Vicarious Surgical Inc.

Hello, everyone, and welcome to Vicarious Surgical's third quarter 2024 earnings call. My name's Lydia, and I'll be your operator today. At the end of the presentation, there'll be an opportunity to ask questions. If you'd like to participate in the Q&A, you can do so by pressing star followed by one on your telephone keypad. I'll now hand you over to Kate Brosco, Director of IR to begin. Please go ahead.

Thank you, Lydia, and thank you all for joining. With me today are Adam Sachs, co-founder and chief executive officer, Bill Kelly, chief financial officer, and Randy Clark, company president. Today after market close, Vicarious Surgical released financial results for the three months ended September 30th, 2024. Copy of the press release is available on the company 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, or operating trends in future financial performance, expense management, market opportunity, and commercialization are based upon our current estimation and various assumptions. These statements involve material risk and uncertainties that would 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. For a list and description of the risk 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. This conference call contains time-sensitive information and is accurate only as of the live broadcast today, November 12, 2024. Icarus 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. Now I'll hand the call over to Adam for prepared remarks.

Good afternoon, everyone. Thank you for taking the time to join us today. At Vicariate Surgical, our mission is to improve lives by transforming robotic surgery. And we believe our unique single port platform will revolutionize surgery by enhancing patient outcomes, improving the surgical experience, and increasing the efficiency of care delivery. Just as multiport robotics advanced minimally invasive surgery beyond traditional open and laparoscopic techniques over two decades ago, Single port robotics is set to redefine the field once more. With its inherent advantages, single port promises to unlock preoperative and interoperative efficiencies that intend to streamline procedures and increase surgical throughput where existing multiport devices fundamentally cannot. Furthermore, there is a growing base of evidence that supports single port's ability to improve surgical outcomes for patients, such as reduced blood loss, shorter hospital length of stay, and minimize pain and opioid use. Not only do we see single port surgery becoming cornerstone of the surgical market for these reasons, but we also believe the unique feature set and clinical value of our single port platform will further amplify these benefits and meaningfully expand upon them to set a new standard for minimally invasive care. During the third quarter, we made meaningful progress toward delivering the first version of our single port platform. We are now weeks away from our year-end cadaver lab, which ultimately denotes the integration of the V1.0 system. Following the completion of this milestone, our focus will shift to verification and validation and the manufacturing effort to support this rigorous testing program. Starting early next year, the integrated V1.0 system and subsystems will undergo informal assessments related to durability, biocompatibility, and electromagnetic and environmental compatibility. that will stimulate the formal verification and validation process. We expect to make minor optimizations throughout this preliminary phase that will better ensure we meet all essential performance and safety standards required to treat our first clinical patient safely and confidently. Upon the successful completion of each of these rigorous essential performance and safety tests, we anticipate treating our first patient in less than one year. We look forward to this opportunity to showcase our single court system's immense potential and the meaningful clinical value we can deliver to patients, surgeons, and hospital systems. In preparation, our clinical and regulatory teams have been hard at work preparing with our CRO to evaluate potential OUS clinical sites for both our first clinical patient and subsequent pivotal clinical trial. Although no formal announcement has been made, We have narrowed our search down to a select few sites within the same country. Conducting the first clinical patient ahead of our pivotal clinical trial will allow us to validate real-world performance at a clinical setting and gain valuable insights that can be used to optimize our pivotal trial design and protocol. As a reminder, in order to expedite our time to market, our clinical trial will focus on one initial indication. eventual hernia repair. With hundreds of thousands of procedures performed annually within the U.S., eventual hernia repair is an attractive first indication for vicarious surgical, and one where we believe our system's differentiated clinical capability is ideally suited. From there, we plan to quickly expand out to our other targeted indications, including inguinal hernia repair and procedures related to gynecology, gallbladder, and colorectal. Our clinical trial's primary performance 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. Following guidance from our pre-submission meetings with the FDA, including the most recent one last month, we plan to enroll and treat approximately 30 to 60 subjects from outside the United States. We believe this approach will allow us to treat subjects and gather clinical data to demonstrate the safety and efficacy of our technology in the most efficient and timely manner. Additionally, numerous precedents, including recent FDA surgical robotic clearances, give us further confidence in our regulatory pathway to market. I'll now turn the call over to Bill for a review of our third quarter financial performance.