Carlsmed, Inc.

Ladies and gentlemen, thank you for standing by and welcome to the Carl Smith Second Quarter 2025 Earnings Conference Call. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during this session, you'll need to press star 1-1 on your telephone. If your question has been answered and you'd like to remove yourself from the queue, simply press star 1-1 again. As a reminder, today's program is being recorded. And now I'd like to turn the conference over to your first speaker for today, Caroline Corner, Investor Relations. Please go ahead, Caroline.

Thank you, Operator. Welcome to Carlsbad Second Quarter 2025 Earnings Call. Joining me on today's call are Mike Cardanier, 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 statement. For more detailed information, please review the cautionary notes on the earnings materials accompanying today's presentation, as well as Carl Smith's filings with SEC, particularly the risk factors described in Carl Smith's Form S-1 and in Carl Smith's quarterly report on Form 10-Q for the second quarter ended June 30, 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 the second quarter of 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 be available on the 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 second quarter 2025 business highlights.

Thank you, Caroline, and welcome everyone to Carls Med's first earnings call as a public company. Following our initial public offering where we successfully raised more than $100 million in growth capital, I would like to thank our entire team at Carls Med, our board, our surgeon partners, and our stockholders for joining us in our mission to improve patient outcomes and reduce the cost of health care for spine surgery and beyond. We're aiming to establish the new architecture of surgery where patient outcomes are not only more predictable, but consistently excellent for every surgeon, hospital, clinic, and patient. Now I'm pleased to report that we delivered a very strong quarter, with $12.1 million in revenue in the second quarter, representing year-over-year growth of 99%. With this strong momentum exiting the first half of the year, we're on track to deliver between 45.5 million and 47.5 million in revenue, full year 2025. Over the past year, we've seen a consistent increase in surgeon adoption with 199 surgeon users that have completed more than one procedure using the Aprivo technology platform by the end of the quarter, which is an increase of approximately 72% over the prior year. With nearly 4,000 spine surgeons in the U.S. and an estimated total addressable market for Aprivo lumbar spine fusions of more than $13 billion, we believe that we have a long runway ahead of us. Our Aprivo technology platform is the first available solution to provide personalized digital surgical plans and the accompanying Aprivo inner body implants that are specifically tailored to each patient's pathology and vertebral bone topography. With the predictability of the personalized surgical plan and the 3D printed Aprivo inner body implants that are personalized to deliver anatomical alignment to the patient, evidence shows a meaningful improvement in patient outcomes. For example, a recent study published by the International Journal of Spine Surgery comparing Aprivo to non-Aprivo procedures showed an 82.6% reduction in re-operation rate after just one year for Aprivo. With the leading cause of revision surgery being misalignment of the spine, we believe the Carlsman Aprivo technology is uniquely tailored to address this much needed patient population. To further support adoption of the Aprivo technology platform, CMS issued three new MS-DRGs that became effective October 1, 2024, for enhanced hospital reimbursement for the Aprivo custom-made anatomically designed fusion devices, which provide enhanced reimbursement for many single-level and multi-level qualifying Aprivo procedures at the higher-paying MCC level. This translates to an incremental reimbursement for most procedures from $20,000 to $50,000, depending on the complexity of the procedure and the hospital's MS-DRG payment schedule. This past July, CMS approved an NTAP, or a new technology add-on payment, for a Prevost cervical spine fusion that goes into effect on October 1st of this year. This NTAP is expected to provide up to $21,125 of additional reimbursement to hospitals that utilize a Prevost cervical for patients. We believe that we've made great strides in the past year in our innovation strategy with our proprietary digital production system. This manages both the upstream and downstream process involved in producing our Aprivo interbody implant system and enables us to design, produce, and deliver the system typically within 10 business days of surgical plan approval or less. This represents a decreased turnaround time from more than four weeks to 10 business days or less in just the past year. With our Capital Life business model, we can manufacture our personalized Aprivo interbody implants on demand and just in time for surgery. With no surgical trays or stock implants, our highly differentiated business allows us to deploy capital directly towards patient-centric innovation and commercial growth. We're not slowing down. We're continuing to innovate the Aprivo technology platform for patients needing cervical spine fusion surgery. We recently completed the first personalized cervical fusion with the Aprivo technology platform and are planning a commercial launch in 2026. With an estimated 370,000 cervical spine fusion procedures to be performed in the U.S. in 2025, our rapid adoption of the Aprivo technology platform, compelling clinical data, and superior reimbursement we remain optimistic about our growth for the years to come. With that, I'd like to turn things over to Leo to review our financial performance. Leo?