使用警語:中文譯文來源為 AI 翻譯,僅供參考,實際內容請以英文原文為主
Operator
Operator
Greetings, and welcome to the Heart beam fourth-quarter 2025 financial results conference call.
各位好,歡迎參加 Heartbeam 2025 年第四季財務業績電話會議。
(Operator Instructions).
(接線員指示)。
As a reminder, today's conference is being recorded. Before we begin the formal presentation, I would like to remind everyone that statements made on the call today and webcast may include predictions, estimates or other information that might be considered forward-looking.
提醒各位,今天的會議將會錄音。在我們開始正式簡報之前,我想提醒大家,今天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。
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.
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,可能導致實際結果出現重大差異。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觀點。
Please keep in mind that we are not obligating ourselves to revise or publicly release the results of any revisions to these forward-looking statements in 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 predictions. You should also review our most recent Form 10-K for a more complete discussion of these factors and other risks, particularly under the heading Risk Factors.
請記得,我們不承擔因新資訊或未來事件而修訂這些前瞻性陳述,或公開發布任何修訂結果之義務。在今天的討論中,我們將嘗試說明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,以更完整了解這些因素與其他風險,特別是「風險因素」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, hartbeam.com. Your host today, Rob Eno, Chief Executive Officer; Tim Crookshank, Chief Financial Officer; and Brian Hamburger, Chief Commercial Officer, will present results of operations for the fourth-quarter ended December 31, 2025.
本日下午,我們已透過新聞稿發布本次業績,並可於本公司網站 hartbeam.com 的投資人關係專區取得。今天的主持人為執行長 Rob Eno、財務長 Tim Crookshank,以及商務長 Brian Hamburger;他們將報告截至 2025 年 12 月 31 日止第四季的營運成果。
It is now my pleasure to turn the call over to Heartbeam Chief Executive Officer, Mr. Rob now. You may begin, sir.
現在我很高興將電話會議交給 Heartbeam 執行長 Rob 先生。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 an overview of the heart beam system, the core technology in our platform. Brian Hamburger, our new Chief Commercial Officer, will provide an overview of our limited commercial launch. We'll then provide updates on heart attack detection; we unveiled the working prototype of our 12-lead patch and provide the latest on our AI initiatives 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在投影片上。我們將先概述 Heartbeam 系統,也就是我們平台的核心技術。我們的新任商務長 Brian Hamburger 將概述我們的有限商業化上市。接著我們將提供心肌梗塞偵測的最新進展;我們將展示 12 導程貼片的可運作原型,並更新我們的 AI 計畫,之後再說明財務結果。最後進行問答。
I also want to note that this presentation as well as an updated company presentation will be available in the investor portion of the Heart beam website. Before we dive into updates since our last call in November, I want to remind everyone about our initial product, the heart beam system, and our platform technology.
我也想說明,本簡報以及更新後的公司簡報將可在 Heartbeam 網站的投資人專區取得。在我們深入說明自上次 11 月電話會議以來的更新之前,我想先提醒大家我們的初始產品 Heartbeam 系統,以及我們的平台技術。
Hart beam is dedicated to developing groundbreaking ECG technology for patients to use at home to allow them to feel confident about their heart health. HeartBeam be has developed the first-ever portable cable-free ECG that can synthesize a 12-lead ECG. Our unique IP-protected approach captures the heart's electrical signals in three dimensions or non-coplanar directions and synthesizes the signal into a 12-lead.
Heartbeam 致力於開發突破性的心電圖(ECG)技術,讓病患可在家中使用,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。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)方向擷取心臟電訊號,並將訊號合成為 12 導程。
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 an on-demand cardiologist who can interpret the clinical grade ECG in triage patients appropriately to ensure timely care.
本系統設計為便於攜帶,且讓病患能在任何地點、任何時間、症狀出現時立即使用。此技術並由按需的心臟科醫師支援,可解讀臨床等級 ECG,並適當分流病患,以確保及時照護。
In December, we achieved a major milestone when Harbin's 12-lead synthesis software received FDA 510(k) clearance for a Rhythmia assessment. This clearance, combined with the foundational 510(k) clearance for the heart beam system itself in December 2024 validates the unique approach of our technology and provides the basis for a limited or initial commercial launch.
在 12 月,我們達成一項重大里程碑:Heartbeam 的 12 導程合成軟體取得 FDA 510(k) 核准,用於心律不整評估。此項核准,加上 2024 年 12 月 Heartbeam 系統本體所取得的基礎 510(k) 核准,驗證了我們技術的獨特方法,並為有限或初期的商業化上市奠定基礎。
Just to note that in November, we received a not substantially equivalent or NSE letter from the FDA but we immediately engaged with the agency and we're able to get the NSE overturned in 2.5 weeks, resulting in the FDA clearance in December. This rapid turnaround is a testament to our regulatory team and the willingness of the FDA to work with us productively to achieve a solution.
補充說明:在 11 月,我們收到 FDA 的「不具實質等同性」(NSE)函,但我們立即與主管機關溝通,並在 2.5 週內成功推翻 NSE,因而於 12 月取得 FDA 核准。如此快速的進展,證明了我們法規團隊的能力,也顯示 FDA 願意與我們以具建設性的方式合作以達成解決方案。
Heart beans technology is a true platform, the core of this system is our 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.
Heartbeam 的技術是真正的平台;本系統的核心是我們的訊號收集技術,可在三個軸向擷取心臟電訊號: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. As I noted, we have our two FDA clearances on the heart beam system the credit card size form factor, and we're embarking on a launch of that system. In the background, we also have been developing a 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 with established reimbursement that consists of the long-term continuous monitor and the mobile cardiac telemetry or MCT segments. We're unveiling the details of our 12 lead patch for the first time today.
這項核心技術可應用於多種外形規格。如我所述,我們已就 Heartbeam 系統(信用卡大小的外形)取得兩項 FDA 核准,並正著手推動該系統的上市。同時,我們也在開發第二種外形規格:可按需取得 12 導程的延長配戴貼片。我們相信此貼片可顛覆可攜式心臟監測市場;該市場年營收約 20 億美元,且已有成熟的給付機制,包含長期連續監測與行動心臟遙測(MCT)等區隔。今天我們將首次揭露 12 導程貼片的細節。
The technology in these 2 form factors has the potential to enable a full range of 12-lead ECG capabilities, including the currently cleared arrhythmia assessment and future indications for heart attack detection and personalized AI algorithms. We'll discuss our progress toward heart attack detection and personalized AI algorithms today.
這兩種外形規格中的技術,具備啟用完整 12 導程 ECG 能力的潛力,包括目前已核准的心律不整評估,以及未來用於心肌梗塞偵測與個人化 AI 演算法的適應症。今天我們將討論在心肌梗塞偵測與個人化 AI 演算法方面的進展。
We want to provide updates on our progress on all 4 of our major initiatives. First, Brian will give an overview of our limited commercial launch. Then I'll provide updates on heart attack detection will unveil our 12-lead patch, and I'll provide the latest on our AI efforts. And with that, I'll hand it over to Brian Homburger, who joined Heartbeam in January as our Chief Commercial Officer. Brian has over 25 years' experience commercializing novel medical technologies, including meeting the commercial efforts at Heart flow, AliveCore and Echo.
我們希望就四項主要計畫的進展提供更新。首先,Brian 將概述我們的有限商業化上市。接著我將更新心肌梗塞偵測、揭露我們的 12 導程貼片,並提供 AI 工作的最新進展。接下來,我把時間交給 Brian Homburger;他於 1 月加入 Heartbeam,擔任我們的商務長。Brian 擁有超過 25 年將創新醫療技術商業化的經驗,曾領導 Heartflow、AliveCor 與 Echo 的商業化工作。
I'm thrilled to have Brian lead our commercial efforts. Brian?
我非常高興由 Brian 來領導我們的商業化工作。Brian?
Branislav Vajdic - President, Founder, Director
Branislav Vajdic - President, Founder, Director
Thank you for the introduction, Rob. I am truly honoured to be joining the heart team at such a pivotal moment for the company. In my first few weeks, I've had the opportunity to travel across the country and witness firsthand the strong demand among both patients and physicians for a wireless personal 12-lead ECG platform.
謝謝你的介紹,Rob。能在公司如此關鍵的時刻加入 Heartbeam 團隊,我深感榮幸。在加入後的前幾週,我有機會走訪全國各地,親眼見證病患與醫師對無線個人 12 導程 ECG 平台的強勁需求。
The enthusiasm for this level of clinical insight delivered in such an accessible form factor is unmistakable. For our initial commercial launch, we are focusing on concierge and preventive cardiology practices, where we expect based on early engagements, strong traction, coming on board, my objectives were clear, prove there is a willingness to pay for the technology and show evidence of demand.
對於以如此易於取得的外形規格提供這種程度臨床洞見的熱情,顯而易見。就我們的初期商業化上市而言,我們聚焦於禮賓醫療與預防心臟科診所;根據早期接觸,我們預期將獲得強勁動能。我上任時的目標很明確:證明市場願意為此技術付費,並展現需求的證據。
In addition to what we are highlighting today, I'm seeing excitement that is leading to Heartbea building a robust pipeline of accounts that are getting in line to deploy our technology. Today, more than 1.5 million Americans already pay out of pocket for concierge medicine.
除了我們今天重點分享的內容之外,我也看到這股興奮正促使 Heartbeam 建立強健的客戶管線,許多客戶正排隊準備部署我們的技術。目前已有超過 150 萬名美國人自費支付禮賓醫療服務。
Many of these patients spend between $3,000 and $10,000 per year on proactive health care. We have conducted extensive market research with high net worth individuals and concierge physicians. High net worth individuals are highly likely to adopt advanced health technology and show a strong willingness to pay for the heart beam system, which combines the 12 league capabilities with access to cardiology expertise.
其中許多患者每年在主動式健康照護上的支出介於 3,000 至 10,000 美元之間。我們已針對高淨值人士與禮賓醫師進行廣泛的市場研究。高淨值人士極有可能採用先進健康科技,並對 Heart beam 系統展現強烈的付費意願;該系統結合 12 導程能力與心臟科專業資源的可近性。
And importantly, physicians and concierge practices are highly likely to recommend Harbin to their patients. Our target price per patient is $500 to $1,000 per year. This is a small fraction of what concierge patients are currently spending for their memberships.
更重要的是,醫師與禮賓診所極有可能向其患者推薦 Harbin。我們的目標定價為每位患者每年 500 至 1,000 美元。這僅占禮賓患者目前為其會員資格所支付費用的一小部分。
Our launch strategy starts with a very focused rollout in concierge cardiology and executive health which is a small subset of the 1.5 million concierge patients. These practices typically serve between 400 and 4,000 patients and are concentrated in key markets like New York, South Florida, Dallas, and Southern California.
我們的上市策略將從禮賓心臟科與高階主管健康管理(executive health)進行高度聚焦的推廣開始;這是 150 萬名禮賓患者中的一個小型子集合。這些診所通常服務 400 至 4,000 名患者,並集中於紐約、南佛羅里達、達拉斯與南加州等關鍵市場。
We are encouraged by these opportunities, and we expect to engage them with a very targeted commercial team. They also tend to be physician-owned and highly innovative in adopting new technologies, even capturing a relatively small portion of this market can create meaningful early revenue for Harte.
我們對這些機會感到振奮,並預期以高度精準的商務團隊與其接洽。這些機構也多為醫師自營,且在採用新技術方面高度創新;即使只取得該市場相對小的一部分,也能為 Harte 帶來具意義的早期營收。
In fact, we believe breakeven could be achieved within this segment alone. Once we validate adoption and refine our implementation model, we then go deeper into the broader concierge market. Beyond the concierge market, there are expansion opportunities in the larger patient pay segment, including direct primary care practices, telehealth networks, and eventually national health care organizations.
事實上,我們相信僅靠這一細分市場就可能達到損益兩平。一旦我們驗證採用情況並精進導入模式,接著將更深入拓展至更廣泛的禮賓市場。除禮賓市場外,我們也有機會擴展至更大的自費患者市場,包括直接初級照護(direct primary care)診所、遠距醫療網路,以及最終的全國性醫療照護組織。
This approach allows us to prove the model in a concentrated market first and then scale. We have a clear plan for commercialization. We are in the exciting position of introducing groundbreaking technology, and we don't expect demand to be a limiting factor. But as we build this market, we will be measured and take a staged approach. As we introduce Heart beam, we will be validating our premium value proposition and refining our systems and processes.
此方法讓我們能先在高度集中的市場中驗證模式,之後再擴大規模。我們有清晰的商業化計畫。我們正處於導入突破性技術的令人振奮位置,且不預期需求會成為限制因素。但在建立市場的過程中,我們將審慎推進並採取分階段策略。在導入 Heart beam 的同時,我們將驗證高端價值主張並精進我們的系統與流程。
In the second half of this year, we will be demonstrating deep adoption with our anchor accounts and establishing the funnel for 2027. 2027 will be all about scaling revenue.
在今年下半年,我們將在核心(anchor)客戶中展現深度採用,並為 2027 年建立銷售漏斗。2027 年將以營收擴張為主軸。
Our business model is designed to scale efficiently rather than selling directly to individual patients. We will partner with medical practices. One relationship with a practice can result in hundreds or even thousands of patients enrolling in Harbin. That approach creates a highly efficient distribution model at a strong recurring revenue stream.
我們的商業模式旨在高效率擴張,而非直接向個別患者銷售。我們將與醫療診所合作。與一家診所建立合作關係,就可能帶來數百甚至數千名患者加入 Harbin。此作法可形成高度高效的通路模式,並帶來強勁的經常性收入來源。
Financially, this translates into a subscription model with margins above 70% and a payback period of just three to five months on initial onboarding costs. We believe that we can reach cash flow breakeven at roughly 30,000 patients. A key part of our launch strategy is partnering with leading cardiology and concierge practices that want to deeply integrate Heart beam into their care models.
在財務面,這將轉化為訂閱制模式,毛利率高於 70%,且初始導入成本的回收期僅約三到五個月。我們相信約在 30,000 名患者規模即可達到現金流損益兩平。我們上市策略的關鍵之一,是與希望將 Heart beam 深度整合至其照護模式的領先心臟科與禮賓診所合作。
We are thrilled to have our first commercial customer Clear Cardio, which will be an excellent early adopter partner. Clear cardio serves a highly engaged premium patient population in markets such as Dallas and New York and are expanding into additional East and West Coast markets this year. Their patients already participate in advanced cardiovascular screening and ongoing monitoring, which makes them an excellent fit for Harbin's at-home 12 ECG technology.
我們非常高興迎來第一位商業客戶 Clear Cardio,這將是極佳的早期採用者合作夥伴。Clear Cardio 在達拉斯與紐約等市場服務高度投入的高端患者族群,並於今年擴展至更多東、西岸市場。其患者已參與先進的心血管篩檢與持續監測,因此非常適合 Harbin 的居家 12 導程心電圖(ECG)技術。
Our goal with partnerships like this is to go deep with adoption in the practice. Our launch strategy is laid out here. We will start with a small number of practices like Clear cardio, we will partner with these practices and drive deep patient adoption and engagement. This will give us the proof points we need such as white papers and testimonials to allow us to expand to a larger number of practices.
我們與此類合作的目標,是在診所內推動深度採用。我們的上市策略在此已列示。我們將從少數幾家如 Clear Cardio 的診所開始,與這些診所合作並推動患者的深度採用與參與。這將提供我們所需的佐證,例如白皮書與見證案例,讓我們得以擴展至更多診所。
And now I'll hand it back to Rob.
接下來我把時間交還給 Rob。
Robert Eno - Chief Executive Officer, Director
Robert Eno - Chief Executive Officer, Director
Thanks so much, Brian. With the 12-lead synthesis software clearance, we're embarking on the product launch, but our opportunity is much greater than that. As I mentioned earlier, we have core technology that powers two form factors: the card and the patch and enables multiple 12 lead applications.
非常感謝你,Brian。隨著 12 導程合成軟體取得核准,我們正啟動產品上市,但我們的機會遠不止於此。如我先前提到,我們擁有可支援兩種外型(form factor)的核心技術:卡片與貼片,並可實現多種 12 導程應用。
So next, I'd like to discuss our efforts on heart attack detection. As we discussed previously, 1 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.
接下來,我想談談我們在心肌梗塞偵測方面的工作。如我們先前討論,心臟科的一大問題是:對於出現胸痛的患者而言,沒有良好的方式判斷自己是否正在心肌梗塞。
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%. 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 are not applicable for home use.
患者在尋求醫療照護前平均會等待 3 到 4 小時,而每延遲 30 分鐘,死亡風險就增加 7.5%。12 導程心電圖(ECG)是偵測心肌梗塞的標準,但傳統 12 導程心電圖需要由技術人員放置 10 個有線電極,因此不適用於居家使用。
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. Hart beam's technology has the potential to address this major need. We have multiple proof-of-concept studies showing that the heart beam ECG is similar to a standard 12-lead ECG in detecting heart attacks.
這是一個重大問題:美國有 2,000 萬人有心肌梗塞風險,其中包括 800 萬名曾發生過心肌梗塞的人。Hart beam 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,Heart beam 的心電圖在偵測心肌梗塞方面與標準 12 導程心電圖相近。
One important point about this effort is that's the same heart team system that we're launching with an expanded indication. We announced last week that we have started patient enrolment in the ALIGN ACS study, a European pilot study comparing the heartbet CG to a standard 12-lead ECG in detecting heart attacks.
關於這項工作的重點之一是:這正是我們即將上市、並擴大適應症的同一套 Heart team 系統。我們上週宣布已在 ALIGN ACS 研究中開始招募患者;這是一項歐洲試點研究,用以比較 heartbet CG 與標準 12 導程心電圖在偵測心肌梗塞方面的表現。
The study is conducted in the emergency room, enrolling patients who arrive with chest pain. This will allow the study to enrol much more rapidly than a study that prescribe devices to patients and waited for them to have events. We expect the study to complete by the end of the third-quarter of 2026, and that study will inform the design of our FDA pivotal study.
該研究在急診室進行,招募因胸痛而就診的患者。這將使研究能比「將裝置開立給患者並等待其發生事件」的研究更快速完成招募。我們預期研究將於 2026 年第三季末完成,而該研究將為我們 FDA 關鍵性試驗(pivotal study)的設計提供資訊。
Our core technology powers two form factors. So far, we've spoken about the heart beam system with its credit card size ECG collection device but we've been working behind the scenes on the development of our second form factor, and we're excited to unveil that here today, an on-demand 12-lead patch.
我們的核心技術可支援兩種外型。到目前為止,我們談的是 Heart beam 系統及其信用卡大小的心電圖採集裝置;但我們也在幕後進行第二種外型的開發,並很高興在今天於此揭露:一款可隨需使用的 12 導程貼片。
We believe that the heart Beam 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 record the patient's heart rhythms, this is a rapidly growing $2 billion revenue market with existing reimbursement.
我們相信 Heart Beam 12 導程貼片能顛覆可攜式(ambulatory)心臟監測市場。此市場由可配戴長達 30 天、並持續記錄患者心律的貼片所構成;這是一個快速成長、年營收達 20 億美元且已有既有給付(reimbursement)的市場。
It consists of two segments, long-term continuous monitors, and mobile cardiac telemetry or MCT. These devices around one to three leads and are limited to arrhythmia detection and monitoring. Heart beam has developed an on-demand 12-lead patch and has produced a working prototype of the device and functions just like existing patches, continually recording the patient's heart rhythms with a single lead.
該市場包含兩個區隔:長期連續監測器,以及行動心臟遙測(mobile cardiac telemetry,MCT)。這些裝置約為 1 到 3 導程,功能受限於心律不整的偵測與監測。Heart beam 已開發一款可隨需使用的 12 導程貼片,並已製作出可運作的原型;其運作方式與現有貼片相同,以單一導程持續記錄患者的心律。
But using Heartbeam's patented core technology, a patient simply places two fingers on the front of the device, to record a clinical grade 12-lead ECG. This has the potential to bring better diagnostic capabilities and even ischemia detection to the patch segment. The device integrates into existing workflows and leverages the existing reimbursement.
但運用 Heartbeam 具專利的核心技術,患者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)。這有潛力為貼片(patch)細分市場帶來更佳的診斷能力,甚至可進行缺血(ischemia)偵測。該裝置可整合至既有工作流程,並善用現有的保險給付(reimbursement)。
We believe this will be the best-in-class patch. We've recently completed a third-party market research survey, which clearly demonstrates the potential of the product. 86% of physicians said they would shift a portion of their patches to the 12-lead patch.
我們相信這將是同級最佳(best-in-class)的貼片。我們近期完成一項第三方市場研究調查,清楚顯示該產品的潛力。86% 的醫師表示,他們會將部分貼片改用 12 導程貼片。
On average, they said they would shift 61% of their patch prescriptions. This implies the potential to shift fully half of the market. In addition, 94% of the physicians said they would shift a portion of other cardiac monitoring devices such as Holter monitors. Many Holter monitors are 12 lead but use traditional wired electrodes so are not practical for extended use.
平均而言,他們表示會將 61% 的貼片處方轉移。這意味著有潛力帶動整體市場中將近一半的轉移。此外,94% 的醫師表示,他們也會將其他心臟監測裝置(例如 Holter 監測器)的一部分轉移過來。許多 Holter 監測器雖為 12 導程,但使用傳統有線電極,因此不適合長時間使用。
The market research also showed that the 12-lead patch could grow the patch market. Patients who feel cardiac symptoms don't know if they're experienced arrhythmias or ischemia, they just know that something doesn't feel right. If there was an on-demand 12-week patch, 64% of physicians said they would prescribe more patches with an average increase of 45%.
市場研究也顯示,12 導程貼片可擴大貼片市場。感覺到心臟症狀的患者並不知道自己經歷的是心律不整(arrhythmias)還是缺血,他們只知道身體感覺不對勁。若有可隨需使用的 12 週貼片,64% 的醫師表示會開立更多貼片處方,平均增加 45%。
This implies that the market as a whole could grow immediately by 30%. Here's a video of the heart beam patch in action. Please note, those of you who have dialled into the call will not hear the audio, so experience approximately a minute of silence.
這意味著整體市場可立即成長 30%。以下是一段 Heartbeam 貼片實際運作的影片。請注意,撥入電話會議的各位將聽不到音訊,因此大約會有一分鐘的靜音。
(video playing)
(影片播放中)
We have a prospective clinical study underway on the device, and we look forward to providing more detail soon. We'll continue to engage with interested parties on the possibility of partnering to bring the 12-week patch to market, and we're excited for these conversations to advance now that we've completed the working prototype of the patch.
我們正在針對該裝置進行一項前瞻性臨床研究,並期待很快提供更多細節。我們也將持續與有興趣的各方就合作將 12 週貼片推向市場的可能性進行交流;隨著我們已完成貼片的可運作原型(working prototype),我們也很期待這些對話能進一步推進。
The final of our strategic initiatives is AI, which can be applied to both the card and the patch form factors. Our 3D signal collection and 12-week synthesis provide valuable information for physicians but we're developing AI algorithms that can provide deeper insights.
我們策略性計畫的最後一項是 AI,可同時應用於卡片式與貼片式兩種產品形態。我們的 3D 訊號收集與 12 導程合成可為醫師提供有價值的資訊,但我們也正在開發 AI 演算法,以提供更深入的洞見。
Deeper algorithms applied to standard 12-lead ECG exist today and are one of the most powerful use cases of AI and medicine. There are dozens of AI algorithms applied to 12 leads that can screen for asymptomatic diseases and predict the onset of disease across a number of conditions.
目前已存在可套用於標準 12 導程心電圖的進階演算法,且是 AI 在醫療領域最強大的應用情境之一。已有數十種應用於 12 導程的 AI 演算法,可用於篩檢無症狀疾病,並在多種病況下預測疾病發生。
But these algorithms are locked in the hospital. They require that the patient undergo a standard 12-lead ECG. Hard BMS the potential to take deep learning algorithms to the patient, applying them every time a patient takes a reading with the heart beam device.
但這些演算法被鎖在醫院裡。它們要求患者接受標準 12 導程心電圖檢查。Heartbeam 具備將深度學習演算法帶到患者端的潛力,讓患者每次使用 Heartbeam 裝置量測時都能套用這些演算法。
This could allow for more robust performance, more personalized risk assessments, and greater predictive power. Expanding beyond symptom-driven assessments such as arrhythmia and hard site detection to disease prediction and ongoing management can open up new markets and has the potential to enable new reimbursement pathways.
這可帶來更穩健的表現、更個人化的風險評估,以及更強的預測能力。從以症狀驅動的評估(如心律不整與缺血偵測)擴展到疾病預測與持續管理,能開啟新市場,並有潛力促成新的保險給付途徑。
Harum's assembled a top AI team led by Lance Myers, the former Head of AI at Google Verily. And just this week, we announced a strategic collaboration with Mount Sinai. This will combine our expertise and our collection technology with Sinise expertise and clinically annotated ECG data. We're very excited about the potential of this collaboration and the benefits to patients of bringing these advanced algorithms to the heart beam device.
Heartbeam 已組建一支頂尖 AI 團隊,由前 Google Verily AI 負責人 Lance Myers 領軍。而就在本週,我們宣布與 Mount Sinai 建立策略合作。此合作將結合我們的專業與訊號收集技術,以及 Sinai 的專業與具臨床註記的心電圖資料。我們對這項合作的潛力,以及將這些先進演算法帶到 Heartbeam 裝置、為患者帶來的效益,感到非常振奮。
One of the initial focuses of the joint effort will be an algorithm to help physicians in the assessment of heart attacks. In addition, there are plans for a series of wellness and clinical algorithms, including screening and prediction.
這項共同計畫的初期重點之一,將是協助醫師評估心肌梗塞(heart attacks)的演算法。此外,也規劃推出一系列健康管理與臨床演算法,包括篩檢與預測。
We've made a lot of progress in recent months, and we have plans to advance all four of these initiatives significantly this year. Here are the major milestones we have planned across our limited commercial launch Arti tech detection, the 12-lead patch in AI. We've already achieved significant milestones on each initiative.
過去幾個月我們取得了許多進展,並計畫在今年大幅推進這四項計畫。以下是我們在有限度商業化上市、心肌梗塞偵測、12 導程貼片與 AI 等方面所規劃的主要里程碑。我們在每項計畫上都已達成重要里程碑。
For the limited commercial launch after receiving the clearance of the 12-week synthesis software in December, we hired Brian as our CCO, and we have signed our initial collaboration agreement with Clear Cardio.
就有限度商業化上市而言,在 12 導程合成軟體於 12 月取得核准(clearance)後,我們聘請 Brian 擔任首席商務長(CCO),並已與 Clear Cardio 簽署初步合作協議。
For Heart is tack Detection, we initiated the Align ACS pilot study in Europe. We've completed development of the working prototype of the 12-lead patch are conducting clinical studies and are continuing discussions with potential partners.
在心肌梗塞偵測方面,我們已在歐洲啟動 Align ACS 試點研究。我們已完成 12 導程貼片可運作原型的開發,正在進行臨床研究,並持續與潛在合作夥伴洽談。
And finally, in the area of AI, we signed a collaborative agreement with Mount Sinai. In the interest of time, I won't go through every milestone listed on this page, but we expect an exciting year of progress on all fronts. And now I'll turn it over to Tim to discuss our financials.
最後,在 AI 領域,我們已與 Mount Sinai 簽署合作協議。為節省時間,我不會逐一說明本頁列出的每個里程碑,但我們預期今年在各方面都會有令人振奮的進展。接下來我把時間交給 Tim,請他說明我們的財務狀況。
Timothy Cruickshank - Chief Financial Officer
Timothy Cruickshank - Chief Financial Officer
Great. Thanks, Rob. I'll briefly review some key financial highlights for the quarter and the year ended December 31, 2025.
好的。謝謝你,Rob。我將簡要回顧截至 2025 年 12 月 31 日止之季度與年度的一些關鍵財務重點。
Our results continue to reflect strong financial discipline as we advanced key milestones while maintaining a highly capital-efficient operating model. For the full year 2025, net loss was $21 million or $0.62 per basic and diluted share.
我們的成果持續反映出強勁的財務紀律:在推進關鍵里程碑的同時,維持高度資本效率的營運模式。2025 全年淨損為 2,100 萬美元,或每股基本及稀釋淨損 0.62 美元。
And for the fourth-quarter, net loss was $5.3 million or $0.15 per share, which was directly in line with expectations. Importantly, a meaningful portion of that net loss relates to noncash expenses, primarily stock-based compensation.
第四季淨損為 530 萬美元,或每股淨損 0.15 美元,與預期完全一致。重要的是,其中相當一部分淨損與非現金費用相關,主要為以股份為基礎的薪酬(stock-based compensation)。
So as a result, net cash used in operating activities was less than $14 million for the full year and just $2.9 million for the fourth-quarter representing a 3% decrease year-over-year and a 30% decrease compared to the same quarter last year.
因此,全年營運活動所使用的淨現金少於 1,400 萬美元;第四季僅 290 萬美元,分別較去年同期下降 3%,且較去年同季下降 30%。
We believe this reflects our continued focus on maintaining a lean organization and carefully pacing investments that support both commercialization and the continued development of our R&D pipeline.
我們認為,這反映我們持續專注於維持精實的組織架構,並審慎掌控投資節奏,以同時支持商業化與研發管線的持續開發。
Cash and cash equivalents and restricted cash combined totalled $4.4 million at December 31, 2025. We have demonstrated access to capital markets, and we continue to have multiple vehicles available for capital, including our shelf registration and at the market facility as well as continued support from long-term stakeholders who believe strongly in the company's trajectory.
截至 2025 年 12 月 31 日,現金及約當現金與受限制現金合計為 440 萬美元。我們已展現進入資本市場的能力,且仍有多種籌資工具可用,包括我們的擱置式註冊(shelf registration)與隨市發行(at-the-market)機制;同時也持續獲得長期利害關係人支持,他們對公司發展軌跡深具信心。
So looking ahead to 2026, when we look at our cash flow, we expect baseline operating cash outflows to remain at approximately that $14 million level. And then we have a cost-effective rollout for our commercial launches. We continue to maintain and as we continue to maintain heavily variable costs structure for additional R&D initiatives.
展望 2026 年,從現金流角度來看,我們預期基礎營運現金流出將大致維持在約 1,400 萬美元的水準。此外,我們的商業化上市推進將採取具成本效益的推廣方式。同時,針對額外的研發計畫,我們也將持續維持高度可變動的成本結構。
So combining those, the incremental investments tied to the milestones Rob outlined on the earlier slides had just $3 million to $5 million to our cost profile. This is prior to factoring in potential cash receipts from customers and implies gross operating cash outflows of approximately $17 million to $19 million for 2026.
因此把這些合併來看,與 Rob 在先前投影片中概述之里程碑相關的增量投資,僅使我們的成本結構增加約 300 萬至 500 萬美元。這尚未將來自客戶的潛在現金收款納入考量,並意味著 2026 年的總營運現金流出約為 1,700 萬至 1,900 萬美元。
2025 was a transformative year for the company, highlighted by FDA 510(k) clearance for our 12-lead ECG synthesis software, which meaningfully derisk the business and we now enter 2026 with a commercial product, a strong development pipeline and a disciplined operating model and cost structure.
2025 年對公司而言是具轉型意義的一年,亮點包括我們的 12 導程 ECG 合成軟體取得 FDA 510(k) 核准,這大幅降低了業務風險;我們如今以一項商業化產品、強勁的研發管線,以及嚴謹的營運模式與成本結構邁入 2026 年。
So we look forward to updating you all on our continued progress. With that, I'll turn the call back over to Rob in his closing summary.
因此我們期待持續向各位更新我們的進展。接下來,我把電話交回 Rob,請他做結語總結。
Robert Eno - Chief Executive Officer, Director
Robert Eno - Chief Executive Officer, Director
Thanks, Tim. To summarize, 2025 was a pivotal year for Heart beam and we expect 2026 to be one of significant advancement on multiple fronts. The FDA clearance of our 12-week synthesis software was a major milestone for the company.
謝謝,Tim。總結來說,2025 年是 Heartbeam 的關鍵一年,我們預期 2026 年將在多個面向取得顯著進展。我們的 12 導程合成軟體獲得 FDA 核准,是公司的一項重大里程碑。
With that clearance behind us, we're beginning our limited commercial launch. Brian clearly laid out the opportunity in our strategy. We're building a new market, and we want to be smart in how we're rolling out the product. We're focusing on signing practices that see value in the technology and want to drive deep adoption with their patients.
在取得該核准後,我們正開始有限度的商業化上市。Brian 已清楚闡述我們策略中的機會。我們正在打造一個新市場,並希望以審慎的方式推動產品上市。我們聚焦於簽下能看見此技術價值的診所,並希望在其病患中推動深度採用。
We're excited to have Clark Cardio be the first of these early practices. We expect to take the proof points from the early experience to drive wider adoption. We've made significant strides in heart attack detection with enrolment underway on the line ACS, the pilot study on the heart beam system compared to a standard 12-lead ECG and detecting heart attacks.
我們很高興 Clark Cardio 成為這些早期診所中的第一家。我們預期將從早期經驗中取得的驗證要點,用以推動更廣泛的採用。在心肌梗塞偵測方面,我們已取得重大進展,Align ACS 試點研究已開始收案;該研究將 Heartbeam 系統與標準 12 導程 ECG 進行比較,以偵測心肌梗塞。
This study is taking place in emergency rooms, which should lead to rapid enrolment and the study will inform our FDA pivotal study. On this call, we unveiled the heart beam on-demand 12 lead patch. We've been working hard on the second form factor for some time and now have a fully working system that's currently being used in clinical trials.
這項研究在急診室進行,應可帶來快速收案,且研究結果將為我們的 FDA 關鍵性試驗提供資訊。在本次電話會議中,我們揭露了 Heartbeam 隨需 12 導程貼片。我們在第二種外形規格上已努力一段時間,現在已擁有一套完整可運作的系統,並正用於臨床試驗。
We believe that this is disruptive to the existing path market and the market research indicates it can drive significant market share shifts and grow the market. We're in discussions with potential partners. Finally, our AI efforts have taken a major step forward with the strategic collaboration we just announced with Mount Sinai.
我們相信這將顛覆既有的貼片市場,而市場研究顯示它可推動顯著的市占率轉移並擴大市場規模。我們正與潛在合作夥伴洽談。最後,我們的 AI 工作也因剛宣布與 Mount Sinai 的策略合作而向前邁出一大步。
By joining forces, we believe we can accelerate bringing advanced algorithms to the heart beam system. As Tim noted, we've made significant progress by maintaining strong financial discipline. We're excited about the major milestones we've achieved and the opportunities in front of us across multiple fronts. We thank you all for attending. I would like to open it up to Q&A. Operator?
透過攜手合作,我們相信能加速將先進演算法導入 Heartbeam 系統。如 Tim 所提,我們透過維持嚴謹的財務紀律取得了顯著進展。我們對已達成的重大里程碑,以及在多個面向所面臨的機會感到振奮。感謝各位出席。我想開放進入問答。接線員?
Operator
Operator
Thank you. We will now begin the question-and-answer session. (Operator Instructions)
謝謝。我們現在開始問答環節。(接線員指示)
Kyle Bauser, Roth Capital Partners.
Kyle Bauser,Roth Capital Partners。
Kyle Bauser - Analyst
Kyle Bauser - Analyst
Great. And congrats on all the updates. A lot going on. Rob, maybe starting with some of the initiatives. So for the LINE pilot study, a really nice trial design obviously makes enrolment about as straightforward as you could ask for. And also appreciate the updates on the patch initiatives. Can you talk a little bit more about the timelines for both of these?
太好了。也恭喜你們所有更新,事情很多。Rob,或許先從一些計畫談起。就 LINE 試點研究而言,試驗設計非常不錯,顯然讓收案幾乎是你能期待的那種順暢程度。也感謝你們對貼片計畫的更新。你能否再多談一些這兩者的時程?
I know things are underway. And as you learn more, it will kind of inform future studies but just trying to get a sense of kind of the cadence, what are the milestones you need to hit and the timelines associated with those.
我知道事情正在進行中。而且隨著你們學到更多,也會在某種程度上為後續研究提供方向;但我想掌握一下節奏:你們需要達成哪些里程碑,以及相對應的時程。
Robert Eno - Chief Executive Officer, Director
Robert Eno - Chief Executive Officer, Director
Sure, Kyle. Yes, I can talk at a high level. It's obviously still early. So for heart attack detection, as I said, we've started the Align ACS pilot study. That's on the order of about 100 patients.
當然可以,Kyle。是的,我可以從較高層次來談。目前顯然仍在早期階段。就心肌梗塞偵測而言,如我所說,我們已啟動 Align ACS 試點研究。規模大約是 100 位病患。
And as you suggested, because it's done in emergency rooms where there are many patients per day showing up with chest pain, it should enrol rapidly. The study design is basically the patients when they come in, they get a 12-lead ECG, then they're waiting for the next step. They then get enrolled. They'll get another 12-week ECG and our device very close in time.
如你所提,因為是在急診室進行,每天都有許多胸痛病患就診,因此應可快速收案。研究設計基本上是:病患進來時先做一次 12 導程 ECG,接著等待下一步。之後他們會被納入研究。他們將再做一次 12 導程 ECG,並在時間上非常接近地使用我們的裝置。
And we compare both of those to the discharge diagnosis, trying to show that we're comparable in terms of the accuracy of detecting a heart attack with the symptoms, history and -- we're expecting battle and real quickly. We're saying by the end of Q3 is our expectation. And we also said that that's going to inform the pivotal study.
我們會將這兩者與出院診斷進行比較,試圖證明在結合症狀、病史以及——我們預期能很快完成收案並迅速得到結果。我們的預期是到第三季末。我們也提到,這將為關鍵性試驗提供資訊。
So there will be a pivotal study needed for FDA. We've had early discussions with them. We need to continue to have discussions. And obviously, this study design and the results will inform the pivotal study. So in general, it's the pilot study followed by the pivotal study and then the regulatory review.
因此,向 FDA 申請仍需要一項關鍵性試驗。我們已與他們進行初步討論。我們需要持續進行討論。而且顯然,這項研究的設計與結果將為關鍵性試驗提供依據。總體而言,就是先試點研究、再關鍵性試驗,然後進入法規審查。
We haven't finalized what the regulatory path will be. So that will be forthcoming both the timelines and the official path as we get further in our discussions with FDA, and we'll keep you posted on that. And as far as the patch goes, A couple of things on that. What we know is that we expect -- although we haven't vetted it fully, we expect it will be a 510(k) because we have predicates of our heart beam system with its 12-lead synthesis as of 510(k) now, and then the patch products are 510(k).
我們尚未最終確定法規路徑。因此,隨著我們與 FDA 的討論更深入,時程與正式路徑都會在後續提供,我們也會持續向各位更新。至於貼片方面,有幾點。我們所知道的是——雖然尚未完全驗證——我們預期會走 510(k),因為我們的 Heartbeam 系統及其 12 導程合成已取得 510(k) 作為既有前例,而貼片產品本身也屬於 510(k)。
So those get combined together. As far as the go-to-market strategy and the timelines still to be determined, we have the ability to bring that to market ourselves. But as I've mentioned, we think if we are able to combine with a partner, we may be able to get this in the hands of more patients quickly. So we're having those discussions. And based on that, we'll have a better sense of how the timelines play out.
因此這些會結合在一起。至於上市策略與時程仍待確定,我們有能力自行將其推向市場。但如我提過,我們認為若能與合作夥伴結合,可能可以更快讓更多病患使用到這項產品。因此我們正在進行相關討論。並將依此更清楚掌握時程如何展開。
Kyle Bauser - Analyst
Kyle Bauser - Analyst
Got it. I appreciate that. And then maybe next for Brian, welcome to the team. Thanks for the thoughts on the commercialization strategy. You talked about the importance of anchor accounts to drive things like white papers and testimonials. Just kind of curious, what does the account pipeline look like? And how many anchor accounts would you expect to have kind of up and running over, call it, the next 6 months or so?
了解。謝謝你的說明。接著可能問 Brian,歡迎加入團隊。也謝謝你對商業化策略的看法。你提到錨定客戶(anchor accounts)對推動白皮書與客戶證言等的重要性。我有點好奇,目前的客戶管線看起來如何?以及你預期在接下來大約 6 個月左右,會有多少個錨定客戶能夠上線運作?
Branislav Vajdic - President, Founder, Director
Branislav Vajdic - President, Founder, Director
Yes. Thanks for the welcome, and great question. So going back to what we laid out before, we're being very focused, very strategic in our entry to the market. So if you talk about the 5 million patients today that are paying for some sort of concierge or preventive medical care. Within that, about $1.5 million are kind of in this concierge space that are really focused on a higher level.
是的。謝謝你的歡迎,問題也問得很好。回到我們先前所說的,我們在進入市場時非常聚焦、非常有策略。如果你談到目前有 500 萬名病患正在支付某種禮賓式或預防性醫療照護的費用。其中大約有 150 萬名屬於這種禮賓式服務領域,且真正聚焦在更高層級的服務。
And then where we are really entering the market is that 10% of that -- the top 10%, it's about 150,000 patients, and they're really concentrated to three or four geographies throughout the United States. The reason we're focusing on those is really because there is the strong willingness to pay by that patient population.
而我們真正切入市場的位置,是其中的 10%——也就是前 10%,大約 15 萬名病患,而且他們主要集中在美國三到四個地理區域。我們之所以聚焦在那些區域,主要是因為該病患族群有很強的付費意願。
It's more of a premium patient population as well as because of the type of concierge, the cardiology concierge and the executive concierge, there's a very high-touch patient physician relationship there. And so with that, we are hyper focused. We really feel that focusing that area, it's a very target-rich environment.
這也是較偏高端的病患族群;此外,由於禮賓服務的型態——心臟科禮賓與高階主管禮賓——病患與醫師之間存在非常高接觸度的關係。因此在這方面,我們會高度聚焦。我們確實認為聚焦在這個領域,是一個目標非常密集的環境。
We don't see or feel that there's going to be a lack of demand. As I mentioned before, we only -- 20% of that population alone could take us to a breakeven point. It's a very large market. It's going to really inform us on what we need to go to scale and move forward. So to answer your question, what we're looking at is really focusing on several accounts in the first couple of quarters here so that we can validate our premium value proposition and then really start to scale after that.
我們不認為、也不覺得需求會不足。如我先前提到的,光是那個族群的 20%——就能讓我們達到損益兩平。這是一個非常大的市場。它也會真正告訴我們,要如何擴大規模並持續往前推進。所以回答你的問題,我們接下來要做的是在接下來一兩個季度先聚焦在幾個客戶帳戶上,以便驗證我們的高端價值主張,之後再真正開始擴張。
The bottom line is we do not need to have very many accounts to do that, and we don't think that the time line is going to be very long for us to be able to execute. What we really want to do is make sure that -- we're focusing on the right people. We're driving deep adoption. We're validating and then we can go out and replicate it.
重點是,我們不需要很多帳戶就能做到這件事,而且我們也不認為執行所需的時間會很長。我們真正想做的是確保——我們聚焦在對的人身上。我們推動深度採用。我們完成驗證,然後就能出去複製這個模式。
Kyle Bauser - Analyst
Kyle Bauser - Analyst
And I might just add, that was really great, Brian. I think -- when you think about what our goals are for this initial rollout, these initial accounts have between 400,000 to 4,000 patients. It's all about proving -- the #1 metric we have is proving we can go deep into these accounts efficiently. And so it's less about the number of accounts early days and the proof points of going deep into them for adoption. When we get that, that gives us the blueprint to start to go after that larger 1.5 million patient population, which has large chains that have hundreds of thousands of patients within them.
我也補充一下,Brian,你剛剛講得很棒。我想——當你思考我們這次初期上線、初期導入的目標時,這些初期帳戶的規模介於 40 萬到 4,000 名病患。重點在於驗證——我們的第一大衡量指標,是證明我們能夠有效率地在這些帳戶中做深做透。因此在早期階段,重點比較不在帳戶數量,而在於深入導入、取得採用的證據點。當我們做到這點,就能得到藍圖,開始去攻佔更大的 150 萬名病患族群;那裡有大型連鎖體系,每個體系內就有數十萬名病患。
So we want to get the proof points of efficient, deep adoption and then we can take that blueprint to these larger, more margin focused chains that have hundreds of thousands of patients and start to scale that way.
所以我們希望先取得「有效率、深度採用」的證據點,接著就能把這套藍圖帶到那些更大型、更加重視毛利的連鎖體系——它們擁有數十萬名病患——並以此方式開始擴張。
Timothy Cruickshank - Chief Financial Officer
Timothy Cruickshank - Chief Financial Officer
Sure. Yes. No, I appreciate that. And Tim, maybe just on OpEx, I think you said $17 million to $19 million for the full year in terms of kind of the cash outflows. In terms of R&D, given all the exciting initiatives going on. How should we think about this line item kind of trending or the cadence? Is it kind of similar levels each quarter? Is it stepping up slightly? Any color here would be helpful.
好的。是的。不,我很感謝這些說明。Tim,另外想問一下營運費用(OpEx),我想你提到全年現金流出大約是 1,700 萬到 1,900 萬美元。就研發(R&D)而言,考量到目前有這麼多令人振奮的計畫在進行。我們應該如何看待這個科目的走勢或節奏?每一季大致相近嗎?會略為上升嗎?如果能提供一些補充說明會很有幫助。
Branislav Vajdic - President, Founder, Director
Branislav Vajdic - President, Founder, Director
Yes. The first half of this year, it steps up slightly because of the clinical trials, enrolment there as well as these advanced developments we have on the patch. So when you compare it to Q4 in quarterly numbers, a slight step-up in the first half of the year, but then it goes back down to kind of the levels they're at now by the time you get to the second half of the year, we've been really effective at having milestone-based expenditure.
是的。今年上半年會略為上升,因為臨床試驗的招募,以及我們在貼片上的這些先進開發。所以若以季度數字與第四季相比,今年上半年會小幅上調;但到了下半年時,就會回落到目前這樣的水準。我們在以里程碑為基礎的支出控管上做得很有效率。
So we're able to keep our kind of baseline $14 million, which a big chunk of that is R&D. The reason our OpEx doesn't go up tremendously this year. is because some of that from last year switched off as we hit milestones and now we're basically just replacing existing costs with new focuses on these milestones. So you think about the $17 million to $19 million overall in cash outflow, it's about $1.5 million total over the course of the year, incremental for R&D initiatives.
因此我們能把基準支出維持在約 1,400 萬美元,其中很大一部分是研發。今年我們的營運費用不會大幅上升的原因,是因為去年有些支出在達成里程碑後就停止了;而現在我們基本上只是用新的里程碑重點來替換既有成本。所以你看全年現金流出 1,700 萬到 1,900 萬美元,研發計畫的增量大約是全年合計 150 萬美元。
So with most of that -- some of that happening in the first half of the year, slightly more than half on a prorated basis.
其中大部分——有一部分會發生在上半年;若按比例分攤,上半年會略多於一半。
Robert Eno - Chief Executive Officer, Director
Robert Eno - Chief Executive Officer, Director
Okay. Got it. Excellent. Congrats again on all the updates.
好的。了解。非常好。再次恭喜你們所有更新進展。
Operator
Operator
Bill Sutherland, the Benchmark Company.
Benchmark Company 的 Bill Sutherland。
Bill Sutherland - Equity Analyst
Bill Sutherland - Equity Analyst
Thank you. Good afternoon, everybody, and congrats on all the progress. Brian, I was curious on this focus that you have initially on the top 10% inside the concierge practices. Is this something you expect will probably be the focus for -- well into '27 before you feel like you've got everything you need to kind of broaden
謝謝。各位下午好,也恭喜你們所有的進展。Brian,我想了解你一開始聚焦在禮賓式診所內前 10% 這個策略。你是否預期這會成為——一直到 2027 年都仍是主要聚焦點,直到你覺得已經具備所有條件可以把範圍擴大?
Branislav Vajdic - President, Founder, Director
Branislav Vajdic - President, Founder, Director
Yes. Thanks, Phil. Good question. Again, I think that we are going to be able to validate very quickly this model. I don't think it's -- we have full intentions of kind of expanding into that [ $1.5 million ] or 1.5 million patient slice of the pie, if you will, before 2027.
是的。謝謝你,Phil。好問題。再說一次,我認為我們能非常快速地驗證這個模式。我不認為——我們完全打算在 2027 年之前,就把版圖擴展到那個「[150 萬美元]」或說 150 萬名病患的那一塊市場份額。
Again, the reason we're focusing on the cardiology concierge groups and the executive health groups is a very target-rich environment, but they also -- these are practices that are owned by the physicians in the pathway to contracting the sales cycle is not real with bureaucracy, which helps us get to the patients quicker.
同樣地,我們之所以聚焦在心臟科禮賓團體與高階主管健康(Executive Health)團體,是因為那是一個目標非常密集的環境;而且——這些診所多由醫師擁有,在簽約路徑與銷售週期上沒有太多官僚流程,這能幫助我們更快觸及病患。
They have very, very high level of patient engagement. And these practices specifically, Bill, are looking at the feedback we are getting from them is that they want all of their practices all their patients in their practice to have this device, right? So it's not being selective. We are going after that 10% because the profile of that customer is so aligned with what we're doing that when we walk in, they say, we want every patient in our practice to have this.
他們的病患參與度非常、非常高。而且這些診所特別是,Bill,從我們收到的回饋來看,他們希望他們診所裡的所有病患都能配戴這個裝置,對吧?所以不是在做選擇性導入。我們鎖定那 10%,是因為那類客戶的輪廓與我們正在做的事情高度契合;當我們走進去時,他們會說:我們希望診所裡的每一位病患都能擁有這個。
Not trying to carve out there's just a specific type of patient. So I think we're going to be able to learn again with a limited number of accounts and a limited number of a time. And then based on that playbook we're putting together, I think we're going to be able to start expanding into these other market opportunities very quickly.
並不是想要切分出只有某一種特定病患才適用。所以我認為,我們可以在有限的帳戶數、有限的時間內再次學到很多。然後基於我們正在整理的這套作戰手冊(playbook),我認為我們將能非常快速地開始擴展到其他市場機會。
Timothy Cruickshank - Chief Financial Officer
Timothy Cruickshank - Chief Financial Officer
Bill, I'd just add, it's probably hard to predict because it's going to be kind of a gradual transition, whether we're into this larger group in '26 or into early '27. But Brian is going to continue to build the funnel with lots of interested accounts.
Bill,我只想補充一下,這可能很難預測,因為這會是一個相當漸進的轉換過程,不論我們是在’26年進入這個更大的族群,或是在’27年初進入。但 Brian 會持續透過許多有興趣的帳戶來建立銷售漏斗。
And then as he described, we as we show the proof points from the deep adoption, then that should accelerate into this next wave, so that kind of comes in parallel.
然後如他所描述的,當我們展示深度採用所帶來的實證成果時,就應該會加速進入下一波,因此這兩者會並行發生。
Robert Eno - Chief Executive Officer, Director
Robert Eno - Chief Executive Officer, Director
And does the pricing include the reader service that you've contracted with.
那定價是否包含你們已簽約的判讀服務(reader service)?
Branislav Vajdic - President, Founder, Director
Branislav Vajdic - President, Founder, Director
Yes. The pricing that we've laid out, the 500 to 1,000, and there's a range and variables that impact that, but that does include the reading service.
是的。我們所提出的定價,500到1,000(之間有一個區間,且會受一些變數影響),其中確實包含判讀服務。
Timothy Cruickshank - Chief Financial Officer
Timothy Cruickshank - Chief Financial Officer
Got you. And so really no plan then and no need to think about reimbursement code for this. Is that true?
了解。所以其實就沒有計畫、也不需要去考慮為此申請給付代碼(reimbursement code)。是這樣嗎?
Robert Eno - Chief Executive Officer, Director
Robert Eno - Chief Executive Officer, Director
Yes. Brian, I can take that one. I think we've said before, now all three of us on this call with Brian and I both worked together at HeartFlow and Tim and in Petamed. We've all gone through the reimbursement journey with previous companies. And it's powerful.
是的。Brian,這題我來回答。我想我們之前提過,這通電話上的三位——Brian 和我曾在 HeartFlow 一起共事,Tim 則在 Petamed。我們都在先前的公司走過給付(reimbursement)的歷程。而那確實很有力。
It takes some time. One of the things I love about what we're doing is we've got optionality. So we obviously not to deviate too hard, but on the patch, that is an existing reimbursed market. On the card, what we're excited about, as Brian laid out, is we have significant patient pay opportunities, starting with concierge and going beyond that.
但也需要一些時間。我很喜歡我們正在做的一點是,我們有可選性(optionality)。所以很明顯地,不要偏題太多,但在貼片(patch)方面,那是一個既有且已可獲得給付的市場。在卡片(card)方面,我們感到興奮的是,如 Brian 所說,我們有相當可觀的病患自費(patient pay)機會,從禮賓醫療(concierge)開始,並可延伸到更多。
So we don't think we necessarily need to get reimbursement codes right away, but it's clearly part of our vision. And I think the way to think about it as we get more use cases that demonstrate the value to the health care system and I think heart attack detection is a really big one, given the clinical and cost effectiveness benefits. The work we're starting to do now will pay off there, whether that's in a value-based care world of ACOs and Medicare Advantage and demonstrating the advantages of having this product or into CPT codes.
因此我們不認為一定需要立刻取得給付代碼,但這顯然是我們願景的一部分。我認為可以這樣看:當我們有更多使用情境能證明對醫療體系的價值——我認為心肌梗塞偵測就是非常重要的一項,考量其臨床效益與成本效益——我們現在開始做的工作將會在那裡產生回報,不論是在以價值為導向的照護(value-based care)世界,例如 ACO 與 Medicare Advantage,去證明擁有此產品的優勢,或是走向 CPT 代碼。
So that's definitely part of the strategy. But what we like is that we can expand and believe we can get to cash flow positive without having to even have the reimbursement kick in, but that becomes a whole second wave on top.
所以這絕對是策略的一部分。但我們喜歡的是,我們可以擴張,並且相信即使沒有給付啟動,我們也能達到現金流轉正(cash flow positive);而給付啟動後,則會在其上再形成第二波成長。
Branislav Vajdic - President, Founder, Director
Branislav Vajdic - President, Founder, Director
Yes. Sounds great. Thanks -- thanks to you all. Appreciate it.
是的。聽起來很棒。謝謝——謝謝各位。非常感謝。
Operator
Operator
Yi Chen, H.C. Wainright.
Yi Chen,H.C. Wainright。
Unidentified Participant
Unidentified Participant
This is Eduardo on for you. Congrats on the year in the quarter. I wanted to ask a question again the LINACS study. Just curious what kind of accuracy you think would be sufficient to kind of move forward with the pivotal study -- and I know that you've conducted previous studies looking at myocardia infarctions more in the context of screening at home.
我是 Eduardo,代替他提問。恭喜年度與本季表現。我想再問一次關於 LINACS 研究的問題。我很好奇,你們認為需要達到什麼樣的準確度才足以推進到關鍵性試驗(pivotal study)——我也知道你們先前做過一些研究,較偏向在居家篩檢情境下觀察心肌梗塞。
And I'm just kind of curious how you envision both the trials and utilization to get conducted. If you kind of still envision the card being used at home for screening and go, no go to the ER or kind of using it in the emergency per se.
我也想了解你們如何構想這些試驗與實際使用會如何進行。你們是否仍然設想這張卡片是在家中用於篩檢、決定要不要去急診,或是更偏向在急診環境中使用?
Robert Eno - Chief Executive Officer, Director
Robert Eno - Chief Executive Officer, Director
Yes. Thanks, appreciate it. A really great question, good to clarify. So the use case for heart attack detection is still at home. We just have this I think, quite interesting study design that's going to allow for quicker enrolment.
是的。謝謝,感謝提問。這是個很好的問題,也很適合釐清。所以心肌梗塞偵測的使用情境仍然是在家中。只是我們有一個我認為相當有趣的研究設計,能夠更快完成收案(enrolment)。
Basically, the way to think about it is when a patient would have chest pain at home, it's basically the same decision and the same information as when they show up to the emergency room.
基本上可以這樣理解:當病患在家中出現胸痛時,所面臨的決策與所需資訊,與他們到急診室報到時其實是相同的。
You would have -- with our device, we'd have the ability to have the ECG and they report their symptoms through our app and then you have their history. And those are the three factors that would happen in the first 10 minutes before troponins and other imaging tests are done.
使用我們的裝置,我們能取得心電圖(ECG),病患也會透過我們的 App 回報症狀,然後我們也有其病史。而這三個因素,就是在抽血驗肌鈣蛋白(troponins)與其他影像檢查完成之前、前10分鐘內會發生的事情。
So that's why we can use that environment and say, if we're able to show similar accuracy to the 12-lead ECG in that, then that should be an analogue for this information that would be there. at home.
因此我們可以利用那樣的環境並說:如果我們能在那裡展現與12導程心電圖相近的準確度,那就可以作為在家中可取得之資訊的類比(analogue)。
As far as the accuracy, so yes, we've done -- we've done two studies, and we've looked at them both with the synthesized 12 lead and the core 3D output. And what we showed in those study designs similar to this that when we look at the accuracy of the 12 lead and our device compared to the hospital discharge diagnosis, we're just trying to show that we're similar to the 12 lead.
至於準確度,是的,我們已經做了——我們做了兩項研究,並且同時以合成的12導程(synthesized 12 lead)與核心3D輸出(core 3D output)來分析。在這些與本次相似的研究設計中,我們所展示的是:當我們把12導程與我們裝置的準確度拿來與出院診斷(hospital discharge diagnosis)相比時,我們的目標是證明我們與12導程相近。
There are going to be times when the ECG alone is not enough, but we're expecting to be in the same level as accuracy. So it's less about the number. It's more about how close we come to the 12-lead ECG.
確實會有一些情況僅靠心電圖是不夠的,但我們預期能達到相同等級的準確度。所以重點不在於某個數字。而在於我們與12導程心電圖的接近程度。
If we show that we're similar, the argument is that same information we showed in the emergency room, that's everything the physician and our reader service would have when the patient does this at home. So that's the way that the trial is designed and what we're thinking about that validating really the home use of it. Does that make sense?
如果我們證明兩者相近,那麼論點就是:我們在急診室所展示的同樣資訊,就是當病患在家中使用時,醫師與我們的判讀服務所能掌握的一切。因此試驗就是以這樣的方式設計,我們的思考是要驗證其居家使用。這樣說清楚嗎?
Branislav Vajdic - President, Founder, Director
Branislav Vajdic - President, Founder, Director
Yes, yes, I guess, agreement with the 12 lead. And I guess, naturally, I guess there's some wiggle room, right? Like if you're using this in a screening context, you don't need it to be as good. You just need like you're going to the negative predictive value is really important there. You can forego the false positives.
是的,是的,我想就是與12導程的一致性。而我想,自然地,應該會有一些彈性空間,對吧?例如如果是在篩檢情境使用,就不需要做到那麼好。你只需要——陰性預測值(negative predictive value)在那裡非常重要。你可以容忍一些偽陽性(false positives)。
Robert Eno - Chief Executive Officer, Director
Robert Eno - Chief Executive Officer, Director
Yes. So there's a right, a couple of key points, right? Obviously, what we'll be arguing is we want to show and the initial studies have shown that within the margin of error were similar to a 12-lead ECG, A couple of key points One is when our previous studies, our proof-of-concept study showed is that for both the standard 12 lead and for ours, when you look at the difference between baseline asymptomatic and the event ECG, that actually increases the accuracy by about 20 points.
是的。所以這裡有幾個關鍵點,對吧?很明顯地,我們要主張的是:我們希望證明,而且初步研究也顯示,在誤差範圍內我們與12導程心電圖相近。幾個關鍵點:第一,我們先前研究、概念驗證(proof-of-concept)研究所顯示的是,無論是標準12導程或我們的裝置,當你比較無症狀基線(baseline asymptomatic)與事件發生時的心電圖(event ECG)之差異時,準確度其實會提高約20個百分點。
We have that, by definition, in our system for every patient. If you were to show up in an emergency room as an unknown patient, you wouldn't have that comparator. So that's one kind of advantage that we have that we think helps in terms of the accuracy. The other thing is the way we're viewing this in discussions with FDA is very much a rule-in device.
而在我們的系統中,對每位病患而言,依定義我們都具備這個資料。如果你以未知病患身分出現在急診室,你不會有那個可比較的基準。所以這是我們的一項優勢,我們認為有助於提升準確度。另一點是,我們在與 FDA 討論時對此的看法非常明確:這是一個用於「確認」(rule-in)的裝置。
What we want to do is attack that three- to four-hour delay that comes from indecision or patients being in denial and in a sense, reduce the time to taking the first action. So the way that we're thinking about it is if the physicians notice something in the ECG, the comparative ECG, they'll tell the patient, you really need to call 911 and get in.
我們想做的是針對那種因猶豫不決或病人否認而造成的三到四小時延遲下手,某種程度上縮短採取第一個行動的時間。所以我們的想法是,如果醫師在心電圖(ECG)或對照心電圖中注意到異常,他們會告訴病人:你真的需要撥打 911 並立刻就醫。
But if they don't notice a difference, it could be a number of things. So the response to physicians will drive the response, but they're going to say something along the lines of you should follow standard of care, if there's significant symptoms or they continue, you should call 911. So the focus really is speeding up the time and getting patients into the system.
但如果他們沒有注意到差異,可能有很多原因。因此,對醫師的回應會帶動後續的回應,但他們大概會說:你應該遵循標準照護;如果症狀明顯或持續,就應該撥打 911。所以重點其實是加快時間,讓病人更快進入醫療體系。
Yi Chen - Analyst
Yi Chen - Analyst
Got it. That's really helpful. And then maybe another one on commercial strategy. I guess there's 2 here. I'm curious about any interest in looking at profit sharing models.
了解。這真的很有幫助。接著也許再問一個關於商業策略的問題。我想這裡有兩點。我想了解你們是否有興趣研究利潤分成模式。
Right now, how much of that 500 to 1,000 subscription is going to the provider versus you all? And would you be interested in looking at more generous profit sharing models as you expand so maybe less premium concierge services? Just kind of a little color and aviation there.
目前那個每年 500 到 1,000 的訂閱費,有多少是給提供者(provider),多少是給你們?以及在你們擴張時,是否有興趣採用更慷慨的利潤分成模式,例如較少走高端禮賓(concierge)服務的溢價路線?想請你們稍微補充一些背景與看法。
Timothy Cruickshank - Chief Financial Officer
Timothy Cruickshank - Chief Financial Officer
Maybe Brian, I'll start and you feel free to add in because I know youâre five, six, six weeks in. But it's a great question. What we believe from what Brian laid out that these practices have aligned incentives. They want to get new technology to their patients. They want to drive differentiate their practice, they want to drive engagement.
也許我先開始,Brian 你也可以補充,因為我知道你才加入五、六週。但這是個很好的問題。我們相信,從 Brian 剛才的說明來看,這些診所的誘因是一致的。他們希望把新技術帶給病人。他們希望讓診所差異化,並提升互動與參與度。
But we also think there may be -- and this is what Brian is learning now is there may be an economic incentive as well if they're sharing in the economics that makes sense. So as Brian is talking to practices, we're talking about list prices and having certain ways that we can work with them along those lines. Brian, I don't know if you want to give any more detail on that or what your thinking is along those lines.
但我們也認為可能還有——而這也是 Brian 現在正在學習的——如果他們能分享經濟利益,或許也會有經濟誘因,且這樣做是合理的。所以當 Brian 與診所洽談時,我們也在談定價(list prices)以及一些可合作的方式。Brian,我不確定你是否想就這點補充更多細節,或談談你在這方面的想法。
Branislav Vajdic - President, Founder, Director
Branislav Vajdic - President, Founder, Director
Yes. I think you outlined it very well. We're really focused on that portion of the 500 to 1,000 that we're talking about is this is a subscription model. It's a model that practices are used to. And we're really focused on that.
是的。我覺得你概括得很好。我們非常聚焦在我們所談的 500 到 1,000 這一部分:這是一個訂閱模式。這也是診所熟悉的模式。我們目前確實是聚焦在這一點上。
I think that, to Tim's point earlier, as we continue to expand out and scale there maybe optionality for different things like things that you're discussing there. But for right now, we're going after kind of those opportunities that we just -- we can have a very easy engagement with the practices in general.
我想就像 Tim 先前提到的,隨著我們持續擴張與規模化,未來可能會有不同選項,例如你剛才提到的那些做法。但就目前而言,我們會先鎖定那些我們能與診所非常容易建立合作與導入的機會。
And again, I've emphasized it many times, but the ones that we're focused on and the ones that are really kind of building our backlog right now, it's a strong willingness to pay by the patients or the practice and the doctors are highly motivated to recommend it to their patients. So that's our starting point, and then we will move from there.
再強調一次,我已經講過很多次:我們目前聚焦的、也正在累積訂單能見度(backlog)的那些案子,病人或診所對付費的意願很強,而且醫師也高度願意推薦給他們的病人。所以這是我們的起點,接著再從那裡往外延伸。
Yi Chen - Analyst
Yi Chen - Analyst
Got it. That's really helpful. And then if I can have a final one. Just any thoughts on tele hub providers is actually -- that seems well aligned with the kind of services and devices you're providing. They're seeking to differentiate.
了解。這真的很有幫助。最後如果我再問一個。你們對 tele hub 供應商有什麼看法?那似乎與你們提供的服務與裝置非常契合。他們也在尋求差異化。
I think Life MD just announced a cardiology telehealth service launch. Kind of curious on your thoughts there and the potential to target that in commercial segment.
我想 Life MD 剛宣布推出心臟科遠距醫療服務。想請教你們對此的看法,以及在商業端(commercial segment)鎖定這類客群的可能性。
Timothy Cruickshank - Chief Financial Officer
Timothy Cruickshank - Chief Financial Officer
Yes. Brian, you can take that one, too.
是的。Brian,這題也請你回答。
Branislav Vajdic - President, Founder, Director
Branislav Vajdic - President, Founder, Director
Yes. So I think it's a great question, and it just kind of reinforces the fact that we're really focusing on the right areas. I mentioned before, been fortunate travel and be in several geographies over the last few weeks and meet with many, many cardiologists. And the great thing about the Harpensystem is the ability to pull it out of your pocket andemo it and show the clinicians how to use it. What is absolutely clear is that our ability to provide clinical-grade 12-lead ECG.
好的。我覺得這是個很好的問題,也再次強化我們確實把重點放在正確的領域。我之前提過,過去幾週我很幸運能出差到多個地區,與非常多的心臟科醫師會面。Harpensystem 的一大優點是你可以從口袋拿出來做示範(demo),並向臨床人員展示如何使用。非常清楚的是,我們能提供臨床等級的 12 導程心電圖(ECG)。
There's been nothing like it on the market before. So when we see other companies that are out there that are doing telehealth cardiology or doing -- working in the same type of environment it's encouraging because it kind of validates that there's a big need.
市場上以前從未有過類似的產品。因此當我們看到其他公司也在做心臟科遠距醫療,或在相同類型的環境中運作時,這是令人鼓舞的,因為這某種程度上驗證了市場存在很大的需求。
But what we get excited about is that we're really the only technology out there that can deliver the clinical grade ECG that is the gold standard in the hospital, but put it in the patient's hands.
但讓我們感到興奮的是,我們幾乎是唯一能提供臨床等級心電圖技術的公司——這是醫院裡的黃金標準——同時又能把它交到病人手上。
And so yes, I think there's going to be lots of opportunities for things like that. And we've already started to see different companies and potential partnerships where they may have used a consumer-grade product in the past, but it's really never met the expectations of what they've needed clinically and having this 12-lead synthesized ECG is really a game changer, and I think we're going to continue to see a lot of interest as we move forward.
所以是的,我認為這類機會會很多。而且我們已經開始看到不同公司與潛在合作夥伴:他們過去可能使用消費級產品,但那從未真正達到臨床所需的期待;而這個 12 導程合成(synthesized)心電圖確實是改變遊戲規則的技術。我認為隨著我們往前推進,市場的興趣只會持續升溫。
Operator
Operator
Leo Carpio, Joseph Gunnar.
Leo Carpio,Joseph Gunnar。
Leo Carpio - Analyst
Leo Carpio - Analyst
Just a couple of quick wrap-up questions. Regarding the Mount Sinai relationship that you announced, can you give us a little background in terms of how that came about? Who approached who? And what was the in point in terms of pivoting to form this alliance? And then the follow-up question being, are you looking at other similar type lives with other major cardio hospitals and TC hospitals across the US
我有幾個簡短的收尾問題。關於你們宣布的 Mount Sinai 合作關係,能否提供一些背景,說明這是如何促成的?是誰先找誰?以及促成你們轉向並建立這個聯盟的切入點是什麼?接著的追問是:你們是否也在與美國其他主要心臟專科醫院與教學醫院(TC hospitals)洽談類似合作?
Branislav Vajdic - President, Founder, Director
Branislav Vajdic - President, Founder, Director
Yes, great question. We've known the Mount Sinai folks for a while that the original connection was from one of our great Board members, Ken Nelson, who is close to the physicians there and is kind of a leader in this field. And there's a number of key physicians. One of them, Josh Lambert actually presented on our AI algorithms at a few conferences in. And so it has been an adviser to us.
是的,這是個好問題。我們認識 Mount Sinai 的團隊有一段時間了,最初的連結來自我們一位很棒的董事會成員 Ken Nelson;他與那裡的醫師關係密切,也是這個領域的領導者之一。那裡有多位關鍵醫師。其中一位 Josh Lambert 曾在幾場會議上介紹過我們的 AI 演算法。因此他也一直擔任我們的顧問。
VivicReady, he's been on our Medical Advisory Board. So it's a relationship we've had for a while and really have great mutual respect, I believe. And then what we we're able to do is realize things were aligned enough that we wanted to get a deeper type of relationship.
VivicReady,他一直在我們的醫療顧問委員會(Medical Advisory Board)。所以這是一段維持已久的關係,我相信彼此也有很高的相互尊重。接著我們能做的是,意識到雙方的方向足夠一致,因此希望建立更深層次的合作關係。
And what I see at a high level, as I laid out, we obviously have great expertise in AI algorithms and they do as well. They really see us as Really, the only way to get these algorithms that are based on 12 leads out to patients at homes, they're very excited about that. And for us, a group like them have this tremendous in addition to their capabilities, they have a tremendous amount of data that's annotated tied to the diseases and the outcomes.
從高層次來看,正如我先前所說,我們在 AI 演算法方面當然有很強的專長,他們也同樣如此。他們把我們視為——真的——唯一能把這些基於 12 導程的演算法帶到居家病人端的方法,他們對此非常興奮。而對我們而言,像他們這樣的團隊除了自身能力很強之外,還擁有大量與疾病與預後結果相連結、並已完成標註(annotated)的資料。
So it becomes a perfect combination. On your second question, we really believe this partnership is a great one, but we're always looking for like-minded partners, we definitely get approached a lot. And if there's a like-minded partner that we think we can really find a way to advance this whole area with -- that's one of the beauties of something where we believe that we're creating a new market.
因此就成了一個完美的組合。關於你的第二個問題,我們確實相信這項合作夥伴關係非常出色,但我們也一直在尋找理念相近的合作夥伴,我們確實經常被接洽。如果有理念相近的夥伴,而我們認為能找到方法推動這整個領域向前發展——這正是我們相信自己正在創造一個新市場這件事的魅力之一。
There's lots of opportunities for collaboration. So definitely open to that if there are other things that seem like they meet the right criteria.
合作的機會很多。所以如果還有其他事情看起來符合正確的標準,我們當然願意保持開放態度。
Yi Chen - Analyst
Yi Chen - Analyst
Okay. And then just a classification question. You said that for new indications that you are pursuing, you're probably able to go to the 510(k) process. Is that correct?
好的。接著是一個分類方面的問題。你提到對於你們正在推進的新適應症,你們可能可以走 510(k) 的流程。是這樣嗎?
Branislav Vajdic - President, Founder, Director
Branislav Vajdic - President, Founder, Director
So I said for the patch, our read is that it's likely a 510(k) because our 12 lead system is a 510(k) and patches or 50 case we haven't determined or really haven't gotten a regulatory read for the pathway for heart attack detection. Could be a 510(k) could be a de novo. There's uncertainty there. And part of our discussions with the FDA will be to really fine-tune that.
我說的是針對貼片(patch),我們的判讀是它很可能走 510(k),因為我們的 12 導程系統是 510(k);而貼片或 50 case(50 個案例)我們尚未確定,或其實尚未就心臟病發作偵測的途徑取得監管方面的判讀。可能是 510(k),也可能是 de novo。這裡存在不確定性。而我們與 FDA 討論的一部分,就是要把這點真正細緻地校準。
As we learn more, we'll certainly keep everybody informed with that as well as the timing of the clinical trials and the overall expectation for clearance.
隨著我們了解得更多,我們也一定會就此以及臨床試驗的時程與整體核准(clearance)的預期,持續向大家更新。
Leo Carpio - Analyst
Leo Carpio - Analyst
All right. Congrats on the quarter.
好。恭喜本季表現。
Operator
Operator
At this time, I would like to turn the floor over to the team at Heart beam to address any questions submitted through the webcast.
此時,我想把時間交給 Heart beam 團隊,回答透過網路直播提交的任何問題。
Branislav Vajdic - President, Founder, Director
Branislav Vajdic - President, Founder, Director
We have a number of great webcast questions. Unfortunately, we have time to take only a couple. So the first question is, will you need the sales team to market the device? Or will that be done from within the group?
我們收到不少很棒的直播提問。很可惜時間只夠回答其中幾個。第一個問題是,你們是否需要銷售團隊來行銷這個裝置?還是會由團隊內部來完成?
Robert Eno - Chief Executive Officer, Director
Robert Eno - Chief Executive Officer, Director
Brian, do you want to take that one quickly?
Brian,你要不要快速回答這題?
Branislav Vajdic - President, Founder, Director
Branislav Vajdic - President, Founder, Director
Yes, absolutely. So initially, as I mentioned, we're focusing on a very strategic set of accounts. I think initially, the reason that we are doing that is because we have the ability to focus with a lean team and execute very well on it.
是的,當然。所以一開始,如我提到的,我們會聚焦在一組非常具策略性的客戶。我認為一開始我們這麼做的原因,是因為我們能以精實的團隊聚焦並把執行做得非常好。
As we continue to scale, we will look at a few major areas for sales, operations, implementation. Implementation is going to be critical to our overall success in growth and adoption. I anticipate that in the near term and sometime in '26, we'll probably expand the team out to three to five additional folks on the commercial team that are a mixture of sales and implementation.
隨著我們持續擴張規模,我們會在幾個主要領域著眼於銷售、營運、導入。導入對我們整體的成長與採用成功將至關重要。我預期在短期內、以及大約在 26 年的某個時間點,我們可能會在商務團隊再擴編 3 到 5 位成員,組合會涵蓋銷售與導入。
I think, again, what plays very well for us is that many of these target accounts that we're focused on are located in the same geographies. So it really puts us in a good position to be lean, be focused and scale very efficiently.
我想再次強調,對我們很有利的一點是,我們聚焦的許多目標客戶都位於相同的地理區域。因此這讓我們能保持精實、保持聚焦,並且非常有效率地擴張。
Timothy Cruickshank - Chief Financial Officer
Timothy Cruickshank - Chief Financial Officer
Next question asks, what is the excitement level among a cardiologist who have been able to use or be educated on the heart being system.
下一個問題是:能夠使用或接受 Heart beam 系統教育訓練的心臟科醫師,他們的興奮程度如何?
Robert Eno - Chief Executive Officer, Director
Robert Eno - Chief Executive Officer, Director
Brian, do you want to take that as well, talk about your recent .
Brian,你也要回答這題嗎?談談你最近的。
Branislav Vajdic - President, Founder, Director
Branislav Vajdic - President, Founder, Director
Absolutely. I touched upon it a little bit before. But again, I've had experience in the space for quite some time and coming to hear beam my expectations were really based off of my experience in the past with other one single leader three or six lead ECG systems, personally seen the lead synthesized results is incredible.
當然。我之前稍微提到過。不過再說一次,我在這個領域有相當長的經驗,加入 Hear beam 之前,我的期待其實是基於過去對其他單導程、三導程或六導程 ECG 系統的經驗;而親眼看到導程合成(synthesized)的結果,真的令人驚艷。
And each physician I just was at a meeting yesterday with physician down in Florida and being able to demo the RPM system and immediately see the 12 lead that was taken in a 30-second time period, which traditionally has to be done in an office with the machine.
而每位醫師——我昨天才在佛羅里達與一位醫師開會——能夠展示 RPM 系統,並立刻看到在 30 秒內取得的 12 導程;而傳統上這必須在診間用機器才能完成。
The reaction is almost universal across the board is, number one, the quality of these tracings are phenomenal. The accuracy and the clarity of the P waves, which is extremely important to these clinicians is phenomenal.
幾乎所有人的反應都很一致:第一,這些波形的品質非常出色。P 波的準確度與清晰度——這對臨床醫師極其重要——也非常出色。
And again, this is really a game changer for the cardiologist for them to be able to see not just a sliver of the information that they're looking for with ECGs from prior technologies but seeing that the entire picture of the heart is really exciting.
再者,這對心臟科醫師而言真的是一個顛覆性的改變,因為他們不再只是看到先前技術所提供、他們在 ECG 上想看的那一小段資訊,而是能看到心臟的完整全貌,這真的令人振奮。
So the excitement is palpable. And we're -- each day that goes by that we get a chance to get in front of surgeons or physicians and them communicating with their patients. It's truly unbelievable.
所以這種興奮感是顯而易見的。而我們——每天只要有機會站到外科醫師或內科醫師面前,並看到他們與病患溝通。真的令人難以置信。
Timothy Cruickshank - Chief Financial Officer
Timothy Cruickshank - Chief Financial Officer
And that concludes our webcast Q&A. Operator?
以上就是我們的直播問答。接線生?
Operator
Operator
Thank you. I would now like to turn the call back over to Mr. Ino for closing remarks.
謝謝。我現在想把電話會議交回給 Ino 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 everyone for joining the earnings call today. We look forward to continuing to update you on our ongoing progress and growth and I know we couldn't get to all of the questions, but if we are unable to answer yours, please reach out to MZ Group, our IR firm, and they'll be more than happy to assist. Thanks again.
謝謝你,接線生。感謝各位今天參加法說會。我們期待持續向各位更新我們正在進行的進展與成長;我知道我們無法回答所有問題,但若我們未能回答你的問題,請聯絡我們的投資人關係顧問公司 MZ Group,他們很樂意協助。再次感謝。
Operator
Operator
The conference has now concluded. Thank you for attending today's presentation, and you may now disconnect your lines.
本次電話會議到此結束。感謝各位參加今天的簡報,現在可以掛斷電話。