Pulse Biosciences Inc (PLSE) 2026 Q1 法說會逐字稿

Hello, and thank you for standing by. My name is Mel, and I will be your conference operator for today. At this time, I would like to welcome everyone to the Pulse Biosciences Q1 2026 earnings call. (Operator Instructions) I would now like to turn the call over to Trip Taylor of Investor Relations. Please go ahead.

您好，感謝各位稍候。我的名字是 Mel，今天將擔任本次電話會議的接線員。此刻，我謹代表主辦方歡迎各位參加 Pulse Biosciences 2026 年第一季（Q1）財報電話會議。（接線員指示）現在我想將電話交給投資人關係部的 Trip Taylor。請開始。

Thank you, operator. Before we begin, I'd like to inform you that comments and responses to your questions during today's call reflect management's views as of today, May 7, 2026, only, and will include forward-looking statements and opinion statements, including predictions, estimates, plans, expectations and other similar information. Actual results may differ materially from those expressed or implied as a result of certain risks and uncertainties. These risks and uncertainties are more fully described in our press release issued on Monday and in our filings with the US Securities and Exchange Commission.

謝謝，接線員。在我們開始之前，我想提醒各位，今天電話會議中管理層對各位問題的評論與回覆，僅反映截至今日（2026 年 5 月 7 日）的管理層觀點，並將包含前瞻性陳述與意見性陳述，包括預測、估計、計畫、預期及其他類似資訊。由於若干風險與不確定性，實際結果可能與明示或暗示的內容存在重大差異。這些風險與不確定性在我們於週一發布的新聞稿以及向美國證券交易委員會（SEC）提交的文件中有更完整的說明。

Our SEC filings can be found on our website or on the SEC's website. Investors are cautioned not to place undue reliance on forward-looking statements. We disclaim any obligation to update or revise these forward-looking statements. We will also discuss certain non-GAAP financial measures. Disclosures regarding these non-GAAP financial measures, including reconciliations with the most comparable GAAP measures can be found in the press release.

我們的 SEC 申報文件可在本公司網站或 SEC 網站查閱。提醒投資人勿過度依賴前瞻性陳述。我們不承擔更新或修訂這些前瞻性陳述的任何義務。我們也將討論若干非 GAAP 財務衡量指標。關於這些非 GAAP 財務衡量指標的揭露（包括與最可比 GAAP 指標的調節表）可在新聞稿中查閱。

Please note that this conference call will be available for audio replay on our website at pulsebiosciences.com in the News and Events section on our Investor Relations page. With that, I would now like to turn the call over to Co-Chair of the Board and Chief Executive Officer, Paul LaViolette.

請注意，本次電話會議將可於我們網站 pulsebiosciences.com 的「新聞與活動」區（投資人關係頁面）提供音訊重播。接下來，我想將電話交給董事會聯席主席兼執行長 Paul LaViolette。

Good afternoon, and thank you for joining us. For those of you that are new to the Pulse Biosciences story, let me start with a brief overview of the technology at the core of everything we do. Pulse Biosciences is the pioneer of Nanosecond Pulsed Field Ablation, or nsPFA, a fundamentally new category of energy that we believe will change the way soft tissues in the human body are treated across multiple disease states.

各位下午好，感謝加入我們。對於初次接觸 Pulse Biosciences 的各位，我先簡要介紹我們一切工作的核心技術。Pulse Biosciences 是奈秒脈衝電場消融（Nanosecond Pulsed Field Ablation，nsPFA）的先驅；我們相信這是一種根本性的全新能量類別，將改變人體軟組織在多種疾病狀態下的治療方式。

Conventional ablation modalities, whether radio frequency, cryoablation, microwave or even today's first-generation microsecond pulsed field systems share common limitations. They rely on relatively long-duration energy delivery windows. They deliver current or temperature changes through tissue inefficiently. They cover small treatment areas, create shallow lesions and often require repeated applications.

傳統的消融方式，無論是射頻、冷凍消融、微波，甚至是當今第一代的微秒脈衝電場系統，都有共同的限制：它們依賴相對較長的能量輸出時間窗；電流或溫度變化在組織中的傳遞效率不佳；治療覆蓋範圍小、病灶較淺，且往往需要重複施作。

Our nsPFA platform creates an entirely different and proprietary approach and experience. We deliver pulses measured in billionths of a second. At that time scale, with each pulse, the duration of a few billionths of a second, the energy interacts with cells through a nonthermal mechanism that initiates regulated cell death in target tissue while leaving collagen, blood vessels, nerves and other noncellular structures intact.

我們的 nsPFA 平台帶來完全不同且具專有性的方式與體驗。我們輸出的脈衝以十億分之一秒為單位衡量。在這樣的時間尺度下，每一次脈衝（持續僅數十億分之一秒）能量會透過非熱機制與細胞互動，啟動目標組織的受調控細胞死亡，同時保留膠原蛋白、血管、神經及其他非細胞結構的完整性。

The practical effect of nsPFA delivery is meaningful. nsPFA creates deeper and more durable lesions delivered in dramatically less time while providing a margin of safety that has been a core challenge for legacy energy sources. Surrounding this core technology, we have built a substantial and growing intellectual property state that positions Pulse Biosciences as the clear first mover and the long-term leader in nanosecond PFA. We are developing this platform to treat atrial fibrillation, where the unmet need is enormous and where our differentiation seems to be pronounced. And we are advancing additional applications that leverage these remarkable underlying therapeutic advantages of nsPFA energy.

nsPFA 的實際效果意義重大。nsPFA 能在大幅縮短時間的情況下形成更深且更持久的病灶，同時提供一個安全邊際，而這一直是傳統能量來源的核心挑戰。圍繞這項核心技術，我們建立了龐大且持續成長的智慧財產權版圖，使 Pulse Biosciences 成為奈秒 PFA 領域明確的先行者與長期領導者。我們正將此平台用於治療心房顫動（atrial fibrillation），該領域未被滿足的需求極為龐大，而我們的差異化優勢似乎也相當明顯。同時，我們也在推進其他應用，以運用 nsPFA 能量這些卓越的底層治療優勢。

Against this backdrop, the first quarter of 2026 produced a true inflection point for Pulse. Three milestones defined the quarter and recent progress produced by our team. First, we presented landmark late-breaking data from our large European feasibility study at the AF Symposium, which set a new bar for what physicians and patients should expect from a pulsed field ablation therapy.

在此背景下，2026 年第一季為 Pulse 帶來真正的轉折點。本季與近期進展由三項里程碑所定義。第一，我們在 AF Symposium 發表了來自大型歐洲可行性研究的里程碑式最新突破數據（late-breaking data），為醫師與病患對脈衝電場消融治療的期待樹立了新標竿。

Second, leveraging this unprecedented clinical data set, we made the decision to strategically reshape Pulse Biosciences to focus on our highest value opportunity, our nPulse Cardiac Catheter for atrial fibrillation and have rapidly reorganized our focus and operations to allocate an increased portion of our overall company resources to this program.

第二，憑藉這套前所未有的臨床數據，我們決定策略性地重塑 Pulse Biosciences，聚焦於我們最高價值的機會——用於心房顫動的 nPulse 心臟導管（nPulse Cardiac Catheter），並已迅速重新調整重點與營運配置，將公司整體資源中更高比例分配至此專案。

And third, in just the past several weeks, we commenced enrollment in our IDE US pivotal study, NANOPULSE-AF, treating our first patients with the nsPFA catheter system in early April. We also released updated follow-up data from the European feasibility study, further validating strong positive outcomes. Each one of these milestones represents a meaningful achievement. Together, they reflect a clinical development program of great importance moving at impressive speed.

第三，就在過去幾週內，我們已啟動 IDE 美國關鍵性試驗 NANOPULSE-AF 的收案，並於 4 月初使用 nsPFA 導管系統治療了首批病患。我們也發布了歐洲可行性研究的最新追蹤數據，進一步驗證強勁的正向結果。上述每一項里程碑都代表重要成就；合在一起，反映出一項極具重要性的臨床開發計畫正以令人印象深刻的速度推進。

Today, I will provide updates on our nsPFA system in more detail, and we'll then turn the call over to our Chief Financial Officer, Jon Skinner, to review the first quarter financial results. We will then conclude with a question-and-answer session joined by Bob Duggan, Co-Chair of the Board; and Liane Teplitsky, Chief Operating Officer.

今天，我將更詳細提供我們 nsPFA 系統的最新進展，接著把電話交給我們的財務長 Jon Skinner，回顧第一季財務結果。最後，我們將進行問答環節，並由董事會聯席主席 Bob Duggan 與營運長 Liane Teplitsky 一同參與。

I will now begin with our nPulse Cardiac Catheter System for AF ablation. Our nPulse Cardiac Catheter System is purpose-built to address atrial fibrillation with a 360-degree circular design. The clinical goal of ablation in the treatment of paroxysmal AF is straightforward, electrically isolate the pulmonary veins from the left atrium to prevent abnormal electrical signals from triggering arrhythmias. Achieving that goal durably, efficiently and safely has been the ongoing challenge in the field.

我現在先從我們用於 AF 消融的 nPulse 心臟導管系統開始。我們的 nPulse 心臟導管系統以 360 度環形設計為核心，專為解決心房顫動而打造。治療陣發性 AF 的消融臨床目標很直接：將肺靜脈與左心房進行電性隔離，以防止異常電訊號觸發心律不整。如何在持久性、效率與安全性上達成此目標，一直是該領域持續面臨的挑戰。

And the ability to advance improvements in AF care will set our catheter apart from existing technology in this rapidly growing market. The nPulse nsPFA system represents what we believe is the world's first true single-shot pulmonary vein ablation treatment platform for AF. Early data suggests a physician can now rapidly position the circular catheter, deliver a single five-second application of nanosecond pulse energy per target location and achieve a complete circumferential and transmural ablation without repositioning, without rotating and without the need to stack multiple overlapping lesions.

而推動 AF 照護改善的能力，將使我們的導管在這個快速成長的市場中有別於既有技術。nPulse nsPFA 系統代表我們所相信的全球首個真正「單次施作」（single-shot）的肺靜脈消融 AF 治療平台。早期數據顯示，醫師如今可快速定位環形導管，針對每個目標位置施加一次 5 秒的奈秒脈衝能量，即可在無需重新定位、無需旋轉、也無需堆疊多個重疊病灶的情況下，達成完整的環周與全層（transmural）消融。

That workflow advantage stems directly from the underlying ultrashort duration and high energy pulse parameters unique to nsPFA energy and Pulse's unique catheter design, which is possible in part because of the unique properties of the energy. Because the energy is delivered in billionth of a second, the total cumulative energy transferred to tissue is dramatically lower, which means no measurable temperature rise and minimal neuromuscular stimulation.

這項工作流程優勢，直接源自 nsPFA 能量所特有的超短脈衝時間與高能量脈衝參數，以及 Pulse 獨特的導管設計；而這種設計在某種程度上也得以因能量的獨特性而實現。由於能量以十億分之一秒的尺度輸出，傳遞至組織的累積總能量大幅降低，意味著不會出現可測得的溫度上升，且神經肌肉刺激極小。

The result is a system designed for speed, reproducibility and durability, qualities that make the procedure more streamlined and efficient for operators as we redefine the standard of care in electrophysiology. Since our last call, we announced a meaningful strategic alignment to prioritize and accelerate the development and future commercialization of our nPulse cardiac catheter ablation system.

其結果是一套以速度、可重現性與持久性為設計核心的系統；當我們重新定義電生理領域的照護標準時，這些特質可讓操作者的手術流程更精簡、更有效率。自上次電話會議以來，我們宣布了一項重要的策略性調整，以優先並加速我們 nPulse 心臟導管消融系統的開發與未來商業化。

The European feasibility study results from 177 patients send a powerful message. The nPulse Cardiac Catheter System has the potential to improve clinical practice for millions of patients living with atrial fibrillation. In response, we are increasingly prioritizing the program by allocating additional resources to our clinical and R&D teams to accelerate time to market for this catheter system.

來自 177 位病患的歐洲可行性研究結果傳遞出強而有力的訊息：nPulse 心臟導管系統有潛力改善數以百萬計心房顫動患者的臨床治療實務。作為回應，我們正進一步提高此專案的優先順序，投入更多資源至臨床與研發團隊，以加速該導管系統的上市時程。

This investment in resources and focus will accelerate the pivotal IDE study, the introduction of additional clinical studies and the development of our next-generation catheters. As part of the strategic realignment, we continue to expand our EP leadership team. Most notably, Dr. David Kenigsberg has transitioned to a full-time Chief Medical Officer. Dr. Kenigsberg will lead our clinical strategy, investigator engagement, medical affairs and study execution as we enroll the pivotal IDE study and expand our clinical data set.

這項在資源與重點上的投資將加速關鍵性的 IDE 研究、推動更多臨床研究的導入，以及我們下一代導管的開發。作為策略性調整的一部分，我們持續擴編 EP（電生理）領導團隊。最值得一提的是，David Kenigsberg 醫師已轉任為全職首席醫療長（Chief Medical Officer）。Kenigsberg 醫師將在我們推進關鍵性 IDE 研究收案並擴充臨床資料集的同時，領導臨床策略、研究者互動、醫療事務與研究執行。

In addition, we welcomed Liane Teplitsky to the Pulse Biosciences executive team as Chief Operating Officer, a newly created role on our executive leadership team. Liane is a seasoned med tech executive with 20 years of experience and an exceptional track record of building and scaling innovative med tech businesses, particularly in electrophysiology.

此外，我們也歡迎 Liane Teplitsky 加入 Pulse Biosciences 高階管理團隊，擔任營運長（Chief Operating Officer），此為我們高階領導團隊中新設立的職位。Liane 是資深醫療科技（med tech）高階主管，擁有 20 年經驗，並在打造與擴大創新醫療科技事業方面具備卓越實績，尤其是在電生理領域。

She held senior marketing and commercial leadership roles at Abbott Laboratories and St. Jude Medical, contributing to the development, clinical validation and global commercialization of electrophysiology therapies. She will oversee our clinical, regulatory, quality and commercial functions and will be focused on accelerating our strategic priorities with emphasis on the cardiac catheter development program.

她曾在 Abbott Laboratories 與 St. Jude Medical 擔任資深行銷與商務領導職務，並為電生理治療的開發、臨床驗證與全球商業化做出貢獻。她將負責監督我們的臨床、法規、品質與商務職能，並將著重於加速我們的策略優先事項，特別是心臟導管開發計畫。

Collectively, the additions of David and Liane strengthen our ability to execute a successful pivotal IDE study and advance toward regulatory approvals.

整體而言，David 與 Liane 的加入強化了我們執行成功的關鍵性 IDE 研究並邁向法規核准的能力。

On the clinical data front, we had a landmark quarter. At the Heart Rhythm 2026 meeting or HRS, Dr. Vivek Reddy, the national principal investigator of our pivotal study, presented late-breaking updated data from our nPulse Cardiac Catheter System first-in-human feasibility study.

在臨床資料方面，我們迎來具有里程碑意義的一季。在 Heart Rhythm 2026 年會（HRS）上，我們關鍵性研究的全國主要研究者（national principal investigator）Vivek Reddy 醫師發表了 nPulse Cardiac Catheter System 首例人體（first-in-human）可行性研究的最新「最新突破（late-breaking）」更新資料。

Building upon the very positive data presented at the AF Symposium in February, this newly expanded data set included six-month follow-up on 95 subjects and 12-month follow-up on 53 subjects within the five-second ablation cohort. The results were simply outstanding and reinforce the differentiated clinical profile we have observed since the earliest cases.

在 2 月 AF Symposium 所發表的非常正向資料基礎上，這次擴增後的資料集納入了五秒消融（five-second ablation）隊列中 95 位受試者的 6 個月追蹤，以及 53 位受試者的 12 個月追蹤。結果非常出色，並再次印證我們自最早期病例以來所觀察到的差異化臨床特性。

Key findings included sustained 100% procedure success by 24-hour Holter of evaluable patients at six months with 95 of 95 patients meeting the endpoint. Sustained 96% procedural success by 24-hour Holter of evaluable patients at one year and sustained 90% Kaplan-Meier estimated freedom from recurrent AF, atrial flutter or atrial tachycardia also at one year. Procedural performance data at HRS improved from the already impressive readout at AS Symposium with lower atrial dwell time, lower average number of applications and lower procedure and fluoroscopy times.

主要發現包括：在 6 個月時，以 24 小時 Holter 評估之可評估患者維持 100% 手術成功率，95 位患者中 95 位達成終點；在 1 年時，以 24 小時 Holter 評估之可評估患者維持 96% 手術成功率；同樣在 1 年時，Kaplan-Meier 估計之無復發 AF、心房撲動或心房心動過速的比例維持 90%。在 HRS 所呈現的手術表現數據亦較 AS Symposium 已相當亮眼的讀出更進一步改善，包括更低的心房停留時間、更低的平均施作次數，以及更短的手術時間與透視（fluoroscopy）時間。

The safety profile also remained excellent with a primary safety endpoint, serious adverse event rate of just 1.7% across 177 treated subjects. These outcomes are remarkable in a field where reported 20% to 25% AF recurrence rates are typical. It is particularly notable that our results were achieved without antiarrhythmic drugs and with a high degree of consistency across operators and sites, which is typically difficult to achieve at an early stage of clinical development. As Dr. Reddy noted, the durability of pulmonary vein isolation plus the procedural efficiency we are observing is a positive combination not typically expected at this point in the clinical program.

安全性表現同樣維持優異，於 177 位接受治療的受試者中，主要安全性終點之嚴重不良事件率僅 1.7%。在一個通常報告 AF 復發率達 20% 至 25% 的領域中，這些結果相當卓越。尤其值得注意的是，我們的結果是在未使用抗心律不整藥物（antiarrhythmic drugs）的情況下達成，且在不同操作者與不同中心之間具有高度一致性；而在臨床開發早期階段，這通常很難做到。如 Reddy 醫師所指出，我們所觀察到的肺靜脈隔離（pulmonary vein isolation）的持久性加上手術效率，是在此臨床計畫階段通常不會預期出現的正向組合。

These results reflect the underlying advantages of nanosecond PFA and our innovative catheter design, deeper lesion formation with fewer applications, lower cumulative energy and durable pulmonary vein isolation in a fast reproducible workflow. We believe our system directly addresses the limitations of current generation microsecond ablation catheters by enabling complete durable isolation in a single energy delivery with the potential to reduce procedure time significantly.

這些結果反映了奈秒 PFA（nanosecond PFA）與我們創新導管設計的根本優勢：以更少的施作次數形成更深的病灶、較低的累積能量、以及在快速且可重複的工作流程中達成持久的肺靜脈隔離。我們相信，我們的系統可透過單次能量輸送即完成完整且持久的隔離，直接解決現世代微秒（microsecond）消融導管的限制，並有潛力大幅縮短手術時間。

This time-saving advantage represents a meaningful potential capacity expansion for EP procedures and would likely drive rapid adoption of nsPFA as the preferred next-generation energy in the market, especially in light of the potential benefits of the efficacy improvements observed to date.

這項節省時間的優勢代表 EP 手術產能具有實質的擴充潛力，並可能推動 nsPFA 成為市場上偏好的下一代能量來源而快速被採用，尤其考量到目前為止所觀察到的療效改善之潛在效益。

As we look ahead toward the migration of AF ablation procedures to ambulatory surgery centers or the ASCs, we expect all the benefits of the nPulse cardiac catheter to align directly with the needs of the ASC and the overall expansion of treating the growing population of patients with atrial fibrillation.

展望未來，隨著 AF 消融手術逐步移轉至門診手術中心（ambulatory surgery centers，ASC），我們預期 nPulse 心臟導管的所有優勢將可直接符合 ASC 的需求，並支持對日益增加的心房顫動患者族群之整體治療擴張。

The compelling body of clinical evidence from our European feasibility study provided a strong foundation for the most important operational milestone of the quarter, the commencement of our US IDE pivotal trial. In early April, we announced that the first patients had been enrolled in our NANOPULSE-AF study, a prospective multicenter IDE pivotal clinical investigation evaluating the nPulse Cardiac Catheter System for the treatment of recurrent drug-resistant symptomatic paroxysmal atrial fibrillation.

我們歐洲可行性研究所累積的具說服力臨床證據，為本季最重要的營運里程碑——啟動美國 IDE 關鍵性試驗——奠定了堅實基礎。4 月初，我們宣布已在 NANOPULSE-AF 研究中完成首批患者收案；該研究為一項前瞻性、多中心的 IDE 關鍵性臨床試驗，評估 nPulse Cardiac Catheter System 用於治療復發、對藥物無反應且具症狀之陣發性心房顫動（paroxysmal atrial fibrillation）。

The first seven patients were treated at St. Bernards Medical Center in Jonesboro, Arkansas in just one day under the leadership of Dr. Devi Nair, principal investigator of the Arrhythmia Research Group. Dr. Nair has not previously used the nPulse catheter. And the efficiency with which the procedures were completed speaks volumes about the short learning curve and usability benefits we can expect from our system.

首 7 位患者在阿肯色州瓊斯伯勒（Jonesboro, Arkansas）的 St. Bernards Medical Center 於同一天完成治療，由 Arrhythmia Research Group 的主要研究者 Devi Nair 醫師領導。Nair 醫師先前未使用過 nPulse 導管，而手術完成的效率充分說明了我們系統預期具備的短學習曲線與易用性優勢。

Early feedback from physician investigators reinforces the user-friendly nature of the system and the efficient reproducible streamlined workflow it supports. This positive feedback has helped create significant enthusiasm for study participation.

來自醫師研究者的早期回饋進一步強化了該系統的易用特性，以及其所支援的高效率、可重複且精簡的工作流程。這些正向回饋有助於激發對參與研究的高度熱忱。

Site activation is accelerating, and we are encouraged by the current and planned enrollment momentum we are seeing. Based on the excitement and momentum coming out of HRS, along with the benefit of our strategic realignment, we are tightening our enrollment time line to reflect the likely faster pace of our study execution. We now anticipate enrollment to be completed in early Q4 2026 compared to prior guidance that planned enrollment completion by the end of 2026.

中心啟動（site activation）正在加速，我們也對目前與規劃中的收案動能感到鼓舞。基於 HRS 會後的熱度與動能，加上策略性調整所帶來的效益，我們正在縮短收案時程，以反映研究執行可能更快的步調。我們目前預期可在 2026 年第 4 季初完成收案，較先前指引（原規劃於 2026 年底完成收案）有所提前。

Regarding study follow-up, the final proportion of participants with primary effectiveness success or freedom from treatment failure through 12 months will be estimated using a Bayesian analysis that includes outcomes at 12 months for a subset of patients and at six months for the remainder. Using a blend of follow-up durations will shorten overall follow-up time for the study.

關於研究追蹤，主要有效性成功比例（primary effectiveness success）或在 12 個月內無治療失敗（freedom from treatment failure）的最終受試者比例，將以貝葉斯分析（Bayesian analysis）估計；該分析納入部分患者的 12 個月結果，以及其餘患者的 6 個月結果。採用不同追蹤期間的組合將縮短研究的整體追蹤時間。

This method allows determination of success earlier than traditional statistical methods used in other studies. Overall, we are accelerating both enrollment and follow-up time lines to optimize the planned filing date for the clinical PMA module.

此方法可較其他研究中使用的傳統統計方法更早判定成功與否。整體而言，我們正同時加速收案與追蹤時程，以最佳化臨床 PMA 模組（clinical PMA module）的預計送件日期。

On the regulatory front in Europe, we expect to use the data from our European feasibility study to finalize our CE submission in the second half of 2026 with the potential for CE Mark approval in mid-2027. We are also continuing discussions with potential strategic partner candidates. Potential partners include the world-class mapping providers and EP market leaders.

在歐洲法規方面，我們預期將使用歐洲可行性研究的資料於 2026 年下半年完成 CE 送件定稿，並有機會在 2027 年年中取得 CE Mark 核准。我們也持續與潛在策略合作夥伴進行討論。潛在合作夥伴包括世界級的定位（mapping）供應商與 EP 市場領導者。

A key advantage of the nPulse cardiac catheter is its ability to be integrated with all mapping systems. This creates a compelling synergy in which our partner or partners may gain access to the most advanced nanosecond PFA energy solution available. These partnership conversations are active, and we will share details of partnership prospects when the time is appropriate.

nPulse 心臟導管的一項關鍵優勢，是可與所有定位系統整合。這創造出具吸引力的協同效應，使我們的合作夥伴可能取得目前可用的最先進奈秒 PFA 能量解決方案。這些合作洽談正在積極進行中，我們將在適當時機分享合作前景的細節。

Let's now discuss our surgical ablation clamp. Our nPulse cardiac clamp pivotal study, NANOCLAMP-AF, is the first and only clinical study of a surgical device delivering PFA to receive FDA IDE approval. The nPulse cardiac clamp applies nanosecond PFA energy to create durable transmural lesion sets during concomitant procedures where the surgeon has direct cardiac tissue access and atrial fibrillation is present. The clinical opportunity is substantial. However, despite strong guideline support for concomitant AF treatment during cardiac surgery, adoption of currently available devices remains low.

接下來談談我們的外科消融夾鉗。我們的 nPulse 心臟夾鉗關鍵性研究 NANOCLAMP-AF，是第一個也是唯一一個獲得 FDA IDE 核准、以 PFA 進行能量輸送的外科器械臨床研究。nPulse 心臟夾鉗在合併手術（concomitant procedures）期間，於外科醫師可直接接觸心臟組織且存在心房顫動的情況下，施加奈秒 PFA 能量以形成持久的全層（transmural）病灶組合。其臨床機會相當可觀。然而，儘管臨床指引強力支持在心臟手術期間同步治療 AF，目前可用器械的採用率仍偏低。

We believe the primary adoption barriers have been procedural complexity, unreliable outcomes and too much time added to the surgery, concerns that nanosecond PFA may directly address through a combination of rapid energy delivery, reproducible lesion formation and a straightforward surgical workflow. We continue to believe that concomitant ablation for preoperative AF is significantly underutilized and that the speed and effectiveness of nsPFA energy can transform this therapy and market.

我們認為主要的採用障礙一直是流程複雜、結果不可靠，以及手術時間增加過多；而奈秒級 PFA 可能可透過快速能量傳遞、可重複的病灶形成，以及簡明的手術工作流程之組合，直接解決這些疑慮。我們仍然認為，針對術前房顫（AF）的同期消融明顯被低度使用，而 nsPFA 能量的速度與有效性可改變此療法與市場。

Enrollment in NANOCLAMP-AF continued to progress during the first quarter. As a reminder, the trial is a prospective single-arm multicenter study designed to assess the primary safety and effectiveness of the nPulse cardiac surgical system in treating AF during concomitant cardiac surgeries. We plan to enroll a target of 136 patients at approximately 20 sites, including two international locations.

NANOCLAMP-AF 在第一季的收案持續推進。提醒各位，該試驗為前瞻性、單臂、多中心研究，旨在評估 nPulse 心臟外科系統在同期心臟手術中治療房顫（AF）的主要安全性與有效性。我們計畫在約 20 個試驗點收案目標 136 名患者，其中包含兩個國際據點。

Reflecting our strategic prioritization of the EP catheter ablation program, including some resource shifts, we now expect to complete enrollment of this IDE study by the end of the first half of 2027. We have moderated near-term development in cardiac surgery while maintaining trial execution and regulatory preparation and clinical site activations continue to expand during Q1.

反映我們對電生理（EP）導管消融計畫的策略性優先排序（包含部分資源調整），我們目前預期將於 2027 年上半年末完成此 IDE 研究的收案。我們在維持試驗執行與法規準備的同時，已放緩心臟外科領域的短期開發；且在第一季期間，臨床試驗點啟動仍持續擴增。

In Europe, we continue to generate excellent results in our cardiac surgery feasibility study. To date, investigators have treated over 60 patients, and we have expanded the study to now include six clinical sites. Within this 60-patient cohort, 34 patients underwent electroanatomical mapping approximately three months after their ablation procedures to assess the effectiveness and durability of the treatment.

在歐洲，我們的心臟外科可行性研究持續產出極佳結果。迄今為止，研究者已治療超過 60 名患者，且我們已將研究擴展至目前共六個臨床試驗點。在這個 60 名患者的隊列中，有 34 名患者於消融手術後約三個月接受電解剖標測，以評估治療的有效性與持久性。

These data were presented at the European Heart Rhythm Association 2026 meeting and are very promising, with individual ablation times averaging a very rapid 41 seconds total per patient. Notably, as patient numbers have increased, the PVI success rate of 94% at approximately three months has remained consistent with the clinical outcomes we reported in our initial data readout in October of 2025.

這些數據已於 2026 年歐洲心律協會（European Heart Rhythm Association）年會發表，結果非常令人振奮；每位患者的單次消融時間平均僅 41 秒，速度極快。值得注意的是，隨著患者數增加，約三個月時的肺靜脈隔離（PVI）成功率 94% 仍維持一致，與我們在 2025 年 10 月初次數據揭露時所報告的臨床結果相符。

Surgeons using the system have reported favorable procedural characteristics, rapid ablation delivery, consistent lesion quality and smooth integration into existing surgical workflows without meaningful time or complexity added to the underlying surgery.

使用該系統的外科醫師回報了良好的手術特性，包括消融施作快速、病灶品質一致，且可順暢整合至既有手術工作流程中，未對原本手術增加具實質意義的時間或複雜度。

Feedback from the surgical community emphasizes that workflow efficiency and predictability matter as much as efficacy in the operating room. And the early signal is that nanosecond PFA delivers very favorably on both. We remain on track to submit for CE Mark by the end of 2026 using the European clinical data set. Turning to our nPulse Vybrance Percutaneous Electrode System.

外科社群的回饋強調，在手術室中，工作流程的效率與可預測性與療效同等重要。而早期訊號顯示，奈秒級 PFA 在這兩方面的表現都非常出色。我們仍按計畫於 2026 年底以前，使用歐洲臨床資料集提交 CE 認證申請。接下來談我們的 nPulse Vybrance 經皮電極系統。

The nPulse Vybrance System applies nanosecond PFA technology to ablate soft tissue in surgical procedures through a percutaneous approach, offering, for example, an alternative to surgical removal for patients with symptomatic benign thyroid nodules. Vybrance is designed to address this patient population through a minimally invasive outpatient procedure that reduces nodule volume, alleviate symptoms and preserve surrounding anatomy and normal thyroid function, outcomes that cannot be achieved with traditional surgical excision.

nPulse Vybrance 系統將奈秒級 PFA 技術透過經皮方式應用於手術中以消融軟組織，例如可為有症狀的良性甲狀腺結節患者提供手術切除以外的替代方案。Vybrance 的設計旨在以微創門診程序服務此患者族群，達到縮小結節體積、緩解症狀，並保留周邊解剖結構與正常甲狀腺功能；這些結果是傳統手術切除所無法達成的。

In the first quarter, the team generated approximately $400,000 in revenue from nPulse Vybrance Systems and electrodes. Our approach continues to be extremely disciplined and remains focused on core market development objectives. We continue to operate at an intentionally limited scale to demonstrate how meaningful over the long term and how well we can service initial Vybrance customers in exploring along with them the potential of the nPulse Vybrance System.

第一季，團隊透過 nPulse Vybrance 系統與電極創造約 40 萬美元營收。我們的方法仍極為嚴謹，並持續聚焦於核心市場開發目標。我們刻意以有限規模運作，以展示其長期意義，以及我們在與初期 Vybrance 客戶共同探索 nPulse Vybrance 系統潛力的同時，能如何良好地提供服務。

Our work is focused on ensuring we generate robust clinical data to support a treatment indication while formalizing patient reimbursement to expand patient access in partnership with key accounts at large hospital systems in select geographies.

我們的工作重點在於確保產出強健的臨床數據以支持治療適應症，同時在特定地理區域與大型醫院體系的關鍵客戶合作，推動病患給付（reimbursement）制度化，以擴大病患可近性。

On the clinical front, the PRECISE-BTN or Benign Thyroid Nodule study reached an important milestone with enrollment of the first 50 patients now completed. We have further expanded the study to 100 patients to broaden the data set supporting adoption and long-term market expansion. It is also notable that scientific recognition of this work continues to build. Data from Dr.

在臨床方面，PRECISE-BTN（良性甲狀腺結節）研究達成重要里程碑，已完成前 50 名患者的收案。我們進一步將研究擴大至 100 名患者，以擴充支持採用與長期市場擴張的資料集。同時也值得注意的是，這項工作的科學認可度持續提升。來自 Dr. 的數據

Stefano Spiezia of Naples, Italy were presented in a podium session at the North American Society of Interventional Thyroidology, or NASIT, in March, which demonstrated remarkable results. Data presented from durable 15- to 22-month results showed 74% volume reduction of treated benign thyroid nodules with overwhelming patient satisfaction reported. Continued volume reduction improvements were seen from one month through 22 months with no regrowth of nodules at 15 to 22 months.

義大利那不勒斯的 Stefano Spiezia 醫師之數據，於 3 月在北美介入甲狀腺學會（North American Society of Interventional Thyroidology，NASIT）的口頭報告場次中發表，並展示了顯著成果。所呈現的 15 至 22 個月持久性結果顯示，接受治療的良性甲狀腺結節體積縮小 74%，且回報的病患滿意度極高。從 1 個月到 22 個月可見結節體積持續改善；在 15 至 22 個月期間未見結節再生長。

In parallel with the PRECISE-BTN study, we are continuing to expand the clinical scope of the Vybrance platform through our research collaboration with the University of Texas MD Anderson Cancer Center. Under this collaboration, we are conducting a first-in-human feasibility study evaluating nsPFA for the treatment of papillary thyroid microcarcinoma, PTMC, on up to 30 patients at two sites, and we are happy to announce that first patient enrollments were completed in Q1. We continue to expect to complete enrollment by year-end 2026.

在進行 PRECISE-BTN 研究的同時，我們也透過與德州大學 MD Anderson 癌症中心的研究合作，持續擴展 Vybrance 平台的臨床範疇。在此合作下，我們正在進行首次人體（first-in-human）可行性研究，評估 nsPFA 用於治療乳頭狀甲狀腺微小癌（papillary thyroid microcarcinoma，PTMC），於兩個試驗點最多收案 30 名患者；我們很高興宣布第一季已完成首批患者收案。我們仍預期於 2026 年底前完成收案。

With that, I will turn the call over to Jon to speak about our first quarter financial results. Jon?

接下來，我將把電話會議交給 Jon，請他說明我們第一季的財務結果。Jon？

Thanks, Paul. Now I will highlight our GAAP and non-GAAP financial results. I encourage listeners to review Monday's earnings release for a detailed reconciliation of non-GAAP measures to the most comparable GAAP measures. In the first quarter, we generated revenues comprised of both nPulse Catheter and Vybrance disposable sales. Total revenue was $401,000 and cost of product revenue was $370,000 for the quarter.

謝謝，Paul。接下來我將重點說明我們的 GAAP 與非 GAAP 財務結果。我建議聽眾查閱週一發布的財報新聞稿，以取得非 GAAP 指標與最可比 GAAP 指標之間的詳細調節表。第一季，我們的營收來自 nPulse 導管與 Vybrance 一次性耗材的銷售。總營收為 401,000 美元，本季產品營收成本為 370,000 美元。

Total GAAP costs and expenses for the quarter increased by $1.6 million to $19.6 million compared to $18 million in the prior year period. The increase in GAAP costs and expenses was primarily driven by increased investment in our clinical programs, partially offset by lower stock-based compensation expense.

本季 GAAP 總成本與費用較去年同期增加 160 萬美元，達 1,960 萬美元；去年同期為 1,800 萬美元。GAAP 成本與費用增加主要由於我們對臨床計畫的投資增加，部分被較低的股份基礎給付（stock-based compensation）費用所抵銷。

To remind everyone, non-GAAP costs and expenses exclude stock-based compensation, depreciation and amortization as well as nonrecurring costs. Total non-GAAP costs and expenses in the first quarter of 2026 increased by $4.7 million to $17.4 million compared to $12.7 million in the prior year period. The expected increase was driven by increasing clinical trial, product development and market development activity.

提醒各位，非 GAAP 成本與費用排除股份基礎給付、折舊與攤銷，以及非經常性成本。2026 年第一季非 GAAP 總成本與費用較去年同期增加 470 萬美元，達 1,740 萬美元；去年同期為 1,270 萬美元。此一預期中的增加主要由臨床試驗、產品開發與市場開發活動的提升所帶動。

GAAP net loss in the first quarter of 2026 was $18.6 million compared to $16.8 million in the prior year period. Non-GAAP net loss in the first quarter of 2026 was $16.4 million compared to $11.4 million in the prior year period. As of March 31, 2026, cash and cash equivalents totaled $68.3 million compared to $80.7 million as of December 31, 2025, representing a decrease of $12.4 million versus the prior quarter.

2026 年第一季 GAAP 淨損為 1,860 萬美元，去年同期為 1,680 萬美元。2026 年第一季非 GAAP 淨損為 1,640 萬美元，去年同期為 1,140 萬美元。截至 2026 年 3 月 31 日，現金及約當現金合計 6,830 萬美元；相較於 2025 年 12 月 31 日的 8,070 萬美元，較前一季減少 1,240 萬美元。

Cash used in operating activities during the first quarter of 2026 was $14.6 million compared to $13.5 million used in the prior year period and $14.8 million in Q4 of 2025. As we discussed last quarter, we completed important corporate housekeeping by filing a $200 million shelf registration, all of which is available.

2026 年第一季營運活動使用的現金為 1,460 萬美元，去年同期為 1,350 萬美元，且 2025 年第四季為 1,480 萬美元。如同我們在上季所討論的，我們已透過提交 2 億美元的擱置式註冊（shelf registration）完成重要的公司例行整理作業，且該註冊目前皆可供使用。

In addition, the company has an ATM program in effect with approximately $60 million of availability as of March 31, 2026. We have received Board of Directors' approval for interested executives and Board members to participate in our ATM program. Our Co-Chairman of the Board and our CEO and Co-Chairman have both indicated they are likely to purchase shares in the near term. Cash usage aligns with investment expenditures in pivotal trials, device scaling and market development. Expense growth remains deliberate and focused on long-term value creation. We continue to maintain ample liquidity to fund operations and clinical programs through major inflection points during 2026.

此外，公司目前已啟動 ATM（按市價發行）計畫，截至 2026 年 3 月 31 日約有 6,000 萬美元的可用額度。我們已取得董事會核准，允許有意願的高階主管與董事會成員參與我們的 ATM 計畫。我們的董事會共同主席以及我們的執行長兼董事會共同主席均表示，近期可能會買進公司股票。現金使用與關鍵性試驗、裝置擴產與市場開發的投資支出相一致。費用成長仍維持審慎，並聚焦於長期價值創造。我們持續維持充足流動性，以支應 2026 年期間跨越主要拐點所需的營運與臨床計畫資金。

With that, I will now turn it back over to Paul for his closing remarks.

接下來，我把時間交還給 Paul，請他做結語。

Thank you, Jon. This was a defining quarter for Pulse Biosciences. We sharpened our strategic focus on electrophysiology, delivered landmark clinical outcomes at Heart Rhythm 2026 and AF Symposium that reinforced the durability and efficiency of our technology and commenced enrollment in our US IDE pivotal trial for our cardiac catheter program. Today, resulting from those efforts, we announced a tightened time line for anticipated completion of enrollment in our paroxysmal AF pivotal study.

謝謝你，Jon。這一季對 Pulse Biosciences 而言是具有指標性意義的一季。我們更聚焦於電生理領域，在 Heart Rhythm 2026 與 AF Symposium 發表具里程碑意義的臨床結果，進一步證實我們技術的持久性與效率，並已開始為我們的心臟導管計畫之美國 IDE 關鍵性試驗招募受試者。基於上述努力，我們今天也宣布，已縮短我們預期完成陣發性 AF 關鍵性研究招募的時程。

We strengthened the team supporting this mission, and we continue to advance our surgical and percutaneous programs in a disciplined manner aligned with our priorities. Our path forward is clear, enroll and complete our pivotal trials, finalize our CE Mark submissions and continue to advance our partnership pipeline, all while maintaining the financial discipline to fund the company through the milestones that will define its future.

我們強化了支持此使命的團隊，並持續以符合優先事項的紀律方式推進我們的外科與經皮計畫。我們前進的路徑很清楚：招募並完成關鍵性試驗、完成 CE Mark 送件，並持續推進合作夥伴管線，同時維持財務紀律，確保公司能在將決定其未來的各項里程碑之前獲得充足資金支持。

This disruptive nsPFA technology we are advancing has the potential to change how ablation is performed across multiple disease states. And we believe that executing toward those near-term milestones will unlock that potential for patients, physicians and shareholders alike. Thank you for your continued support.

我們正在推進的這項具顛覆性的 nsPFA 技術，有潛力改變多種疾病狀態下的消融治療方式。我們相信，達成這些近期里程碑將能為病患、醫師與股東共同釋放其潛力。感謝各位持續的支持。

Now joining us for the question-and-answer session are Bob Duggan, Co-Chairman of the Board, and for her first earnings call with Pulse Biosciences, our Chief Operating Officer, Liane Teplitsky. Operator, please open the call for questions.

現在加入我們問答環節的有董事會共同主席 Bob Duggan，以及首次參與 Pulse Biosciences 法說會的營運長 Liane Teplitsky。接線生，請開放提問。

(Operator Instructions)

（接線生指示）

Suraj Kalia, Oppenheimer.

Suraj Kalia，Oppenheimer。

Gentlemen, congrats on all the progress and the excitement at HRS. Paul, many calls going on. So please forgive me, I'll ask all my questions together. First, did you highlight the number of sites that are as part of the clinical trial? The limits to each site because you don't want too much concentration. And finally, if these patients are consciously sedated or general anesthesia.

各位先生，恭喜在 HRS 取得所有進展並引發熱烈關注。Paul，現在很多電話會議同時進行，請見諒，我會把問題一次問完。第一，你們是否提到臨床試驗包含多少個中心？第二，每個中心的收案上限（因為你們不希望過度集中）。最後，這些病患是採清醒鎮靜還是全身麻醉？

Thank you, Suraj. And yes, we are happy to take all your questions at once. Regarding the number of sites, we have approval for up to 30 sites, and that's important in part because it determines how many total rolling patients can be advanced in the study, and that affects the total number of patients that we can enroll, bringing that number up to 215. So total number of sites is 30. We do not anticipate reaching that many sites just based on the total size of the study enrollment, the likelihood that a number of sites entering early in the protocol will, as you allude to in your second question, enroll at or close to the limit of their total enrollee allocation.

謝謝你，Suraj。是的，我們很樂意一次回答你所有問題。關於中心數量，我們已獲核准最多可設 30 個中心；這點很重要，部分原因在於它決定研究中可同時推進的滾動式受試者總數，進而影響我們可招募的總受試者數，將總數提高到 215 人。因此，中心總數上限是 30。基於研究招募的總規模，我們不預期會用到那麼多中心；而且如你第二個問題所提到的，較早進入試驗流程的部分中心，很可能會收案達到或接近其分配的收案上限。

And as a result of that, we're likely to involve active sites less than the number that we were allowed in our protocol of 30. As it relates to the limits per site, you're right. Every protocol limits the number of sites based on a percent of total so that there's not an unbalanced skew toward too few enrolling locations. And that number is typical in this study as it is with many others. Usually, it's around 15% to 20% of total enrollment is the cap for an individual site, and that is the case here, which limits our sites to between, let's just say, the low 20s of patients per site maximum.

因此，我們實際啟用的中心數可能會少於試驗計畫書允許的 30 個。至於每個中心的上限，你說得沒錯。每個試驗計畫書通常會以總收案比例來限制單一中心的收案量，以避免收案過度集中在少數地點而造成偏差。本研究的設定與許多研究相同，通常單一中心的上限約為總收案的 15% 到 20%，本研究亦是如此；因此每個中心最多大約落在 20 多位受試者（上限）這個範圍。

And then as it relates to our anesthesia protocol, you raised a really good question because conscious sedation is a likely viable sedation protocol for these patients. We've seen that in Europe, and we're quite enthusiastic about the potential for lower sedation long term, particularly as we enter the US market and migrate patient therapies to the ambulatory surgery setting. That being said, the protocol in the pivotal study calls for general anesthesia.

至於麻醉方案，你提出了一個非常好的問題，因為清醒鎮靜對這些病患而言很可能是可行的鎮靜方式。我們在歐洲已看到這點，也對長期降低鎮靜程度的潛力感到相當振奮，特別是當我們進入美國市場並將治療逐步移轉到門診手術場域時。不過，關鍵性試驗的計畫書規定採全身麻醉。

(Operator Instructions)

（接線生指示）

Anthony Petrone, Mizuho.

Anthony Petrone，Mizuho。

Congrats on a strong start to the year and the two good medical meetings, AF Symposium, HRS. Maybe taking it from HRS, the podium presentation, Dr. Reddy, maybe a little bit of noise that crept into the dialogue there at HRS relative to AF Symposium, sort of the idea that as we expand to more sites in the US, we potentially enroll a somewhat sicker patient population in the US, that we can see at least some degradation to the durability statistics that we saw out of the early feasibility study. So maybe just walk through the expectations for the capability to maintain durability, how continuous mapping can potentially help to improve that. And any risk that there may be just from the differences in patient populations.

恭喜今年開局強勁，也在兩場重要醫學會議（AF Symposium、HRS）表現亮眼。或許從 HRS 的講台報告談起，Dr. Reddy 的報告中，相較於 AF Symposium，HRS 的討論裡似乎出現一些雜音：也就是當我們在美國擴展到更多中心時，可能會在美國招募到病情稍重的病患族群，因此我們可能會看到相較於早期可行性研究的持久性（durability）統計數據出現一些下滑。能否請你談談維持持久性的能力之預期、連續性標測（continuous mapping）如何可能幫助改善，以及不同病患族群所帶來的任何風險？

And I'll have one quick follow-up.

我還有一個簡短的追問。

Thanks, Anthony. Very good question. We're very pleased with the data. The data set so far has been extremely strong. And obviously, just to remind folks, at six months, 100% efficacy against our primary endpoint of rhythm control as measured by Holter monitor at that 180-day point.

謝謝你，Anthony。非常好的問題。我們對這些數據非常滿意。目前為止的資料集表現非常強勁。也提醒大家，在 6 個月時點，針對我們的主要終點（以 Holter 監測在第 180 天評估的節律控制）達到 100% 的有效性。

Same thing at 12 months, 96%, and of course not a primary endpoint per se, but a broader measure of efficacy would be the data that we represented in our Kaplan-Meier curve of 90% success with respect to freedom from atrial fibrillation, a flutter and atrial tachycardia. So those are the numbers that we're starting with.

在 12 個月時點也是一樣，為 96%；當然這本身不算主要終點，但更廣義的有效性衡量，則是我們在 Kaplan-Meier 曲線中呈現的數據：在「無心房顫動、心房撲動與心房心動過速」方面的成功率為 90%。因此，這些是我們目前的起始數字。

As it relates to the comparison of patient severity between the European feasibility study and the pivotal study, for the most part, there is no difference. These are both principally paroxysmal patients. A patient enrolled in the European feasibility study was by definition, per his or her medical record, a paroxysmal patient. The same severity measure will be applied in the United States.

至於歐洲可行性研究與關鍵性試驗之間病患嚴重程度的比較，大多數情況下並沒有差異。兩者主要都是陣發性病患。歐洲可行性研究納入的病患，依其病歷定義即為陣發性病患；在美國也會採用相同的嚴重程度衡量標準。

As it relates to some changes, let's say, in the population background, you will see, just based on moving to the United States and enrolling the vast majority of patients in the US, you will see minor changes in factors such as BMI, right? The United States patient population is slightly heavier, and so we would expect the BMI which was 28 in Europe to go up in the US, but that's not a significant risk factor.

至於族群背景可能出現的一些變化，舉例來說，當我們移到美國並在美國招募絕大多數病患時，像 BMI 這類因素可能會有些微變動。美國病患族群平均略重，因此我們預期 BMI 會從歐洲的 28 在美國略為上升，但這不是顯著的風險因子。

The CHADS score, which is an important cardiovascular measure was relatively low. That will be consistent in the US based on a paroxysmal population. And other factors in the medical history, whether it's hypertension or heart failure, we expect to have a relatively generic paroxysmal patient population, most notably with a relatively near-term onset of atrial fibrillation typically in the one- to two-year time frame.

CHADS 分數（重要的心血管衡量指標）先前相對偏低；在以陣發性族群為主的前提下，美國也會維持一致。至於其他病史因素，不論是高血壓或心衰竭，我們預期納入的仍會是相對典型的陣發性病患族群，最顯著的特徵是心房顫動的發作時間通常相對較近，多落在一到兩年的時間範圍內。

So I think overall, the patient population, while representing the US population and maybe a little bit less healthy is not representing, I'll call it, a higher risk factor than the US. And therefore, degradation is not to be expected.

因此我認為整體而言，這個病患族群雖然代表美國人口、而且可能健康狀況略差一些，但並不代表——我稱之為——比美國更高的風險因子。因此，不預期會出現效能劣化。

This is a pulmonary vein isolation strategy using a highly effective novel energy, which we've now seen evidence that produces a really impressive ablation and impressive electrical isolation. We've treated more patients in Europe actually than we'll enroll in the United States. The endpoints that we're using in this case of freedom from AF as measured by Holter are the same. So the same endpoints. And I would also say the sites that we're moving to, while we will have more sites in the United States, we use multiple sites, multiple operators in Europe.

這是一種肺靜脈隔離策略，採用一種高度有效的新型能量；我們現在已看到證據顯示，它能產生非常令人印象深刻的消融效果與電性隔離。我們在歐洲實際治療的病患數，已經多於我們將在美國納入的受試者數。本案所使用、以 Holter 量測之無房顫（AF）發作的終點相同，也就是相同的終點。我也要說，我們所轉移到的試驗中心，雖然在美國會有更多中心，但在歐洲我們同樣使用多個中心、不同術者。

And the sites that we're going to in the United States represent the best in the world. So we believe that -- and we've seen this, I think, early on in our enrollment experience. We believe that we are going to see outstanding clinical results. Physicians are, I'd say, rapidly assimilating our technology into their workflow, and it's performing the way we expected it to in the US, based on how we observe those cases performed in our European sites. Lastly, I think you make a great point about mapping.

而我們在美國所選擇的中心代表全球最頂尖的水準。因此我們相信——而且我想我們在早期的收案經驗中也看到了——我們將會看到非常出色的臨床結果。醫師們可以說正迅速地把我們的技術融入其工作流程中；而它在美國的表現也如同我們預期，並且與我們在歐洲中心觀察到的案例表現一致。最後，我認為你提出了關於 mapping（標測）的重點。

Mapping is now tightly integrated, as we've mentioned, with the Abbott EnSite system. That mapping, I'll call it, refinement, that fidelity provides our US pivotal trial operators with a very high degree of precision location of the catheter, enabling them to localize catheter placement and ablation placement very rapidly in our procedures and very accurately. And so we think the risk of experiencing a meaningfully different outcome in the US is managed well by all of these consistencies between Europe and the US and that we don't see the introduction of a meaningful new risk that would dilute expected clinical performance.

如我們所提到的，標測現在已與 Abbott EnSite 系統緊密整合。這種我稱之為標測「精修」的能力、這種高擬真度，為我們美國關鍵性試驗的術者提供了非常高精度的導管定位，使他們能在手術中非常快速且非常準確地定位導管放置與消融位置。因此，我們認為在美國出現顯著不同結果的風險，已透過歐洲與美國之間的這些一致性而得到良好管理；我們也不認為會引入任何有意義的新風險，進而稀釋預期的臨床表現。

My last comment there would be success is not defined in our case explicitly by a specific number that is 96% or 95%. We have we have the potential here to redefine the way atrial fibrillation is treated, the workflow, the efficiency associated with this technology, which we see, of course, in an acute way, we don't need follow-up data for that. That is a dramatic change. This is a significant disruptive technology in the hands of physicians going against the number one most common arrhythmia in medicine. And I do believe we have something that's very significant here. And it's going to be a combination of both acute and long-term outcomes that will reinforce that for us coming out of the US trial.

我在這裡最後一點想說的是：在我們的情況下，成功並不是明確以某個特定數字來定義，例如 96% 或 95%。我們在此有機會重新定義心房顫動的治療方式、工作流程，以及與這項技術相關的效率；這些我們當然可以在急性期就看到，不需要追蹤數據來證明。那是一個戲劇性的改變。這是一項重大的顛覆性技術，交到醫師手中，用來對抗醫學上最常見的第一大心律不整。我確實相信我們在這裡擁有非常重要的成果。而從美國試驗出來後，將會是急性與長期結果的組合，一起強化我們的信心。

And just the follow-ups in here real quick would be just to confirm in the pivotal study here, IDE study, will EnSite be the only mapper, or will you bring in additional mapping technologies? And then a quick one just on soft tissue ablation, papillary thyroid microcarcinoma, new collaboration with MD Anderson. Maybe just a high level on the underlying TAM opportunity on the carcinoma side of the equation for the thyroid. Congratulations again.

我這裡快速追問兩點：第一，確認一下在這個關鍵性研究、IDE 研究中，EnSite 會是唯一的標測系統嗎？還是你們會引入其他標測技術？第二個快速問題是關於軟組織消融、甲狀腺乳頭狀微小癌（papillary thyroid microcarcinoma），以及與 MD Anderson 的新合作。能否從高層次談一下，在甲狀腺癌這一端的方程式中，底層 TAM（可服務總市場）機會大概如何？再次恭喜。

Thank you very much, Anthony. Yes, on EnSite, based on the speed of enrollment and the availability of EnSite, it would appear today that EnSite will be the most common, predominant and likely the only system used in our IDE. That is against the backdrop that our technology really will work with multiple mapping systems. We have used different mapping systems. In fact, the European feasibility data set is a compilation of patients treated using three different mapping systems, and we would integrate with not only different systems over time, but because of the number, we have 12 sensors built into our device, we have now a magnet for electroanatomical connectivity, if you will, to the mapping system.

非常感謝你，Anthony。是的，關於 EnSite，基於收案速度以及 EnSite 的可用性，目前看來 EnSite 將會是我們 IDE 中最常見、最主要，且很可能是唯一使用的系統。這是在一個背景之下：我們的技術其實可以與多種標測系統配合。我們曾使用不同的標測系統。事實上，歐洲可行性資料集是彙整了使用三種不同標測系統治療的病患；而我們也會隨時間與不同系統整合。此外，由於我們的裝置內建 12 個感測器，我們現在也具備一個磁性元件，用於與標測系統的電解剖連結（如果你願意這麼稱呼的話）。

So our system is capable now of higher fidelity mapping and navigation than we saw in our European data set. But principally, we expect EnSite to be the system used. As it relates to the PTMC opportunity or papillary thyroid microcarcinoma, that is the single most commonly diagnosed thyroid cancer. And so if we think about the TAM, to your question, the TAM for soft tissue ablation focused on benign thyroid nodules begins with the annual diagnosis of about 250,000 patients with benign nodules. So converting from that, approximately 150,000 thyroidectomies are performed.

因此，我們的系統現在具備比歐洲資料集所見更高擬真度的標測與導航能力。但原則上，我們預期 EnSite 會是使用的系統。至於 PTMC 機會，也就是甲狀腺乳頭狀微小癌，那是最常被診斷的甲狀腺癌類型。因此就你問到的 TAM 而言，針對良性甲狀腺結節的軟組織消融 TAM，起點是每年約 250,000 名良性結節患者的診斷量。由此轉換下來，大約會進行 150,000 例甲狀腺切除術（thyroidectomies）。

And we believe the benign indication goes after some combination of surgical conversion and treatment of patients avoiding surgery now and going into active surveillance. So if you think about 250,000 as the annual diagnostic volume in benign nodules. If we flip over then to papillary microcarcinoma, that number is lower. That number is about 25,000. And if we then take -- because this is a slow-growing non-metastasizing cancer, which makes it very amenable to our therapy, we believe, there is also a very large prevalence pool of papillary microcarcinoma patients who are living with cancer and who would want that cancer treated if a minimally invasive approach proved effective.

我們相信良性適應症將涵蓋某種組合：把原本會手術的患者轉換為接受本療法，以及治療那些目前為了避免手術而採取主動監測（active surveillance）的患者。因此，如果你把每年良性結節的診斷量視為 250,000。接著再看甲狀腺乳頭狀微小癌，這個數字較低，大約是 25,000。再者——因為這是一種生長緩慢、非轉移性的癌症，我們認為這使其非常適合我們的療法——我們也相信存在一個非常大的乳頭狀微小癌盛行（prevalence）患者池，他們帶癌生活，若有微創方式證實有效，將會希望接受治療。

And so the way we think about the addressable market there is that you have those 25,000 new diagnoses, you have a large prevalence pool seeking treatment, you're likely to yield perhaps 50,000 incremental procedures. So if we think about the TAM driven by the benign indications, that could be 100,000 to 200,000 based on annual incidents and conversion of patients from a watchful waiting pool, add a number that might be an incremental 25% to 35% of that population based on the addition of a papillary microcarcinoma indication in the future.

因此，我們對可觸及市場的看法是：你有每年 25,000 個新診斷，還有一個龐大的盛行患者池在尋求治療，這可能會帶來約 50,000 例的增量手術量。所以如果我們考慮由良性適應症驅動的 TAM，依據每年發生量以及將患者從觀察等待（watchful waiting）池轉換出來，可能是 100,000 到 200,000；再加上未來若新增乳頭狀微小癌適應症，可能會在此基礎上增加約 25% 到 35% 的人口規模。

Thank you. That will conclude our question-and-answer session. I will now turn the call back over to Mr. Paul LaViolette, CEO and Co-Chairman, sir, for closing remarks.

謝謝。問答環節到此結束。我現在把電話交回給執行長兼共同董事長 Paul LaViolette 先生，請您做結語。

Well, thank you, operator, and thank you all for joining us on our first quarter earnings call. We look forward to providing updates on our very active operating plans in upcoming financial conferences in Q2 and on our Q2 earnings call later this summer. Thank you all very much.

好的，謝謝接線員，也謝謝各位參加我們第一季財報電話會議。我們期待在第二季即將舉行的財務會議，以及今年夏末的第二季財報電話會議上，提供我們非常積極的營運計畫更新。非常感謝各位。

Ladies and gentlemen, that concludes today's call. Thank you all for joining. You may now disconnect.

各位女士、先生，今天的電話會議到此結束。感謝各位參與。您現在可以掛線。