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Lawsuit filed for Investors who lost money with shares of iRhythm Technologies, Inc. (NASDAQ: IRTC)

02-22-2024 06:47 AM CET | Business, Economy, Finances, Banking & Insurance

Press release from: Shareholders Foundation

A lawsuit was filed on behalf of investors in iRhythm Technologies, Inc. (NASDAQ: IRTC) shares.

A lawsuit was filed on behalf of investors in iRhythm Technologies, Inc. (NASDAQ: IRTC) shares.

An investor, who purchased shares of iRhythm Technologies, Inc. (NASDAQ: IRTC), filed a lawsuit over alleged violations of Federal Securities Laws by iRhythm Technologies, Inc. in connection with certain allegedly false and misleading statements.

Investors who purchased shares of iRhythm Technologies, Inc. (NASDAQ: IRTC) have certain options and for certain investors are short and strict deadlines running. Deadline: April 8, 2024. NASDAQ: IRTC investors should contact the Shareholders Foundation at mail@shareholdersfoundation.com or call +1(858) 779 - 1554.

San Francsico, CA based iRhythm Technologies, Inc., a digital healthcare company, provides ambulatory electrocardiogram (ECG) monitoring products for patients at risk for arrhythmias in the United States. The Company's principal product is a monitoring patch that provides electrocardiogram ("ECG") monitoring for up to 14 days, called Zio XT. The Zio XT is intended for non-critical patients, as it does not provide real-time reporting.

In 2017, iRhythm Technologies, Inc. developed Zio AT, a device the Company described as "offer[ing] the full benefits of [its] Zio XT Service, with the addition of real-time data transmission and notification of actionable clinical events." Actionable arrhythmic events include atrial fibrillation, a condition that can cause troubling symptoms and serious medical complications, including blood clots that can lead to stroke and heart failure. The Zio AT comes with a cellular transmittal device that provides connectivity between the Zio AT and the proprietary algorithmic software that analyzes the ECG data and detects arrhythmic events for the 14-day wear period. Importantly, given its purported capabilities to provide "real-time" notifications of arrhythmic events, the Zio AT device is marketed to high-risk patients as a mobile cardiac telemetry device. These types of heart monitors that are approved for high-risk patients and provide near real-time alerts are also referred to as "real-time" monitors. Real-time monitors sell for a premium over monitors that do not provide real-time notifications of arrhythmic events.

On November 1, 2022, iRhythm Technologies, Inc. reported its revised fourth quarter and full-year guidance, in part due to "Zio AT utilization." The Company explained during a conference call with investors that "coming into the fourth quarter, [iRhythm] voluntarily issued a Customer Advisory Notice to [its] Zio AT customers." Consequently, the Company lowered its Zio AT forecast for the quarter from the 40% growth target it had provided through the past three quarters to just 20%.

On November 4, 2022 the Company disclosed that it initiated the Customer Advisory Notice on September 28, 2022, following issues raised by the FDA during an inspection that culminated in an inspection observation report on Form 483, and that the Customer Advisory Notice warned patients of a "labeling correction" related to "the device's maximum transmission limits during wear," as well as other critical issues that prevent the device from working as advertised.

Then, on May 4, 2023, iRhythm Technologies, Inc. announced that "on April 4, 2023, [it] received a Subpoena Duces Tecum from the Consumer Protection Branch, Civil Division of the U.S. Department of Justice, requesting production of various documents regarding [its] products and services."
In a May 5, 2023, report, J.P. Morgan analysts noted that one of iRhythm's competitors, Boston Scientific, had also disclosed that it received a subpoena from the DOJ relating to its real-time monitoring product, which indicated to the analysts that the DOJ investigation into iRhythm was related to the Zio AT.

Finally, on May 30, 2023, iRhythm Technologies, Inc. disclosed that it had received a warning letter from the FDA, which addressed a series of deficiencies tied to the marketing and capabilities of the Zio AT device. In particular, the FDA noted that iRhythm had falsely marketed the Zio AT as approved for use in high-risk patients that require real-time cardiac monitoring. In truth, according to the FDA, Zio AT is only approved for "long-term monitoring of arrhythmia events for non-critical care patients where real-time monitoring is not needed."

Shares of iRhythm Technologies, Inc. (NASDAQ: IRTC) declined from $140.23 per share on April 21, 2023, to as low as $94.11 per share on June 28, 2023, respectively $70.24 per share on November 10, 2023.

The plaintiff claims that between January 11, 2022, and May 30, 2023, that the defendants falsely represented to investors that the Zio AT monitor was a real-time monitor intended for high-risk patients, that the Defendants repeatedly touted the potential growth for the Zio AT as an innovative product that had only just begun to penetrate the market for real-time monitoring, which investors looked upon favorably given the premium selling price associated with devices approved for high-risk patients, and that as a result of these misrepresentations, the price of iRhythm common stock traded at artificially inflated prices between January 11, 2022, and May 30, 2023.

Those who purchased shares of iRhythm Technologies, Inc. (NASDAQ: IRTC) have certain options and should contact the Shareholders Foundation.

Contact:
Michael Daniels
Shareholders Foundation, Inc.
3111 Camino Del Rio North
Suite 423
San Diego, CA 92108
Tel: +1-(858)-779-1554
E-Mail: mail@shareholdersfoundation.com

About Shareholders Foundation, Inc.
The Shareholders Foundation, Inc. is a professional portfolio monitoring and settlement claim filing service, and an investor advocacy group, which does research related to shareholder issues and informs investors of securities lawsuits, settlements, judgments, and other legal related news to the stock/financial market. Shareholders Foundation, Inc. is in contact with a large number of shareholders and offers help, support, and assistance for every shareholder. The Shareholders Foundation, Inc. is not a law firm. Referenced cases, investigations, and/or settlements are not filed/initiated/reached and/or are not related to Shareholders Foundation. The information is provided as a public service. It is not intended as legal advice and should not be relied upon.

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