HeartBeam, Inc. (BEAT) 2026 Q1 法說會逐字稿

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  • Operator

    Operator

  • Greetings, and welcome to the HeartBeam first quarter 2026 financial results conference call. (Operator Instructions) As a reminder, this conference call is being recorded. 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 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.

    各位好,歡迎參加 HeartBeam 2026 年第一季財務業績電話會議。(接線員指示) 提醒各位,本次電話會議將被錄音。在我們開始正式簡報之前,我想提醒大家,電話會議與網路直播中的陳述可能包含預測、估計或其他可能被視為前瞻性之資訊。雖然這些前瞻性陳述代表我們目前對未來的判斷,但其仍受風險與不確定性影響,可能導致實際結果與所述內容出現重大差異。

  • You are cautioned not to place undue reliance on these forward-looking statements, which reflect our opinions only as of 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 the light of new information or future events. Throughout today's discussion, we will attempt to present some important factors relating to our business that may affect our prediction. 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.

    敬請注意,勿過度依賴這些前瞻性陳述;其僅反映截至本次簡報日期我們的看法。也請記得,我們並無義務因應新資訊或未來事件而修訂或公開發布對這些前瞻性陳述之任何修訂結果。在今天的討論中,我們將嘗試呈現一些與我們業務相關、可能影響我們預測的重要因素。您也應查閱我們最新的 Form 10-K 與 Form 10-Q,以更完整了解這些因素及其他風險,特別是「風險因素」(Risk Factors) 章節。

  • A press release detailing these results crossed the wire this afternoon and is available in the Investor Relations section of our company's website, heartbeam.com. Your host today, Rob Eno, Chief Executive Officer; Tim Cruickshank, Chief Financial Officer; and Bryan Humbarger, Chief Commercial Officer, will present results of operation for the first quarter ended March 31, 2026.

    本日下午,我們已發布一則詳述本次業績的新聞稿,並可於本公司網站 heartbeam.com 的投資人關係(Investor Relations)專區取得。今天的主持人為執行長 Rob Eno、財務長 Tim Cruickshank,以及商務長 Bryan Humbarger;他們將報告截至 2026 年 3 月 31 日止第一季的營運成果。

  • At this time, I will turn the call over to HeartBeam's Chief Executive Officer, Mr. Rob Eno. Please go ahead.

    現在,我將把電話會議交給 HeartBeam 執行長 Rob Eno 先生。請開始。

  • Robert Eno - Chief Executive Officer, Director

    Robert Eno - Chief Executive Officer, Director

  • Thank you, operator. The topics we'll cover on today's call are listed on the slide. We'll start with a brief summary of our recent progress, followed by a reminder of the HeartBeam system and our unique technology platform. Bryan Humbarger, our Chief Commercial Officer, will provide an overview of our limited commercial launch. We'll then provide updates on our major growth initiatives, the on-demand 12-lead patch and our heart attack detection and AI efforts, followed by the financial results. We'll end with Q&A.

    謝謝,接線員。我們今天電話會議將涵蓋的主題已列於投影片上。我們將先簡要總結近期進展,接著再次介紹 HeartBeam 系統與我們獨特的技術平台。我們的商務長 Bryan Humbarger 將概述我們的有限商業化上市。之後我們將更新主要成長計畫:隨需 12 導程貼片,以及心肌梗塞偵測與 AI 相關工作,接著說明財務結果。最後進行問答。

  • I'll briefly summarize our recent progress. We'll cover each of these in more detail throughout the presentation. We continue to execute well across both commercialization and our growth initiatives. On commercialization, we signed our first commercial partnership in Q1 with ClearCardio, anchoring us in New York City, Dallas and South Florida. We've since added Atelier Health of Beverly Hills concierge practice led by physicians affiliated with Cedars-Sinai, extending us to Southern California and giving us flagship sites in all four of our target geographies.

    我先簡要總結近期進展。我們將在簡報中更詳細地逐一說明。我們在商業化與成長計畫兩方面持續良好執行。在商業化方面,我們於第一季與 ClearCardio 簽署首個商業合作夥伴關係,使我們在紐約市、達拉斯與南佛羅里達建立據點。此後我們又新增由與 Cedars-Sinai 相關聯之醫師領導的比佛利山莊禮賓醫療機構 Atelier Health,將版圖延伸至南加州,並使我們在四個目標地理區域皆擁有旗艦據點。

  • Together, these partnerships establish our initial foothold in the direct pay segment, which represents roughly 5 million US patients. On heart attack detection, we enrolled the first patient in our ALIGN-ACS pilot study, which compares HeartBeam to a standard 12-lead ECG in chest-pain patients in the emergency department.

    這些合作夥伴關係共同奠定我們在自費(direct pay)市場的初步立足點;該市場約涵蓋 500 萬名美國患者。在心肌梗塞偵測方面,我們已在 ALIGN-ACS 試點研究中納入首位受試者;該研究在急診胸痛患者中比較 HeartBeam 與標準 12 導程心電圖(ECG)。

  • Enrollment's ahead of schedule. The study is a key step toward FDA indication expansion into a market of 20 million at-risk patients. On the 12-week patch, we completed our first working prototype in Q1, and we've now initiated a pilot study focused on ischemia detection, we believe this will be the best-in-class patch in a $2 billion market with established reimbursement. Partnership discussions continue to progress. On AI, we announced a strategic collaboration with Mount Sinai, pairing their AI and clinical expertise with our 3D ECG signal collection technology to develop next-generation algorithms for heart attack detection, wellness and personalized cardiac assessment.

    收案進度超前。該研究是邁向 FDA 適應症擴增的關鍵一步,目標市場為 2,000 萬名具風險的患者。在 12 週貼片方面,我們於第一季完成首個可運作原型,目前已啟動一項聚焦缺血(ischemia)偵測的試點研究;我們相信這將成為在具既有給付(reimbursement)的 20 億美元市場中同級最佳(best-in-class)的貼片。合作夥伴洽談持續推進。在 AI 方面,我們宣布與 Mount Sinai 展開策略合作,結合其 AI 與臨床專業,以及我們的 3D ECG 訊號收集技術,共同開發下一代用於心肌梗塞偵測、健康管理(wellness)與個人化心臟評估的演算法。

  • Before we dive into detailed updates, I want to remind everyone about our initial product, the HeartBeam system and our platform technology. HeartBeam is dedicated to developing groundbreaking ECG technology for patients to use at home to empower them to feel confident about their heart health. HeartBeam has developed the first ever portable cable-free ECG that can synthesize a 12-lead ECG.

    在深入更新細節之前,我想先提醒大家我們的初始產品:HeartBeam 系統與平台技術。HeartBeam 致力於開發突破性的心電圖(ECG)技術,讓患者可在家中使用,並賦能患者對自身心臟健康更有信心。HeartBeam 已開發出史上首款可攜、無導線的 ECG,能夠合成 12 導程 ECG。

  • Our unique IP-protected approach captures the heart's electrical signals in three dimensions or non-coplanar directions and synthesizes it signals into a 12-lead ECG. The system is designed to be easy to carry and easy for patients to use at the time of symptom onset anywhere, anytime. The technology is supported by a team of US-based board-certified cardiologists who are available 24/7 to interpret the clinical grade ECG in triage patients appropriately to ensure timely care.

    我們獨特且受智慧財產權保護的方法,可在三維或非共平面方向捕捉心臟電訊號,並將其訊號合成為 12 導程 ECG。該系統設計為便於攜帶,且讓患者能在任何地點、任何時間於症狀出現時立即使用。此技術由一支位於美國、具董事會認證(board-certified)的心臟科醫師團隊提供支援,24/7 可解讀臨床等級 ECG,並適當分流(triage)患者,以確保及時照護。

  • The system has received two FDA clearances for arrhythmia assessment with these two clearances in place, we're embarking on our limited commercial launch. As you'll hear, we're extremely pleased with the reception of the system among leading concierge physicians and preventive cardiologists. Our team is more than just the first cable-free synthesized 12-lead ECG. It is true platform technology.

    該系統已取得兩項 FDA 核准,用於心律不整(arrhythmia)評估;在具備這兩項核准後,我們正展開有限商業化上市。如各位將聽到的,我們對該系統在頂尖禮賓醫師與預防心臟科醫師間的反應感到非常滿意。我們的團隊所打造的不僅是首款無導線、可合成的 12 導程 ECG。這是一項真正的平台技術。

  • The major advance that we pioneered and what our key IP is based around is our novel signal collection technology, which captures the heart's electrical signals in three axes, left and right, up and down, and into the body. These 3D signals can be converted into a familiar 12-lead waveform.

    我們所開創的重大突破、也是核心智慧財產權所依據者,是我們新穎的訊號收集技術;其可在三個軸向捕捉心臟電訊號:左右、上下,以及朝向身體內部。這些 3D 訊號可轉換為熟悉的 12 導程波形。

  • This core technology can be applied to multiple form factors. We're embarking on the launch of the HeartBeam system, the credit card size form factor. Recently, we announced the second form factor, an on-demand 12-lead extended wear patch. We believe that this patch can disrupt the ambulatory cardiac monitoring market, a $2 billion revenue market. The technology in these two form factors has the potential to enable a full range of 12-lead ECG capabilities, including currently cleared arhythmia assessment and future indications of heart attack detection and personalized AI algorithms.

    這項核心技術可應用於多種外形(form factor)。我們正著手推出 HeartBeam 系統,其外形為信用卡大小。近期我們宣布第二種外形:隨需 12 導程長時間配戴貼片。我們相信該貼片可顛覆可攜式(ambulatory)心臟監測市場;該市場年營收規模約 20 億美元。這兩種外形中的技術具備潛力,可實現完整的 12 導程 ECG 能力範圍,包括目前已核准的心律不整評估,以及未來的心肌梗塞偵測適應症與個人化 AI 演算法。

  • We'll discuss our progress toward heart attack detection and AI algorithm shortly, but now I want to turn it over to Bryan Humbarger, HeartBeam's Chief Commercial Officer, to provide an update on our commercial efforts. Bryan?

    我們稍後將討論在心肌梗塞偵測與 AI 演算法方面的進展;但現在我想把時間交給 HeartBeam 商務長 Bryan Humbarger,請他更新我們的商業化進展。Bryan?

  • Bryan Humbarger - Chief Commercial Officer

    Bryan Humbarger - Chief Commercial Officer

  • Thank you, Rob. Our commercial goals remain consistent and execution of the plan is well underway. As a review, we stated that in the first half of 2026, where we are today, we are focused on validating our premium value proposition, refining the HeartBeam systems and processes, signing and on-boarding our anchor accounts and proving the scale and efficiency of the model. In the second half of 2026, we will shift to proving deep adoption inside those anchor accounts, establishing the funnel that will support our 2027 revenue and adoption goals developing white papers and clinical proof points to drive further adoption and beginning to expand the sales team around our anchor geographies.

    謝謝你,Rob。我們的商業化目標維持一致,計畫的執行也已順利展開。回顧一下,我們曾表示在 2026 年上半年,也就是我們目前所處的階段,我們聚焦於驗證高端(premium)價值主張、精進 HeartBeam 系統與流程、簽約並導入(anchor)核心客戶,以及證明該模式的可擴展性與效率。在 2026 年下半年,我們將轉向證明在這些核心客戶內部的深度採用,建立可支撐 2027 年營收與採用目標的漏斗(funnel),撰寫白皮書與臨床證據要點以推動進一步採用,並開始以核心地理區域為中心擴編銷售團隊。

  • And then in 2027 and beyond, we will scale revenue move to train the trainer model for implementation, expand our clinical research opportunities and expand the sales, clinical and account management teams. These are the specific goals we set for in the first half of 2026 alongside our status against each one. Our first two goals are focused on signing and on-boarding anchor accounts in key targeted markets and executing a concentrated rollout strategy in four key geographies: New York City, Dallas, South Florida and Southern California. We've now built flagship accounts in all four markets.

    接著在 2027 年及之後,我們將擴大營收規模,轉向「訓練講師」(train the trainer)的導入模式,擴增臨床研究機會,並擴編銷售、臨床與客戶管理團隊。以下是我們在 2026 年上半年所設定的具體目標,以及各項目標目前的達成狀態。我們前兩項目標聚焦於在關鍵目標市場簽約並導入核心客戶,並在四個關鍵地理區域執行集中式推廣策略:紐約市、達拉斯、南佛羅里達與南加州。我們目前已在這四個市場皆建立旗艦客戶。

  • Since our last call, we've added Atelier Health located in Beverly Hills and led by physicians affiliated with Cedars Sinai. This establishes access of the HeartBeam technology in Southern California. Additionally, our first customer, ClearCardio has recently expanded its footprint from Dallas to New York and South Florida, bringing along our technology as part of their offering in these markets. These are technology forward customers that are rapidly growing in the preventive cardiology space. We also set out to validate our premium value proposition, early physician engagement and flagship account traction have clearly reinforced demand for our personalized 12-lead ECG capability.

    自上次通話以來,我們新增了位於比佛利山莊、由與 Cedars Sinai 有關聯的醫師領導的 Atelier Health。這使 HeartBeam 技術得以進入南加州。此外,我們的第一位客戶 ClearCardio 近期已將其版圖從達拉斯擴展至紐約與南佛羅里達,並在這些市場的服務中一併導入我們的技術。這些都是以技術為導向、在預防心臟病學領域快速成長的客戶。我們也著手驗證我們的高端價值主張;早期醫師參與與旗艦客戶的進展,已清楚強化市場對我們個人化 12 導程心電圖(ECG)能力的需求。

  • Physicians who have spent time with the technology are confirming what we believe that this is a meaningfully differentiated tool. And finally, we prioritize the need to refine physician workflows. We've been working directly with Clear Cardio and Atelier on rollout planning, workflow integration and the implementation processes. And what we are learning is informing a cleaner, faster on-boarding playbook. We will continue to improve our ability to scale efficiently.

    花時間使用該技術的醫師正在確認我們的看法:這是一項具明顯差異化的工具。最後,我們將優先聚焦於精進醫師工作流程的需求。我們一直直接與 Clear Cardio 與 Atelier 合作,進行上線推動規劃、工作流程整合與導入流程。我們所學到的內容正在形成一套更精簡、更快速的導入(on-boarding)作戰手冊。我們將持續提升高效率擴張的能力。

  • We are demonstrating this by accessing large patient populations through a focus that have strategically selected practices with a lean commercial team. Our focus will be on growth, which is the expansion of HeartBeam access in the target geography and adoption, the penetration of patients in our contracted accounts.

    我們透過以下方式展現這一點:以精實的商務團隊,聚焦並策略性地選擇診所,從而觸及龐大的病患族群。我們的重點將放在成長,也就是在目標地理區域擴大 HeartBeam 的可及性,以及採用(adoption)—在已簽約的客戶帳戶中提升病患滲透率。

  • For the limited commercial launch, we plan to execute this strategy with a sales director and one implementation specialist. After this phase, we plan to have a sales director and one to two implementation specialists per geography to support our growth and adoption efforts. Finally, we will begin measuring growth and adoption in addition to other key metrics as we move into this next phase of commercialization.

    在有限度的商業化上市階段,我們計畫以一位銷售總監與一位導入專員來執行此策略。在此階段之後,我們計畫在每個地理區域配置一位銷售總監與一至兩位導入專員,以支援我們的成長與採用推動。最後,隨著我們進入下一個商業化階段,除其他關鍵指標外,我們也將開始衡量成長與採用情況。

  • Now I'll turn it back to Rob.

    現在我把時間交還給 Rob。

  • Robert Eno - Chief Executive Officer, Director

    Robert Eno - Chief Executive Officer, Director

  • Thanks so much, Bryan. Next, I want to discuss our key growth initiatives, the 12-lead on-demand patch and our efforts on heart attack detection and AI. I'll start with the 12-lead patch. As I mentioned when we unveiled it last quarter, we believe that the HeartBeam 12-lead patch can disrupt the ambulatory cardiac monitoring market. This market consists of patches that are warrant for up to 30 days and continually records the patient's heart rhythms.

    非常感謝你,Bryan。接下來,我想談談我們的關鍵成長計畫:隨需 12 導程貼片,以及我們在心肌梗塞偵測與 AI 方面的努力。我先從 12 導程貼片開始。如同我在上季揭露時提到的,我們相信 HeartBeam 的 12 導程貼片能顛覆可攜式(ambulatory)心臟監測市場。這個市場由可配戴最長 30 天、並持續記錄病患心律的貼片所構成。

  • It's a rapidly growing $2 billion revenue market with existing reimbursement, consisting of two segments: long-term continuous monitors and mobile cardiac telemetry, or MCT. These existing devices are one to three leads and are limited to arrhythmia detection and monitoring. HeartBeam has developed an on-demand 12-lead patch and has produced a working prototype of the device. It functions just like existing patches, continually recording the patient's heart rhythms with a single lead. But using Heartbeam's patented technology, a patient simply places two fingers on the front of the device to record a clinical grade 12-lead ECG.

    這是一個快速成長、年營收約 20 億美元且已有既有給付(reimbursement)的市場,包含兩個區隔:長期連續監測器與行動心臟遙測(mobile cardiac telemetry,MCT)。這些既有裝置多為 1 到 3 導程,功能侷限於心律不整的偵測與監測。HeartBeam 已開發出一款隨需 12 導程貼片,並已製作出可運作的裝置原型。它的運作方式與現有貼片相同,以單一導程持續記錄病患心律。但透過 HeartBeam 的專利技術,病患只需將兩根手指放在裝置正面,即可記錄臨床等級的 12 導程心電圖(ECG)。

  • This has the potential to bring better diagnostic capabilities, including ischemia detection to the patch segment. The device integrates into existing workflows and leverages the existing reimbursement, we believe this will be the best-in-class patch. During the last call, we presented the results of market research surveys of cardiologists, electrophysiologists and emergency medicine physicians.

    這有潛力為貼片類產品帶來更佳的診斷能力,包括缺血(ischemia)偵測。該裝置可整合至既有工作流程並利用現有給付機制;我們相信這將成為同級最佳(best-in-class)的貼片。在上次通話中,我們呈現了針對心臟科醫師、心律電生理專科醫師與急診醫師所做的市場研究調查結果。

  • The research indicated that a 12-lead patch could cause fully half of the market to shift and could grow the market as a whole by 1/3. We announced on Monday that we have initiated a pilot clinical study in Europe aimed at demonstrating the ability of the HeartBeam patch to detect ischemia.

    研究顯示,12 導程貼片可能促使多達一半的市場轉移,並可使整體市場規模成長三分之一。我們於週一宣布,已在歐洲啟動一項試點臨床研究,旨在證明 HeartBeam 貼片偵測缺血的能力。

  • The pilot study will enroll approximately 50 patients with a high risk of coronary artery disease. Each patient undergoes exercise stress testing, a standard diagnostic procedure used to identify ischemic changes while wearing the HeartBeam patch, meaningly following exercise patients will obtain a synthesized 12-lead ECG by placing two fingers on the front of the patch. This ECG will be compared directly with the standard 12-lead ECG recorded at the same time. The study will help inform the company's regulatory strategy for the HeartBeam patch.

    該試點研究將納入約 50 名冠狀動脈疾病高風險病患。每位病患在配戴 HeartBeam 貼片的情況下接受運動負荷測試(exercise stress testing)—這是一項用於辨識缺血變化的標準診斷程序;也就是說,在運動後不久,病患將把兩根手指放在貼片正面以取得合成的 12 導程心電圖(ECG)。此 ECG 將與同一時間記錄的標準 12 導程 ECG 直接比較。該研究將有助於公司制定 HeartBeam 貼片的法規策略。

  • Also, as previously noted, we're in discussions with a number of industry players on a potential partnership to bring the patch to market. We've had several productive meetings since our last call, including at the American College of Cardiology and the Heart Rhythm Society meetings, and we'll keep you informed of the progress. At HeartBeam, we think about the card in the patch, not just as two products, but as entry points into the patient's cardiac monitoring journey.

    此外,如先前所述,我們正與多家產業業者討論潛在合作夥伴關係,以將貼片推向市場。自上次通話以來,我們已進行數場富有成效的會議,包括在美國心臟病學會(American College of Cardiology)與心律學會(Heart Rhythm Society)年會期間;我們會持續向各位更新進展。在 HeartBeam,我們看待卡片與貼片,不僅是兩項產品,而是病患心臟監測旅程的入口。

  • First, as you see on the left, patients use the HeartBeam system, the card, as an episodic monitor for peace of mind and to get physician feedback as symptoms occur. They're able to use the device throughout their lives to provide the physician with information to identify and monitor heart abnormalities. Often, a cardiologist will want more information, such as the arrhythmia burden that will necessitate use of the patch. So the card can directly lead to the patch. On the right-hand side is the 12-lead patch, a continuous monitor that's worn for a period of weeks. It can create a 12-lead ECG on demand.

    首先,如左側所示,病患使用 HeartBeam 系統(卡片)作為間歇性(episodic)監測器,以獲得安心感,並在症狀出現時取得醫師回饋。他們能在一生中持續使用該裝置,向醫師提供資訊以辨識並監測心臟異常。心臟科醫師往往會希望取得更多資訊,例如心律不整負荷(arrhythmia burden),這將需要使用貼片。因此,卡片可直接導向貼片。右側是 12 導程貼片,屬於連續監測器,可配戴數週。它可在需要時產生 12 導程 ECG。

  • This could be prescribed when physicians want this continuous information to assist in a new diagnosis or after an emergency department visit or a procedure such as re-vasculation or cardiac ablation. A patient who finishes with the HeartBeam patch could transition to the card for a number of reasons.

    當醫師希望取得這些連續資訊以協助新的診斷,或在急診就醫後,或在血管再通(re-vasculation)或心臟消融等處置後,便可能開立此貼片。完成 HeartBeam 貼片監測的病患,可能因多種原因轉換為使用卡片。

  • For example, to monitor intermittent episodes over their lifetime or if the patch is prescribed after a procedure, once this acute phase is over, the patient who's still high risk could transition to the card. So the patch can directly lead to the card. This is a flywheel that can drive further usage and deeper engagement with the technology. As we've discussed previously, one of the major problems in cardiology is that there's no good way for patients who experience chest pain to know if they're having a heart attack. Patients wait an average of 3 to 4 hours before seeking care and every 30 minutes of delay increases the risk of death by 7.5%.

    例如,用於在其一生中監測間歇性發作;或若貼片是在處置後開立,當急性期結束後,仍屬高風險的病患可轉換為使用卡片。因此,貼片也可直接導向卡片。這是一個飛輪效應,可帶動更高的使用頻率與更深度的技術黏著。如我們先前討論過的,心臟科的一大問題是:對於出現胸痛的病患,沒有好的方式判斷自己是否正在心肌梗塞。病患平均會等待 3 到 4 小時才尋求醫療照護,而每延遲 30 分鐘,死亡風險就增加 7.5%。

  • The 12-lead ECG is the standard for heart attack detection, but traditional 12-lead ECGs have 10 wired electrodes that need to be placed by a technician and they're not applicable for home use. This is a major problem with 20 million people in the US at risk of a heart attack, including 8 million who have had a previous heart attack.

    12 導程心電圖(ECG)是偵測心肌梗塞的標準,但傳統 12 導程 ECG 需要 10 個有線電極由技術人員放置,並不適用於居家使用。這是一個重大問題:美國有 2,000 萬人面臨心肌梗塞風險,其中包括 800 萬名曾經心肌梗塞的患者。

  • HeartBeam's technology has the potential to address this major need. We have multiple proof-of-concept studies showing that the HeartBeam ECG is similar to a standard 12-lead ECG in detecting heart attacks. One important point about this effort is that it's the same HeartBeam system that we're launching with an expanded indication.

    HeartBeam 的技術有潛力滿足這項重大需求。我們已有多項概念驗證研究顯示,HeartBeam 的 ECG 在偵測心肌梗塞方面與標準 12 導程 ECG 相近。此項工作的一個重點是:這與我們正在上市的同一套 HeartBeam 系統,只是適應症(indication)將擴大。

  • The ALIGN-ACS pilot study is underway in Europe, comparing the HeartBeam ECG to a standard 12-lead ECG detecting heart attacks. The study is conducted in the emergency room, enrolling patients who arrive with chest pain. This will allow the study to enroll much more rapidly than a study that prescribe devices to patients and waited for them to have events. We expect the study to complete enrollment by the end of the third quarter of 2026, and the study will inform the design of our FDA pivotal study. The study is enrolling well and is currently ahead of schedule.

    ALIGN-ACS 試點研究正在歐洲進行中,比較 HeartBeam ECG 與標準 12 導程 ECG 在偵測心肌梗塞方面的表現。該研究在急診室進行,納入因胸痛前來就診的病患。這將使研究的收案速度遠快於那種把裝置開立給病患、再等待事件發生的研究設計。我們預期該研究將於 2026 年第三季末完成收案,並將為我們的 FDA 關鍵性(pivotal)研究設計提供依據。目前收案進展良好,且進度領先於原定計畫。

  • Next, I'd like to describe the vision of how our system will work with heart attack detection. But first, here's the workflow today. A patient with symptoms uses the HeartBeam system and the data is sent to a cardiologist who's available 24/7. The cardiologist reviews the ECG and the symptoms and responds to the patients in just a few minutes with an ECG interpretation of the patients arrhythmic state. In our vision of heart attack detection, the workflow is very similar from a patient perspective.

    接下來,我想說明我們的系統在心肌梗塞偵測方面將如何運作的願景。但首先,先看目前的工作流程。出現症狀的患者使用 HeartBeam 系統,資料會傳送給 24/7 待命的心臟科醫師。心臟科醫師會檢視心電圖(ECG)與症狀,並在幾分鐘內回覆患者,提供對患者心律不整狀態的心電圖判讀。在我們對心肌梗塞偵測的願景中,從患者角度來看,工作流程非常相似。

  • But with the expanded indication, the on-call cardiologists will review for the presence of heart attacks, reviewing the ECG in comparison with the baseline ECG symptoms and history. But the physician will also benefit from an AI algorithm specifically for MI detection.

    但在適應症擴大後,值班心臟科醫師將會檢視是否存在心肌梗塞,並將心電圖與基準心電圖、症狀與病史進行比對審閱。同時,醫師也將受益於一套專門用於心肌梗塞(MI)偵測的 AI 演算法。

  • We plan to develop a deep learning model trained on ECG's taken when patients present with chest pain, the algorithm is trained on all of the data, including which patients go on to be re-vascularized. In general, there are two types of heart attacks, ST elevation myocardial infarctions, or STEMIs, are the classic heart attack, which can be readily identified on an ECG, but non-ST elevation myocardial infarctions, or NSTEMIs, are more subtle and sometimes are not picked up by a physician reviewing the ECG.

    我們計畫開發一個深度學習模型,使用患者因胸痛就診時所取得的心電圖進行訓練;該演算法將以所有資料進行訓練,包括哪些患者後續接受血運重建。一般而言,心肌梗塞有兩種類型:ST 段抬高型心肌梗塞(ST elevation myocardial infarctions,或 STEMIs)是典型的心肌梗塞,通常可在心電圖上清楚辨識;但非 ST 段抬高型心肌梗塞(non-ST elevation myocardial infarctions,或 NSTEMIs)較為細微,有時醫師在審閱心電圖時未必能察覺。

  • By training the algorithm on which patients actually need a revascularization, we believe we'll be able to catch NSTEMIs as well as STEMIs. Back to the workflow. Our vision is that the patient's data will be sent to the physician, but in parallel, we've run through the AI algorithm, which will provide insights on the potential of both STEMI and NSTEMI heart attacks so the physician's interpretation and recommendation will be informed by the AI algorithm.

    透過以實際需要血運重建的患者作為訓練目標,我們相信將能同時捕捉 NSTEMI 與 STEMI。回到工作流程。我們的願景是:患者資料會傳送給醫師;同時並行地,資料也會經由 AI 演算法分析,提供對 STEMI 與 NSTEMI 兩種心肌梗塞可能性的洞見,使醫師的判讀與建議能由 AI 演算法提供資訊支持。

  • We'll have further updates on these efforts, including the clinical and regulatory time lines. Our robust clinical trial pipeline, which includes the ALIGN-ACS pilot study, the Indonesia Head Start ACS study and a US pivotal study should provide on the order of 1,000 patients to further validate the AI algorithm we're developing. We showed this slide in the last call two months ago, laying out the key milestones for the year. We're making excellent progress, achieving what we said we would.

    我們將就這些工作提供進一步更新,包括臨床與法規時程。我們強健的臨床試驗管線,包括 ALIGN-ACS 試點研究、印尼 Head Start ACS 研究,以及美國關鍵性(pivotal)研究,預期可提供約 1,000 名患者,用於進一步驗證我們正在開發的 AI 演算法。我們在兩個月前的上一通電話會議中展示過這張投影片,列出今年的關鍵里程碑。我們進展非常順利,達成了我們所承諾的事項。

  • All of the milestones for Q1 are complete and we're well on the way to achieving the Q2 milestones. On commercialization, as Bryan walked through, we have signed and are on-boarding our first two accounts, giving us flagship sites in all four of the key geographies that we laid out last quarter. The early traction of these accounts is validating our premium positioning, physicians who have spent meaningful time with the system are confirming that this is a highly differentiated product. On heart attack detection, enrollment for the ALIGN-ACS pilot study is underway, and we expect to have updates in the coming months on Headstart ACS and the ALIGN-ACS enrollment completion.

    第一季(Q1)的所有里程碑均已完成,我們也正穩步邁向達成第二季(Q2)里程碑。在商業化方面,如 Bryan 所說明,我們已簽約並正在導入(on-boarding)前兩個客戶,使我們在上季所列出的四個關鍵地理市場皆擁有旗艦據點。這些客戶的早期進展正在驗證我們的高端定位;花了相當時間使用系統的醫師確認這是一項高度差異化的產品。在心肌梗塞偵測方面,ALIGN-ACS 試點研究已開始收案,我們預期在未來幾個月就 Headstart ACS 與 ALIGN-ACS 收案完成情況提供更新。

  • On AI, with the Mount Sinai collaboration finalized, we're focusing on developing algorithms, including MI focused and wellness algorithms, which will enhance the value of the heart beam system for our initial patient population. And finally, in the 12-lead patch, we're in the midst of partnership discussions, and we added to this chart the pilot ischemia study on the patch, which is underway.

    在 AI 方面,隨著與 Mount Sinai 的合作定案,我們正專注於開發演算法,包括以 MI 為重點及健康(wellness)演算法,這將提升 HeartBeam 系統對我們初期患者族群的價值。最後,在 12 導程貼片方面,我們正進行合作夥伴洽談;我們也在此圖表中新增了貼片的缺血(ischemia)試點研究,目前已在進行中。

  • Next, Tim will run us through the financials. Tim?

    接下來,Tim 將帶我們看財務數據。Tim?

  • Timothy Cruickshank - Chief Financial Officer

    Timothy Cruickshank - Chief Financial Officer

  • Great. This past month, we strengthened our financial position through an $11.5 million financing. We closed the underwritten public offering of common stock in April 16, total gross proceeds of $10 million before costs and the underwriter as well exercised the over-allotment option of $1.5 million in common stock for further gross proceeds.

    好的。上個月,我們透過 1,150 萬美元的融資強化了財務狀況。我們於 4 月 16 日完成承銷公開發行普通股,扣除費用前總募集金額為 1,000 萬美元;此外,承銷商亦行使超額配售選擇權,額外發行 150 萬美元的普通股,帶來進一步的總募集金額。

  • The offering was led by our first commercial customer, ClearCardio, alongside our executive leadership, board members, a number of existing investors as well as several fundamental institutional investors. This level of participation in the financing, including the fundamental institutional participation is a strong signal of conviction in the business model and our trajectory.

    本次發行由我們的第一位商業客戶 ClearCardio 領投,並有我們的執行管理團隊、董事會成員、多位既有投資人,以及數家基本面機構投資人共同參與。此次融資的參與程度(包含基本面機構投資人的參與)是對我們商業模式與發展軌跡具高度信心的強烈訊號。

  • We ended March 31, 2026, with a cash balance of just over $2 million. So when you include the net proceeds from the recent offering and over-allotment, we'd have a pro forma cash balance of approximately $12.4 million. This provides the cash runway to advance HeartBeam into our next phase of growth, and the common stock only financing continues to provide the company with a clean cap table and lots of optionality moving forward.

    截至 2026 年 3 月 31 日,我們的現金餘額略高於 200 萬美元。因此,若納入近期發行與超額配售的淨募集款項,我們的備考(pro forma)現金餘額約為 1,240 萬美元。這為推動 HeartBeam 進入下一階段成長提供了資金跑道;而僅以普通股進行融資也持續讓公司維持乾淨的股權結構(cap table),並在未來保有高度的策略彈性。

  • Our focus remains on execution towards our operational milestones while managing cash and dilution responsibly. We believe the progress we're making commercially combined with continued advanced development of our strategic initiatives that Rob walked us through, they position us well to execute in a meaningful way throughout 2026 and into 2027.

    我們仍聚焦於達成營運里程碑,同時負責任地管理現金與稀釋。我們相信,我們在商業化上的進展,加上 Rob 先前說明的策略性計畫持續推進,將使我們在 2026 年乃至 2027 年都能以具實質意義的方式執行。

  • Taking a look at the Q1 2026 financials. We had a net loss of $4.7 million, with net cash used in operating activities of $3.6 million. This is a 19% decrease in operating cash outflow compared to the same quarter in the prior year. The Q1 spend and EPS came in ahead of expectations. In Q1 of every year, there are several onetime annual payments within it. And we also made a few timely investments into our commercial launch and the 12-lead patch development.

    來看 2026 年第一季(Q1)的財務表現。我們的淨損為 470 萬美元,營運活動使用的淨現金為 360 萬美元。相較前一年度同季,營運現金流出下降 19%。第一季的支出與每股盈餘(EPS)表現優於預期。每年第一季通常包含數筆一次性的年度付款。我們也適時對商業上市與 12 導程貼片開發進行了幾項投資。

  • Even with these investments, we continue to show our ability to execute on our aggressive milestones while still delivering the 19% year-over-year expenditure reduction you saw in the quarter. We've got a really lean, but dedicated team, and we continue to judiciously time our investments, providing us with the ability to maintain a low cost profile. To that end, we previously stated our cash outflow expectations for 2026 would be in the $17 million to $19 million range.

    即便進行這些投資,我們仍展現出在達成具挑戰性的里程碑同時,仍能實現本季所見的 19% 年對年支出下降。我們的團隊精實但投入,我們也持續審慎安排投資時點,使我們能維持低成本結構。基於此,我們先前已表示,2026 年的現金流出預期將落在 1,700 萬至 1,900 萬美元區間。

  • That was based on a more aggressive hiring of the sales team that we believe is necessary in the early days. As Bryan described earlier, we have the ability to continue to prove out our initial commercial launch with the focused lean team. So based on that, we estimate our cash outflow will be below $16 million for all of 2026. So if you take the cash outflows of $3.6 million in Q1 of this year, that equates to approximately $12 million in cash outflows for the remaining three quarters for 2026 and that is prior to factoring in cash receipts from customers from our commercialization efforts. So this provides us funding into 2027 and the runway necessary to accomplish several critical milestones we have ahead.

    該預期是基於我們認為在早期階段需要更積極擴編銷售團隊。如 Bryan 先前所述,我們有能力以聚焦且精實的團隊持續驗證初期商業上市。因此,我們估計 2026 全年的現金流出將低於 1,600 萬美元。若以今年第一季 360 萬美元的現金流出推算,則 2026 年剩餘三個季度約為 1,200 萬美元的現金流出,且此尚未納入我們商業化努力所帶來的客戶現金收款。因此,這將為我們提供延伸至 2027 年的資金,並具備完成多項關鍵里程碑所需的跑道。

  • In summary, the financing we closed this past month extends our runway as we continue to advance our commercial launch and our exciting development initiatives in the 12-lead patch as well as our MI detection and AI initiatives. Combined with our balanced financial discipline, including the 19% year-over-year reduction in operating cash burn delivered in Q1, we believe we have the cash runway to advance HeartBeam well into our next phase of growth. With that, Rob, I'll turn it back over to you.

    總結而言,我們上個月完成的融資延長了資金跑道,使我們能持續推進商業上市,以及在 12 導程貼片、MI 偵測與 AI 等令人振奮的開發計畫。結合我們均衡的財務紀律(包括第一季實現的營運現金消耗年對年下降 19%),我們相信我們具備足夠的現金跑道,推動 HeartBeam 順利進入下一階段成長。接下來,Rob,我把時間交還給你。

  • Robert Eno - Chief Executive Officer, Director

    Robert Eno - Chief Executive Officer, Director

  • Thanks so much, Tim. We're pursuing a massive $40 billion opportunity, and we're executing on our plan to address major markets. The technology is significantly de-risked with the achievement of the first ever FDA-cleared cable-free synthesized 12-lead ECG for arrhythmia assessment. But the platform technology is backed by strong IP and clinical evidence. We strengthened our balance sheet with the April 2026 offering, and we're following a capital-efficient strategy with thoughtful and judicious timing of investments, as Tim laid out and crucially, we're executing on multiple value creation opportunities in 2026.

    非常感謝你,Tim。我們正在追逐一個高達400億美元的龐大機會,並正按計畫執行,以切入主要市場。隨著我們達成史上首個獲FDA核准、無導線的合成12導程心電圖(ECG),用於心律不整評估,這項技術的風險已大幅降低。此外,該平台技術有強大的智慧財產權與臨床證據作為後盾。我們透過2026年4月的募資強化了資產負債表,並如Tim所述,採取資本效率導向的策略,以審慎且合宜的投資時點配置資金;更關鍵的是,我們正在2026年同時推進多項創造價值的機會。

  • On the limited commercial launch, we have built flagship account presence in New York, Dallas, South Florida and Southern California, and our cost-effective expansion strategy does not require a huge sales force. On heart attack detection, we're rapidly advancing clinical validation to support indication expansion with the same HeartBeam system. The ALIGN-ACS pilot study is enrolling rapidly and is ahead of schedule.

    就有限度的商業化上市而言,我們已在紐約、達拉斯、南佛羅里達與南加州建立旗艦客戶據點,而我們具成本效益的擴張策略並不需要龐大的銷售團隊。在心肌梗塞偵測方面,我們正快速推進臨床驗證,以支援在同一套HeartBeam系統上擴增適應症。ALIGN-ACS試點研究收案進展迅速,且進度超前。

  • We believe that HeartBeam's on demand 12-lead patch will be the best-in-class product in the $2 billion revenue market with existing reimbursement. It will be the only 12-lead extended wear patch and its ability to detect ischemia as well as arrhythmia will be game changing. We've initiated the pilot study that's aimed at demonstrating the ischemia detection capabilities.

    我們相信,HeartBeam的隨需12導程貼片將成為在既有給付(reimbursement)下、年營收規模20億美元市場中的同級最佳產品。它將是唯一的12導程長時間配戴貼片,其同時偵測缺血(ischemia)與心律不整的能力將帶來顛覆性改變。我們已啟動試點研究,目標是證明其缺血偵測能力。

  • We're advancing our efforts on the strategic partnership to speed adoption as well. And finally, the Mount Sinai agreement is key to our AI strategy and the development of next-generation algorithms, including MI detection and wellness algorithms. Longer term, we'll be partnering with Mount Sinai to create a new class of 12-lead screening and predictive algorithms that are with the patient at home. We thank you all for attending. And now I would like to open it up to Q&A. Operator?

    我們也在推進策略合作夥伴關係,以加速採用。最後,與西奈山(Mount Sinai)的協議是我們AI策略與下一代演算法開發的關鍵,包括心肌梗塞(MI)偵測與健康(wellness)演算法。從長期來看,我們將與西奈山合作,打造一個新的12導程篩檢與預測演算法類別,讓病患在家中即可使用。感謝各位出席。接下來我想開放問答。接線員?

  • Operator

    Operator

  • (Operator Instructions) Kyle Bauser, (inaudible) Partners.

    (接線員指示) Kyle Bauser,(聽不清)Partners。

  • Kyle Bauser - Analyst

    Kyle Bauser - Analyst

  • Congrats on all the recent progress here, it's impressive. Maybe I'll start with the commercial rollout following your two anchor partners. Can you talk about how many patients are collectively managed by these partners? And also any updates on pricing? Are we still thinking the $500 to $1,000 range.

    恭喜近期取得的各項進展,令人印象深刻。我先從你們兩個核心合作夥伴之後的商業推廣談起。能否談談這些合作夥伴合計管理了多少名病患?另外,定價方面有沒有更新?我們是否仍以500到1,000美元的區間為目標?

  • Bryan Humbarger - Chief Commercial Officer

    Bryan Humbarger - Chief Commercial Officer

  • Yes. Kyle, it's Bryan. Thanks for the question. So yes. As we've discussed really this first half of the year is signing and getting these anchor accounts on board.

    是的。Kyle,我是Bryan。謝謝你的問題。所以是的。如我們先前討論的,今年上半年主要是在簽約並讓這些核心客戶(anchor accounts)上線。

  • So we're really focused on that. And as we move through the second half of Q2 and into the second half of the year, we will be focused much more on the adoption in those specific practices. The number of patients in those specific practices are really shared publicly. But as we go back and look at why we focus on these specific geographies, looking at our premium value proposition and where the patients are, our focus is really going after those 150,000 patients that are in this preventative concierge market and getting to 30,000 of those patients to our breakeven point.

    因此我們確實聚焦在這件事上。而當我們進入第二季後半段、以及下半年時,我們將更著重於這些特定診所中的實際採用情況。這些特定診所的病患數其實是公開可得的資訊。但回頭看我們為何聚焦這些特定地理區域,考量我們高端的價值主張以及病患所在位置,我們的重點是鎖定預防型禮賓醫療(preventative concierge)市場中的15萬名病患,並在其中達到3萬名病患以達成損益兩平。

  • And when we look at these four markets, they represent between the anchor accounts and other similar customers in the area, tens of thousands of patients in these specific geographies. So we feel very confident about that. Regarding the pricing spot on, I think we talked about on the last call, 750 to 1,000 is what we look at from a pricing perspective on the annual basis for the subscription fee and early indications that we haven't received any pushback on that. So we're confident that we're coming in and being able to establish that value rate out of the gate.

    當我們看這四個市場時,這些地區中,核心客戶加上周邊其他類似客戶,合計代表了數以萬計的病患。因此我們對此非常有信心。至於定價,你說得很準;我想我們在上次電話會議提到,從年度訂閱費的定價角度來看,我們的目標是750到1,000美元,而目前初步跡象顯示我們沒有收到任何反對意見。所以我們有信心,一開始就能以這個價值水準切入並建立定價。

  • Robert Eno - Chief Executive Officer, Director

    Robert Eno - Chief Executive Officer, Director

  • And Kyle, this is Rob. Great to hear from you. Just to add one quick thing, what Bryan said. Great answer, Bryan. On the number of patients that Bryan said, because they're private accounts, they don't like us saying that.

    Kyle,我是Rob。很高興聽到你的聲音。我只補充Bryan剛才說的一點。回答得很好,Bryan。關於Bryan提到的病患數,因為這些是私人客戶,他們不希望我們對外透露。

  • But I think you can expect in the near future as we have more and more accounts, we'll be able to give a number that says collectively under these accounts this number of pension -- number of patients is being managed just like you're getting to. It's a little early because it exposes too much about the customers. But you can expect us to report that as part of what Bryan said, some of the metrics that we're looking at.

    但我想你可以預期,在不久的將來,隨著我們擁有越來越多客戶,我們將能提供一個數字,說明這些客戶合計管理了多少名病患——就像你所問的那樣。現在還稍早,因為那會暴露太多客戶資訊。但你可以期待我們會把這項資訊,作為Bryan所說我們正在追蹤的一些指標之一來揭露。

  • Kyle Bauser - Analyst

    Kyle Bauser - Analyst

  • Okay. Excellent. Makes sense. Appreciate that. And then maybe moving on to heart attack detection in the ALIGN-ACS pilot study.

    好的。非常好。有道理。謝謝說明。接著也許談談ALIGN-ACS試點研究中的心肌梗塞偵測。

  • Rob, I believe you mentioned previously, it will be about 100 patients, correct me if I'm wrong. And given the nice design of just enrolling ER chest pain patients, it sounds like it's ahead of schedule. Once you finalize the design for the pivotal study, can you talk a little bit about the timing and what that will look like for the enrollment of that pivotal?

    Rob,我記得你之前提到大約會是100名病患,如有不對請糾正我。而且以只收急診胸痛病患的這種不錯的設計來看,聽起來進度超前。當你們完成關鍵性(pivotal)研究的設計後,能否談談時程,以及那項關鍵性研究的收案會是什麼樣子?

  • Robert Eno - Chief Executive Officer, Director

    Robert Eno - Chief Executive Officer, Director

  • Sure. So yes, the ALIGN-ACS is on the order of 100 to 120 patients. It's enrolling well ahead of schedule. We still believe we're comfortable in that enrollment by the end of Q3. What we're doing is, as I mentioned, is that study design, we're learning a lot from and that will inform the discussions with FDA for the pivotal study design.

    當然。是的,ALIGN-ACS大約是100到120名病患的規模。收案進度遠超預期。我們仍然相信,到第三季末完成收案是沒有問題的。我們正在做的是,如我提到的,我們從該研究設計中學到很多,這將為與FDA就關鍵性研究設計的討論提供依據。

  • So we're in communication with FDA on everything from the regulatory pathway to the clinical study design. We're also talking with potential investigators in the US. So nothing more to update in terms of further timing beyond the ALIGN-ACS. But as soon as we know more, we'll make sure that we lay it out for you.

    因此我們正就從法規路徑到臨床研究設計等各方面與FDA保持溝通。我們也在與美國潛在的研究者(investigators)洽談。所以除了ALIGN-ACS之外,關於更進一步的時程目前沒有更多更新。但一旦我們掌握更多資訊,我們一定會向各位清楚說明。

  • Kyle Bauser - Analyst

    Kyle Bauser - Analyst

  • Okay. Appreciate that. And maybe I can just slip one more in regarding the headstart ACS study, how will that differ from ALIGN-ACS and number of patients, et cetera.

    好的。謝謝。另外我再插問一題,關於headstart ACS研究,它與ALIGN-ACS在設計與病患數等方面會有何不同?

  • Robert Eno - Chief Executive Officer, Director

    Robert Eno - Chief Executive Officer, Director

  • Yes. We'll talk more about that in a little bit, but it's broadly the same design, meaning that it's looking at patients in emergency rooms with chest pain and comparing it to a 12-lead ECG. It's been sponsored by the government of Indonesia that's very interested in potential usage of our system. So it's going to be a bigger study on the order of 500 patients. And because of the design and the interest of Indonesia, it's largely paid for by the government.

    是的。我們稍後會再多談一些,但整體而言設計大致相同,也就是觀察急診室胸痛病患,並與12導程心電圖(ECG)做比較。該研究由印尼政府贊助,他們對我們系統的潛在使用非常有興趣。因此這會是一項更大型的研究,規模約500名病患。而由於研究設計與印尼方面的興趣,費用主要由政府支付。

  • So it's a good opportunity for us to get more patients, both for our overall learning of the manual interpretation but also as I suggested to be able to have a pool of patients to validate our upcoming AI algorithm as well. So more details on that in the coming weeks, I believe.

    因此這對我們而言是個很好的機會,可以納入更多病患,一方面有助於我們對人工判讀(manual interpretation)的整體學習,另一方面也如我所提到的,能建立一個病患資料池,用於驗證我們即將推出的AI演算法。我相信未來幾週我們會提供更多細節。

  • Operator

    Operator

  • Yi Chen, H.C. Wainright.

    Yi Chen,H.C. Wainright。

  • Unidentified Participant

    Unidentified Participant

  • This is Katie on for Yi. I was hoping we could get a little bit more clarification on how we should model revenue from this subscription billing? Is it -- do you expect it to build consistently quarter-over-quarter? Or is it going to be ebb and flows throughout the year? And then what is a realistic revenue expectation for full year 2026 with the current number of deployed accounts?

    我是 Katie,代替 Yi 發言。我想請教一下,我們在建模這項訂閱式計費帶來的營收時,應該如何處理,能否再更清楚說明?也就是說——你們預期它會在每一季相較前一季穩定成長嗎?還是會在一年當中出現起伏波動?另外,以目前已部署的帳戶數量來看,對於 2026 全年合理的營收預期會是多少?

  • Timothy Cruickshank - Chief Financial Officer

    Timothy Cruickshank - Chief Financial Officer

  • Great. Thank you, Happy to take that.

    很好。謝謝,我很樂意回答。

  • Robert Eno - Chief Executive Officer, Director

    Robert Eno - Chief Executive Officer, Director

  • Go ahead, Tim.

    Tim,你先請。

  • Timothy Cruickshank - Chief Financial Officer

    Timothy Cruickshank - Chief Financial Officer

  • So from a revenue perspective, it will be largely straight-lined over the course of the year. It's all about performance obligations and the commitment we have to these annual contracts with customers. So if you take $750 as an average price, that's largely straight lined over the course of the year. There will be a portion that would -- you may expect to see recognized earlier in the contract in recognition of some of the obligations we have of on-boarding customer, some of the additional costs required getting the device off the door on-boarding.

    就營收角度而言,它在一年期間大致會以直線法平均認列。這主要取決於履約義務,以及我們與客戶簽訂這些年度合約所承諾的內容。因此,如果以 750 美元作為平均價格,基本上會在全年期間以直線法認列。其中會有一部分——你可能會看到在合約較早期就被認列,因為要反映我們在客戶導入(on-boarding)上的部分義務,以及為了完成設備出貨與導入所需的一些額外成本。

  • And so there will be a slight higher portion of revenue early in the contract and then from there straight lining of it. What's interesting or what's helpful to the company from a cash flow perspective, we expect the majority of customers to pay for the first year upfront. So when you look at it from a -- from a cash perspective, you take the majority of that right up front from a P&L perspective, it's straight lines if that helps.

    因此,在合約初期會有略高比例的營收,之後就會以直線法攤提認列。從現金流角度來看,對公司有利的一點是:我們預期多數客戶會在第一年預先一次付清。所以從現金角度,你會在一開始就收到大部分款項;但從損益表(P&L)角度,則是以直線法認列——希望這樣說明有幫助。

  • Unidentified Participant

    Unidentified Participant

  • Great could I ask one follow-up. Looking at your discussion on deep adoption within those flagship accounts, can you give us an idea of what that full adoption looks like in a single practice, like how many devices for practice and what is a fully penetrated flagship accounts generate annually?

    很好,我可以再追問一題嗎?你們提到在那些旗艦帳戶中推動深度採用(deep adoption),能否讓我們了解在單一診所中「完全採用」大概是什麼樣子——例如每家診所大約會有多少台設備?以及一個完全滲透的旗艦帳戶每年大概能帶來多少營收?

  • Bryan Humbarger - Chief Commercial Officer

    Bryan Humbarger - Chief Commercial Officer

  • Yes. Thanks for that. And again, we can't get really too far into the actual numbers at these accounts at this stage. But what I can tell you from an adoption standpoint is -- we're really looking at this from an on-boarding process of the new patients on board, existing patients that are in the practice.

    可以。謝謝你的提問。再次說明,現階段我們無法在這些帳戶的實際數字上透露太多。但就採用情況而言,我們主要是從新病患的導入流程、以及診所內既有病患兩個面向來看。

  • And then another pool of patients that are actually coming to the practice because of the HeartBeam technology. So what we will begin to start showing and sharing probably in the August time frame is a little bit more detail on that question, and we'll have some more data to share. But again, we're tracking how far, how many patients within those given practices, the HeartBeam technology benefits at a given time. And then I think as we continue forward, we're going to have additional strategies. But more to come on that.

    另外還有一群病患,是因為 HeartBeam 的技術而實際前來該診所就診。因此,我們大概會在 8 月左右開始展示並分享更多與這個問題相關的細節,屆時也會有更多數據可以提供。但再次強調,我們正在追蹤在特定時間點、在這些診所中有多少病患能從 HeartBeam 技術中受益,以及受益的程度。我想隨著我們持續推進,還會有更多策略。後續會再提供更多資訊。

  • I think we'll have much more detail for you in August.

    我想我們在 8 月會提供更完整的細節給你。

  • Timothy Cruickshank - Chief Financial Officer

    Timothy Cruickshank - Chief Financial Officer

  • And then, Katie, just to round out your question on revenue projections and then give you some insights for modeling in terms of what average accounts look like adding to what Bryan said. We've said historically, these early accounts have anywhere from 400 to 4,000 patients. If you take the kind of middle number of 2,000, anywhere from 500 to 1,000 of those patients, we would be expecting to get on to our technology, if not more.

    另外,Katie,為了補充你關於營收預測的問題,並就建模提供一些平均帳戶的洞見,延續 Bryan 的說法。我們過去曾提到,這些早期帳戶的病患數大約介於 400 到 4,000 人。如果取中間值 2,000 人,其中大約有 500 到 1,000 人,我們預期會採用我們的技術,甚至可能更多。

  • That's not going to be the case for massive rollout when we're scaling, but for these early accounts, if we can get to of those accounts from a modeling perspective, that -- so, say, 1,000 patients at $1,000 or $750, that $750,000 to $1 million kind of per account, if you think about it that way. Not speaking specifically to these first two accounts, but just in terms of in general. And the way we look at it is we've talked about 30,000 patients being our breakeven point. And it's a two-year pathway to breakeven if you take the very slow kind of methodical rollout of going after all of these smaller accounts individually.

    在我們擴大規模、進行大規模推廣時,情況不一定會是這樣;但就這些早期帳戶而言,若從建模角度假設能達到——例如 1,000 名病患、每人 1,000 美元或 750 美元,那麼每個帳戶大約就是 75 萬到 100 萬美元的規模,你可以用這樣的方式來思考。這不是在特指前兩個帳戶,而是一般性的說明。而我們的看法是,我們曾談到 30,000 名病患是我們的損益兩平點。如果採取非常緩慢、較為按部就班的方式,逐一開發這些較小的帳戶,那麼達到損益兩平大約是一條兩年的路徑。

  • So to kind of back into the number of accounts or sites that would be required to get there over that time frame, you can back into those numbers. But what we believe is going to happen is if you break that 30,000 patients' number down into about 1/3 of them coming from this early segment. We believe we'll have the data points we need with these reference sites with the flagship accounts that are going to lead to channel partners and/or distributors that are -- sorry, chains, some of these large chains, that would make up the next 20,000 wave of patients.

    因此,若要回推在那段期間內達標所需的帳戶數或據點數,你可以用這些數字倒推。但我們認為會發生的是:如果把 30,000 名病患拆分,大約三分之一會來自這個早期區隔。我們相信,透過這些旗艦帳戶作為示範據點(reference sites)所取得的數據點,將會引導我們接觸通路夥伴和/或經銷商——抱歉,我是說連鎖體系,一些大型連鎖機構——它們將構成下一波 20,000 名病患。

  • So that's the way we plan to accelerate that timeline ahead of the kind of longer ground in towns 2-year, 2.5-year time frame. We get the initial adoption from about 10,000 patients in these smaller accounts, get the proof points we need, and then we'll be able to quickly go to these larger chains and accelerate from there.

    這就是我們計畫加速時程、把它提前於原本較長的、在各地逐步推進的 2 年到 2.5 年時間框架的方式。我們先在這些較小的帳戶中取得約 10,000 名病患的初期採用,拿到所需的驗證點,接著就能快速切入這些大型連鎖體系,並從那裡加速成長。

  • Operator

    Operator

  • (Operator Instructions)

    (接線員指示)

  • Unidentified Company Representative

    Unidentified Company Representative

  • We have a couple of webcast questions that we are going to take. And the webcast question is do you contemplate making your product known to investors and patients alike by producing television commercials to air on business channels like Fox Business, CNBC, et cetera.

    我們接下來會回答幾個網路直播的提問。其中一個問題是:你們是否考慮製作電視廣告,投放在 Fox Business、CNBC 等商業頻道,讓投資人與病患都能更認識你們的產品?

  • Robert Eno - Chief Executive Officer, Director

    Robert Eno - Chief Executive Officer, Director

  • Yes, I'll take that one. One of the things I really like about our strategy is that we don't need to do a DTC campaign, direct-to-consumer campaign, which can be very, very expensive. We're targeting specifically accounts that have high net worth individuals. Our market research showed that high net worth individuals have a high likelihood to pay. And interestingly, those who are in concierge practices willing to pay even more.

    是的,這題我來回答。我很喜歡我們策略的一點是:我們不需要做 DTC(direct-to-consumer,直接面向消費者)行銷活動,因為那可能非常、非常昂貴。我們鎖定的是擁有高淨值個人的特定帳戶。我們的市場研究顯示,高淨值個人具有較高的付費意願。而且有趣的是,在禮賓式(concierge)診所就診的人,甚至願意付更多。

  • So this is, we believe, the best way to access this market by as Bryan described, by going after a relatively small amount of practices, these practices work with us to, in a sense, sell it to their patients. So that's part of the reason why this strategy and our target of getting to 30,000 patients for for breakeven could be done efficiently because we signed a concentrated set of practices and then the practices work with us to drive deeper adoption.

    因此,我們認為,如同 Bryan 所描述的,透過鎖定相對少量的診所來切入市場,是接觸這個市場的最佳方式;這些診所會與我們合作,某種程度上把產品「銷售」給他們的病患。這也是為什麼我們的策略、以及以 30,000 名病患達到損益兩平的目標能夠有效率地完成:因為我們簽下的是一組高度集中的診所,然後由診所與我們一起推動更深度的採用。

  • I will say, though, that in early discussions with these practices, some of these practices are ones that have very well-known personalities as patients and the physicians have expressed a willingness to work with us if there's patients that are to get on our technology, they may be interested in speaking on behalf of it. So that could come out organically with what we're doing, but we don't have plans to be spending for advertising, et cetera. We think this in a sense, B2B model that we have now is the quickest and most efficient way to grow.

    不過我也想補充,在與這些診所的早期討論中,其中一些診所的病患包含非常知名的人士,而醫師也表達願意與我們合作;如果有病患採用我們的技術,他們可能有興趣代表產品發聲。因此,這可能會以更自然的方式隨著我們的推進而出現,但我們目前沒有計畫投入廣告支出等。我們認為,就某種意義而言,我們目前的 B2B 模式是最快、也最有效率的成長方式。

  • Unidentified Company Representative

    Unidentified Company Representative

  • Our next question asked, can you please walk us through management's thought process to not raise funds on a spike after approval and to wait until the price was under to raise capital?

    下一個問題是:能否請管理層說明,為何在核准後股價上漲時沒有趁勢募資,而是等到價格下跌後才籌資?

  • Timothy Cruickshank - Chief Financial Officer

    Timothy Cruickshank - Chief Financial Officer

  • Sure. I can take that. Look, thank you for the question. I know it's on a lot of people's minds, and so happy to take it. There's a number of factors that go into financing decisions.

    當然。我可以回答這題。你提出這個問題,謝謝。我知道這是很多人關心的點,所以很樂意說明。融資決策會受到多項因素影響。

  • I think they stem from listening to current shareholders working within any commitments or historic covenants that might be present. But importantly, as well, bringing the right new shareholders on to the register that are going to properly support the company and support the share price moving forward. I mean this is especially true in the medical device space where additional funding is often required.

    我認為這些源自於傾聽現有股東的意見,同時在任何既有承諾或可能存在的歷史契約條款之下運作。但同樣重要的是,將合適的新股東納入股東名冊,讓他們能夠在未來真正支持公司並支持股價走勢。我的意思是,這在醫療器材領域尤其如此,因為往往需要額外資金挹注。

  • At the end of the day, the takeaways I have, we closed a clean deal with common stock only. We believe we brought very strong partners on in terms of long-term investors onto the register. And now it's our job to continue to execute, bring visibility to the story and get the valuation to a level we all know this technology and the company deserves.

    歸根結底,我的重點結論是:我們以僅發行普通股的方式完成了一筆乾淨的交易。我們相信,就股東名冊上的長期投資人而言,我們引入了非常強而有力的合作夥伴。而現在,我們的工作就是持續落實執行、提升市場對這個故事的能見度,並把估值提升到我們都知道這項技術與公司應得的水準。

  • And I think we've got a lot of optionality in terms of how clean we've kept the cap table the types of institutional investors and retail investors we have on the register. And with all of the milestones we have ahead, we're extremely confident in where we're headed and believe we can get this valuation to the place that we all want it to be.

    我認為,從我們保持資本結構表乾淨的程度、以及股東名冊上機構投資人與散戶投資人的類型來看,我們在策略上有很大的彈性。而且,面對前方所有里程碑,我們對未來走向極具信心,並相信我們能把估值提升到大家都希望達到的位置。

  • Unidentified Company Representative

    Unidentified Company Representative

  • Next question asks, do we expect Q2 revenue?

    下一個問題是:我們是否預期第二季會有營收?

  • Timothy Cruickshank - Chief Financial Officer

    Timothy Cruickshank - Chief Financial Officer

  • I'm happy to take that, Rob, if you want me to. Yes. So we're right on track. Sure, yes. Q1, we're right on track with all the plans we've laid out.

    Rob,如果你希望我來回答,我很樂意。是的。所以我們完全按計畫推進。當然,是的。第一季,我們與先前制定的所有計畫都保持在正軌上。

  • Bryan has done a great job providing updates, and we're really excited about where we're headed. We will see some revenue in Q2, but as we've said from the beginning or for the last couple of quarters, the first half of the year, not a revenue story, we're not focused on driving revenue, we're focused on driving the right partners to this technology, proving deep adoption so that we have a repeatable, scalable model for the long term. And so there will be revenue and as well as cash received from customers to a small degree in Q2.

    Bryan 在提供最新進展方面做得非常好,我們也對未來方向感到非常振奮。第二季會看到一些營收,但正如我們從一開始、或過去幾個季度所說,今年上半年不是營收故事;我們不把重點放在推動營收,而是專注於為這項技術導入合適的合作夥伴、證明深度採用,讓我們長期擁有可重複、可擴展的商業模式。因此,第二季會有營收,也會有少量來自客戶的現金入帳。

  • And as we head into the second half of this year, that's when things start to get more exciting, and we really put the funnel in place, give the visibility to The Street in terms of where we're headed for scaling revenue in 2027. So you can expect a little, but consistent with what we've said historically, it's all about getting the right people, the right accounts into the technology and driving deep into those accounts so that we can show you the trajectory ahead.

    而當我們進入今年下半年,事情就會開始變得更令人期待;我們會真正把銷售漏斗建立起來,並向華爾街提供我們在 2027 年擴大營收規模的方向能見度。所以你可以預期會有一些、但不多的營收;而且與我們過去一貫的說法一致,重點在於把對的人、對的客戶導入這項技術,並在這些客戶中深耕,讓你們看到未來的成長軌跡。

  • Unidentified Company Representative

    Unidentified Company Representative

  • And our last webcast question asks, could you elaborate on the medical professionals feedback on the product? How it's differentiating itself in justifying its use as opposed to traditional 12-lead systems? Specifically, do medical professionals think the more frequent measurements from HeartBeam are beneficial as opposed to taking measurements twice a month with a 12-lead?

    我們網路直播的最後一個問題是:能否更詳細說明醫療專業人士對產品的回饋?它如何展現差異化,並合理化其使用,相較於傳統 12 導程系統?具體而言,醫療專業人士是否認為 HeartBeam 更頻繁的量測有益,相較於使用 12 導程每月量測兩次?

  • Robert Eno - Chief Executive Officer, Director

    Robert Eno - Chief Executive Officer, Director

  • Great. Bryan, do you want to handle that one and I'll follow on.

    很好。Bryan,你要不要先回答這題,我再補充。

  • Bryan Humbarger - Chief Commercial Officer

    Bryan Humbarger - Chief Commercial Officer

  • Yes. Yes, I'll start out with that one. So it's a great question. The feedback has been actually exceeded my expectations coming into this. I've had a lot of experience with single and other multi-lead technologies in the past and what's clear from the clinicians is that with other technologies out there, it gives you a little bit of information and maybe opens the door on what's going on with the patient.

    好的。是的,我先來回答。這是個很好的問題。實際收到的回饋,超出我在開始做這件事時的預期。我過去在單導程以及其他多導程技術方面有很多經驗;臨床醫師很清楚的一點是,市面上其他技術只能提供一點資訊,或許能讓你初步了解病人可能發生什麼狀況。

  • But typically, the next step for those patients where there's any concern whatsoever is bringing the patient into the office to get a 12-lead ECG or sometimes into the emergency department.

    但通常,只要對這些病人有任何疑慮,下一步就是把病人帶回診間做 12 導程心電圖(ECG),有時甚至要送到急診。

  • So I think the -- what's really been interesting to see with our clinicians is the fact that they can finally arm their patients with the same medical grade product that they -- and the same type of technology that if the patient was in the emergency department, they would be getting the full picture of what's going on with that patient. And now it's something that their patients can have anytime anywhere. So it's been really encouraging to see that.

    所以我認為——讓我們的臨床醫師覺得非常有意思的一點是,他們終於可以讓病人配備與醫療等級相同的產品——以及同類型的技術;也就是說,如果病人在急診,他們會得到完整的資訊來了解病人的狀況。而現在,病人可以在任何時間、任何地點擁有它。因此看到這點真的很令人鼓舞。

  • Some of the feedback that we've heard and we were just recently at the HRS conference and some of these other national or international conferences is -- to the second part of that question, I think because there's never really been an opportunity to take 12-lead ECG outside of a hospital or clinic environment, there is a lot of interest to say if we were to have our patients do this once a month or once a week and start looking at the data longitudinally, what are some of the things that we can learn.

    我們聽到的一些回饋——我們最近也參加了 HRS 年會以及其他一些全國性或國際性會議——針對問題的第二部分,我認為因為過去從未真正有機會在醫院或診所環境之外做 12 導程心電圖,所以大家很有興趣探討:如果讓病人每月一次或每週一次進行量測,並長期追蹤這些資料,我們能學到哪些事情。

  • And again, as part of our early adopter experience, these are exactly the types of customers that we're focused on. They're bringing these types of questions. They're very eager to see what the data can provide. And eyes wide open from the standpoint that no one's been able to do this before out of hospital setting on a consistent basis. Rob, anything to add?

    再者,作為我們早期採用者體驗的一部分,這正是我們鎖定的客戶類型。他們提出這類問題。他們非常渴望看看資料能帶來什麼洞見。同時也很清楚:在院外環境中,過去沒有人能夠以一致、持續的方式做到這件事。Rob,你有要補充的嗎?

  • Robert Eno - Chief Executive Officer, Director

    Robert Eno - Chief Executive Officer, Director

  • Great answer, Bryan. The only very little to add. I'll just say that the other thing which is interesting is some of the things we have in the pipeline that we've talked about before, such as wellness algorithms like cardiac age that we can do off of the ECG based on 12-lead ECG is, we think, really differentiated and the physicians are quite excited about.

    回答得很好,Bryan。我只補充一點點。我想說,另一個有趣的地方是,我們先前談過的一些研發管線內容,例如健康(wellness)演算法,像是我們可以基於 12 導程心電圖(ECG)推算的心臟年齡;我們認為這非常具差異化,醫師們也相當興奮。

  • Unidentified Company Representative

    Unidentified Company Representative

  • That concludes our question-and-answer session.

    以上結束我們的問答環節。

  • Operator

    Operator

  • Thank you. Ladies and gentlemen, we have reached the end of question-and-answer session. I would now like to turn the floor over to Mr. Eno for closing comments.

    謝謝。各位女士、先生,我們已到達問答環節的結束。接下來我想把時間交給 Eno 先生做結語。

  • Robert Eno - Chief Executive Officer, Director

    Robert Eno - Chief Executive Officer, Director

  • Thank you, operator. I'd like to thank each of you for joining our earnings conference call today. We look forward to continue to update you on our ongoing progress and growth. If we were unable 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 very much.

    謝謝,接線員。感謝各位今天參加我們的財報電話會議。我們期待持續向各位更新我們正在進行的進展與成長。若今天未能回答各位的任何問題,請聯繫我們的投資人關係(IR)公司 MZ Group,他們將非常樂意提供協助。非常感謝。

  • Operator

    Operator

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

    謝謝。今天的電話會議到此結束。您現在可以掛斷電話線。感謝您的參與。