Carlsmed's AI Platform Fuels 86% Revenue Surge in Spine Surgery

CARLSBAD, Calif. – January 12, 2026 – Medical technology company Carlsmed (Nasdaq: CARL) today announced preliminary full-year 2025 revenues of approximately $50.5 million, an explosive 86% increase over the previous year, driven by the accelerating adoption of its AI-powered personalized spine surgery platform, aprevo®.

The company also reported preliminary fourth-quarter 2025 revenue of approximately $15.2 million, a 61% jump compared to the same period in 2024. These unaudited figures, which surpass the company's own full-year guidance of $45.5 million to $47.5 million, signal strong market confidence and a pivotal year for the firm, which went public in July 2025.

The AI-Powered Surgical Revolution

At the heart of Carlsmed's growth is its aprevo® platform, an AI-enabled system designed to transform the entire surgical workflow for spinal fusion procedures. Unlike traditional approaches that rely on standardized implants, aprevo® creates a digital twin of the patient's spine from standard CT scans. AI algorithms then analyze the patient's unique anatomy and pathology to generate a customized preoperative surgical plan. This plan includes the design of patient-specific, 3D-printed interbody implants tailored to achieve optimal spinal alignment and stability.

The platform's benefits extend into the operating room with intraoperative visualization tools to guide the precise placement of the bespoke implants. Postoperatively, the system collects data to continuously refine and improve its AI-driven surgical planning capabilities. This comprehensive, data-driven approach has earned the aprevo® platform the distinction of being the only FDA-designated Breakthrough Technology for both lumbar and cervical patient-specific interbody spine fusion.

Clinical evidence supporting the technology's impact is mounting. Recent data highlights a remarkable 82.6% reduction in reoperation rates for patients treated with aprevo® compared to traditional surgical methods. Further validation came in January 2026 with the publication of two-year clinical data for aprevo® Lumbar in the peer-reviewed Global Spine Journal, lending significant credibility to the platform's long-term efficacy and safety.

Financial Momentum and Market Confidence

The impressive revenue growth is a direct reflection of the technology's increasing acceptance within the surgical community. Carlsmed reported adding 101 new surgeon users in 2025, a 61% increase that brought its total user base to nearly 200 surgeons by mid-year. Since its full commercial launch in late 2021, the aprevo® platform has been used to treat over 1,500 patients.

“Our fourth quarter commercial performance capped a transformational year for Carlsmed and underscores the power of aprevo®,” said Mike Cordonnier, Chairman and CEO of Carlsmed, in a statement. “This platform technology provides surgeons with greater procedural predictability and has the potential to meaningfully improve clinical outcomes in spine fusion and lower the total cost of care for the healthcare system.”

This rapid expansion follows the company’s successful initial public offering in July 2025, which secured $93.5 million in net proceeds to fuel its commercial and research initiatives. While the company's aggressive growth strategy is reflected in its negative operating and net profit margins—reported at -57.99% and -57.52% respectively for 2025—the substantial top-line growth and high gross margin of nearly 75% demonstrate strong product demand and a scalable business model.

Redefining Value in Spine Care

Carlsmed's claim that aprevo® can lower the total cost of care is a critical component of its value proposition, particularly as healthcare systems worldwide shift toward value-based models. The primary driver of this cost reduction is the significant decrease in complications and the need for costly and complex revision surgeries. By improving surgical predictability and achieving better patient alignment from the outset, the platform directly addresses a major source of long-term expense in spine care.

This potential for economic benefit has already gained regulatory recognition. In a significant move, the Centers for Medicare & Medicaid Services (CMS) granted a New Technology Add-On Payment (NTAP) for aprevo® cervical procedures, effective October 1, 2025. The NTAP program provides additional payment for new technologies that demonstrate substantial clinical improvement over existing options, signaling that regulators see the platform's potential to improve outcomes and, by extension, manage costs.

Expanding Horizons and Competitive Edge

With a strong 2025 in the books, Carlsmed is poised for its next phase of growth. The company is executing the full commercial launch of its aprevo® Cervical system in 2026, following a successful first personalized cervical spine surgery in July 2025 and highly encouraging early feedback from surgeons.

“As we enter 2026, we are focused on executing our strategy for the next phase of growth with operational excellence,” Cordonnier stated. “We are energized by the momentum in our business... we anticipate growing recognition and adoption of aprevo® as a platform technology that we believe is capable of transforming surgical standards and patient outcomes in spine fusion.”

The company is entering a dynamic market where demand for minimally invasive procedures and AI-enhanced surgical tools is projected to drive a 5.3% compound annual growth rate through 2033. While facing competition from established spine devicemakers, Carlsmed’s focus on a comprehensive, AI-first, patient-specific platform provides a powerful differentiator. By aiming to establish aprevo® as the new standard of care, the company is not just selling a product but is pioneering a new surgical philosophy, positioning it as a formidable player in the future of personalized medicine.