can enable prevention and screening for a very large number of patients. So it really shows the progression with sample segments from symptom-driven diagnosis through monitoring into prevention and screening.

最終，除此之外，我們認為患者隨著時間的推移頻繁進行 12 導程心電圖檢查，尤其是與人工智慧演算法相結合，可以為大量患者提供預防和篩檢。因此，它確實顯示了從症狀驅動的診斷到監測再到預防和篩檢的樣本片段的進展。

Thanks. Our next question. You mentioned that the VALID-ECG study has completed enrollment. What are the results of the study?

謝謝。我們的下一個問題。您提到 VALID-ECG 研究已完成入組。研究結果是什麼？

Yeah, Rob, please shed some light on that.

是的，羅布，請解釋一下。

Sure. So first, as a reminder, VALID-ECG was a study with simultaneously collected ECGs. So the patient had both a standard 12-les ECG and AIMIGo at the same time. And the goal was to demonstrate the similarity between the standard 12-lead signals and our synthesized 12-lead signals. And we've had two pre-submission meetings with FDA that are largely focused on the endpoints of the study.

當然。首先，提醒一下，VALID-ECG 是一項同時收集心電圖的研究。因此，患者同時接受了標準 12 列心電圖和 AIMIGo。目標是證明標準 12 導聯訊號與我們合成的 12 導聯訊號之間的相似性。我們與 FDA 舉行了兩次提交前會議，主要關注研究的終點。

So we've -- where we are right now is we've completed enrollment back in June, as I mentioned, but the data is currently being analyzed. So the results are not available. We do anticipate completing that analysis soon as that will be the basis for the second FDA submission that we plan to submit shortly.

所以，正如我所提到的，我們現在的情況是，我們已經在 6 月完成了註冊，但目前正在分析數據。所以結果無法得到。我們確實預計盡快完成該分析，因為這將成為我們計劃很快提交的第二份 FDA 報告的基礎。

I would note that we did complete this 80-patient pilot study with the same protocol. We can't say the results of that because it's been accepted for a presentation in November at the American Heart Association. But based on the results of those studies, that study, we did proceed with VALID-ECG.

我要指出的是，我們確實使用相同的方案完成了這項 80 名患者的試驗研究。我們不能透露結果，因為它已被接受用於 11 月在美國心臟協會的演講。但根據這些研究的結果，我們確實進行了有效心電圖檢查。

Great. Thank you. The next question, if the 12-L ECG is being evaluated by a physician, why do you need AI?

偉大的。謝謝。下一個問題，如果醫生正在評估 12-L 心電圖，為什麼需要人工智慧？

Yeah. Let me answer that question. Our vision is that with HeartBeam AI, the user will get an automated arrhythmia classification, and that's going to happen immediately after every use. However, of course, it is important that a physician review patient clinical picture, the complete clinical picture, which includes ECG.

是的。讓我回答這個問題。我們的願景是，透過 HeartBeam AI，用戶將獲得自動心律不整分類，並且這將在每次使用後立即發生。然而，當然，醫生檢查患者的臨床情況（包括心電圖在內的完整臨床情況）很重要。

We actually anticipate like having two workflows here. If the user is experiencing symptoms, the ECG will be automatically sent to the user's physician or to a physician breathing service for evaluation. On the other hand, if the user is not experiencing symptoms but is taking a routine recording to add to their database or ECGs, the ECG will not automatically go to a physician for interpretation.

我們實際上預計這裡有兩個工作流程。如果使用者出現症狀，心電圖將自動發送給使用者的醫生或呼吸服務醫生進行評估。另一方面，如果使用者沒有出現症狀，但正在進行常規記錄以添加到他們的資料庫或心電圖，則心電圖不會自動交給醫生進行解釋。

This is asymptomatic recording, but the user will have the option to do so. In either case, symptomatic or not symptomatic, AI will play a key role in informing the patient and helping physicians diagnose the patient.

這是無症狀記錄，但用戶可以選擇這樣做。無論是有症狀還是無症狀，人工智慧都將在告知患者並幫助醫生診斷患者方面發揮關鍵作用。

Great. Thanks. Next question. Will the initial AIMIGo product to be able to detect heart attacks from the get-go? Or will there need to be further R&D before that claim can be made?

偉大的。謝謝。下一個問題。最初的 AIMIGo 產品能否從一開始就檢測出心臟病發作？或者在提出這項主張之前是否需要進一步的研發？

We have actually done a lot of research, and we've done two studies related to heart attack detection. So in terms of the developments, there is still some work to do. But fundamentally, we believe that we have a technology that's going to provide leading insight into the patients with chest pain.

我們實際上做了很多研究，我們做了兩項與心臟病檢測相關的研究。因此，就發展而言，仍有一些工作要做。但從根本上說，我們相信我們擁有一項技術，可以為胸痛患者提供領先的見解。

So all in all, at this point, we are focusing on arrhythmia detection, especially complex arrhythmias that other technologies cannot detect. And our plan is as soon as that is productized is as soon as that is in the marketplace that we will apply all our resources to enable the product to detect heart attacks.

所以總而言之，目前我們的重點是心律不整檢測，尤其是其他技術無法偵測到的複雜心律不整。我們的計劃是，一旦產品化，即進入市場，我們將利用我們所有的資源，使該產品能夠檢測心臟病發作。

Thanks. Next question, is it possible to speak to pursuing FDA approval for atrial flutter versus atrial fibrillation?

謝謝。下一個問題，是否可以討論尋求 FDA 批准心房撲動與心房顫動？

Yes. You want me to take that one, Branislav?

是的。你想讓我拿那個嗎，布拉尼斯拉夫？

Yes, go ahead.

是的，繼續吧。

Yes, it's just similar to what Branislav said before, we're taking a stepwise approach with FDA. And so the initial indications are for arrhythmia and it's for a range of arrhythmias. So those do cover atrial flutter and atrial fibrillation, and we'll have clinical data on that. So yes, pursuing those are within the scope of the initial clearance.

是的，這與 Branislav 之前所說的類似，我們正在與 FDA 採取逐步的方法。因此，最初的適應症是針對心律不整，並且是針對一系列心律不整。所以這些確實涵蓋了心房撲動和心房顫動，我們將擁有這方面的臨床數據。所以是的，追求這些都在最初許可的範圍內。

Great. That is the final question there. I'll turn now the call back over to Dr. Vajdic for his closing remarks.

偉大的。這是最後一個問題。現在我將把電話轉回給 Vajdic 博士作總結發言。

Thank you, operator. I would like to thank each of you for joining our earnings conference today and look forward to continuing to update you on our ongoing progress and growth. If we were not able to answer any of your questions today, please reach out to our IR firm, MZ Group, who would be more than happy to assist. Thank you again.

謝謝你，接線生。我要感謝你們今天參加我們的收益會議，並期待繼續向你們通報我們持續取得的進展和成長的最新情況。如果我們今天無法回答您的任何問題，請聯絡我們的投資者關係公司 MZ Group，他們將非常樂意為您提供協助。再次感謝您。

The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.

會議現已結束。感謝您參加今天的演講。您現在可以斷開連線。