{"id":27684,"date":"2025-02-26T03:00:48","date_gmt":"2025-02-26T03:00:48","guid":{"rendered":"https:\/\/allonlinebanglanewspapers.com\/news\/integra-alert-bragar-eagel-squire-p-c-is-investigating-integra-lifesciences-holdings-corp-on-behalf-of-long-term-stockholders-and-encourages-investors-to-contact-the-firm\/"},"modified":"2025-02-26T03:00:48","modified_gmt":"2025-02-26T03:00:48","slug":"integra-alert-bragar-eagel-squire-p-c-is-investigating-integra-lifesciences-holdings-corp-on-behalf-of-long-term-stockholders-and-encourages-investors-to-contact-the-firm","status":"publish","type":"post","link":"https:\/\/allonlinebanglanewspapers.com\/news\/integra-alert-bragar-eagel-squire-p-c-is-investigating-integra-lifesciences-holdings-corp-on-behalf-of-long-term-stockholders-and-encourages-investors-to-contact-the-firm\/","title":{"rendered":"INTEGRA ALERT: Bragar Eagel & Squire, P.C. is Investigating Integra LifeSciences Holdings Corp. on Behalf of Long-Term Stockholders and Encourages Investors to Contact the Firm"},"content":{"rendered":"
\n

NEW YORK, Feb. 25, 2025 (GLOBE NEWSWIRE) — Bragar Eagel & Squire, P.C., a nationally recognized shareholder rights law firm, is investigating potential claims against Integra LifeSciences Holdings Corp. (NASDAQ: IART) on behalf of long-term stockholders following a class action complaint that was filed against Integra on September 12, 2023 with a Class Period from March 11, 2019 to May 22, 2023. Our investigation concerns whether the board of directors of Integra have breached their fiduciary duties to the company.<\/p>\n

The claims against Defendants arise from the Company\u2019s violations of federal\u00a0manufacturing regulations governing medical devices, which are intended to\u00a0protect patients receiving these medical devices from infections and other\u00a0medical complications. In October 2018, the FDA inspected the Boston Facility\u00a0and found that Integra was in violation of the good manufacturing practice requirements of the Quality System Regulation. Consequently, on November 2,\u00a02018, the FDA issued a Notice of Inspectional Observations on Form 483 (the\u00a0\u201c2018 Form 483\u201d) to put Integra on notice of those violations. Most\u00a0significantly, the FDA found that Integra failed to adequately test for\u00a0bacterial endotoxins in the medical devices manufactured at the Boston\u00a0Facility. On March 7, 2019, Integra received a warning letter (the \u201c2019\u00a0Warning Letter\u201d) from the FDA that detailed the Company\u2019s continued failure to\u00a0remediate the violations that the FDA identified in the 2018 Form 483.<\/p>\n

Since 2018, Integra has received multiple warnings from the FDA that its\u00a0Boston Facility is not in conformity with the good manufacturing practice\u00a0requirements of the Quality System Regulation. However, throughout the Class\u00a0Period, Defendants assured investors that they had \u201cundertaken significant\u00a0efforts\u201d and were working closely with the FDA to remediate the violations in\u00a0the Boston Facility identified by the FDA in the 2018 Form 483 and 2019\u00a0Warning Letter. One Defendant went so far as to say that \u201c[t]here are no\u00a0patient safety issues\u201d in the Boston Facility.<\/p>\n

In the third quarter of 2021, the Company submitted an application to the FDA\u00a0for premarket approval (\u201cPMA\u201d) for SurgiMend to be used in implant-based\u00a0breast reconstruction. This was the first PMA application for an implant-based\u00a0breast reconstruction surgical matrix and represented a major opportunity for\u00a0the Company to grow SurgiMend\u2019s addressable market. As part of the approval\u00a0process for SurgiMend\u2019s PMA application, Integra and the SurgiMend product\u00a0would be required to undergo rigorous testing and review by the FDA to assess\u00a0the product\u2019s safety, efficacy, and quality. Throughout the Class Period,\u00a0Defendants repeatedly touted that Integra was on track to grow SurgiMend\u2019s\u00a0addressable market by obtaining FDA approval for use as implant-based breast\u00a0reconstruction surgical matrix.<\/p>\n

According to the complaint, the truth began to emerge on April 26, 2023, when the Company revealed that it\u00a0had paused production at the Boston Facility. The Company also disclosed\u00a0declining operating margins for the quarter and flat revenue growth\u00a0projections, which the Company attributed to the manufacturing stoppage. As a\u00a0result of these disclosures, the price of Integra common stock declined by\u00a0$4.64 per share, or 8%. Later that same day, Integra further disclosed that\u00a0the FDA had commenced another inspection at the Boston Facility and that the\u00a0Company expected to receive another Notice of Inspectional Observations on\u00a0Form 483 documenting good manufacturing practices failures as a result of that\u00a0inspection. However, Defendants continued to reassure investors by downplaying\u00a0the pause at the Boston Facility and reiterating their confidence in obtaining\u00a0PMA for SurgiMend to be used in implant-based breast reconstruction.<\/p>\n

Then, on May 23, 2023, the Company announced that it was recalling all\u00a0products made at the Boston Facility between March 1, 2018 and May 22, 2023.\u00a0Integra explained that it had determined that the Boston Facility deviated\u00a0from good manufacturing practices in testing for bacterial endotoxin and\u00a0allowed the release of products with higher levels of endotoxins. Accordingly,\u00a0the Company implemented a \u201cvoluntary recall\u201d and extended the pause on\u00a0production in the Boston Facility. The recalled products included SurgiMend,\u00a0PriMatrix, Revize, and TissueMend. As a result of the recall and manufacturing\u00a0shutdown, the Company revised its guidance for the second quarter of 2023,\u00a0lowering its revenue expectations by 6% and adjusted earnings per diluted share by 26%. The Company further disclosed that it expected to take a $22\u00a0million impairment charge in the second quarter due to the inventory\u00a0write-off. These disclosures caused the price of Integra stock to decline by\u00a0an additional $10.24 per share, or 20%.<\/p>\n

If you are a long-term stockholder of Integra, have information, would like to learn more about these claims, or have any questions concerning this announcement or your rights or interests with respect to these matters, please contact Brandon Walker or Marion Passmore by email at investigations@bespc.com<\/a>, by telephone at (212) 355-4648, or by filling out this contact form<\/a>. There is no cost or obligation to you.<\/p>\n

About Bragar Eagel & Squire, P.C.:<\/strong><\/p>\n

Bragar Eagel & Squire, P.C. is a nationally recognized law firm with offices in New York, California, and South Carolina. The firm represents individual and institutional investors in commercial, securities, derivative, and other complex litigation in state and federal courts across the country. For more information about the firm, please visit www.bespc.com<\/u><\/a>. Attorney advertising. Prior results do not guarantee similar outcomes.<\/p>\n

Contact Information:<\/strong><\/p>\n

Bragar Eagel & Squire, P.C.
Brandon Walker, Esq.
Marion Passmore, Esq.
(212) 355-4648
investigations@bespc.com<\/u><\/a>
www.bespc.com<\/u><\/a><\/p>\n

\n <\/div>\n","protected":false},"excerpt":{"rendered":"

NEW YORK, Feb. 25, 2025 (GLOBE NEWSWIRE) — Bragar Eagel & Squire, P.C., a nationally recognized shareholder rights law firm, is investigating potential claims against Integra LifeSciences Holdings Corp. (NASDAQ: IART) on behalf of long-term stockholders following a class action complaint that was filed against Integra on September 12, 2023 with a Class Period from […]<\/p>\n","protected":false},"author":2,"featured_media":27685,"comment_status":"","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"fifu_image_url":"https:\/\/ml.globenewswire.com\/Resource\/Download\/29481954-f2ff-4756-b5a9-d982a6497bd0","fifu_image_alt":"","footnotes":""},"categories":[11],"tags":[],"class_list":["post-27684","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-globenewswire"],"acf":[],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/allonlinebanglanewspapers.com\/news\/wp-json\/wp\/v2\/posts\/27684","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/allonlinebanglanewspapers.com\/news\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/allonlinebanglanewspapers.com\/news\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/allonlinebanglanewspapers.com\/news\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/allonlinebanglanewspapers.com\/news\/wp-json\/wp\/v2\/comments?post=27684"}],"version-history":[{"count":0,"href":"https:\/\/allonlinebanglanewspapers.com\/news\/wp-json\/wp\/v2\/posts\/27684\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/allonlinebanglanewspapers.com\/news\/wp-json\/wp\/v2\/media\/27685"}],"wp:attachment":[{"href":"https:\/\/allonlinebanglanewspapers.com\/news\/wp-json\/wp\/v2\/media?parent=27684"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/allonlinebanglanewspapers.com\/news\/wp-json\/wp\/v2\/categories?post=27684"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/allonlinebanglanewspapers.com\/news\/wp-json\/wp\/v2\/tags?post=27684"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}