Q4 2024 Vicarious Surgical Inc Earnings Call

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Cameron: 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.

Cameron: Good afternoon. Thank you for attending the vicarious Surgical's 2020 for fourth quarter and full year earnings call. My name is Cameron and I will be your moderator for today all lines will be muted during the presentation portion of the call with an opportunity for question and answers at the end. If you would like to ask a question. Please press star followed by <unk>.

Cameron: All lines will be muted during the presentation portion of the call with an opportunity for questions and answers at the end. If you would like to ask a question, please press star followed by one on your telephone keypad.

One on your telephone keypad.

Kaitlyn Brosco: I would now like to pass the conference over to your host, Kaitlyn Brosco, Director of IR. You may proceed. Thank you, Cameron. And thank you all for joining.

Now like to pass the conference over to your host Caitlin <unk> director of IR you May proceed.

Cameron: Okay.

Cameron: Thank you Catherine and thank you all for joining.

Kaitlyn Brosco: With me on today's call is Adam Sachs, Co-Founder and Chief Executive Officer and Randy Clark, Company President.

Cameron: With me on today's call is Adam co founder and Chief Executive Officer, Randy Clark Company comparable.

Kaitlyn Brosco: Today after market closed, Vicarious Surgical released financial results for the three months and full year ended December 31, 2024. A copy of the press release is available on the company website.

Cameron: Today after market close by Jerry first of all of the financial results for the three months and full year ended December 31, 2020, correct copy of the press release is available on the company website.

Kaitlyn Brosco: 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 that relate to expectations of creation of future events, results, or performance are forward-looking statements. All forward-looking statements, including, without limitation, those relating to obtaining approval for the vicarious surgical system and timing for any such approval, are operating trends in future financial performance, expense management, market opportunity, and commercialization are based upon our current estimates and various assumptions.

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 law.

Cameron: They are made pursuant to the safe Harbor provisions of the private Securities Litigation Reform Act.

Cameron: Any statements contained in this call that relate to expectations of future events results or performance are forward looking statements.

Cameron: All forward looking statements, including without limitation those relating to obtaining approval for the vicarious physical system.

Cameron: Tiny for any such approval, our operating trends and future financial performance expense management market opportunity and commercialization are based upon our current off necessary Samsung.

Kaitlyn Brosco: These statements involve material risks and uncertainties that cause actual results or events to materially differ from those anticipated or implied by these forward-looking statements. Accordingly, you should not place any undue reliance on these statements.

Cameron: <unk> 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. Accordingly, you should not place any undue reliance on these statements.

Kaitlyn Brosco: 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.

Cameron: 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.

Cameron: Including our most recent Form 10-K Form 10-Q.

Kaitlyn Brosco: This conference call contains time-sensitive information and is accurate only as of the live broadcast today, March 17, 2025. Vicarious Surgical disclaims any intention or obligation, 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.

Cameron: This conference call contains time sensitive information.

Cameron: Current only as of the live broadcast today March 17 2025.

Adam: Surgical disclaims any intention or obligation, 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 I will now hand, the call over to Adam for prepared remarks.

Adam Sachs: I'll now hand the call over to Adam for prepared remarks. Thanks, Kate. Good morning, everyone. And welcome. Good afternoon, everyone.

Adam: Thanks Keith.

Adam: Good morning, everyone and welcome and good.

Adam Sachs: And welcome to our fourth quarter and full year 2024 earnings call. We appreciate you joining us today.

Adam: Good afternoon, everyone and welcome to our fourth quarter and full year 2024 earnings call. We appreciate you joining us today and by carrier surgical our mission is to improve lives by transforming robotic surgery and 2024 was a pivotal year in advancing that mission.

Adam Sachs: At Vicarious Surgical, our mission is to improve lives by transforming robotic surgery. And 2024 was a pivotal year in advancing that mission. Throughout the past year, we achieved a number of key development, regulatory and commercial milestones that have positioned us incredibly well 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 2025 marks our transition into a clinical stage company.

Adam: The past year, we achieved a number of key development regulatory and commercial milestones that are positioned incredibly well for continued success in 2025.

Adam: We'll discuss in more detail today these accomplishments have.

Adam: Laid the groundwork for what we believe will be a truly transformative year ahead.

Adam: At 25 marks our transition into a clinical stage company.

Adam Sachs: Our most anticipated milestone in 2024 was the successful completion of our version 1.0 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 this key development milestone. We're thrilled to share this cadaver lab with the success, demonstrating the functionality and performance of our V1.0 system in a cadaveric preclinical static. This achievement represents a significant step forward in bringing our innovative robotic surgery platform to market and validates the hard work and dedication of our entire 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.

Adam: Our most anticipated milestone in 2024 was the successful completion of our version one point of system integration.

Adam: As you May recall from our last earnings call. We were just a week away from our year end Cadaver lab, a critical event that would signify the achievement of the key development milestones were thrilled to share that today have elaborate the success demonstrating a functionality and performance of our <unk> system and a cat of Barrick preclinical static.

Adam: <unk> 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.

Adam: The version one point our system the platform, we intend to use in our first clinical use is uniquely architected to deliver differentiated value to patients surgeons and hospitals are proprietary decoupled actuators provide a novel mechanism of action.

Adam Sachs: Our proprietary decoupled actuators provide a novel mechanism of action, separating it apart from anything currently available. This innovative design allows our system to achieve minimally invasive outcomes to a single small 18 millimeter incision, while still generating the high forces necessary to address a broad range of soft tissue indication. Furthermore, the decoupled actuators enable additional intraabdominal joints, eliminating the need for complex instrument triangulation and providing surgeons with 13 degrees of freedom for instruments for advanced dexterity and near 360 degrees visualization and anatomical accuracy. We are incredibly 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.

Adam: Operating and apart from anything currently available.

Adam: This innovative design allows our system to achieve minimally invasive outcome through a single small 18 millimeter and Susan while still generating the high forces necessary to address a broad range of soft tissue indications.

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

Adam: We are incredibly excited about the potential.

Adam: Our first generation platform not only to make a meaningful impact in our initial target indication in ventral hernia repair, but also across a wide range of soft tissue procedure.

Adam Sachs: Beyond its core surgical capabilities, the Virgin 1.0 lays the foundation for future advanced AI features that leverage sensing technologies such as multimodal fluorescent wavelengths, LiDAR and dot 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. hospitals.

Adam: Beyond its core surgical capability the version one point, though.

Adam: As the foundation for future advanced AI features that leverage sensing technologies, such as multi modal fluorescence labeling lidar adopt protection essentially the same suite of technologies used in self driving cars today.

Adam: It is our unique approach to surgical robotics that has garnered significant interest from leading U S Hospital.

Adam Sachs: In 2024, we continue to expand our community of top tier hospital system partners. We announced an agreement with Louisiana's premier academic health institution, LSU Health New Orleans, and toward 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. 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.

Adam: In 2024, we continue to expand our community of top Tier Hospital system partners, We announced an agreement with Louisiana Premier academic health institutions, LSU help New Orleans and towards the end of the year, we officially inked partnership with two other major academic.

Adam: Health Networks Company, excuse me Temple Health and University of Illinois Health.

Adam: Like LSU Health, New Orleans Temple Health and <unk> health are ideal regional partners with renowned academic and training program tempo health, a leading Philadelphia academic Medical Center offers comprehensive care through its network of hospitals clinics and research institutions.

Adam: Our robust research infrastructure will be invaluable for post market system evaluation and validation.

Adam Sachs: UI Health, anchored by the University of Illinois in 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. Our newest hospital system partners will be instrumental in developing and refining our medical education and training protocols, equipping healthcare professionals to effectively utilize our technology once on market.

Speaker Change: You I hope anchored by the University of Illinois, and Chicago is a major regional referral center with a distinguished Robotics program.

Speaker Change: Our integrated network of hospitals and clinics combined with a strong focus on research and medical education.

Speaker Change: <unk> access to a diverse patient populations and extensive clinical and robotic expertise.

Speaker Change: Our newest hospital system partners will be instrumental in developing and refining our medical education and training protocols equipping healthcare professionals to effectively utilize our technologies one on market.

Adam Sachs: We're excited to partner with these esteemed experts to advance our shared mission of improving patient care and look forward to demonstrating this real world clinical value starting later this year with our first human cases.

Speaker Change: We are excited to partner with these esteemed experts to advance our shared mission of improving patient care and look forward to demonstrating this real world clinical value. Starting later this year with our first human cases.

Adam Sachs: In preparation for this important milestone, our regulatory and clinical team dedicated 2024 to developing necessary clinical protocol and evaluating potential international clinical sites. 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. 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.

Speaker Change: In preparation for this important milestone our regulatory and clinical team dedicated 2024 to developing necessary clinical protocol and evaluating potential international clinical sites.

Speaker Change: 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 state.

Speaker Change: Once all IEC approval granted the next step in our regulatory process is to submit a comprehensive package to the ministry of health often referred to as a technical dossier. This.

Speaker Change: <unk> will provide a thorough review of our system addressing the key performance and safety requirements such as biocompatibility.

Speaker Change: <unk> electrical safety functional testing and supporting cat of Eric and animal data.

Adam Sachs: Now that the version 1.0 system integration is complete, our development 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.

Speaker Change: Now that the version one point our system integration is complete our development team has initiated the manufacturing build out of the instrument arm camera and capital equipment required to support the rigorous testing scheduled leading to our ministry of health technical dossier submission.

Adam Sachs: 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 disruption. 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 month of this year, we've also encountered some instances of gating components and clear to build hurdles with a select few suppliers impacting the pace of inventory buildup.

Speaker Change: Throughout 2024, we've made significant strides in establishing a robust scalable manufacturing foundation.

Speaker Change: We strategically built out and streamlined our internal manufacturing capabilities, while simultaneously selecting key manufacturing partners to provide additional capacity and expertise.

Speaker Change: It strengthened our supply chain and built certain redundancies to mitigate potential disruption.

Speaker Change: 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.

Speaker Change: While we made significant progress in our procurement and build efforts during the first months of this year. We've also encountered some instances of data components and cleared to build hurdles with a select few suppliers impacting the pace of inventory buildup. We escalated these challenges with those suppliers, while also leveraging our other.

Adam Sachs: We escalated these challenges with those suppliers while also leveraging 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.

Speaker Change: Suppliers and internal resources to mitigate the effort, but given the large quantities of inventory required are scheduled to have experienced a limited impact.

Adam Sachs: We still expect to treat our first clinical patient this year. However, it'll be closer to year end.

Speaker Change: We still expect to treat our first clinical patients. This year, however, it'll be closer to year end.

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

Speaker Change: Consequently, we now expect our de Novo submission to be late in 2026.

Speaker Change: We're focused on controlling what we are able mitigating risks where possible and maintaining our commitment to delivering a safe and effective product.

Adam Sachs: Now, before we turn to our 2024 financial results, I want to reiterate our excitement about our new CFO.

Speaker Change: Now before we turn to our 2024 financial results I want to reiterate our excitement.

Speaker Change: About our new CFO.

Adam Sachs: As we announced last week, Sarah Romano will officially join us on April 1st. Sarah brings decades of financial leadership, including significant experience in capital markets and driving growth through fundraising and strategic corporate transactions. Most recently, at Intero Therapeutics and Kira Pharmaceuticals.

Speaker Change: As we announced last week zero or amount of wealth officially joined us on April one.

Speaker Change: Tara brings decades of financial leadership, including significant experience in capital markets and driving growth through fund raising and strategic corporate transactions.

Speaker Change: Most recently at Antero Therapeutics and Keira Pharmaceuticals.

Adam Sachs: We're thrilled to welcome Sarah to the Vicarious Surgical.

Speaker Change: We're thrilled to welcome Sarah if I carry surgical team.

Randy Clark: For today, however, Randy will review our 2024 financials.

Speaker Change: For today, However, Randy will review, our 2024 financials I'll now turn the call over to him.

Randy Clark: I'll now turn the call over. Thank you, Adam. And jumping into the financial 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, down from $26.9 million in 2023. and full year 2024 sales and marketing expenses were $4.5 million compared to $6.2 million in the prior year. Adjusted net loss for the full year 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 year.

Randy: 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.

Randy: R&D expenses for the full year, 2024, or $42 million down from $47 6 million in 2023.

Randy: General and administrative expenses totaled $21 $90 million and the full year 2024.

Randy: Down from $26 9 million in 2003 and.

Randy: And full year 2024 sales and marketing expenses were $4 5 million compared to $6 2 million in the prior year.

Randy: Adjusted net loss for the full year 2024 was $63 3 million.

Randy: Waiting to an adjusted net loss of $10 75 per share as compared to an adjusted net loss of $76 3 million, an adjusted net loss of $15 67 per share for the prior year.

Randy Clark: Gapped net loss for full year 2024 was $63.2 million, equating to a net loss of $10.74 per share, as compared to a gapped net loss of $71.1 million, or $14.60 per share for the full year 2023.

Randy: GAAP net loss for full year 2024 was $63 2 million.

Randy: Equating to a net loss of $10 74 per share as compared to a GAAP net loss of $71 1 million or $14 60 per share for the full year 2023.

Randy Clark: 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 in balance of approximately $49 million in cash, cash equivalents, and short-term investments, underscoring our commitment to financial discipline.

Randy: For a reconciliation of all non-GAAP measures to GAAP. Please review our earnings press release.

Randy: Our 2020 for cash burn rate was $49 million, achieving a favorable variance from our original guidance of approximately $50 million.

Randy: This resulted in a year end balance of approximately $49 million in cash cash equivalents and short term investments and underscoring our commitment to financial discipline.

Randy Clark: Looking ahead to 2025, we again anticipate a cash burn of approximately $50 million and will continue to actively monitor and evaluate market conditions and strategically reinforce our balance sheet at the appropriate We look forward to updating you in the quarters to come as we execute on our business initiatives.

Randy: Looking ahead to 2025, we again anticipate a cash burn of approximately $50 million and we will continue to actively monitor and evaluate market conditions and strategically reinforce our balance sheet at the appropriate time.

Randy: 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.

Adam Sachs: With that, I'll turn the call back to Adam for closing remarks. Adam. Thanks, Randy.

Adam: Thanks Randy.

Adam Sachs: I'd like to close out by reiterating the significant progress we've made throughout 2024. We successfully integrated our version 1.0 system, built a robust supply chain and manufacturing foundation, forged new key partnerships with leading hospital systems, and took meaningful steps toward treating our first patients this year. As of today, we've 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. We eagerly look forward to providing, excuse me, to proving out the value of our V1.0 system in the clinic later this year.

Randy: I'd like to close out by reiterating the significant progress we made throughout 2024, we successfully integrated our version one point a system built a robust supply chain and manufacturing foundation forged new partnerships with leading hospital systems and took meaningful steps towards treating our first patient this year.

Randy: As of today, we've assembled instruments that are coming off the cleaner and production line ready for testing with our capital system scheduled to be completed later this week the excitement internally is palpable.

Randy: We eagerly eagerly look forward to providing excuse me to proving out the value of our <unk> system in the clinic later this year.

Adam Sachs: A huge thanks to our dedicated team for their hard work and commitment and to our investors and other stakeholders for their continued support. Thank you to everyone who joined the call today. We appreciate your support and look forward to updating you on our continued progress.

Randy: A huge thanks to our dedicated team for their hard work and commitment and to our investors and other stakeholders for their continued support thank.

Randy: Thank you to everyone who joined the call today.

Randy: We appreciate your support and look forward to updating you on our continued progress.

Cameron: With that, Cameron, we're ready for questions. Thank you.

With that Cameron, we're ready for questions.

Cameron: We will now begin the question and answer session. If you would like to ask a question, please press star followed by one on your telephone keypad. If for any reason you would like to remove that question, please press star followed by two. Again, to ask a question, press star one. And as a reminder, if you are using a speakerphone, please remember to pick up your handset before asking a question.

Randy: Thank you we will now begin the question and answer session. If you would like to ask a question. Please press star followed by one on your telephone keypad.

Randy: The reason you would like to remove that question. Please press star followed by two again to ask a question press Star one and as a reminder, if you are using a speaker phone. Please remember to pick up your handset before asking a question we will pause briefly as questions are registered.

Cameron: And we will pause here briefly as questions are registered.

Ryan Zimmerman: The first question is from the line of Ryan Zimmerman with BTIG, you may proceed. Good afternoon. Thanks for taking my question. Can you hear me okay, Adam? Yeah, we can hear you. Okay.

Ryan Zimmerman: The first question is from the line of Ryan Zimmerman with <unk> you May proceed.

Ryan Zimmerman: Good afternoon, Thanks for taking my questions.

Speaker Change: Can you hear me okay.

Speaker Change: Yeah, we can hear you.

Speaker Change: Okay cool.

Adam Sachs: maybe You know, on the supplier dynamic, just want 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.

Speaker Change: Maybe just.

Speaker Change: On the supplier dynamic just wanted to understand.

Speaker Change: Not specifically.

Is being held up.

Speaker Change: How is that impacting.

Speaker Change: Your ability to manufacture specifically systems for the clinical trial.

Speaker Change: And if you could talk about kind of what it does or doesn't do for your clinical trial activities. This year start there.

Randy Clark: Yeah, I'll be 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. You know, 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. So, you know, these delayed gated items directly hindered our manufacturing progress as several of these components were, you know, referred, we refer to them as golden screws or critical parts that we need to complete production.

Speaker Change: Yeah.

Speaker Change: Happy to jump in Ryan and then ill see them has any comments to add as well, but let's say within our supply chain, we encountered material procurement challenges with a few key suppliers. This led to delays in component deliver deliverables, which gated are built just to.

Speaker Change: 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.

Speaker Change: So these delayed dated items directly hindered our manufacturing progress at several of these components were referred we refer to them as Golden screws are critical parts that we need to complete production.

Randy Clark: You know, as Adam indicated, our team literally at all levels did a great job in escalating with these suppliers and in leveraging our other suppliers and internal resources to minimize the impact to our timeline.

Speaker Change: As Adam indicated our team literally at all levels did a great job and escalating with these suppliers and in leveraging our other suppliers and internal resources to minimize the impact to our timeline. The good news is because I wanted to per the beginning part of your question. We currently have located items and have resumed capital and dispose.

Randy Clark: The good news is, because I wanted to, you know, per the beginning part of your question, we currently have no gated items and have resumed capital and disposable production.

Speaker Change: Mill production.

Adam Sachs: And I'll just kind of come on top a little bit here and say that, you know, one one positive of this is that we've been able to flush out every every one of these challenges during this earlier build for all the essential performance and safety and can use all of those learnings and already are in the next build for for the chronic Okay, and so, you know, I guess that dovetails in the next question. So when do you anticipate, I know you're, you're narrowing down the sites now, when do you anticipate the clinical trial beginning?

Speaker Change: I'll just kind of come on top of it here I would say.

Speaker Change: That one one positive of this is that we've been able to flush out every every one of these challenges during this earlier build for all of the essential performance in safety and can be used all of those learnings and already are in the next builds for the clinical.

Speaker Change: Okay and so.

I guess that dovetails into my next question. So when do you anticipate.

Speaker Change: No. You are you are narrowing down the sites now when do you anticipate the clinical trial.

Adam Sachs: I think we kind of assumed maybe mid year this year, is that still the plan? And then What you know, as you go through the IRB process, and you know, at some of these sites, as you as you talk to the clinical site, you know, 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? Yeah, good question.

Speaker Change: Beginning.

Speaker Change: Because I think we kind of assume maybe midyear. This year is that still the plan and then.

Speaker Change: Okay.

Speaker Change: As you go through the IRB process.

Speaker Change: Some of these sites.

Speaker Change: As you talk to the clinical sites.

Speaker Change: 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.

Speaker Change: Yeah. Good question so.

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

Speaker Change: First I'll say that it's going to be later in the year.

Speaker Change: That we're going to be doing our first patients and just as a reminder, these fees will be outside of the pivotal and then as.

Speaker Change: As quickly as we can after that will kick off the pivotal but leaving room for you now.

Speaker Change: I used to have any necessary changes.

Speaker Change: We need, especially to the clinical protocol and trial protocol as <unk>.

Speaker Change: Feedback from our side, it's a great question.

Speaker Change: The feedback from our site has been first of all generally incredibly excited and engaged.

Adam Sachs: I think these these sites, especially in outside the US countries are eagerly 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, as well, even while our first approval will be in the US, you know, they want to be able to buy and use these, which is, you know, incredibly exciting for us to hear.

The sites are especially outside the U S countries are eagerly 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.

Speaker Change: As well, even while our first approval well be in the U S. They want to be able to buy and use these which is an incredibly exciting for us to hear and I'll say that I personally visited a number of the sites and.

Adam Sachs: And I'll say that, you know, I personally visited a number of these sites, and the engagement and reception has been incredible.

Speaker Change: The engagement and the reception has been incredible.

Ryan Zimmerman: Okay, I'll hop back in queue. Thanks. Thanks for the question.

Speaker Change: Okay I'll hop back in queue. Thanks, guys.

Speaker Change: Thanks for the question.

Adam Master: The next question is from the line of Adam Master with Piper Sandler. You may proceed. Hey, Adam, Randy, Kate, thanks for taking the questions and congrats on the progress and 1.0 integration. Just a couple of 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, you know, dating, you know, instances that were impacting supply chain. 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.

Speaker Change: The next question is from the line of Adam Master with Piper Sandler You May proceed.

Speaker Change: Okay.

Adam: Hey, Adam Randy.

Speaker Change: Thanks for taking my questions and congrats on the progress on <unk> integration.

Speaker Change: Just a couple of 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.

Speaker Change: Dating.

Speaker Change: The incentives that were impacting supply chain. That's now largely behind you did I hear that correct, but still.

Speaker Change: The result of that is starting the first in human later in 2025 is that a fair characterization.

Randy Clark: Is that a fair characterization? Yes, absolutely. Okay, okay, perfect.

Speaker Change: Yes, absolutely.

Speaker Change: Okay, Okay perfect.

Randy Clark: 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. Yeah, it'll be somewhere right around the middle of So, you know, that makes the, frankly, the first patient timing, and it usually takes a few months to approve. And following that approval, we're going to as quickly as humanly possible start those those cases. Okay, fantastic. Thank you for that.

Speaker Change: And I guess just in terms of the dossier submission are you able to kind of put out.

Speaker Change: Any timing around that when we should expect you guys to submit the dossier.

Speaker Change: Yes, it'll be somewhere right around the middle of this year. So that makes the frankly they are.

Speaker Change: First patient timing and it usually takes a few months to approve them.

Speaker Change: Following that approval, we're going to as quickly as humanly possible start those that those cases.

Speaker Change: Okay fantastic.

Randy Clark: And just for the follow up, I guess maybe we'd love to hear just a little bit more about and Neurological Surgeons. So, I think, you know, the version 1.0 integration, exactly kind of what that exercise entailed and what that means kind of in the, you know, the grand scheme of things. You know, number of cadaver procedures, who was driving the machine, 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. Thank you.

Speaker Change: For that and just for the follow up.

Speaker Change: Guess, maybe love to hear just a little bit more about.

Speaker Change: The version one point integration exactly kind of what that exercise entailed and what that means kind of in the grand scheme of things.

Speaker Change: Number of cadaver procedures, who is driving the machine does this mean that you have kind of officially.

Speaker Change: <unk>, just would love to hear a little bit more about kind of that exercise.

Speaker Change: And the confidence that gives you going forward in 'twenty five thank you.

Randy Clark: 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. So, you know, I'd say the results were gaining a ton of confidence in the reliability of the systems, especially if the disposable instruments were very good, especially as compared to previous builds and, you know, had cost and goods improvements as well that we brought in.

Speaker Change: Yeah. So so true kind of final design lock will come after all of that preliminary testing and all of the essential performance and safety.

Speaker Change: That was a handful of cadavers and a large number of manage taxes.

Speaker Change: Through a series that essentially allowed us to gain confidence in the system. No. If there were any any changes or tweaks that we wanted to make as we ramp up manufacturing in order to do all of that testing. So I would say that the results were gaining a ton of confidence in the reliability of our systems, especially.

Speaker Change: It would be disposable instruments.

Speaker Change: Very good especially.

Speaker Change: Compared to creative build them and.

Pat.

Speaker Change: Cost of goods improvements as well that we brought in so I'd say overall, it's something that we're really excited about.

Randy Clark: So I'd say overall, it's something that we're really excited about.

Adam Master: Thanks, Adam.

Speaker Change: Yeah.

Speaker Change: Thanks, Adam.

Josh Jennings: The next question is from the line of Josh Jennings with Cohen. You may proceed. Hi, good afternoon. Thanks for taking the questions. Nice to hear about all the progress and wanted to just ask about the cadaver lab results and and the success that you reported is.

Speaker Change: The next question is from the line of Josh Jennings with Cowen You May proceed.

Speaker Change: Okay.

Josh Jennings: Hi, good afternoon, thanks for taking the questions.

Speaker Change: Thanks, Jeff.

All the progress.

Speaker Change: One is just to ask about the cadaver lab results.

Speaker Change: And the success that you reported.

<unk>.

Adam Sachs: Were ventral hernia maneuvers performed in the catheter lab or any other details you can just share and and how important those results are in terms of this future submission in the Ministry of Health and moving forward in the clinical moving forward into the clinical trial. Yeah, so these cadaver labs are performed by Dr. Beliansky and Dr. Barry Green, our chief medical officer, and they were to perform, absolutely to perform ventral hernia repair. Repairs with both defects, closure and mesh implantation. And overall, they, you know, Certainly, the initial tests are not without some hiccups, but we were incredibly impressed, especially how smoothly mesh fixation went and the ability to sew all the way around that mesh in multiple quadrants in a very short amount of time.

Speaker Change: We're ventral hernia.

Speaker Change: <unk> performed a misstep relentless any other details you can just share in and how important those results are in terms of future submission of the Ministry of health in moving forward in the clinic with import into a clinical trial.

Speaker Change: Yes. So these cadaver labs are performed by Dr. <unk>.

Speaker Change: Dr. Barry Greene, our Chief Medical officer, and that they were to perform absolutely to perform ventral hernia repair.

Speaker Change: Repairs with both.

Speaker Change: Defect closure and mesh implantation.

Speaker Change: And overall Bay.

Speaker Change: Certainly the initial tests are not without some hiccups, but we were incredibly impressed, especially how smoothly mesh fixation.

Speaker Change: And the ability to sell all the way around that mesh and multiple quadrants.

Speaker Change: And.

Speaker Change: Very short amount of time.

Adam Sachs: So it's something that we're all incredibly excited and proud of.

Speaker Change: We're all incredibly excited and proud of.

Adam Sachs: Actually, 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 recent discussions with the FDA or any updates? Yes, we've done multiple pre submissions with the FDA leveraging the safer technologies program that we're a part of. And they've been, you know, very collaborative with us. So we've gone through full detailed trial design, as far as when it truly gets locked and finalized, it'll be after these first patients, which is a big chunk of the point of them is to be able to, you know, evaluate outside of a clinical trial, 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.

Speaker Change: And then just on the clinical trial design win mix.

Speaker Change: Gets locked in.

Speaker Change: Any updates there just in terms of how many patients are expected or is there any any changes to your outlook in terms of discussion recent discussion with the FDA.

Speaker Change: Updates.

Speaker Change: Yeah, So we've done.

Speaker Change: Multiple pre submissions with the FDA leveraging the assay for technologies program.

Speaker Change: Net debt for a part of and they've been very collaborative with us so.

Speaker Change: We've gone through full details.

Speaker Change: Trial design.

Speaker Change: <unk> has been a truly get locked and finalize the it'll be after these first patients which is a big chunk of the point of them is to be able to.

Valuate outside of a clinical trial of course, you start to report anything but its not evaluated as part of the actual submit.

Speaker Change: Submission package, which gives us the flexibility to make changes.

Speaker Change: After our first clinical patients and before the first pivotal trial patients.

Josh Jennings: Great.

Randy Clark: And just lastly, I think you spoke about the need to build inventory in front of the clinical trial. Maybe you can just help us quantify kind of that, that the inventory build and how challenging or straightforward that process is. Thanks for taking all the questions.

Speaker Change: Great and then just lastly, I think you spoke about the <unk>.

Speaker Change: We need to build inventory in front of it.

Speaker Change: Clinical trial, maybe can you just help us quantify that.

The inventory build.

Speaker Change: So challenging.

Speaker Change: Straightforward processes. Thanks.

Speaker Change: Thanks for taking my questions.

Randy Clark: Yeah, happy to jump in there. And just to reiterate some of the prior remarks is where again, our teams did a great job in escalating the procurement challenges that we spoke to, leveraging our internal capabilities.

Speaker Change: Yeah happy to jump in there and just to reiterate some of the.

Speaker Change: Prior remarks is where again our teams did a great job and escalate the procurement challenges that we spoke to leveraging our internal capabilities and again want to reiterate at this point in time, we do not.

Randy Clark: And again, want to reiterate at this point in time, you know, we don't have any gated components. So we have really focused on scaling up our testing inventory and have literally finished instruments coming off of our cleanroom lines. As Adam mentioned, as well, you know, our first unit of Surgeon Consul in Patient Consul are expected to be completed at the end of this week. And for our testing and our first clinical patient, you know, I believe we've stated previously, but just to reiterate here, 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.

Speaker Change: <unk> indicated component. So we have really focused on scaling up our testing inventory and have literally finished instruments coming off of our clean room lines as Adam mentioned as well our first unit of surgeon console and patient consoles are expected to be completed at the end of this week.

Speaker Change: And for our testing and our first clinical patients I believe we stated previously but just to reiterate we're anticipating only leading a few capital systems and then larger amounts of the instruments correlated to that text submission or technical dossier.

Adam Sachs: 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 that, you know, coming and seeing the cleanroom, and instrument being manufactured in, you know, quantities and coming off the line Being packaged, ready for sterilization, and the capital equipment can't tilt up at all. All of cosmetic covers, all of the internal wiring, it's everything is coming together.

Speaker Change: As well and if I can come on top just because I mean this has been one of the most exciting things internally for us.

Speaker Change: Coming out seeing the clean room.

Speaker Change: Instrument being manufactured.

Speaker Change: Quantities and coming off the line.

Speaker Change: <unk> package ready for sterilization and the capital equipment cant tell topic all of cosmetic covers all of the internal wiring. It's everything is coming together it is.

Cameron: It is the single most exciting time that I've ever had in this company. That's good to hear. Thanks for all the answers. Appreciate it. There are currently no questions registered. So as a brief reminder, it is star one to ask a question. There are no further questions waiting at this time.

Speaker Change: The single most exciting time that I've ever had in this company.

Speaker Change: That's good to hear thanks for all the answers appreciate it.

Speaker Change: There are currently no questions registered so as a brief reminder is star one to ask a question.

Speaker Change: 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.

Adam Sachs: I would like to pass the conference back to the management team for any closing remarks. 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.

Speaker Change: Yeah, I think with that I'd, just like to say thank you. So much to everybody. Thank you Karen for being operate on this call and with that we can.

Cameron: 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.

Speaker Change: That concludes the vicarious surgical was 2020 for fourth quarter and full year earnings call. Thank you for your participation and enjoy the rest of your day.