Vicarious Surgical Inc (RBOT) 2023 Q3 法說會逐字稿

Good afternoon, and welcome to Vicarious Surgical's Third Quarter 2023 Earnings Conference Call. My name is Kate, and I'll be your operator for today's call.(Operator Instructions) As a reminder, this call is being recorded for replay purposes.

下午好，歡迎參加 Vicarious Surgical 的 2023 年第三季財報電話會議。我叫凱特，我將擔任您今天通話的接線員。（接線員說明） 謹此提醒，本次通話將被錄音以供重播之用。

I would now like to turn the call over to Kaitlyn Brosco with Vicarious Surgical for a few introductory comments.

我現在想將電話轉給 Vicarious Surgical 的 Kaitlyn Brosco，請其發表一些介紹性意見。

Thanks Kate and thank you all for participating in today's call. Earlier today, Vicarious Surgical released financial results for the 3 months ended September 30, 2023. A copy of the press release is available on the company's website.

感謝凱特並感謝大家參加今天的電話會議。今天早些時候，Vicarious Surgical 發布了截至 2023 年 9 月 30 日的三個月財務業績。新聞稿的副本可在該公司網站上取得。

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 provision of the Private Securities Litigation Reform Act of 1995. Any statements contained in this call that relate to expectations or predictions 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期間發表聲明，其中包括聯邦證券法含義內的前瞻性聲明，這些聲明是根據1995 年《私人證券訴訟改革法案》的安全港條款制定的. 本次電話會議中包含的任何與對未來事件、結果或業績的預期或預測相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. 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.

所有前瞻性陳述，包括但不限於與獲得替代手術系統批准以及任何此類批准的時間表、我們的營運趨勢和未來財務業績、費用管理、市場機會和商業化有關的陳述，均基於我們當前的估計和各種假設。這些陳述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陳述預期或暗示的結果或事件有重大差異。

Accordingly, you should not place 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陳述。有關與我們業務相關的風險和不確定性的清單和描述，請參閱我們向證券交易委員會提交的文件中列出的風險因素，包括我們最新的表格 10-K 和表格 10-Q。

This conference call contains time-sensitive information that is accurate only as of the live broadcast today, November 13, 2023. Vicarious Surgical disclaims any intention or obligation, except 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（2023 年 11 月 13 日）直播時準確。除法律要求外，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義務，無論是因為新資訊、未來事件還是其他原因。

With that, I'll now turn the call over to Adam Sachs, Chief Executive Officer.

現在，我將把電話轉給執行長 Adam Sachs。

Thanks, Kate, and thank you, everyone, for joining us. The third quarter brought several successes for our business, but also introduced new challenges. Our successes included the announcement of our fourth hospital system partnership with Intermountain Health as well as completing a $47 million equity follow-on offering that significantly bolstered our balance sheet and meaningfully extended our cash runway.

謝謝凱特，也謝謝大家加入我們。第三季為我們的業務帶來了一些成功，但也帶來了新的挑戰。我們的成功包括宣布與 Intermountain Health 建立第四次醫院系統合作夥伴關係，以及完成 4700 萬美元的股權後續發行，這極大地增強了我們的資產負債表，並有意義地擴展了我們的現金跑道。

Further we are pleased with the significant progress made within the individual V1.0 subsystem bills. Currently our surgeon console, patient cart, robotic instruments and camera components are all built and functioning as subsystems.

此外，我們對各個 V1.0 子系統法案中所取得的重大進展感到高興。目前，我們的外科醫生控制台、病患推車、機器人器械和攝影機組件均作為子系統建構和運作。

Conversely, we also experienced some setbacks, challenging market conditions and their resulting pressure on our business drove us to make the difficult decision to once again downsize our team and reduced future planned spending in order to prioritize capital efficiency and better ensure our long-term success.

相反，我們也經歷了一些挫折，充滿挑戰的市場環境及其對我們業務造成的壓力促使我們做出艱難的決定，再次縮小團隊規模並減少未來計劃支出，以便優先考慮資本效率並更好地確保我們的長期成功。

Additionally, as we entered the initial system integration process, we identified certain software and hardware components of the V1.0 systems that will require additional development efforts in order to ensure system compliance, reliability and safety ahead of formal verification and validation testing.

此外，當我們進入初始系統整合流程時，我們確定了V1.0 系統的某些軟體和硬體組件需要額外的開發工作，以便在正式​​驗證和確認測試之前確保系統合規性、可靠性和安全性。

With the impact of the cost cutting initiatives, combined with some integration challenges, we predict a 12 to 18 month delay in the overall program. We believe this will ultimately push the completion of the V1.0 build, an integration to fall of 2024 and our de novo submission early to mid-2026.

由於成本削減措施的影響，再加上一些整合挑戰，我們預計整個計畫將延遲 12 至 18 個月。我們相信這最終將推動 V1.0 建置的完成、2024 年秋季的整合以及我們在 2026 年初到中期的重新提交。

Developing a surgical robot is complex and capital-intensive. It involves building multiple medical devices and integrating them so as one to perform precise procedures safely and reliably. But we always have them and remain committed to delivering the best product possible for surgeons and hospitals. We understand the importance of this announcement and will continue to provide updates as we progress through the integration process and address existing software and hardware challenges.

開發手術機器人是複雜且資本密集的。它涉及建立多種醫療設備並將它們整合在一起，以便安全可靠地執行精確的手術。但我們始終擁有它們，並繼續致力於為外科醫生和醫院提供最好的產品。我們了解此公告的重要性，並將隨著整合過程的進展並解決現有的軟體和硬體挑戰而繼續提供更新。

We have a powerfully, differentiated technology and a unique opportunity to revolutionize robotic surgery. Over the recent months, we've had the opportunity to attend medical meetings such as the American Hernia Society as well as our internal hospital partner summit.

我們擁有強大的差異化技術和獨特的機會來徹底改變機器人手術。最近幾個月，我們有機會參加美國疝氣協會等醫學會議以及我們內部醫院合作夥伴高峰會。

Throughout these engagements, one common theme emerged. Surgeons and hospitals are hungry for a new truly differentiated surgical platform and even more importantly, there is strong excitement around the unique Vicarious Surgical offering. Despite our recent challenges, I continue to be enthusiastic about our mission and our potential to improve patient lives.

在這些活動中，出現了一個共同的主題。外科醫生和醫院渴望一個新的真正差異化的手術平台，更重要的是，人們對獨特的 Vicarious Surgical 產品感到非常興奮。儘管我們最近面臨挑戰，但我仍然對我們的使命和改善患者生活的潛力充滿熱情。

With that, I will now turn the call over to Bill Kelly to review our financial performance.

現在，我將把電話轉給比爾凱利，以審查我們的財務表現。

Thanks, Adam. Over the course of this year, we have taken the necessary steps to appropriately adjust our costs to better align the challenging economic conditions, we and other similar early-stage companies have been and are continuing to experience.

謝謝，亞當。今年，我們採取了必要的措施，適當調整我們的成本，以更好地適應充滿挑戰的經濟條件，我們和其他類似的早期階段公司已經並將繼續經歷這種情況。

That being the case, total operating expenses for the third quarter of 2023 were down slightly at $21.4 million compared to $22.2 million in the third quarter of 2022. General and administrative expenses, as well as sales and marketing expenses were down year over year. G&A expenses in the third quarter were $6.9 million compared to $8.1 million in the prior year quarter. And sales and marketing expenses were $1.4 million in the third quarter compared to $1.9 million in the third quarter of 2022.

在這種情況下，2023 年第三季的總營運費用略有下降，為 2,140 萬美元，而 2022 年第三季為 2,220 萬美元。一般和管理費用以及銷售和行銷費用同比下降。第三季的一般管理費用為 690 萬美元，去年同期為 810 萬美元。第三季銷售和行銷費用為 140 萬美元，而 2022 年第三季為 190 萬美元。

The only operating expense line item up year-over-year was R&D as we continue to invest in the critical product development aspects of our business. R&D expenses for the third quarter was $13 million, up 8% compared to $12.1 million in the prior year. GAAP net loss for the third quarter was $15.7 million equating to a net loss of $0.10 per share. This compares to a net loss of $24.7 million or a net loss of $0.20 per share respectively, for the same period in the prior year. Adjusted net loss for the third quarter of 2023 was $20.4 million, equating to an adjusted net loss of $0.12 per share as compared to an adjusted net loss of $21.7 million or an adjusted net loss of $0.18 per share for the same period in the prior year.

唯一同比增長的營運費用項目是研發，因為我們繼續投資於業務的關鍵產品開發方面。第三季研發費用為 1,300 萬美元，較上年同期的 1,210 萬美元成長 8%。第三季 GAAP 淨虧損為 1,570 萬美元，相當於每股淨虧損 0.10 美元。相比之下，去年同期的淨虧損為 2,470 萬美元，每股淨虧損為 0.20 美元。 2023年第三季調整後淨虧損為2,040萬美元，相當於調整後淨虧損為每股0.12美元，而上年同期調整後淨虧損為2,170萬美元，調整後淨虧損為每股0.18美元。

For a reconciliation of all non-GAAP measures to GAAP, please review our earnings press release. At the end of the third quarter, cash, cash equivalents and short-term investments were approximately $110 million, including the $47 million in gross follow-on proceeds. Including these proceeds, third quarter cash burn was $16.8 million, and we now expect full year 2023 cash burn to be between $60 million and $65 million, which is on the higher end of our previously communicated guidance range. Taking into account our recent cost cutting initiatives, we now estimate preliminary full year 2024 cash burn to be between $40 million and $55 million and cash runway out to Q1 2026.

有關所有非公認會計準則衡量標準與公認會計準則的調整，請查看我們的收益新聞稿。截至第三季末，現金、現金等價物和短期投資約為 1.1 億美元，其中包括 4,700 萬美元的後續收益總額。包括這些收益在內，第三季現金消耗為 1,680 萬美元，我們現在預計 2023 年全年現金消耗將在 6,000 萬美元至 6,500 萬美元之間，這是我們先前傳達的指導範圍的高端。考慮到我們最近的成本削減舉措，我們現在估計 2024 年全年的初步現金消耗將在 4,000 萬至 5,500 萬美元之間，現金跑道將持續到 2026 年第一季。

I'll again reiterate Adam's sentiment that the third quarter brought both new successes and challenges for the business, but we remain committed to acting in the best interest of shareholders and therefore have taken the necessary steps to better position the company to be successful in the long run.

我將再次重申亞當的觀點，即第三季度為公司帶來了新的成功和挑戰，但我們仍然致力於以股東的最佳利益行事，因此已採取必要的措施，以更好地定位公司，以便在長跑。

I'll now turn the call back over to Adam for closing remarks.

現在我將把電話轉回給 Adam 作結束語。

Thank you, Bill. I'd like to close by thanking all Vicarious Surgical employees for their hard work and dedication. Although there are still challenges that remain, I'm confident that our team will rise to the occasion and deliver an exceptional product. There is still much to be excited about.

謝謝你，比爾。最後，我要感謝所有 Vicarious Surgical 員工的辛勤工作和奉獻精神。儘管仍有挑戰，但我相信我們的團隊將迎難而上並提供卓越的產品。還有很多值得興奮的事。

With that, we'll be happy to take questions. Kate?

這樣，我們將很樂意回答問題。凱特？

Thank you. (Operator Instructions) T

謝謝。 （操作員說明）T

Ryan Zimmerman, BTIG.

瑞安·齊默爾曼，BTIG。

Thanks for taking my question. Good afternoon. So I guess to start, wondering if we can kind of walk through milestones with the impact of timing in terms of a clinical trial, when do you expect to complete that? And most importantly, do you think you have sufficient cash to get through that trial, based on the timing you just said, Bill, first quarter '26 before you submit what are your de novo plans?

感謝您提出我的問題。午安.所以我想先想知道我們是否可以透過臨床試驗的時間影響來完成里程碑，您預計什麼時候完成？最重要的是，根據你剛才所說的時間，比爾，在你提交你的從頭計劃之前，你認為你有足夠的現金來完成該試驗嗎？比爾，26 年第一季？

Thanks for the question, Ryan. So to start with the milestones that we're looking at into the near future, some of the most important milestones that we'll be having over just the next 12 months, will be around our V1.0 system. So we're in the midst of integration right now. We're hitting some speed bumps as we bring all of these subsystems together, but we expect them to be up and running fairly shortly, and we'll be doing our first cadaver procedures with the system next spring.

謝謝你的提問，瑞安。因此，從我們正在考慮的不久的將來的里程碑開始，我們將在接下來的 12 個月內實現的一些最重要的里程碑將圍繞我們的 V1.0 系統。所以我們現在正處於整合之中。當我們將所有這些子系統整合在一起時，我們遇到了一些減速帶，但我們預計它們很快就會啟動並運行，並且我們將在明年春天使用該系統進行第一個屍體程序。

We're then thinking that likely will have some remediation to perform with our system, and we'll be doing that over the summer and that's all in anticipation of our first clinical patients, in our first clinical use, which will be in the mid to late 2025. So that's getting pushed back out approximately 12 months. And that'll all be with multiple clinical patients that following that in our OUS clinical trial and then an FDA de novo submission in early to mid-2026. And before I hand it over to Bill, I'd also like to emphasize that and the entire goal of these changes was to make our Company significantly more efficient and more streamlined, to give us -- to get us as far as possible with the capital that we have, given our current market cap and the huge change in ratio of burn to market cap that occurred over the last quarter. So Bill?

然後我們認為我們的系統可能需要進行一些補救措施，我們將在整個夏天進行這項工作，這一切都是為了我們的第一批臨床患者的預期，在我們的第一次臨床使用中，這將在中期進行到 2025 年底。因此，這一時間被推遲了大約 12 個月。這一切都將在我們的 OUS 臨床試驗中針對多名臨床患者進行，然後在 2026 年初至中期向 FDA 重新提交。在我將其交給比爾之前，我還想強調一點，這些變革的總體目標是使我們公司的效率和精簡程度顯著提高，讓我們盡可能地實現考慮到我們目前的市值以及上個季度燒錢與市值之比的巨大變化，我們擁有的資本。那麼比爾?

Yeah, just to echo that, I think we want to make sure that we remain prudent with our fiscal spend and that's really the lens that we continue to look at our spending this quarter as we always do. So as we have given guidance that cash burn will be $40 million to $55 million in 2024, and that should get us into 2026 as well.

是的，只是為了回應這一點，我認為我們希望確保對財政支出保持謹慎，這確實是我們一如既往地繼續審視本季支出的視角。因此，正如我們所給予的指導，2024 年現金消耗將達到 4,000 萬至 5,500 萬美元，這也應該讓我們進入 2026 年。

Okay. And then just more specifically, what did you cut back on and just going from $60 million to $65 million down to $40 million to $35 million, what's the delta that you're giving up there?

好的。更具體地說，你削減了什麼，從 6000 萬美元到 6500 萬美元減少到 4000 萬美元到 3500 萬美元，你要放棄的增量是多少？

So we made pretty significant cuts to our team as well as to external spending. Within our team, we've had a very large change over the course of this year, including two reductions overall to the total team size. The first reduction, as you'll recall, was really targeted at non R&D functions and then decreasing external R&D spending. And then this was significantly R&D functions as well as significant outsourced R&D spending that was throughout the budget, most of the functions that we've cut, our functions that are parallel effort, functions where we're working on remediating things that we expect to come up, taking the top 10 issues or areas like that and coming up with remediation in anticipation of challenges. Instead, we're going to do this in much more serial more capital efficient, but slower method have a waiting till the issues come up and then remediating them at that time.

因此，我們對團隊和外部支出進行了相當大的削減。在我們的團隊內部，今年我們發生了很大的變化，包括團隊總規模的兩次縮減。您可能還記得，第一次削減實際上是針對非研發職能，然後減少外部研發支出。然後，這是重要的研發職能以及整個預算中的大量外包研發支出，我們削減的大部分職能，我們並行工作的職能，我們正在努力糾正我們期望的事情的職能提出，找出排名前10 的問題或類似領域，並針對挑戰提出補救措施。相反，我們將以更連續、更資本效率、但更慢的方法來執行此操作，等待問題出現，然後在那時進行修復。

Okay, got it. Thanks for taking the question.

好，知道了。感謝您提出問題。

Thank you. Adam Maeder, Piper Sandler.

謝謝。亞當梅德，派珀桑德勒。

Hi, guys. Thank you for taking the questions here. Maybe just to start, I guess the first one would be following on Ryan's question just on cash runway, and maybe I'll ask it a little bit different, but the from the [IDE] study for ventral hernia, do you guys have any kind of just rough ring-fence around spend there? I mean, how do we think about the cost of that study? And then I had a follow-up or two

嗨，大家好。感謝您在這裡提出問題。也許只是開始，我想第一個問題會是關於瑞安在現金跑道上提出的問題，也許我會問得有點不同，但是從 [IDE] 腹疝氣研究來看，你們有什麼問題嗎？那種只是粗糙的圍欄周圍花在那裡？我的意思是，我們如何考慮這項研究的成本？然後我進行了一兩次後續行動

Yeah, we haven't given the external guidance on what that would be. But as we have talked about, it's going to be about a 30 to 60 patient trial, probably closer to the 35, hopefully. It's within the guidance that we would have earned that we provided here, it's probably less than a month's worth of burn.

是的，我們還沒有給出關於具體內容的外部指導。但正如我們所討論的，這將是一項涉及 30 到 60 名患者的試驗，希望可能接近 35 名患者。這在我們在這裡提供的指導範圍內，可能還不到一個月的消耗量。

Okay, that's helpful, Bill, thank you for that. And then I guess just in terms of the integration process and trying to better understand exactly kind of some of the bottlenecks or speed bumps that you're hitting, I heard comments referring to both software and hardware components. Maybe just flesh that out for us in a little bit more detail and what's being done to remedy those? Thanks.

好的，這很有幫助，比爾，謝謝你。然後我想就整合過程而言，並試圖更好地理解您所遇到的一些瓶頸或減速帶，我聽到了有關軟體和硬體組件的評論。也許只是更詳細地為我們充實這一點，以及正在採取哪些措施來補救這些問題？謝謝。

Yeah, so the V1.0 system, as we've mentioned in the past, is our kind of, ground up re-architecting of the Beta 2 system, the Beta 2 was the final prototype had all the functionality we needed, got great reviews from our hospital partners and surgeons. And over the course of the last year and a half has been re-architected and redesigned it to into the V1.0 system product that we have today.

是的，所以 V1.0 系統，正如我們過去提到的，是我們對 Beta 2 系統的徹底重新架構，Beta 2 是最終的原型，擁有我們需要的所有功能，非常棒我們的醫院合作夥伴和外科醫生的評論。經過一年半的時間，我們對其進行了重新架構和重新設計，成為我們今天擁有的V1.0系統產品。

That system the way to think about, it's somewhere around eight or so, depending on how you slice it different fairly complex medical devices and patient carts, surgeon console, arms, the [GUI] and the camera, et cetera. And each of those has been designed by their own subsystem team, brought up and is running effectively. And as they're all being integrated together as we use the term integration phase, we're starting to encounter some bugs and some issues across the system.

該系統的思考方式是，大約有八個左右，具體取決於您如何將其分割為不同的相當複雜的醫療設備和患者推車、外科醫生控制台、手臂、[GUI] 和相機等。其中每一個都是由自己的子系統團隊設計、建立並有效運作的。當我們使用術語整合階段時，它們都被整合在一起，我們開始在整個系統中遇到一些錯誤和問題。

So overall, most components are functioning effectively, but we're starting to encounter some software challenges which are then as things come up, uncovering some hardware challenges. They're nothing that's particularly significant, hence why we're looking at instead of around now having it integrated looking at next spring. So really just a one or probably two quarter delay there and the rest being the anticipated impact of reduced spending and our inability to pre-emptively resolve challenges, that may come up.

總體而言，大多數組件都可以有效運行，但我們開始遇到一些軟體挑戰，隨著事情的發展，會發現一些硬體挑戰。它們並不是特別重要，因此我們現在考慮而不是現在就在明年春天將其整合起來。因此，實際上只是一個或兩個季度的延遲，其餘的是支出減少的預期影響以及我們無法先發制人地解決挑戰的能力，這可能會出現。

That's helpful color, thanks, Adam. And if I could just sneak in one more another kind of follow-on to Ryan's question just around the organization. Can you be a little bit more specific in terms of what the R&D org looks like, kind of at the beginning of the year versus where we are today, just trying to get a better understanding through kind of the magnitude of the reduction and how many folks are currently working on the development of the system.

這是有用的顏色，謝謝，亞當。如果我能就瑞安在組織中提出的問題再提出另一種後續問題的話。您能否更具體地介紹一下研發組織的情況，例如年初與今天的情況，只是想透過削減的幅度和數量來更好地了解人們目前正在致力於該系統的開發。

Thank you for taking the questions.

感謝您提出問題。

Yeah, I don't have the exact numbers in front of me, but it is -- we started the [air ballpark] of 230 people and reduced to about 130, and that is just the internal, we obviously indexed more on external reduction than internal reduction for capital efficiency reasons.

是的，我面前沒有確切的數字，但確實如此——我們開始了 230 人的[空中棒球]，然後減少到大約 130 人，這只是內部的，我們顯然在外部減少上索引了更多而非出於資本效率原因的內部削減。

I would say if you look at, people touching the product between operations, quality, R&D, all those sorts of things, that's probably 70%, 75% of the business are people touching product, still in this reduced headcount?

我想說，如果你看一下，人們在營運、品質、研發以及所有這些事情之間接觸產品，這可能是 70%、75% 的業務是人們接觸產品，但仍然在減少人員數量嗎？

Thanks for the color, guys.

謝謝你們的顏色。

Yeah, thanks for the question here.

是的，謝謝你在這裡提問。

Josh Jennings, TD Cowen.

喬許·詹寧斯，TD·考恩。

Yeah, good afternoon, thank you. I was hoping, Adam, just to ask about verification and validation testing. And I know there's a process it and you've mapped out these timelines that includes the [DNB] assuming, but I guess, where does that stand? And is there any timeline specifically for verification validation, I guess, and then the real point of the question is to ask that on the manufacturing side, my understanding is the and the agency has to control, manufacturing systems are in place and where does that stand today? And when do you plan to have a feel to be done in manufacturing in a place where you can move forward?

是的，下午好，謝謝。亞當，我只是希望詢問有關驗證和驗證測試的問題。我知道有一個流程，而且您已經制定了這些時間表，其中包括 [DNB] 假設，但我想，這是什麼意思？我想，是否有專門用於驗證驗證的時間表，然後問題的真正要點是問在製造方面，我的理解是，機構必須控制，製造系統已經到位，在哪裡今天站著嗎？您打算什麼時候在一個可以前進的地方感受到在製造業中完成的工作？

Yes, really good question. So some of the kind of the timeline after the V1.0 is integrated and up and running is all about verification and validation, begins with less formal and with subsystems and then it culminates in summative testing, which is kind of the end of system level of validation for the product. So the way to think about most of the work that we'll be doing any remediation after next spring. It is all about the system, how it performs in our kind of preliminary DNB testing that we perform on the subsystems evaluating that finding any issues that might occur in DNB, and then burning those issues down and remediating them in order to decrease the risk of the DNB process.

是的，確實是個好問題。因此，V1.0 整合、啟動和運行後的某些時間軸都是關於驗證和驗證，從不太正式的子系統開始，然後以總結性測試結束，這是系統層級的結束產品的驗證。因此，我們要考慮明年春天之後我們將進行的大部分補救工作。這一切都與系統有關，它在我們對子系統進行的初步 DNB 測試中的表現如何，評估發現 DNB 中可能發生的任何問題，然後解決這些問題並進行修復，以降低出現問題的風險。DNB 流程。

So one of the benefits, if I can call it that of that time line shift here is decreasing some of the risk and pulling some of the risk out of the DNB process and into the earlier process of these remediation in the V1.0 builds. As far as manufacturing, that part of what needs to be all in place. And we are well underway with our CM partners as well as internally in order to build all of that out. So especially given the, what we're discussing on today's call. I certainly don't anticipate any challenges with that from a timeline perspective.

因此，如果我可以稱之為時間軸轉移的好處之一，那就是降低了一些風險，並將一些風險從 DNB 流程中拉出來，轉移到 V1.0 版本中這些修復的早期流程中。就製造而言，這部分需要全部到位。我們正在與我們的 CM 合作夥伴以及內部進行良好的合作，以實現這一切。特別是考慮到我們今天的電話會議所討論的內容。從時間軸的角度來看，我當然預期不會遇到任何挑戰。

Excellent. And then wanted to just ask about the integration challenges and where you stood earlier in the year in terms of locking in on V1.0 and the design and the go forward, does this delay was it caused or is there an opportunity to explore differentiated visualization sensing, the data collection enhancements for the system relative to where you started or as you continue down the line in terms of what you had locked in from a design standpoint from V1.0 earlier in the year. Thanks for taking the questions.

出色的。然後想問整合挑戰，以及您今年早些時候在鎖定 V1.0 和設計以及前進方面處於什麼位置，這種延遲是造成的還是有機會探索差異化可視化感測，系統的數據收集增強功能相對於您開始時的位置或隨著您從今年早些時候從V1.0 的設計角度鎖定的內容繼續下去。感謝您提出問題。

Yeah, it's a fair question on. There's a lot of things that we're really excited about as you guys know, from an advanced visualization standpoint, we're making sure that we can roll all of those things and shortly after our initial launch that have being said, given the reduction in resources, our focus right now is almost entirely on remediating any of the challenges that we've faced and then setting ourselves up for success through the DNB process and through FDA authorizations.

是的，這是一個公平的問題。正如你們所知，有很多事情讓我們感到非常興奮，從高級視覺化的角度來看，我們確保我們可以在我們最初發布後不久推出所有這些事情，考慮到減少在資源方面，我們現在的重點幾乎完全是解決我們所面臨的任何挑戰，然後為我們透過DNB 流程和FDA 授權取得成功做好準備。

Understood. Thank you.

明白了。謝謝。

Caitlin Cronin with Canaccord Genuity.

凱特琳·克羅寧 (Caitlin Cronin) 與 Canaccord Genuity。

Hi, thanks for taking the question. Just to start off in terms of clinical trial plans, are there any changes for your plans for pursuing other indications

您好，感謝您提出問題。首先就臨床試驗計劃而言，您追求其他適應症的計劃是否有任何變化

No, not at this time, other than, that would be a obviously expected way back time line change, that we're discussing. We're still going to pursue other indications as quickly as we can. Frankly, the OUS opportunity gives us the ability to do that significantly more equally, and we are taking the extra time that we have now with our clinical engineering team to evaluate all these other procedures and really built as best we can in anticipation effects.

不，不是在這個時候，除了，這顯然是我們正在討論的時間線變化的預期方式。我們仍將盡快尋找其他跡象。坦白說，OUS 的機會使我們能夠更加平等地做到這一點，我們正在利用我們的臨床工程團隊現在擁有的額外時間來評估所有這些其他程序，並真正盡可能地建立預期效果。

Got it, okay. And then any kind of risk to current or future hospital or surgeon partnerships given kind of this delayed timeline?

明白了，好吧。那麼，考慮到這種延遲的時間表，當前或未來的醫院或外科醫生合作夥伴關係是否會面臨任何風險？

Yeah, I think the risk is relatively low, but there is always some risk, it's a competitive market. That being said, our hospital partners have been incredibly supportive of what we're doing. What we're doing remain very differentiated and frankly, my personal biggest disappointment and are taking extra time here is that it will take that much longer for us to be able to deliver this really important product for our hospital and surgeon partners, they need it.

是的，我認為風險相對較低，但總是有一些風險，這是一個競爭激烈的市場。話雖這麼說，我們的醫院合作夥伴非常支持我們所做的事情。我們正在做的事情仍然非常差異化，坦率地說，我個人最大的失望和在這裡花費額外的時間是，我們需要更長的時間才能為我們的醫院和外科醫生合作夥伴提供這種非常重要的產品，他們需要它。

Got it. Thanks for taking the questions.

知道了。感謝您提出問題。

Yeah, thank you.

是的，謝謝。

Thank you. At this time, there are no additional questions registered in the queue.

謝謝。目前，隊列中沒有登記任何其他問題。

So that will conclude today's Q&A session as well as today's conference call. Thank you all for your participation, and you may now disconnect your lines.

今天的問答環節和電話會議就到此結束。感謝大家的參與，現在您可以斷開線路了。