Integra LifeSciences Holdings Corporation
A securities class action has been filed in the USDC – N.J. against Integra LifeSciences Holdings Corporation (IART) (“Integra” or the “Company”) on behalf of a class consisting of all persons and entities that purchased or otherwise acquired Integra common stock between March 11, 2019 through May 22, 2023, both dates inclusive (the “Class Period”).
Integra develops regenerative tissue technologies and neurological solutions. The Company’s Tissue Technologies business—which generates approximately one-third of Integra’s total revenue—manufactures and sells collagen-based medical devices that are used for complex wound care, peripheral nerve repair, and reconstruction surgery. Several of those products are produced at the Company’s manufacturing plant located in Boston, Massachusetts (the “Boston Facility”), including SurgiMend, PriMatrix, Revize, and TissueMend. SurgiMend, one of Integra’s principal wound care products, is an implant approved by the U.S. Food and Drug Administration (“FDA”) for use as a reinforcement for soft tissue where weakness exists, including within plastic and reconstructive surgery.
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.
The Complaint alleges that throughout the Class Period, Integra repeatedly touted that it was on track to grow SurgiMend’s addressable market by obtaining FDA approval for use in post-mastectomy reconstruction. These misrepresentations caused the price of Integra common stock to trade at artificially inflated prices throughout the Class Period, thereby harming investors.
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Lowey Dannenberg is a national firm representing institutional and individual investors, who suffered financial losses resulting from corporate fraud and malfeasance in violation of federal securities and antitrust laws. The firm has significant experience in prosecuting multi-million-dollar lawsuits and has previously recovered billions of dollars on behalf of investors.
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