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Integra LifeSciences Holdings Corporation

Company NameIntegra LifeSciences Holdings Corporation
Stock SymbolIART
Class PeriodMarch 11, 2019 to May 22, 2023
Lead Plaintiff Motion DeadlineNovember 13, 2023

On April 26, 2023, Integra announced that it had paused production at its Boston Facility and disclosed declining operation margins for the quarter and flat revenue growth projections, which the Company attributed to the manufacturing pause. On this news, Integra’s stock price fell $4.64, or 7.9%, to close at $54.20 per share on April 26, 2023, thereby injuring investors.

Then, on May 23, 2023, Integra disclosed that it had initiated a recall of its SurgiMed, PriMatrix, Revize, and TissueMend products manufactured at its Boston facility as far back as March 1, 2018. The Company attributed the recall to a finding that products may have been distributed with higher levels of endotoxins than permitted by the product specifications. As a result, the Company expects to write off approximately $22 million in inventory. On this news, Integra’s stock price fell $10.24, or 20.2%, to close at $40.48 per share on May 23, 2023, thereby injuring investors further.

 

The complaint filed in this class action alleges that throughout the Class Period, Defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Company’s business, operations, and prospects. Specifically, Defendants failed to disclose to investors that: (1) Integra had failed to take sufficient measures to remediate the violations identified by the FDA in the 2018 Form 483, 2019 Warning Letter, and the 2021 Form 483; (2) As a result of those deficiencies, since March 2018, all products manufactured in the Boston Facility had the potential for higher-than-permitted levels of endotoxin and would need to be recalled; (3) The Company was not making progress towards obtaining its 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; and (4) as a result, Defendants’ positive statements about the Company’s business, operations, and prospects were materially misleading and/or lacked a reasonable basis at all relevant times.

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