According to the Complaint, Integra LifeSciences Holdings Corporation is a medical device company that manufactures, among other things, regenerative technology focused on the areas of complex wound surgery, surgical reconstruction, and peripheral nerve repair. Several of these products, which include SurgiMend, PriMatrix, Revize, and TissueMend, are principally manufactured at the Company’s Boston Facility. SurgiMend, one of Integra’s principal Tissue Technologies products, is an implant approved by the U.S. Food and Drug Administration for use as a reinforcement for soft tissue where weakness exists, including within plastic and reconstructive surgery.
The Complaint alleges that during the Class Period, the Company repeatedly touted that it was on track to grow SurgiMend’s addressable market by obtaining FDA approval for use in post-mastectomy reconstruction, and that these misrepresentations caused the price of Integra common stock to trade at artificially inflated prices throughout the Class Period.
On May 23, 2023, the Company announced a “recall” of all products manufactured 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 unsafe levels of endotoxins. The Company also extended the pause on all production at the Boston Facility. 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 Complaint alleges that as a result of Defendants’ wrongful acts and omissions, and the precipitous decline in the market value of the Company’s common stock, Plaintiff and other Class members have suffered significant losses and damages when the truth was revealed.