CARLSMED INC

Carlsmed Inc. is a medical device company whose primary commercial product is a spinal implant system designed for use in spinal fusion surgeries. The company's business model is predicated on the sale of implants and instruments, which are tested for safety and efficacy using animal models as a standard industry practice prior to human clinical trials. This reliance on animal testing for product development and regulatory submission triggers the animal exploitation exclusion.

The company's S-1 registration statement filed with the SEC in June 2025 explicitly identifies compliance with animal welfare laws as a material risk, noting that failure to comply could result in substantial penalties. This disclosure acknowledges the company's operational involvement in activities governed by the Animal Welfare Act and similar regulations. While specific details of Carlsmed's testing protocols are not public, the regulatory framework referenced is designed for entities conducting research, testing, or education with live animals.

Independent reports, such as a November 2025 audit of U.S. laboratories, have documented widespread animal welfare violations within the research sector, providing evidence of systemic suffering. Companies like Carlsmed, which depend on animal data to bring new medical devices to market, are integrated into this commercial research ecosystem. The absence of a publicly available animal testing policy or commitment to alternative methods places the company within the standard industry model that exploits animals as a means to a commercial end.