Stereotaxis Inc (STXS) 2025 Q2 法說會逐字稿

Good afternoon. Thank you for joining us for Stereotaxis second-quarter 2025 earnings conference call. Certain statements during the conference call and question-and-answer period to follow may relate to future events, expectations and as such, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.

午安.感謝您參加 Stereotaxis 2025 年第二季財報電話會議。電話會議和後續問答環節中的某些陳述可能與未來事件或預期有關，因此構成《1995 年私人證券訴訟改革法》所定義的前瞻性陳述。

Such statements involve known and unknown risks, uncertainties and other factors, which may cause the actual results, performance or achievements of the company in the future to be materially different from the statements that the company's executives may make today.

此類陳述涉及已知和未知的風險、不確定性和其他因素，可能導致公司未來的實際結果、績效或成就與公司高階主管今天可能做出的陳述有重大差異。

These risks are described in detail in our public filings with the Securities and Exchange Commission, including our latest periodic report on Form 10-K or 10-Q. We assume no duty to update these statements. (Operator Instructions) As a reminder, today's call is being recorded.

這些風險已在我們提交給美國證券交易委員會的公開文件中詳細描述，包括我們最新的10-K或10-Q表格定期報告。我們不承擔更新這些聲明的義務。 （操作員指示）提醒您，今天的電話會議正在錄音中。

It is now my pleasure to turn the floor over to your host, Mr. David Fischel, Chairman and CEO of Stereotaxis.

現在我很高興將發言權交給主持人、Stereotaxis 董事長兼執行長 David Fischel 先生。

Thank you, operator, and good afternoon, everyone. We've described this year as a pivotal milestone-rich year in which we advance a broad portfolio of strategic innovations to market and demonstrate their initial commercial impact. We are diligently executing on multiple fronts, and I'm pleased with our results. From both a regulatory and commercial perspective, our results are in line with the guidance provided at the start of this year.

謝謝接線員，大家下午好。我們將今年描述為一個充滿里程碑的關鍵年份，在這一年中，我們將一系列策略創新產品推向市場，並展示其初步的商業影響。我們正在多個方面勤勉執行，我對我們的業績感到滿意。從監管和商業角度來看，我們的業績均符合年初提供的指引。

I'll keep our prepared remarks brief, providing updates on our key innovation and commercial efforts. As a reminder, our innovation strategy rests on four primary pillars. First, making our robot widely available by innovating it such that it doesn't require construction and can be rapidly installed in the majority of labs.

我將簡短地介紹我們的主要創新和商業舉措。需要提醒的是，我們的創新策略是基於四大支柱。首先，透過創新，使我們的機器人無需建造，能夠在大多數實驗室快速安裝，從而實現廣泛普及。

Second, building an ecosystem of catheters and integrations in our core EP ablation market, so physicians have greater choice in technologies while we reduce our dependencies and build an attractive razor blade business.

其次，在我們的核心 EP 消融市場中建立導管和整合的生態系統，以便醫生在技術方面擁有更多的選擇，同時我們減少依賴並建立有吸引力的剃刀片業務。

Third, developing the right interventional devices so that our robots become a platform for endovascular surgery more broadly, providing value in several new clinical indications. And fourth, establishing a digital backbone that introduces connectivity and AI to our robot and the broader cath lab environment. GenesisX is the key technological innovation, enabling robotics to be more broadly accessible.

第三，開發合適的介入器械，使我們的機器人成為更廣泛的血管內手術平台，在多種新的臨床適應症中發揮價值。第四，建立數位化主幹網，將互聯互通和人工智慧引入我們的機器人以及更廣泛的導管室環境。 GenesisX 是關鍵的技術創新，使機器人技術能夠更廣泛地普及。

We received CE Mark in Europe and have been working through the regulatory process for FDA clearance in the US. On our last call, we described having addressed the vast majority of FDA's questions and that we received additional questions on a few final topics.

我們已獲得歐洲 CE 標誌，並正在辦理美國 FDA 審批的監管流程。在上次電話會議中，我們表示已經解答了 FDA 的絕大多數問題，並收到了一些關於最後幾個主題的補充問題。

We addressed these topics in a submission to the FDA late in the second quarter and view regulatory approval of GenesisX as likely still this summer. Concurrent with the regulatory effort, we are working to enhance compatibility of the robot with various X-rays and preparing our supply chain, manufacturing, installation and commercial processes for a full launch.

我們在第二季末提交給FDA的申請中討論了這些問題，並預計GenesisX在今年夏天仍可能獲得監管部門的批准。在監管工作的同時，我們正在努力增強該機器人與各種X射線的兼容性，並為全面上市做好供應鏈、製造、安裝和商業流程的準備。

We successfully completed transfer to manufacturing of GenesisX in the second quarter, manufacturing the first commercial GenesisX system. That system is expected to be installed at our first customer in Europe as soon as they complete installation of X-ray in their lab as they are placing GenesisX in a newly built cath lab.

我們在第二季度成功完成了 GenesisX 的製造轉制，並生產了首套商用 GenesisX 系統。該系統預計將在我們位於歐洲的首位客戶完成實驗室 X 光安裝後立即安裝到位，因為他們正在新建的導管室安裝 GenesisX。

We expect to demonstrate GenesisX working in daily clinical use in one or two hospitals still this year, upon which we should be ready for full launch in Europe and the US. We continue to see steady demand for Genesis, but expect GenesisX orders to outpace the tempo of Genesis orders following full launch.

我們預計今年將在一兩家醫院驗證 GenesisX 在日常臨床應用中的有效性，之後我們就能為在歐洲和美國全面上市做好準備。我們預計 Genesis 的需求將持續穩定，但預計 GenesisX 的訂單量在全面上市後將超過 Genesis 的訂單量。

Our effort to build an ecosystem of proprietary EP catheters in our core EP ablation market has seen two significant regulatory milestones so far this year. CE Mark of the MAGiC ablation catheter during the first quarter and FDA clearance of the MAGiC Sweep high-density mapping catheter just a couple of weeks ago.

我們致力於在核心電生理消融市場建立專有電生理導管生態系統，今年迄今已取得兩個重要的監管里程碑。 MAGiC 消融導管於第一季獲得 CE 標誌認證，MAGiC Sweep 高密度標測導管於幾週前獲得 FDA 批准。

We have talked about the importance and impact of MAGiC on previous calls. In line with our guidance, MAGiC contributed approximately a couple of hundred thousand dollars in revenue from initial European customers during the second quarter.

我們在先前的電話會議上討論過MAGiC的重要性和影響。根據我們的預期，MAGiC在第二季度從首批歐洲客戶那裡貢獻了約幾十萬美元的收入。

Initial procedures have now taken place at approximately 30% of our EU accounts and administrative efforts at others are ongoing. We continue to work on an FDA approval for MAGiC and maintain a continuous dialogue with FDA.

目前，我們約30%的歐盟帳戶已完成初步程序，其他帳戶的行政工作正在進行中。我們將繼續爭取FDA批准MAGiC，並與FDA保持持續溝通。

FDA received formal clinical results from our ongoing MAGiC study in the second quarter, and we are working with FDA through a body of questions on sterility, biocompatibility and manufacturing practices. We continue to expect US regulatory approval of MAGiC later this year. US regulatory clearance of MAGiC Sweep was a major milestone for Stereotaxis.

FDA 已於第二季度收到我們正在進行的 MAGiC 研究的正式臨床結果，我們正在與 FDA 合作，就無菌性、生物相容性和生產實踐等一系列問題展開討論。我們預計 MAGiC 將在今年稍後獲得美國監管機構的批准。 MAGiC Sweep 在美國的核准是 Stereotaxis 的一個重要里程碑。

We discussed on our previous call, the impact of high-density mapping on the EP field and why a robotic HD mapping catheter is a significant opportunity to positively impact physicians clinical results and workflow, the relevance of robotics in EP and our commercial results. Prominent KOLs were quoted in the press release announcing Sweep's clearance, describing the importance of the catheter and how the lack of a mapping catheter has held back overall adoption of robotics.

我們在先前的電話會議上討論了高密度標測對電生理領域的影響，以及機器人高清標測導管為何能為醫生的臨床結果和工作流程帶來積極影響，並探討了機器人技術在電生理領域的應用以及我們的商業成果。在宣布Sweep獲準的新聞稿中，我們引用了知名關鍵意見領袖的觀點，闡述了該導管的重要性，並指出標測導管的缺乏如何阻礙了機器人技術的全面應用。

MAGiC Sweep promises rapid and detailed electroanatomical mapping with the precision and inherent safety of our technology, the ability to map otherwise difficult to reach areas of the heart and more anatomically accurate maps by avoiding distension caused by rigid catheters.

MAGiC Sweep 承諾透過我們技術的精確性和固有安全性進行快速和詳細的電解剖映射，能夠繪製難以到達的心臟區域，並透過避免硬導管引起的膨脹來繪製更解剖精確的地圖。

There are many EPs who think similar to those KOLs and are excited to use the catheter. We're already working through hospital administrative processes at several hospitals that will be the first users of the catheter and expect usage at multiple accounts this quarter.

許多EP和這些KOL的想法類似，也對使用導管感到興奮。我們已經在幾家醫院開展醫院管理流程，這些醫院將成為導管的首批用戶，預計本季將在多個帳戶上投入使用。

We expect the combination of MAGiC and MAGiC Sweep to increase our disposable revenue per procedure significantly and expand our user base and robotic utilization. Stepping back, FDA clearance of MAGiC Sweep is reflective of a major strategic transformation underway. It's the first FDA clearance Stereotaxis has received for a catheter in nearly 20 years.

我們預計 MAGiC 和 MAGiC Sweep 的結合將顯著提升我們每例手術的可支配收入，並擴大我們的用戶群和機器人的使用率。回顧一下，MAGiC Sweep 獲得 FDA 批准，體現了我們正在進行的一項重大策略轉型。這是近 20 年來 Stereotaxis 首次獲得 FDA 核准的導管產品。

It demonstrates the foresight of our strategy to bring catheter development and manufacturing expertise in-house with the acquisition of APT last year. It's a tangible reflection of our progress building a robust ecosystem of robotically navigated interventional devices, a strategy that provides a much more attractive technological and commercial foundation for growth.

這體現了我們去年收購APT並引入導管開發和製造專業知識的策略的遠見卓識。這切實體現了我們在建構強大的機器人導航介入器材生態系統方面取得的進展，這項策略為公司的成長提供了更具吸引力的技術和商業基礎。

It is even more exciting that this is just one of several proprietary catheters we are advancing to market across key geographies this year. In addition to MAGiC and MAGiC Sweep, we've developed a portfolio of catheters and wires that enable our robot to provide value in several new clinical indications.

更令人興奮的是，這只是我們今年在主要地區推廣的幾款專有導管之一。除了 MAGiC 和 MAGiC Sweep 之外，我們還開發了一系列導管和導絲，使我們的機器人能夠在多種新的臨床適應症中發揮價值。

We submitted the EMAGIN catheter for regulatory approval earlier this year and continue to expect clearance this quarter. Following clearance, we look forward to beginning the process of demonstrating that our robot can serve as a broad platform for endovascular surgery. We have initial physician interest in working with us to pioneer use across several neurointerventional, interventional cardiology and interventional radiology procedures.

我們已於今年稍早提交了EMAGIN導管的監管審批，預計本季將獲得批准。獲批後，我們期待開始驗證我們的機器人可以作為血管內手術的廣泛平台。目前已有醫生有意與我們合作，在多項神經介入、介入性心臟病學和介入放射學手術中率先應用。

We expect that following regulatory clearance, we'll have several quarters of clinical updates demonstrating initial use and clinical value in these procedures. This transition of Stereotaxis from a single application robot to a platform endovascular robot is a significant driver of strategic value and ultimately increases our total addressable market multiple fold.

我們預計，在獲得監管部門批准後，我們將在接下來的幾季內發布臨床更新，以展示這些手術的初步應用和臨床價值。 Stereotaxis 從單一應用機器人轉向平台型血管內機器人的轉變，是戰略價值的重要驅動力，最終將使我們的潛在市場規模倍增。

The final significant innovation effort nearing regulatory milestones is our digital surgery platform that enables operating room connectivity and smart AI capabilities in the cath lab. Synchrony and SynX digitize the various disparate systems in the cath lab, allow for seamless control of all those systems from a consolidated cockpit, offer modern cloud-based connectivity between the lab and the external world and provide attractive opportunities for smart AI features to be integrated into the operating room.

我們即將取得監管里程碑的最後一個重大創新成果是數位化手術平台，該平台實現了導管室的手術室互聯互通和智慧AI功能。 Synchrony和SynX將導管室中各種不同的系統數位化，允許從統一的駕駛艙無縫控制所有這些系統，在導管室與外部世界之間提供基於雲端的現代化連接，並為將智慧AI功能整合到手術室提供了極具吸引力的機會。

The technology has been designed for use with our robot, but also as a very attractive independent offering across non-robotic cath labs. We have completed all regulatory testing for Synchrony and expect to submit it for FDA clearance and declare CE Mark in Europe very shortly. During the recently completed second quarter, we began limited commercialization of just the first technologies in this comprehensive innovation strategy.

該技術專為與我們的機器人配合使用而設計，同時也是一款極具吸引力的獨立產品，適用於非機器人導管室。我們已完成 Synchrony 的所有監管測試，預計很快提交 FDA 批准並在歐洲獲得 CE 標誌。在剛結束的第二季度，我們已開始對這項全面創新策略中的首批技術進行小規模商業化。

Our results in the quarter benefited from revenue recognition on the first GenesisX system and initial MAGiC sales in Europe. These launches will accelerate and as we achieve additional regulatory milestones, we will benefit from the layering of additional growth tailwinds. While these innovations are modestly contributing to system and recurring revenue in 2025, they set us up for breakout growth as we look towards 2026.

本季業績得益於首款 GenesisX 系統和 MAGiC 在歐洲的首次銷售帶來的收入確認。這些產品的發布將加速，隨著我們取得更多監管的里程碑，我們將受益於層層遞增的成長動力。雖然這些創新在 2025 年對系統收入和經常性收入的貢獻有限，但它們為我們在 2026 年實現突破性成長奠定了基礎。

Kim will now provide additional commentary on our financial results, and then I'll make a few financial comments as well before opening the call to Q&A. Kim?

Kim 現在將對我們的財務結果提供補充評論，然後我也會發表一些財務評論，然後再開始問答環節。 Kim？

Thank you, David, and good afternoon, everyone. Revenue for the second quarter of 2025 totaled $8.8 million, growth of 95% from $4.5 million in the prior year second quarter and growth of 18% sequentially compared to $7.5 million in the first quarter of 2025. System revenue for the second quarter was $3 million, and recurring revenue was $5.8 million compared to $0.2 million and $4.3 million in the prior year second quarter.

謝謝David，大家下午好。 2025年第二季營收總計880萬美元，較去年同期的450萬美元成長95%，較2025年第一季的750萬美元較上季成長18%。第二季系統收入為300萬美元，經常性收入為580萬美元，去年同期分別為20萬美元和430萬美元。

System revenue in the quarter reflects revenue recognition on a Genesis system and our first GenesisX system. Recurring revenue growth reflects the contribution of Map-iT catheters from last year's acquisition of APT as well as initial sales of our robotically navigated MAGiC ablation catheter.

本季系統收入反映了Genesis系統和我們首款GenesisX系統的收入確認。經常性收入成長反映了去年收購APT帶來的Map-iT導管的貢獻，以及我們機器人導航MAGiC消融導管的首次銷售。

Gross margin for the second quarter 2025 was 52% of revenue. Recurring revenue gross margin was 68% and system gross margin was 22%. Gross margins remain impacted by acquisition-related accounting that temporarily reduces disposable margin and by fixed overhead allocated over low system production levels.

2025年第二季毛利率為營收的52%。經常性收入毛利率為68%，系統毛利率為22%。毛利率仍然受到收購相關會計處理的影響，該處理暫時降低了可支配利潤，並且由於系統產量較低而分配了固定間接費用。

Operating expenses in the quarter of $8.6 million included $2.6 million in non-cash charges for stock compensation expense, a favorable mark-to-market adjustment for acquisition-related contingent earn-out consideration and amortization of acquired intangible assets. Excluding these non-cash charges, adjusted operating expenses were $6 million compared to the prior year adjusted operating expenses of $6.8 million.

本季營運費用為860萬美元，其中包括260萬美元的非現金股票薪酬費用、因收購相關或有收益對價以及收購無形資產攤銷而產生的有利市值調整。扣除這些非現金費用後，調整後營運費用為600萬美元，而去年同期調整後營運費用為680萬美元。

Approximately half of the decline in adjusted operating expenses is from the receipt of an employee retention tax credit for the 2020 tax year, with the remaining decline due to natural reductions in R&D spending with the completion of certain larger projects.

調整後營業費用下降的約一半是由於獲得了 2020 納稅年度的員工保留稅收抵免，其餘下降是由於某些較大項目的完成導致研發支出自然減少。

Operating loss and net loss in the second quarter of 2025 were $4 million and $3.8 million compared with $6 million and $5.8 million in the previous year. Adjusted operating loss and adjusted net loss for the quarter, excluding non-cash charges, were $1.4 million and $1.3 million compared with $3.5 million and $3.3 million in the previous year.

2025年第二季營運虧損和淨虧損分別為400萬美元和380萬美元，去年同期分別為600萬美元和580萬美元。本季調整後營運虧損和調整後淨虧損（不含非現金費用）分別為140萬美元及130萬美元，去年同期分別為350萬美元及330萬美元。

Negative free cash flow for the second quarter was $3.7 million compared to $3.1 million in the previous year. At June 30, Stereotaxis had cash and cash equivalents of $7 million and no debt. Subsequent to the end of the quarter, in July, Stereotaxis announced a registered direct financing for the sale of $12.5 million of its shares of common stock to a strategic industry partner and select institutional investors.

第二季自由現金流為負370萬美元，去年同期為負310萬美元。截至6月30日，Stereotaxis持有現金及現金等價物700萬美元，無負債。本季結束後，即7月，Stereotaxis宣布了一項註冊直接融資，將向策略產業合作夥伴和部分機構投資者出售價值1,250萬美元的普通股。

A first closing of $8.5 million was completed in July with the remaining $4 million to be completed in a second closing within four months. Incorporating the net proceeds from this offering, Stereotaxis would have $18.8 million in cash and no debt. I will now hand the call back to David.

首輪融資850萬美元已於7月完成，剩餘400萬美元將於四個月內完成第二輪融資。算上本次發行的淨收益，Stereotaxis將擁有1,880萬美元現金，且無任何債務。現在，我將把發言權交還給David。

Thank you, Kim. As mentioned in our press release, we are reiterating our revenue guidance of double-digit revenue growth for the full year 2025 with system revenue in any given quarter fluctuating between approximately $2 million to $3 million and recurring revenue scaling to approximately $7 million in the fourth quarter.

謝謝你，Kim。正如我們在新聞稿中提到的，我們重申2025年全年收入預期，即實現兩位數增長，每個季度的系統收入將在約200萬美元至300萬美元之間波動，第四季度的經常性收入將增至約700萬美元。

Our revenue expectations assume only modest contribution from GenesisX and no system revenue from China. We have demonstrated the ability to launch new technologies while maintaining stable operating expenses.

我們對收入的預期假設是GenesisX僅貢獻少量收入，且中國市場不提供系統收入。我們已證明有能力在保持穩定營運支出的同時推出新技術。

Our recently completed equity financing offers us a stronger balance sheet with which to accelerate adoption of our comprehensive innovation strategy as the puzzle pieces come together, and we are preparing for a full launch.

我們最近完成的股權融資為我們提供了更強大的資產負債表，隨著各個部分逐漸整合，我們可以加速採用全面的創新策略，並且我們正在為全面啟動做準備。

We expect to launch our new technologies with a balanced focus on accelerating growth while also ensuring improved margins, earnings accretion and achievement of profitability. We will now take your questions.

我們期望在推出新技術的同時，兼顧加速成長，同時確保提高利潤率、增加收益並實現盈利。現在我們將回答您的問題。

Operator, can you please open the line to Q&A?

接線員，您能開闢問答專線嗎？

Thank you. We will now begin the question-and-answer session. (Operator Instructions)

謝謝。我們現在開始問答環節。 （操作員指示）

Adam Maeder, Piper Sandler.

亞當梅德、派珀桑德勒。

Hi, good afternoon. Thank you for taking the questions and congrats on all the progress, great to see. David, maybe we can start on kind of your closing remarks there and a little bit of discussion around the financing and kind of how you're thinking about use of proceeds. The portfolio has obviously transformed a lot here over the past 12, 18 months and kind of a complete refresh.

大家下午好。感謝您回答問題，也祝賀您取得的所有進展，很高興看到這些進展。 David，也許我們可以先從您的總結發言開始，然後稍微討論一下融資情況，以及您對收益用途的考慮。在過去的12到18個月裡，投資組合顯然發生了很大的變化，可以說是徹底的更新。

And so will you -- I think you've run pretty lean from a commercial standpoint historically. Will you start to build up the sales force to push more aggressively? Maybe just talk about the commercial strategy there with the new products in hand. And if you could provide some kind of headcount figures, too, that would be appreciated. Thanks.

您也是一樣——我認為從商業角度來看，你們一直以來的營運都比較精簡。您會開始組建銷售隊伍，以更積極地推進業務嗎？或許可以談談新產品的商業策略。如果您能提供一些員工人數數據，我們將不勝感激。謝謝。

Sure. Thanks a lot, Adam, for the questions. Good afternoon. So it's a great question. We -- obviously -- this is the year in which we are getting regulatory approvals and starting the initial launches of many technologies as described in the prepared remarks, both capital systems and then several catheters in the EP space and outside of EP. And so that is kind of exciting for our sales team and for us as a company.

當然。非常感謝Adam的提問。午安.這個問題問得真好。顯然，正如準備好的演講稿中所述，今年我們將獲得監管部門的批准，並開始推出多項技術，包括資本系統以及EP領域和EP領域以外的多種導管。這對我們的銷售團隊和我們公司來說都是一件令人興奮的事情。

We have a good existing commercial team direct in both the US, Europe and even have direct sales members in Asia. In total, the commercial team numbers about 40 people, of which about 20 are in the US, 15 are in Europe and 5 are in Asia, that spans clinical support and capital sales and sales management and training.

我們在美國和歐洲都擁有一支優秀的商業團隊，甚至在亞洲也有直銷人員。商業團隊總共約有40人，其中約20人在美國，15人在歐洲，5人在亞洲，涵蓋臨床支援、資本銷售、銷售管理和培訓等工作。

So it's kind of a broader commercial team with the predominant focus on the clinical side. We have demonstrated, I believe you've seen pretty nicely that both with the Map-iT catheters since the acquisition of APT a year ago and more recently with the MAGiC catheters, and we're seeing already the start of activity with MAGiC Sweep very quickly after the regulatory approval that our team has the ability to do much more than what historically they were doing.

所以，我們是一個更廣泛的商業團隊，主要專注於臨床方面。我們已經證明，我相信您已經很好地看到了這一點，無論是一年前收購APT以來的Map-iT導管，還是最近的MAGiC導管，而且我們已經看到MAGiC Sweep在獲得監管部門批准後很快就開始投入使用，這證明我們的團隊有能力做比以往更多的事情。

And in some ways, it's not just adding additional work to them, it makes their work much more successful and it contributes to the success of their work. So I think there's a lot of synergy to the product portfolio and the way it's coming together in allowing each of the team members to actually be much more successful than what they've been historically.

從某種程度上來說，這不僅增加了他們的工作量，還能讓他們的工作更成功，並有助於他們工作的成功。所以我認為產品組合及其整合方式之間有著很大的綜效，能夠讓每個團隊成員都取得比以往更大的成功。

It's very synergistic all of these product approvals and the addition of them to their back. With that said, I know that we have a relatively lean team, and we could increase our team significantly. And so there's going to be a balanced approach between -- on the one hand, during the initial launch stage, our existing team is fantastic and able to do everything with the products that are gaining approval and starting to launch.

所有這些產品的審批以及新增的資源投入，都具有強烈的綜效。話雖如此，我知道我們的團隊相對精簡，而且我們還可以大幅擴充團隊規模。因此，我們需要採取平衡的方法——一方面，在初始發布階段，我們現有的團隊非常出色，能夠處理所有正在獲得批准並開始發布的產品。

As we start to see traction at individual accounts, we definitely plan to shift gradually to the model of having one clinical rep per hospital rather than our current model where we have about one clinical rep for every three or four hospitals.

隨著我們開始看到個人帳戶的吸引力，我們肯定計劃逐步轉向每家醫院配備一名臨床代表的模式，而不是目前的每三到四家醫院配備一名臨床代表的模式。

That will allow us to go much deeper in terms of utilization and provide much better support and the revenue model with our own proprietary catheters allows that model to be very attractive and sustainable. And so that's definitely a model that we're going to be implementing both in Europe and the US as we gain the regulatory approvals.

這將使我們能夠更深入地利用這些技術，並提供更好的支援。我們自主研發的導管所帶來的收入模式也使此模式極具吸引力且可持續。因此，一旦獲得監管部門的批准，我們肯定會在歐洲和美國推行這個模式。

I think we can do that in an accretive way, so we can build up the sales force while the adoption of these new catheters is growing, and that all can happen accretively, but we will be reinvesting a lot of the incremental gross profit and operating profit from these catheters back into the sales team for that growth. On the capital side, we have a very lean team.

我認為我們可以以增值的方式做到這一點，這樣我們就可以隨著這些新導管的普及而壯大銷售隊伍，所有這些都可以增值，但我們會將這些導管帶來的大量增量毛利潤和營業利潤重新投資到銷售團隊中，以實現這一增長。在資本方面，我們的團隊非常精簡。

They've been able to continue a relatively steady tempo of Genesis orders and sales, but as we have GenesisX transitioning to a full launch later this year, we'd probably invest a couple of million dollars in a more robust dedicated capital team, both in Europe and the US, and that should allow us to see capital sales next year growing very significantly. And so that's kind of our -- that's our overall high-level plan. I hope that gave you enough color to help you.

Genesis 的訂單和銷售一直保持著相對穩定的成長速度，但隨著 GenesisX 在今年稍後全面上市，我們可能會在歐洲和美國投資數百萬美元，組建一支更強大的專業資本團隊，這應該能讓我們明年的資本銷售額實現大幅增長。這就是我們的總體規劃。希望以上內容對您有幫助。

That was fantastic. Thank you, for the detailed response, David. And for the follow-up, I'll ask about Europe and the catheter business. And a two part question. I guess, first, you talked a little bit about the progress that MAGiC RF is making in Europe in terms of account penetration. Could you just maybe double-click on how your customers are using the MAGiC RF catheter? Is it still largely SVT, VT? Are they doing kind of broader, more simple cases as well? And then just quickly, [Genesis] Sweep the mapping catheter, just OUS time lines there, and I'll drop back in the queue. Thank you.

太棒了！謝謝David的詳細回覆。接下來我想問關於歐洲和導管業務的問題。這個問題分為兩部分。首先，您稍微談到了MAGiC RF在歐洲的客戶滲透率方面的進展。能否簡單介紹一下您的客戶如何使用MAGiC RF導管？它仍然主要用於SVT（室上性心動過速）和VT（室上性心動過速）嗎？它們也用於更廣泛、更簡單的病例嗎？然後，請快速地掃描映射導管，然後記錄OUS時間線，之後我會回到隊列中。謝謝。

Sure, thanks. So yeah, MAGiC in Europe, we talked about approximately 30% of our European accounts have now started to use MAGiC in procedures. That's up from about 20% when we talked last quarter. And we see kind of steady -- it's amazing the administrative burdens in various countries in Europe and how just getting through tenders and getting on contract in certain countries and certain hospitals just takes -- it's kind of an administrative grind, but we're working on many of those in tandem.

當然，謝謝。是的，關於歐洲的MAGiC，我們之前提到過，大約30%的歐洲客戶已經開始在診療過程中使用MAGiC。這比我們上個季度談到的20%有所上升。我們看到歐洲各國的行政負擔相當穩定，令人驚訝，在某些國家和某些醫院，僅僅透過招標和簽訂合約就需要——這確實是一項繁瑣的行政工作，但我們正在同步處理其中的許多問題。

So kind of I see that percentage very naturally increasing month-by-month. We see usage of MAGiC so far across the full breadth of procedures. So you're correct that predominantly, our robot has been used and is being used to treat more complex arrhythmias, VTs, PVCs, congenital patients. But we've seen MAGiC being used already in AF, in AVNRTs, AVRTs, flutters. So really kind of across the spectrum from the simpler cases to the most complex.

所以我看到這個比例很自然地逐月成長。到目前為止，我們看到MAGiC的應用已涵蓋所有類型的手術。你說得對，我們的機器人主要用於治療更複雜的心律不整、心室心搏過速、心室早搏和先天性疾病患者。但我們已經看到MAGiC被用於治療心房顫動、房室傳導阻滯（AVNRT）、房室傳導阻滯（AVRT）和撲動。所以，MAGiC的應用範圍涵蓋了從簡單病例到最複雜的病例。

And so that's kind of obviously been nice to see that usage and to see the value that the catheter can provide across a broader spectrum of procedures. In Europe, we have a very broad label for ablation in all four chambers of the heart. And so that obviously supports kind of a broad utilization across the spectrum.

看到這種用途，以及導管在更廣泛的手術領域中所能發揮的價值，顯然令人欣慰。在歐洲，我們對心臟四個腔的消融有著非常廣泛的應用範圍。這顯然支持了導管在各領域的廣泛應用。

We're still in the earlier stages of this launch, right? The second quarter was our first real quarter of sales and revenue. And so I kind of -- I don't have any statistics yet on how MAGiC will grow utilization at individual accounts.

我們還處於產品發布的早期階段，對吧？第二季是我們第一個真正實現銷售額和收入的季度。所以我還沒有任何關於MAGiC如何提升個人帳戶使用率的統計數據。

But obviously, as we kind of -- as we penetrate further in these accounts and go kind of more broadly across all of the accounts in Europe, I do expect MAGiC to have a positive halo effect on overall utilization. If we step back to your second question was related to, I remember MAGiC Sweep, European regulatory time line, and there was something else that I'm now missing. But on the Europe MAGiC Sweep, we've talked about still getting clearance in Europe this quarter. That's our expectation.

但顯然，隨著我們進一步滲透這些帳戶，並更廣泛地涵蓋歐洲所有帳戶，我確實預期MAGiC會對整體利用率產生正面的光環效應。回到你的第二個問題，我記得MAGiC Sweep，歐洲監管時間表，還有一些我現在遺漏的內容。但關於歐洲MAGiC Sweep，我們已經討論過本季仍將在歐洲獲得批准。這是我們的預期。

But it obviously depends on the notified body. And so as we know more, we will share more.

但這顯然取決於公告機構。因此，隨著我們了解的增多，我們會分享更多資訊。

That's perfect thanks again.

太好了，再次感謝。

Thank you.

謝謝。

Frank Takkinen, Lake Street Capital Markets.

Frank Takkinen，湖街資本市場。

Great, thanks for taking the questions, and congrats on all the progress in the next quarter. I was hoping to start with some additional color on MAGiC FDA interactions. Previous -- I appreciate the update you provided today, but maybe help us understand kind of the -- how long some of these interactions could take with the FDA, when those could be submitted and then the time line from when those are submitted, answered and then hearing back, just bridging us from kind of where we are today to that second half approval.

太好了，感謝您回答這些問題，也祝賀您在下一季取得的所有進展。我本來想先補充一些關於MAGiC與FDA的互動情況。之前，我很感謝您今天提供的最新情況，但或許這有助於我們了解一些與FDA的互動需要多長時間，什麼時候可以提交申請，以及從提交申請到得到答复再到收到回复的整個流程，這些流程將幫助我們從目前的階段過渡到下半年的審批。

Okay, sure, we -- FDA does, professional diligent work in its reviews. We see that across all of our submissions and, they're very much active and. Kind of fulfill their professional mandate in reviewing submissions. We have been working with FDA very collaboratively in a lot of back and forth on the very, the many topics that are part of the PMA submission and PMA approval process.

好的，當然，FDA 在審查過程中確實非常專業、盡職盡責。我們在所有提交的申請中都看到了這一點，他們非常積極，在審查申請方面履行了他們的專業職責。我們一直與 FDA 就上市前許可 (PMA) 提交和審批流程中的諸多主題進行著密切的合作。

I mentioned in the prepared remarks that we are predominantly working. Through a body of questions on sterility, biocompatibility, and GMP good manufacturing practices. And so that's where most of the effort is. We submitted clinical data from the ongoing trial in Europe in the second quarter and so overall kind of there is a Regular tempo of interaction between FDA and us.

我在準備好的演講中提到，我們的主要工作是解決一系列關於無菌性、生物相容性和GMP良好生產規範的問題。因此，我們在這方面投入了大部分精力。我們在第二季度提交了正在進行的歐洲試驗的臨床數據，因此，總體而言，我們與FDA之間的互動節奏比較規律。

We feel given that tempo and given the type of commentary from the ongoing discussions that approval in the second half of this year still makes a lot of sense and I think The FDA is also aware of that and of the importance of this catheter to US patients and US physicians who benefit from robotics and so we're just grinding through the process and I've appreciated the collaborative nature of FDA in this process.

我們認為，考慮到這種節奏和正在進行的討論的評論類型，在今年下半年批准仍然很有意義，我認為 FDA 也意識到了這一點，也意識到了這種導管對受益於機器人技術的美國患者和美國醫生的重要性，所以我們只是在努力完成這個過程，我很欣賞 FDA 在這個過程中的合作性質。

Got it. That's helpful. And then maybe just sizing up Sweep in the US a little bit more. Happy to hear that's off to a strong start, but maybe talk about kind of what that can contribute per procedure, what -- how many of your current cases today may use the catheter and then just kind of extrapolating that into how much revenue that could contribute?

明白了。這很有幫助。然後，也許可以再稍微評估Sweep在美國的業績。很高興聽到它開局良好，但或許可以談談它對每台手術的貢獻，目前有多少病例可能使用導管，然後可以推斷出它能帶來多少收入？

Sure. So high-density mapping catheters are typically priced north of $2,000 per procedure. And so you should expect kind of similar numbers for us. I'd say that high-density mapping is probably used in the majority and the majority probably means somewhere in the 70% or so, perhaps a little bit more than that percent of the procedures that we see on our robots. So it's not every procedure, but it's a significant number of them.

當然。高密度映射導管通常每台手術的價格在2000美元以上。所以你應該可以預料到我們的價格也差不多。我想說，高密度映射可能在大多數手術中都有應用，而「大多數」可能指的是70%左右，可能比我們用機器人進行的手術比例略高一些。所以，雖然不是所有手術都用高密度映射，但佔比相當大。

I think that kind of one of the big benefits of MAGiC Sweep, though, is not just having it used in our existing procedures, but this is really -- if you think about our existing utilization and our core business, it has been -- it's predicated on still a catheter that is by now 20 years old with no catheter innovation for these physician users for many, many years, essentially since they started using us.

我認為 MAGiC Sweep 的一大優勢不僅僅在於它可用於我們現有的程序，而是 — — 如果你考慮一下我們現有的利用率和核心業務，它仍然基於一種已有 20 年曆史的導管，這些醫生用戶多年來一直沒有導管創新，基本上自從他們開始使用我們產品以來。

And so this is a significant opportunity, I think, to have them rethink how they do workflow and to kind of -- to have other benefits from the robot beyond what they've historically experienced. And so I think this is a real opportunity also to grow utilization to engage with physicians at existing sites that perhaps historically weren't using our robot as much. And so I think that there's going to be a broader benefit beyond just the step-up in revenue per procedure.

因此，我認為這是一個重要的機會，可以讓他們重新思考工作流程，並從機器人中獲得更多超越以往經驗的益處。因此，我認為這也是一個真正的機會，可以提高利用率，與現有診所的醫生進行互動，這些診所過去可能不太常用我們的機器人。因此，我認為除了增加每台手術的收入之外，它還將帶來更廣泛的好處。

Perfect, really helpful thank you.

非常好，非常有幫助，謝謝。

Thank you.

謝謝。

Thank you. I'm not showing any further questions in the queue. I would now like to turn it back to David for closing remarks.

謝謝。隊列中沒有其他問題了。現在我想把發言時間交還給David，請他做最後發言。

Okay. Thank you very much for your questions and for your continued support. We look forward to working hard on your behalf and speaking again soon. Thank you very much.

好的。非常感謝您的提問以及一直以來的支持。我們期待為您竭誠服務，並很快再次與您聯繫。非常感謝。

And ladies and gentlemen, this concludes today's call. Thank you all for joining. You may now disconnect.

女士們，先生們，今天的電話會議到此結束。感謝各位的參與。現在可以掛斷電話了。