NeuroPace, Inc. (NPCE) 2026 Q1 法說會逐字稿

Ladies and gentlemen, thank you for standing by. My name is Abby, and I will be your conference operator today. At this time, I would like to welcome everyone to the NeuroPace first-quarter earnings call. (Operator Instructions)

各位女士、先生，感謝您稍候。我是 Abby，今天將擔任本次電話會議的接線員。此刻，我謹代表公司歡迎各位參加 NeuroPace 第一季財報電話會議。(接線員指示)

Thank you. And I would now like to turn the conference over to Scott Schaper, Head of Investor Relations. You may begin.

謝謝。接下來我想把會議交給投資人關係主管 Scott Schaper。您可以開始了。

Thank you, operator, and welcome to NeuroPace's first-quarter 2026 earnings conference call. Our agenda begins with Joel Becker, NeuroPace's Chief Executive Officer, who will summarize our recent performance and strategic progress; followed by a detailed financial review and outlook from Patrick Williams, our Chief Financial Officer. Following our prepared remarks, we will open the call for questions.

謝謝，接線員，也歡迎各位參加 NeuroPace 2026 年第一季財報電話會議。今天的議程將先由 NeuroPace 執行長 Joel Becker 概述我們近期的營運表現與策略進展；接著由財務長 Patrick Williams 進行更詳細的財務回顧與展望。在我們的準備發言結束後，將開放提問。

Before we begin, I would like to remind you that certain statements made on today's call may constitute forward-looking statements within the meaning of federal securities laws. These statements include, among others, comments regarding our financial outlook for 2026, our commercial strategy, clinical and product development initiatives, regulatory matters including our IGE PMA supplement, and our expectations regarding operating performance and profitability.

在開始之前，我想提醒各位，今天電話會議中的部分陳述可能構成聯邦證券法所定義的前瞻性陳述。這些陳述包括但不限於：我們對 2026 年的財務展望、商業策略、臨床與產品開發計畫、監管事項（包括我們的 IGE PMA 補充申請），以及我們對營運表現與獲利能力的預期。

Forward-looking statements are based on management's current expectations and assumptions and are subject to risks and uncertainties that could cause actual results to differ materially. The discussion of these risks and uncertainties can be found in today's press release and in our filings with the Securities and Exchange Commission, including our most recent Form 10-K and Form 10-Q. We undertake no obligation to update or revise any forward-looking statements except as required by law.

前瞻性陳述係基於管理階層目前的預期與假設，並受各項風險與不確定性影響，可能導致實際結果與前瞻性陳述所述有重大差異。相關風險與不確定性的討論載於今日新聞稿，以及我們向美國證券交易委員會提交的文件中，包括最近一期的 Form 10-K 與 Form 10-Q。除法律要求外，我們不承擔更新或修訂任何前瞻性陳述之義務。

In addition, we will discuss certain non-GAAP financial measures on today's call, including adjusted EBITDA. Reconciliations of non-GAAP measures to the most directly comparable GAAP measures are included in our earnings release, which is available on the Investor Relations section of our website.

此外，我們今天也將討論若干非 GAAP 財務衡量指標，包括調整後 EBITDA。非 GAAP 指標與最直接可比之 GAAP 指標的調節表已包含在我們的財報新聞稿中，該新聞稿可於本公司網站的投資人關係專區取得。

With that, I will now turn the call over to NeuroPace's Chief Executive Officer, Joel Becker. Joel?

接下來，我將把電話會議交給 NeuroPace 執行長 Joel Becker。Joel？

Thanks, Scott, and good afternoon, everyone. I will start with an overview of our first-quarter results and how the team is executing against our strategy, followed by updates on key clinical and product development initiatives. After that, Patrick will walk through the financials and our revised outlook before we open the line for Q&A.

謝謝，Scott，各位下午好。我將先概述第一季業績，以及團隊如何依照我們的策略持續執行，接著更新幾項關鍵的臨床與產品開發計畫。之後，Patrick 會說明財務狀況與我們修訂後的展望，然後我們將開放 Q&A。

The first quarter reflects continued execution against the priorities we outlined earlier this year. We delivered total revenue of $22.1 million in the quarter. And excluding DIXI Medical, we delivered $22 million in revenue, representing 8% year-over-year growth with RNS system revenue of $21.7 million. Importantly, the underlying fundamentals of the business remained solid as we reached new all-time highs in active prescribers, accounts, and patient pipeline during the quarter. These are leading indicators we track closely and give us confidence in the durability of demand for the RNS system.

第一季反映出我們持續落實今年稍早所提出的優先事項。本季我們的總營收為 2,210 萬美元。若排除 DIXI Medical，我們營收為 2,200 萬美元，年增 8%，其中 RNS 系統營收為 2,170 萬美元。重要的是，本業的基本面依然穩健：本季活躍開立醫師數、合作帳戶數與病患管線均創下歷史新高。這些是我們密切追蹤的領先指標，讓我們對 RNS 系統需求的持續性更具信心。

The majority of growth continues to be driven by Level 4 comprehensive epilepsy centers, which remain the core of our commercial focus. In addition, we continue to see encouraging trends in the front end of the patient funnel, with the rate of new patients being added to the pipeline continuing to accelerate. While the majority of procedures remain concentrated within Level 4 comprehensive epilepsy centers, community relationships are increasingly serving as durable referral channels. We believe this is important not only for continued penetration of the adult focal population, but also for establishing referral pathways that will be relevant as we potentially expand into IGE.

成長的主要動能仍來自第 4 級（Level 4）綜合癲癇中心，這些中心仍是我們商業布局的核心。此外，我們也持續看到病患漏斗前端的正向趨勢，新病患加入管線的速度持續加快。雖然大多數手術仍集中在第 4 級綜合癲癇中心，但社區端的合作關係正日益成為穩健的轉介管道。我們認為這不僅有助於成人局灶性族群的持續滲透，也有助於建立轉介路徑；若未來我們可能擴展至 IGE，這些路徑將具相關性。

Regarding guidance, we are raising our full-year 2026 revenue guidance to a range of $99 million to $101 million, up from $98 million to $100 million previously. This reflects 21% to 23% underlying RNS growth from our existing adult focal indication and does not include any contribution from idiopathic generalized epilepsy indication expansion.

關於財測指引，我們將 2026 年全年營收指引上調至 9,900 萬至 1.01 億美元，先前為 9,800 萬至 1.00 億美元。此指引反映我們既有成人局灶性適應症所帶來的 RNS 基礎成長 21% 至 23%，且不包含任何特發性全身性癲癇（IGE）適應症擴展的貢獻。

From a market development perspective, we continue to invest in the commercial organization. This includes targeted sales representative additions in key geographies, updates to our sales incentive structure to better align with growth objectives, and additional resources dedicated to helping patients navigate the funnel from identification to implant. These investments are designed to reduce friction in the patient pathway and increase procedural consistency over time. We expect them to become increasingly productive throughout 2026.

從市場開發角度來看，我們持續投資於商業組織。這包括在關鍵地區有針對性地增聘業務代表、更新銷售獎酬架構以更貼合成長目標，以及投入更多資源協助病患從辨識到植入的整個漏斗流程。這些投資旨在降低病患路徑中的摩擦，並隨時間提升手術量的穩定性與一致性。我們預期這些投入將在 2026 年逐步展現更高的生產力。

Let me now turn to clinical development. During the quarter, we completed our FDA mid-cycle review meeting for the NAUTILUS PMA supplement, sometimes referred to as a Day 100 meeting, which we viewed as a productive step in the overall regulatory pathway.

接下來談臨床開發。本季我們完成了 NAUTILUS PMA 補充申請的 FDA 期中審查會議（mid-cycle review meeting），有時也稱為 Day 100 會議；我們認為這是整體監管路徑中一個具生產力的步驟。

As a reminder, the PMA supplement was submitted on December 15, and the 180-day review clock began upon acceptance of that submission. As part of the PMA supplement review process, the FDA has the ability to pause the 180-day review clock to request additional information or clarification.

提醒各位，該 PMA 補充申請於 12 月 15 日提交，並在該提交被受理後啟動 180 天審查時鐘。在 PMA 補充申請的審查過程中，FDA 可暫停 180 天審查時鐘，以要求補充資訊或釐清說明。

During the quarter, the agency exercised that option to seek certain follow-up information in conjunction with our mid-cycle review meeting. We view this as a standard and constructive part of the review process. And we were pleased with how quickly the agency provided their questions, which allowed us to respond promptly and thoroughly with robust information during and following the meeting. At this time, we have responded to the agency's requests, and the dialog continues to be productive. Importantly, based on our interactions to date, we continue to believe a mid-year determination remains on track.

本季，主管機關行使該選項，配合我們的期中審查會議要求若干後續資訊。我們將此視為審查流程中標準且具建設性的一部分。我們也很高興主管機關能迅速提出問題，使我們得以在會議期間及會後即時且完整地以充分資訊回覆。目前我們已回應主管機關的要求，且雙方的對話仍持續具建設性。重要的是，基於迄今的互動，我們仍相信年中做出決定的時程維持在軌道上。

The breakthrough device designation continues to be meaningful in this process, allowing for more consistent interaction and timely feedback as the review progresses. The ongoing dialog we are experiencing, including the ability to address clarifying questions in real time, is consistent with the intent of that program and reflects the collaborative nature of the review.

突破性醫療器材認定（breakthrough device designation）在此流程中仍具重要意義，使我們在審查推進期間能更一致地互動並獲得及時回饋。我們目前所經歷的持續對話，包括能即時處理釐清性問題，符合該計畫的設計初衷，也反映出審查過程的協作性。

As a reminder, our 2026 revenue guidance does not include any contribution from IGE indication expansion. If approved on our current timeline, contribution would begin in the second half of the year, and we would provide updated guidance at the appropriate time once we have greater visibility into timing and reimbursement dynamics.

再次提醒，我們的 2026 年營收指引不包含 IGE 適應症擴展的任何貢獻。若依目前時程獲准，相關貢獻將自下半年開始，我們也會在對時程與給付（reimbursement）動態有更高能見度後，於適當時點提供更新指引。

From a data perspective, we remain confident in the totality of the NAUTILUS clinical results. As a reminder, 18-month data presented at the American Academy of Neurology Annual Meeting in April demonstrated a 77% median reduction in generalized tonic-clonic seizures with sustained reductions over time, along with favorable safety outcomes in a highly refractory population. Additionally, reductions in absence and myoclonic seizures exceeded those observed for generalized tonic-clonic seizures.

就數據而言，我們對 NAUTILUS 臨床結果的整體證據仍具信心。提醒各位，4 月於美國神經學學會（American Academy of Neurology）年會發表的 18 個月數據顯示：全身性強直—陣攣性發作（generalized tonic-clonic seizures）的中位數降低 77%，且隨時間維持下降，同時在高度難治族群中呈現良好的安全性結果。此外，失神發作（absence）與肌陣攣發作（myoclonic seizures）的降低幅度，亦高於全身性強直—陣攣性發作的降低幅度。

Injury events also declined by approximately 30% following treatment. And the use of benzodiazepines as rescue medication for generalized tonic-clonic seizures was 44% lower compared with baseline, with strong physician and patient-reported clinical improvement. These clinical findings are meaningful because they speak to the real-world impact beyond seizure counts, including fewer seizure-related injuries and reduced reliance on rescue interventions. Both of which can translate into improved safety and quality of life.

治療後，受傷事件亦約下降 30%。此外，相較於基準期，使用苯二氮平類藥物作為全身性強直—陣攣性發作之救援用藥的比例降低 44%，且醫師與病患回報的臨床改善明顯。這些臨床發現具重要意義，因其反映的不僅是發作次數的變化，也包括更貼近真實世界的影響，例如較少與發作相關的受傷，以及對救援介入的依賴降低。兩者皆可轉化為更佳的安全性與生活品質。

In parallel, we continue to build our leadership position in clinical evidence. Our three-year post-approval study results in drug-resistant focal epilepsy were published in the journal Neurology in late April, demonstrating an 82% median seizure reduction in study subjects. This publication reflects data from a rigorously conducted FDA-monitored prospective study, not retrospective registry data, and reinforces the durability and strength of long-term outcomes with the RNS system.

同時，我們持續鞏固在臨床證據方面的領導地位。我們在藥物抗性局灶性癲癇的三年上市後研究結果於四月底發表於《Neurology》期刊，顯示研究受試者的癲癇發作中位數減少 82%。此篇發表反映的是一項嚴謹執行、由 FDA 監督的前瞻性研究數據，而非回溯性登錄資料，並強化了 RNS 系統長期療效結果的持久性與穩健性。

Now turning to product development. The roadmap we outlined on our fourth-quarter call remains on track. Our priorities continue to be our suite of NeuroPace AI tools, development of a multimodal foundational model, remote care, and progress toward automated detection and next-generation system development.

接下來談產品開發。我們在第四季電話會議中概述的路線圖仍按計畫推進。我們的優先事項仍包括 NeuroPace AI 工具套件、多模態基礎模型的開發、遠距照護，以及朝向自動化偵測與下一代系統開發的進展。

Our ECoG Assistant, previously known as Seizure ID, represents the first step in our NeuroPace AI suite. This is an AI-enabled tool designed to assist clinicians in analyzing patients' iEEG records of interest and efficiently identify likely electrographic seizure activity upon which to focus their clinical decision-making. This is a highly desired capability, addressing a real workflow challenge and supports clinicians in their ability to individualize care.

我們的 ECoG Assistant（先前稱為 Seizure ID）代表 NeuroPace AI 套件的第一步。這是一項 AI 賦能工具，旨在協助臨床醫師分析患者感興趣的 iEEG 記錄，並有效率地辨識可能的腦電圖癲癇發作活動，以便聚焦其臨床決策。這是一項高度被期待的能力，可解決實際工作流程上的挑戰，並支持臨床醫師提供個人化照護的能力。

We are encouraged by the early performance we are seeing in internal testing and validation work of this tool.

我們對該工具在內部測試與驗證工作中所呈現的早期表現感到鼓舞。

We believe this product can serve two important purposes. First, it lowers the barrier for new physicians adopting RNS by simplifying data review. Second, it deepens engagement among existing, high-utilizing centers by improving efficiency and allowing clinicians to manage more RNS patients within their practice. Importantly, the submission is paired with moving our clinician platform to the cloud, which improves scalability and supports faster deployment of software and data products over time.

我們認為此產品可達成兩個重要目的。第一，透過簡化資料審閱，降低新醫師採用 RNS 的門檻。第二，透過提升效率，並讓臨床醫師能在其執業中管理更多 RNS 患者，進一步加深既有高使用量中心的參與度。重要的是，此次送件也搭配將我們的臨床醫師平台移轉至雲端，提升可擴展性，並支持隨時間更快速部署軟體與資料產品。

We expect eCoG Assistant approval in the second quarter of 2026. We are also advancing the development of a multimodal foundational model leveraging our proprietary intracranial EEG dataset and the clinical experience derived from more than 8,000 patient implants across 35,000 patient years. The EEG component of this model is currently in training. And although we are approximately one-third of the way through the training process, early internal validation work has been encouraging. Even at this early stage, the model is outperforming prior internal algorithmic approaches we had been developing.

我們預期 eCoG Assistant 將於 2026 年第二季獲得核准。我們也正推進多模態基礎模型的開發，運用我們專有的顱內 EEG 資料集，以及來自超過 8,000 例患者植入、累計 35,000 個患者年之臨床經驗。該模型的 EEG 組件目前正在訓練中。雖然我們約完成訓練流程的三分之一，但早期內部驗證工作令人鼓舞。即便在此早期階段，該模型的表現已優於我們先前開發的內部演算法方法。

We believe this reflects the power of scale in our dataset and reinforces the strategic value of the more than 26 million intracranial EEG recordings we have accumulated. Importantly, we are uniquely positioned here. No other neuromodulation platform has a comparable depth of longitudinal intracranial EEG data linked to therapy and outcomes, and leadership in this area matters as the field moves toward a data-guided, personalized neuromodulation approach.

我們認為這反映了資料集規模的力量，並再次印證我們累積超過 2,600 萬筆顱內 EEG 記錄的策略價值。重要的是，我們在此具備獨特優勢。沒有任何其他神經調控平台擁有可比擬的、與治療與結果相連結的縱向顱內 EEG 資料深度；而隨著領域朝向資料導引、個人化神經調控方法發展，在此領域的領導地位至關重要。

As the model continues to train and refine, we see meaningful opportunity to enhance treatment optimization, improve outcomes, and further differentiate the RNS platform.

隨著模型持續訓練與精進，我們看到顯著機會可強化治療最佳化、改善療效結果，並進一步凸顯 RNS 平台的差異化。

With that, I'll turn it over to Patrick for a review of the financials and outlook. Patrick?

接下來，我把時間交給 Patrick，請他回顧財務表現與展望。Patrick？

Thank you, Joel. I will review our Q1 2026 performance in more detail and then discuss our updated 2026 guidance.

謝謝你，Joel。我將更詳細回顧我們 2026 年第一季的表現，接著說明我們更新後的 2026 年財測指引。

Before I walk through the quarter, I want to clarify our reporting presentation. While we previously anticipated presenting DIXI Medical as discontinued operations beginning in the first quarter, we now expect the discontinued operations presentation to begin with our Q2 2026 results. In the meantime, we are providing supplemental non-GAAP disclosures that exclude DIXI Medical in both current and prior periods to facilitate comparability.

在我逐季說明之前，我想先釐清我們的報導呈現方式。雖然我們先前預期自第一季起將 DIXI Medical 以停業部門呈列，但我們現在預期停業部門的呈列將自 2026 年第二季的結果開始。在此期間，我們提供補充性的非 GAAP 揭露，在當期與前期皆排除 DIXI Medical，以利可比性。

In addition, beginning this quarter, we are presenting gross margin and operating expenses on an adjusted non-GAAP basis, excluding stock-based compensation, consistent with full-year guidance given on our fourth-quarter call. Reconciliations to the most directly comparable GAAP measures are included in today's press release.

此外，自本季起，我們以調整後的非 GAAP 基礎呈列毛利率與營業費用，排除以股份為基礎之薪酬，與我們在第四季電話會議中提供的全年指引一致。與最直接可比的 GAAP 指標之調節表已包含於今日的新聞稿中。

Excluding DIXI, total non-GAAP revenue in Q1 2026 was $22 million, or 20.1% year over year, compared with $18.3 million in the prior-year quarter. Growth was primarily driven by increased sales of the RNS system, which grew 19.5% to $21.7 million versus $18.2 million in Q1 2025. As we previewed on our fourth-quarter call, growth in the first half tends to moderate relative to the acceleration we see exiting the prior year, and that pattern held true again.

排除 DIXI 後，2026 年第一季非 GAAP 總營收為 2,200 萬美元，年增 20.1%，相較於去年同期的 1,830 萬美元。成長主要由 RNS 系統銷售增加所帶動，該項目年增 19.5% 至 2,170 萬美元，對比 2025 年第一季的 1,820 萬美元。如同我們在第四季電話會議中所預告，上半年成長通常會相對於前一年年底的加速而趨於溫和，而此一模式本次亦再次成立。

Service revenue tied to our data collaborations in the quarter, including a new partnership, totaled $314,000. Excluding DIXI, non-GAAP gross margin in Q1 2026 was 82.5%, compared to 83.6% in the prior-year quarter. The Q1 2025 gross margin included a one-time inventory revaluation benefit of approximately 120 basis points. Excluding that impact, underlying gross margin expanded year over year, driven primarily by favorable pricing conversion.

本季與我們資料合作相關的服務營收（包含一項新合作夥伴關係）合計為 314,000 美元。排除 DIXI 後，2026 年第一季非 GAAP 毛利率為 82.5%，相較於去年同期的 83.6%。2025 年第一季毛利率包含一次性的存貨重估利益，約 120 個基點。排除該影響後，基礎毛利率年增擴張，主要由有利的價格轉換所驅動。

Total non-GAAP operating expenses for Q1 2026 were $21.5 million, compared with $19.4 million in the prior-year quarter, and came in better than expectations driven by hiring cadence and other personnel-related expenses. Non-GAAP operating expense growth of approximately 10% in the quarter remained meaningfully below our revenue growth of 20%, again demonstrating underlying operating leverage as we scale. Non-GAAP sales and marketing expense was $11 million, up from $9.6 million in the prior-year quarter, reflecting headcount growth and personnel-related expenses as we continue investing in the commercial team and other sales-related expenses.

2026 年第一季非 GAAP 營業費用總額為 2,150 萬美元，相較於去年同期的 1,940 萬美元；由於招募節奏及其他人員相關費用，實際結果優於預期。本季非 GAAP 營業費用約 10% 的成長率，仍顯著低於我們 20% 的營收成長，再次展現我們在規模擴張下的營運槓桿。非 GAAP 銷售與行銷費用為 1,100 萬美元，高於去年同期的 960 萬美元，反映人力編制成長與人員相關費用，因我們持續投資商業團隊及其他銷售相關支出。

Non-GAAP research and development expense was $6.5 million compared to $6.6 million in the prior-year quarter. The slight decline reflects lower clinical study spend compared to the prior-year period, partially offset by personnel investments supporting our AI roadmap and next-generation platform. Non-GAAP general and administrative expense was $4 million, up from $3.3 million in the prior-year quarter, primarily reflecting increased personnel costs. Total stock-based compensation in the quarter was $2.3 million, with $2.1 million included in operating expenses and the balance in cost of goods. Non-GAAP loss from operations for Q1 2026 was $3.3 million, compared with the loss from operations of $4.1 million in the prior-year quarter.

非 GAAP 研發費用為 650 萬美元，相較於去年同期的 660 萬美元。小幅下降反映臨床研究支出較去年同期降低，部分被支持我們 AI 路線圖與下一代平台的人員投資所抵銷。非 GAAP 一般與行政費用為 400 萬美元，高於去年同期的 330 萬美元，主要反映人員成本增加。本季以股份為基礎之薪酬總額為 230 萬美元，其中 210 萬美元列入營業費用，其餘列入銷貨成本。2026 年第一季非 GAAP 營業損失為 330 萬美元，相較於去年同期的營業損失 410 萬美元。

Adjusted EBITDA loss was $3.3 million in the first quarter, an improvement compared to a loss of $4.1 million in the prior-year quarter. GAAP net loss was $6.7 million for Q1 2026, compared with net loss of $6.6 million in the prior-year quarter, which included DIXI Medical in both periods. We ended the quarter with $54.8 million in cash, cash equivalents, short-term investments, and restricted cash, compared to $61.2 million at year-end 2025. This sequential decrease reflects typical first-quarter cash outflows, primarily driven by annual corporate bonus payments.

第一季調整後 EBITDA 虧損為 330 萬美元，較去年同期虧損 410 萬美元有所改善。2026 年第一季 GAAP 淨損失為 670 萬美元，相較於去年同期淨損失 660 萬美元；兩期均包含 DIXI Medical。本季期末現金、約當現金、短期投資及受限制現金為 5,480 萬美元，相較於 2025 年底的 6,120 萬美元。此一季減反映典型第一季現金流出，主要由年度公司獎金支付所致。

Please note that as of March 31, 2026, we had approximately $700,000 of restricted cash related to DIXI Medical. Approximately $600,000 has since been converted to cash and cash equivalents, and we expect the balance will be converted by the end of Q2 2026.

請注意，截至 2026 年 3 月 31 日，我們持有約 70 萬美元與 DIXI Medical 相關的受限制現金。其中約 60 萬美元其後已轉為現金及約當現金，我們預期餘額將於 2026 年第二季末前完成轉換。

Turning now to our outlook for 2026. As Joel mentioned, we are raising full-year 2026 revenue guidance to $99 million to $101 million, up from previous guidance of $98 million to $100 million. The $1 million increase at the midpoint is driven by two factors. Approximately $500,000 reflects improved visibility into service revenue, and approximately $500,000 reflects improved visibility into our core RNS outlook. Our increased guidance reflects underlying RNS revenue growth of 21% to 23% in our core business and continues to exclude any potential contribution from IGE indication expansion.

接下來談談我們對 2026 年的展望。如 Joel 所提到，我們將 2026 全年營收指引上調至 9,900 萬至 1.01 億美元，高於先前的 9,800 萬至 1.00 億美元指引。中位數上調 100 萬美元主要由兩項因素帶動。約 50 萬美元反映我們對服務營收的能見度提升，另約 50 萬美元反映我們對核心 RNS 展望的能見度提升。我們上調後的指引反映核心業務 RNS 基礎營收成長 21% 至 23%，並且仍不包含 IGE 適應症擴張可能帶來的任何貢獻。

On service revenue specifically, last quarter, we noted that while we may generate modest service revenue during 2026, it was not included in our initial outlook given limited visibility at that time. As our planning has progressed and certain activities have become more predictable, we are now incorporating approximately $500,000 of service revenue into our updated 2026 guidance. As we have previously stated, given the underlying dynamics of the procedure-based business, it can be more informative to evaluate RNS performance over six-month periods.

就服務營收而言，上季我們曾提到，雖然 2026 年期間我們可能會產生少量服務營收，但由於當時能見度有限，因此未納入我們最初的展望。隨著規劃推進且部分活動變得更可預測，我們現在在更新後的 2026 年指引中納入約 50 萬美元的服務營收。如我們先前所述，鑑於以手術量為基礎的業務之內在特性，以六個月期間來評估 RNS 表現往往更具參考性。

We remain confident in our ability to deliver 20% underlying RNS focal indication growth over time, and we expect the first half of 2026 to be consistent with that framework. Quarter-to-quarter fluctuations can occur, but our focus remains on sustained adoption and utilization trends across a broader time horizon.

我們仍對長期實現 20% 的 RNS 局灶性適應症基礎成長充滿信心，並預期 2026 年上半年將符合該框架。季度之間可能出現波動，但我們的重點仍是更長時間範圍內的持續採用與使用趨勢。

We continue to expect full-year non-GAAP or adjusted gross margin to be between 81.5% and 82.5%, reflecting continued leverage and favorable pricing. We continue to expect full-year non-GAAP or adjusted operating expenses to remain in the range of $90 million to $92 million, excluding approximately $10 million in stock-based compensation, consistent with prior guidance.

我們仍預期全年非 GAAP（或調整後）毛利率介於 81.5% 至 82.5%，反映持續的規模效益與有利的定價。我們仍預期全年非 GAAP（或調整後）營業費用維持在 9,000 萬至 9,200 萬美元區間，不含約 1,000 萬美元的股權基礎薪酬，與先前指引一致。

For the full-year 2026, we continue to expect non-GAAP or adjusted sales and marketing expense to total between $46 million and $48 million. Sales and marketing expense growth in 2026 reflects the continued commercial investment, and we expect productivity and leverage from these investments to increase meaningfully as we move through 2026 and into 2027.

就 2026 全年而言，我們仍預期非 GAAP（或調整後）銷售與行銷費用合計介於 4,600 萬至 4,800 萬美元。2026 年銷售與行銷費用的成長反映持續的商業化投資；我們預期隨著 2026 年推進並進入 2027 年，這些投資所帶來的生產力與槓桿效益將顯著提升。

We continue to expect full-year non-GAAP or adjusted research and development expense to total approximately $27 million. R&D expense growth in 2026 reflects continued investment in our next-generation platform and the development of the NeuroPace AI suite of tools designed to enhance physician workflow and drive further adoption.

我們仍預期全年非 GAAP（或調整後）研發費用合計約 2,700 萬美元。研發費用在 2026 年的成長反映我們持續投資於下一代平台，以及開發 NeuroPace AI 工具套件，旨在強化醫師工作流程並推動進一步採用。

We remain focused on disciplined allocation of R&D capital toward programs that strengthen the platform, enhance differentiation, and support long-term growth. We continue to expect full-year non-GAAP or adjusted general administrative expense to total approximately $17 million. G&A expense in 2026 primarily reflects the infrastructure required to support a growing commercial organization and corporate systems necessary to operate at scale.

我們仍專注於以嚴謹的方式將研發資本配置於能強化平台、提升差異化並支持長期成長的計畫。我們仍預期全年非 GAAP（或調整後）一般與行政費用合計約 1,700 萬美元。一般與行政費用在 2026 年主要反映支援成長中的商業組織所需的基礎設施，以及以規模化方式營運所需的公司系統。

We remain disciplined in managing overhead as we drive operating leverage across the organization. We now expect more favorable full-year adjusted EBITDA to be a loss in the range of $8.5 million to $9.5 million, improved from a loss of $9 million to $10 million.

在推動全組織營運槓桿的同時，我們仍以紀律方式管理間接費用。我們目前預期全年調整後 EBITDA 將更為有利，虧損介於 850 萬至 950 萬美元，較先前預期虧損 900 萬至 1,000 萬美元有所改善。

And with that, I'll turn it back to Joel.

接下來我把時間交還給 Joel。

Thanks, Patrick. We are energized by the opportunity in front of us. We are executing and penetrating the adult focal market, progressing toward potential indication expansion into the IGE population, and advancing a differentiated product roadmap anchored in unique proprietary data where we are developing first of its kind and unique assistive and foundational AI data analysis tools. We believe that we are uniquely positioned at the intersection of data, device, and neuromodulation.

謝謝你，Patrick。我們對眼前的機會感到振奮。我們正在執行並深化成人局灶性市場的滲透，推進 IGE 人群的潛在適應症擴張，同時推動具差異化的產品藍圖；該藍圖以我們獨特的專有資料為核心，我們正在開發同類首創且獨特的輔助型與基礎型 AI 資料分析工具。我們相信，我們在資料、裝置與神經調控的交會點上具備獨特的定位。

We will continue to lead on product innovation and clinical evidence, and we remain focused on disciplined execution and thoughtful investment to drive durable long-term growth.

我們將持續在產品創新與臨床證據方面保持領先，並專注於以紀律執行與審慎投資來推動可持續的長期成長。

With that, operator, please open the line for questions.

接下來，請接線員開放提問。

(Operator Instructions) Mike Kratky, Leerink Partners.

（接線員指示）Leerink Partners 的 Mike Kratky。

Congrats on all the progress, and thanks very much for taking our questions. So first, you had some really encouraging updates on achieving new all-time highs in active prescribers, accounts, patient pipeline. One of your epilepsy competitors also recently mentioned a strengthening of the patient funnel in the US.

恭喜各項進展，也非常感謝你們回答我們的問題。首先，你們在活躍開立處方醫師數、客戶帳戶數、患者管線等方面創下新的歷史新高，這些更新非常令人鼓舞。你們的一家癲癇領域競爭對手最近也提到美國的患者漏斗正在增強。

So can you just help us understand what factors seem to be most responsible for this dynamic? And where specifically are you seeing this materialize?

所以能否請你們協助我們理解，哪些因素似乎是造成這種動態的最主要原因？以及你們具體是在哪些地方看到這種情況開始顯現？

Thanks, Mike, and it's a great question. So for us, we're particularly pleased with the trends that we see with regard to patient pipeline. Our patient pipeline numbers are as strong as we've ever seen. And I think a lot of that comes -- well, a lot of that comes from both our work -- really three things. One, our work with our Level 4 Center traditional customers to make sure that we're doing everything we can to collaborate with them, to have patients identified as they're moving through Level 4 Centers.

謝謝你，Mike，這確實是個好問題。就我們而言，我們對患者管線的趨勢特別感到滿意。我們的患者管線數據是我們所見過最強勁的水準。我認為其中很大一部分來自——嗯，很大一部分來自我們的工作——其實是三件事。第一，我們與 Level 4 Center 的傳統客戶合作，確保我們盡一切所能與他們協作，讓患者在通過 Level 4 Center 的過程中就能被識別出來。

Two, we've talked about in the past the work that we've been doing in the community and with the referral population, and that's beginning to contribute nicely to the patient pipeline as well. And then thirdly, the investments we've made in our commercial organization, both the breadth of that organization as well as the way the leadership team is executing in the discipline, systems, and processes that we've put in place to make sure that we have good visibility to and are tracking well the execution around that priority, I think, are all leading toward building and really as good as we've seen it patient pipeline to date.

第二，我們過去談到我們在社區端以及轉診人群方面所做的工作，而這也開始對患者管線帶來不錯的貢獻。第三，我們對商業組織所做的投資——包括組織覆蓋的廣度，以及領導團隊在我們建立的紀律、系統與流程下的執行方式——以確保我們對該優先事項的執行有良好的能見度並能有效追蹤；我認為這些都在推動患者管線的建立，而且就目前而言，確實是我們迄今所見最好的患者管線。

Yeah. The only thing I would add to that, Mike, is we're starting to look a lot deeper into the patient pipeline in terms of analytics and tracking that differently with our commercial team. And we think about it as sort of the velocity of that patient, which we know has a long sales cycle, but better understanding where they're at within that healthcare continuum, we'll call it, until they actually go to a neuromodulation device.

是的。Mike，我唯一想補充的是，我們開始在分析層面更深入地檢視患者管線，並與商業團隊以不同方式進行追蹤。我們把它視為患者的某種「速度」——我們知道這是一個銷售週期很長的流程——但若能更好地理解他們在我們所稱的醫療照護連續體中的位置，直到他們最終使用神經調控裝置，將會很有幫助。

So more to come on that, but wanted to throw in there that leveraging predictive tools that are AI-based, et cetera, to get a little bit smarter in that area.

這部分後續還會有更多分享，但我想先補充一點：我們正在運用以 AI 為基礎的預測工具等方式，讓我們在這個領域變得更聰明一些。

Understood. Very helpful. And maybe just as a follow-up, but can you share any specifics in terms of what information FDA was looking for, specifically as part of its mid-cycle review?

了解。非常有幫助。另外也許作為追問，你們能否分享一些具體細節：FDA 在期中審查（mid-cycle review）中，特別是在尋找哪些資訊？

You bet, Mike. We had a very productive and interactive meeting with the agency. A couple of things I'd punch up there. One, we were really pleased to get the questions that we got in such a timely fashion, so it made for a good opportunity to prepare and then a robust and again interactive discussion with the agency.

當然可以，Mike。我們與主管機關進行了一場非常有成效且互動性很高的會議。我想強調其中幾點。第一，我們很高興能在如此及時的時間點收到相關問題，這讓我們有很好的機會進行準備，並與主管機關展開充分、而且再次強調是互動性很高的討論。

I would characterize the nature of the questions that we received were really focused on both clarification of and context around various aspects of the data and the associated analyses that had gone into the PMA supplement. So it's clear that they're paying good and close attention to the data, as we would expect. And again, the questions were really around clarifying some of that data, how to best understand and interpret it, and then where we had provided associated analysis, wanting to make sure that they had appropriate context for that analysis.

我會將我們收到的問題性質描述為：主要聚焦於釐清資料的各個面向，以及與納入PMA補充申請之相關分析所需的背景脈絡。因此很明顯，他們正如我們所預期地，對資料保持良好且密切的關注。再者，這些問題確實是圍繞著釐清部分資料、如何最佳理解與解讀，以及在我們提供相關分析之處，他們希望確保自己對該分析具備適切的背景脈絡。

But again, I would, in addition to those facts, I would emphasize that we thought that one, we got real good questions, we got them in a timely fashion, it resulted in a good and engaged discussion. And we have since followed up and submitted our formal responses to those and all questions that we've received until now. So, yeah.

不過再次強調，除了上述事實之外，我還想強調：第一，我們認為收到的問題非常好；第二，問題來得很及時，促成了一場良好且投入的討論。此後我們也已跟進，並就這些問題以及截至目前收到的所有問題提交了正式回覆。所以，是的。

Priya Sachdeva, UBS.

Priya Sachdeva，瑞銀（UBS）。

Congrats on a strong start to the year. Maybe first, if I could just -- really encouraging to see the strong growth in RNS revenues, but would love to maybe if you could parse out how much of that was deeper market penetration, increasing utilization across your existing centers versus new physician capture.

恭喜今年開局強勁。也許先問第一個問題——看到RNS營收強勁成長非常令人振奮，但想請你們拆解一下，其中有多少來自更深的市場滲透、在既有中心提升使用率， versus 新增醫師的導入。

And if there was any pricing dynamics in the quarter. I think you did call up some increasing ASP. If you could maybe just help us level set contributions from each, and then one follow-up.

以及本季是否有任何定價動態。我記得你們確實提到ASP有所上升。如果可以的話，請協助我們校準各項因素的貢獻度，然後我還有一個追問。

You bet. I'll start here, Priya, and then ask Patrick if he has anything he'd like to add. So as has been the case, the growth in the business really has been centered around increasing adoption and utilization within our Level 4 Centers. So adoption, you can see by the ongoing increasing number of all-time-high prescribers, and so we continue to be pleased with that. But then also continuing to work utilization and expansion of where the RNS system plays within those people's practices.

沒問題。Priya，我先回答，然後再請Patrick看看是否有想補充的。如同以往，業務成長的核心確實在於我們Level 4中心內的採用率與使用率提升。採用率方面，你可以從持續增加、屢創新高的開立處方醫師數看出來，因此我們對此仍感到滿意。同時，我們也持續推動使用率，並擴大RNS系統在這些醫師臨床實務中的角色與應用範圍。

And then the second part would be, as I mentioned earlier, the increasing contribution of patients who are identified for and either implanted at or referred from community settings. So patients who are identified as good candidates for RNS in the community and either undergo the therapy there at a Level 3 or community hospital or are identified for RNS therapy and then referred in for surgical placement of an RNS device in a Level 4 Center.

第二部分是，如我先前提到的，來自社區場域被辨識出的病患，其貢獻正在提升。也就是在社區中被辨識為適合RNS的病患，可能在Level 3或社區醫院接受治療，或是被辨識適合RNS治療後，轉介至Level 4中心進行RNS裝置的手術植入。

The third thing I'd identify here is our DTC, our direct-to-patient efforts, as well as then in our Q4 call, we made mention of investment in our nurse navigator team. And that's all designed to help fill the pipeline and then move patients with increasing velocity and decreasing friction through the pipeline. And so I think our nurse navigator team is beginning to have a nice impact there as well.

第三點是我們的DTC，也就是直接面向病患的推廣，以及我們在第四季電話會議中提到對護理師導航（nurse navigator）團隊的投資。這些措施的目的都是為了充實管線，並以更高速度、較低摩擦讓病患在管線中推進。因此我認為我們的護理師導航團隊也開始在這方面帶來不錯的影響。

With regard to pricing, as you know, we have had consistent and good execution with regard to pricing. Pricing is somewhat of a tailwind for us here in the quarter, but the majority of the revenue is really associated with unit volume rather than a significant price effect, but a good tailwind.

就定價而言，如你所知，我們在定價方面一直有穩定且良好的執行。本季定價對我們而言算是些許順風，但營收的大部分仍主要來自出貨量（unit volume），而非顯著的價格效應；不過確實是個不錯的順風。

Yeah. The only thing I would add on pricing -- Joel articulated that well, is that we do plan to take pricing as we have in prior years going forward, so this is not a one-time event. And as we said, we will continue to take pricing each and every year that we can, and it will be -- you can expect kind of that low single-digit type pricing increases that we would look to get.

是的。我在定價方面唯一想補充的是——Joel已經說得很清楚——我們確實計畫如同過去幾年一樣，未來持續進行調價，所以這不是一次性的事件。如我們所說，我們會在每一年只要有機會就持續調價；你可以預期大致是低個位數百分比的調價幅度。

Okay, got it. That was super helpful. And just one more for me. When we're thinking about IGE, and I know it's not baked into guidance for this year, but when approval does come online, how quickly can we see a contribution? And then maybe if you could just remind us what the pathway from a reimbursement perspective looks like and how quickly that could come online. Thanks so much.

好的，了解。這非常有幫助。我再問最後一個問題。談到IGE，我知道今年的指引尚未納入，但當核准真的到位後，我們多快能看到貢獻？另外，也請提醒我們從給付（reimbursement）的角度來看，路徑會是什麼，以及多快能上線。非常感謝。

I'll maybe start us out here, and then I'll ask Patrick, who's very much involved with our reimbursement team and process here, to comment on that as well. So first steps first, we're focused on getting the indication expansion, getting the approval from the agency. You know what that process looks like. I described it earlier here in my comments of working through that here now with the agency.

我先開個頭，接著我會請Patrick補充；他在我們的給付團隊與流程中參與很深。首先，我們的首要重點是完成適應症擴增，取得主管機關的核准。你也知道那個流程大概長什麼樣子。我先前在評論中也提到，我們目前正與主管機關一起推進這個流程。

In parallel with that, we are working with our internal team to make sure they are trained and well-prepared for the launch, and all of our launch plans, et cetera, are moving in parallel with that as well. Once we do have approval, we will move into what is really a coverage expansion exercise. We have the device covered today. It'll be the same codes for tomorrow.

與此同時，我們也在與內部團隊合作，確保他們受過訓練並為上市做好充分準備，而所有上市計畫等也都在同步推進。一旦取得核准，我們就會進入實質上的「擴大給付涵蓋」工作。我們目前的裝置已經有給付涵蓋。明天也會使用相同的代碼（codes）。

And our exercise then is really going to be working with the private payers to get coverage expansion. Obviously, we're going to be working to do that on an off-cycle basis, but certainly, we've got good visibility to contract cycles and ensuring that we're well prepared to be engaged with medical directors and health plans that, at the very least, it's part of an on-cycle process. And we intend to make sure that there's a case-by-case submission associated with the coverage expansion.

因此我們接下來的工作，主要是與民間保險支付方合作，推動給付涵蓋的擴大。顯然我們會努力以非例行週期（off-cycle）的方式推進，但我們也對合約週期有相當好的能見度，並確保我們已準備好與醫療主管（medical directors）及健康保險計畫進行互動；至少也會把它納入例行週期（on-cycle）的流程中。我們也打算確保針對給付擴大，會有逐案（case-by-case）的申請提交。

Very important as part of that process will be the published manuscript of the NAUTILUS data, and I'm really pleased with the progress we've been making there. We're ahead of expectations in terms of the timing of the submission and review of the NAUTILUS manuscript and results, and so I'm encouraged by having that.

在這個流程中，非常重要的一環將是NAUTILUS資料的已發表論文（manuscript），我對我們在這方面的進展非常滿意。就NAUTILUS論文與結果的投稿與審查時程而言，我們的進度超出預期，因此有這項支撐讓我感到鼓舞。

And the timeline it's on and being able to show the results that it shows and the early review from the editorial reviewers was very light. It was a well-done manuscript and is on a good timeline there. So I think we've also been preparing from a reimbursement perspective. And here I'll hand it over to Patrick, but we have been planning and doing our research around coverage expansion and have a number of outside experts as well that we're working with up to and including even having advisory board types of discussions for how people are going to be thinking about and reacting to the data and what will be particularly important to them, et cetera.

而且目前的時程安排、以及它所呈現的結果，再加上編輯審稿人的初步意見非常少。這是一篇寫得很好的論文，時程也很理想。因此我認為我們在給付層面也一直在做準備。接下來我交給Patrick，不過我們一直在規劃並進行與給付擴大相關的研究，也與多位外部專家合作，甚至包括以顧問委員會形式討論：大家會如何看待並回應這些資料、哪些點對他們特別重要等等。

So it's approval with internal training and market development in parallel, then all of the logistics, mechanics, and publication associated with extending coverage from the current focal indication for the current product with the private payers.

總結來說，就是：取得核准，同步進行內部訓練與市場開發，接著處理所有與從目前的局部（focal）適應症、針對現有產品向民間支付方延伸給付涵蓋相關的物流、機制與發表等事項。

Patrick, what would you add?

Patrick，你會補充什麼？

Yeah, I think just some highlights. You asked the question just sort of cadence of when we can expect, and so we're still focused on mid-year approval. Thank you for pointing out that we had a good quarter with RNS. We did raise guidance to not only include that beat in Q1, but raise guidance on top of that, above the beat. We do not have IGE indication expansion in there, as we said.

是的，我想提幾個重點。你問到的是我們預期何時會看到貢獻的節奏，因此我們仍以年中核准為目標。也謝謝你指出我們RNS本季表現不錯。我們上調了指引，不僅納入第一季的超預期表現（beat），還在此基礎上進一步上調，也就是高於這個beat。如我們所說，指引中並未納入IGE適應症擴增。

So the cadence on that, because of what Joel just went through in detail in terms of the coverage policies with the private payers, which is close to 80%, we'll call it, when you include the Advantage programs with Medicare/Medicaid. It's going to take a little bit of time to get on there, so I would say it's definitely a back-end loaded if we think about the first 12 months, let's say, of launch. And so you're going to see more coverage policies come on board as we move into months 7, 9, 10, 11, 12, and so forth.

因此，關於這個推進節奏，基於 Joel 剛才就民間付費方的給付涵蓋政策所做的詳細說明——若把 Medicare/Medicaid 的 Advantage 計畫也納入，涵蓋比例接近 80%，我們就姑且這麼稱呼。要把這些納入涵蓋需要一點時間，所以我會說，如果我們以上市後前 12 個月來看，這明顯會是後段發力（back-end loaded）。因此，當我們進入第 7、9、10、11、12 個月等階段時，你會看到更多的涵蓋政策陸續到位。

And so, at the appropriate time, we'll come back and give guidance to everyone. But I think the takeaway for you all is that it's the same exact DRG and CPT, as Joel said. We believe we're being very proactive and being very patient advocate focused on making sure they get this approval. And so that's really the only thing that's going to hold us back in terms of the adoption from a reimbursement standpoint.

因此，在適當的時間點，我們會再回來向各位提供指引。但我認為你們要帶走的重點是：正如 Joel 所說，DRG 與 CPT 完全相同。我們相信我們非常積極主動，並且以病患倡議為核心，確保他們能取得這項核准。因此，就報銷角度的採用而言，真正可能拖慢我們的就只有這一點。

I would just wrap up there, Priya. When we've had discussions on the reimbursement side, I've been impressed as to hearing the feedback for how pleased people were with the clinical data. And how attuned people were that there aren't approved options for these patients. And so it's just been encouraging to hear from that constituency, from that stakeholder group, the recognition of the value of the data and the recognition of the clinical gap that exists today.

Priya，我就補充到這裡。在我們就報銷端進行討論時，我對於聽到的回饋印象深刻——大家對臨床數據感到非常滿意。而且大家也很清楚，這些病患目前沒有已核准的選項。因此，從那個群體、那個利害關係人群組聽到他們對數據價值的認可，以及對當前臨床缺口的認知，確實令人振奮。

We're actually augmenting our internal reimbursement with some third-party, especially as we launch, to ensure that on a case-by-case basis, we can continue to advocate for those patients. And we're feeling good about it. Again, we're kind of saying a couple things. We're excited about it.

我們其實正在以第三方資源來強化內部的報銷支援，特別是在上市初期，以確保我們能在個案層級持續為這些病患發聲。我們對此感覺良好。再次強調，我們大概在傳達幾件事。我們對此感到興奮。

But at the same time, we want to be thoughtful as we do get approval and find out what that revenue cadence will look like. But we think there's a really good opportunity here to move things along quicker than maybe what most people may think of.

但同時，當我們取得核准並了解營收節奏會長什麼樣子時，我們也希望能審慎思考。不過我們認為這裡有一個非常好的機會，能把事情推進得比多數人想像的更快。

Larry Biegelsen, Wells Fargo.

Larry Biegelsen，Wells Fargo。

This is Ralph Osborn on for Larry. Thanks for taking our questions. So looking at your RNS volumes, did this system as a diagnostic or a companion to surgery contribute to growth during the quarter? And how do you see this evolving over time?

我是代替 Larry 的 Ralph Osborn。謝謝你們回答我們的問題。就你們的 RNS 量來看，這套系統作為診斷工具或作為手術的輔助，在本季是否對成長有所貢獻？你們如何看待它隨時間的演變？

It's a great question. I think that as we think about both of those dynamics, one, the unique capability to provide the window into the brain to see what's really going on with these patients has been increasingly recognized. And as we mentioned in our prepared comments, we really see the field moving more and more toward the ability to individualize and tailor therapy for patients.

這是個很好的問題。我認為，當我們思考這兩個面向時，第一，這種獨特的能力——提供一扇「看進大腦」的窗口，去了解這些病患真正發生了什麼——正被越來越多地認可。而且如同我們在事先準備的發言中提到的，我們確實看到這個領域正越來越朝向能為病患進行個人化、量身打造治療的方向發展。

And it's really that unique diagnostic capability that allows us to do that, to monitor, record, and then analyze that data, and subsequently then tailor therapy, and that's we think part of why we see improving results over time. So yes, the diagnostic capabilities of the device absolutely are contributing to our growth.

而正是這種獨特的診斷能力讓我們能做到：監測、記錄、再分析數據，接著據此調整治療；我們認為這也是為什麼我們看到結果會隨時間改善的一部分原因。所以是的，這個裝置的診斷能力絕對正在推動我們的成長。

And secondly, with regard to hybrid therapy or as a complement to resection therapy, we do hear that more and more, especially within centers that you might consider to be somewhat more, in quotes, classically trained to really look for resection first. In places where either they know they can't resect or to be able to inform surgical procedures, the use of the implantation of an RNS device prior to a surgical procedure to be able to best localize where they want to resect, or if they have a clear area for surgical intervention.

第二，關於混合治療或作為切除手術的補充，我們確實越來越常聽到這樣的使用方式，特別是在一些你可能會認為較偏「傳統訓練」（打引號）的中心——他們通常會先尋求切除。在一些地方，若他們知道無法切除，或需要為手術程序提供資訊，他們會在手術前先植入 RNS 裝置，以便更精準地定位要切除的位置，或確認是否存在明確可進行手術介入的區域。

But the diseases diffuse enough and they know they can't resect some areas of eloquent cortex, for example, they'll use an RNS device in combination as part of a hybrid therapy. So as we've talked about before, really the modern RNS story, we're going from a particularly kind of niche application within a focal patient population to multifocal disease to network stimulation to adjacent to surgical procedures is really the progression that we see. And we do hear about adjacent to resection procedures more and more.

但如果疾病的分布足夠彌漫，而且他們知道某些區域（例如功能性皮質，eloquent cortex）無法切除，他們就會把 RNS 裝置與其他方式結合，作為混合治療的一部分。因此，如同我們之前談過的，現代 RNS 的故事是：我們正從在局灶性病患族群中的相對利基應用，走向多灶性疾病、走向網路刺激（network stimulation）、以及走向與手術程序相鄰/搭配使用——這就是我們看到的演進路徑。而且我們確實越來越常聽到它與切除手術相鄰/搭配使用。

Great. And then apologies if I missed this in your prepared remarks, but would you walk through your latest advances and timelines for pediatric and LGS?

很好。另外，如果我在你們事先準備的發言中漏聽了先說聲抱歉，但你們能否說明一下你們在兒科與 LGS 的最新進展與時間表？

You did not miss it. We did not include it in our prepared comments, but I'll address both. With regard to pediatrics, as you know, we're working on a real-world evidence strategy here using retrospective metadata analysis, working with the agency itself, as well as a number of external parties to really aggregate and analyze the published data that's out there.

你沒有漏聽。我們確實沒有把它放在事先準備的發言裡，但我會一併回應兩者。就兒科而言，如你所知，我們正在採用真實世界證據（real-world evidence）策略，透過回溯性的後設資料分析（retrospective metadata analysis），並與主管機關本身以及多個外部單位合作，去彙整並分析目前已發表的數據。

We've worked to try and prospectively enroll trials on the pediatric side, and as sometimes is the case where you have devices that are approved in the adult population. It's difficult to get people to -- for understandable reasons, to get people to consent to enroll children in the trial. We think that the real-world data approach is a particularly good one at this time, in that if you look at the interest from the clinical and scientific community, as well as the amount of data that has been gathered and published, it is increasingly gathering momentum.

我們也曾嘗試在兒科端以前瞻性方式納入試驗；但有時候確實會遇到一種情況：當裝置已在成人族群獲准時，出於可理解的原因，要讓人們同意讓孩子參與試驗會很困難。要讓人們——出於可理解的原因——同意讓孩子參與試驗是困難的。我們認為此時採用真實世界數據的方法特別合適，因為如果你看臨床與科學社群的興趣，以及已蒐集並發表的數據量，都正在持續累積動能。

Since 2020, for example, so in a little over the last five or maybe six years, in 2020, there were about eight peer-reviewed publications for pediatric use of the RNS system. Today, there are 29. And so, there is an increasing amount of both interest as well as published data that really supports this kind of a real-world evidence analysis. So we're underway in that process.

例如自 2020 年以來，也就是過去大約五到六年之間，2020 年時，關於 RNS 系統兒科使用的同儕審查論文大約只有 8 篇。而今天已經有 29 篇。因此，無論是興趣或已發表的數據，都在增加，這些都確實支持進行這類真實世界證據分析。所以我們已經在推進這個流程。

I think as you've heard me explain before, it's a little bit inverted from a prospective trial, where in a retrospective trial, you do a lot of the work on the data alignment and structure upfront. And then once you have that, the back end of the process can go a little bit quicker, whereas in a prospective trial, you can go a little bit quicker on the front end, and then you have to do all the work downstream. So we're in the middle of that hard work now.

我想你之前也聽我解釋過，這和前瞻性試驗有點相反：在回溯性研究中，你需要在前端先做大量的資料對齊與結構化工作。一旦完成這些，後端流程就可能會快一些；而在前瞻性試驗中，你前端可以快一些，但之後下游還得做大量工作。所以我們現在正處於那段艱難工作的中段。

I'm not going to quote a timeline for you, but I would want you to know that it remains a significant priority for us. And again, I think there's a lot of momentum and a lot of interest within the clinical and scientific community here.

我不會給你一個具體時間表，但我希望你知道，這仍然是我們非常重要的優先事項。而且再次強調，臨床與科學社群在這方面有很強的動能與高度興趣。

On LGS, as folks may know, we have announced enrollment completion on our LGS trial, the first of its kind in a collaborative effort with NIH, to enroll a pilot group of 20 patients in a trial looking at both safety as well as efficacy endpoints, although in a pilot trial design. More to come on the results here with regard to LGS, but we're encouraged with what we see. We're in the process of developing our plans right now for how we will engage with the agency further but encouraged with what we see from that early data and do plan on advancing our work in LGS.

至於 LGS，如大家可能知道的，我們已宣布完成 LGS 試驗的收案（enrollment completion）。這是首個同類型試驗，並與 NIH 合作，納入 20 名病患作為先導（pilot）族群，在先導試驗設計下同時評估安全性與有效性終點。關於 LGS 的結果後續會有更多資訊，但我們對目前看到的情況感到鼓舞。我們正在制定接下來如何進一步與主管機關互動的計畫；我們對這些早期數據所呈現的結果感到鼓舞，也確實計畫推進我們在 LGS 上的工作。

And again, stay tuned there, more to come in not too long, but LGS is absolutely on our minds, and we're encouraged with what we've seen.

再一次，請持續關注，過不了多久還會有更多消息；但 LGS 絕對在我們的考量之中，而且我們對目前看到的進展感到鼓舞。

I think the takeaway is that as we think about adoption dynamics in the clinical setting, not only IGE, but as well with pediatrics and LGS, as Joel went through, we think that adoption dynamics are very exciting for us and much more so than what we've seen with Focal over time. And so just another thing to look for in the future as we think about our clinical development efforts.

我認為重點在於，當我們思考臨床場域中的採用動態時，不僅是 IGE，還包括兒科與 LGS（如 Joel 所說明），我們認為這些採用動態對我們而言非常令人振奮，而且相較於我們長期在局灶性（Focal）方面所看到的情況更為明顯。因此，這也是未來在我們思考臨床開發工作時值得關注的另一個面向。

Lily Lozada, JP Morgan.

Lily Lozada，摩根大通。

Maybe just to go back to the quarter-end guidance, like you said, you raised by more than the B. You beat by a couple hundred thousand and you're raising guidance by $1 million. So can you talk through your thinking behind raising the guide this early in the year and where specifically that better visibility and incremental upside is coming from, especially on the RNS side of the business?

或許回到季末指引：如你所說，你們上調幅度超過 B。你們實際超預期約幾十萬美元，且把指引上調了 100 萬美元。能否談談為何在年初這麼早就上調指引的思考邏輯，以及更佳能見度與額外上行空間具體來自哪裡，特別是在業務的 RNS 端？

Absolutely, Lily. It's a great question. And I think both the performance in the quarter as well as then historically what we've seen in the business is really our basis for thinking about the business that way.

當然可以，Lily。這是個很好的問題。我認為，無論是本季的表現，或是我們過去在業務中看到的歷史趨勢，都是我們以這種方式看待業務的基礎。

If you go back over the past, I'll call it the last three years, my direct involvement here, just to speak to it personally. If you look at '23, '24, and '25, we have seen more revenue in the second half of the year than the first half of the year. We've seen about 500-basis-point increase in growth rates in the second half of the year versus the first half of the year. And that's been very consistent across that time. And so that's what the calendarization looks like.

如果回顧過去，我稱之為最近三年，也就是我直接參與的期間，從個人角度說明。若看 2023、2024 與 2025 年，我們在下半年看到的營收都高於上半年。我們也看到下半年的成長率相較上半年約高出 500 個基點。而且這段期間一直非常一致。因此，這就是我們對年度分布（calendarization）的看法。

Additionally, we have a team that we are investing in commercially, both from a sales perspective and from a marketing perspective. And we expect those investments to ramp and become more productive over the year, both the people to become more productive and the programs to become more installed.

此外，我們也在商業端持續投資團隊，包含銷售與行銷兩個面向。我們預期這些投資會在一年內逐步爬坡並提升產出：不僅人員會更有效率，相關方案也會更完整地落地。

And then finally, as I mentioned, the patient funnel is as strong as we've seen it. And so it's growing and robust really across the business. And so, all of those factors are really dynamics within the business that put us in position to be able to make the decision to raise the guide at this point.

最後，如我提到的，病患漏斗（patient funnel）是我們所見過最強勁的狀態。因此，它正在成長，且在整體業務上都相當穩健。綜合以上因素，這些都是業務內部的動態，使我們能在此時做出上調指引的決定。

And then finally, from more of an internal perspective, as I mentioned, we continue to really strengthen the operating system around the business, and in particular, the organization and the discipline around the leadership, the training, incentives, referral management, as Patrick mentioned. And so it's not that we can't, and I suspect we won't have quarter-to-quarter variability in some of the results, but with what we see in the business today, as well as what we've seen in the business over time, those are the dynamics that we're working to reflect in the guidance.

最後，從更內部的角度來看，如我所說，我們持續強化圍繞業務的營運系統，特別是在組織與管理紀律方面，包括領導力、訓練、獎酬機制、轉介管理（如 Patrick 提到）。因此，並不是說我們不能、或我猜我們不會出現季度間的結果波動；但就我們目前在業務中看到的情況，以及我們長期以來觀察到的趨勢，這些就是我們希望在指引中反映的動態。

Great, very helpful. And then just to follow-up on generalized, you mentioned there's no generalized included in the guidance. I know the main gating factor from here after approval is really getting commercial reimbursement. So it sounds like that's more of a 2027 event for that to be felt more materially in the numbers, but to my understanding, you can go after that 20% of the population that's Medicaid right off the bat.

很好，非常有幫助。接著追問一下關於全身性（generalized）：你提到指引中沒有納入全身性。我知道從核准之後往下的主要關卡其實是取得商業給付（reimbursement）。所以聽起來，這更可能在 2027 年才會在數字上更明顯地反映出來；但據我理解，你們一開始就可以先鎖定占人口 20% 的 Medicaid。

So why not include some contribution from Medicaid? Is that just conservatism, or is there some other reason that's not baked into the guidance for this year? Thanks so much.

那為什麼不把 Medicaid 的一些貢獻納入呢？這只是保守起見，還是今年的指引沒有把它納入有其他原因？非常感謝。

Yeah, no, it's a fair question. And just to say again a little bit more on that is that, again, we are anticipating a mid-year approval. But to stick with how we've been doing this since back in late 2025, we have kept IGE indication expansion out of our guidance, and we will continue to do so until we get approval.

是的，這是個合理的問題。再補充說明一下：我們確實預期會在年中獲得核准。但延續我們自 2025 年底以來的做法，我們一直把 IGE 適應症擴張排除在指引之外，並且在取得核准之前都會維持這樣的做法。

Upon that time, you are correct. We would expect that on a case-by-case basis with that 20% Medicare/Medicaid. We can likely move pretty quickly on that. That's why we're augmenting with third-party reimbursement help, et cetera, and then we'll work with the other 80%, which is across private paying in the Advantage program. So I guess I would call it more than anything being thoughtful about waiting for an approval, that's a bit of a binary event.

在那之後，你說得沒錯。我們預期針對那 20% 的 Medicare/Medicaid，可採個案方式處理。我們很可能能相當快速地推進。這也是為什麼我們會搭配第三方給付協助等資源，然後再處理其餘 80%——也就是 Advantage 計畫中各家商業保險。因此，我想主要是審慎地等待核准，因為那是一個相對二元（binary）的事件。

We feel very cautiously optimistic about when that's going to happen, and we said it, but we want to make sure we don't get ahead of ourselves. And at the point of approval, we will absolutely come back and let people know what they can expect in contribution. And I stated already that you should expect that it would be, to your point, as we get those private payers on board, that it will be more of a month 7 to 12, we'll call it, impact when we cycle through all those coverage policies.

我們對核准時間點抱持非常審慎的樂觀態度，我們也已經說過，但我們想確保不會操之過急。一旦核准，我們一定會再回來告訴大家可以期待的貢獻程度。我也已經提到，你應該可以預期：如你所說，當我們把這些商業保險納入後，影響會更偏向第 7 到第 12 個月（我們姑且這麼稱呼），因為需要時間輪轉並完成各項給付政策的覆蓋。

Frank Takkinen, Lake Street Capital Markets.

Frank Takkinen，Lake Street Capital Markets。

I was hoping to start with one, and apologies if it already came up, I don't think it has, on the reimbursement changes for 2026. I think last year or last quarter you spoke to the improvements in both OPPS and the physician fee schedule effective at the beginning of 2026. Any anecdotal feedback or direct feedback from the field on how that reimbursement has been received or impacted the business?

我想先從一個問題開始，如果之前已經提到過先致歉；我想應該還沒有：關於 2026 年的給付變更。我記得去年或上季你們提到 OPPS 與醫師費用表（physician fee schedule）在 2026 年初生效的改善。現場端是否有任何軼聞回饋或直接回饋，說明這些給付變更如何被接受，或對業務造成了什麼影響？

Yeah, hey, Frank. 2026 was still a good year for us from a reimbursement standpoint. A lot of the legwork that we did in '25 came to fruition in '26. So I would say, overall, when you don't hear news and pushback from your field team, that's a good thing. As we go into '27, we'll keep everyone posted on that, but at this point, we're in comment period, et cetera.

是的，嗨 Frank。從給付角度來看，2026 年對我們仍然是個不錯的一年。我們在 2025 年做的許多前置工作在 2026 年開始開花結果。所以我會說，整體而言，當你沒有從前線團隊聽到消息或反彈時，那通常就是好事。至於邁入 2027 年，我們會持續向大家更新；但目前我們仍在意見徵詢期（comment period）等階段。

We're not anticipating, nor have we obviously given 2027 guidance yet, but rest assured, you can expect us to continue to push hard on making sure that we not only advocate for patients, but that the hospital accounts are being reimbursed appropriately to make sure that that doesn't become an impediment to installing our modulation device.

我們目前既不預期、也當然尚未提供 2027 年指引；但請放心，你可以期待我們會持續大力推動，確保我們不僅為病患發聲，也確保醫院客戶能獲得適當給付，避免這成為我們安裝調控裝置（modulation device）的阻礙。

The only thing I'd add there, Frank, is that we did have a positive development from an OPPS perspective, as you mentioned. The replacement cycle for us is still a small amount of the business. But I know I don't need to emphasize for this group that that's on its way.

Frank，我唯一想補充的是，如你所提到的，我們在 OPPS 方面確實有一項正向進展。對我們而言，更換週期（replacement cycle）目前仍只占業務的一小部分。但我想我不需要對在座各位強調：那個趨勢正在到來。

And so that's something that we believe will hold us in good stead here as those RNS-320 devices increasingly come back around for replacement. We'll be in a positive and improved reimbursement position with regard to outpatient device replacement as that cycle increases.

因此，當這些 RNS-320 裝置日後愈來愈多進入更換期時，我們相信這會讓我們處於更有利的位置。隨著門診端裝置更換的週期增加，我們在門診裝置更換的給付方面，將處於更正向且改善後的給付環境。

Got it. That's helpful. And then maybe just a bigger picture question on Project CARE. I think we're about two years into when that initiative was kicked off. Joel, maybe give us a review, I mean, puts and takes, what has surprised positively, maybe what's been proven to be more challenging in this setting, anything on utilization, if that's what's been driving some improvement, if it's new site activations.

了解。這很有幫助。接著可能是一個更宏觀的問題，關於 Project CARE。我想這個倡議啟動至今大約兩年了。Joel，也許你可以幫我們回顧一下：有哪些得失（puts and takes）、哪些地方有正向驚喜、哪些在這個情境下被證明更具挑戰；以及在使用量（utilization）方面是否有任何資訊——如果改善是由使用量帶動，或是由新站點啟用（new site activations）所驅動。

Just any kind of big picture commentary that you've noticed over the last two years on that would be great. Thanks.

過去兩年你在這方面觀察到的任何宏觀層面評論都很棒。謝謝。

Thank you, Frank. I think -- things we've learned. We have learned, and you've heard me comment on some of this previously, is that there are a number of different segments. That exist in the community or referral population. And having the flexibility to be able to address the needs of those different segments is important.

謝謝你，Frank。我想——我們學到的事情。我們已經學到，而且你也聽過我之前評論過其中一些，就是社區或轉介族群中存在若干不同的分群。而能夠有彈性去滿足這些不同分群的需求很重要。

One, we have some centers, community centers, level three centers, who really, they've got the patient population, they've got the epileptologists and neurologists there, they've got the functional neurosurgeons with capacity, the surgical capital equipment requirements are there, and maybe there's a software package that is required and a contracting activity. But other than that, they're really ready to go, and we can turn them into an implanting center where they can self-sustain, and that's great.

第一，我們有一些中心——社區中心、第三級中心——他們其實已經具備病患族群，也有癲癇專科醫師與神經科醫師，也有具備量能的功能性神經外科醫師；手術所需的資本設備也都到位，可能只需要一套軟體套件以及一些簽約作業。但除此之外，他們基本上已經準備就緒，我們可以把他們轉變成可植入的中心，讓他們能自給自足，這很棒。

There are others that will eventually look like that, but since they hadn't had access to the technology, it wasn't something that they were planning for, and so it takes some time then to develop those centers. And as you know, capital cycles and trainings and everything else that goes on at the hospital level, that takes a little longer, but that's also a very important and viable segment for us, especially as we think about the idiopathic generalized population and not needing the Phase II monitoring that requires someone to be transferred to a Level 4 Center for invasive EMU/SEEG monitoring that can abrogate the referral pathway timing.

還有一些中心最終也會變成那樣，但因為他們過去無法取得這項技術，原本並沒有把它納入規劃，所以需要一些時間來建置這些中心。而如你所知，資本支出週期、訓練以及醫院層級的各種流程都會讓進度稍微拉長，但這對我們而言也是非常重要且可行的一個分群，特別是當我們考量特發性全身性（idiopathic generalized）族群，且不需要第二期（Phase II）監測——也就是需要轉送到第四級中心進行侵入性 EMU/SEEG 監測、而可能拉長轉介路徑時間的那種監測。

The third segment has been interesting, and that is centers that have all of the patient population and the neurology and epileptology capability and management infrastructure. And they don't really want to have the patients implanted at their center. Not that they don't want patients implanted at their centers, but they would like to prioritize management of the patients. And so, they're happy to have a connection made and a referral relationship developed that puts them in a position where they feel like their patients are going to be taken care of.

第三個分群很有意思：這些中心擁有完整的病患族群，也具備神經科與癲癇專科的能力以及管理基礎設施。但他們並不真的想在自己的中心替病患進行植入。不是說他們不希望病患在他們中心植入，而是他們更希望優先把重點放在病患的管理上。因此，他們很樂意建立連結並發展轉介關係，讓他們覺得自己的病患會被妥善照顧。

Remember, these are patients that have multi-year relationships with their clinicians as they proceed through medication management and their disease progression. So to have a relationship developed where they can have somebody handed off and make sure they can get them back, and then we can do the training and the support around programming those patients, that's a third segment that exists and really works out quite well.

請記得，這些病患在用藥管理與疾病進程的過程中，往往與臨床醫師建立了多年關係。因此，若能建立一種關係，讓他們可以把病患交接出去、並確保之後能再把病患接回來，同時我們也能針對這些病患的程式設定提供訓練與支援——這就是存在的第三個分群，而且運作得相當好。

And so I think we had maybe thought going into it. It'd be a little more homogeneous than that. But those have been some learnings.

所以我想，我們一開始可能以為情況會更同質一些。但以上就是一些學習。

I think maybe not a negative, I guess maybe I'd characterize it a little bit as a negative. There's just -- there's a lot of awareness building and development to do. And so on the one hand, that's work that needs to be done and there's a little bit of a, air quotes, negative surprise. You can't assume that people are aware of things.

我想也許不算負面——但我猜可以稍微把它形容成有點負面。就是——還有很多需要去建立認知與推動發展的工作。所以一方面，那是必須做的工作，也算是有點「負面驚喜」（加引號）。你不能假設大家都知道這些事情。

On the other hand, we found it to be just a great opportunity and to be able to get out in the community the way we are now on an increasing basis and be able to make people aware of and understand recent developments in and the data associated with, as well as referral opportunities for.

但另一方面，我們也發現這其實是很好的機會；我們現在能以越來越高的頻率走入社區，讓大家了解並理解近期的進展與相關數據，以及可供轉介的機會。

Again, all associated with learning and why I think overall, to your point on big picture, from a big picture perspective, staging things the way that we have, where we got the PMA supplement to permit expansion beyond Level 4 Centers with the focal indication and doing that work has allowed us to learn about that dynamic and the referral population even more. And then we think that will skate rather nicely into here the work that we're doing for indication expansion with IGE and beyond. It's a little bit of a long way around, but hopefully that answers your question.

同樣地，這些都與學習有關；而就你提到的宏觀層面而言，從大局來看，我們以目前這種方式分階段推進——也就是取得 PMA 補充許可，讓我們在局灶性適應症下得以從第四級中心以外擴展，並完成相關工作——使我們能更深入了解這種動態以及轉介族群。接著我們認為，這將能相當順利地銜接到我們正在進行的、針對 IGE 及更廣泛適應症擴張的工作。這說法有點繞，但希望有回答到你的問題。

No, that's perfect. Comprehensive. Thank you very much.

沒有，這很完美。很全面。非常感謝。

Anthony Petrone, Mizuho.

Mizuho 的 Anthony Petrone。

Congrats on the progress so far on '26. Maybe just come back to two reimbursement questions. One on the new APC mapping for vagus nerve stimulators there. It was a shift for new patient implants to APC 1580, that was a 48% increase for the category.

恭喜目前在 2026 年（'26）的進展。我想再回到兩個給付（reimbursement）問題。第一個是關於迷走神經刺激器新的 APC 對應（mapping）。新病患植入被調整到 APC 1580，該類別提高了 48%。

And then end of service shifted from level four to level five, and that was also roughly a 47%, 48% uplift. So, it just seems like, from the Medicare level on an outpatient basis, there's receptivity to, good, healthy levels of reimbursement for epilepsy. So is there any kind of read-through from what we've seen in vagus nerve kind of transferred over to the RNS system once we get there for generalized?

另外，服務終止（end of service）從第四級調到第五級，這也大約帶來 47%、48% 的上調。所以看起來，從 Medicare 的門診層面來看，對癲癇給付是有意願提供良好、健康水準的。那麼，從我們在迷走神經那邊看到的情況，是否能推論一旦我們在全身性（generalized）適應症走到那一步，這些趨勢也會轉移到 RNS 系統上？

And then I think, I believe, there's no WISeR program exposure here, but just to confirm that the RNS system is not seeing any kind of prior authorization impact in those six states from the WISeR program. Thanks.

第二個，我想、我相信這裡沒有 WISeR 計畫的曝險，但想確認一下：RNS 系統在 WISeR 計畫涵蓋的那六個州，沒有受到任何事前授權（prior authorization）的影響，對嗎？謝謝。

Thank you, Anthony. And I'll start here, and then Patrick can help me. The first point is with regard to end of service and moving from four to five, we had the same improvement in what I mentioned earlier with regard to the replacement cycle and the OPPS increase in reimbursement. So that's absolutely the case.

謝謝你，Anthony。我先回答，然後 Patrick 可以補充。第一點，關於服務終止以及從四級移到五級，我們也獲得了同樣的改善，正如我先前提到的更換週期以及 OPPS 給付上調所帶來的效果。所以確實如此。

And I agree with your comments 100% that when we saw those increases in reimbursement, we were encouraged not only because of the effect on RNS replacement reimbursement, obviously, but that overall and generally, the reimbursing bodies are seeing the value associated with neuromodulation and are open to making sure that there's good access for hospitals and clinicians to be able to access the technology.

而且我 100% 同意你的評論：當我們看到那些給付上調時，我們受到鼓舞，不僅是因為對 RNS 更換給付的影響（這當然很明顯），也因為整體而言、一般來說，給付單位正在看見神經調控（neuromodulation）所帶來的價值，並且願意確保醫院與臨床醫師能夠有良好的可近性來使用這項技術。

So one, also four to five an improvement in OPPS. Two, I shared with you on. It's good news when people are investing in neuromodulation broadly. And three, there is no impact with regard to WISeR for us, and we're not included.

所以第一，從四級到五級也是 OPPS 的一項改善。第二，我也跟你分享過：當大家在更廣泛的神經調控領域投入資源時，這是好消息。第三，WISeR 對我們沒有任何影響，我們也不在其涵蓋範圍內。

Michael Polark, Wolfe Research.

Wolfe Research 的 Michael Polark。

On the topic of generalized with the FDA, Joel, I'm curious just as you assess their interest in the data, questions that you've received and answered. How much focus have they placed on the primary endpoint in the NAUTILUS study, which did not meet significance versus all of the supplemental analysis? I'm just trying to envision, in light of the kind of headline squish in the trial and all the constructive data underneath, how they may kind of, are they wrestling with that, how they might conclude, and what a label may or may not look like. Thank you.

在與 FDA 討論全身性（generalized）這個主題時，Joel，我很好奇：當你評估他們對數據的興趣、以及你收到並回覆的問題時，他們對 NAUTILUS 研究的主要終點（primary endpoint）——也就是未達顯著性——相較於所有補充分析（supplemental analysis），到底放了多少重點？我只是想像一下：在試驗標題結果有點「被擠壓」（headline squish）、但底下有很多建設性數據的情況下，他們可能會如何看待、是否正在為此權衡、可能如何做出結論，以及標示（label）可能會或不會長什麼樣子。謝謝。

Thanks, Mike. As you might imagine -- and I won't speak on FDA's behalf, but I will give you my observations. My observations would be, as you might expect, they're focused on the totality of the data. They're looking at all of it, the primary safety, which did meet; the primary efficacy, as you mentioned, which didn't; and the pre-specified secondaries that again, we think are particularly impactful and clinically relevant. And so, I would say that they're taking a comprehensive and appropriate view of the totality of the evidence.

謝謝，Mike。如你所想——我不會代表 FDA 發言，但我可以分享我的觀察。我的觀察是，如你所預期，他們聚焦於數據的整體性（totality of the data）。他們會看全部：主要安全性（primary safety）——有達標；主要療效（primary efficacy）——如你所說，沒有達標；以及預先指定的次要終點（pre-specified secondaries），我們認為這些特別有影響力且具臨床相關性。因此，我會說他們正在以全面且恰當的方式，審視整體證據。

With regard to label, it's our interest to pursue a label that is aligned with the study population and the inclusion/exclusion criteria in the study, and that's really been our approach.

就標籤而言，我們的利益在於推動一個與研究族群以及研究中的納入／排除標準一致的標籤，而這一直是我們的做法。

Appreciate that, Joel. Thank you. I have one other reimbursement question. Conviction in this question is not sky high, but I believe the RNS first-time implant is on the so-called inpatient-only list maintained by Medicare. And I think over the years to come, it may come off and could trigger the creation of the Level 6 outpatient APC.

了解，Joel，謝謝。謝謝你。我還有一個關於給付的問題。我對這個問題的把握不是特別高，但我相信 RNS 的首次植入在 Medicare 維護的所謂「僅限住院」清單上。而我認為在未來幾年，它可能會被移除，並可能觸發建立第 6 級門診 APC。

Now, it may be most of -- if not all the cases, it would still be inpatient, but by virtue of Medicare cleaning up this inpatient-only list, and they'd have to provide a pathway for the RNS system and some other devices in the outpatient setting. And given the cost of the cases a lot higher, that would necessitate and maybe pull forward and finally make come to fruition this Level 6 creation.

現在，可能大多數——如果不是全部——案例仍會是住院，但由於 Medicare 清理這份僅限住院清單，他們必須為 RNS 系統以及其他一些裝置在門診環境中提供一條途徑。而鑑於這些案例的成本高得多，這將使得有必要，並可能提前推動，最終讓這個第 6 級的建立得以實現。

I'm sorry for the long-winded ramp, but it's a very -- it's been a topic in [Neuristan]. It's been discussed for a while, and I'm curious if you agree or disagree strongly with anything I just said there. Thank you.

抱歉鋪陳得有點長，但這是一個——一直是[Neuristan] 的話題。已經討論了一段時間，我想知道你是否強烈同意或不同意我剛才說的任何內容。謝謝。

Mike, what I would tell you, and there are a lot of moving parts there associated with that, is that we have been very engaged with regard to virtually all aspects of reimbursement, from inpatient to outpatient to physician reimbursement, the move from four to five, the maintenance of the DRG categorization, change from the proposed rule to the final rule, the improvement in CPT rates, really across all fronts.

Mike，我想告訴你的是，這裡面有很多相互牽動的因素：我們在幾乎所有給付面向都非常投入，從住院到門診到醫師給付、從第 4 級到第 5 級的調整、DRG 分類的維持、從擬議規則到最終規則的變更、CPT 費率的改善，基本上是全方位。

We've been both pleased with and highly engaged from a reimbursement perspective. I think at this point, to talk further about going from five to six and kind of a secondary dependency for what may or may not happen with the inpatient is a couple of degrees removed from where I feel like I could credibly comment.

從給付角度來看，我們既感到滿意也高度投入。我認為在這個時間點，若要進一步談從第 5 級到第 6 級，以及與住院端可能或不可能發生的事情之間那種次要依賴關係，距離我覺得自己能夠有可信度地評論的範圍還差了幾個層級。

I would leave you with we're very engaged in -- you can see from the results associated with and are highly involved with reimbursement across all fronts. And again, back to the question that was asked earlier, I think it's encouraging for us to see the payers signaling a general openness to recognizing the value, both clinically as well as economically. So I can't answer the five to six potentialities specifically, given where we sit today, but I like where general trends are headed from a reimbursement perspective around neuromodulation.

我想留給你的是：我們非常投入——你也可以從相關結果看得出來——並且在各個面向都高度參與給付議題。而且回到先前有人問的問題，我認為令人鼓舞的是，我們看到付款方釋出一種整體上的開放態度，願意認可其價值，無論是臨床面或經濟面。所以就目前我們所處的位置而言，我無法具體回答從第 5 級到第 6 級的各種可能性，但就神經調控的給付趨勢而言，我喜歡目前的大方向。

Yeah, and I would just add, because this is a -- I appreciate the question, but I want to be crystal clear with everyone. We feel very good about the reimbursement that we advocated for our patients through '25 that came into effect in '26. We feel good about the pricing that we have as we move forward.

是的，我也想補充一下，因為這是一個——我很感謝這個問題，但我想讓大家非常清楚。我們對於我們為病患所爭取、涵蓋到 2025 年並在 2026 年生效的給付感到非常滿意。我們也對未來推進時的定價感到有信心。

And as Joel said, we continue to see the payers advocate on behalf of these patients that need intervention in order to get their lives back and have some life-changing outcomes. And so we're not in the game of speculation, but rest assured, we are doing everything we can, including advocacy at the Hill, society advocacy, et cetera. And so, this will not be a headwind for us in our minds. We will continue to advocate on behalf of patients on the reimbursement side.

而且如 Joel 所說，我們持續看到付款方代表這些需要介入治療、以便重拾生活並獲得改變人生結果的病患發聲。因此我們不做臆測，但請放心，我們正在盡一切所能，包括在國會山莊的倡議、學會倡議等等。所以在我們看來，這不會成為逆風。我們會持續在給付面為病患發聲。

Yi Chen, HC Wainwright.

Yi Chen，HC Wainwright。

Hi, this is Katie on for Yi. Just real quick to wrap this up. Could you give us an idea of how many implants for replacements versus new implants this quarter? And do you think that's kind of a typical mix of what we should expect going through the rest of 2026?

嗨，我是 Katie，代 Yi 發言。很快問一下作結。你們能否讓我們了解一下本季更換植入與新植入各有多少？以及你們認為這是否大致會是 2026 年剩餘期間我們應預期的典型組合？

I'll ask Patrick to comment here, but we did see an increase in replacements. It's still a small number, but we did see a mild increase in replacements. Again, remember, the RNS-320s have got a nominal battery life of 11 years. And so we should be right at kind of the front edge here of that replacement cycle, but still not seeing meaningful volume in the last quarter, would you?

我請 Patrick 在這裡回覆，不過我們確實看到更換案例增加。數量仍然不大，但我們確實看到更換有小幅上升。再次提醒，RNS-320 的名目電池壽命是 11 年。所以我們應該正處在那個更換週期的前緣，但上一季仍未看到有意義的量，你同意嗎？

Yeah, I agree. And what we talked about historically, we said we're less than 5% of our revenue is replacement over time at this point, a little less than 10% as well on the unit side. And that's because when we do a replacement, we don't have to replace the leads. We just replace the 320 device, so there's less of an ASP that we incur -- the accounts incur.

是的，我同意。而且我們過去談到的是：到目前為止，長期來看更換占我們營收不到 5%，在出貨量（單位數）方面也略低於 10%。這是因為我們做更換時不需要更換導線。我們只更換 320 裝置，因此我們承擔——客戶端承擔——的 ASP 較低。

So I think the point here for everyone is that we're excited about the replacement revenue that we come of a recurring revenue stream as we go forward, but we're in the very early stages of that. But it'll become more meaningful as we move throughout this year and certainly as we get into '27, '28, and beyond.

所以我想要讓大家理解的重點是：我們對於更換帶來、作為未來經常性收入來源的更換營收感到興奮，但我們仍處於非常早期的階段。不過，隨著今年的推進，當然也會在 2027、2028 以及更往後變得更有意義。

And ladies and gentlemen, that is all the time we have for questions today. I will now turn the conference back over to Mr. Joel Becker for closing remarks.

各位女士先生，今天的提問時間到此為止。我現在把電話會議交回給 Joel Becker 先生作結語。

Thank you. Thank you all for your time and attention today. 2026 is a year with transformational potential for NeuroPace. And we are well on our way to executing on this potential while building on the momentum in our current business. We look forward to keeping you up to date throughout the year as we continue to execute our strategy and progress toward these significant opportunities. And thanks again for your interest in and support in NeuroPace.

謝謝。感謝各位今天撥冗並專注聆聽。2026 年對 NeuroPace 而言是一個具有轉型潛力的一年。我們在延續現有業務動能的同時，也正穩步推進以落實這個潛力。我們期待在全年持續向各位更新進展，因為我們將繼續執行策略並朝這些重大機會邁進。也再次感謝各位對 NeuroPace 的關注與支持。

And ladies and gentlemen, this concludes today's call, and we thank you for your participation. You may not disconnect.

各位女士先生，今天的電話會議到此結束，感謝各位的參與。您現在可以掛線。