Detailed Narrative
Reimbursement Enhancements for Aprivo Lumbar Procedures
CMS issued the FY27 Inpatient Prospective Payment System (IPPPS) final rule on July 31, 2026, creating three new MS-DRG codes (523, 524, 525) specifically for Aprivo lumbar procedures. These new codes, effective October 1, 2026, replace 11 existing codes, simplifying coding and enhancing reimbursement for hospitals. Management believes this policy will expand hospital and patient access to the APRIVO procedure, acting as a tailwind for 2027 and beyond by accelerating VAC committee processes and deepening penetration.
Clinical Evidence and Product Expansion in Lumbar Franchise
Peer-reviewed data published in the Global Spine Journal showed a 74% reduction in reoperations for adult spinal deformity patients treated with Aprivo personalized lumbar implants. This significant clinical advancement supports the platform's efficacy. The company is also expanding its lumbar franchise with the limited market evaluation of the Aprivo bilateral system, which addresses an estimated 30,000 procedures annually in the U.S. and is on track for a Q4 commercial launch.
Momentum and Expansion in Cervical Franchise
Aprivo Cervical completed its second full quarter of commercialization, receiving excellent reception from surgeons and contributing approximately 10% of Q2 revenue. The procedure provides precise implant fit and maximized implant coverage, potentially benefiting patients with low vertebral bone density. To further expand, the CORA Cervical Plating System is progressing for a Q4 commercial launch, targeting approximately 60% of cervical ACDF procedures in the US that utilize fixation plates.
Medical Education and Surgeon Adoption
Carlsmed's medical education program, including residents and fellows programs and the Aprivo Power Forum, continues to expand, with the Power Forum anticipating more than double the surgeon attendees compared to 2025. This focus on training early and mid-career surgeons, who are eager to adopt 3D planning and personalized surgery, is central to the company's long-term growth strategy and drives new surgeon onboarding and utilization.
Operational Efficiency and Capital-Light Model
The company's proprietary digital platform enables efficient delivery of patient-specific surgical kits in about a week, without the heavy capital investments of traditional medtech. This capital-light, digital-first business model contributed to a 340 basis point gross margin expansion year-over-year and is expected to enable contribution margin dollars to grow faster than fixed costs, underpinning future adjusted EBITDA improvement and a visible pathway to cash flow breakeven.