Vicarious Surgical Inc.

Good afternoon, thank you for attending the vicarious surgicals 2024 fourth quarter in full year earnings call my name is Cameron and i'll 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 one on your telephone keypad. I would now like to pass the conference over to your host Caitlin broskow director of ir you may proceed.

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 after market close, Vicarie Surgical released financial results for the three months and full year ended December 31st, 2024. A 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, appreciation 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. 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. 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. 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. I'll now hand the call over to Adam for prepared remarks.

Thanks, Kate. Good morning, everyone, and welcome. Good afternoon, everyone, and welcome to our fourth quarter and full year 2024 earnings call. We appreciate you joining us today. 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. 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 setting. 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 team. 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. This innovative design allows our system to achieve minimally invasive outcomes through a single small 18 millimeter incision, while still generating the high forces necessary to address a broad range of soft tissue indications. Furthermore, the decoupled actuators enable additional intra-abdominal 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 access. 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. Beyond its core surgical capabilities, 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. hospital systems. 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. 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. 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. 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. Now that the version 1.0 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 schedule leading to our Ministry of Health technical dossier submission. 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. 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. We still expect to treat our first clinical patients this year. However, it'll be closer to year end. 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. Now, before we turn to our 2024 financial results, I want to reiterate our excitement about our new CFO. 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 Interra Therapeutics and Kira Pharmaceuticals. 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.