Heartbeam Inc (BEAT) 2025 Q3 法說會逐字稿

完整原文

使用警語:中文譯文來源為 Google 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 HeartBeam third quarter 2025 financial results conference call. (Operator Instructions) As a reminder, this conference call is being recorded.

    各位好,歡迎參加 HeartBeam 2025 年第三季財務業績電話會議。(操作員說明)提醒各位,本次電話會議正在錄音。

  • Before we begin the formal presentation, I would like to remind everyone that statements made on the call and webcast may include predictions, estimates and 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 risk and uncertainties that could cause actual results to differ materially.

    在正式開始演講之前,我想提醒大家,電話會議和網路直播中發表的聲明可能包括預測、估計和其他可能被認為是前瞻性的資訊。雖然這些前瞻性陳述代表了我們目前對未來方向的判斷,但它們受到風險和不確定性的影響,可能導致實際結果與預期有重大差異。

  • You are cautioned not to place undue reliance on these forward-looking statements, which reflect our opinions only as of the date of this presentation. Please keep in mind that we're not obligating ourselves to revise or publicly release the results of any revision to these forward-looking statements in light of new information or future events.

    請注意,不要過度依賴這些前瞻性陳述,這些陳述僅反映我們截至本次演示之日的觀點。請注意,我們沒有義務根據新的資訊或未來事件修改或公開披露對這些前瞻性聲明的任何修改結果。

  • Throughout today's discussion, we will attempt to present some important factors relating to our business that may affect our predictions. You should also review our most recent Form 10-K and Form 10-Q for a more complete discussion of these factors and other risk, particularly under the heading Risk Factors.

    在今天的討論中,我們將嘗試介紹一些可能影響我們預測的與我們業務相關的重要因素。您還應該查看我們最新的 10-K 表格和 10-Q 表格,以更全面地了解這些因素和其他風險,尤其是在「風險因素」標題下的內容。

  • 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; and Tim Cruickshank, Chief Financial Officer will present results of operations for the third quarter ended September 30, 2025.

    今天下午,我們發布了詳細介紹這些業績的新聞稿,您可以在我們公司網站 heartbeam.com 的投資者關係欄位中查看。今天,執行長 Rob Eno 和財務長 Tim Cruickshank 將為大家介紹截至 2025 年 9 月 30 日的第三季營運表現。

  • And at this time, I would like to turn the call over to HeartBeam's Chief Executive Officer, Mr. Rob Eno. Please go ahead.

    此時,我想把電話交給 HeartBeam 的執行長羅伯伊諾先生。請繼續。

  • Robert Eno - Chief Executive Officer, Director

    Robert Eno - Chief Executive Officer, Director

  • Thank you, operator. The topics we'll cover in today's call are listed on the slide. We'll start with an overview of the HeartBeam system and the product vision. We'll touch on our recently achieved and upcoming milestones and highlight the upcoming commercial launch strategy, followed by financial results, and we'll end with a Q&A.

    謝謝接線生。今天電話會議將討論的主題已列在投影片上。我們將首先概述 HeartBeam 系統和產品願景。我們將簡要介紹我們最近的成就和即將取得的里程碑,並重點介紹即將推出的商業發布策略,然後公佈財務業績,最後進行問答環節。

  • Before we dive into updates since our last call in August, I wanted to remind everyone about our vision and our initial product, the HeartBeam System. HeartBeam is dedicated to developing groundbreaking ECG technology for patients to use at home to allow them to feel confident about their heart health.

    在我們深入探討自 8 月上次通話以來的最新進展之前,我想提醒大家一下我們的願景和最初的產品——HeartBeam 系統。HeartBeam致力於開發突破性的心電圖技術,供患者在家中使用,讓他們對自己的心臟健康充滿信心。

  • HeartBeam is developing the first ever portable cable-free ECG that can synthesize a 12-Lead ECG. A unique IP-protected approach captures the heart's electrical signals in three dimensions or non-coplanar directions and synthesizes the 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.

    HeartBeam 正在開發首款可合成 12 導程心電圖的隨身無線心電圖儀。一種獨特的受智慧財產權保護的方法,可以捕捉心臟在三維或非共面方向上的電訊號,並將這些訊號合成為 12 導聯心電圖。此系統設計便於攜帶,方便患者在任何時間、任何地點出現症狀時使用。

  • The technology is supported by an on-demand cardiologist who can interpret the clinical-grade ECG and triage patients appropriately to ensure timely care. As a reminder, in December 2024, we received our foundational FDA 510(k) clearance. This was for the system as a whole for arrhythmia assessment, the credit card signal collection device, the patient application, a physician portal and signal quality algorithms.

    該技術由一位可隨時待命的心臟科醫生提供支持,他能夠解讀臨床級別的心電圖,並對患者進行適當的分診,以確保及時治療。再次提醒大家,我們在 2024 年 12 月獲得了 FDA 510(k) 基礎許可。這是針對整個心律不整評估系統、信用卡訊號擷取設備、患者應用程式、醫生入口網站和訊號品質演算法而言的。

  • This major milestone validated our unique approach. In January, we submitted our second FDA 510(k) application. This is for the software that synthesizes a 12-Lead ECG from our 3D signals for arrhythmia assessment. We're engaging in the final steps with the FDA related to our 510(k) submission and continue to anticipate clearance by the end of the year.

    這一重大里程碑驗證了我們獨特的方法。1月份,我們提交了第二份FDA 510(k)申請。這是用於從我們的 3D 訊號合成 12 導程心電圖以進行心律不整評估的軟體。我們正在與 FDA 進行 510(k) 申請的最後步驟,並繼續預計在年底前獲得批准。

  • This clearance will be a major inflection point for HeartBeam as these two clearances together will form the product with which we'll start our initial commercialization. We believe that the HeartBeam system can be part of one of the most important trends in medicine today, the movement of clinical-grade devices from the hospital and clinic to becoming a part of daily life at home.

    此次審批將是 HeartBeam 的一個重要轉折點,因為這兩項批准將共同構成我們將開始初步商業化的產品。我們相信,HeartBeam 系統可以成為當今醫學領域最重要的趨勢之一,即臨床級設備從醫院和診所走向家庭日常生活的一部分。

  • Connected clinical-grade technologies are changing the healthcare landscape by expanding access, reducing healthcare costs and enabling personalized medicine. From continuous glucose monitors to home blood pressure cuffs, these technologies empower patients and provide physicians with insights that lead to identifying conditions earlier and monitoring trends over time.

    互聯的臨床級技術正在改變醫療保健格局,擴大醫療服務範圍,降低醫療成本,並實現個人化醫療。從持續血糖監測儀到家用血壓計,這些技術為患者提供了便利,並為醫生提供了有助於更早發現病情和監測長期趨勢的見解。

  • Heart disease is the leading cause of death worldwide and most cardiac events, whether arrhythmias or ischemia happen outside of the medical setting. Diagnosing these events is crucial and ECGs are the most common cardiac test, yet most at-home options have been limited to downgraded versions unable to provide a clinical-grade 12-Lead output.

    心臟病是全球首要死因,大多數心臟事件,無論是心律不整或缺血,都發生在醫療環境之外。診斷這些事件至關重要,心電圖是最常見的心臟檢查,但大多數家用設備都僅限於降級版本,無法提供臨床等級的 12 導聯輸出。

  • HeartBeam's credit card size system will change that by delivering a synthesized 12-Lead ECG into the patient's hands, starting with the arrhythmia assessment application. The ability to get clinical-grade insights when they need it, wherever they are, will enable patients to get more timely care.

    HeartBeam 的信用卡大小的系統將改變這種狀況,它將合成的 12 導聯心電圖送到患者手中,首先從心律不整評估應用程式開始。患者無論身在何處,都能在需要時獲得臨床等級的見解,這將使他們能夠更及時地獲得治療。

  • When a patient has symptoms and uses the HeartBeam system, they first open the smartphone application, which guides the patient through the process of taking a recording. Once the recording is complete, it's sent to the HeartBeam Cloud where it's processed and immediately sent to a cardiologist for review.

    當患者出現症狀並使用 HeartBeam 系統時,他們首先會打開智慧型手機應用程序,該應用程式會指導患者完成錄製過程。錄製完成後,影片會被傳送到 HeartBeam 雲端平台進行處理,然後立即發送給心臟科醫生進行審核。

  • Last month, we announced an agreement with HeartNexus, a group of U.S.-based board-certified cardiologists with coverage across the United States. When a patient has arrhythmia symptoms and takes a recording with the HeartBeam system, a HeartNexus cardiologist will send an ECG interpretation back to the patient.

    上個月,我們宣布與 HeartNexus 達成協議,HeartNexus 是由一群總部位於美國的、委員會認證的心臟病專家組成的團體,服務涵蓋全美。當患者出現心律不整症狀並使用 HeartBeam 系統進行記錄時,HeartNexus 心臟科醫師會將心電圖解讀結果傳送給患者。

  • This agreement is a key part of the product and one of the final pieces needed for our commercial launch, which is anticipated to be early next year after our FDA clearance for the 12-week synthesis software for arrhythmia assessment, which we anticipate receiving before the end of the year.

    該協議是產品的重要組成部分,也是我們商業化推出所需的最後幾個環節之一。我們預計將在明年年初,在我們獲得 FDA 對用於心律不整評估的 12 週合成軟體的批准之後,正式推出該產品。我們預計在年底前獲得批准。

  • Next, I'd like to remind you about the larger ecosystem we're building around the HeartBeam system. This ecosystem dramatically increases the overall value of the system and will drive deeper adoption. As I mentioned, at the core of the ecosystem is the HeartBeam system itself, the first and only credit card-sized cable-free device that synthesizes a 12-Lead ECG. This is complemented by an on-demand U.S.-based board-certified cardiologist available to review ECG readings 24/7.

    接下來,我想提醒大家,我們正在圍繞 HeartBeam 系統建立一個更大的生態系統。此生態系將顯著提升系統的整體價值,並推動更深入的應用。正如我之前提到的,這個生態系統的核心是 HeartBeam 系統本身,它是第一款也是唯一一款信用卡大小的無線設備,可以合成 12 導程心電圖。此外,我們還提供全天候 (24/7) 的美國認證心臟科醫生隨時待命,為您審查核心電圖讀數。

  • Our market research confirms that this concept resonates strongly with both physicians and patients who have indicated a willingness to pay a premium for this functionality. Building around this foundation, we're creating an ecosystem to maximize the benefits of our technology and encourage stronger engagement among patients.

    我們的市場調查證實,這一理念引起了醫生和患者的強烈共鳴,他們都表示願意為這項功能支付更高的價格。在此基礎上,我們正​​在創建一個生態系統,以最大限度地發揮我們技術的優勢,並鼓勵患者更積極地參與其中。

  • Key components of our ecosystem include automated arrhythmia assessments for use during routine recordings, integration with wearables that trigger patients to take readings when their wearable produces inconclusive results or if worrisome underlying parameters are detected.

    我們生態系統的關鍵組成部分包括:用於日常記錄的自動心律不整評估;與可穿戴設備的集成,當可穿戴設備產生不確定結果或檢測到令人擔憂的潛在參數時,觸發患者進行讀數。

  • Community features with tailored educational content and AI wellness features such as ECG-based cardiac age insights. We'll also be able to provide long-term trending of the HeartBeam synthesized 12-Lead ECGs, allowing the patient's physician to get longitudinal insights, including the trending of specific ECG parameters over time. Creating this ecosystem will add unique insights and actionable data for both patients and physicians that are unavailable elsewhere and add to the premium offering of HeartBeam.

    社群功能包括客製化的教育內容和人工智慧健康功能,例如基於心電圖的心臟年齡分析。我們也能夠提供 HeartBeam 合成的 12 導程心電圖的長期趨勢分析,使患者的醫生能夠獲得縱向見解,包括特定心電圖參數隨時間變化的趨勢。創建此生態系統將為患者和醫生提供其他地方無法獲得的獨特見解和可操作數據,並增強 HeartBeam 的高級服務。

  • The team has done an exceptional job of achieving the milestones we said we're going to achieve over the past year. The highlights are listed here. Last December, we received our foundational FDA clearance for the HeartBeam system for arrhythmia assessment. In January, we submitted our second FDA 510(k) application for the 12-Lead ECG synthesis software for arrhythmia assessment.

    過去一年,團隊出色地完成了我們設定的各項里程碑目標。重點內容如下。去年 12 月,我們的 HeartBeam 系統獲得了 FDA 的基礎性批准,用於評估心律不整。1 月,我們向 FDA 提交了第二個 510(k) 申請,用於心律不整評估的 12 導聯心電圖合成軟體。

  • We successfully met the clinical endpoints in the VALID-ECG pivotal study, which is the basis for this 12-Lead synthesis submission. The study demonstrated a 93.4% overall diagnostic agreement between the HeartBeam synthesized 12-Lead ECG and a standard 12-Lead ECG in the assessment of arrhythmia. These results were presented at the Heart Rhythm Society meeting in April.

    我們在 VALID-ECG 關鍵性研究中成功達到了臨床終點,這是本次 12 導聯合成提交的基礎。研究表明,在評估心律不整方面,HeartBeam 合成的 12 導程心電圖與標準 12 導程心電圖的整體診斷一致性為 93.4%。這些結果已於四月在心律學會會議上發表。

  • We also started our early access program, or beta testing, which has provided us with valuable feedback, allowing us to enhance the onboarding, training and overall user experience. And finally, as I mentioned, we signed the agreement with HeartNexus to service the cardiology reader service.

    我們還啟動了早期訪問計劃或 Beta 測試,這為我們提供了寶貴的回饋,使我們能夠改善使用者引導、培訓和整體使用者體驗。最後,正如我之前提到的,我們與 HeartNexus 簽署了協議,為其提供心臟病學閱讀服務。

  • We have a number of important milestones in the coming weeks and months. We continue to anticipate the FDA 510(k) clearance for the 12-Lead ECG synthesis software for arrhythmia assessment this quarter. In 2026, we expect to start enrollment on additional clinical trials on the clinical and cost-effectiveness benefits of HeartBeam. The focus of our clinical studies to date has been a comparison with standard 12-Lead ECGs. These planned post-market studies will be important for adoption and ultimately for payment and reimbursement.

    未來幾週和幾個月,我們將迎來一系列重要的里程碑。我們繼續期待本季 FDA 批准用於心律不整評估的 12 導聯心電圖合成軟體的 510(k) 上市許可。預計在 2026 年,我們將開始招募更多受試者參與 HeartBeam 的臨床和成本效益臨床試驗。到目前為止,我們的臨床研究重點是與標準 12 導程心電圖進行比較。這些計劃中的上市後研究對於產品的推廣應用以及最終的支付和報銷都至關重要。

  • We're also preparing for commercialization. We anticipate hiring the Chief Commercial Officer and other key members on the commercial team upon FDA clearance. We also anticipate initial commercial agreements with concierge and preventive cardiology practices.

    我們也在為商業化做準備。我們預計在獲得 FDA 批准後,將聘請首席商務官和商業團隊的其他關鍵成員。我們也預計將與私人醫療服務和預防心臟病診所達成初步商業協議。

  • While our focus remains squarely on working with the FDA toward the 12-Lead ECG synthesis clearance and preparing for commercial launch, we achieved several milestones that help us toward our longer-term goals. Important data were presented at two recent scientific meetings. First, at the HRX Live meeting in September, an abstract was presented on the capabilities of the HeartBeam AI algorithm in classifying arrhythmias. And earlier this week at the American Heart Association Scientific Sessions, data were presented on the promise of the HeartBeam 3D3-lead technology for the detection of coronary occlusions.

    雖然我們的重點仍然是與 FDA 合作,爭取獲得 12 導聯心電圖合成許可,並為商業上市做準備,但我們已經取得了一些里程碑式的成就,這有助於我們實現長期目標。最近兩次科學會議上公佈了重要數據。首先,在 9 月的 HRX Live 會議上,展示了 HeartBeam AI 演算法在心律不整分類方面的能力的摘要。本週早些時候,在美國心臟協會科學會議上,公佈了有關 HeartBeam 3D3 導聯技術在檢測冠狀動脈阻塞方面的應用前景的數據。

  • These studies add to the growing body of clinical evidence. They demonstrate the progress and promise of our AI efforts, as well as the potential to apply the HeartBeam technology to heart attack detection. IP continues to be at the core of the company's efforts.

    這些研究進一步豐富了臨床證據。它們展示了我們在人工智慧領域的進展和前景,以及將 HeartBeam 技術應用於心臟病發作檢測的潛力。智慧財產權仍然是公司工作的核心。

  • With three newly issued patents, we now have 24 issued patents worldwide. In addition, HeartBeam was recognized as a global IP and technology leader in portable cardiac diagnostics and a report from the IP firm PatentVest, with Heartbeam ranking No. two worldwide in the 12-Lead ECG innovation out of 243 companies analyzed.

    隨著三項新專利的頒發,我們現在在全球擁有24項已頒發專利。此外,HeartBeam 被公認為便攜式心臟診斷的全球智慧財產權和技術領導者。智慧財產權公司 PatentVest 的一份報告顯示,在分析的 243 家公司中,HeartBeam 在 12 導程心電圖創新方面排名全球第二。

  • As we prepare for our initial launch, we've established clear strategic pillars. First, we're creating a new product category, and the overarching focus of our efforts will be establishing the HeartBeam system as the first personal cable-free synthesized 12-Lead ECG.

    在籌備首次發布之際,我們已確立了明確的策略支柱。首先,我們正在創建一個新的產品類別,我們工作的重點是將 HeartBeam 系統打造為第一個個人無線合成 12 導聯心電圖系統。

  • We believe that the HeartBeam system is clearly differentiated from other offerings by combining an easy-to-use device that can produce a 12-Lead ECG with an on-demand cardiologist who can provide ECG assessment.

    我們相信,HeartBeam 系統與其他產品明顯不同,它將易於使用的 12 導程心電圖產生設備與可隨時提供心電圖評估的心臟科醫師結合。

  • Second, we're preparing a controlled market entry. We anticipate starting with a small number of prominent concierge and preventive cardiology practices, both independent practices and those associated with major healthcare systems. These practices will provide an opportunity to get early real-world feedback and will serve as reference accounts.

    其次,我們正在準備有控制地進入市場。我們預計首先會與少數幾家知名的私人醫生和預防心臟病診所合作,包括獨立診所和隸屬於大型醫療保健系統的診所。這些實踐將提供獲得早期真實世界回饋的機會,並可作為參考案例。

  • Beyond that, our strategy is to focus initially on two U.S. geographic regions to prove the business model, followed by expansion of this model into additional regions. We plan to establish a small direct sales and marketing organization in the U.S. with sales reps and implementation specialists focused on a geographic region. We're exploring multiple options that will allow efficient expansion, including distribution partners and chains of concierge practices.

    除此之外,我們的策略是先集中在美國的兩個地理區域驗證商業模式,然後再將該模式擴展到其他地區。我們計劃在美國建立一個小型直銷和行銷機構,配備銷售代表和實施專家,專注於特定地理區域。我們正在探索多種能夠實現高效擴張的方案,包括分銷合作夥伴和連鎖禮賓服務機構。

  • A final key element of the strategy is demonstrating the value of the HeartBeam system to patients and practices, driving retention of our users over time. We'll focus on the patient experience and provider engagement to drive recurring use of the system as part of our strategy of developing a subscription model.

    此策略的最後一個關鍵要素是向患者和診所展示 HeartBeam 系統的價值,從而提高用戶留存率。我們將專注於病患體驗和醫護人員參與度,以推動系統重複使用,這是我們發展訂閱模式策略的一部分。

  • And now I'll turn it over to Tim to discuss our financial.

    現在我將把發言權交給提姆,讓他來討論我們的財務狀況。

  • Timothy Cruickshank - Chief Financial Officer

    Timothy Cruickshank - Chief Financial Officer

  • Great. Thank you, Rob. I'll quickly go through some of the key financial data for the quarter ended September 30, 2025. We continue to be focused on our cash management as we maintain strong financial discipline aligned to achieving milestones. When we look at the quarter, net loss for the period was $5.3 million or $0.15 per basic and diluted share, consistent with the prior quarter and also in line with our expectations and analyst consensus.

    偉大的。謝謝你,羅布。我將快速瀏覽截至 2025 年 9 月 30 日的季度的一些關鍵財務數據。我們將繼續專注於現金管理,保持嚴格的財務紀律,以實現既定目標。從季度來看,該季度淨虧損為 530 萬美元,即每股基本及攤薄虧損 0.15 美元,與上一季一致,也符合我們的預期和分析師的共識。

  • Of that net loss, I'll note a significant portion was related to noncash expenses such as stock-based compensation. So the result in net cash used in operating activities was under $3.2 million. That's an 8% decrease quarter-over-quarter, and it builds on the 23% decrease we had from the prior quarter.

    需要指出的是,淨虧損中有相當一部分與非現金支出有關,例如股票選擇權激勵。因此,經營活動所用現金淨額低於 320 萬美元。這比上一季下降了 8%,而且是在上一季下降 23% 的基礎上進一步下降的。

  • So we're pleased with our ability to balance competing priorities we have over the recent quarters by both maintaining a capital-efficient organization and also judiciously timing the key investments we need into the commercial readiness activities. So you're seeing evidence of this as we continue to reduce our cash outflow.

    因此,我們很高興能夠在過去幾季中平衡各種相互衝突的優先事項,既保持了高效的資本組織,又謹慎地把握了商業準備活動所需的關鍵投資時機。因此,隨著我們不斷減少現金流出,你們已經看到了這方面的跡象。

  • And we'll continue to take this approach as we derisk the business and while we're building the proof points we need prior to accelerating investments into commercial traction and scale. Cash and cash equivalents at September 30 were $1.9 million. Obviously, with a tight balance sheet, we're monitoring things closely, but we're confident in our approach of strategically funding the company consistent with how we've outlined it in the past.

    我們將繼續採取這種方法,降低業務風險,並在加速投資以實現商業成功和規模化之前,建立我們需要的證明點。截至9月30日,現金及現金等價物為190萬美元。顯然,由於資產負債表緊張,我們正在密切關注事態發展,但我們對我們過去製定的策略性公司融資方式充滿信心。

  • We've got optionality in place both in the vehicles and the sources of funding, and we have confidence in our ability to achieve near-term milestones, including the FDA clearance, which we believe will be a major inflection point for the company. We remain committed to minimizing dilution for our shareholders so that they're rewarded for their time and commitment to our company and our vision.

    我們在車輛和資金來源方面都採取了多種選擇,我們有信心實現近期里程碑,包括獲得 FDA 批准,我們認為這將是該公司的重要轉折點。我們始終致力於最大限度地減少股東權益的稀釋,以確保股東們對公司和願景投入的時間和精力得到回報。

  • Our Board, management team and key insiders are more excited than ever about what lies ahead with commercialization on the near-term horizon. We believe very strongly in the value we're creating here at HeartBeam and getting this critical technology into the hands of clinicians and patients is going to be a really rewarding step for us here in the very near future.

    我們的董事會、管理團隊和關鍵內部人士對近期商業化前景比以往任何時候都更加興奮。我們堅信我們在 HeartBeam 所創造的價值,並將這項關鍵技術交付給臨床醫生和患者,這將是我們在不久的將來取得的非常有意義的成就。

  • With that, Rob, I'll turn the call back over to you for closing summary.

    羅布,那我就把電話交還給你,請你做個總結。

  • Robert Eno - Chief Executive Officer, Director

    Robert Eno - Chief Executive Officer, Director

  • Thanks so much, Tim. So to summarize, this is an incredibly exciting time for HeartBeam. We continue to engage in positive and productive discussions with the FDA and our anticipated time line for the clearance by year-end remains intact. Combined with the foundational FDA clearance received in December 2024, this clearance will mark a pivotal milestone for the company to initiate our commercial launch.

    非常感謝,提姆。總而言之,對於HeartBeam來說,這是一個無比令人興奮的時刻。我們繼續與FDA進行積極有效的討論,預計年底前獲得批准的時間表仍然不變。加上 2024 年 12 月獲得的 FDA 基礎性批准,此次批准將標誌著公司啟動商業化推廣的關鍵里程碑。

  • We've made significant progress with our commercial readiness plans in anticipation of the FDA clearance. Of note, we announced a partnership with HeartNexus to provide on-demand board-certified cardiologist reviews of synthesized 12-week ECGs for arrhythmia assessment. These two elements, an ECG that's capable of synthesizing a 12-week ECG and a cardiologist on call 24/7 able to provide ECG assessments to the patient, they're the core of our system.

    為獲得 FDA 批准,我們在商業準備計劃方面取得了重大進展。值得一提的是,我們宣布與 HeartNexus 建立合作關係,提供由認證心臟科醫生對合成的 12 週心電圖進行按需審核,以評估心律不整。這兩個要素,一台能夠合成 12 週心電圖的心電圖儀,以及一位 24/7 全天候待命、能夠為患者提供心電圖評估的心臟病專家,是我們系統的核心。

  • While our focus is squarely on the interactions with the FDA and preparing for the commercial launch, we continue to prepare for the company's future. We added to the body of clinical evidence with 2 recent presentations at scientific meetings, one on AI and the other on heart attack detection. In addition, we added three newly issued patents, bringing the total to 24, and we're pleased to be recognized for our IP, ranking No. two worldwide in 12-Lead ECG innovation out of 243 companies analyzed.

    雖然我們目前的重點完全放在與美國食品藥物管理局 (FDA) 的溝通以及為商業上市做準備上,但我們仍在繼續為公司的未來做好準備。我們最近在科學會議上做了兩次報告,一次是關於人工智慧,另一次是關於心臟病發作檢測,為臨床證據體系增添了新的內容。此外,我們新增了三項已頒發的專利,使專利總數達到 24 項。我們很高興我們的智慧財產權得到認可,在分析的 243 家公司中,我們在 12 導程心電圖創新領域位列全球第二。

  • HeartBeam is at a very exciting inflection point, and we'll continue to work with our partners to strategically finance the company in a manner that adds to and creates shareholder value. We believe that HeartBeam's technology is poised to be a fundamental advance in cardiac care.

    HeartBeam 正處於一個令人興奮的轉折點,我們將繼續與合作夥伴共同努力,以增加和創造股東價值的方式對公司進行策略性融資。我們相信,HeartBeam 的技術有望成為心臟護理領域的根本性進步。

  • Our team has worked incredibly hard on the development and validation of the technology, and we're excited to be nearing the next stage in the company's growth, introducing the groundbreaking technology of HeartBeam for patients to use at home to allow them to feel confident about their heart health.

    我們的團隊在技術開發和驗證方面付出了巨大的努力,我們很高興即將進入公司發展的下一個階段,推出突破性的 HeartBeam 技術,供患者在家中使用,讓他們對自己的心臟健康充滿信心。

  • We thank you all for attending, and now I would like to open it up to Q&A. Operator?

    感謝各位的出席,現在我想進入問答環節。操作員?

  • Robert Eno - Chief Executive Officer, Director

    Robert Eno - Chief Executive Officer, Director

  • (Operator Instructions)

    (操作說明)

  • Kyle Bauser, ROTH Capital Partners.

    Kyle Bauser,ROTH Capital Partners。

  • Kyle Bauser - Analyst

    Kyle Bauser - Analyst

  • Maybe we could start off on the discussions you've had with the FDA. Can you talk a little bit more about sort of what you're working on and responses and factors that you'll want to address ahead of a clearance?

    或許我們可以先從你與FDA的討論開始。您能否再詳細談談您正在進行的工作、需要回應的問題以及在獲得許可之前需要解決的因素?

  • Robert Eno - Chief Executive Officer, Director

    Robert Eno - Chief Executive Officer, Director

  • Yes. I can't really comment much more than that. I guess what I'd reiterate is that, we continue to categorize our interactions with FDA as productive. The normal process of FDA questions and us answering them, and we're continuing to anticipate the FDA clearance before the end of the year. But from the last clearance in this one, we haven't gone into more details of the characterization of the questions.

    是的。我實在沒什麼好說的了。我想重申的是,我們仍然認為與FDA的互動是富有成效的。FDA提出問題,我們按正常流程回答,我們繼續預計在年底前獲得FDA的批准。但從上次的澄清來看,我們還沒有更詳細地探討這些問題的性質。

  • I'll just leave it there.

    我就把它放在那裡吧。

  • Kyle Bauser - Analyst

    Kyle Bauser - Analyst

  • Fair enough. Good to know the time line is still on track before year-end. As you gear up for the commercial launch, you sort of talked about it a little bit, Rob. Are you still kind of focused on a couple of territories initially to gather feedback and intel ahead of a broader launch to, say, five to ten territories?

    很公平。很高興得知專案進度仍按計畫進行,能在年底前完成。羅布,在為商業發布做準備的時候,你稍微談到了一些事情。你們目前是否仍傾向於先在幾個地區進行初步篩選,收集回饋和情報,然後再向五到十個地區全面推廣?

  • Robert Eno - Chief Executive Officer, Director

    Robert Eno - Chief Executive Officer, Director

  • That's exactly right. Yes. I think the nuance on that is the very first accounts, we believe, will be prominent accounts, some really exciting ones that we're talking to. Some of them are independent. Some of them are associated with major healthcare institutions.

    完全正確。是的。我認為其中的微妙之處在於,我們相信,首批合作對象將會是一些知名人士,一些我們正在洽談的非常令人興奮的客戶。他們當中有些是獨立的。其中一些與大型醫療機構有關。

  • And in a sense, those can be reference accounts, those can be our pilot accounts. And then beyond that, we start to go deep into the two regions to start. And then exactly, as you say, we want to prove the model there to show everything around our sales model, that the expected coverage, we think. And as we get that, we can expand to a larger number of regions exactly.

    從某種意義上說,這些可以作為參考帳戶,可以作為我們的試點帳戶。然後,在此基礎上,我們開始深入研究這兩個地區。正如你所說,我們希望證明該模型能夠展示我們銷售模型的方方面面,以及我們認為的預期覆蓋範圍。隨著我們掌握了這些信息,我們可以將範圍擴展到更多地區。

  • Kyle Bauser - Analyst

    Kyle Bauser - Analyst

  • Got it. And how should we be thinking about pricing regarding sort of symptomatic versus asymptomatic readings? I know you're able to charge a premium potentially for symptomatic readings and great to know about the recent partnership with HeartNexus, but just trying to understand how you're thinking through that. Now it's a little bit early.

    知道了。那麼,我們該如何考慮有症狀檢測和無症狀檢測之間的定價差異呢?我知道你們可能會對症狀讀數收取額外費用,也很高興得知你們最近與 HeartNexus 建立了合作關係,但我只是想了解你們是如何考慮這個問題的。現在時間還早。

  • Robert Eno - Chief Executive Officer, Director

    Robert Eno - Chief Executive Officer, Director

  • Yes, sure. No, yes, it is a little bit early, but what we've identified so far are a few things. We're planning on a subscription offering. The initial thought is that the -- it will be upfront a one-year subscription and that one-year subscription gives you the device itself and access to a certain number of cardiology reads. And so we'll work on the details of that pricing level and how many reads.

    當然可以。不,是的,現在說這些還為時過早,但我們目前已經確定了一些事情。我們計劃推出訂閱服務。最初的想法是——這將是一年的訂閱,這一年的訂閱將為您提供設備本身以及訪問一定數量的心臟病學讀物的權限。因此,我們將著手研究定價水平和閱讀次數等細節。

  • What we're building into the system, not exactly at the initial launch, but we're building in is the automated assessment, algorithmic assessment. So the vision that we're building toward there as that comes in, that requires an FDA clearance.

    我們正在系統中建構的,雖然不是在最初發佈時就建構的,但我們正在建立的是自動化評估、演算法評估。因此,我們正在朝著這個方向努力,而這需要獲得 FDA 的批准。

  • As that comes in will be one pathway for routine recordings, which the patient will have an unlimited number of routine recordings because we want them to practice and to build up their data. And then when they're having symptoms, they go down this symptomatic pathway, and that is what uses one of their credits and activates the reader service.

    屆時,將有一條途徑用於常規記錄,患者將擁有無限數量的常規記錄,因為我們希望他們練習並累積數據。然後,當他們出現症狀時,他們就會走上這條症狀路徑,這會消耗他們的一個積分並啟動閱讀服務。

  • Kyle Bauser - Analyst

    Kyle Bauser - Analyst

  • That's helpful. Got it. And maybe one more. As you prepare for the commercial launch, how are you managing inventory levels? And how does your sort of manufacturing capabilities look at this point?

    那很有幫助。知道了。或許還有一個。在準備商業發布之際,你們是如何管理庫存水準的?那麼,貴公司目前的生產能力如何?

  • Robert Eno - Chief Executive Officer, Director

    Robert Eno - Chief Executive Officer, Director

  • Great. Tim, do you want to take that one?

    偉大的。提姆,你想接那個任務嗎?

  • Timothy Cruickshank - Chief Financial Officer

    Timothy Cruickshank - Chief Financial Officer

  • Sure. Yes. Thank you so much. Yes, we've got a great partner for manufacturing, U.S.-based contract manufacturer. What's great about the latest round of our device that we have for commercialization, it's all off-the-shelf componentry, nothing customized.

    當然。是的。太感謝了。是的,我們有一個很棒的生產合作夥伴,一家位於美國的合約製造商。我們最新一批用於商業化的設備最棒的地方在於,它的所有組件都是現成的,沒有任何客製化零件。

  • So from a product line or from a build line standpoint, we've got the capabilities built out. So it's all about -- for us, in the near term, when you talk about launch over the first year plus, the building of devices isn't a concern to us, line of sight to part, no real long lead time parts, obviously, dynamic situation, so monitoring that. But given they're all off-the-shelf components, we've got a number of different areas we can source -- known areas we can source parts from.

    所以從產品線或生產線的角度來看,我們已經具備了相對應的能力。所以對我們來說,近期內,談到第一年多的發布,設備製造對我們來說不是問題,零件供應有保障,沒有真正的長交貨期零件,顯然情況瞬息萬變,所以我們需要監控這一點。但鑑於它們都是現成的組件,我們可以從許多不同的地區採購——我們可以從中獲取零件的已知地區。

  • So really confident in the manufacturing side, and it's all about determining the demand and building into it. And then the real area of focus is on workflow and really making sure we nail the onboarding piece. So, I would say that is more of a focal area of getting it right than the manufacturing side.

    我對生產製造方面非常有信心,關鍵在於確定需求並順勢而為。然後,真正的重點在於工作流程,確保我們做好新進員工入職培訓環節。所以,我認為比起製造方面,這才是更需要重點關注的領域。

  • Operator

    Operator

  • Bill Sutherland, Benchmark Company.

    比爾·薩瑟蘭,基準公司。

  • Bill Sutherland - Equity Analyst

    Bill Sutherland - Equity Analyst

  • Wanted to just maybe find out a little more color on the two initial market launches that you had planned. Maybe a sense of the available TAM that you're going to be looking at there? And just a couple of assumptions to help us think about the numbers that we might just begin to think about for next year and maybe the following year.

    我想了解您計劃的最初兩次市場推廣活動的更多資訊。或許可以了解一下您將要關注的潛在市場規模(TAM)?我們不妨做一些假設,幫助我們思考明年甚至後年可能出現的數字。

  • Robert Eno - Chief Executive Officer, Director

    Robert Eno - Chief Executive Officer, Director

  • Tim, would you take that?

    提姆,你願意收下嗎?

  • Timothy Cruickshank - Chief Financial Officer

    Timothy Cruickshank - Chief Financial Officer

  • Yes, sure. No problem at all. Yes. So, the first two geographies, we've said before, most likely we have Southern California and South Florida, two really strong territories with a lot of great accounts and inbound demand there. The way we sort of look at it is the territory size, if you think about an average, the initial territories we're going after, 75,000 patients roughly in those -- that we would be targeting in those regions.

    當然可以。完全沒問題。是的。所以,前兩個地區,我們之前說過,很可能是南加州和南佛羅裡達,這兩個地區實力非常強勁,有許多優質客戶和入境需求。我們看待這個問題的方式是看地域面積,如果你想想一個平均水平,我們最初瞄準的地區,大約有 75,000 名患者——我們將以這些地區的患者為目標。

  • You can do a really concentrated rollout in terms of the number of accounts that you really need to talk to, to start to get some good penetration there.

    你可以集中精力,針對真正需要溝通的客戶群進行推廣,從而開始取得良好的市場滲透率。

  • And we plan on going to, as Rob indicated, individual practices and some of the institutions that have concierge practices associated with them to nail workflow, really make sure that the patient experience is right. But then within those territories, as we build that out, there are a number of concierge chains that we'll be able to look at to help accelerate adoption and growth.

    正如羅布所指出的那樣,我們計劃走訪各個診所和一些設有私人醫療服務的機構,以完善工作流程,真正確保患者體驗到正確的服務。但是,在這些地區,隨著我們業務的拓展,我們將能夠與許多禮賓服務連鎖機構合作,以幫助加速普及和成長。

  • So, it's all about getting it right in the first couple of quarters, so keeping expectations modest in terms of what that means from a revenue and user perspective. But as we get to the second half of '26 is when we start to see some of the real penetration into those geographies and as we head to '27, when those concierge chains likely come on. Obviously, we'll be working to accelerate that faster, but I think that those three waves are how we're looking at it.

    所以,關鍵在於前幾季能否做好,因此,對於收入和用戶數量方面的影響,不要抱持過高的期望。但到了 2026 年下半年,我們才開始看到這些地區真正開始滲透,到了 2027 年,這些禮賓連鎖店可能會出現。顯然,我們會努力加快這個進程,但我認為我們目前是這樣看待這個問題的:這三個階段。

  • Bill Sutherland - Equity Analyst

    Bill Sutherland - Equity Analyst

  • Okay. And how does the -- how do you sort of target the marketing because it's partly, I guess, involving the cardiologist themselves, but then some direct to the patient. I know that this is an out-of-pocket type of expense.

    好的。那麼,如何進行針對性行銷呢?因為這其中一部分可能涉及心臟科醫師本身,但也有一部分是直接面對患者的。我知道這是一筆需要自掏腰包的費用。

  • Robert Eno - Chief Executive Officer, Director

    Robert Eno - Chief Executive Officer, Director

  • Sure. Yes, I'll take that one. Right, so it's -- to start with, it's obviously for, it's a prescription device, and we're targeting these practices, concierge and preventive cardiology practices. These are practices that have these patients and are comfortable having discussions about items that are patient pay. And so, the first stage in our process is talking to those accounts, explaining the product, explaining that -- how it can help their practice.

    當然。是的,我要那個。沒錯,首先,它顯然是用於處方設備的,我們的目標客戶是私人醫生和預防心臟病診所。這些診所接收這類患者,並且樂於與患者討論由患者自費的項目。因此,我們流程的第一步是與這些客戶溝通,解釋產品,解釋產品如何幫助他們的業務。

  • And then we plan to work with the practice to support them in outreach to their patients. So, to really be the practice talking to their patients about the technology and potentially adopting it, and we can certainly give the materials and support them through that.

    然後我們計劃與診所合作,支持他們開展患者外展服務。因此,要真正讓診所與患者談論這項技術並有可能採用它,我們當然可以提供材料並為他們提供支援。

  • So, in a sense, working with and through the practices. We think over time, part of the way of thinking about this region by region is there are other ways to move beyond the patients that are already at these concierge practices.

    所以,從某種意義上來說,是透過實踐來進行工作的。我們認為,隨著時間的推移,逐一地區地思考這個問題的方式之一是,除了已經在這些私人診所就診的患者之外,還有其他方法可以擴大服務範圍。

  • We think that can happen through a referral business where patients can refer patients who can either go join the concierge practice or get access to the technology through other clinicians and potentially some direct-to-consumer marketing.

    我們認為這可以透過轉診業務來實現,患者可以推薦其他患者,這些患者可以加入私人診所,或者透過其他臨床醫生獲得該技術,並可能透過一些直接面向消費者的行銷方式獲得該技術。

  • We obviously think we to be as efficient as possible, those first couple of approaches of working with the concierge practice in the preventive cardiology practice and adding referral is probably the most efficient, but that's part of what we learn as we do the early stages of these commercialization in these couple of regions.

    我們當然認為要盡可能提高效率,最初與預防心臟病學診所的私人醫生合作並增加轉診的做法可能是最有效的,但這是我們在幾個地區進行這些商業化早期階段所學到的一部分。

  • Bill Sutherland - Equity Analyst

    Bill Sutherland - Equity Analyst

  • Great. And then I'm wondering, you are establishing this as a new category. But when you go into the practices, are they using something at this point that gets at some of the functionality of HeartBeam and that you'll have to take the position?

    偉大的。然後我就在想,你們是要把它設立為一個新的類別嗎?但是當你進入實踐環節時,他們目前使用的某些東西是否能夠實現 HeartBeam 的一些功能,而你必須接受這種定位?

  • Robert Eno - Chief Executive Officer, Director

    Robert Eno - Chief Executive Officer, Director

  • Yes. There's -- it's going to vary. Some of them don't have anything like this. Some of them may be using the existing one lead ECGs that are out there from various companies. We don't think there's anything that is commonly used that can synthesize the 12-Lead, but also has the reader service tied to it.

    是的。情況會有所不同。他們當中有些人根本沒有這樣的東西。他們中的一些人可能正在使用市面上各公司生產的現有單導聯心電圖儀。我們認為目前市面上還沒有常用的方法可以合成 12 芯音訊訊號,同時還能提供與之配套的讀取服務。

  • So, it's a mix. Some might be new and some might be offering things already or encouraging their patients to use things already.

    所以,這是一種混合體。有些可能是新推出的,有些可能已經提供某些服務或鼓勵患者使用現有的服務。

  • The feedback has been very positive in our market research with patients and in market research to practices and in direct conversations with practices that even despite that current landscape, they see incremental value in this offering and are excited about taking advantage of it.

    我們對患者進行的市場調查、對診所進行的市場調查以及與診所的直接對話都得到了非常積極的反饋,即使在當前形勢下,他們也看到了這項服務的增量價值,並很高興能夠利用它。

  • Operator

    Operator

  • We will now turn for any webcast questions.

    現在我們來回答大家對網路直播的提問。

  • Our first webcast question asks, you ended Q3 with $2 million in cash. What are your plans for additional funding?

    我們的第一個網路直播問題是:你們第三季末擁有 200 萬美元現金。你們有什麼額外的資金籌措計劃?

  • Timothy Cruickshank - Chief Financial Officer

    Timothy Cruickshank - Chief Financial Officer

  • Sure. Happy to take that one. Yes. Yes, I can't share specifics on plans, but I'm happy to add as much color as I can from my prepared remarks. I think I mentioned the optionality we have in place, both vehicles and sources of funding and just reiterating our confidence in our ability to achieve these near-term milestones right ahead of us.

    當然。我樂意接受這個任務。是的。是的,我不能透露具體的計劃細節,但我很樂意根據我準備好的發言稿盡可能多地補充細節。我想我之前提到過我們擁有的各種選擇,包括融資工具和資金來源,並且再次重申我們有信心實現眼前的這些近期里程碑。

  • So, we believe with those -- the inflection point we're going to see will provide us an opportunity to strategically look at the balance sheet.

    因此,我們相信,隨著這些——我們將看到的轉折點將為我們提供一個從戰略角度審視資產負債表的機會。

  • We're balancing two important priorities. One, heavily -- we care deeply about minimizing dilution for our existing shareholders. We've got -- but having a proper balance sheet to capitalize the opportunity ahead of us is obviously important. And I believe it will unlock the stock by having a proper capital markets profile in place, one that this company deserves based on the opportunity ahead of us.

    我們正在權衡兩項重要優先事項。第一,我們非常重視──我們非常重視最大限度地減少現有股東的權益被稀釋。我們已經擁有——但顯然,擁有合理的資產負債表來掌握眼前的機會至關重要。我相信,透過建立合適的資本市場形象,這家公司憑藉其面臨的機遇,理應獲得這樣的形象,這將釋放其股票的價值。

  • So, we are strategically balancing those priorities, and we believe we're getting close to having the opportunity to make both of them a reality for the company. But we're going to stay steadfast on the path to get there.

    因此,我們正在策略性地平衡這些優先事項,我們相信我們即將有機會將這兩個目標都變為現實。但我們將堅定不移地朝著目標前進。

  • Operator

    Operator

  • And one of the webcast questioner asks, if there are any contracts that are currently sitting on your front burner?

    一位網路直播提問者問道,目前是否有任何正在優先處理的合約?

  • Robert Eno - Chief Executive Officer, Director

    Robert Eno - Chief Executive Officer, Director

  • Yes. I'd characterize that as we've had -- we're having great discussions with sites that we think could be the early users of the system. And there are some large practices. There are some very prominent practices, and we'll be -- so we had really good discussions there. And post FDA clearance and early commercialization, we're looking forward to being able to announce more of those.

    是的。我會這樣描述:我們正在與一些我們認為可能成為該系統早期用戶的網站進行深入的討論。還有一些規模較大的診所。有一些非常突出的做法,我們會——所以我們在那方面進行了非常好的討論。在獲得 FDA 批准並實現早期商業化之後,我們期待能夠宣布更多此類消息。

  • Operator

    Operator

  • And do you have any expectations for the level of sales next year following the commencement of commercialization?

    您對明年商業化開始後的銷售水準有何預期?

  • Timothy Cruickshank - Chief Financial Officer

    Timothy Cruickshank - Chief Financial Officer

  • Yes, happy to take that, Rob, if you want.

    好的,羅布,如果你願意的話,我很樂意收下。

  • Robert Eno - Chief Executive Officer, Director

    Robert Eno - Chief Executive Officer, Director

  • Please.

    請。

  • Timothy Cruickshank - Chief Financial Officer

    Timothy Cruickshank - Chief Financial Officer

  • So, I haven't provided guidance, but again, let me provide as much color as I can in context to help answer it. I think, first, HeartBeam is becoming a commercial entity for the first time in 2026. So, we're going to be hyper focused on user experience, getting things right for physicians and patients.

    所以,我還沒有提供指導,但是,讓我盡可能提供更多背景資訊來幫助回答這個問題。我認為,首先,HeartBeam 將於 2026 年首次成為商業實體。因此,我們將高度重視使用者體驗,力求為醫師和患者提供最佳服務。

  • That means we may need to go slow in the very early days of the first quarter of launch, the first half of the year. But we anticipate, as I was describing to Bill, the second half of the year is where sales and user base begins to increase in a more meaningful way.

    這意味著在產品發布初期(第一季度,也就是今年上半年),我們可能需要放慢腳步。但正如我向比爾描述的那樣,我們預計下半年銷售額和用戶群將開始以更有意義的方式成長。

  • Obviously, I mean, based on some of the inbound demand we've gotten, we believe we can begin -- we can get things going faster than that. But just knowing that we are becoming commercial for the first time, we're trying -- when we model this out, we try to be pragmatic in doing so.

    顯然,我的意思是,根據我們收到的一些需求,我們相信我們可以開始——我們可以讓事情進展得更快。但正因為我們第一次走向商業化,所以我們在嘗試——在建立模型時,我們努力務實。

  • We've got newly issued coverage on the company. And so, the active research reports that are out there do a really good job of capturing how we model things out early days.

    我們已發布了關於該公司的最新報導。因此,現有的活躍研究報告很好地記錄了我們早期是如何建立模型的。

  • As we get the data points we need to expand into additional territories, we're going to be looking for ways to accelerate growth and have some inbounds demand on how that's going to happen. But based on the conversations we've had with concierge and preventative cardiology accounts to date, we're very excited by what could be meaningful demand.

    隨著我們獲得拓展到其他地區所需的數據點,我們將尋找加速成長的方法,並且會收到一些關於如何實現這一目標的諮詢。但根據我們迄今為止與私人醫療和預防心臟病診所的溝通,我們對可能出現的巨大需求感到非常興奮。

  • Operator

    Operator

  • And once you obtain FDA clearance for arrhythmia detection, what is your planned pathway for pursuing an additional indication for myocardial infarction detection?

    一旦獲得 FDA 對心律不整檢測的批准,您計劃如何推進心肌梗塞檢測此額外適應症的研發?

  • Robert Eno - Chief Executive Officer, Director

    Robert Eno - Chief Executive Officer, Director

  • Yes, it's a great question. We've addressed that previously, but I'll go through it again here. We have announced that we already have started initial discussions with FDA. So yes, we are planning to pursue that. We believe it's the same product and an expanded indication.

    是的,這是一個很好的問題。我們之前已經討論過這個問題,但我在這裡再重申一次。我們已宣布,我們已開始與FDA進行初步磋商。是的,我們正計劃推進此事。我們認為這是同一種產品,只是適應症擴大了。

  • We have two proof-of-concept studies that have been done and presented of the similarity between our output and that of a standard 12-Lead in patients with ischemia heart attacks. We have -- what we'll do is we want to talk to FDA to understand more about the regulatory path and more about the clinical trial needs.

    我們已經完成了兩項概念驗證研究,並展示了我們的輸出結果與缺血性心臟病患者標準 12 導程心電圖輸出結果的相似性。我們打算與FDA溝通,以便更了解監管途徑和臨床試驗需求。

  • So, the expectation is that we will need to do a clinical study in one way or another that will show the performance of our system in comparison to a 12-Lead in that population. We have ideas of that and looking forward to talking more with FDA about what they're looking for and how to implement on those plans.

    因此,我們預計需要以某種方式進行臨床研究,以顯示我們的系統與該族群中的 12 導聯繫統相比的表現。我們對此有一些想法,並期待與FDA進一步討論他們正在尋找什麼以及如何實施這些計劃。

  • Operator

    Operator

  • And will you work exclusively with HeartNexus? Or are you planning to -- or open to expanding your network to other telcardiology firms?

    你會只與HeartNexus合作嗎?或者您是否計劃——或者是否願意——將您的人脈擴展到其他遠距心臟病學公司?

  • Robert Eno - Chief Executive Officer, Director

    Robert Eno - Chief Executive Officer, Director

  • Yes. We -- first of all, we think HeartNexus is great and excited to partner with them. And the real -- the strategy is, we want this to be something that patients can use if they have symptoms 24/7. And we want to make sure that we don't put the prescribing physician necessarily on the front line if they don't want to be 24/7. We are getting feedback from some accounts that they might want to take on that themselves.

    是的。首先,我們認為 HeartNexus 非常棒,很高興能與他們合作。真正的策略是,我們希望患者在出現症狀時可以全天候使用該產品。我們希望確保不會讓開處方的醫生被迫站在一線,如果他們不想全天候待命的話。我們從一些帳戶收到回饋,他們可能希望自己承擔這項工作。

  • So, we're working on a version of the product offering to specific accounts in which the account themselves will take on the capability to do the reading.

    因此,我們正在開發一個特定帳戶的產品版本,在該版本中,帳戶本身將具備讀取資料的能力。

  • Beyond that, we don't have any plans right now to go beyond HeartNexus. We think their ability to scale with us is there, but have this option if accounts are interested in doing that function of the offering themselves.

    除此之外,我們目前沒有任何超越 HeartNexus 的計畫。我們認為他們有能力與我們一起擴展規模,但如果客戶有興趣自行實現該功能,我們也提供此選項。

  • Timothy Cruickshank - Chief Financial Officer

    Timothy Cruickshank - Chief Financial Officer

  • Yes. I would just add, I think what's great about HeartNexus at our stage of launch is they have coverage across the U.S. So, for a company of ours where we're going to be learning what our usage rates are, they have the ability to go quickly with us early days. And I think it's just an amazing group over at HeartNexus, and they want -- they believe in this technology and want what's best. So, they are open to exploring all sorts of avenues with us as we really start to scale.

    是的。我還要補充一點,我認為HeartNexus在我們這個階段的優勢在於他們的服務涵蓋全美。因此,對於我們這樣一家正在了解使用率的公司來說,他們能夠在早期階段迅速與我們合作。我認為HeartNexus的團隊非常出色,他們相信這項技術,並且想要做到最好。因此,隨著我們真正開始擴大規模,他們願意與我們一起探索各種途徑。

  • So, I think both of us are open to expanding as we really learn what demand looks like.

    所以,我認為我們雙方都願意根據市場需求情況進行擴張。

  • Robert Eno - Chief Executive Officer, Director

    Robert Eno - Chief Executive Officer, Director

  • That's great context. They really are a great partner.

    這提供了很好的背景資訊。他們真的是很棒的合作夥伴。

  • Operator

    Operator

  • And regarding your commercial launch, are you looking or considering partnering with other companies as strategic partners to increase production or operational capabilities in any way?

    關於您的商業化發布,您是否正在尋找或考慮與其他公司建立策略合作夥伴關係,以任何方式提高生產或營運能力?

  • Robert Eno - Chief Executive Officer, Director

    Robert Eno - Chief Executive Officer, Director

  • Yes, sorry, let me just, yes, absolutely. So, I'm just trying to make sure I can answer the question in the best way. We're definitely looking at all different types of strategic partners. We've talked a lot about that one of the areas we want to focus on is how do we scale most efficiently. And there's a couple of ways we believe we can scale efficiently, and that's with distribution partners or focusing on concierge and preventive cardiology chains.

    是的,不好意思,讓我先說明一下,是的,當然可以。所以,我只是想確保我能以最佳方式回答這個問題。我們肯定會考慮各種類型的策略夥伴。我們已經多次討論過,我們想要重點關注的領域之一是如何以最有效的方式擴大規模。我們相信可以透過兩種方式有效地擴大規模,那就是與分銷合作夥伴合作,或專注於私人醫生和預防心臟病連鎖機構。

  • So, that from a sales and distribution perspective is one of the key things we're going to look into as we prove the concept and start to progress.

    因此,從銷售和分銷的角度來看,這是我們在驗證概念並開始推進時要重點研究的問題之一。

  • We are open to and have had ongoing discussions with strategic partners in all kinds of different areas and are certainly open to exploring collaborations. We've talked about collaborations in the past on the AI algorithm side and the data side and even potential partners that could be co-development partners for some of the technologies that are in our pipeline.

    我們一直與各領域的策略夥伴進行討論,並對此持開放態度,當然也樂於探索合作的可能性。我們過去曾討論過在人工智慧演算法和數據方面的合作,甚至討論過一些潛在合作夥伴,他們可以成為我們正在研發的一些技術的共同開發夥伴。

  • Operator

    Operator

  • Thank you. And that concludes our webcast questions.

    謝謝。我們的網路直播問答環節到此結束。

  • I would like to turn the call back over to Mr. Eno for his closing remarks. Please go ahead.

    現在我把電話交還給伊諾先生,請他作總結發言。請繼續。

  • Robert Eno - Chief Executive Officer, Director

    Robert Eno - Chief Executive Officer, Director

  • Great. Thank you, operator. I want to thank each one of you for joining the earnings conference call today. We look forward to continuing 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.

    偉大的。謝謝接線生。感謝各位今天參加財報電話會議。我們期待繼續向您報告我們的最新進展和發展。如果您今天還有任何疑問需要解答,請聯絡我們的投資者關係公司 MZ Group,他們將非常樂意為您提供協助。

  • Thank you.

    謝謝。

  • Operator

    Operator

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

    會議已經結束。感謝各位參加今天的報告會。您現在可以斷開連線了。