Heartbeam Inc (BEAT) 2023 Q3 法說會逐字稿

Greetings and welcome to the HeartBeam Third Quarter 2023 Financial Results Conference Call. (Operator Instructions) As a reminder, this conference is being recorded.

歡迎參加 HeartBeam 2023 年第三季財務業績電話會議。 （操作員指示）謹此提醒，本次會議正在錄製中。

Before we begin the formal presentation, I would like to remind everyone that the statements made on the call and webcast may include predictions, estimates, and other information that may be considered forward-looking.

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、估計和其他可能被視為前瞻性的資訊。

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. 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.

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。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。

Throughout today's discussion, we will attempt to present some important factors 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 wires this afternoon and is available in the Investor Relations section of our company's website, HeartBeam.com.

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因素。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公司網站 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 Rick Brounstein, Chief Financial Officer, will present results of operations for the third quarter ended September 30, 2023. At this time, I will turn the call over to HeartBeam's Chief Executive Officer, Branislav Vajdic. Please go ahead, Sir.

今天的主持人是執行長兼創辦人 Branislav Vajdic；羅布·伊諾，總裁；財務長 Rick Brounstein 將介紹截至 2023 年 9 月 30 日的第三季營運業績。此時，我將把電話轉給 HeartBeam 執行長 Branislav Vajdic。請繼續，先生。

Thank you, operator, and good afternoon, everyone. I'm pleased to welcome you to today's third quarter 2023 financial results conference call. On today's call, we will be relating some very important updates about our business, our products, including our landmark, peer reviews, study publication, and a significant enhanced HeartBeam team.

謝謝接線員，大家下午好。我很高興歡迎您參加今天的 2023 年第三季財務業績電話會議。在今天的電話會議上，我們將介紹有關我們業務、產品的一些非常重要的更新，包括我們的里程碑、同行評審、研究出版物以及顯著增強的 HeartBeam 團隊。

We continue to make steady progress towards upcoming clinical and regulatory milestones. I'd like to give you a brief overview of HeartBeam and our technology for those of you who just joined for the first time and as a reminder for those of you who are already familiar with us. It's really important to understand how our VECG technology is different from and that's more powerful than the most common personal ECG technologies that are in the marketplace today.

我們繼續朝著即將到來的臨床和監管里程碑穩步前進。我想向那些剛加入的人簡要介紹 HeartBeam 和我們的技術，並提醒已經熟悉我們的人。了解我們的 VECG 技術與當今市場上最常見的個人心電圖技術有何不同，並且比其更強大，這一點非常重要。

There are many ECG technologies offered to consumers and patients outside of a medical facility. You can see a couple of examples on this slide. These are not 12-lead ECG instead they are 1-lead, 3-lead or 6-lead. This is adequate for detecting many arrhythmias but is not sufficient to detect the heart attack or complex arrhythmias. Well, there are complex -- I'm sorry, but there are many 12-lead ECG the -- I'm so sorry. Basically, what I'd like to say is that a couple of ECG technologies that are out there today that are indicated for its home use. But we do not believe that these are adequate for an easy to use for the consumer and patients to adopt them.

有許多心電圖技術可供醫療機構以外的消費者和病患使用。您可以在這張投影片上看到幾個範例。這些不是 12 導程心電圖，而是 1 導聯、3 導聯或 6 導聯。這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。嗯，有複雜的——我很抱歉，但有很多12導聯心電圖——我很抱歉。基本上，我想說的是，目前已有的幾種心電圖技術適合家庭使用。但我們認為這些不足以讓消費者和患者易於使用。

We believe our technology has the potential to solve the problem of heart detection outside our medical institution. The key aim of the HeartBeam technology is to quickly and accurately help clinicians identify a heart attack. HeartBeam AIMIGo is a personal portable and easy-to-use system that generates 12-lead ECG. The AIMIGo device, coupled with a smartphone app and cloud-based diagnostic software system facilitate remote evaluation of cardiac symptoms by physicians. In addition, by collecting these signals of the heart electrical activity, HeartBeam AIMIGo has the potential to provide unparalleled data for the development of AI algorithms and the creation of a rich data set for AI.

我們相信我們的技術有潛力解決我們醫療機構以外的心臟檢測問題。 HeartBeam 技術的主要目標是快速且準確地幫助臨床醫生識別心臟病發作。 HeartBeam AIMIGo 是一款易於使用的個人可攜式系統，可產生 12 導程心電圖。 AIMIGo 裝置與智慧型手機應用程式和基於雲端的診斷軟體系統相結合，有助於醫生對心臟症狀進行遠端評估。此外，透過收集這些心電活動訊號，HeartBeam AIMIGo 有潛力為 AI 演算法的開發以及為 AI 創建豐富的資料集提供無與倫比的資料。

We believe that AIMIGo could reduce the critical time to intervention for heart attack patients. The average patient waits three to four hours before seeking care. Future action will reduce complications and save lives. In addition, more than 80% of the patients -- be chest pain -- they go to the emergency room and are not having a heart attack. An effective triage tool in the hands of the patient could reduce the number of unnecessary emergency visits and thus, reduce costs to the healthcare system.

我們相信 AIMIGo 可以縮短心臟病患者介入的關鍵時間。患者平均要等待三到四小時才能尋求治療。未來的行動將減少併發症並挽救生命。此外，超過 80% 的患者——胸痛——去急診室就診，但並不是心臟病發作。患者手中的有效分流工具可以減少不必要的緊急就診次數，進而降低醫療保健系統的成本。

The opportunity for our technology in the United States is six times larger than the atrial fibrillation or AFib market with approximately 3 million AFib patients, representing a $2 billion market. At the same time, there are approximately 20 million total coronary artery disease patients, representing a $12 billion market. These are estimated market numbers for the US only.

我們的技術在美國的機會是心房顫動或 AFib 市場的六倍，美國約有 300 萬 AFib 患者，相當於 20 億美元的市場。同時，冠狀動脈疾病患者總數約 2,000 萬，代表 120 億美元的市場。這些只是美國的估計市場數字。

We have the opportunity to our conditions beyond arrhythmia as the AIMIGo technology will bring the power of standalone care throughout the ECG to physicians from their patients that are anywhere and at any time. These diagnostic capabilities have the potential to go beyond the 12-lead ECG standard of care, capable of recording and processing vector electrocardiography, VECG signals, and using powerful 3D vector-based algorithm to detect heart attacks.

我們有機會治療心律不整以外的疾病，因為 AIMIGo 技術將為醫生隨時隨地為患者帶來整個心電圖的獨立照護能力。這些診斷功能有可能超越 12 導程 ECG 護理標準，能夠記錄和處理向量心電圖、VECG 訊號，並使用強大的 3D 向量演算法來檢測心臟病發作。

We have been working on our core technology, AIMIGo with a credit card core factor, but our deep product pipeline that is well-protected with our -- presents us with an extraordinary opportunity. We believe to form alliances with key strategic players and multiple industrial players, including variables and ambulatory monitoring.

我們一直在致力於我們的核心技術 AIMIGo 與信用卡核心因素的合作，但我們的深層產品線受到我們的良好保護，為我們提供了一個非凡的機會。我們相信與關鍵策略參與者和多個工業參與者結盟，包括變數和動態監測。

Our risk pipeline of products includes our on-demand 12-lead extended wear patch. We recently were granted our third US patents on this technology, which will be bringing 12-lead technology to the established extended-wear patch segment which is estimated to reach $4.8 billion by 2030. We also have extensive IP on continuous cardiac monitoring through our acquisition of LIVMOR, which developed the first FDA-cleared prescription wearable for continuous cardiac written moratory.

我們的風險產品系列包括我們的按需 12 導聯延長磨損貼片。我們最近獲得了有關該技術的第三項美國專利，該技術將為成熟的長佩戴貼片領域帶來12 導聯技術，預計到2030 年該領域的價值將達到48 億美元。透過收購，我們還擁有持續心臟監測方面的廣泛知識產權LIVMOR 開發了首款經 FDA 批准的處方可穿戴設備，用於連續心臟書面停搏。

Also in our pipeline is our integrated system, which combines continuous cardiac monitoring with our 12-lead patient carried ECG. The HeartBeam watch which combines a 12-lead ECG, a continuous cardiac monitor into a single form factor. Lastly, we are applying the latest in deep learning to our cardiac signals. We look forward to updating you soon on these efforts.

我們的整合系統也在我們的研發中，它將連續心臟監測與我們的 12 導聯患者攜帶的心電圖相結合。 HeartBeam 手錶將 12 導程心電圖和連續心臟監視器整合到一個外形尺寸中。最後，我們將最新的深度學習應用到我們的心臟訊號中。我們期待盡快向您通報這些努力的最新情況。

I would now like to turn the call over to our President, Rob Eno to provide product and business updates. Rob?

我現在想將電話轉給我們的總裁 Rob Eno，以提供產品和業務最新資訊。搶？

Thank you, Branislav, and thanks to everyone joining us today. Turning to recent milestones our landmark study based on our novel VECG technology was published in JACC: Advances, a Journal of the American College of Cardiology. This peer reviewed study demonstrated the ability of HeartBeam's VECG technology platform to detect the presence of coronary artery occlusion. This is a very interesting study design that use balloon inflation during a stent procedure also called a percutaneous coronary intervention, or PCI, to simulate coronary occlusions.

謝謝你，布拉尼斯拉夫，也謝謝今天加入我們的所有人。談到最近的里程碑，我們基於新穎的 VECG 技術的里程碑式研究發表在《JACC：Advances》（美國心臟病學會雜誌）上。這項同儕審查的研究證明了 HeartBeam 的 VECG 技術平台檢測冠狀動脈阻塞是否存在的能力。這是一項非常有趣的研究設計，在支架手術（也稱為經皮冠狀動脈介入治療 (PCI)）期間使用球囊充氣來模擬冠狀動脈閉塞。

HeartBeam's technology and a standard 12-lead ECG were both tested for their ability to detect coronary occlusions. There are three main takeaways from the study. First, on the left, HeartBeam's technology matched the performance of a standard in-hospital 12-lead ECG with similar accuracy. This in itself is important as HeartBeam's technology is intended to be used by patients outside of a healthcare institution.

HeartBeam 的技術和標準 12 導程心電圖都經過了檢測冠狀動脈阻塞的能力測試。該研究得出三個主要結論。首先，在左側，HeartBeam 的技術與標準醫院內 12 導程心電圖的性能相匹配，且精度相似。這本身就很重要，因為 HeartBeam 的技術旨在供醫療機構以外的患者使用。

Second, the study showed that both for HeartBeam's technology and a standard 12-lead ECG when assessing chest pain, performance was much better when the reading was accompanied by a baseline ECG taken before the event. The area under the curve, or AUC, a measure of accuracy was 0.95 for greater when including both the symptomatic and baseline recordings. The AUC when only the symptomatic was included was much lower around 0.7. In other words, assessing payers of ECGs or VECGs, the patient's baseline plus one taken during an event can increase accuracy by more than 30%. 12 plus 12 is better than just a 12-lead ECG. And this is particularly important because HeartBeam's technology by design always includes the patients asymptomatic baseline taken when he or she is onboarded.

其次，研究表明，無論是 HeartBeam 技術還是標準 12 導程心電圖，在評估胸痛時，如果讀數附有事件發生前採集的基線心電圖，性能都會好得多。當包括症狀和基線記錄時，曲線下面積 (AUC) 是一種準確度測量值，為 0.95。僅包含症狀時的 AUC 低得多，約 0.7。換句話說，評估 ECG 或 VECG 的付款人、患者的基線加上事件期間採集的基線可以將準確性提高 30% 以上。 12 加 12 比僅 12 導程心電圖更好。這一點尤其重要，因為 HeartBeam 的技術在設計上始終包含患者就診時的無症狀基準。

And the final takeaway is that in practice, the HeartBeam technology could have a dramatic improvement in accuracy over a 12-lead ECG taken in an emergency room. While the HeartBeam technology will always have a patient's asymptomatic VECG, and we'll be able to assess the pairs of readings. When a patient's ECG is assessed in an emergency room, there's often no baseline. So our HeartBeam's 12 plus 12 reading could be almost 40% more accurate than a single 12-lead ECG recording in the emergency room with the AUC increasing from 0.68 to 0.95.

最後的結論是，在實務中，HeartBeam 技術的準確性比在急診室採集的 12 導程心電圖有顯著提高。雖然 HeartBeam 技術始終具有患者的無症狀 VECG，但我們將能夠評估成對的讀數。當在急診室評估患者的心電圖時，通常沒有基線。因此，我們的 HeartBeam 的 12 加 12 讀數比急診室中單一 12 導程心電圖記錄準確度高出近 40%，AUC 從 0.68 增加到 0.95。

So when all this study demonstrates the potential that the AIMIGo system holds, and we'll be conducting additional studies focused on our 12-lead synthesis and on the performance of the system as a whole. We believe these studies will be key to driving clinical and patient adoption.

因此，當所有這些研究都證明了 AIMIGo 系統所具有的潛力時，我們將進行更多研究，重點關注我們的 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。

During the quarter, we were privileged to add multiple new respected industry executives and physicians to our leadership team, Board of Directors, and Scientific Advisory Board. We strengthened our Board of Directors with the appointment of Dr. Michael R. Jaff, Chief Medical Officer and Vice President of Clinical Affairs, Technology and Innovation of the Peripheral Interventions division at Boston Scientific. Dr. Jaff is a renowned vascular physician and researcher, bringing a wealth of clinical and industry experience to the Board. This follows the recent additions of Ken Nelson and Mark Strome.

在本季度，我們很榮幸在我們的領導團隊、董事會和科學顧問委員會中增加了多位受人尊敬的新行業高管和醫生。我們任命了波士頓科學公司首席醫療官兼週邊幹預部門臨床事務、技術和創新副總裁 Michael R. Jaff 博士，從而加強了我們的董事會。 Jaff 博士是一位著名的血管內科醫生和研究員，為董事會帶來了豐富的臨床和行業經驗。在此之前，肯·尼爾森 (Ken Nelson) 和馬克·斯特羅姆 (Mark Strome) 最近也加入了。

We also made three key hires to our senior management team; Richa Gujarati joined HeartBeam as Senior Vice President of Product. Richa has over 13 years of experience collecting market-level insights and translating them into business needs for companies ranging from St. Jude and iRhythm to Apple. Her deep expertise in go-to-market strategies for health sensing technologies will be instrumental as we ready the HeartBeam AIMIGo system for market release.

我們還聘請了三名關鍵人員加入我們的高階管理團隊； Richa Gujarati 加入 HeartBeam，擔任產品資深副總裁。 Richa 擁有超過 13 年的經驗，收集市場層面的見解並將其轉化為 St. Jude、iRhythm 和 Apple 等公司的業務需求。她在健康感測技術上市策略方面的深厚專業知識將在我們準備 HeartBeam AIMIGo 系統上市時發揮重要作用。

Debbie Castillo joined HeartBeam as Vice President of Regulatory Affairs. Debbie is an experienced biomedical engineer with extensive knowledge of FDA, EU, and Health Canada regulations. She has experience as well and -- she has industry experience as well in various positions with the FDA. She is responsible for leading our regulatory affairs function and overseeing the company's interactions with regulatory agencies worldwide.

Debbie Castillo 加入 HeartBeam，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，對 FDA、歐盟和加拿大衛生部法規有豐富的了解。她也擁有豐富的經驗，而且她還擁有在 FDA 擔任多個職位的行業經驗。她負責領導我們的監管事務職能並監督公司與全球監管機構的互動。

And finally, we welcomed Pooja Chatterjee, as Vice President of Clinical. She brings over 15 years of extensive clinical leadership experience in the medical device industry, most recently at Abbott, and will oversee our clinical studies and related efforts.

最後，我們歡迎 Pooja Chatterjee 擔任臨床副總裁。她在醫療器材行業擁有超過 15 年的豐富臨床領導經驗（最近在 Abbott），並將監督我們的臨床研究和相關工作。

We recently added five distinguished physicians to our Scientific Advisory Board. This group brings expertise in interventional cardiology, electrophysiology, clinical research, and new technologies. The new members are Charles L. Brown III, Tony Das, Robert Harrington, Campbell Rogers, and Niraj Varma. They joined our Chief Medical Officer, Peter Fitzgerald, and the previously announced Chair of the Scientific Advisory Board, Michael Gibson. I encourage you to read our press release of the appointments to get a sense of the wealth of experience at favoring.

最近，我們的科學顧問委員會增加了五位傑出的醫生。該小組帶來了介入性心臟病學、電生理學、臨床研究和新技術方面的專業知識。新成員包括查爾斯·L·布朗三世、東尼·達斯、羅伯特·哈林頓、坎貝爾·羅傑斯和尼拉吉·瓦爾馬。他們加入了我們的首席醫療官彼得·菲茨杰拉德（Peter Fitzgerald）和先前宣布的科學顧問委員會主席邁克爾·吉布森（Michael Gibson）。我鼓勵您閱讀我們關於任命的新聞稿，以了解在支持方面的豐富經驗。

We continue to make steady progress toward our key product milestones, as previously discussed, we will have two 510(k) submissions to the FDA. The first, which we call version 1 is for clearance of the HeartBeam AIMIGo VECG device. This application, which was submitted to the FDA in May is for the hardware clearance of a 3-lead VECG collection device. This submission is progressing well. We've received questions from FDA and have submitted our responses.

我們繼續在關鍵產品里程碑方面取得穩步進展，如前所述，我們將向 FDA 提交兩份 510(k) 申請。第一個版本（我們稱之為版本 1）用於 HeartBeam AIMIGo VECG 設備的許可。該申請於 5 月向 FDA 提交，旨在獲得 3 導聯 VECG 採集設備的硬體許可。此次提交進展順利。我們已收到 FDA 的問題並已提交答复。

The second submission planned for after we receive the clearance for version 1 is for the software, including the algorithms that generate a synthesized 12-lead ECG for physician review. On this application, which we call version 2, we have held a successful pre-submission meeting with the FDA. This meeting focused on the design of the clinical study that will demonstrate the performance of our synthesized 12-lead ECG in relation to a standard 12-lead ECC. We're encouraged by our interactions with FDA, and we continue to expect the product will be ready for limited market release during the second half of 2024.

我們收到版本 1 的許可後計劃提交的第二份文件是軟體，包括生成合成 12 導聯心電圖以供醫生審查的演算法。對於這個我們稱為版本 2 的申請，我們已經與 FDA 成功舉行了提交前會議。本次會議的重點是臨床研究的設計，該研究將展示我們合成的 12 導聯 ECG 相對於標準 12 導聯 ECC 的性能。我們與 FDA 的互動讓我們深受鼓舞，我們繼續預計該產品將在 2024 年下半年準備好在有限的市場上發布。

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財務長 Rick Brounstein，討論營運更新和財務狀況。

Thank you, Rob. Turning to our financials, I will 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 closed today.

謝謝你，羅布。談到我們的財務狀況，我現在將簡要概述我們的財務表現。我們的監管文件和今天收市後發布的新聞稿中提供了完整的詳細資訊。

General and administrative expenses for the third quarter of 2023 were $2.1 million compared to $2 million for the third quarter of 2022. Although, overall G&A expense is flat, cash spending is actually down in looking at 2023 compared to 2022. In 2022, we were invested in the commercial team and due to our change in the near-term focus in early '23, we're not currently emphasizing commercial activities.

2023 年第三季的一般及管理費用為210 萬美元，而2022 年第三季為200 萬美元。儘管整體管理及行政費用持平，但與2022 年相比，2023 年的現金支出實際上有所下降。2022 年，我們投資於商業團隊，並且由於我們在 23 年初改變了近期重點，我們目前不強調商業活動。

The reduced sales and marketing expense was offset by increased noncash stock-based compensation of about $0.4 million, resulting primarily from the issuance of employee stock options following the May 2023 financings. Research and development expenses for the third quarter of 2023 were $1.6 million, approximately the same level of expense as compared to the third quarter of 2022.

銷售和行銷費用的減少被約 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選擇權。 2023 年第三季的研發費用為 160 萬美元，與 2022 年第三季的費用水準大致相同。

In addition to the current development focus on HeartBeam AIMIGo, in both periods, we also invested in research costs in support of the future product pipeline coming from our patented VECG platform technology, which is the basis for our patent portfolio of 11 issued patents.

除了目前重點開發 HeartBeam AIMIGo 之外，在這兩個時期，我們還投資了研究成本，以支援來自我們專利 VECG 平台技術的未來產品線，這是我們 11 項已發布專利的專利組合的基礎。

With current interest rates in the short-term markets around 5%, we earned $267,000 in interest income in the third quarter of 2023 compared to $28,000 in the third quarter last year. Net loss for the third quarter of 2023 was $3.5 million compared to a net loss of $3.6 million for the third quarter of 2022. We ended the third quarter of 2023 ahead of plan with $19.2 million in cash and cash equivalents compared to $3.6 million as of December 31 last year.

目前短期市場利率約為 5%，我們在 2023 年第三季的利息收入為 267,000 美元，而去年第三季為 28,000 美元。 2023 年第三季的淨虧損為350 萬美元，而2022 年第三季的淨虧損為360 萬美元。我們提前於計畫結束2023 年第三季度，現金和現金等價物為1,920 萬美元，而截至2023年第三季的淨虧損為360 萬美元去年12月31日。

As mentioned in May, we closed the common stock financing with gross proceeds of $26.5 million. The cash is planned to last into early 2025, while we expect to receive FDA clearance or HeartBeam AIMIGo version 2, which is our commercial product in the second half of 2024. We remain confident that we have sufficient funds to deliver on these important milestones and to get prepared to move into the commercialization phase of HeartBeam AIMIGo.

正如 5 月所提到的，我們完成了普通股融資，總收益為 2,650 萬美元。該現金計劃持續到 2025 年初，同時我們預計將在 2024 年下半年獲得 FDA 批准或 HeartBeam AIMIGo 版本 2，這是我們的商業產品。我們仍然相信，我們有足夠的資金來實現這些重要的里程碑，為進入HeartBeam AIMIGo 的商業化階段做好準備。

Also of importance in the May '23 financings is the fact that they were common stock only financings. They did not include any warrants in our balance sheet as a result, has a very simple and straightforward capital structure with approximately 26 million shares outstanding now. Finally, I would also 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.

23 年 5 月的融資中另一個重要的事實是，它們只是普通股融資。因此，他們沒有在我們的資產負債表中包含任何認股權證，其資本結構非常簡單直接，目前已發行約 2,600 萬股。最後，我也想跟大家分享我們最近的股東年會的結果，所有提案都獲得通過，其中包括在2022年股權激勵計畫中增加400萬股授權股。

I'll now turn the call back over to Branislav for closing thoughts.

現在，我將把電話轉回給布拉尼斯拉夫，以便結束思考。

Thank you, Rick. Let me just say that we remain incredibly optimistic for the future of HeartBeam. Now, I would like to summarize the recent efforts in the following categories. Continued validation and company momentum, progress towards key milestones, and financial soundness.

謝謝你，瑞克。我只想說，我們對 HeartBeam 的未來仍然非常樂觀。現在，我想從以下幾方面總結近期的努力。持續驗證和公司動力、關鍵里程碑的進展以及財務穩健性。

First, we had several announcements that demonstrated external validation of the technology and continued momentum of the company. Our landmark clinical study was published in Journal American College of Cardiology Advances. We made several key additions to our Board of Directors, our Senior Management team, and our Scientific Advisory Board. And the US patent has trademarked and granted the third patent on 12-lead extended wear patch, our eleventh patent overall.

首先，我們發布了幾項公告，證明了該技術的外部驗證以及公司的持續發展勢頭。我們具有里程碑意義的臨床研究發表在《美國心臟病學會進展》雜誌。我們對董事會、高階管理團隊和科學顧問委員會進行了幾項重要的補充。美國專利已註冊商標並授予 12 導聯延長磨損貼片的第三項專利，這是我們的第十一項專利。

Next, as Rob has summarized, we have made steady progress toward our key milestones with productive discussions with FDA on our initial application, our AIMIGo hardware. Equally importantly, we had a successful pre-submission meeting with the FDA on our second application, which will be on the algorithm that synthesizes the 12-lead ECG from our AIMIGo device. Our expectation is for a limited launch in the second half of 2024 remains unchanged.

接下來，正如 Rob 所總結的那樣，透過與 FDA 就我們的初始應用 AIMIGo 硬體進行富有成效的討論，我們在關鍵里程碑方面取得了穩步進展。同樣重要的是，我們與 FDA 就我們的第二個申請成功舉行了預提交會議，該申請將涉及從我們的 AIMIGo 設備合成 12 導聯心電圖的演算法。我們對 2024 年下半年有限推出的預期保持不變。

We have a strong cash position. We ended the quarter with significant cash position of $19.2 million well ahead of the plan. And this $19.2 million in cash includes also cash equivalents and short-term investments providing the runway very importantly to early 2025.

我們擁有充足的現金狀況。本季結束時，我們的現金狀況已達 1,920 萬美元，遠遠超出了計劃。這 1,920 萬美元現金還包括現金等價物和短期投資，為 2025 年初提供了非常重要的資金支持。

I would like to close by reiterating that we have positive interactions with the FDA in the past quarter, and we remain on track for our key product milestones. I look forward to providing our shareholders with further updates in the near term.

最後，我想重申，我們在過去一個季度與 FDA 進行了積極的互動，並且我們仍然在實現關鍵產品里程碑的軌道上。我期待在短期內向我們的股東提供進一步的更新。

I thank you all for attending. And now the HeartBeam team would like to answer your questions. Operator?

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) Ben Haynor, Alliance Global Markets.

（操作員說明）Ben Haynor，Alliance Global Markets。

Good afternoon, gentlemen. Thanks for taking the questions. First off for me, congrats on all the progress. Just curious on the interactions with the FDA, the questions on the first submission, I mean, it sounds like it's been a productive dialogue, but just knowing that you've answered the questions. I presume there aren't any things that look like showstoppers in there, is that a fair assumption?

下午好，先生們。感謝您提出問題。首先對我來說，祝賀所有的進步。只是對與 FDA 的互動、第一次提交的問題感到好奇，我的意思是，聽起來這是一次富有成效的對話，但只是知道你已經回答了問題。我認為那裡沒有任何看起來像攪局者的東西，這是一個公平的假設嗎？

Yes. We definitely had a number of interactions now with the FDA on our first submission, that's under consideration as well as on our V2 future submission, which was subject of our pre-submission meeting with the FDA.

是的。在我們的第一次提交（正在考慮中）以及我們未來的 V2 提交（這是我們與 FDA 的提交前會議的主題）上，我們肯定與 FDA 進行了許多互動。

Without going into details, we definitely tackled the issues that FDA basically brought up. But we really don't have anything on our horizon that would be of serious concern or as you turn the showstopper. So all-in-all, it's quite a bit a work, no question about that, but there are no points that would -- in our judgment be negative nature and so not being able to achieve our goal.

無需贅述，我們確實解決了 FDA 基本上提出的問題。但我們確實沒有任何值得嚴重關注或令人震驚的事情。總而言之，這是一項相當大的工作，毫無疑問，但根據我們的判斷，沒有任何一點是消極的，因此無法實現我們的目標。

Okay. Great. That's definitely helpful and sounds positive. And then just on the pre-sub meeting, any takeaways that you can potentially share on the study design? I mean, is it bigger than a bread box? I mean, is it something that you can do in animals? Is it in humans? Is it dozens? Is it hundreds? Is it thousands? What's kind of -- is there any sort of guide rails you can give us on what that might look like?

好的。偉大的。這絕對有幫助，而且聽起來很積極。然後就在預備會議上，您可以分享有關研究設計的任何要點嗎？我的意思是，它比麵包盒大嗎？我的意思是，這可以在動物身上做到嗎？它在人類身上嗎？是幾十個嗎？是幾百個嗎？是幾千嗎？您能給我們一些什麼樣的指導嗎？

Yes. Indeed, that was a significant topic in our pre-sub meeting with the FDA -- the clinical studies, the nature of the endpoints. And as far as, of course, it's going to be in humans, it's going to be a fairly simple study for what we are proposing now and what FDA appears to be basically positive on in terms of how the study will be designed and executed. And in terms of cost and the number of subjects, it's always the range that we expected, and it is not high. So all-in-all on the study, everything is looking as we have envisioned so far.

是的。事實上，這是我們與 FDA 會前會議的重要主題——臨床研究、終點的本質。當然，就人類而言，這將是一項相當簡單的研究，對於我們現在提議的研究來說，FDA 似乎對研究的設計和執行方式基本上持正面態度。而且從成本和科目數來看，一直都是我們預期的範圍，而且並不高。總而言之，就這項研究而言，到目前為止，一切都如我們所設想的那樣。

Okay. So, it sounds like everything is going according to plan or as you put it earlier, well ahead of plan on the cash utilization. And then just lastly for me and then I'll jump back in queue. You know -- a big deal with the JACC publication. Can you share any reaction that you've gotten from folks on that? I know there was the editorial that came away positive that was published but just any kind of color that you have from the other folks -- their insights and are interested by its findings?

好的。因此，聽起來一切都按計劃進行，或者正如您之前所說，遠遠超出了現金利用計劃。最後對我來說，然後我會跳回隊列。你知道——JACC 出版物是一件大事。能分享一下人們對此的反應嗎？我知道有一篇社論發表後得到了積極的評價，但你從其他人那裡得到的任何顏色——他們的見解以及對其研究結果感興趣嗎？

Rob, would you please answer?

羅布，請你回答一下好嗎？

Yes. Sure. Yes. No -- that's a good question. The feedback has been really positive. I think as I highlighted, I think a lot of the physicians we spoke to were intrigued by the study design using the balloon inflation as a really an interesting way to look at this problem. And I think the themes really resonated. The theme that this is a good way to show kind of apples-to-apples that were equivalent to a standard 12-lead, even though we're outside the hospital. And then this insight, which I think was new to a lot of people of the importance of the baseline, especially when assessing potential heart attack, a potential occlusion and how much that adds to the accuracy, both for a 12-lead and for ours.

是的。當然。是的。不——這是一個好問題。反饋非常正面。我認為正如我所強調的，我認為我們採訪過的許多醫生都對使用氣球充氣作為看待這個問題的一種非常有趣的方式的研究設計感興趣。我認為這些主題確實引起了共鳴。主題是，這是一種很好的方式來展示相當於標準 12 導聯的同類情況，即使我們在醫院外面。然後這個見解，我認為對許多人來說，基線的重要性是新的，特別是在評估潛在的心臟病發作、潛在的閉塞以及這對 12 導聯和我們的準確性的增加程度時。

So I think, as I tried to allude to, the feedback we're getting is that it's really interesting when you put those two together because not everybody who goes to the emergency room gets -- they have a baseline readily accessible that actually our baseline being accessible provides a potential advantage. So, I think the physicians we talked to were very excited about it and see it as a really great first step to prove the feasibility of the study and looking forward to continuing to work with us and provide more data.

所以我認為，正如我試圖提到的，我們得到的反饋是，當你把這兩者放在一起時，這真的很有趣，因為並不是每個去急診室的人都會得到——他們有一個容易獲得的基線，而實際上我們的基線易於接近提供了潛在的優勢。因此，我認為與我們交談的醫生對此感到非常興奮，並將其視為證明研究可行性的非常好的第一步，並期待繼續與我們合作並提供更多數據。

Okay. Great. That's helpful. Thanks for taking the questions, guys.

好的。偉大的。這很有幫助。謝謝你們提出問題，夥伴們。

Thank you.

謝謝。

(Operator Instructions) We have no further questions on the conference call at the moment. And I would like to take the webcast questions.

（操作員指示）目前我們在電話會議上沒有其他問題。我想回答網路廣播的問題。

The first webcast question asks, if you have a 12-lead ECG with the patient at home, who will read or interpret the heart attack, the patient, AI, or a cardiologist? If the latter, how will they get the ECG?

第一個網路廣播問題是，如果您在家中對患者進行 12 導程心電圖，誰會讀取或解釋心臟病發作、患者、人工智慧還是心臟病專家？如果是後者，他們將如何獲得心電圖？

Yes, I can take this one as well. Yes, it's a great question, and it's really -- it's an important thing. We believe it's crucial for the ECG to be evaluated by a physician. We don't want to be in a position that HeartBeam's algorithm is saying whether or not you -- especially in the case of a heart attack (technical difficulty) will be set up. The idea is the patient will perform the use of AIMIGo device at home or with the device and the app and that gets sent up to the cloud where the signals are processed, checked for quality, and then the 12-lead is synthesized. And then that is sent to the reader service, which then analyzes it. And then the physician in that reader service will reply to the patient, giving them the interpretation and can even initiate a telehealth visit or consultation if needed.

是的，我也可以拿這個。是的，這是一個很好的問題，而且確實是一件重要的事情。我們認為由醫師評估心電圖至關重要。我們不想讓 HeartBeam 的演算法判斷您是否會被設定——尤其是在心臟病發作（技術困難）的情況下。這個想法是，患者將在家中或透過設備和應用程式使用 AIMIGo 設備，並將其發送到雲端，在雲端處理訊號、檢查質量，然後合成 12 導聯。然後將其發送到閱讀器服務，然後閱讀器服務對其進行分析。然後，該讀者服務中的醫生將回覆患者，為他們提供解釋，甚至可以在需要時發起遠距醫療訪問或諮詢。

So we think it's important, especially when we're dealing with things like potential heart attacks that there's a physician in the loop and are building the workflow to incorporate that.

因此，我們認為這很重要，尤其是當我們處理潛在的心臟病發作等問題時，有一名醫生參與其中，並正在建立工作流程來整合這一點。

Our next question asks, you mentioned the application of deep learning to your system. Do you have more details on that effort?

我們的下一個問題是，您提到了深度學習在您的系統中的應用。你有關於這項工作的更多細節嗎？

Yes. When it comes to deep learning in general AI, it's always -- it's in the headlines in terms of its impact on various areas of our society. And in the future impact is really quite relevant when it comes to medical area.

是的。當談到通用人工智慧中的深度學習時，它總是因其對我們社會各個領域的影響而成為頭條新聞。未來的影響在醫療領域確實非常重要。

So all in all, looking at the impact AI will have on specific area of ECG, we believe that it's going to be impactful. And that technology combined with our unique advantages that we call the data set and very importantly, longitudinal data set collected over time, frequently over time for that patient will provide, we believe, value that goes beyond what a data set, traditional data set of 12-lead ECGs can offer.

總而言之，看看人工智慧對心電圖特定領域的影響，我們相信它將產生影響。該技術與我們稱為數據集的獨特優勢相結合，非常重要的是，隨著時間的推移，經常為該患者收集的縱向數據集，我們相信，將提供超越數據集、傳統數據集的價值。12 導程心電圖可以提供。

So we are keenly interested in AI, and we will be making some announcement in terms of our plans and efforts in this area in the near future.

所以我們對人工智慧非常感興趣，我們將在不久的將來發布一些關於我們在這個領域的計劃和努力的公告。

Our next question asked, do you have enough capital for 2025 commercial launch?

我們的下一個問題是，你們有足夠的資金來進行 2025 年的商業發布嗎？

So, that sounds like a good question for the CFO.

所以，對於財務長來說，這聽起來是一個很好的問題。

Yes.

是的。

Yes. So, a couple of points on that. Yes, we have enough money to get through the second FDA clearance, which is the commercial product and get it ready for launch. That said, we clearly plan to do another round of financing to fully fund the commercialization, so a little bit of both, but we have probably several months of leeway between when we expect to get ready for commercialization and when we would need another round to really carry on. So, we're feeling very comfortable from the cash position today.

是的。因此，有幾點。是的，我們有足夠的資金來獲得 FDA 的第二次批准，即商業產品，並為上市做好準備。也就是說，我們明確計劃進行另一輪融資，為商業化提供充分資金，因此兩者兼而有之，但在我們預計為商業化做好準備和需要另一輪融資之間，我們可能有幾個月的餘地真的繼續下去。因此，我們對今天的現金狀況感到非常滿意。

The next question asks, what are your near-term milestones?

下一個問題是，您的近期里程碑是什麼？

We made the decision to approach our regulatory submissions in two steps. The first one is what we call the V1 system, the hardware system, the credit card-sized hardware system. That's very important foundational to our ability to synthesize that well lead. Synthesized well lead is our second submission, the V2 clear that we will be seeking for the 12 weeks. And indeed, as stands right now, we expect both of these to be cleared in 2024.

我們決定分兩步驟處理我們的監管申請。第一個就是我們所說的V1系統，硬體系統，信用卡大小的硬體系統。這對於我們合成先導化合物的能力來說是非常重要的基礎。合成井鉛是我們第二次提交的材料，V2 明確表示我們將在 12 週內尋找。事實上，按照目前的情況，我們預計這兩個問題都將在 2024 年解決。

Our next question asks, can you talk about new business development opportunities?

我們的下一個問題是，您能談談新的業務發展機會嗎？

Sure. I can cover that one.

當然。我可以涵蓋那個。

Rob?

搶？

Branislav touched on that in his overview of the new technologies. So, our focus, obviously, right now is on the AIMIGo system, getting that through FDA and commercializing that. And as we described, we believe we're making really good progress on that. That is very much our company's focus.

布拉尼斯拉夫在他對新技術的概述中談到了這一點。因此，顯然我們現在的重點是 AIMIGo 系統，透過 FDA 批准並將其商業化。正如我們所描述的，我們相信我們在這方面取得了非常好的進展。這是我們公司的重點。

At the same time, we have this rich pipeline of products would that have strong IP associated with them. So, the continuous monitor watch, what we call the integrated system, which is the watch plus the card and also the 12-lead ECG HeartBeam watch. And we think some of those, given the size of our company, really lend themselves well the strategic partnerships, especially in the area of wearables and ambulatory monitoring. So, we will -- we're going to be pursuing discussions in the coming months with companies for some of those future areas.

同時，我們擁有豐富的產品線，並且擁有與之相關的強大智慧財產權。那麼，連續監護手錶，我們所說的整合系統，就是手錶加卡，也是12導聯心電圖HeartBeam手錶。我們認為，考慮到我們公司的規模，其中一些確實非常適合建立策略合作夥伴關係，特別是在穿戴式裝置和動態監控領域。因此，我們將在未來幾個月內與公司就其中一些未來領域進行討論。

And maybe I'll just -- I touched on another question that I had seen come through, which is on the go-to-market strategy for the AIMIGo system. And so, we are planning to go forward bringing that product to market ourselves. We're going to be unveiling more about what our go-to-market plans are. We are making good progress in developing those plans. And in the coming months, we'll outline them in a lot more detail.

也許我會——我談到了我遇到的另一個問題，即 AIMIGo 系統的上市策略。因此，我們計劃自行將該產品推向市場。我們將公佈更多有關我們的上市計劃的資訊。我們在製定這些計劃方面正在取得良好進展。在接下來的幾個月中，我們將更詳細地概述它們。

Our next question asks, current CMS guidelines for chest pain patients is to go to the emergency department. And therefore, how do you plan on becoming a CMS guideline?

我們的下一個問題是，目前的 CMS 胸痛患者指南是去急診室。因此，您打算如何成為 CMS 指南？

Yes. I'll -- I can take that one as well. It's another really interesting question. First of all, the right the guidelines are if you have chest pain, you should go to the emergency room, the reality is patients often delay three to four hours before going. We think that's really one of the fundamental issues that exist today. The ultimate goal is for this technology to be accepted and go down a path of unique reimbursement as well as getting into the guidelines.

是的。我會——我也可以接受那個。這是另一個非常有趣的問題。首先，正確的指導方針是，如果你有胸痛，你應該去急診室，現實是病人經常推遲三到四個小時才去。我們認為這確實是當今存在的基本問題之一。最終目標是讓這項技術被接受並走上獨特的報銷之路並進入指南。

And so the short answer is that all will be done with studies and evidence. It's going to be really important for us to generate evidence and data that show the clinical effectiveness and the cost effectiveness. And so it takes time, ultimately, but with evidence showing the benefit when patients use this device, that's the kind of work that would ultimately help to get something like this into the guidelines.

因此，簡短的回答是，一切都將透過研究和證據來完成。對我們來說，產生顯示臨床有效性和成本效益的證據和數據非常重要。因此，最終需要時間，但有證據表明患者使用該設備的好處，這種工作最終將有助於將此類內容納入指南。

And our last question asks, where do you see the 3-lead finding a market. There are several dozen companies in this market. And what is the value of another 3-lead?

我們的最後一個問題是，您認為三巨頭在哪裡找到市場。這個市場上有幾十家公司。另一個 3 導聯的價值是多少？

Yes, I can take that one as well. Now these are touching on some really good points. When we talk about our 3-lead collection device, it is collecting 3 orthogonal leads, X, Y and Z -- and that's the basis of vector cardiography VCG. And when you're collecting those specific three axes, that gives you all the data -- all the electrical data in the heart. And from that you can then synthesize the 12-lead. Other 3-lead devices, other reduced lead set devices are not using three orthogonal leads, so they're not -- their projections that aren't getting the full signal.

是的，我也可以接受那個。現在這些涉及到一些非常好的觀點。當我們談論 3 導聯採集設備時，它正在收集 3 個正交導聯：X、Y 和 Z，這就是心電圖 VCG 的基礎。當您收集這些特定的三個軸時，就會為您提供所有數據——心臟中的所有電數據。然後您就可以合成 12 導聯。其他 3 導聯設備、其他減少導聯組的設備不使用三個正交導聯，因此它們的投影無法獲得完整的訊號。

So our difference for the 3-lead is that we are 3-lead VCG, so we're collecting all the heart signals. But as we've laid out the strategy, it's a stepwise approach, getting the hardware cleared as a 3-lead collection device that allows us to move on to taking those three orthogonal leads and then synthesizing the 12-lead. We believe it's important for physicians who are involved, as we mentioned earlier, to be able to analyze the 12-lead together with the baseline because that's what they're used to seeing.

因此，3 導聯的不同之處在於我們是 3 導聯 VCG，因此我們正在收集所有心臟訊號。但正如我們制定的策略一樣，這是一個逐步的方法，將硬體清除為 3 導聯收集設備，使我們能夠繼續採用這三個正交導聯，然後合成 12 導聯。正如我們前面提到的，我們認為，對於參與其中的醫生來說，能夠分析 12 導聯和基線非常重要，因為這是他們習慣看到的。

So it's a stepping stone having the three orthogonal leads to get to the 12-lead synthesis, which is our true differentiator.

因此，它是具有 3 個正交導聯的墊腳石，可實現 12 導聯合成，這是我們真正的差異化因素。

Thank you, sir. Ladies and gentlemen, we have reached the end of the question-and-answer session. And I would like to turn the call back to Dr. Branislav for some closing remarks.

謝謝你，先生。女士們、先生們，問答環節已經結束。我想將電話轉回給布拉尼斯拉夫博士，請他發表一些結束語。

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 we were not able to answer any of your questions here today, please reach out to our IR FMC group, who would be more than happy to assist. Good day.

謝謝你，接線生。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，請聯繫我們的 IR FMC 團隊，他們將非常樂意為您提供協助。再會。

Thank you very much, sir. Ladies and gentlemen, that then concludes today's conference. Thank you for joining, and you may disconnect your lines at this time.

先生非常感謝您。女士們、先生們，今天的會議到此結束。感謝您的加入，此時您可以斷開線路。