Regulatory Approval Challenges: Obtaining and maintaining necessary FDA and international regulatory clearances and approvals for their personalized medical devices is complex, time-consuming, and subject to evolving standards, which could delay product launches or limit market access.

Market Adoption and Commercialization Hurdles: Gaining widespread acceptance and adoption by surgeons and hospitals for their AI-driven personalized spinal implants requires significant educational efforts, demonstration of superior clinical outcomes, and overcoming established practices, which may be slower than anticipated.

Intense Competitive Landscape: Carlsmed operates in a highly competitive medical device market with established players and new entrants offering alternative spinal solutions, potentially limiting market share or putting pressure on pricing.