Cases & investigations

Cases & investigations

Integra LifeSciences

Kaskela Law LLC announces that it is investigating Integra LifeSciences Holdings Corp. (NASDAQ: IART) (“Integra”) on behalf of the company’s long-term investors.

Recently a securities fraud complaint was filed against Integra on behalf of investors who purchased shares of the company’s stock between March 11, 2019 and May 22, 2023 (the “Class Period”).  According to the complaint, during the Class Period Integra and certain of the company’s senior executive officers issued a series of materially false and misleading statements to investors.

As detailed in the complaint, on October 9, 2018, the FDA began an inspection of the company’s Boston Facility, during which it observed that Integra’s quality systems and manufacturing conditions were “not in conformity with the current good manufacturing practice requirements of the Quality System Regulation.” As a result, on November 2, 2018, the FDA issued a Notice of Inspectional Observations on Form 483 to put Integra on notice of those violations.  After receiving the 2018 Form 483, Integra issued a series of responses purporting to address the problems identified by the FDA.

On April 26, 2023, Integra 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 it attributed to the manufacturing stoppage. As a result of these disclosures, shares of Integra’s common stock declined by $4.64 per share, or 8% in value, to close at $54.20 per share.  Later that day Integra further revealed that, on March 1, 2023, the FDA had commenced another inspection of the Boston Facility and that the company expected to receive another Form 483 as a result of that inspection.

Then, on May 23, 2023, the Company announced a “recall” of products manufactured at its 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 unsafe levels of endotoxins.  Integra further disclosed that it expected to take a $22 million impairment charge in the second quarter due to the inventory write-off.  Following these additional disclosures, shares of Integra’s common stock fell an additional $10.24 per share, or 20% in value, to close on May 23, 2023 at $40.48 per share.

The investigation seeks to determine whether the members of Integra’s board of directors violated the securities laws and/or breached their fiduciary duties in connection with the above alleged misconduct.

Current Integra stockholders who purchased or acquired IART shares prior to April 26, 2023 are encouraged to contact Kaskela Law LLC (D. Seamus Kaskela, Esq. or Adrienne Bell, Esq.) at (484) 229 – 0750, or by completing the form on this page, for additional information about this investigation and their legal rights and options.

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