Integra LifeSciences Holdings Corporation

May 23, 2023

Principle Contacts

Jeffrey P. Campisi

JCampisi@kaplanfox.com

NEW YORK, NY – May 23, 2023 – Kaplan Fox & Kilsheimer LLP (www.kaplanfox.com) is investigating potential claims on behalf of investors who purchased Integra LifeSciences Holdings Corporation (Nasdaq: IART) securities. Click Here to Join Investigation.

If you purchased Integra securities and would like to discuss our investigation, please click here, or contact us by emailing jcampisi@kaplanfox.com or calling (212) 329-8571. 

On May 23, 2023, before the market opened, Integra filed a report with the SEC that stated in part the following:

“Integra LifeSciences Holdings Corporation (the “Company”), after consultation with the U.S. Food and Drug Administration (the “FDA”), initiated a voluntary global recall of all products manufactured in its Boston, Massachusetts facility (the “Boston facility”) distributed between March 1, 2018 and May 22, 2023 (the “voluntary recall”). As a result, the Company concluded on May 22, 2023 that it expects it will incur an impairment charge related to the write-off of inventories, net, of approximately $22 million. The Company expects this charge will be recorded in the quarter ending June 30, 2023. . . .

The Company identified through an internal investigation process in its Boston facility deviations with endotoxin testing that may have resulted in the release of products with higher levels of endotoxins than permitted by the product specifications. Higher levels of endotoxins can induce an immune response, leading to a post-operative fever. Although there is no specific indication of any reported product complaints related to high endotoxin levels, the Company, in accordance with its commitment to patient safety and product quality, has decided to initiate the voluntary recall and extend the temporary halt of manufacturing at its Boston facility to implement additional detection and quality controls. The Company expects to resume manufacturing at its Boston facility following implementation of such controls. 

The voluntary recall includes the SurgiMend, PriMatrix, Revize™ and TissueMend™ products. 

The Company expects that the voluntary recall and manufacturing stoppage will have the greatest impact on the Tissue Technologies segment, including Private Label, and has revised guidance. For the second quarter, the Company expects reported revenues in the range of $372 million to $376 million and adjusted earnings per diluted share to be in the range of $0.55 to $0.59. 

While it is difficult to estimate at this time the impact of the voluntary recall for the full year, if the manufacturing stoppage continued through the remainder of 2023, the Company estimates full-year revenue and adjusted earnings per share guidance provided during the Company’s April earnings announcement would be negatively affected by approximately $60 million and $0.35, respectively. Products manufactured at the Boston facility represent approximately 5% of the Company’s consolidated revenues. The Company expects to provide updated details on its full-year guidance during its second quarter 2023 financial results conference call.” 

On May 23, 2023, Integra’s shares declined from a closing price on May 22, 2022 of $50.72 per share to close at $40.48 per share, a decline of $10.24 per share, or by over 20%, on heavier than average trading volume.  

WHY CONTACT KAPLAN FOX – Kaplan Fox is a leading national law firm focusing on complex litigation with offices in New York, Oakland, Los Angeles, Chicago and New Jersey.  With over 50 years of experience in securities litigation, Kaplan Fox offers the professional experience and track record that clients demand.  Through prosecuting cases on the federal and state levels, Kaplan Fox has successfully shaped the law through winning many important decisions on behalf of our clients.  For more information about Kaplan Fox & Kilsheimer LLP, you may visit our website at www.kaplanfox.com.  

If you have any questions about this investigation, please contact: 

Jeffrey P. Campisi
KAPLAN FOX & KILSHEIMER LLP
800 Third Avenue, 38th Floor
New York, New York 10022
(212) 329-8571
E-mail: jcampisi@kaplanfox.com

Laurence D. King
KAPLAN FOX & KILSHEIMER LLP
1999 Harrison Street, Suite 1560
Oakland, California 94612
(415) 772-4704
Fax:  (415) 772-4707
E-mail: lking@kaplanfox.com