Integra LifeSciences Holdings Corporation (NASDAQ: IART) Investor Alert: Investigation of potential Wrongdoing

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Investigations into possible fiduciary duty breaches by specific Integra LifeSciences Holdings Corporation directors and officials were announced on behalf of current long-term investors in the company’s shares (NASDAQ: IART).

Individuals who are currently long-term investors in shares of Integrated LifeSciences Holdings Corporation (NASDAQ: IART) may contact the Shareholders Foundation by phone at +1(858) 779 15554 or by email at [email protected] to discuss their options.

A lawsuit alleging violations of securities laws was filed against Integrated LifeSciences Holdings Corporation, prompting a law firm representing long-term investors in NASDAQ: IARTstocks to launch an inquiry. Investigating whether certain directors of Integrated LifeSciences Holdings Corporation are accountable for the claims made in that case is the goal of the existing long-term investors in NASDAQ: IARTstocks.

Integra LifeSciences Holdings Corporation was found to be in breach of the Quality System Regulation’s good manufacturing practice criteria during an FDA inspection of the Boston facility in October 2018.

Integra LifeSciences Holdings Corporation was notified of these infractions by the FDA through a Notice of Inspectional Observations on Form 483 (the 2018 Form 483), which was published on November 2, 2018. The FDA’s main discovery was that Integra had not sufficiently tested the medical devices produced at the Boston Facility for bacterial endotoxins.

The FDA sent Integra LifeSciences Holdings Corporation a warning letter on March 7, 2019, which was referred to as the 2019 Warning Letter. The letter emphasized the company’s ongoing inability to address the breaches that the FDA had found on the 2018 Form 483.

Integra LifeSciences Holdings Corporation applied for premarket approval (PMA) of SurgiMend, a medication used in implant-based breast reconstruction, with the FDA in the third quarter of 2021. This was the first PMA application for a surgical matrix based on implants for breast reconstruction, and it offered the company a significant chance to expand SurgiMend’s addressable market. Integra LifeSciences Holdings Corporation and the SurgiMend product would have to go through extensive testing and assessment by the FDA in order to evaluate the product’s quality, safety, and efficacy as part of the approval process for SurgiMend’s PMA application.

According to Integra LifeSciences Holdings Corporation, its yearly Net Income increased from $136.15 million in 2021 to $180.55 million in 2022, and its Total Revenue increased from over $1.54 billion in 2021 to over $1.55 billion in 2022.

Integra LifeSciences Holdings Corporation announced on April 26, 2023, that manufacturing at the Boston Facility had been halted. In addition, Integra LifeSciences Holdings Corporation reported flat revenue growth estimates and decreasing operating margins for the quarter, both of which it ascribed to the manufacturing stoppage. Later on that same day, Integra LifeSciences Holdings Corporation also revealed that the FDA had started a second inspection at the Boston Facility and that, as a result of that inspection, the Company anticipated receiving a second Notice of Inspectional Observations on Form 483 detailing failures related to good manufacturing practices.

Integra LifeSciences Holdings Corporation declared on May 23, 2023, that it had completed an internal inquiry, which resulted in a worldwide recall of all goods made at its facilities in Boston, Massachusetts. Distribution of the impacted products took place between March 1, 2018, and May 22, 2023. The facility’s manufacturing operations were discontinued by Integra LifeSciences Holdings Corporation. These steps were taken because the company discovered variations in endotoxin testing that might have led to the release of products with endotoxin levels higher than those allowed by the product specifications.

On May 22, 2023, Integra LifeSciences Holdings Corporation (NASDAQ: IART) saw a decrease in share price from $50.87 to as low as $37.44 on May 31, 2023.

A lawsuit alleging violations of federal securities laws was filed against Integra LifeSciences Holdings Corporation on September 12, 2023. According to that complaint filed in the U.S. District Court for the District of New Jersey the plaintiff alleges that the defendants failed to disclose to investors that Integra had failed to take sufficient measures to remediate the violations identified by the FDA in the 2018 Form 483, 2019 Warning Letter, and the 2021 Form 483, that as a result of those deficiencies, since March 2018, all products manufactured in the Boston Facility had the potential for higher-than-permitted levels of endotoxin and would need to be recalled, that the Company was not making progress towards obtaining its PMA indication for SurgiMend, in part, because the manufacturing site that would produce the PMA product, the Boston Facility, was in continued violation of the FDA standards that Integra failed to rectify years after the initial notice of the violations and as a result the facility had to be shutdown to correct those ongoing deficiencies, and that as a result, Defendants positive statements about the Company s business, operations, and prospects were materially misleading and/or lacked a reasonable basis at all relevant times.

Investors of Integra LifeSciences Holdings Corporation (NASDAQ: IART) may contact the Shareholders Foundation to learn more about their options.

Get in touch:

Shareholders Foundation, Inc. +1-(858)-779-1554 Christopher Clausen 3111 Camino Del Rio North Suite 42392108 San Diego+1-(858)[email protected] is the fax number.

Regarding:

As a professional portfolio monitoring and settlement claim filing service, The Shareholders Foundation, Inc. notifies investors of securities class actions, settlements, verdicts, and other legal developments pertaining to the stock and financial markets. It also conducts research on shareholder issues. With a vast network of contacts, Shareholders Foundation, Inc. provides support, guidance, and aid to each and every shareholder. It is not a law firm, The Shareholders Foundation, Inc. The Shareholders Foundation is not involved in the filed, reached, or settled cases, investigations, or settlements mentioned. The public is offered this information as a service. It should not be relied upon and is not meant to be legal advice.

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