If you purchased or acquired securities in Integra stock or options between March 11, 2019 and May 22, 2023 and would like to discuss your legal rights, call Faruqi & Faruqi partner Josh Wilson directly at 877-247-4292 or 212-983-9330 (Ext. 1310). You may also click here for additional information: www.faruqilaw.com/IART.
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NEW YORK, Nov. 04, 2023 (GLOBE NEWSWIRE) -- Faruqi & Faruqi, LLP, a leading national securities law firm, is investigating potential claims against Integra LifeSciences Holdings Corporation (“Integra” or the “Company”) (NASDAQ: IART) and reminds investors of the November 13, 2023 deadline to seek the role of lead plaintiff in a federal securities class action that has been filed against the Company.
Faruqi & Faruqi is a leading minority and Woman-owned national securities law firm with offices in New York, Pennsylvania, California and Georgia.
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.
The truth began to emerge on April 26, 2023, when the Company revealed that it had paused production at the Boston Facility. The Company also disclosed declining operating margins for the quarter and flat revenue growth projections, which the Company attributed to the manufacturing stoppage. As a result of these disclosures, the price of Integra common stock declined by $4.64 per share, or 8%. Later that same day, Integra further disclosed that the FDA had commenced another inspection at the Boston Facility and that the Company expected to receive another Notice of Inspectional Observations on Form 483 documenting good manufacturing practices failures as a result of that inspection. However, Defendants continued to reassure investors by downplaying the pause at the Boston Facility and reiterating their confidence in obtaining PMA for SurgiMend to be used in implant-based breast reconstruction.
Then, on May 23, 2023, the Company announced that it was recalling all products made at the Boston Facility between March 1, 2018 and May 22, 2023. Integra explained that it had determined that the Boston Facility deviated from good manufacturing practices in testing for bacterial endotoxin and allowed the release of products with higher levels of endotoxins. Accordingly, the Company implemented a “voluntary recall” and extended the pause on production in the Boston Facility. The recalled products included SurgiMend, PriMatrix, Revize, and TissueMend. As a result of the recall and manufacturing shutdown, the Company revised its guidance for the second quarter of 2023, lowering its revenue expectations by 6% and adjusted earnings per diluted share by 26%. The Company further disclosed that it expected to take a $22 million impairment charge in the second quarter due to the inventory write-off. These disclosures caused the price of Integra stock to decline by an additional $10.24 per share, or 20%.
The court-appointed lead plaintiff is the investor with the largest financial interest in the relief sought by the class who is adequate and typical of class members who directs and oversees the litigation on behalf of the putative class. Any member of the putative class may move the Court to serve as lead plaintiff through counsel of their choice, or may choose to do nothing and remain an absent class member. Your ability to share in any recovery is not affected by the decision to serve as a lead plaintiff or not.
Faruqi & Faruqi, LLP also encourages anyone with information regarding Integra’s conduct to contact the firm, including whistleblowers, former employees, shareholders and others.
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