INTEGRA DEADLINE ALERT

Bragar Eagel & Squire, P.C. Reminds Investors that a Class Action Lawsuit Has Been Filed Against Integra LifeSciences Holdings Corp. and Encourages Investors to Contact the Firm

Bragar Eagel & Squire, P.C., a nationally recognized stockholder rights law firm, reminds investors that a class action lawsuit has been filed against Integra LifeSciences Holdings Corp. (“Integra” or the “Company”) (NASDAQ: IART) in the United States District Court for the District of New Jersey on behalf of all persons and entities who purchased or otherwise acquired Integra securities between March 11, 2019 and May 22, 2023, both dates inclusive (the “Class Period”). Investors have until November 13, 2023 to apply to the Court to be appointed as lead plaintiff in the lawsuit.

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The claims against Defendants arise from the Company’s violations of federal manufacturing regulations governing medical devices, which are intended to protect patients receiving these medical devices from infections and other medical complications. In October 2018, the FDA inspected the Boston Facility and found that Integra was in violation of the good manufacturing practice requirements of the Quality System Regulation. Consequently, on November 2, 2018, the FDA issued a Notice of Inspectional Observations on Form 483 (the “2018 Form 483”) to put Integra on notice of those violations. Most significantly, the FDA found that Integra failed to adequately test for bacterial endotoxins in the medical devices manufactured at the Boston Facility. On March 7, 2019, Integra received a warning letter (the “2019 Warning Letter”) from the FDA that detailed the Company’s continued failure to remediate the violations that the FDA identified in the 2018 Form 483.

Since 2018, Integra has received multiple warnings from the FDA that its Boston Facility is not in conformity with the good manufacturing practice requirements of the Quality System Regulation. However, throughout the Class Period, Defendants assured investors that they had “undertaken significant efforts” and were working closely with the FDA to remediate the violations in the Boston Facility identified by the FDA in the 2018 Form 483 and 2019 Warning Letter. One Defendant went so far as to say that “[t]here are no patient safety issues” in the Boston Facility.

In the third quarter of 2021, the Company submitted an application to the FDA for premarket approval (“PMA”) for SurgiMend to be used in implant-based breast reconstruction. This was the first PMA application for an implant-based breast reconstruction surgical matrix and represented a major opportunity for the Company to grow SurgiMend’s addressable market. As part of the approval process for SurgiMend’s PMA application, Integra and the SurgiMend product would be required to undergo rigorous testing and review by the FDA to assess the product’s safety, efficacy, and quality. Throughout the Class Period, Defendants repeatedly touted that Integra was on track to grow SurgiMend’s addressable market by obtaining FDA approval for use as implant-based breast reconstruction surgical matrix.