Carls Med (CARL) Q4 2025: 61% Revenue Growth as Personalized Spine Surgery Scales, Lead Times Cut to 6 Days
Carls Med delivered rapid expansion in Q4 2025, marked by 61% revenue growth and a step-change in operational efficiency, as lead times for personalized spine implants dropped to six business days. The company’s digital-first, AI-enabled platform drove robust surgeon adoption and supported margin expansion, even as investments in R&D and commercial scale accelerated. With cervical and lumbar launches gaining traction and a clear path to profitability, Carls Med positions itself as a differentiated leader in personalized spine surgery for 2026 and beyond.
Summary
- Operational Efficiency Milestone: Six-day production lead times unlock faster surgeon adoption and improved responsiveness.
- Personalized Platform Momentum: Rapid new surgeon onboarding and cervical launch signal expanding addressable market.
- Profitability Pathway: Margin leverage and digital-first scale set up for improved EBITDA as growth investments normalize.
Performance Analysis
Carls Med’s Q4 2025 results highlight a business scaling quickly in a high-value niche—personalized spine surgery—powered by AI-driven planning and 3D-printed, patient-specific implants. Fourth quarter revenue growth of 61% year-over-year was propelled by both a surge in new surgeon users and sustained utilization rates. The company ended 2025 with 101 new surgeon users, reflecting successful commercialization and education efforts. Gross margins expanded to 76.5% in Q4, up from 74.7% a year ago, as digital production system investments reduced contract manufacturing costs and improved internal case design productivity.
Operating expenses rose sharply, with R&D and sales and marketing outlays supporting new product launches and commercial footprint expansion. While net loss widened to $8.6 million in Q4 and $29.6 million for the year, management emphasized that expanding contribution margins and operating leverage from a capital-light, digital-first model will drive a path to cash flow break-even as the business scales. Cash and investments totaled $109.9 million at year-end, with a manageable $15.6 million outstanding on a low-cost debt facility.
- Surgeon Adoption Surge: 101 new surgeon users added in 2025, fueling procedure volume and future utilization growth.
- Margin Expansion: Gross margin improvement driven by digital production efficiencies and lower manufacturing costs.
- Growth Investment: Higher R&D and sales expenses reflect deliberate scaling of the platform and expansion into cervical and posterior markets.
Revenue growth remains volume-driven, with average revenue per procedure steady, and early cervical launch traction suggests further upside as utilization deepens across both new and existing surgeon users.
Executive Commentary
"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."
Mike Cordonier, Chief Executive Officer and Chairman
"Our 61% year-over-year quarterly revenue growth was driven by continued expansion of our total surgeon users and utilization rates. Our average revenue per procedure was consistent between these two periods as it was for the full year. So our revenue performance in the fourth quarter and for the full year 2025 remains driven by growth in approval procedure volumes."
Leo Greenstein, Chief Financial Officer
Strategic Positioning
1. Digital-First, Personalized Surgery Platform
Carls Med’s core business model leverages AI-enabled preoperative planning and 3D-printed, patient-specific implants (the Prevo and Aprivo platforms) to deliver improved surgical outcomes and reduce revision rates. This approach differentiates the company from traditional “one-size-fits-all” device manufacturers and underpins its margin structure.
2. Rapid Expansion into Cervical and Posterior Markets
The launch of Prevo Cervical and the first-in-human bilateral posterior Aprivo procedure open up new addressable markets. Management expects cervical to become a significant portfolio contributor, with early adoption among both surgeons and hospitals aided by a new CMS NTAP reimbursement code.
3. Surgeon Education and Commercial Scale
Carls Med’s intensive surgeon education programs—fully enrolling residency and fellowship courses months in advance—are building a pipeline of digitally native practitioners. The direct sales force doubled its US regions and now partners with over 100 contracted agents, supporting high-touch onboarding and procedure support.
4. Operational Excellence and Lead Time Reduction
Production lead times have been cut from 20 days a year ago to just six business days, a 25% reduction in Q4 alone. This milestone enables faster case turnaround, supports emergent procedures, and is cited by management as a key driver for new surgeon adoption and reorder rates.
5. Capital-Light Model and Margin Leverage
With a fully integrated digital production line spanning both cervical and lumbar products, Carls Med is positioned to scale without heavy capital outlays. Management projects continued margin leverage as revenue growth outpaces fixed cost increases, supporting a credible path to profitability.
Key Considerations
Carls Med’s Q4 reflects a business at the intersection of digital health, personalized medicine, and medtech manufacturing. The company’s ability to sustain rapid growth while improving margins and compressing lead times is central to its investment case.
Key Considerations:
- Surgeon Onboarding Funnel: High rate of new surgeon additions in 2025 sets the stage for compounding utilization as these practitioners ramp procedural volume.
- Reimbursement Tailwind: The NTAP code for cervical spine procedures and robust DRG coverage in lumbar provide a strong payer foundation, supporting hospital adoption and pricing stability.
- Product Pipeline Visibility: Upcoming launches of the bilateral posterior Aprivo and CORA personalized fixation portfolio in 2H 2026 expand the platform and reinforce the innovation narrative.
- Operating Leverage: Management expects R&D and sales investments to yield improved EBITDA as a percent of revenue, with G&A declining as a share of sales due to fixed cost absorption.
Risks
Key risks include: execution risk as the company scales its commercial and manufacturing footprint, potential delays or adoption hurdles in new product launches, and the need to maintain gross margin discipline as cervical procedures (with lower ASPs) ramp. Competitive pressure from legacy device manufacturers and evolving reimbursement dynamics could challenge pricing or market share, while ongoing net losses require continued balance sheet discipline.
Forward Outlook
For Q1 2026, Carls Med guided to:
- Continued revenue growth driven by both new surgeon additions and deeper utilization across the user base
- Gross margins in the mid-70% range as operational efficiencies persist
For full-year 2026, management maintained guidance of:
- $70 million to $75 million in revenue, representing 44% annual growth at the midpoint
Management highlighted several factors that support guidance:
- Ongoing ramp of cervical procedures and personalized fixation products
- Operating leverage from prior-year investments in sales, R&D, and production systems
Takeaways
Carls Med’s Q4 marks a pivotal step in scaling personalized spine surgery, with rapid surgeon adoption, strong margin profile, and a differentiated, digital-first model that is gaining traction across both lumbar and cervical markets.
- Surgeon Adoption Drives Growth: The onboarding of 101 new surgeons in 2025 is expected to compound future utilization and revenue growth as these practitioners ramp up procedures.
- Margin Leverage and Efficiency: Operational milestones, including six-day lead times and integrated manufacturing, are expanding gross margins and positioning the business for improved EBITDA as growth investments normalize.
- Pipeline and Platform Expansion: The upcoming launches of bilateral posterior and CORA fixation products, and continued ramp of cervical, provide multi-year growth visibility and reinforce the innovation thesis.
Conclusion
Carls Med exits 2025 with strong momentum, a robust balance sheet, and a business model delivering both rapid growth and expanding margins. The company’s digital-first, personalized approach is resonating with surgeons and hospitals, positioning CARL as a leader in the transformation of spine surgery. Investors should watch for continued utilization gains, successful product launches, and evidence of margin leverage as the next phase unfolds.
Industry Read-Through
Carls Med’s results signal accelerating adoption of digital, personalized solutions in the broader medtech and orthopedics space. The success of AI-enabled planning and 3D-printed, patient-specific implants highlights a shift away from traditional stock devices toward outcome-driven, data-rich platforms. Hospitals’ willingness to adopt new reimbursement codes and surgeons’ eagerness for digital workflow training suggest that the next wave of medtech growth will be driven by companies that can deliver both clinical and operational value. Legacy device makers and emerging digital health players alike will need to invest in similar digital-first capabilities or risk losing share in high-value procedural markets.