ARTICLE SUMMARY:
By combining advances in AI and machine learning, image data extraction, and 3D printing, Carlsmed believes it can bring precision medicine to spine surgery. Investors supported the company’s strategy with a $52.5 million Series C.
Adult spinal deformity surgery has high complication and revision rates. Studies show that 68% of spine surgeries achieved their preoperative alignment goals, and data from the International Spine Study Group (ISSG) has found that misalignment is the leading cause of poor outcomes. Alignment is critical for spinal stability, nerve protection, and posture—and patients with misalignments are 10 times more likely to require revisions.
The relentless challenge to attain optimal alignment gnawed at Mike Cordonnier, an engineer and seasoned orthopedics device executive, who co-founded Carlsmed in 2018 with the mission to improve outcomes of spine surgery. The company combines advances in data technologies that are enabling surgeons to bring precision medicine to a field that impacts a large patient population and has intractable gaps in clinical care.
The result was aprevo patient-specific spine technology. Initially approved for lumbar fusion in 2020, it was the first implant to receive both Breakthrough Device designation and 510(k) clearance. Following a tightly controlled release at a few academic medical centers in 2021 in the middle of the COVID-19 pandemic, its use has since expanded. In addition, it was approved for New Technology Add-on Payment (NTAP) in 2021, making users eligible for up to 65% in additional reimbursement beyond standard Medicare rates for spinal fusion procedures. Around the same time, CMS also granted Transitional Pass-Through (TPT) payment for use of the device in outpatient facilities with an incremental Medicare payment for procedures that use aprevo.
