Integra LifeSciences Holdings Corporation
Investors that purchased the Company’s securities and have suffered a loss, please fill in transaction information below, or email to info@portnoylaw.com.
There is no cost or obligation associated with submitting your information. If you are a shareholder who suffered a loss, please submit your contact information and purchase information to participate in the putative class action.
We also encourage you to contact Lesley F. Portnoy of The Portnoy Law Firm, at 310.692.8883, to discuss your rights free of charge. You can also reach us through the firm’s website at www.portnoylaw.com, or by email at info@portnoylaw.com.
If you choose to take no action, you can remain an absent class member.
Joining the case through the Portnoy Law website enables investors to learn about their legal claims and take an active role in recovering their losses.
The Portnoy Law Firm represents investors around the world and specializes in securities class action lawsuits and shareholder rights litigation.
CONTACT:
Portnoy Law Firm
Lesley F. Portnoy, Esq.,
www.portnoylaw.com
Office: 310.692.8883
1800 Century Park East, Suite 600
Los Angeles, CA 90067
info@portnoylaw.com
According to the lawsuit, during the Class Period, the defendants were alleged to have made false statements and/or concealed information. This information pertained to Integra’s failure to take adequate actions to address the violations that had been pointed out by the U.S. Food and Drug Administration (“FDA”) in several instances: the Notice of Inspectional Observations on Form 483 issued on November 2, 2018, the FDA warning letter of March 6, 2019, and the Form 483 issued on November 12, 2021. Consequently, since March 2018, all products manufactured at Integra’s Boston Facility, which includes SurgiMend, PriMatrix, Revize, and TissueMend, had the potential to contain levels of endotoxin exceeding the permitted limits, necessitating recalls.
Additionally, Integra was not making progress towards obtaining premarket approval (“PMA”) for SurgiMend. One of the reasons for this lack of progress was the ongoing violation of FDA standards at the Boston Facility, a facility intended for producing the PMA product. Integra failed to rectify these violations even years after the initial notice, ultimately leading to the facility’s shutdown for corrective measures. When the true facts regarding these matters became known, the lawsuit alleges that investors incurred financial losses.
