Carlsmed (NASDAQ:CARL) used its presentation at Canaccord Genuity’s Musculoskeletal Conference to outline its mission to improve outcomes and reduce the cost of spine surgery by lowering reoperation rates in spine fusion procedures through a personalized, data-driven technology platform. CEO Mike Cordonnier said the company, founded in 2018 and newly public, has built a preoperative, intraoperative, and postoperative workflow that combines patient-specific digital surgical planning with build-on-demand implants and post-op data collection.
Recent financial performance and 2025 outlook
Cordonnier highlighted Carlsmed’s recent results and guidance, emphasizing rapid revenue growth and high gross margins. He said the company delivered “north of $15 million” in fourth-quarter revenue and reported a 76.5% gross margin. He also cited year-on-year growth of 61% over the prior quarter in Q4.
Looking ahead, Cordonnier said the company’s most recent guidance calls for $70 million to $75.5 million in revenue this year, which he described as 44% growth at the midpoint.
Surgeon adoption and commercial model
Cordonnier said early customer traction has been strong, noting Carlsmed expanded its user base by nearly 70% last year and ended the year with 253 trained surgeon users. He described the company’s commercial approach as a hybrid model: a traditional operating-room presence supported by sales agents and distributors, combined with a direct team focused on customer acquisition, training, and account support—particularly in the preoperative planning phase.
Market focus and platform overview
Carlsmed is focused on the U.S. spine market and now serves both lumbar and cervical segments following its recent cervical platform launch. Cordonnier estimated the annual U.S. addressable procedure volume at about 445,000 lumbar spine fusion procedures and roughly 373,000 cervical procedures, totaling more than 800,000 procedures.
He attributed Carlsmed’s differentiation to its aprevo Technology Platform, which he said enables the company to:
- Use standard imaging inputs (X-ray and CT) to reconstruct patient anatomy in 3D.
- Create a patient-specific surgical plan and personalized implants designed to achieve targeted alignment.
- Provide the plan to surgeons via the myaprevo platform for review and approval.
- Manufacture sterile-packed, single-use instruments and 3D-printed implants on demand.
- Collect postoperative data in the aprevo Intelligence Platform to compare planned versus achieved alignment and how results are maintained over time.
Cordonnier said this closed-loop dataset is used to continuously train and refine the platform, including personalization for patient populations and individual surgeons.
Clinical data and reimbursement
Cordonnier pointed to clinical validation as central to the company’s value proposition. He said two-year data published in the Global Spine Journal showed a 74% reduction in revision rates at two years for patients treated with the aprevo personalized approach compared with traditional fusion procedures using stock devices.
On reimbursement, he said Carlsmed secured FDA Breakthrough Device Designation for its lumbar offering, which helped the company obtain a New Technology Add-on Payment (NTAP) during early commercialization. He added that after continued clinical data collection, Carlsmed received permanent DRG reimbursement that went into place in late 2024, providing incremental reimbursement for lumbar fusion using the aprevo technology versus traditional stock devices. Cordonnier said this reimbursement profile creates incentives for hospitals to adopt the technology.
Cervical expansion, product updates, and operations
Cordonnier said Carlsmed recently expanded into cervical spine procedures, targeting ACDF (anterior cervical discectomy and fusion) cases, particularly in patients with osteopenia or osteoporosis where subsidence can lead to loss of correction and higher revision risk. He said Carlsmed developed patient-specific cervical implants designed to fit the anatomy, with a wider footprint extending to the uncinate joint to increase surface area contact—an approach he contrasted with typical wedge-shaped cervical interbodies that may require endplate drilling.
He said early cervical clinical evaluation data was presented at the CSRS meeting in December, coinciding with the product launch, demonstrating the company’s ability to deliver specific intervertebral alignment.
For cervical reimbursement, Cordonnier said Carlsmed also received Breakthrough Device Designation and an active NTAP that provides “north of $21,000” incremental reimbursement to hospitals in addition to current DRG payments, with a focus on inpatient, typically older patients.
Operationally, Cordonnier discussed improvements in lead times. He said early in the company’s launch, order-to-delivery timelines were around eight weeks, but the company has now reduced this to six days—an improvement he described as important for addressing the broader mass market.
He also cited newer product and procedural milestones, including completion of the first posterior minimally invasive bilateral approach using the aprevo platform, and the announcement of a CORRA personalized cervical plating platform designed to offer personalized planning and alignment along with external plating options. Cordonnier emphasized the company’s “zero inventory” model for hospitals, with sterile-packed, on-demand delivery intended to avoid central processing and reduce tray logistics.
During Q&A, Cordonnier said Carlsmed is not directly integrating wearable technology for post-op monitoring, though it is aware of clinical studies using wearables to track recovery. Asked about competition from expandable cages in lumbar spine, he said the company’s surgeons value the preplanned, anatomy-fitting approach and described the implants as “self-distracting.” He also confirmed the company’s devices are porous, 3D-printed titanium alloy designed for osseointegration. On expansion beyond spine, he said the company remains focused on U.S. spine and expects to add further indications within spine before considering other markets.
About Carlsmed (NASDAQ:CARL)
We are a commercial-stage medical technology company pioneering AI-enabled personalized spine surgery solutions with a mission to improve outcomes and decrease the cost of healthcare for spine surgery and beyond. We are focused on becoming the standard of care for spine fusion surgery. The aprevo Technology Platform consists of artificial intelligence (“AI”)-enabled software solutions, and interbody implants that we custom design for each patient’s unique pathology and vertebral bone topography, and single-use surgical instruments (the “aprevo Technology Platform”).
