AtriCure Inc (ATRC) 2024 Q1 法說會逐字稿

Good afternoon, and welcome to AtriCure's First Quarter 2024 Earnings Conference Call. This call is being recorded for replay purposes. (Operator Instructions)

下午好，歡迎參加 AtriCure 2024 年第一季財報電話會議。此通話正在錄音以供重播。 （操作員說明）

I would now like to turn the call over to Marissa Bych from the Gilmartin Group for a few introductory comments.

我現在想將電話轉給吉爾馬丁集團的瑪麗莎·比奇 (Marissa Bych)，請其發表一些介紹性意見。

Thank you. By now, you should have received a copy of the earnings press release. If you have not received a copy, please call (513) 644-4484 to have one e-mailed to you.

謝謝。到目前為止，您應該已經收到了收益新聞稿的副本。如果您尚未收到副本，請致電 (513) 644-4484，讓我們透過電子郵件向您發送副本。

Before we begin today, let me remind you that the company's remarks include forward-looking statements. Forward-looking statements are subject to numerous risks and uncertainties, many of which are beyond AtriCure's control, including risks and uncertainties described from time to time in AtriCure's SEC filings. These statements include, but are not limited to, financial expectations and guidance, expectations regarding the potential market opportunity for AtriCure's franchises and growth initiatives, future product approvals, clearances, reimbursement and clinical trial outcomes. AtriCure's results may differ materially from those projected. AtriCure undertakes no obligation to publicly update any forward-looking statements.

在今天開始之前，讓我提醒您，該公司的言論包含前瞻性陳述。前瞻性陳述受到眾多風險和不確定性的影響，其中許多風險和不確定性超出了 AtriCure 的控制範圍，包括 AtriCure 不時向 SEC 文件中描述的風險和不確定性。這些聲明包括但不限於財務預期和指導、對 AtriCure 特許經營和成長計劃的潛在市場機會的預期、未來產品批准、許可、報銷和臨床試驗結果。 AtriCure 的結果可能與預期的結果有重大差異。 AtriCure 不承擔公開更新任何前瞻性聲明的義務。

Additionally, we refer to non-GAAP financial measures, specifically revenue reported on a constant currency basis, adjusted EBITDA and adjusted loss per share. A reconciliation of these non-GAAP financial measures with the most directly comparable GAAP measures is included in our press release, which is available on our website.

此外，我們也參考非公認會計準則財務指標，特別是以固定匯率計算的收入、調整後的 EBITDA 和調整後的每股虧損。這些非公認會計原則財務指標與最直接可比較的公認會計原則指標的對帳已包含在我們的新聞稿中，該新聞稿可在我們的網站上取得。

And with that, I would like to turn the call over to Mike Carrel, President and CEO.

接下來，我想將電話轉給總裁兼執行長 Mike Carrel。

Thank you, Marissa. Good afternoon, everyone, and thank you for joining us today. I am pleased to report a strong start to 2024 as we expand our global impact on patients with atrial fibrillation and postoperative pain.

謝謝你，瑪麗莎。大家下午好，感謝您今天加入我們。我很高興地向大家報告，隨著我們擴大對心房顫動和術後疼痛患者的全球影響，我們在 2024 年取得了良好的開局。

In the first quarter, we achieved total revenue of $109 million, reflecting 16% growth from the first quarter of 2023, driven by steady demand and activity across our franchises and geographies. In addition, we improved gross margins and expanded profitability with a nearly 50% increase in adjusted EBITDA in the first quarter of 2024 compared to the first quarter of 2023.

第一季度，我們的總收入達到 1.09 億美元，較 2023 年第一季成長 16%，這得益於我們特許經營店和地區的穩定需求和活動。此外，我們提高了毛利率並擴大了獲利能力，2024 年第一季調整後 EBITDA 較 2023 年第一季成長了近 50%。

As we continue efforts to grow adoption across our portfolio, we are reiterating expectations to generate full year 2024 revenue of $459 million to $466 million, reflecting 15% to 17% year-over-year growth. We are also reaffirming our plans to deliver a full year adjusted EBITDA of $26 million to $29 million with annual improvements thereafter. We remain confident in our strategy to invest in innovation and growth while driving increasing profitability and cash flow generation.

隨著我們繼續努力提高整個產品組合的採用率，我們重申預計 2024 年全年營收將達到 4.59 億美元至 4.66 億美元，年增 15% 至 17%。我們也重申，我們計劃實現全年調整後 EBITDA 達到 2,600 萬至 2,900 萬美元，並在此後逐年改進。我們對投資創新和成長、同時提高獲利能力和現金流產生的策略仍然充滿信心。

As I think about the future of AtriCure, our strong growth outlook is the result of many years of innovation, clinical investments and market development initiatives. As you all know, AtriCure is the leader in the treatment of advanced atrial fibrillation, and we are #1 in each of our multibillion-dollar markets. As we uphold this position, we do not take competition lightly. We have long anticipated that our success, marked by consistent double-digit growth within vastly underpenetrated disease states would invite new entrants into the markets.

當我思考 AtriCure 的未來時，我們強勁的成長前景是多年創新、臨床投資和市場開發舉措的結果。眾所周知，AtriCure 是治療晚期心房顫動的領導者，我們在每個價值數十億美元的市場中排名第一。當我們堅持這一立場時，我們不會掉以輕心地對待競爭。我們長期以來一直預計，我們的成功，以在疾病滲透率嚴重不足的國家持續實現兩位數增長為標誌，將吸引新的進入者進入市場。

In fact, we have intentionally executed a strategy that involves market expansion and development activities for over a decade in anticipation of some competition, which we are beginning to see today. We believe competition validates the immense opportunity still ahead for our business. And of course, we expect new market entrants to be able to generate business by entering our markets. We know that physicians try new products. That said, we are confident in our long-term prospects because we know that competition creates greater therapy awareness and stimulates strong long-term market growth.

事實上，十多年來，我們有意執行一項涉及市場擴張和開發活動的策略，以應對一些競爭，而我們今天開始看到這種競爭。我們相信競爭證明我們的業務仍然存在巨大的機會。當然，我們希望新的市場進入者能夠透過進入我們的市場來創造業務。我們知道醫生會嘗試新產品。也就是說，我們對我們的長期前景充滿信心，因為我們知道競爭可以提高治療意識並刺激強勁的長期市場成長。

For example, look at TAVR and percutaneous appendage management markets over the past 15 years. New entrants have helped grow those markets and drive multibillion-dollar franchises. Our confidence is also founded in the exceptional quality and safety of our innovative products, which are further supported by compelling clinical outcomes. We will continue to differentiate AtriCure from the field by investing in innovation, which you will see this year through our recent cryoSPHERE+ launch and upcoming AtriClip Flex Mini launch, both of which we expect to be game-changing technologies.

例如，看看過去 15 年的 TAVR 和經皮附件管理市場。新進入者幫助發展了這些市場並推動了價值數十億美元的特許經營權。我們的信心也建立在我們創新產品的卓越品質和安全性之上，而引人注目的臨床結果進一步支持了這一點。我們將繼續透過投資創新來讓 AtriCure 在該領域脫穎而出，今年您將透過我們最近推出的 CryoSPHERE+ 和即將推出的 AtriClip Flex Mini 看到這一點，我們預計這兩項技術都將成為改變遊戲規則的技術。

And we will keep investing in market expanding clinical evidence in support of our technology, such as the only stroke trial ever done for concomitant cardiac surgery in our LeAAPS trial. Lastly, one of our greatest long-term differentiators is the deep knowledge and strength of our commercial and education teams. We have over 400 field personnel globally, building and strengthening relationships with cardiac and thoracic surgeons and EPs. We will continue to invest across these differentiators in our business: innovation, clinical science and field expertise to enable AtriCure to remain a market leader.

我們將繼續投資擴大市場的臨床證據以支持我們的技術，例如我們的 LeAAPS 試驗中唯一針對伴隨心臟手術進行的中風試驗。最後，我們最大的長期優勢之一是我們商業和教育團隊的深刻知識和實力。我們在全球擁有 400 多名現場人員，致力於建立和加強與心臟和胸腔外科醫生以及急診科醫生的關係。我們將繼續對我們業務的這些差異化因素進行投資：創新、臨床科學和現場專業知識，以使 AtriCure 保持市場領先地位。

Looking forward, we expect to stay several steps ahead of our peers in the market and development -- and market development and expansion. To date, our investments have culminated in a robust cadence of innovation and the launch of multiple growth drivers of our business. More recently, in our open ablation franchise, we have had tremendous success with our EnCompass Clamp. The EnCompass Clamp leverages the proven technology of our synergy ablation system to provide simpler and faster ablations in open heart procedures. This increased procedure efficiency over legacy solutions continues to drive exceptional adoption of this device in opening up new opportunities for growth. We are pleased to see EnCompass highlighted at the recent AATS meeting in Toronto across many papers and presentations.

展望未來，我們期望在市場和發展以及市場開發和擴張方面領先於同行幾步。迄今為止，我們的投資最終帶來了強勁的創新節奏和業務的多種成長動力。最近，在我們的開放式消融特許經營中，我們的 EnCompass Clamp 取得了巨大的成功。 EnCompass Clamp 利用我們經過驗證的協同消融系統技術，在心臟直視手術中提供更簡單、更快速的消融。與傳統解決方案相比，程式效率的提高繼續推動該設備的廣泛採用，從而開闢新的成長機會。我們很高興看到 EnCompass 在最近於多倫多舉行的 AATS 會議上透過許多論文和簡報得到強調。

We are committed to making concomitant treatment, the standard of care for patients undergoing cardiac surgery and still see significant opportunity ahead in both pre-op Afib patients and eventually postop Afib reduction. Building on this, we anticipate EU MDR approval and the European launch of the EnCompass Clamp in the back half of 2024, further expanding the impact of this outstanding product.

我們致力於制定伴隨治療，這是接受心臟手術的患者的護理標準，並且仍然看到術前心房顫動患者和最終術後心房顫動減少的巨大機會。在此基礎上，我們預計 EnCompass Clamp 將於 2024 年下半年獲得歐盟 MDR 批准並在歐洲推出，進一步擴大這項出色產品的影響力。

Our founding mission is to advance the treatment of atrial fibrillation, leading to the development of stand-alone minimally invasive treatments for patients. Our Hybrid AF therapy is an important extension of our expertise in effective treatment and is the only approved stand-alone treatment for long-standing persistent Afib. The evidence is clear that the most effective way to treat those patients is with the combined epicardial and endocardial approach, making our Hybrid AF therapy complementary to all catheter-based technologies.

我們的創始使命是推進心房顫動的治療，從而為患者開發獨立的微創治療方法。我們的混合性心房顫動療法是我們在有效治療方面專業知識的重要延伸，也是唯一獲得批准的長期持續性心房顫動的獨立療法。證據明確表明，治療這些患者的最有效方法是採用心外膜和心內膜聯合治療方法，使我們的混合性心房顫動治療成為所有基於導管的技術的補充。

I am pleased to see the strength of our fourth quarter 2023 results carried into the first quarter of this year, resulting in increasing adoption across a growing base of accounts. As we expected, 2024 is shaping up to be a pivotal year for stand-alone treatment of Afib with the availability of multiple PFA catheter technologies in the U.S., highlighting this attractive and vastly underserved market. We are finding the physician interest in PFA technology encourages robust conversations on approaches to treating Afib and the varying needs of patients across the spectrum of this progressive disease. Our hybrid approach is complementary to PFA, and we believe the focus on more efficient endocardial ablation is a tailwind for everyone in the market long term.

我很高興看到我們 2023 年第四季的強勁業績延續到今年第一季度，從而導致越來越多的客戶群採用該技術。正如我們預期的那樣，隨著多種 PFA 導管技術在美國上市，2024 年將成為單獨治療心房顫動的關鍵一年，凸顯了這個極具吸引力且服務嚴重不足的市場。我們發現醫生對 PFA 技術的興趣鼓勵人們就心房顫動的治療方法以及這種進行性疾病的患者的不同需求進行熱烈的討論。我們的混合方法是對 PFA 的補充，我們相信，從長遠來看，對更有效的心內膜消融術的關注對市場上的每個人來說都是有利的。

In fact, we have several customers already using endocardial PFA catheters in the second stage of their hybrid procedures, further validating our thoughts that PFA is part of a rising tide in this market. As we move through 2024, we remain focused on targeted efforts to support accounts as they develop Hybrid AF therapy programs.

事實上，我們有幾位客戶已經在混合手術的第二階段使用心內膜 PFA 導管，這進一步證實了我們的想法，即 PFA 是該市場上升趨勢的一部分。邁入 2024 年，我們仍將重點放在有針對性的努力上，為客戶開發混合心房顫動治療計畫提供支援。

In addition, we are in the early stages of the launch of our Steerable EPi-Sense device in Europe, providing another catalyst for this franchise in our international markets.

此外，我們正處於在歐洲推出可操縱 EPi-Sense 設備的早期階段，這為我們在國際市場上的特許經營提供了另一個催化劑。

Our emphasis on innovation also extends to our appendage management franchise. Over a dozen years ago, we set out to transform the standard of care for patients with atrial fibrillation by offering a safer and more reliable method to exclude the appendage. Today, our AtriClip products are the most widely used appendage management devices in the world with more than 0.5 million devices sold. Given the strength and long-standing contribution of our AtriClip platform, we understand the competitive dynamics in this market are top of mind for investors.

我們對創新的重視也延伸到了我們的附屬物管理特許經營權。十幾年前，我們開始透過提供更安全、更可靠的心耳切除方法來改變心房顫動患者的照護標準。如今，我們的 AtriClip 產品是全球使用最廣泛的肢體管理設備，已售出超過 50 萬台設備。鑑於我們 AtriClip 平台的實力和長期貢獻，我們知道這個市場的競爭動態是投資人最關心的問題。

However, we are pleased to continue driving healthy adoption in this business, marked by over 15% growth in our U.S. open appendage management business in the first quarter and record sales of our AtriClip Flex-V device even in the presence of competitive device trialing. We are already seeing the availability of a competitive device yield in-depth discussions on treating the appendage, allowing us to highlight the advantages of our AtriClip technology. Over the long term, we expect this to promote therapy awareness in way that we could not do on our own. In the short term, we are ready to compete and remain focused on delivering differentiated solutions.

然而，我們很高興繼續推動該業務的健康採用，第一季我們的美國開放式附件管理業務成長了15% 以上，即使在有競爭性設備試用的情況下，我們的AtriClip Flex-V 設備的銷售也創下了紀錄。我們已經看到一種具有競爭力的設備的出現，引發了關於治療肢體的深入討論，使我們能夠突出 AtriClip 技術的優勢。從長遠來看，我們希望這能以我們自己無法做到的方式提高治療意識。短期內，我們已做好競爭準備，並繼續專注於提供差異化的解決方案。

To that end, we are preparing for another significant innovation in this market with our AtriClip Flex Mini device, which is on track for FDA clearance and commercial launch later this year. The AtriClip Flex Mini builds on the solid foundation of our AtriClip technology, known for ease of use, unparalleled safety and outstanding closure results with a substantially smaller profile in this new device.

為此，我們正在準備透過 AtriClip Flex Mini 設備在這個市場上進行另一項重大創新，該設備預計在今年稍後獲得 FDA 批准並進行商業推出。 AtriClip Flex Mini 建立在我們的 AtriClip 技術的堅實基礎上，該技術以易用性、無與倫比的安全性和出色的閉合效果而聞名，而且這款新設備的外形要小得多。

We also view our market opportunity for appendage management as multiples of where we began dozens of years ago -- a dozen years ago. The investment in our LeAAPS clinical trial has the potential to dramatically expand the use of the AtriClip devices as the standard of care for all patients undergone cardiac surgery, which represents over 1.5 million patients per year globally. The LeAAPS clinical trial is investigating the use of the AtriClip products in patients without preoperative Afib diagnosis, seeking to demonstrate a clinically meaningful reduction in ischemic and systemic arterial embolism. If successful, this massive clinical trial, along with existing robust clinical evidence would further separate our products from all other surgical left atrial appendage management devices.

我們也認為，我們的肢體管理市場機會是我們數十年前開始的市場機會的數倍。對我們 LeAAPS 臨床試驗的投資有可能大幅擴大 AtriClip 設備的使用範圍，作為所有接受心臟手術患者的護理標準，全球每年有超過 150 萬名患者接受心臟手術。 LeAAPS 臨床試驗正在研究 AtriClip 產品在術前未診斷出心房顫動的患者中的使用情況，試圖證明對缺血性和全身性動脈栓塞的減少具有臨床意義。如果成功，這項大規模的臨床試驗以及現有的強有力的臨床證據將進一步將我們的產品與所有其他外科左心耳管理設備區分開來。

Enrollment in the LeAAPS clinical trial has continued rapidly, with almost 2,300 enrollments today, driven by strong demand for patient inclusion across 77 sites in the U.S. and Canada. We anticipate the first patient enrollment in our European sites in the coming weeks, and we now expect to complete full enrollment of 6,500 patients by the middle of 2025.

由於美國和加拿大 77 個中心對患者納入的強烈需求，LeAAPS 臨床試驗的註冊人數持續迅速增長，目前註冊人數已接近 2,300 人。我們預計未來幾週內將在歐洲站點進行首批患者入組，現在預計到 2025 年中期完成 6,500 名患者的全部入組。

Beyond our offerings in Afib, we have been successful in creating and expanding our pain management franchise, where our cryoSPHERE product line provides temporary relief from postoperative pain. Since launching in 2019, adoption of the cryoSPHERE probe has been remarkable with over 60,000 Cryo Nerve Block procedures performed to date. The momentum behind commercial adoption of the cryoSPHERE probe speaks to the meaningful reduction in pain patients experience following thoracic surgery. As this therapy continues to grow, we are making investments in clinical data to support a comprehensive value proposition for both patients and physicians.

除了 Afib 的產品之外，我們還成功地創建和擴大了我們的疼痛管理特許經營權，其中我們的 CryoSPHERE 產品線可暫時緩解術後疼痛。自 2019 年推出以來，cryoSPHERE 探頭的採用率非常高，迄今已執行了 60,000 多次冷凍神經阻斷手術。 CryoSPHERE 探頭商業化應用背後的動力表明，胸腔外科手術後患者所經歷的疼痛明顯減少。隨著這種療法的不斷發展，我們正在對臨床數據進行投資，以支持患者和醫生的全面價值主張。

At the same time, we are actively improving our current technology to advance therapy adoption. Recently, we announced the limited launch of our cryoSPHERE+ device, which features new insulation technology to reduce freeze times by 25%. The limited launch is progressing well, the feedback has been excellent, and we remain on track for a full-scale launch by the end of this quarter.

同時，我們正在積極改進現有技術以促進治療的採用。最近，我們宣布限量推出 CryoSPHERE+ 設備，該設備採用新的隔熱技術，可將冷凍時間縮短 25%。限量發布進展順利，反饋也很好，我們仍有望在本季結束時全面發布。

As cryoSPHERE+ made its debut, we are completing studies to show the benefits of our new cryoSPHERE MAX probe, which incorporates this new insulation technology and features a larger ball tip. We expect cryoSPHERE MAX probe to show even further reduction in ablation and procedure time and expect to launch the cryoSPHERE MAX probe late in 2024. We are confident that the improvements we are making will strengthen the case for adoption in an expanded set of use cases, including the sternotomy market.

隨著 CryoSPHERE+ 首次亮相，我們正在完成研究，以展示新型 CryoSPHERE MAX 探頭的優勢，該探頭採用了這種新的絕緣技術並具有更大的球尖。我們預計 CryoSPHERE MAX 探頭將進一步減少消融和手術時間，並預計在 2024 年稍後推出 CryoSPHERE MAX 探頭。市場。

As we innovate and execute against our current market opportunity, we are researching additional market expanding applications for Cryo Nerve Block therapy and look forward to updating you on our progress.

當我們針對當前的市場機會進行創新和執行時，我們正在研究冷凍神經阻斷療法的其他市場擴展應用，並期待向您通報我們的最新進展。

In closing, I would like to reiterate my earlier comments. We have made investments across multiple growth vectors that will enable AtriCure to remain a market leader, and we expect to stay several steps ahead of peers in the market development and expansion. Over the past decade, our company has consistently delivered outstanding growth even in the context of pressure in different markets. Looking forward, we remain positioned to penetrate each of our markets meaningfully and sustainably, driving durable growth and leverage throughout our organization.

最後，我想重申我之前的評論。我們在多個成長領域進行了投資，這將使 AtriCure 保持市場領導者的地位，我們預計在市場開發和擴張方面將領先於同行幾個步驟。過去十年來，即使在不同市場的壓力下，我們公司仍然持續實現了出色的成長。展望未來，我們仍有能力以有意義且永續的方式滲透到每個市場，推動整個組織的持久成長和影響力。

I believe the future at AtriCure is even more compelling now than ever before with new market entrants validating this position. Therefore, as we look forward into 2024, we remain focused on expanding the reach of our solutions for patients with advanced forms of Afib, managing the left atrial appendage in patients undergoing cardiac surgery and reducing postoperative pain. We are also eager to launch several new products across our markets and expand our clinical research initiatives, all while continuing our efforts to improve profitability in our business.

我相信 AtriCure 的未來比以往任何時候都更加引人注目，新的市場進入者證實了這一地位。因此，展望 2024 年，我們仍然專注於擴大我們的解決方案對晚期心房顫動患者的覆蓋範圍，管理接受心臟手術的患者的左心耳並減少術後疼痛。我們也渴望在我們的市場上推出多種新產品並擴大我們的臨床研究計劃，同時繼續努力提高我們業務的獲利能力。

And with that, I'll turn the call over to Angie Wirick, our Chief Financial Officer. Angie?

接下來，我會將電話轉給我們的財務長 Angie Wirick。安吉？

Thank you, Mike. Our first quarter 2024 worldwide revenue of $108.9 million increased 16.4% on a reported basis and 16.3% on a constant currency basis when compared to the first quarter of 2023. We saw strong growth across franchises and geographies, demonstrating the diversified growth drivers of our business in each of our markets globally. Sequentially, worldwide sales grew $2.3 million or 2.2% over the fourth quarter of 2023.

謝謝你，麥克。與2023 年第一季相比，我們2024 年第一季的全球收入為1.089 億美元，按報告計算增長了16.4%，按固定匯率計算增長了16.3%。強勁成長，展現了我們業務的多元化成長動力在我們全球每個市場。隨後，全球銷售額較 2023 年第四季成長 230 萬美元，即 2.2%。

First quarter 2024 U.S. revenue was $90.2 million, a 15.4% increase from the first quarter of 2023. Open ablation product sales were $29.3 million compared to $25.1 million, up 16.5% over the first quarter 2023 and propelled by ongoing adoption of our EnCompass Clamp across both new and existing accounts. U.S. sales of appendage management products were $35.9 million, up 11% over the first quarter of 2023. We saw robust growth in our AtriClip FLEX V device, driving our open appendage management products to an overall growth rate of approximately 15.4%.

2024 年第一季美國營收為9,020 萬美元，較2023 年第一季成長15.4%，開放式消融產品銷售額為2,930 萬美元，較2,510 萬美元成長16.5%，較2023 年第一季成長16.5% ，這得益於我們的EnCompass Clamp 的持續採用新帳戶和現有帳戶。美國闌尾管理產品的銷售額為 3,590 萬美元，比 2023 年第一季成長 11%。

As Mike noted in his comments, our strong first quarter growth in open appendage management products is against the backdrop that included accounts choosing to trial the Medtronic device. However, our appendage management franchise revenue saw pressure from a decline in our minimally invasive appendage management products, primarily from a reduction in LARIAT system sales where we have a very limited base of users, and following an outstanding fourth quarter of growth in our MIS AtriClip products.

正如麥克在評論中指出的那樣，我們開放式肢體管理產品第一季的強勁成長是在客戶選擇試用美敦力設備的背景下進行的。然而，我們的肢體管理特許經營收入受到了微創肢體管理產品下降的壓力，這主要是由於我們的用戶基礎非常有限的 LARIAT 系統銷量的減少，以及我們的 MIS AtriClip 第四季度的出色增長產品。

Pain Management sales were $12.7 million, up 15.1% over the first quarter of 2023 and with limited revenue contribution from our new cryoSPHERE+ probe. Finally, minimally invasive ablation sales were $12.3 million, up 27.8% over the first quarter of 2023. Similar to the end of 2023, our results this quarter reflect an increasing demand for our Hybrid AF therapy with more accounts adopting this treatment for advanced Afib patients.

疼痛管理銷售額為 1,270 萬美元，比 2023 年第一季成長 15.1%，而我們新的 CryoSPHERE+ 探針的收入貢獻有限。最後，微創消融銷售額為1,230 萬美元，比2023 年第一季成長27.8%。這種治療方法治療晚期心房顫動患者。

International revenue totaled $18.6 million, up 21.5% on a reported basis and up 21.1% on a constant currency basis as compared to the first quarter of 2023. European sales accounted for $11.3 million, up 20.7% and Asia Pacific and other international markets accounted for $7.3 million and international sales, up 22.9%. We are excited by the continued strength of our international business across franchises and geographies and see pathways for accelerated growth to extend throughout 2024. Gross margin for the first quarter 2024 was 74.7%, up 21 basis points from the first quarter of 2023. The increase was driven primarily by both product and geographic mix, along with operational efficiencies.

國際營收總計 1,860 萬美元，較 2023 年第一季報告成長 21.5%，以固定匯率計算成長 21.1%。 ，成長22.9%。我們對跨特許經營權和地區的國際業務持續強勁感到興奮，並看到整個 2024 年加速成長的途徑。主要由產品和地理組合以及營運效率驅動。

Now moving on to operating expenses for the quarter. For comparability of operating costs, my remarks will exclude the $4 million gain on legal settlement recorded as an offset to SG&A in the first quarter of 2023. Operating expenses increased $12.8 million or 16.1% from $79.4 million in the first quarter of 2023 to $92.2 million in the first quarter of 2024. Overall, the change was a result of our continued investments in research and development activities, which increased approximately 29% from the first quarter 2023, reflecting robust enrollment in our LeAAPS clinical trial and progress on several research and product development initiatives.

現在轉向本季的營運費用。為了營運成本的可比性，我的言論將排除2023 年第一季SG&A 抵銷的400 萬美元法律和解收益。 ，即16.1% 2024 年第一季。組以及多項研究和產品的進展發展措施。

We saw leverage within SG&A as expenses increased by approximately 13% from the first quarter of 2023. And as we navigate the remainder of 2024, we will prioritize investments in research and development to ensure a future of -- with an enhanced pipeline of products and clinical evidence, balanced with our commitment to realize increasing economies of scale to expand profitability.

我們看到 SG&A 內部的槓桿率比 2023 年第一季增加了約 13%。實現規模經濟以擴大獲利能力的承諾相平衡。

Now turning to the bottom line. We drove adjusted EBITDA of $2.8 million for the first quarter 2024 compared to adjusted EBITDA of $1.9 million for the first quarter of 2023 for an increase of approximately 46%. Our loss per share was $0.28 in the first quarter of 2024 compared to a loss per share of $0.14 in the first quarter 2023, while the adjusted loss per share each period was $0.25 and $0.23, respectively.

現在轉向底線。 2024 年第一季調整後 EBITDA 達到 280 萬美元，而 2023 年第一季調整後 EBITDA 為 190 萬美元，成長約 46%。 2024 年第一季的每股虧損為 0.28 美元，而 2023 年第一季的每股虧損為 0.14 美元，而每個期間調整後的每股虧損分別為 0.25 美元和 0.23 美元。

We ended the first quarter with $106 million in cash and investments, reflecting our normal pattern of a heavy burn -- heavy first quarter burn driven by share vesting, variable compensation payments and operational needs. We expect to generate positive cash flows for the remainder of 2024, resulting in a modest overall burn for the year, which is consistent with our guidance earlier this year. We remain in a very solid position with our balance sheet to fund the current and future operating needs of the business.

第一季結束時，我們有 1.06 億美元的現金和投資，這反映了我們嚴重燒錢的正常模式——由股票歸屬、可變薪酬支付和營運需求驅動的第一季嚴重燒錢。我們預計 2024 年剩餘時間內將產生正現金流，導致今年整體支出適度，這與我們今年稍早的指導一致。我們的資產負債表仍然處於非常穩固的地位，可以為企業當前和未來的營運需求提供資金。

And now closing with our outlook for 2024. As Mike mentioned, we are reiterating our expectations for full year revenue of $459 million to $466 million, reflecting growth of 15% to 17% over the full year 2023. Underlying procedure trends and the operating environment remains stable in our key markets worldwide. Therefore, we expect to see sequential revenue growth from the first to second quarter that is in line with historical seasonality in our business. In other words, we expect to see mid-single-digit to upper single-digit growth on a sequential basis.

現在結束我們對 2024 年的展望。我們在全球主要市場保持穩定。因此，我們預計第一季到第二季的營收將連續成長，這與我們業務的歷史季節性相符。換句話說，我們預期環比將出現中個位數到高個位數的成長。

From a margin perspective, we continue to expect 2024 gross margin to be in line with 2023 gross margin with the potential for varying impacts from cost savings initiatives, product and geographic mix.

從利潤率角度來看，我們繼續預期 2024 年毛利率將與 2023 年毛利率保持一致，但成本節約措施、產品和地理組合可能會產生不同的影響。

As I stated earlier in my comments and on previous calls, our primary focus with capital allocation is to incubate the next set of growth drivers for AtriCure. Therefore, we expect to maintain R&D as a percentage of revenue at roughly 19% to 20% in 2024. Our spending across SG&A will moderate in proportion to revenue as the year progresses, providing leverage and sustained improvement to profitability.

正如我之前在評論和先前的電話會議中所說，我們資本配置的主要重點是為 AtriCure 孵化下一組成長動力。因此，我們預計到2024 年，研發費用佔收入的比例將保持在19% 至20% 左右。槓桿作用並持續改善獲利能力。

With this in mind, we are reiterating our expectations for full year 2024 adjusted EBITDA of $26 million to $29 million, translating to an adjusted loss per share of approximately $0.74 to $0.82. We expect the remaining improvement to full year 2024 adjusted EBITDA over full year 2023, will occur in the third and fourth quarters of 2024, largely based on timing and expansion of R&D costs from the comparable quarters in 2023.

考慮到這一點，我們重申 2024 年全年調整後 EBITDA 為 2,600 萬至 2,900 萬美元的預期，相當於調整後每股虧損約 0.74 至 0.82 美元。我們預計 2024 年全年調整後 EBITDA 較 2023 年全年的剩餘改善將出現在 2024 年第三和第四季度，這主要基於 2023 年可比季度的研發成本的時間表和擴張。

Overall, the first quarter 2024 results demonstrate that the strength and depth of our product portfolio. We are extremely pleased with our performance and the advancements of many impactful initiatives across the globe along with increasing profitability in 2024.

總體而言，2024 年第一季的業績證明了我們產品組合的實力和深度。我們對我們的業績以及全球許多有影響力的舉措的進展以及 2024 年盈利能力的提高感到非常滿意。

Now I will turn the call back to Mike.

現在我將把電話轉回給麥克。

Thank you, Angie. We have begun 2024 on a solid footing across our business with strong growth on both top and bottom line while delivering on many key product and clinical milestones, which will drive growth for years to come. I would like to thank the entire AtriCure team for your commitment to our patient-first mission. Continue to live our values every day as we work together to build an even brighter future for our business. We have the unique opportunity to both advance and further expand our markets as we work to heal the lives of those affected by Afib and pain after surgery.

謝謝你，安吉。 2024 年伊始，我們的業務已打下堅實的基礎，營收和利潤均實現強勁增長，同時實現了許多關鍵產品和臨床里程碑，這將推動未來幾年的成長。我要感謝整個 AtriCure 團隊對我們病人至上使命的承諾。每天繼續實踐我們的價值觀，共同努力為我們的企業打造更光明的未來。當我們致力於治癒心房顫動和手術後疼痛患者的生活時，我們擁有獨特的機會來推進和進一步擴大我們的市場。

And with that, I'll turn it over to the operator for questions.

然後，我會將其轉交給接線員詢問。

(Operator Instructions) Our first question comes from Robbie Marcus with JPMorgan.

（操作員說明）我們的第一個問題來自摩根大通的 Robbie Marcus。

Great. Congrats on a good quarter here. Maybe I could start on the guidance. You beat revenue versus The Street by $2 million. Looks like missed EBITDA just slightly by $1 million yet kept guidance on the top line reiterated for the year. So maybe just walk us through the thought process there and how you're thinking about the guidance in light of the first quarter.

偉大的。恭喜您度過了一個美好的季度。也許我可以開始指導。您的收入比《華爾街日報》高出 200 萬美元。看起來 EBITDA 只略微少了 100 萬美元，但仍重申了今年的營收指引。因此，也許請向我們介紹那裡的思考過程，以及您如何根據第一季的情況考慮指導意見。

Thanks, Robbie. I'd say it's still pretty early in the year. And while we're really pleased with the results of the first quarter, I felt like it was prudent to keep the guide in place. Mike walked through several new product introductions in his comments as well as increasing penetration of the market throughout the year as really the big growth drivers as we operate through the remainder of 2024, and we're seeing really robust momentum in our international business as well, which gives us good confidence in the ability to deliver and perform through the remainder of the year. So it just felt like it was early in the year and prudent to keep the guide where we were at.

謝謝，羅比。我想說現在還太早。雖然我們對第一季的結果非常滿意，但我認為保持指南不變是謹慎的做法。麥克在評論中介紹了幾款新產品的推出，以及全年市場滲透率的不斷提高，這確實是我們在 2024 年剩餘時間內運營的巨大增長動力，而且我們也看到了我們國際業務的強勁勢頭，這讓我們對今年剩餘時間的交付和執行能力充滿信心。所以感覺現在還為時過早，謹慎地將指南保留在我們現在的位置。

Got it. You talked a bit about AtriClip and the competitor out in the market. I was hoping you could go into that a little more. When I look at the results, it's the one line item where you didn't beat in the first quarter, there is obviously a lot of concern out in the market. So I was hoping you could walk through your expectations for that line item for the rest of the year and what you're seeing competitively out in the market.

知道了。您談到了 AtriClip 和市場上的競爭對手。我希望你能多談一點。當我查看結果時，這是第一季沒有擊敗的一個項目，市場顯然有很多擔憂。因此，我希望您能詳細介紹一下您對該訂單項目在今年剩餘時間的期望以及您在市場上看到的競爭情況。

Yes, I think we're going to tag team on that one, Robbie. So I appreciate the question. I know that it's top of mind for a lot of investors. I'll start with just kind of what we're seeing out in the field. As I mentioned in my comments, we definitely see the competition in a lot of sites trialing the competition out there. We're not seeing any kind of massive shift in any kind of market share from that standpoint, but we definitely see them in the field. Our team has done a really nice job of understanding what's happening at every one of the accounts. But they've also got relationships at a variety of different accounts around the country.

是的，我想我們要在那個問題上標記團隊，羅比。所以我很欣賞這個問題。我知道這是很多投資人最關心的問題。我將從我們在現場看到的情況開始。正如我在評論中提到的，我們確實在許多嘗試競爭的網站中看到了競爭。從這個角度來看，我們沒有看到任何類型的市場份額發生任何巨大的變化，但我們確實在該領域看到了它們。我們的團隊在了解每個帳戶的情況方面做得非常出色。但他們也在全國各地的各種不同帳戶上建立了關係。

That being said, as I mentioned in my comments, I feel really confident in both our product that exists today, which we think is, by far, the best in the market. It's a great product that has been proven from both a safety and efficacy standpoint. I believe most customers understand and believe that, but they're going to try it. I mean, they're human beings, physicians like to try new things, and we definitely see sites trying out the new product because they want to kind of see what else is on the market.

話雖這麼說，正如我在評論中提到的，我對我們現有的產品非常有信心，我們認為這是迄今為止市場上最好的產品。這是一款出色的產品，從安全性和功效的角度都得到了證明。我相信大多數客戶都理解並相信這一點，但他們會嘗試。我的意思是，他們是人，醫生喜歡嘗試新事物，我們肯定會看到網站嘗試新產品，因為他們想看看市場上還有什麼。

As I mentioned in my comments, it's really important to understand that I think this drives great conversation. They're going to get some market share on it. Obviously, we understand that, but it drives discussion about managing the appendage. It drives discussion about the guidelines that just came out from both STS and AHA and ACC recently an era over in Europe that say you must treat the appendage every time someone has Afib. And obviously, there's a great way to treat the appendage with the AtriClip. So it drives a really good conversation around treatment of the appendage and then leads into the conversation around.

正如我在評論中提到的，了解我認為這會推動良好的對話非常重要。他們將獲得一些市場份額。顯然，我們理解這一點，但它引發了有關管理附肢的討論。它引發了有關 STS、AHA 和 ACC 最近在歐洲剛發布的指南的討論，該指南規定，每次有人患有心房顫動時，都必須治療附肢。顯然，有一種用 AtriClip 治療附肢的好方法。因此，它引發了一場圍繞附肢治療的非常好的對話，然後引發了周圍的對話。

Well, we've got this trial, and we're getting sites up and running. As you heard, we've got 77 sites up and running on our LeAAPS trial from that standpoint. So yes, we're seeing competition out there. We definitely see them in the field and we see people trialing their product. But overall, I think that we're in a really good position. You saw it in our numbers with over 15% growth on our open part of our business.

好吧，我們已經進行了這次試驗，並且我們正在啟動並運行網站。正如您所聽到的，從這個角度來看，我們已經有 77 個站點在 LeAAPS 試驗中啟動並運行。所以，是的，我們看到了競爭。我們確實在現場看到他們，也看到人們在試用他們的產品。但總的來說，我認為我們處於一個非常好的位置。您可以從我們的資料中看到這一點，我們的開放業務部分成長了 15% 以上。

I'll let Angie talk a little bit more maybe about kind of how we're projecting and looking at the rest of the year as well.

我會讓安吉多談談我們如何預測和展望今年剩餘時間。

Yes. So our guidance for the full company is a growth rate of 15% to 17% for the full year. I think that being said, we understand that there may be some fluctuations in different areas. But as a business over a very long track record, we've been able to deliver high growth from the business overall. And our expectations where we started the year, that each component of the business, each of our franchises would start to converge around that corporate growth rate. We still feel like that is intact at this point in time.

是的。因此，我們對整個公司的指導是全年成長率為 15% 至 17%。我認為話雖這麼說，我們理解不同領域可能會有一些波動。但作為一家有著悠久歷史的企業，我們能夠實現整體業務的快速成長。我們的期望是，從今年開始，業務的每個組成部分、我們的每個特許經營權都將開始圍繞公司成長率趨同。目前我們仍然覺得這一點完好無損。

I think very different from our expectations last year in 2023, where we knew that there would be some areas, some particular franchises that have very outsized growth and then others that may be behind, we feel like still each area of the business converging around that kind of overall corporate growth rate. So the pressure that you see in the U.S. appendage management number in the first quarter, just to frame this up.

我認為這與我們去年對2023 年的預期有很大不同，當時我們知道某些領域、一些特定的特許經營業務會出現非常大的增長，而其他業務可能會落後，我們覺得業務的每個領域仍然圍繞著這個成長點企業整體成長率。所以你在第一季美國肢體管理數字中看到的壓力只是為了說明這一點。

About 75% of our U.S. appendage management revenue is in our open chest setting. The remaining 25% is in a minimally invasive setting, and we're still seeing nice and strong attachment to our hybrid procedures. But where we've got the competitive device. Like Mike said, we grew 15.4% in the first quarter. It saw really outsized pressure from a reduction in our LARIAT system revenue as well as some transition on our MIS AtriClip revenue, which brought the overall U.S. appendage management revenue growth rate down for the quarter.

我們美國肢體管理收入的約 75% 來自我們的開胸機構。剩下的 25% 處於微創環境中，我們仍然看到人們對我們的混合手術有良好而強烈的依戀。但我們擁有有競爭力的設備。正如麥克所說，我們第一季成長了 15.4%。我們的 LARIAT 系統收入減少以及 MIS AtriClip 收入的一些轉變確實帶來了巨大的壓力，這導致本季度美國附屬器管理整體收入成長率下降。

Appreciate it.

欣賞它。

Thank you. Our next question comes from William Plovanic with Canaccord Genuity.

謝謝。我們的下一個問題來自 Canaccord Genuity 的 William Plovanic。

Yes, great. I was wondering just a little bit more on the LARIAT, I think that's been a business. Have you discontinued that product in the U.S.? Is that going away? Or is that a one quarter kind of deal? And then just competitively, have you seen any change in pricing or bundling strategy in terms of the Penditure device. And then just since we're around that, Mike, how do you think about long-term growth in the LAA market today? Is this going to be a 50% grower at 20% -- 15% grower, 20% grower? And I'm talking about the U.S.

對，很好。我對 LARIAT 有更多的疑問，我認為這是一門生意。你們在美國已經停產該產品了嗎？那會消失嗎？或者說這是四分之一的交易？然後就競爭對手而言，您是否看到 Penditure 設備的定價或捆綁策略有任何變化。麥克，既然我們已經討論了這個問題，您如何看待當今 LAA 市場的長期成長？這將是 50% 的種植者還是 20% - 15% 的種植者，還是 20% 的種植者？我說的是美國

Yes. I'll start on the first one. So -- because I think there are three different questions in there. So the first was about LARIAT. As you know, back several years ago, when we did the readout on the trial, while the device actually worked incredibly well for closure, it actually had better closure than any percutaneous device on the market today and also had a great safety record in the trial. And if you recall, it was a 600-patient trial. It did not meet the endpoint of reducing Afib. It reduced Afib by 4.3%, and we needed to hit about 8% in order to win the trial and have superiority.

是的。我將從第一個開始。所以——因為我認為其中有三個不同的問題。第一個是關於 LARIAT 的。如您所知，幾年前，當我們在試驗中進行讀數時，雖然該設備的閉合效果實際上非常好，但它實際上比當今市場上的任何經皮設備具有更好的閉合效果，並且在該領域也擁有良好的安全記錄。如果你還記得的話，這是一項有 600 名患者參加的試驗。它沒有達到減少心顫的終點。它使心顫降低了 4.3%，我們需要達到 8% 左右才能贏得審判並擁有優勢。

So as a result, the product has still been on the market under the 510(k) that it was originally on. People continue to use it, but we weren't adding any net new sites. And so what you're seeing now with LARIAT is we're trying to evaluate what our next steps. We know this product is an exceptional product. It works very well. It is a product that does not get left in the bloodstream like you do on the other percutaneous catheter market. But we've got to consider what are our next steps with that product and likely would have to run a stroke trial, and I'm not saying we are going to, that would have to be the logical thing for someone to consider with it at some point in time.

因此，該產品仍然按照最初的 510(k) 規定在市場上銷售。人們繼續使用它，但我們沒有添加任何新網站。因此，您現在在 LARIAT 上看到的是，我們正在嘗試評估我們的後續步驟。我們知道該產品是一款出色的產品。它運作得很好。該產品不會像其他經皮導管市場上那樣留在血液中。但我們必須考慮該產品的下一步是什麼，並且可能必須進行中風試驗，我並不是說我們會這樣做，這對於有人考慮使用它來說必須是合乎邏輯的事情在某個時間點。

We're not shutting it down because it is being used. That being said, the pressure is as you've seen in this market, it's not a lot of revenue. But as you've seen in this market, you've got new products coming on that are in trials. So there was a product called conformal and then also the Laminar just came out. So many sites are now getting involved in new trials on the new devices that are coming out. And my -- our suspicion is that you're seeing a little bit of pressure on that because it's not a lot and the sites that we're using our products tended to be the more advanced sites that are out there that would tend to be part of some trials like that. So we think that's kind of where maybe some of that pressure is happening on the LARIAT product. We're not promoting it. We're not pushing it in the market, but we have not shut it down either.

我們不會因為它正在被使用而關閉它。話雖這麼說，正如您在這個市場上看到的那樣，壓力並不是很大的收入。但正如您在這個市場上看到的那樣，您已經推出了正在試用的新產品。於是就有了一種叫做 Conformal 的產品，然後 Laminar 也剛問世。現在許多網站都在參與即將推出的新設備的新試驗。我的——我們的懷疑是，你會看到一點壓力，因為壓力不是很大，而且我們使用我們產品的網站往往是更先進的網站，而這些網站往往是類似的一些試驗的一部分。所以我們認為這可能是 LARIAT 產品面臨一些壓力的地方。我們不是在宣傳它。我們不會將其推向市場，但我們也沒有關閉它。

As it relates to kind of the kind of market dynamics, we're seeing good, consistent pricing in the market and feel really good about that from that standpoint. We think it makes a lot of sense from that standpoint. And then finally, as we look at the long-term rates for appendage management, I'm not going to give a specific number, but there's a reason we're running the LeAAPS trial.

由於它與某種市場動態有關，我們看到市場上有良好、一致的定價，從這個角度來看，我們對此感覺非常好。我們認為從這個角度來看，這是很有意義的。最後，當我們研究肢體管理的長期費率時，我不會給出具體數字，但我們進行 LeAAPS 試驗是有原因的。

The LeAAPS trial is about close to tripling maybe quadrupling the size of the overall market for people that can get their appendage managed, that full 1 million patients around the globe that are undergoing cardiac surgery, we believe the LeAAPS trial will demonstrate if you put an AtriClip on those patients prophylactically or even when they're in Afib, but prophylactically in the trial that you are going to reduce their stroke rate in their incidence of strokes. And we think that will be a big global trend that will happen once that product reads out. That should longer term, drive significant growth out of the appendage management business for a very long period of time.

LeAAPS 試驗將使能夠管理肢體的患者整體市場規模增加近三倍甚至四倍，全球有 100 萬正在接受心臟手術的患者，我們相信 LeAAPS 試驗將證明，如果您將AtriClip 對這些患者進行預防性治療，甚至當他們患有心房顫動時，但在試驗中預防性地降低他們的中風發生率。我們認為，一旦該產品問世，這將成為一個全球大趨勢。從長遠來看，這應該會在很長一段時間內推動附屬物管理業務的顯著成長。

And so without giving a specific number, we do see that this market is less than 20% penetrated in the U.S. when you kind of calculate all those patients and less than really between 5% and 10% on a global basis. So a long way to go without giving a specific growth rate, Bill.

因此，在沒有給出具體數字的情況下，我們確實看到，當你計算所有這些患者時，這個市場在美國的滲透率還不到20%，而在全球範圍內，這個市場的滲透率實際上上不到5% 到10%。因此，如果不給出具體的成長率，還有很長的路要走，比爾。

Great. And then a follow-up, if I could, on EPi-Sense. Has PFA been a distraction, the EPi-Sense number was great. So the question we've been getting asked from investors is, is PFA going to be a distraction as those EPs adopt PFA and it makes it harder for you to kind of get in there and get those new accounts because they're focused on getting trained on other technologies. And then on PFA, what product are you targeting first with PFA in your own portfolio?

偉大的。如果可以的話，然後在 EPi-Sense 上進行後續報導。 PFA 是否會分散人們的注意力，EPi-Sense 的數字非常好。因此，投資者向我們提出的問題是，PFA 是否會分散注意力，因為這些 EP 採用 PFA，這會讓你更難進入那裡並獲得這些新帳戶，因為他們專注於獲得接受過其他技術培訓。然後，關於 PFA，您在自己的產品組合中首先使用 PFA 瞄準什麼產品？

Sure. As it relates to the catheter-based PFAs and the excitement that's out there. As I mentioned in my comments, we think it's actually engaging conversations. It's allowing us to have conversation with EP that maybe we weren't having before. We've got several sites, as I mentioned, that are now actually using PFA in the convergent procedure. So it's not actually having an impact on us in terms of getting and setting up new sites or any kind of major distraction from that standpoint. It really actually drives good discussion and conversation around, well, how would PFA work in a hybrid type setting, and so there's a lot of discussion about that.

當然。因為它與基於導管的 PFA 和令人興奮的事物有關。正如我在評論中提到的，我們認為這實際上是一種引人入勝的對話。它讓我們能夠與 EP 進行以前可能沒有過的對話。正如我所提到的，我們有幾個網站現在實際上在收斂過程中使用 PFA。因此，從這個角度來看，它實際上並沒有對我們獲取和建立新網站或任何重大干擾產生影響。它確實引發了圍繞 PFA 如何在混合類型環境中工作的良好討論和對話，因此對此有很多討論。

And so we believe that discussion and awareness is good. Remember, PFA is an efficiency gain more than anything else when you look at the data and the results from all those companies. CONVERGE is an efficiency gain in terms of you reduce the time that someone has to do an ablation when they go in. So you've got double efficiency gains. People recognize the importance of that, and that's actually been a lot and a big part of the conversation relative to that. I know there was a second part of the conversation.

因此，我們相信討論和認識是好的。請記住，當您查看所有這些公司的數據和結果時，PFA 比其他任何東西都更能提高效率。 CONVERGE 是一種效率增益，可以減少某人進入時必須進行消融的時間。人們認識到這一點的重要性，這實際上是與之相關的對話的很大一部分。我知道談話還有第二部分。

It was PFA general for your own portfolio, what's the first product?

這是您自己的產品組合的 PFA 一般，第一個產品是什麼？

Yes. I mean, we think PFA can fit really well into every one of our technologies, very well as an option for people to utilize. As we've mentioned on this call before, we've definitely got programs underway and are making really good progress on that front, and it would be across pretty much our entire portfolio of products.

是的。我的意思是，我們認為 PFA 可以很好地融入我們的每項技術，非常適合人們使用。正如我們之前在這次電話會議中提到的，我們確實已經在進行一些計劃，並且在這方面取得了非常好的進展，而且這幾乎將涵蓋我們的整個產品組合。

Thank you. Our next question comes from Rick Wise with Stifel.

謝謝。我們的下一個問題來自 Stifel 的 Rick Wise。

Mike, Angie, this is John on for Rick today. First question, just curious about price in the quarter and also in the year ahead, you have several product launches. Just curious how it might have factored into growth here and how you're looking at it for the rest of the year?

麥克、安吉，今天我是約翰為瑞克代言。第一個問題，只是對本季和未來一年的價格感到好奇，你們有幾款產品發表會。只是好奇它如何影響這裡的成長以及您如何看待今年剩餘時間的成長？

John, when you think about a couple of the product launches that we outlined on the call, I think we've said the cryoSPHERE+, the newest technology that we're in the process of a limited launch currently in our pain management business, we would expect that to launch at similar pricing to the device that's on the market today.

約翰，當你想到我們在電話會議中概述的幾個產品發佈時，我想我們已經說過了 CryoSPHERE+，這是我們目前在疼痛管理業務中正在有限推出的最新技術，我們預計該設備的推出價格與目前市場上的設備類似。

There's a time savings benefit. We do think that most accounts will migrate over to this, and there's actually a cost savings benefit to the company. It's a better gross margin profile, but keeping the price the same on that. So not going to be a big driver of growth throughout the year.

有一個節省時間的好處。我們確實認為大多數帳戶都會遷移到此，並且實際上對公司有節省成本的好處。這是一個更好的毛利率，但價格保持不變。因此，不會成為全年成長的主要推動力。

I'd say AtriClip Flex Mini, which would be kind of next step in terms of the launch to be determined at a future date when we're closer to the launch on that, the way that we're thinking about this, though, from how that factored into the guide is just looking for the impact from a volume perspective and not an uplift on a pricing perspective.

我想說的是 AtriClip Flex Mini，這將是下一步的發布，將在我們接近發佈時確定，不過，我們考慮這個問題的方式，從如何將其納入指南來看，只是從數量角度尋找影響，而不是從定價角度來看的提升。

With a couple of the products in our European markets where we've gotten premiums in the U.S., the strategy would be the same when we launched the EnCompass Clamp in Europe, it would be at a higher price than our existing devices. So that's been factored into kind of the outlook again, minimal quantities in 2024 more impactful in 2025, but that has been factored into the overall guide. So taking a step back when you look at the quality of growth for 2024, we believe most of this is driven by just sheer volume growth as we continue to penetrate each of our markets.

我們在歐洲市場上的一些產品在美國獲得了溢價，我們在歐洲推出 EnCompass Clamp 時的策略是一樣的，它的價格會比我們現有的設備更高。因此，這再次被納入展望中，2024 年的最低數量對 2025 年的影響更大，但這已納入總體指南中。因此，當您審視 2024 年的成長品質時，我們認為，隨著我們繼續滲透各個市場，這大部分是由純粹的銷售成長所推動的。

Great. That's helpful. And just a follow-up. You talked about starting up the first LeAAPS site in Europe. I was just curious, you saw pretty strong growth again, OUS in the appendage management business. I'm just curious maybe how LeAAPS can help get the OUS business potentially growing faster, more sites interested. Just sort of any thoughts there on appendage management outside the U.S.

偉大的。這很有幫助。只是後續行動。您談到了在歐洲建立第一個 LeAAPS 網站。我只是很好奇，您再次看到了 OUS 在附肢管理業務中的強勁成長。我只是好奇 LeAAPS 如何幫助 OUS 業務成長得更快，讓更多網站感興趣。只是對美國以外的附屬物管理有什麼想法嗎？

Yes, I think when we think about long term the impact of LeAAPS, the reason we're doing a global trial and including both Europe and Asia in the trial, we're trying to get them up and running fast because it's enrolled so fast in the U.S. is because we do want to make the standard of care changes everywhere around the globe. That's what this trial is meant to be. It's one of the reasons the trial is so large.

是的，我認為當我們考慮 LeAAPS 的長期影響時，我們正在進行全球試驗並將歐洲和亞洲納入試驗的原因，我們正在努力讓它們快速啟動並運行，因為它的註冊速度如此之快在美國是因為我們確實希望改變全球各地的護理標準。這就是這次審判的目的。這是試驗規模如此之大的原因之一。

And so we're really excited about getting Europe up and running now and hopefully within the next 3 to 6 months, getting some sites in Asia as well. So they can be truly an international trial on that front. And we believe that's going to change adoption rates around the globe. As I mentioned, it's only like 5% penetrated around the globe. And so if we can prove stroke reduction in this patient population, that's obviously a significant benefit for society and for those patients, which we believe can change payer practices in countries throughout the world. And that is one of the reasons that we're doing that trial. So I do think that, that's going to be a critical piece for us to change care is the LeAAPS trial overall.

因此，我們對現在在歐洲啟動並運行感到非常興奮，並希望在接下來的 3 到 6 個月內，在亞洲也獲得一些站點。因此，它們可以成為這方面真正的國際試驗。我們相信這將改變全球的採用率。正如我所提到的，全球只有 5% 左右的滲透率。因此，如果我們能夠證明該患者群體的中風減少，這顯然對社會和這些患者有重大好處，我們相信這可以改變世界各國的付款方式。這就是我們進行該試驗的原因之一。所以我確實認為，整個 LeAAPS 試驗將成為我們改變護理的關鍵部分。

In the short term, what we're seeing is the recognition with all the guideline changes that you've seen, first, the guidelines in the U.S. and then now [Era] just came out recently where they made a Class 1A guideline that you must manage the appendage, it's basically telling everybody that they need to increase that. I believe that guideline changes that we've seen over the last 12 months will probably have a more dramatic effect on our business OUS, just because they're so lowly penetrated at this point in time. It takes time though because they've got to work out reimbursement by country and things like that. But I do believe that there's the potential to have some impact based on those guideline changes.

在短期內，我們看到的是對您所看到的所有指南變更的認可，首先是美國的指南，然後現在 [Era] 最近剛剛發布，他們制定了 1A 級指南，您可以在必須管理附肢，這基本上是告訴每個人他們需要增加它。我相信，我們在過去 12 個月中看到的指導方針變化可能會對我們的業務 OUS 產生更顯著的影響，因為它們目前的滲透率很低。但這需要時間，因為他們必須按國家和類似的事情來計算報銷。但我確實相信這些指導方針的變化有可能產生一些影響。

One moment for our next question. Our next question comes from Marie Thibault with BTIG.

請稍等一下我們的下一個問題。我們的下一個問題來自 BTIG 的 Marie Thibault。

I want to revisit the LARIAT and AtriClip discussion, just to try to triangulate some of the numbers you offered us. It looks like LARIAT and minimally invasive AtriClip were flat growth year-over-year at about $9 million of the U.S. appendage management revenue this quarter. And then AtriClip in the open setting, which is where we're seeing the competition was about $27 million, which grew 15.5% you said. Do those numbers sound about right to you?

我想重新審視 LARIAT 和 AtriClip 的討論，只是為了嘗試對您提供給我們的一些數字進行三角測量。看起來 LARIAT 和微創 AtriClip 年成長平穩，本季美國附器管理收入約 900 萬美元。然後是開放環境中的 AtriClip，我們看到競爭的金額約為 2700 萬美元，您說增長了 15.5%。這些數字聽起來合適嗎？

And then secondly, is that the right way to think about kind of a similar breakdown and growth trend for those two parts for the rest of the year, mid-teens in the open AtriClip and then flat in other appendage management. Just want to make sure that we understand some of those puts and takes.

其次，這是考慮今年剩餘時間這兩個部分類似的細分和成長趨勢的正確方法，在開放的 AtriClip 中為青少年，然後在其他附屬物管理中持平。只是想確保我們理解其中的一些內容。

Marie, you are directionally correct on the revenue components. The open AtriClip business just under $28 million and the MIS appendage management business, a little over $8 million for the quarter at the -- close to $36 million for the quarter. We did actually see our MIS appendage management business go down. That is largely driven by the LARIAT product. Our Q1 of last year was kind of an outsized quarter, and we have just very few customers. So activity within a pretty small base of customers can skew the results there. And following a pretty strong fourth quarter for our MIS AtriClip, we saw a bit of softness in that area of the business in the first quarter.

瑪麗，你對收入組成部分的方向是正確的。本季開放的 AtriClip 業務略低於 2,800 萬美元，MIS 肢體管理業務略高於 800 萬美元，接近 3,600 萬美元。我們確實看到我們的 MIS 肢體管理業務正在下降。這主要是由 LARIAT 產品推動的。我們去年的第一季是一個過大的季度，而且我們的客戶很少。因此，一小部分客戶的活動可能會影響結果。在我們的 MIS AtriClip 在第四季度表現相當強勁之後，我們在第一季看到該業務領域出現了一些疲軟。

I'd say longer term, would expect LARIAT to not be a big driver behind fluctuations either to the positive or negative just based on the comparable quarters in 2023. And when we think about our MIS AtriClip business, we're still seeing really strong attachment in our hybrid procedures and would expect as you continue to see strong results within our MIS ablation business for that to be a bit of a carry. But in the longer term, I think you'll see probably more of what we've seen in the past from that particular franchise, meaning our appendage management franchise. The growth typically has been driven more by the open side of the business, but I think that there's a pathway given the adoption and trends that we're seeing in MIS ablation to see an uplift on our MIS AtriClip in the future.

我想說的是，從長遠來看，僅根據2023 年的可比季度，預計LARIAT 不會成為正向或負向波動背後的主要推動因素。非常強勁的表現附件在我們的混合程序中，並且隨著您繼續在我們的 MIS 消融業務中看到強勁的成果，您會期望這會有所幫助。但從長遠來看，我認為你可能會看到更多我們過去從該特定特許經營權中看到的東西，這意味著我們的附屬物管理特許經營權。成長通常更多是由業務的開放性所推動的，但我認為，考慮到我們在 MIS 消融中看到的採用和趨勢，未來我們的 MIS AtriClip 將會有所提升。

Okay. That's really helpful, Angie. And then I want to ask about open ablation. That segment was, again, really strong here in the U.S. I think, as of the latest about half or more of it was -- of the U.S. business was EnCompass Clamp. Can you give us an update on the pace of adoption of that new-ish system? It does seem like there's more runway ahead, and I recall there was some price uplift as well. But just wondering where you are in the adoption curve and what growth drivers are there for the volume side?

好的。這真的很有幫助，安吉。然後我想問一下開放性消融的情況。我認為，該細分市場在美國非常強大，截至最近，大約一半或更多的美國業務是 EnCompass Clamp。能為我們介紹一下這個新系統的採用進度嗎？看來前面確實有更多的跑道，而且我記得價格也有所上漲。但只是想知道您處於採用曲線的哪個位置以及數量方面有哪些成長動力？

All right. So another great product here with the EnCompass Clamp that you are -- it's still a little bit under 50% of the revenue in the first quarter. And we think we're still in pretty early innings when it comes to adoption. Our EnCompass Clamp for the quarter, over 450 accounts were users of that device, up from the fourth quarter and up from each quarter in 2023.

好的。 EnCompass Clamp 是另一款出色的產品，但它仍略低於第一季收入的 50%。我們認為在採用方面我們仍處於早期階段。我們的 EnCompass Clamp 本季有超過 450 個帳戶是該設備的用戶，比第四季度和 2023 年每個季度都有所增加。

When you think about the kind of number of accounts that we've got in the U.S. in terms of users on our open side, still plenty of accounts to bring this to. And I'd say even within existing accounts, plenty of doctors, surgeons that we could be using the product as well. So that we're really targeting in terms of our efforts on the EnCompass Clamp rollout. The open chest market, so our cardiac surgery market still remains vastly underpenetrated. So while we've seen great traction with this device, we sit here today and say there's still plenty of room to grow and are really targeting on new users and making sure that adoption happens for every patient that's on the table. Thank you.

當你考慮一下我們在美國擁有的開放用戶帳戶數量時，仍然有很多帳戶可以使用。我想說，即使在現有的帳戶中，很多醫生、外科醫生我們也可以使用該產品。因此，我們真正的目標是推出 EnCompass Clamp。開胸市場，因此我們的心臟手術市場仍然嚴重不足。因此，雖然我們已經看到了該設備的巨大吸引力，但我們今天坐在這裡表示，仍有很大的成長空間，並且真正針對的是新用戶，並確保每位患者都能採用。謝謝。

Thank you. Our next question comes from Matthew O'Brien with Piper Sandler.

謝謝。我們的下一個問題來自馬修·奧布萊恩和派珀·桑德勒。

This is (inaudible). First, if we could ask a little bit more about the guidance and what that implies for the rest of the year? And then also maybe what we can expect sequentially throughout the rest of '24?

這是（聽不清楚）。首先，我們是否可以多問一些有關該指導意見的問題以及這對今年剩餘時間意味著什麼？然後也許我們可以在 24 年剩下的時間裡依次期待什麼？

[Sam], we caught the back part of your question. Can you repeat the first part?

[Sam]，我們聽到了你問題的後半部。你能重複一下第一部分嗎？

Sure. Yes. I guess I'm just asking about what guidance implies for the rest of the year.

當然。是的。我想我只是想知道今年剩餘時間的指導意味著什麼。

Okay. Sorry. Thanks for repeating that. Like we said in my prepared comments, our expectation is just given I'd say the stability that we're seeing in end user markets, both in the U.S. and internationally that we would expect some of the historical patterns that you've seen in the business in the past to be present when you think about sequential growth. So that means kind of mid- to upper single-digit growth from the first to the second quarter of 2024.

好的。對不起。感謝您重複一遍。就像我們在準備好的評論中所說的那樣，我們的期望只是給出了我想說的是，我們在美國和國際上的最終用戶市場中看到的穩定性，我們預計您會看到一些歷史模式當你考慮連續成長時，過去的業務就會出現。因此，這意味著 2024 年第一季到第二季將出現中上個位數成長。

And again, reaffirming the guidance for the full year of the 15% to 17%, driven by the full business. And as we think through that and think through those numbers, I think understand the interest in each of the components of the business and how that they'll drive. I think we've been -- you're aware that the company overall, the different growth drivers have been able to promote very robust growth of AtriCure and deliver and both meet and exceed our guidance as we operate throughout the year, and we have the same expectations as we think through out of the operations of the remainder of the year.

再次重申全年指引15%至17%，由全業務推動。當我們仔細思考並思考這些數字時，我認為了解了對業務每個組成部分的興趣以及它們將如何推動。我認為我們一直 - 你知道公司整體而言，不同的增長動力已經能夠促進 AtriCure 非常強勁的增長，並在我們全年運營中實現並超過我們的指導，並且我們已經與我們對今年剩餘時間運營的預期相同。

Great. And then just one more on the appendage management business also. I guess how long do you expect this trial in (inaudible) And I know (inaudible), you think this will help grow the market. When do you think you could see that kick in?

偉大的。然後再談一談附屬物管理業務。我猜您預計這次試驗需要多長時間（聽不清楚）而且我知道（聽不清楚），您認為這將有助於擴大市場。你認為什麼時候可以看到這種效果？

I think that trialing is going to continue on. I mean, the -- we've got a competitor in the market as we mentioned. And as everybody is well aware of, they're going to be in the market. People are going to try it. Some are going to keep using it and they're going to have some market share relative to that. But as we talked about, we did -- we grew 15% in one of our largest franchises, 15.4% in the U.S. And we haven't even kicked in a new product that's going to be introduced later on the year. And obviously, LeAAPS coming out kind of in subsequent years after that and future product iterations that we have.

我認為審判將會繼續下去。我的意思是，正如我們所提到的，我們在市場上有一個競爭對手。正如每個人都清楚的那樣，他們將進入市場。人們會去嘗試。有些人將繼續使用它，並且他們將擁有一定的市場份額。但正如我們所說，我們確實做到了——我們最大的特許經營權之一增長了 15%，在美國增長了 15.4%，而且我們甚至還沒有推出將於今年晚些時候推出的新產品。顯然，LeAAPS 會在隨後幾年以及我們未來的產品迭代中出現。

So we think that you're already starting to see a little bit of the benefit because they did get some share this quarter, and we still saw some solid robust growth relative to that. So whether or not we're going to see kind of uptick on that, we're not going to put that out there right now. I do think that the LeAAPS trial long term plus the continued innovation will drive this market out for a long period of time.

因此，我們認為您已經開始看到一些好處，因為他們本季度確實獲得了一些份額，而且我們仍然看到了相對於此的一些穩健的強勁增長。因此，無論我們是否會看到這一點有所上升，我們現在都不會把它放在那裡。我確實認為 LeAAPS 的長期試驗加上持續的創新將在很長一段時間內推動這個市場的發展。

Our next question comes from Danielle Antalffy with UBS.

我們的下一個問題來自瑞銀集團的 Danielle Antalffy。

Mike, you're going to be so sick of talking about AtriClip after Penditure after this call. But I'm going to ask one more question here. And I'd love a little bit if you could give more color on where you see the most adoption. I mean, I know Medtronic has barely any presence on the open ablation side of things, but they do have some legacy users there. Is it adoption in open procedures where an AtriCure ablation is being done? Like is it broad-based this trialing? Or is it more specific to one area versus one product than another?

Mike，在這次電話會議之後，你一定會厭倦在 Penditure 之後談論 AtriClip。但我想在這裡再問一個問題。如果您能在您看到最多採用的地方提供更多信息，我會很高興。我的意思是，我知道美敦力在開放式消融方面幾乎沒有任何存在，但他們確實有一些遺留用戶。是否在進行 AtriCure 消融的開放性手術中採用？這項試驗是否具有廣泛基礎？或者它比另一種產品更具體地針對某一領域？

And maybe to be clear, I mean they're trialing everywhere. I mean, it's all over the country. It's -- so you're definitely seeing them in markets -- in almost every market around the country. I would gather that most of it has to do with good relationships. Medtronic has some good relationships with accounts. That's probably where they've targeted first and gotten into in terms of where we've noticed. But of course it's definitely happening in procedures where AtriCure's got an ablation going on and then they're testing out and using the Medtronic product on that front, so we definitely see it there. But it's happening everywhere. I mean, they've done a full launch on it. They've talked about it. They've marketed to it. And so we see them all across the country.

也許需要澄清的是，我的意思是他們正在各地進行試驗。我的意思是，全國各地都有。所以你肯定會在全國各地的市場上看到它們。我認為這大部分與良好的人際關係有關。美敦力與客戶有一些良好的關係。根據我們注意到的情況，這可能是他們首先瞄準並進入的地方。但當然，這種情況肯定會發生在 AtriCure 進行消融的手術中，然後他們正在測試並使用美敦力（Medtronic）的產品，所以我們肯定會在那裡看到它。但這種事到處都在發生。我的意思是，他們已經全面啟動了它。他們已經討論過了。他們已經對其進行了行銷。所以我們在全國各地都能看到它們。

Okay. Got it. So it doesn't sound like there's any difference in your use in procedures being done where AtriCure open ablation is also being done. It sounds like you're seeing some dots pick up Penditure in that procedure as well.

好的。知道了。因此，聽起來您在進行 AtriCure 開放式消融術的手術中使用並沒有任何區別。聽起來您也看到一些點在過程中拾取了 Pendture。

That does happen for sure, yes.

這確實會發生，是的。

Yes. Okay. All right. And just one quick follow-up on (inaudible). I mean, another really good quarter. So just trying to get a sense of how much of this is new center add versus same-store sales. I think you guys have talked about new center adds sort of not as much of a focus more focused on driving adoption, higher at existing centers. Can you just talk about whether that continues? Are you seeing more new centers come on board? Any color there? That would be great.

是的。好的。好的。只是一個快速跟進（聽不清楚）。我的意思是，又一個非常好的季度。因此，我只是想了解新中心新增銷售額與同店銷售額的比例。我想你們已經討論過新的中心增加了一些關注點，而不是更多地關注於推動採用，而不是現有中心的關注度更高。您能談談這種情況是否會持續下去嗎？您是否看到更多新中心加入？那裡有什麼顏色嗎？那太好了。

Yes, Danielle, I'd say across the board, the new centers add very little revenue to any individual quarter and that's to a T for each of the franchises. When I think about each area of the business, we do continue to add accounts. I'd say in some places, like our pain management business at a much faster pace than other areas like our EPi-Sense accounts. That being said, we are adding new accounts just at a slower pace. So the revenue that you're seeing in the first quarter of 2024 is largely from existing customers with some incremental pieces from newer accounts that over time will become a much higher revenue contribution.

是的，丹妮爾，我想說的是，從整體上看，新中心為任何一個季度增加的收入都非常少，這對每個特許經營權來說都是一個T。當我考慮業務的每個領域時，我們確實會繼續增加帳戶。我想說的是，在某些地方，例如我們的疼痛管理業務，其發展速度比其他領域（例如我們的 EPi-Sense 帳戶）要快得多。話雖這麼說，我們新增帳戶的速度只是較慢。因此，您在 2024 年第一季看到的收入主要來自現有客戶，以及來自新客戶的一些增量部分，隨著時間的推移，這些收入將成為更高的收入貢獻。

Our next question comes from Daniel Stauder with Citizens JMP.

我們的下一個問題來自 Citizens JMP 的 Daniel Stauder。

So just my first one just on international sales. EnCompass Clamp has its European launch later this year. And then I think you said that EPi-Sense will also be introduced internationally and you're coming off a strong growth year outside the U.S. in 2023. So just wanted to ask how should we be thinking about international sales contributions this year at a high level as we modeling throughout the year?

這只是我關於國際銷售的第一個。 EnCompass Clamp 將於今年稍晚在歐洲推出。然後我想您曾說過 EPi-Sense 也將在國際上推出，並且 2023 年您將在美國以外地區迎來強勁增長。的水平？

Yes, Danny, when we look at our international business, just really pleased with the developments and the activities of that team over the past several years, leading to an accelerated growth rate. You saw that throughout 2023, and that repeated in this first quarter to start 2024. Our expectations are both of those products, the steerable EPi-Sense device. We do have the original EPi-Sense device on the market, but the steerable device, EPi-Sense ST is right now in the process of a launch. We expect that to be a nice catalyst for that business where they just have done very much fewer converged procedures. So we're hoping that, that's a nice catalyst for that area of the business.

是的，丹尼，當我們審視我們的國際業務時，我們對團隊過去幾年的發展和活動感到非常滿意，從而實現了加速的成長。您在 2023 年全年都看到了這種情況，並且在 2024 年開始的第一季重複了這種情況。我們在市場上確實有原始的 EPi-Sense 設備，但可操縱設備 EPi-Sense ST 目前正在推出。我們預計這將成為該業務的良好催化劑，他們只是做了更少的融合程序。因此，我們希望這對該業務領域來說是一個很好的催化劑。

And then the EnCompass Clamp, our hope is that, that's much later in 2024 once we've been through EU MDR approval and ready to launch on that. But our hope is that that's a really solid catalyst for our open ablation business, much like you've seen here in the U.S. I think we're all aware that pricing a bit more sensitivity in the international markets, but I think ease of use of the device in the differentiated technology give us a lot of confidence that this is going to be a really great product for that market. So longer term, we've said, look, U.S. and international generally at the same growth rates. I think you've got a lot of reasons based on historical performance and some of the catalysts in our international markets to say that, that might be bigger leading edge of growth.

然後是 EnCompass 夾，我們希望在 2024 年晚些時候，一旦我們通過了歐盟 MDR 批准並準備推出該產品。但我們希望這對我們的開放式消融業務來說是一個真正堅實的催化劑，就像您在美國看到的那樣。差異化技術讓我們充滿信心，這將成為該市場的一款真正出色的產品。我們說過，從長遠來看，美國和國際的成長率總體上是相同的。我認為，基於歷史表現和國際市場的一些催化劑，你有很多理由可以說，這可能是更大的成長前沿。

Great. And then just one follow-up on the pain management side. You've talked about the Plus and the MAX helping with the time aspect, but just wanted to ask more about progress in gaining direct reimbursement. I know there's a handful of studies in this area, but what in your mind moves the needle in terms of gaining reimbursement for these products?

偉大的。然後是疼痛管理的一個後續行動。您談到了 Plus 和 MAX 在時間方面的幫助，但只是想詢問更多有關獲得直接報銷的進展。我知道這個領域有一些研究，但您認為什麼可以推動這些產品的報銷？

I think the key to reimbursement on pain management is clinical data, clinical evidence showing a combination of cost savings in some way, whether it's length of stay or fewer calls or return visits back to the ER and hospital that happen a lot in some of these cases because of the pain that somebody experiences 2, 3, 4 weeks out, that is, quite frankly, really helped out by the use of our Cryo Nerve Block.

我認為疼痛管理報銷的關鍵是臨床數據，臨床證據表明在某種程度上可以節省成本，無論是住院時間長短還是更少的電話或回急診室和醫院的回訪（在某些情況下經常發生）案例是因為有人在2、3、4 週後經歷了疼痛，也就是說，坦白說，使用我們的冷凍神經阻斷確實有所幫助。

In addition to that, if there are studies that are being done that kind of demonstrate the true reduction in opioid use afterwards. We've seen some studies, but I think you've got to have enough studies that are out there. We funded a lot of these studies. It's going to take some time, though. We saw that in cardiac surgery. It took us about 8 years. And I know that sounds like a really long time. But through papers that were written over time, that were studied to show the benefits of treating Afib at the time of cardiac surgery. You're now starting to see CMS over the last two years increase reimbursement quite dramatically for that. And I believe the same thing will happen eventually for pain management, but we just need a lot more studies to be done, and we're helping fund a lot of those.

除此之外，如果正在進行的研究表明阿片類藥物的使用確實減少了。我們已經看到了一些研究，但我認為你必須有足夠的研究。我們資助了很多這樣的研究。不過，這需要一些時間。我們在心臟手術中看到了這一點。我們花了大約8年的時間。我知道這聽起來很長一段時間。但透過長期撰寫的論文，我們對這些論文進行了研究，以顯示在心臟手術時治療心房顫動的益處。現在您開始看到 CMS 在過去兩年中大幅增加了報銷金額。我相信疼痛管理最終也會發生同樣的事情，但我們只需要進行更多的研究，我們正在幫助資助其中的許多研究。

Our next question comes from Mike Matson with Needham & Company.

我們的下一個問題來自 Needham & Company 的 Mike Matson。

So Mike, when you were at our conference a few weeks ago, you mentioned that you were working on launching or developing, I guess, clamps that would use PFA for open ablation. I just wanted to see if you could give us an update on that, kind of any timing and what would be required? Is it a new clamp? Or is it just a new generator?

麥克，當您幾週前參加我們的會議時，您提到您正在致力於推出或開發，我猜，將使用 PFA 進行開放式消融的夾具。我只是想看看您能否提供我們最新情況、具體時間表以及需要什麼？是新的夾子嗎？或者它只是一個新的發電機？

Yes. As we did mention briefly, we have been working on -- work in that particular area. It's got a combination of generator and clamp and quite frankly, other technologies as well to be distributed across our product line. No update on timing. I mean, we believe that we need to have all of the energy sources available for our customers. And so we think PFA is an exciting new technology that we're going to make sure we have incorporated into the procedures that we've basically been a part of for many, many years.

是的。正如我們簡要提到的，我們一直在致力於該特定領域的工作。它結合了發電機和箝位器，坦白說，其他技術也分佈在我們的產品線中。沒有更新時間。我的意思是，我們相信我們需要為客戶提供所有可用的能源。因此，我們認為 PFA 是一項令人興奮的新技術，我們將確保將其納入我們多年來基本上已經參與的程序中。

Still early to give any kind of specific updates on what that looks like. A product like that's going to have to go through some clinical work and regulatory work, et cetera. So there's definitely work to be done on that front. But from a product standpoint, we've made a lot of progress.

現在就具體情況提供任何具體更新還為時過早。像這樣的產品必須經過一些臨床工作和監管工作等等。因此，這方面肯定還有很多工作要做。但從產品的角度來看，我們已經取得了很大的進展。

Okay. And then just on the LeAAPS trial. So obviously, doing really well, enrolling pretty fast. Do you -- when -- and if it's successful, do you think that it would create kind of a class effect and benefit any of the products clips that are out there? Or do you think it would really be just specific to AtriClip? I mean, I know you would be the one with indication, but for stroke or I guess, prophylactic use. But do you think that would kind of help out your competitor to any degree as well?

好的。然後就是 LeAAPS 試驗。很明顯，做得非常好，註冊速度很快。你是否——何時——如果它成功了，你認為它會產生某種階級效應並使現有的任何產品剪輯受益嗎？或者您認為它真的只是 AtriClip 特有的嗎？我的意思是，我知道你會是那個有適應症的人，但對於中風或我猜是預防性使用。但您認為這也會在某種程度上幫助您的競爭對手嗎？

Well, I mean, to your point, I mean, let's start -- I mean, we're investing in this trial because we believe it's the right thing to do for patient care for the long term. And number one, it's going to be our product exclusively use. So it's going to be a 6,500 patient trial. The product that's going to be used to get the stroke label is going to be the AtriClip. That's what we'll have the stroke label. Our competitor products would not have that.

好吧，我的意思是，就你的觀點而言，我的意思是，讓我們開始——我的意思是，我們投資這項試驗是因為我們相信從長遠來看，這對於患者護理來說是正確的事。第一，這將是我們的產品專用。因此，這將是一項涉及 6,500 名患者的試驗。用於獲取筆劃標籤的產品將是 AtriClip。這就是我們的筆畫標籤。我們的競爭對手的產品不會有這個。

Is that a differentiator? Absolutely. There's no question about it that once we're able to get that kind of label, it should be a differentiator. However, if somebody else has a product on the market and somebody feels like they want to use that product and believe that, that product has some benefits to it, I'm sure there'll be some level of a class effect on that point. At that point, we're talking about 1.5 million patients around the globe that will be using some sort of clip just in cardiac surgery, not including what's going to be used in any other area. So to me, obviously, you're going to have competition.

這是差異化因素嗎？絕對地。毫無疑問，一旦我們能夠獲得這種標籤，它就應該成為一個差異化因素。然而，如果其他人在市場上有一種產品，並且有人覺得他們想要使用該產品並相信該產品有一些好處，我確信在這一點上會產生一定程度的階級效應。到那時，我們談論的是全球 150 萬名患者將僅在心臟手術中使用某種夾子，不包括將在任何其他領域使用的夾子。所以對我來說，顯然，你將會面臨競爭。

I mentioned it earlier, when you build big multibillion-dollar markets, you're going to have competition and competition is going to get some level of share during that period of time. We saw it in TAVR. We saw it in the occlusion market. And in both those cases, they've created multibillion dollar markets and the competition has been there as well. And then it becomes who's got the best clinical evidence, who's got the best product in the market.

我之前提到過，當你建立數十億美元的大市場時，你將面臨競爭，而競爭將在這段時間內獲得一定程度的份額。我們在 TAVR 中看到了它。我們在咬合市場中看到了它。在這兩種情況下，他們都創造了數十億美元的市場，而且競爭也一直存在。然後就變成誰擁有最好的臨床證據，誰擁有市場上最好的產品。

And our next question comes from Suraj Kalia with Oppenheimer.

我們的下一個問題來自蘇拉吉·卡利亞和奧本海默。

Mike, Angie, can you hear me all right?

麥克，安吉，你們聽得到我說話嗎？

We can hear you.

我們能聽到你的聲音。

Perfect. So Mike, a couple of questions your way. One is in terms of a PFA clamp. For open, I understand, but can you walk us through the -- I believe in your prepared remarks, you talked about the complementarity you were seeing with your existing clamp with PFA catheters. In long-standing persistent AF, PFA, I believe they have just started clinical trials, right? So we don't have any data yet. And I'm curious if you could just kind of thread the needle for us as to how it is complementary in terms of the clamp and PFA catheters.

完美的。麥克，請教幾個問題。一種是 PFA 夾具。對於開放性，我理解，但是您能否向我們介紹一下——我相信在您準備好的發言中，您談到了您所看到的與 PFA 導管現有夾鉗的互補性。在長期存在的持續性AF、PFA方面，我相信他們才剛開始臨床試驗吧？所以我們還沒有任何數據。我很好奇您是否可以為我們介紹一下它在夾鉗和 PFA 導管方面如何互補。

Yes, the complementary aspects, think about PFA catheter today, if it's going to do the pulmonary veins, that's exactly what is being used and has been used with CONVERGE. When you do a CONVERGE procedure and you do a lot of the back wall ablation, in our trial, it was RF. In our upcoming trial and a lot of the usage today, it's with cryo doing just the PVI on it and kind of finishing out the veins. PFA can be used very similar to that. So the EPs may choose to use that instead of using their cryo or their RF when they complement it with what they're getting from the epicardial surface approach that we bring to the table.

是的，互補的方面，想想今天的 PFA 導管，如果它要用於肺靜脈，那正是正在使用的並且已經與 CONVERGE 一起使用。當您進行 CONVERGE 手術並進行大量後壁消融時，在我們的試驗中，是射頻消融。在我們即將進行的試驗和今天的大量使用中，冷凍技術僅對其進行 PVI 並完成靜脈處理。 PFA 的使用方式與此非常相似。因此，當 EP 與我們從心外膜表面方法中獲得的技術進行補充時，他們可能會選擇使用它，而不是使用冷凍或射頻。

We absolutely believe and has been shown clinical trial after clinical trial, but when you add epicardial to endocardial, you get a much more durable, long-lasting lesion and you get almost double the success rate as a result of that. And so you're definitely -- you are starting to see people begin to use that, both in Europe and in the U.S. to complement what they're doing. They're just kind of using that instead of some other catheter that they would have otherwise used when they were doing the endocardial portion.

我們絕對相信，並且已經在一個又一個的臨床試驗中得到證明，但是當您將心外膜添加到心內膜時，您會得到更持久、持久的病變，因此您的成功率幾乎翻倍。所以你肯定會開始看到人們開始使用它，無論是在歐洲還是在美國，來補充他們正在做的事情。他們只是使用它來代替他們在進行心內膜部分時本來會使用的其他導管。

So Mike, just to be clear, and forgive me for belaboring this. The argument being made is that PFA doesn't achieve transmurality .

麥克，我想澄清一下，請原諒我對此的闡述。爭論的焦點在於 PFA 沒有實現透壁性。

No, no. I'm not saying PFA it is. What I'm suggesting is PFA works incredibly well, and we've seen the data from the results in these -- and most of them have been for the pulmonary veins. And so CONVERGE does a really good backlog ablation to areas that catheters don't typically get to or get to very well. And that they can't get transmural for a variety of reasons, some of which is the safety reasons, some of which is that there are fat pads and other things, and there are differences between the epicardial surface and the endocardial surface, where the epi and the endo together getting much better results.

不，不。我並不是說 PFA 是這樣。我想說的是，PFA 的效果非常好，我們已經看到了這些結果中的數據，其中大部分是針對肺靜脈的。因此，CONVERGE 對導管通常無法到達或無法很好到達的區域進行了非常好的積壓消融。而且不能透壁有多種原因，有的是安全原因，有的是有脂肪墊之類的東西，還有心外膜表面和心內膜表面有區別，其中Epi 和 Endo 一起獲得更好的結果。

The endocardial products do very well doing the pulmonary veins, as you well know, Suraj. And so I'm not saying that they don't get transmural, they get transmural in the veins, for sure, and we've seen that. And I think you've seen that with the PFA technology that they've been doing a very good job on the veins, for sure.

正如你所知道的，Suraj，心內膜產品對肺靜脈的作用非常好。所以我並不是說它們不會變得透壁，它們肯定會在血管中變得透壁，我們已經看到了這一點。我認為您已經看到，透過 PFA 技術，他們在靜脈方面做得非常好，這是肯定的。

Got it. And Mike, I know -- forgive me, I have to ask, could you quantify the impact of LARIAT in the quarter? Obviously, LARIAT is MIS, you have AtriClip MIS. You have AtriClip open and then Penditure open. Just kind of quantifying these two buckets, what impact you saw from, let's say, from Penditure for open and LARIAT for MIS.

知道了。麥克，我知道 - 請原諒我，我不得不問，你能量化 LARIAT 在本季度的影響嗎？顯然，LARIAT是MIS，你有AtriClip MIS。您先開啟 AtriClip，然後開啟 Penditure。只是量化這兩個桶，您從開放的 Penditure 和 MIS 的 LARIAT 中看到了什麼影響。

Yes. Suraj, on the LARIAT question, it's roughly 50 basis points of growth impact for the company overall for the quarter. When you exclude LARIAT, again, it was an outsized kind of Q1 in 2023, we saw a decline throughout 2023, and just a very soft first quarter, again, a very limited number of users with this particular product, supported by a 510(k) clearance, but not other clinical data otherwise.

是的。 Suraj，關於 LARIAT 問題，該季度對該公司整體成長的影響約為 50 個基點。當你再次排除LARIAT 時，2023 年第一季的規模過大，我們看到整個2023 年都在下降，而且第一季度非常疲軟，同樣，使用這種特定產品的用戶數量非常有限，並得到510 ( k) 清除，但不包括其他臨床數據。

And on the open AtriClip side of our business, I just would reiterate that we drove growth of 15.4% for the quarter and feel really good about those results.

在我們業務的開放 AtriClip 方面，我只想重申，我們在本季度推動了 15.4% 的成長，並對這些結果感到非常滿意。

I'm showing no further questions at this time. I would now like to turn it back to Mike Carrel, President and Chief Executive Officer, for closing remarks.

我目前沒有提出任何進一步的問題。現在我想請總裁兼執行長 Mike Carrel 致閉幕詞。

Great. Thank you again, everyone, for joining us on the call today. Another great quarter for AtriCure and enjoyed the question-and-answer session here. Everybody, have a great evening. Bye now.

偉大的。再次感謝大家今天加入我們的電話會議。 AtriCure 又度過了一個精彩的季度，很享受這裡的問答環節。祝大家有個愉快的夜晚。再見了。

This concludes today's conference call. Thank you for participating. You may now disconnect. .

今天的電話會議到此結束。感謝您的參與。您現在可以斷開連線。 。