This page is part of our public exclusion list — a transparency tool that shows which companies we screen out and why. It is not investment advice, and it is not an accusation. But it is subject to change as our understanding of the facts evolves.
Beta Bionics develops and manufactures automated insulin delivery systems, including the iLet Bionic Pancreas, which is designed to manage diabetes. The company's core product development and regulatory testing processes rely on animal testing. The U.S. Food and Drug Administration's (FDA) standard pre-clinical pathway for such medical devices requires animal studies to demonstrate safety and efficacy before human trials can begin. Beta Bionics' regulatory submissions and quality control systems are structured around this animal-dependent development model.
A January 2026 FDA inspection (MARCS-CMS 717927) documented Quality System Regulation violations at Beta Bionics, specifically citing failures in establishing and maintaining procedures for corrective and preventive action. This regulatory finding indicates ongoing operations and quality processes that are integrally tied to the company's animal testing protocols. The company's reliance on animal models is a foundational and non-trivial component of its business, as reflected in its regulatory compliance framework and product development lifecycle.
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A digest of changes to our exclusion list — new additions, removals, and the evidence behind them. We review the list continuously as new evidence surfaces.
Companies appear on our exclusion list based on our investment judgment — not because they've done anything illegal. This is a difference of values and opinion, not an accusation of wrongdoing. Exclusion does not constitute a recommendation against investing in any company, and absence from the list does not constitute a recommendation to invest.
This information is provided for educational and transparency purposes only and should not be relied upon as investment advice. Data is drawn from independent watchdogs, NGOs, government registries, and Ethical Capital's ongoing research — see Research Sources for the full list.
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