Vicarious Surgical Inc (RBOT) 2024 Q4 法說會逐字稿

完整原文

使用警語:中文譯文來源為 Google 翻譯,僅供參考,實際內容請以英文原文為主

  • Operator

    Operator

  • Good afternoon. Thank you for attending the Vicarious Surgical's 2024 fourth quarter and Full Year Earnings Call. My name is Cameron, and I will be your moderator for today (Operator Instructions)

    午安.感謝您參加 Vicarious Surgical 2024 年第四季和全年財報電話會議。我叫卡梅倫,今天我將擔任主持人。(操作員指示)

  • And I would now like to pass the conference over to your host, Kaitlyn Brosco, Director of IR. You may proceed.

    現在我想將會議交給主持人、投資者關係總監凱特琳·布羅斯科 (Kaitlyn Brosco)。您可以繼續。

  • Kaitlyn Brosco - Investor Relations

    Kaitlyn Brosco - Investor Relations

  • Thank you, Cameron, and thank you all for joining. With me on today's call is Adam Sachs, Co-Founder and Chief Executive Officer; and Randy Clark, Company President. Today aftermarket closed by Vicarious Surgical released financial results for the three months and full year ended December 31, 2024. The A copy of the press release is available on the company website.

    謝謝你,卡梅倫,也謝謝大家的參與。今天與我一起參加電話會議的是共同創辦人兼執行長亞當‧薩克斯 (Adam Sachs);以及公司總裁蘭迪‧克拉克 (Randy Clark)。今天,Vicarious Surgical 在收盤後發布了截至 2024 年 12 月 31 日的三個月和全年財務業績。新聞稿的副本可在公司網站上查閱。

  • Before we begin, I'd like to remind you that management will make statements during this call that include forward-looking statements within the meaning of federal securities laws which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Any statements contained in this call not related to expectations of creation of future events, results, or performance are forward-looking statements.

    在我們開始之前,我想提醒您,管理層將在本次電話會議中發表聲明,其中包括根據 1995 年《私人證券訴訟改革法案》的安全港條款作出的聯邦證券法所定義的前瞻性聲明。本次電話會議中包含的任何與未來事件、結果或績效預期無關的陳述均為前瞻性陳述。

  • All forward-looking statements, including, without limitation, those relating to obtaining approval for the Vicarious surgical system and timing for any such approval, our operating trends and future financial performance, expense management, market opportunity and commercialization are based upon our current estimates and various assumptions.

    所有前瞻性陳述,包括但不限於與 Vicarious 手術系統批准和任何此類批准的時間有關的陳述、我們的經營趨勢和未來財務業績、費用管理、市場機會和商業化均基於我們當前的估計和各種假設。

  • These statements involve material risks and uncertainties that could cause actual results or events to materially differ from those anticipated or implied by these forward-looking statements.

    這些聲明涉及重大風險和不確定性,可能導致實際結果或事件與這些前瞻性聲明預期或暗示的結果或事件有重大差異。

  • Accordingly, you should not place any undue reliance on these statements. For a list and description of the risks and uncertainties associated with our business, please refer to the risk factors set forth in our Securities and Exchange Commission filings, including our most recent Form 10-K and Form 10-Q.

    因此,您不應過度依賴這些聲明。有關與我們的業務相關的風險和不確定性的清單和說明,請參閱我們向美國證券交易委員會提交的文件中列出的風險因素,包括我們最新的 10-K 表格和 10-Q 表格。

  • This conference call contains time sensitive information as accurate only as of the live broadcast today. March, 17 2025. Vicarious Surgical disclaims any intention or publication except as required by law, to update or revise any financial projections or forward-looking statements, whether because of new information, future events or otherwise.

    本次電話會議所包含的時間敏感資訊僅截至今天的現場直播時準確。2025 年 3 月 17 日。Vicarious Surgical 不承擔任何更新或修改任何財務預測或前瞻性陳述的意圖或出版物,除非法律要求,無論是由於新資訊、未來事件或其他原因。

  • I'll now hand the call over to Adam for prepared remarks.

    我現在將電話交給亞當,請他發表準備好的發言。

  • Adam Sachs - Chief Executive Officer, Co-Founder, Director

    Adam Sachs - Chief Executive Officer, Co-Founder, Director

  • Thanks, Kate. Good morning, everyone, and -- good afternoon, everyone, and welcome to our fourth quarter and full year 2024 earnings call. We appreciate you joining us today. As Vicarious Surgical, our mission is to improve lives by transforming robotic surgery. And 2024 was a pivotal year in advancing that mission.

    謝謝,凱特。大家早安,大家下午好,歡迎參加我們的 2024 年第四季和全年財報電話會議。感謝您今天加入我們。作為 Vicarious Surgical,我們的使命是透過改造機器人手術來改善生活。2024年是推進這項使命的關鍵一年。

  • Throughout the past year, we achieved a number of key development, regulatory and commercial milestones that have positioned us incredibly help for continued success in 2025. As we'll discuss in more detail today, these accomplishments have laid the groundwork for what we believe will be a truly transformative year ahead as '25 marks our transition into a clinical stage company.

    在過去的一年裡,我們在開發、監管和商業方面取得了許多關鍵的里程碑,這些里程碑為我們在 2025 年繼續取得成功提供了極大的幫助。正如我們今天將詳細討論的那樣,這些成就為未來真正變革的一年奠定了基礎,因為 25 年標誌著我們向臨床階段公司的轉型。

  • Our most anticipated milestone in 2024 was the successful completion of our V1.0 system integration. As you may recall from our last earnings call, we were just weeks away from our year-end Cadaver Lab, a critical event that would signify the achievement of the key development milestones.

    2024 年我們最期待的里程碑是成功完成 V1.0 系統整合。您可能還記得,在我們上次的收益電話會議中,距離年底屍體實驗室的成立僅剩幾週時間,這是一個標誌著關鍵發展里程碑實現的關鍵事件。

  • We're thrilled to share with Cadaver Lab with the success, demonstrating a fungal and performance of our V1.0 system in a cadaveric preclinical state. This achievement represents a significant step forward in bringing our innovative robotic surgery platform to market and validate the hard work and dedication of our entire team.

    我們很高興與 Cadaver Lab 分享這一成功,展示了我們的 V1.0 系統在屍體臨床前狀態下的真菌和性能。這項成就代表我們向創新機器人手術平台市場邁出了重要一步,也證明了我們整個團隊的辛勤工作和奉獻精神。

  • The Version 1.0 system, the platform we intend to use in our first clinical use is uniquely architected to deliver differentiated value to patients, surgeons and hospitals. Our proprietary decoupled actuators provide a novel mechanism of action, separating it apart from anything currently available.

    我們打算在首次臨床使用中使用的平台是版本 1.0 系統,它採用獨特的架構,旨在為患者、外科醫生和醫院提供差異化的價值。我們專有的解耦致動器提供了一種新穎的作用機制,使其與目前的任何產品截然不同。

  • This innovative design allows our system to achieve minimally invasive outcomes through its single small 18-millimeter incision, while still generating the high forces necessary to address a broad range of soft tissue indications.

    這種創新設計使我們的系統能夠透過單一 18 毫米的小切口實現微創效果,同時仍能產生解決各種軟組織適應症所需的高強度。

  • Furthermore, the decoupled actuators enable additional intraabdominal joint eliminating the need for complex instrument triangulation and providing surgeons with 13 degrees of freedom per instrument for advanced dexterity in near 360-degree visualization and anatomical access.

    此外,分離式致動器可實現額外的腹腔內關節,從而無需進行複雜的儀器三角測量,並為外科醫生提供每個儀器 13 個自由度,從而實現近 360 度可視化和解剖訪問的高級靈活性。

  • We are excited about the potential of our first-generation platform not only to make a meaningful impact in our initial target indication of ventral hernia repair, but also across a wide range of soft tissue procedures.

    我們對第一代平台的潛力感到非常興奮,它不僅能對我們最初的腹疝修復目標指徵產生有意義的影響,而且還能對廣泛的軟組織手術產生影響。

  • Beyond its core surgical capabilities, V1.0 lays the foundation for future advanced AI features that leverage sensing technologies such as multimodal florescent labeling, LIDAR adopt projection. Essentially the same suite of technologies used in self-driving cars today. It is our unique approach to surgical robotics that has garnered significant interest from leading U.S. hospital systems.

    除了核心的手術功能之外,V1.0 還為未來利用多模態螢光標記、雷射雷達採用投影等感測技術的先進 AI 功能奠定了基礎。本質上與當今自動駕駛汽車使用的技術相同。我們對手術機器人的獨特方法引起了美國主要醫院系統的極大興趣。

  • In 2024, we continue to expand our community of top-tier hospital system partners. We announced an agreement with Louisiana's premier academic health institutions, LSU Health New Orleans, and towards the end of the year, we officially inked partnerships with two other major academic health networks, Temple Health and University of Illinois Health. Like LSU Health, New Orleans, Temple Health and UI Health are ideal regional partners with renowned academic and training programs.

    2024年,我們將繼續擴大頂級醫院系統合作夥伴社區。我們宣布與路易斯安那州首屈一指的學術健康機構路易斯安那州立大學新奧爾良分校達成協議,並於今年年底與另外兩家主要學術健康網絡坦普爾健康和伊利諾伊大學健康中心正式簽署了合作協議。與路易斯安那州立大學健康中心、新奧爾良大學健康中心、天普大學健康中心和伊利諾大學健康中心一樣,都是擁有知名學術和培訓計畫的理想區域合作夥伴。

  • Temple Health, a leading Philadelphia academic medical center offers comprehensive care through its network of hospitals, clinics and research institutions. Their robust research infrastructure will be invaluable for post-market system evaluation and validation.

    坦普爾健康中心 (Temple Health) 是費城一家領先的學術醫療中心,透過其醫院、診所和研究機構網絡提供全面的醫療服務。他們強大的研究基礎設施對於上市後系統評估和驗證將非常有價值。

  • UI Health by the University of Illinois and Chicago is a major regional referral center with a distinguished robotics program. Their integrated network of hospitals and clinics, combined with a strong focus on research and medical education provides access to a diverse patient population and extensive clinical and robotic expertise.

    伊利諾大學和芝加哥大學的 UI Health 是一個主要的區域轉診中心,擁有傑出的機器人計畫。他們的綜合醫院和診所網絡,加上對研究和醫學教育的高度重視,為多樣化的患者群體提供了廣泛的臨床和機器人專業知識。

  • Our newest hospital system partners will be instrumental in developing and refining our medical education and training protocols equipping health care professionals to effectively utilize our technology once on market. We are excited to partner with these to advance our shared mission of improving patient care, this real-world clinical value starting later this year with our first human cases.

    我們最新的醫院系統合作夥伴將在開發和完善我們的醫學教育和培訓協議方面發揮重要作用,使醫療保健專業人員能夠在我們的技術上市後有效地利用它。我們很高興與他們合作,推進我們改善病患照護的共同使命,這現實世界的臨床價值將從今年稍後我們的第一例人體病例開始。

  • In preparation for this important milestone, our regulatory and clinical teams dedicated 2024 to developing necessary clinical protocol and evaluating potential international clinical sites.

    為了準備這一重要里程碑,我們的監管和臨床團隊致力於在 2024 年制定必要的臨床方案並評估潛在的國際臨床站點。

  • With their diligent efforts, we have narrowed down our search to a few state-of-the-art sites and are now in the process of securing institutional ethics committee approval for each respective site. Once all IEC approvals are granted, the next step in the regulatory process is to submit a comprehensive package to the Ministry of Health often referred to as a technical dossier.

    在他們的辛勤努力下,我們將搜尋範圍縮小到幾個最先進的站點,目前正在為每個站點爭取機構倫理委員會的批准。一旦獲得所有 IEC 批准,監管流程的下一步就是向衛生部提交一份綜合文件,通常稱為技術檔案。

  • This dossier will provide a thorough review of our system, addressing the key performance and safety requirements such as biocompatibility, sterility, electrical safety, functional testing and supporting cadaveric and animal data.

    該檔案將對我們的系統進行全面審查,以解決關鍵性能和安全要求,如生物相容性、無菌性、電氣安全、功能測試以及支援屍體和動物資料。

  • Now that the Version 1.0 system integration is complete, our developed team has initiated the manufacturing build-out of the instrument arms, camera and capital equipment required to support the rigorous testing schedule leading to our Ministry of Health technical dossier submission.

    現在,1.0 版系統整合已經完成,我們的開發團隊已開始製造儀器臂、攝影機和資本設備,以支援嚴格的測試計劃,從而向衛生部提交技術檔案。

  • Throughout 2024, we've made significant strides in establishing a robust scalable manufacturing foundation. We strategically built out and streamlined our internal manufacturing capabilities while simultaneously selecting key manufacturing partners to provide additional capacity and expertise. This has strengthened our supply chain and built certain redundancies to mitigate potential disruptions.

    在整個 2024 年,我們在建立強大的可擴展製造基礎方面取得了重大進展。我們策略性地建立和簡化了我們的內部製造能力,同時選擇了關鍵的製造合作夥伴來提供額外的能力和專業知識。這加強了我們的供應鏈,並建立了一定的冗餘以減輕潛在的中斷。

  • We prioritize establishing relationships with trusted partners who share our commitment to quality and precision, ensuring we have the resources and expertise needed to meet our production goals. While we've made significant progress in our procurement and build efforts during the first months of this year, we've also encountered some instances of dating components and clear to build hurdles with a select few suppliers impacting the pace of inventory buildup.

    我們優先與值得信賴的合作夥伴建立關係,他們與我們一樣致力於品質和精確度,確保我們擁有實現生產目標所需的資源和專業知識。雖然我們在今年頭幾個月的採購和建設工作中取得了重大進展,但我們也遇到了一些組件過時和少數供應商建設障礙的情況,影響了庫存積累的速度。

  • We escalated these challenges with those suppliers while also leveraging how our other suppliers and internal resources to mitigate the effort. But given the large quantities of inventory required, our schedules have experienced a limited impact. We still expect to treat our first clinical patients this year.

    我們向這些供應商提出了這些挑戰,同時也利用我們的其他供應商和內部資源來減輕努力。但考慮到所需庫存數量龐大,我們的計劃受到的影響有限。我們仍希望今年能治療第一批臨床患者。

  • However, it will be closer to year-end.

    然而,這將接近年底。

  • Consequently, we now expect our de novo submission to be late in 2026. They're focused on controlling what we are able, mitigating risks who are possible and maintaining our commitment to delivering a safe and effective product.

    因此,我們現在預計我們的重新提交將在 2026 年底。他們專注於控制我們能夠控制的事情、降低可能的風險並維持我們提供安全有效產品的承諾。

  • Now, before we turn to our 2024 financial results, I want to reiterate our excitement about our new CFO. Announced last week, Sarah Romano will officially join us on April 1. And Sarah brings decades of financial reship, including significant experience in capital markets and driving growth through fundraising and strategic transactions, most recently at Antero Therapeutics and Cira Pharmaceuticals.

    現在,在我們討論 2024 年的財務業績之前,我想重申我們對新任財務長的興奮之情。上週宣布,莎拉羅馬諾 (Sarah Romano) 將於 4 月 1 日正式加入我們。Sarah 擁有數十年的金融經驗,包括在資本市場和透過籌資和策略交易推動成長的豐富經驗,最近在 Antero Therapeutics 和 Cira Pharmaceuticals 工作。

  • We're thrilled to welcome Sarah to the Vicarious surgical team. For today, however, Randy will review our 2024 financials. I'll now turn the call over to him.

    我們非常高興歡迎 Sarah 加入 Vicarious 手術團隊。不過,今天蘭迪將回顧我們 2024 年的財務狀況。我現在將電話轉給他。

  • Randolph Clark - Analyst

    Randolph Clark - Analyst

  • Thank you, Adam, and jumping into the financials, starting with total operating expenses for full year 2024. They were $66.6 million, down 17% year-over-year. R&D expenses for the full year 2024 were $40.2 million, down from $47.6 million in 2023. General and administrative expenses totaled $21.9 million in the full year 2024 and $26.9 million in 2023. In full year 2024 sales and marketing expenses were $4.5 million compared to $6.2 million in the prior year.

    謝謝你,亞當,現在開始討論財務問題,首先是 2024 年全年的總營運費用。為 6,660 萬美元,年減 17%。2024 年全年研發費用為 4,020 萬美元,低於 2023 年的 4,760 萬美元。2024 年全年一般及行政開支總計 2,190 萬美元,2023 年為 2,690 萬美元。2024 年全年銷售和行銷費用為 450 萬美元,而前一年為 620 萬美元。

  • Adjusted net loss for the year of 2024 was $63.3 million, equating to an adjusted net loss of $10.75 per share as compared to an adjusted net loss of $76.3 million or an adjusted net loss of $15.67 per share for the prior.

    2024 年調整後淨虧損為 6,330 萬美元,相當於每股調整後淨虧損 10.75 美元,而上年調整後淨虧損為 7,630 萬美元,或每股調整後淨虧損 15.67 美元。

  • GAAP net loss for full year was $63.2 million, equating to a net loss of $10.74 per share as compared to GAAP net loss of $71.1 million or $14.60 per share for the full year 2023. For a reconciliation of all non-GAAP measures to GAAP, please review our earnings press release. our 2024 cash burn rate was $49 million, achieving a favorable variance from our original guidance of approximately $50 million. This resulted in a year-end balance of approximately $49 million in cash equivalent and short-term investments and underscoring our commitment to financial discipline.

    全年 GAAP 淨虧損為 6,320 萬美元,相當於每股淨虧損 10.74 美元,而 2023 年全年 GAAP 淨虧損為 7,110 萬美元,即每股 14.60 美元。若要了解所有非 GAAP 指標與 GAAP 指標的對照,請查看我們的收益新聞稿。我們 2024 年的現金消耗率為 4900 萬美元,與我們最初指導的約 5000 萬美元相比有了有利的差異。這使得現金等價物和短期投資的年末餘額達到約 4,900 萬美元,並強調了我們對財務紀律的承諾。

  • Looking ahead to 2025, we again anticipate a cash burn of approximately $50 million and we'll continue to actively monitor and evaluate market conditions and strategically reinforce our balance sheet at the appropriate time. We look forward to updating you in the quarters to come as we execute on our business initiatives. With that, I'll turn the call back to Adam for closing remarks. Adam?

    展望 2025 年,我們再次預期現金消耗約為 5000 萬美元,我們將繼續積極監測和評估市場狀況,並在適當的時候策略性地加強我們的資產負債表。我們期待在未來幾季內向您通報我們執行業務計劃的最新進展。說完這些,我會把電話轉回給亞當,請他做最後發言。亞當?

  • Adam Sachs - Chief Executive Officer, Co-Founder, Director

    Adam Sachs - Chief Executive Officer, Co-Founder, Director

  • Thanks, Randy. I'd like to close out by reiterating the significant progress we made throughout 2024. We successfully integrated our V1.0 system, built a robust supply chain and manufacturing foundation, forged new key partnerships with leading hospital systems and took meaningful steps who are treating our first patients this year.

    謝謝,蘭迪。最後,我想重申我們在 2024 年取得的重大進展。我們成功整合了 V1.0 系統,建立了強大的供應鏈和製造基礎,與領先的醫院系統建立了新的關鍵合作夥伴關係,並採取了有意義的措施,今年我們將治療第一批患者。

  • As of today, we have assembled instruments that are coming off the Cleanroom production line ready for testing with our capital system scheduled to be completed later this week. The excitement internally is palpable.

    截至今天,我們已經組裝好了從無塵室生產線上下來的儀器,準備進行測試,我們的資本系統計劃在本週晚些時候完成。內心的興奮之情溢於言表。

  • We eagerly look forward to providing -- excuse me, to proving out the value of our V1.0 system in the clinic later this year. a huge thanks to our dedicated team for their hard work and commitment and to our investors and other stakeholders for their continued support.

    我們熱切地期待——對不起,在今年稍後在臨床上證明我們的 V1.0 系統的價值。非常感謝我們敬業的團隊的辛勤工作和承諾,以及我們的投資者和其他利害關係人的持續支持。

  • Thank you to everyone who joined the call today. We appreciate your support and look forward to updating you on our continued progress. And with that, Cameron, we're ready for questions.

    感謝今天參加電話會議的所有人。我們感謝您的支持,並期待向您通報我們的持續進展。卡梅倫,現在我們可以回答問題了。

  • Operator

    Operator

  • (Operator Instructions)

    (操作員指示)

  • Ryan Zimmerman from BTIG.

    BTIG 的 Ryan Zimmerman。

  • Ryan Zimmerman - Analyst

    Ryan Zimmerman - Analyst

  • A good afternoon. Thanks for taking my question. Can you hear me okay? Adam?

    午安.感謝您回答我的問題。你聽見我說話嗎?亞當?

  • Adam Sachs - Chief Executive Officer, Co-Founder, Director

    Adam Sachs - Chief Executive Officer, Co-Founder, Director

  • Yeah, I can hear you.

    是的,我聽得到你的聲音。

  • Ryan Zimmerman - Analyst

    Ryan Zimmerman - Analyst

  • Okay, cool, maybejust on the supplier dynamic, just wanted to understand what specifically is being held up? And how is that impacting your ability to manufacture specifically systems for the clinical trial. And if you could talk about kind of what it does or doesn't do for your clinical trial activities this year. Start there.

    好的,很酷,也許只是關於供應商的動態,只是想了解具體是什麼被阻礙了?這對您製造臨床試驗專用系統的能力有何影響?您能否談談它對今年的臨床試驗活動有何作用或無效果?從那裡開始。

  • Randolph Clark - Analyst

    Randolph Clark - Analyst

  • Yeah, I'll -- happy to jump in, Ryan, and then I'll see if Adam has any comments to add as well. But I'd say within our supply chain, we encountered material procurement challenges with a few key suppliers. This led to delays in component deliverables, which gated our build. Just to provide an example, one of our partners sub-tier suppliers had unforeseen financial issues, creating a cascading effect and disrupting the flow of essential materials.

    是的,我很高興加入,瑞安,然後我會看看亞當是否還有任何評論要補充。但我想說,在我們的供應鏈中,我們在與一些關鍵供應商的材料採購方面遇到了挑戰。這導致組件交付延遲,阻礙了我們的建置。舉個例子,我們的一個合作夥伴的次級供應商出現了不可預見的財務問題,產生了連鎖反應並擾亂了基本材料的流動。

  • So these delayed gated items directly hindered our manufacturing progress as several of these components were we refer to them as golden screws or critical parts that we need to complete production.

    因此,這些延遲的門控項目直接阻礙了我們的製造進度,因為其中一些組件是我們完成生產所需的黃金螺絲或關鍵部件。

  • As Adam indicated, our team literally at all levels, did a great job in escalating suppliers and in leveraging our other suppliers and internal resources to minimize the impact to our time line. The good news is because I wanted to -- per the beginning part of your question, we currently have no gated items and have resumed capital and disposable production.

    正如亞當所指出的,我們各個級別的團隊在升級供應商以及利用其他供應商和內部資源以最大限度地減少對我們時間表的影響方面做得非常出色。好消息是,因為我想——根據你問題的開頭部分,我們目前沒有門控項目,並且已經恢復了資本和一次性生產。

  • Adam Sachs - Chief Executive Officer, Co-Founder, Director

    Adam Sachs - Chief Executive Officer, Co-Founder, Director

  • And I'll just kind of come on top of it here and say, that one positive of this is that we've been able to flush out every one of these challenges during this earlier build for all the essential point and can use all of those learnings and already are in the next build for the clinical.

    我在這裡只想說,這件事的一個積極方面是,我們已經能夠在早期構建過程中消除所有關鍵點的每一個挑戰,並且可以利用所有這些經驗教訓,並且已經為下一次臨床構建做好了準備。

  • Ryan Zimmerman - Analyst

    Ryan Zimmerman - Analyst

  • Okay. And so I guess that dovetails into the next question. So when do you anticipate -- I know you're narrowing down the sites now. When do you anticipate the clinical trial beginning because I think we kind of assume maybe midyear this year. Is that still the plan?

    好的。所以我想這與下一個問題相吻合。那麼您預計什麼時候——我知道您現在正在縮小網站範圍。您預計臨床試驗何時開始?我認為我們假設可能是今年年中。這還是計劃嗎?

  • And then what -- as you go through the IRB process and as you talk to the clinical sum, what kind of questions are they asking? What's their comfort level with the system as you kind of get rolling here to move into this clinical stage?

    然後呢——當您經歷 IRB 流程並與臨床主管交談時,他們會問什麼樣的問題?當您進入臨床階段時,他們對系統的舒適度如何?

  • Adam Sachs - Chief Executive Officer, Co-Founder, Director

    Adam Sachs - Chief Executive Officer, Co-Founder, Director

  • Yeah, a good question. So, first, I'll say that it's going to be later in the year that we're going to be doing our first patients. And just as a reminder, these will be outside of the pivotal. And then as quickly as we can after that, we'll kick off the pivotal but leaving room for us to have any necessary changes that we need, especially to the clinical protocol and trial protocol.

    是的,這是個好問題。首先,我要說的是,我們將在今年稍後接待第一批患者。需要提醒的是,這些都不在關鍵範圍內。然後,我們會盡快啟動關鍵工作,但也要留出空間,以便我們進行必要的更改,特別是臨床方案和試驗方案。

  • As far as feedback from the site, it's a great question. The feedback from the site has been, first of all, generally incredibly excited and engaged. I think these sites, especially in outside the US countries are equally looking forward to not only getting to try our system in a clinical setting, but also have been talking about our plans for in-country approvals.

    就網站的回饋而言,這是一個很好的問題。首先,該網站的回饋普遍令人興奮且正面。我認為這些站點,特別是美國以外的站點,同樣期待不僅在臨床環境中嘗試我們的系統,而且還一直在討論我們的國內批准計劃。

  • As well, even while our first approval will be in the US they want to be able to buy and use these, which is incredibly exciting for us to hear.

    同樣,即使我們的第一次批准是在美國,他們也希望能夠購買和使用這些產品,這讓我們非常興奮。

  • And I'll say that I personally visited a number of these sites and the engagement and reception has been incredible.

    我要說的是,我親自訪問過許多這樣的網站,它們的參與度和反響都令人難以置信。

  • Ryan Zimmerman - Analyst

    Ryan Zimmerman - Analyst

  • Okay, I'll hop back in cue. Thanks guys.

    好的,我會跳回來的。謝謝大家。

  • Operator

    Operator

  • Adam Maeder from Piper Sandler.

    派珀桑德勒 (Piper Sandler) 的亞當梅德 (Adam Maeder)。

  • Adam Maeder - Analyst

    Adam Maeder - Analyst

  • Hey Adam, Randy, Kate. Congrats on the progress in 1.0 integration. Just a couple follow on here to Ryan's line of questioning. So I guess I just wanted to make sure I'm thinking about this right in terms of supply chain. It sounds like you had some dating instances that were impacting supply chain.

    嘿,亞當、蘭迪、凱特。祝賀 1.0 整合取得進展。這裡只有幾個人繼續回答 Ryan 的提問。所以我想我只是想確保我從供應鏈的角度正確地考慮了這一點。聽起來你的一些約會狀況對供應鏈產生了影響。

  • That's now largely behind you, did I hear that correct? But still, the result of that is starting the first-in-human later in 2025. Is that a fair characterization?

    現在這基本上已經過去了,我聽得對嗎?但其結果仍是將於 2025 年稍後開始首次人體試驗。這是一個公正的描述嗎?

  • Randolph Clark - Analyst

    Randolph Clark - Analyst

  • Yes. Absolutely.

    是的。絕對地。

  • Adam Maeder - Analyst

    Adam Maeder - Analyst

  • Okay. Okay. Perfect. And I guess just in terms of the dossier submission, are you able to kind of put a -- any timing around that when we should expect you guys to submit the dossier?

    好的。好的。完美的。我想就提交檔案而言,您能否給出一個大概的時間,我們預計你們什麼時候提交檔案?

  • Adam Sachs - Chief Executive Officer, Co-Founder, Director

    Adam Sachs - Chief Executive Officer, Co-Founder, Director

  • Yeah, it will be somewhere right around the middle of this year. So that makes the -- frankly, the first patient timing it usually takes a few months to approve. And following that approval, we're going to as quickly as humanly possible, start those cases.

    是的,大概會在今年年中左右。坦白說,第一位患者入院通常需要幾個月的時間才能獲得批准。獲得批准後,我們將盡快開始處理這些案件。

  • Adam Maeder - Analyst

    Adam Maeder - Analyst

  • Okay. Fantastic. And just for the follow-up, I guess, maybe I would love to hear just a little bit more about the Version 1.0 integration, exactly kind of what that exercise entailed and what that means kind of in the grand scheme of things, number of cadaver procedures, who is driving the machine?

    好的。極好的。只是為了後續問題,我想,也許我很想聽到更多關於 1.0 版集成的信息,確切地說,這項練習包含什麼內容,以及從總體上來說意味著什麼,屍體處理程序的數量,誰在駕駛這台機器?

  • Does this mean that you have kind of officially design lock? Just would love to hear a little bit more about kind of that exercise and the confidence that gives you going forward in '25.

    這是否意味著您有一種官方設計的鎖?我很想多聽聽關於這種練習的情況,以及它給你在 25 年繼續前進的信心。

  • Adam Sachs - Chief Executive Officer, Co-Founder, Director

    Adam Sachs - Chief Executive Officer, Co-Founder, Director

  • Thank You.

    謝謝。

  • Adam Maeder - Analyst

    Adam Maeder - Analyst

  • Yeah, So true kind of final design lock will come after all the preliminary testing and all the essential performance and safety. The process was a handful of cadavers and a large number of bench tests through a series that essentially allowed us to gain confidence in the system, know if there were any changes or tweaks that we wanted to make as we ramp up manufacturing in order to do all of this testing.

    是的,真正的最終設計鎖將在經過所有初步測試以及所有必要的性能和安全性後問世。這個過程包括使用少量屍體並進行一系列台架測試,這基本上使我們對系統有了信心,知道在加大生產力度以進行所有這些測試時是否需要進行任何更改或調整。

  • So, I would say the results we're gaining a ton of confidence in the reliability of the systems, especially at the disposable instruments were very good, especially compared to creative builds and had cost of goods improvements as well that we brought in. So I'd say, overall, it's something that we're really excited about.

    因此,我想說,我們對系統的可靠性獲得了極大的信心,特別是一次性儀器非常好,特別是與創造性構建相比,並且還降低了我們引入的商品成本。所以我想說,總的來說,這是一件讓我們非常興奮的事情。

  • Thanks Adam.

    謝謝亞當。

  • Operator

    Operator

  • Josh Jennings from TD Cowen.

    TD Cowen 的 Josh Jennings。

  • Josh Jennings - Analyst

    Josh Jennings - Analyst

  • Hi, good afternoon. Thanks for taking the questions.

    嗨,下午好。感謝您回答這些問題。

  • Nice to hear about all the progress. And I wanted to just ask about the Cadaver Lab results and the success that you reported. I mean should -- is where. We were ventral hernia, maneuvers perform in the Cadaver Lab. Any other details you can just share and how important those results are in terms of future submission of the Ministry of Health and moving forward in the putting forward into the clinical trial?

    很高興聽到所有的進展。我只想詢問一下屍體實驗室的結果以及您報告的成功。我的意思是應該--在哪裡。我們患有腹疝,在屍體實驗室進行手術。能分享其他細節嗎?這些結果對於未來提交衛生部以及推動臨床試驗有多重要?

  • Adam Sachs - Chief Executive Officer, Co-Founder, Director

    Adam Sachs - Chief Executive Officer, Co-Founder, Director

  • Yeah, so these cadaver lots are performed by Dr. Bellinski and Dr. Barry Greene, our Chief Medical Officer, and they were to perform absolutely to perform ventral hernia repairs with both defect closure and mesh implantation. And overall, the certainly, the initial tests are not without some hiccups, but we were incredibly impressed, especially how smoothly mesh fixation length and the ability to sell all the way around that mesh in multiple quadrants in a very short amount of time.

    是的,這些屍體手術是由貝林斯基博士和我們的首席醫療官巴里格林博士進行的,他們絕對要進行腹部疝氣修復,包括缺損閉合和網片植入。總體而言,初步測試當然不是沒有問題,但我們印象非常深刻,尤其是網狀固定長度的平滑度以及在很短的時間內在整個網狀多個象限中銷售的能力。

  • So it's something that we're all incredibly excited and proud of.

    所以這是我們所有人都感到無比興奮和自豪的事情。

  • Josh Jennings - Analyst

    Josh Jennings - Analyst

  • Excellent. And just on the clinical trial design and when that gets locked in. Any updates there just in terms of how many patients are expected? Are there any changes to your outlook in terms of discussion -- recent discussions with the FDA or any updates?

    出色的。並且只關注臨床試驗設計以及何時確定。關於預計有多少名患者,有任何最新消息嗎?就討論而言,您的觀點有任何變化嗎——最近與 FDA 的討論或有任何更新?

  • Adam Sachs - Chief Executive Officer, Co-Founder, Director

    Adam Sachs - Chief Executive Officer, Co-Founder, Director

  • Yes, So we've done multiple pre-submissions with the FDA, leveraging the Safer Technologies program that we're a part of. And they've been very collaborative with us. So we've gone through full detailed trial design. As far as it truly gets locked and finalized, it will be after these first patients, which is a big chunk of the point of them is to be able to evaluate outside of the clinical trial.

    是的,我們利用我們參與的更安全技術計劃,向 FDA 進行了多次預先提交。他們與我們合作非常密切。我們已經完成了全面且詳細的試驗設計。至於它是否真正被鎖定和最終確定,將在第一批患者之後進行,其中很大一部分目的是能夠在臨床試驗之外進行評估。

  • Of course, you still have to report anything, but it's not evaluated as part of the actual submission package, which gives us the flexibility to make changes after our first clinical patients and before the first pivotal trial patients.

    當然,您仍然需要報告任何內容,但它不會作為實際提交包的一部分進行評估,這使我們能夠在第一批臨床患者之後和第一批關鍵試驗患者之前靈活地進行更改。

  • Josh Jennings - Analyst

    Josh Jennings - Analyst

  • Great. And I guess lastly, I think you spoke about the need to build inventory in front of clinical trial. Maybe can you just help us quantify kind of that the inventory build and how challenging we're straightforward, that process is?

    偉大的。最後,我想您談到了在臨床試驗前建立庫存的必要性。也許您能幫助我們量化庫存的建立以及這個過程有多困難嗎?

  • Randolph Clark - Analyst

    Randolph Clark - Analyst

  • Yeah, happy to jump in there. And just to reiterate some of the prior remarks as where, again, our team did a great job in escalating the procurement challenges that we spoke to leveraging our internal capabilities. And again, I want to reiterate at this point in time, we don't have gated components. So we have really focused on scaling up our testing inventory and have literally finished instruments coming off of our clean room lines.

    是的,很高興跳進去。我再次重申之前的一些評論,我們的團隊在利用內部能力應對我們談到的採購挑戰方面做得非常出色。再次,我想重申一下,我們沒有門控組件。因此,我們真正專注於擴大我們的測試庫存,並真正完成了從我們的無塵室生產線上下來的儀器。

  • As Adam mentioned as well, our first unit of surgeon console and patient console are expected to be completed at the end of this week. And for our testing our first clinical patients, I believe we stated previously, but just to reiterate, we're anticipating only needing a few capital systems and then larger amounts of the instruments correlated to that tech submission or technical dossier as well.

    正如亞當所提到的,我們的第一個外科醫生控制台和病人控制台單元預計將於本週末完成。對於我們對第一批臨床患者的測試,我相信我們之前已經說過,但只是重申一下,我們預計只需要幾個資本系統,然後需要大量與該技術提交或技術檔案相關的儀器。

  • Adam Sachs - Chief Executive Officer, Co-Founder, Director

    Adam Sachs - Chief Executive Officer, Co-Founder, Director

  • And if I can come on top just because it's, I mean this has been one of the most exciting things internally for us, it's, coming and seeing the clean room and instruments being manufactured in, quantities and coming off the line being packaged ready for sterilization.

    如果我能名列前茅,那是因為,我的意思是,這是我們內部最令人興奮的事情之一,那就是親眼目睹潔淨室和正在製造的儀器,數量眾多,下線後包裝好準備進行消毒。

  • And the capital equipment can built up with all of cosmetic covers, all of the internal wiring, it's everything is coming together. It is the single most exciting time that I've ever had in this company.

    而資本設備可以透過所有裝飾蓋、所有內部線路組裝起來,所有一切都組合在一起。這是我在這家公司度過的最令人興奮的時刻。

  • Josh Jennings - Analyst

    Josh Jennings - Analyst

  • That's good to hear. Thanks for the all the answers. Appreciate it.

    聽到這個消息真好。感謝大家的回答。非常感謝。

  • Operator

    Operator

  • (Operator Instructions) And there are no further questions waiting at this time. I would like to pass the conference back to the management team for any closing remarks.

    (操作員指示)現在沒有其他問題了。我想將會議交還給管理團隊,以便他們發表結束語。

  • Adam Sachs - Chief Executive Officer, Co-Founder, Director

    Adam Sachs - Chief Executive Officer, Co-Founder, Director

  • Yeah, I think with that, I'd just like to say thank you so much to everybody. Thank you, Cameron, for being the operator on this call. And with that, we can end.

    是的,我想,我只想向大家表達衷心的感謝。感謝卡梅倫接聽本次電話。就這樣,我們就可以結束了。

  • Operator

    Operator

  • That concludes the Vicarious Surgical's 2024 fourth quarter and full year earnings call. Thank you for your participation, and enjoy the rest of your day.

    Vicarious Surgical 2024 年第四季和全年財報電話會議到此結束。感謝您的參與,祝您今天過得愉快。