Vicarious Surgical Inc.

Good afternoon and welcome to Vicarious Surgical's second quarter 2023 earnings conference call. My name is Sierra and I'll be your operator for today's call. At this time, all participants are in a listen-only mode. We will be facilitating a question and answer session towards the end of today's call. As a reminder, this call is being recorded for replay purposes. I would now like to turn the call over to Caitlin Brosco with Vicarious Surgical for a few introductory comments.

Thank you, Ciara, and thank you all for participating in today's call. Earlier today, Vicarious Surgical released financial results for the three months ended June 30th, 2023. A copy of the press release is available on the company's website. 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 or predictions 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 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. 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 filing, including our most recent Form 10-K and Form 10-Q. This conference call contains time-sensitive information that is accurate only as of the live broadcast today, July 27, 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. With that, I'll now turn the call over to Adam Sachs, Chief Executive Officer.

Good afternoon, and thank you for joining us today. We've been looking forward to today's earnings call, as we have a number of important updates to share. First, we are making strong progress as we advance from design freeze toward manufacturing and testing of our version 1.0 system. Second, based on a series of meetings with the FDA, we now have clarity and reassurance on our path to complete both our clinical and regulatory submission plans. With this clarity, we are excited to announce that we intend to perform our first eventual hernia procedure in a patient mid-next year. Finally, we are proud to assign a fourth major US hospital system as a partner, bringing the total number of hospitals represented by our partners to over 250. Starting with system progress. In April, we froze design of our version 1.0 system, the system we anticipate deploying in our clinical trial next year. Informed by surgeon and hospital system insights Our V1.0 design incorporates a number of enhancements relative to our previous version, the Beta 2 system. These changes enable a further refined motion profile, higher image quality, and optimized system safety for surgeons and patients. Positive surgeon feedback from several members of our Surgeon Luminary Board over the recent months has reaffirmed our immense excitement around the potential of our system and the future ahead. With our V1.0 system design freeze, we are continuing to the next phase in our development cycle with a focus on manufacturing units in preparation for verification and validation. To ensure a coordinated and focused effort on deliverables for V&V in our clinical trial, we recently promoted John Mazzola to Chief Operating Officer. John joined our team in March of 2022 and was previously SVP of operations. And in the past year, he has led strategic manufacturing for our robotics system, overseeing both the operations and quality organizations. In the newly created COO role, John's scope has expanded to include product development and clinical and regulatory affairs. With over 35 years of medical device industry experience and direct involvement in over 25 class two and class three medical device product launches, we know John is the right leader to drive our transition from an R&D organization to a company prepared for clinical trial and then commercial launch. As such, the integration and build of the version 1.0 system remains on track for this fall. Moving to regulatory clarity. We are grateful for the collaboration with the FDA, and as such, we have had several pre-submission meetings where they have provided guidance and clarity on the authorization process. Based on direct guidance and input from the FDA, we plan to complete a clinical trial with 30 to 60 patients total, including patients from outside the United States. We are pleased with the agency's suggestion to include OUS clinical study data as this will allow us to capture clinical data across a larger population and meaningfully facilitate our ability to enroll patients in our study and be in a position to complete patient procedures within the next year. With this clarity, we plan to pursue our first ventral hernia procedure in a clinical patient mid-next year. And driven by our system progress and these developments in clinical plans, We now anticipate filing a de novo submission in early 2025. As expected, we will need to show strong preclinical data prior to patient procedures in addition to demonstrating our ability to safely and reliably manufacture our system as part of verification and validation testing. This will be our focus over the coming quarters. Additionally, we continue to work closely with our hospital system partners to confirm surgeon and site participation in our clinical trial and establish the detailed clinical steps for use in the trial. These plans are now informed by a clear understanding of the processes needed to meet our two clinical objectives, safety and efficacy. After discussion with the FDA, our primary endpoint will be the ability of the surgeon to complete the intended ventral hernia repair. And our safety endpoint will be adverse event rates through a 30-day post-surgery follow-up as compared to existing laparoscopic data. Given the design of our device is focused on patient outcomes and surgeon usability, and given our preclinical success to date, we believe that we can meet these objectives and clearly prove the safety and efficacy of the vicarious surgical system. Needless to say, we are thrilled to enter this next transformational phase of our company with the necessary clarity to best position ourselves to capitalize on the numerous milestones along our pathway to market. With that, I will turn the call over to Bill Kelly, our Chief Financial Officer.