According to the lawsuit, throughout the Class Period defendants made false statements and/or concealed that Integra had failed to take sufficient measures to remediate the violations identified by the U.S. Food and Drug Administration (“FDA”) in the November 2, 2018 Notice of Inspectional Observations on Form 483, the March 6, 2019 FDA issued warning letter, and the November 12, 2021 FDA issued Form 483. As a result of those deficiencies, since March 2018, all products manufactured in the Company’s manufacturing plant located in Boston, Massachusetts (the “Boston Facility”), including SurgiMend, PriMatrix, Revize, and TissueMend, had the potential for higher-than-permitted levels of endotoxin and would need to be recalled. Moreover, Integra was not making progress towards obtaining its premarket approval (“PMA”) indication for SurgiMend, in part, because the manufacturing site that would produce the PMA product, the Boston Facility, was in continued violation of the FDA standards that Integra failed to rectify years after the initial notice of the violations and as a result the facility had to be shutdown to correct those ongoing deficiencies. When the true details entered the market, the lawsuit claims that investors suffered damages.

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