Carlsmed, Inc.

Ladies and gentlemen, thank you for standing by, and welcome to the Carls Med Fourth Quarter and Full Year 2025 Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. I would now like to turn the conference over to your first speaker today, Caroline Corner, Investor Relations. Please go ahead, Caroline.

Thank you, operator. Welcome to Carl Smith's fourth quarter and full year 2025 earnings call. Joining me on today's call are Mike Cordonier, Chief Executive Officer and Chairman, and Leo Greenstein, Chief Financial Officer. Before we begin, I would like to caution that comments made during this call will include forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements made on this call that do not relate to matters of historical fact should be considered forward-looking statements including statements regarding the market in which Carls Med operates, trends, expectations, and demands for Carls Med's products, and Carls Med's expected financial performance and position in the market. Any forward-looking statement provided during this call, including projections for future performance, is based on management's expectations as of today. Carls Med undertakes no obligation to update these statements except as required by applicable law. These statements are neither promises nor guarantees and are subject to known and unknown risks and uncertainties that could cause actual results, performance, or achievements to differ materially from those expressed or implied by the forward-looking statements. For more detailed information, please review the cautionary notes on the earnings materials accompanying today's presentation, as well as CARLS-MED's filings with the SEC, particularly the risk factors described in CARLS-MED's annual report on Form 10-K for the year ending December 31st, 2025. I encourage you to review all Carls Med filings with the SEC concerning these and other matters. These filings, along with Carls Med's press release for fourth quarter and full year 2025 results, are available on Carls Med's website at www.carlsmed.com under the Investor section and include additional information about Carls Med's financial results. A recording of today's call will also be available on Carls Med's website by 5 p.m. Pacific time today. Now, I'd like to turn the call over to Mike to go over the Carls Med 2025 business highlights.

Thank you, Caroline, and welcome, everyone. 2025 was a rapid growth year for Carls Med, and I could not be prouder of what our team has accomplished to advance our mission of improving outcomes and decreasing the cost of healthcare for spine surgery. In July of 2025, we successfully completed our initial public offering, raising over $100 million, and we are efficiently deploying our resources towards patient-centric innovation, surgeon education, and commercial execution. In 2025, we delivered $50.5 million in revenue and 75.3% gross margins. This represents 86% year-over-year top line growth and 151 basis points of margin expansion. In the fourth quarter, we delivered a record 15.2 million of revenue with 61% year-over-year growth and 76.5% gross margins. With further advancements in our digital production system, we have driven increased productivity and reduced lead times for Prevo lumbar and our Prevo cervical patient-specific interbody portfolio. With these recent advancements, we are now at a lead time of six business days. Most importantly, we continue to see evidence of favorable patient outcomes. Two-year data from a retrospective cohort study published in the Global Spine Journal showed a 74% reduction in re-operation rates among adult spinal deformity patients receiving a Prevo lumbar implant as compared to a separately published patient cohort receiving conventional stock implants. These company highlights are the result of consistent operational excellence and commercial execution driven by our AI-enabled digital planning and patient-specific devices with a laser focus on what matters most, clinical outcomes. At Carls Med, we aim to improve spine surgery through our preoperative, intraoperative, and postoperative Aprivo digital surgery platform. We create AI-driven personalized surgical plans and 3D-printed, custom-made, anatomically designed spine fusion systems. Unlike traditional one-size-fits-all approaches, Real-world evidence suggests that our PREVO platform solution has the potential to improve outcomes and reduce the number of revision surgeries. We are fundamentally changing how spine surgery is planned and executed and how patients are treated. Our digital surgery and preoperative planning capabilities were designed to enhance operational efficiency and deliver more predictable and effective patient outcomes. And we believe we have substantial market opportunity ahead. In November, we launched our next generation MyAprevo ecosystem that seamlessly integrates mobile and web-based applications enabling deeper integration with surgeons' preoperative and postoperative clinical workflow. Our compelling clinical outcome data and economic value proposition has provided us a robust reimbursement foundation in lumbar surgery, where we have three MS-DRG codes that cover single-level and multi-level lumbar fusion surgeries for degenerative and deformity conditions. In October of last year, we were granted the new technology add-on payment, or NTAP, from CMS for a Prevo cervical spine fusion. This NTAP provides up to $21,125 of additional reimbursement per procedure to hospitals that utilize a Prevo patient-specific devices for inpatient cervical procedures. In 2025, we successfully added 101 new surgeon users on our platform, showcasing our rapid clinical adoption in a market hungry for innovation and improving outcomes. With the Prevo lumbar adoption tracking rapidly, we launched our technology into the cervical fusion market with the Prevo Cervical in December at the Cervical Scoliosis Research Society meeting. Cervical spine surgeries have historically been plagued by high variability in outcomes, and publications suggest these are prominent in patients with poor bone quality, long construct fusions, and deformity. About a third of cervical spine fusion patients have osteoporosis or osteopenia or soft bones. We're deeply focused on evaluating how Aprivo may benefit this patient population with osteoporosis and osteopenia, where it's challenging to deliver predictable outcomes. I'm deeply encouraged by the strong market traction in the early days of this launch. Operational excellence is the foundation of our rapidly scaling personalized surgery business. We've achieved another business milestone for our customers by reducing lead times by 25% with production timelines now at just six business days compared with eight business days in Q4 of last year and 20 days we saw a year prior. This milestone represents the final phase of our operational excellence initiative and positions us to scale meaningfully as we drive further market penetration. Also of note, our manufacturing is now a fully integrated process that spans both cervical and lumbar products on the same production line. The combination of positive patient outcome data, operational excellence, and expanding surgeon adoption across both lumbar and cervical indications reinforce our position as a true innovation leader in spine surgery. Now I'd like to walk you through our areas of strategic focus and some recent highlights and how our achievements position us to continue the durable, high-quality growth we've demonstrated today. Our first area of focus is patient-centric innovation. This month, we announced the first in human bilateral posterior aprivo procedure that was performed at the University of Colorado. This FDA-cleared breakthrough technology allows a surgeon to address degenerative disease conditions posteriorly with maximal bone-to-implant coverage through a minimally invasive surgical approach. The bilateral approach benefits from the same planning as the transferaminal approach while effectively doubling the bone-to-implant contact area. We have commenced the limited market evaluation of this new procedure on track for our launch in the second half of 2026. This month, we also announced the introduction of the CORA personalized fixation portfolio and the first in human personalized CORA cervical plate procedure performed at UCSF. The FDA 510 cleared CORA cervical plates are fully personalized to the patient's anatomy to provide harmonious plating fixation for the Aprivo cervical interbody. The CORA cervical plates are digitally designed using our proprietary AI-enabled planning system to optimize fixation to maintain the anatomical correction provided in the Aprivo planning platform. The CORA plates are available in a monoblock, multilevel plate configuration, as well as segmental plating configurations for short and long construct cervical fusions. We anticipate a second half of 2026 launch for the CORA cervical plating portfolio to further support the personalization of cervical spine surgery. Our second area of strategic focus is surgeon education. We've expanded our medical education team to meet the accelerating demand for a Prevo lumbar and a Prevo cervical. We continue to see strong interest in adoption from early to mid-career surgeons who are seeking to implement digital surgical workflows in their practice as they seek to increase predictability and improve patient outcomes. For example, our second annual Carls Med residents and fellows course, which will be held in Q2 at Columbia University, is fully enrolled months in advance of the course. We're really excited about our funnel of training, which gives us confidence that we're onboarding the next generation of Aprivo surgeon users who will support our efforts to drive adoption and increase procedure penetration. The third area is commercial execution. In the fourth quarter, we continued with our robust cadence of surgeon additions and ended the year with 101 new fully trained surgeons, each having performed one or more of Prevost procedures in 2025. During 2025, with further investments in our commercial footprint, we doubled our sales regions in the U.S. with our direct sales team partnering with more than 100 contracted sales agents to provide a high level of service to our customers. Looking forward to 2026, we're committed to continuing our momentum and delivering high-quality, sustainable growth for personalized spine surgery. I'm very excited about the year ahead of us. I'd like to express my personal gratitude to our shareholders, team members, and surgeon users for their unwavering support of our mission to revolutionize patient care. With that, I'll turn it over to Leo, who will review our financial performance.