A lawsuit was filed on behalf of investors in Integra LifeSciences Holdings Corporation (NASDAQ: IART) shares over alleged securities laws violations.
San Diego, CA -- (SBWIRE) -- 09/25/2023 -- An investor, who purchased shares of Integra LifeSciences Holdings Corporation (NASDAQ: IART), filed a lawsuit over alleged violations of Federal Securities Laws by Integra LifeSciences Holdings Corporation in connection with certain allegedly false and misleading statements.
Investors who purchased shares of Integra LifeSciences Holdings Corporation (NASDAQ: IART) have certain options and for certain investors are short and strict deadlines running. Deadline: November 13, 2023. NASDAQ: IART investors should contact the Shareholders Foundation at firstname.lastname@example.org or call +1(858) 779 - 1554.
Princeton, NJ based Integra LifeSciences Holdings Corporation manufactures and sells surgical instruments, neurosurgical products, and wound care products for use in neurosurgery, neurocritical care and otolaryngology. Several of those products are produced at the Company's manufacturing plant located in Boston, Massachusetts (the "Boston Facility"), including SurgiMend, PriMatrix, Revize, and TissueMend. SurgiMend, one of Integra's principal Tissue Technologies products, is an implant approved by the U.S. Food and Drug Administration ("FDA") for use as a reinforcement for soft tissue where weakness exists, including within plastic and reconstructive surgery.
In October 2018, the FDA inspected the Boston Facility and found that Integra LifeSciences Holdings Corporation was in violation of the good manufacturing practice requirements of the Quality System Regulation.
On November 2, 2018, the FDA issued a Notice of Inspectional Observations on Form 483 (the "2018 Form 483") to put Integra LifeSciences Holdings Corporation on notice of those violations. Most significantly, the FDA found that Integra failed to adequately test for bacterial endotoxins in the medical devices manufactured at the Boston Facility.
On March 7, 2019, Integra LifeSciences Holdings Corporation received a warning letter (the "2019 Warning Letter") from the FDA that detailed the Company's continued failure to remediate the violations that the FDA identified in the 2018 Form 483.
In the third quarter of 2021, Integra LifeSciences Holdings Corporation submitted an application to the FDA for premarket approval ("PMA") for SurgiMend to be used in implant-based breast reconstruction. This was the first PMA application for an implant-based breast reconstruction surgical matrix and represented a major opportunity for the Company to grow SurgiMend's addressable market. As part of the approval process for SurgiMend's PMA application, Integra LifeSciences Holdings Corporation and the SurgiMend product would be required to undergo rigorous testing and review by the FDA to assess the product's safety, efficacy, and quality.
Integra LifeSciences Holdings Corporation reported that its annual Total Revenue rose from over $1.54 billion in 2021 to over $1.55 billion in 2022, and that its Net Income increased from $136.15 million in 2021 to $180.55 million in 2022.
On April 26, 2023, Integra LifeSciences Holdings Corporation revealed that it had paused production at the Boston Facility. Integra LifeSciences Holdings Corporation also disclosed declining operating margins for the quarter and flat revenue growth projections, which the Company attributed to the manufacturing stoppage. Later that same day, Integra LifeSciences Holdings Corporation further disclosed that the FDA had commenced another inspection at the Boston Facility and that the Company expected to receive another Notice of Inspectional Observations on Form 483 documenting good manufacturing practices failures as a result of that inspection.
On May 23, 2023, Integra LifeSciences Holdings Corporation announced that it had conducted an internal investigation, leading to a global recall of all products produced at its Boston, Massachusetts facility. The affected products were distributed between March 1, 2018, and May 22, 2023. Integra LifeSciences Holdings Corporation ceased manufacturing operations at the facility. The reason behind these actions was the company "identified deviations with endotoxin testing that may have resulted in the release of products with higher levels of endotoxins than permitted by the product specifications."
Shares of Integra LifeSciences Holdings Corporation (NASDAQ: IART) declined from $50.87 per share on May 22, 2023, to as low as $37.44 per share on May 31, 2023.
The plaintiff claims that between March 11, 2019 and May 22, 2023, 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.
Those who purchased shares of Integra LifeSciences Holdings Corporation (NASDAQ: IART) have certain options and should contact the Shareholders Foundation.
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