Humacyte's study of its lab-grown blood vessels to measure blood flow success faced significant patient complications, including four deaths and four amputations. While the FDA approved the vessels based on the study, internal concerns about sufficiency and patient outcomes were noted. Despite the negative outcomes, Humacyte presented these patients as successes in investor communications. This situation highlights tensions between regulatory approval processes and patient safety, especially as the company began aggressive marketing of the product to hospitals and military applications after approval.
In a controversial study by Humacyte, the FDA approved lab-grown blood vessels despite concerns raised by scientists about patient safety and the quality of the study.
Despite the serious complications faced by patients in the Humacyte study, including deaths and amputations, the company marketed the results as successful to investors.
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