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iRhythm Technologies Announces Results of GUARD-AF Trial

Published

4 months ago

September 2, 2024

GUARD-AF trial results presented at European Society of Cardiology (ESC) Congress 2024
Leveraging iRhythm’s Zio^® patch-based long-term continuous monitoring (LTCM), GUARD-AF is the largest randomized trial in a primary care setting to evaluate the impact of screening for undiagnosed atrial fibrillation (AF)
Screening with iRhythm’s Zio^® XT¹ LTCM led to increase in new diagnosis of AF (5.0% vs 3.3%) over an average follow-up of 15 months.
No difference in stroke hospitalization vs usual care in the context of reduced statistical power due to truncated enrollment and follow-up.

SAN FRANCISCO, Sept. 01, 2024 (GLOBE NEWSWIRE) — iRhythm Technologies, Inc. (NASDAQ:IRTC), a leading digital health care company focused on creating trusted solutions that detect, predict, and prevent disease, today announced the presentation and publication of the GUARD-AF (ReducinG stroke by screening for UndiAgnosed atRial fibrillation in elderly inDividuals) randomized clinical trial at the European Society of Cardiology (ESC) Congress 2024. The trial was sponsored by Bristol-Myers Squibb-Pfizer Alliance and iRhythm provided the Zio XT patch ECG long-term continuous monitoring (LTCM) monitor used in the interventional (screening) arm of the study.

GUARD-AF was a prospective, parallel-group, randomized controlled trial designed to test whether screening for AF in people aged ‰¥70 years using an on-label Zio^® XT 14-day single-lead LTCM could identify patients with undiagnosed AF and reduce stroke. Participants were randomized 1:1 to screening with Zio XT LTCM or usual care. The primary efficacy and safety outcomes were hospitalization due to all-cause stroke and bleeding, respectively.

During a median follow-up of 15 months in 11,905 enrolled patients from 149 primary care sites in the US (5,952 assigned to screening), the study found that Zio XT LTCM led to an increase in new diagnosis of AF vs usual care (5.0 vs 3.3%) through the end of follow-up. There was no significant difference between groups in incidence of the primary endpoint of stroke hospitalization, although event rates were low and the trial was stopped before achieving enrollment of the planned total of 52,000 patients during the COVID-19 pandemic², thereby reducing statistical power. Findings were presented by Dr. Renato Lopes, Professor of Medicine at the Duke Clinical Research Institute and Duke University, at the ESC Congress on September 1 and simultaneously published in two tandem manuscripts in the Journal of the America College of Cardiology (JACC)³ and the JACC: Clinical Electrophysiology.⁴

Owing in part to the low event rate and truncated enrollment, the study found no reduction in the rate of stroke, said Dr. Lopes. However, there are some important lessons here. Our study confirms that AFib is common in older patients and can be identified with cardiac monitoring in primary care ” upstream of cardiology care, which many patients will not have access to. Most participants with AFib also had short, infrequent episodes that would be missed with a pulse check, single ECG, shorter duration of monitoring. Identification of these short episodes could be a useful prompt for physicians to more aggressively treat heart disease risk factors and may reduce the downstream risk of heart failure, which will be evaluated in future trials.

The study had several notable implications:

Screening with Zio XT LTCM led to an increase in diagnosis of AF over the maximum 2.5 years of follow up vs usual care (5.0% vs 3.3%), an increase in initiation of oral anticoagulation that is used for prevention of stroke in AF (4.2% vs 2.8%), and no increase in the rate of hospitalization for bleeding.³
Primary care-initiated home-based monitoring in an older population is feasible. GUARD-AF is the largest randomized trial to evaluate the impact of AF screening with a patch-based ECG monitor on care delivery in a primary care setting; more than half of participants enrolled were women.³
Virtual, home-based diagnostics are feasible. In GUARD-AF, 20% of participants were enrolled virtually and received the Zio XT LTCM device by mail for self-application. Wear time and analyzable time were similar and high in self-applied and clinic-applied groups³, confirming prior studies and clinical experience with Zio LTCM service.⁵
In the 252 participants with AF detected on 14-day LTCM, most (88%) had low-burden paroxysmal AF. Of those with detected AF, most had AF 3, suggesting that many patients with diagnosed AF may miss detection with 12-lead ECG (10 seconds), smartwatch ECG (30 seconds), or ambulatory monitoring of shorter duration such as 48 hours. Only 32 of 252 had AF at the start of the ECG recording.

Additionally, this research underscores how large pragmatic trials powered by the Zio LTCM service are feasible at scale. iRhythm’s clinical research services have supported over 100 prospective studies at nearly 500 sites in over 40,000 participants.

These findings support the totality of evidence that undiagnosed AFib is common and can be found with Zio’s 14-day long-term monitoring ” even when it is not likely to be found with point-of-care ECGs or short-term monitors due to the short, infrequent episodes in the early stages of atrial fibrillation, said Mintu Turakhia MD, iRhythm’s Chief Medical and Scientific Officer and EVP, Product Innovation. iRhythm’s undiagnosed arrhythmia pilot programs leverage many features seen in GUARD-AF, such as virtual enrollment and self-applied patches at home. These programs, as well as ongoing clinical trials, such as AMALFI⁶, and those in development will have longer follow-up or assess a wider range of outcomes, including heart failure, which occurs in one-third of patients with AFib, along with cardiovascular hospitalization, health care utilization, and costs.

Also at ESC, Evangelos Hytopoulos, PhD, iRhythm’s Sr. Director of Data Science, presented separate work performed in collaboration with Scripps Research, New insights from the ECG: screening and prediction⁷, that used machine learning on ECG signal of 14-days of patch-based monitoring without AF to successfully predict episodes of AF in the subsequent year. The research presented is part of a scientific study only and is not part of any commercial product offering in any market.

About iRhythm Technologies, Inc.
iRhythm is a leading digital health care company that creates trusted solutions that detect, predict, and prevent disease. Combining wearable biosensors and cloud-based data analytics with powerful proprietary algorithms, iRhythm distills data from millions of heartbeats into clinically actionable information. Through a relentless focus on patient care, iRhythm’s vision is to deliver better data, better insights, and better health for all. To learn more about iRhythm, go to iRhythmtech.com.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These statements include statements regarding clinical developments and market opportunity. Such statements are based on current assumptions that involve risks and uncertainties that could cause actual outcomes and results to differ materially. These risks and uncertainties, many of which are beyond our control, include risks described in the section entitled Risk Factors and elsewhere in the company’s public filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof and should not be unduly relied upon. iRhythm disclaims any obligation to update these forward-looking statements.

iRhythm Contact Information

Investor Relations Contact
Stephanie Zhadkevich
investors@irhythmtech.com

Media Contact
Kassandra Perry
irhythm@highwirepr.com

¹ The Zio XT Patch is a prescription-only, single patient use, continuously recording ECG monitor that can be worn up to 14 days. It is indicated for use on patients who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light-headedness, pre-syncope, syncope, fatigue, or anxiety.
² Singer DE, et al. American Heart Journal. 2022 Jul:249:76-85. doi: 10.1016/j.ahj.2022.04.005.
³ Lopes RD, et al. J Am Coll Cardiol. 2024.
⁴ Singer DE, et al. JACC Clin Electrophysiol. 2024.
⁵ Goergen JA, et al. Heart Rhythm. 2023 Mar;20(3):407-413. doi: 10.1016/j.hrthm.2022.11.020.
⁶ About AMALFI https://www.amalfitrial.org/about
⁷ M Gadaleta, et al, Predicting 1-year atrial fibrillation risk from a patch-based ambulatory ECG monitoring without atrial fibrillation, European Society of Cardiology (ESC) 2024 Congress, August 30 “ September 2, London.

Stock Markets

14 lessons from 2024 to remember in 2025: BofA

Published

13 hours ago

December 22, 2024

Investing.com — In a recent note, Bank of America outlined 14 key lessons from 2024 that investors should keep in mind as they head into 2025, warning that market momentum and stretched valuations could face headwinds in the year ahead.

While this year resembled the steady gains of 1996-97, rather than the bubble peaks of 1998-99, risks are mounting—from geopolitical tensions and rising debt to market fragility highlighted by the VIX.

BofA points to opportunities in Europe, China, and Japan but cautions that volatility, trade disputes, and macroeconomic uncertainty will shape the next leg of the market cycle.

Below are the 14 lessons that BofA highlighted.

1. 2024 was a strong year for markets, but it might only be the beginning.

2. The market’s performance in 2024 looked more like the steady gains of 1996-97 than the bubble peaks of 1998-99.

3. In a bubble environment, market leadership can persist for longer than investors can afford to stay underweight.

4. However, the combination of strong momentum and high valuations is already too stretched to avoid a potential bust.

5. The has shown that markets remain fragile, and a major shock may be overdue.

6. August 2024 suggests buying market dips and locking in volatility spikes; using smarter strategies like skewed delta positioning may be key for 2025.

7. Rising debt levels and persistent inflation mean bond vigilantes remain the most visible macroeconomic tail risk.

8. Market fragility, faster reactions, and elevated valuations suggest a repeat of the calm volatility seen in 2017 is unlikely.

9. A Trump election victory has reignited concerns around tariffs, with European companies favored by dollar strength potentially becoming the next trade targets.

10. European equities remain cheap and unloved—investors should be cautious about being caught short, as fewer crowded trades mean less volatility pain.

11. China’s outperformance over Japan in 2024 could continue if U.S. interest rates decline.

12. VIX options data indicates that positioning risks in the market have not gone away.

13. Eurozone bank dividends have outperformed the for much of the past year; investors may need to hedge against a different outcome in 2025.

14. The risk of sharp movements in the Japanese yen, driven by volatility, could cause instability for the in 2025.

Stock Markets

Class Action Lawsuit Reminder WOLF: Kessler Topaz Meltzer & Check, LLP Reminds Wolfspeed, Inc. (WOLF) Investors – A Securities Fraud Class Action Lawsuit Has Been Filed

Published

13 hours ago

December 22, 2024

RADNOR, PA. – (NewMediaWire) – December 21, 2024 – The law firm of Kessler Topaz Meltzer & Check, LLP (www.ktmc.com) informs investors that a securities class action lawsuit has been filed against Wolfspeed (NYSE:), Inc. (Wolfspeed) (NYSE: WOLF) on behalf of those who purchased or otherwise acquired Wolfspeed securities between August 16, 2023, and November 6, 2024, inclusive (the Class Period). The lead plaintiff deadline is January 17, 2025.

CONTACT KESSLER TOPAZ MELTZER & CHECK, LLP:

If you suffered Wolfspeed losses, you may CLICK HERE or go to: https://www.ktmc.com/new-cases/wolfspeed-inc?utm_source=PR&utm_medium=link&utm_campaign=wolf&mktm=r

You can also contact attorney Jonathan Naji, Esq. by calling (484) 270-1453 or by email at info@ktmc.com .

DEFENDANTS ALLEGED MISCONDUCT:

The complaint alleges that, throughout the Class Period, Defendants made false and/or misleading statements and/or failed to disclose that: (1) Wolfspeeds optimistic claims of potential growth of its Mohawk Valley fabrication facility and general demand for Wolfspeeds 200mm wafers in the electronic vehicle market fell short of reality; and (2) Wolfspeed had overstated demand for its key product and placed undue reliance on purported design wins while the Mohawk Valley facilitys growth had begun to taper before recognizing the $100 million revenue per quarter allegedly achievable with only 20% utilization of the fabrication, let alone the promised $2 billion revenue purportedly achievable by the facility.

Please CLICK HERE to view our video or copy and paste this link into your browser: https://youtu.be/zMLfnSRjg2Y

THE LEAD PLAINTIFF PROCESS:

Wolfspeed investors may, no later than January 17, 2025, seek to be appointed as a lead plaintiff representative of the class through Kessler Topaz Meltzer & Check, LLP or other counsel, or may choose to do nothing and remain an absent class member. A lead plaintiff is a representative party who acts on behalf of all class members in directing the litigation. The lead plaintiff is usually the investor or small group of investors who have the largest financial interest and who are also adequate and typical of the proposed class of investors. The lead plaintiff selects counsel to represent the lead plaintiff and the class and these attorneys, if approved by the court, are lead or class counsel. Your ability to share in any recovery is not affected by the decision of whether or not to serve as a lead plaintiff.

Kessler Topaz Meltzer & Check, LLP encourages Wolfspeed investors who have suffered significant losses to contact the firm directly to acquire more information.

ABOUT KESSLER TOPAZ MELTZER & CHECK, LLP:

Kessler Topaz Meltzer & Check, LLP prosecutes class actions in state and federal courts throughout the country and around the world. The firm has developed a global reputation for excellence and has recovered billions of dollars for victims of fraud and other corporate misconduct. All of our work is driven by a common goal: to protect investors, consumers, employees and others from fraud, abuse, misconduct and negligence by businesses and fiduciaries. The complaints in this action were not filed by Kessler Topaz Meltzer & Check, LLP. For more information about Kessler Topaz Meltzer & Check, LLP please visit www.ktmc.com .

CONTACT:

Kessler Topaz Meltzer & Check, LLP

Jonathan Naji, Esq.

(484) 270-1453

280 King of Prussia Road

Radnor, PA 19087

info@ktmc.com

May be considered attorney advertising in certain jurisdictions. Past results do not guarantee future outcomes.

View the original release on www.newmediawire.com

Stock Markets

Starbucks workers’ union strikes across US as talks hit impasse

Published

13 hours ago

December 22, 2024

By Savyata Mishra, Gursimran Mehar and Renee Hickman

(Reuters) -Some members of the Starbucks (NASDAQ:) workers’ union that represents more than 10,000 baristas walked off their jobs in multiple U.S. cities on Friday, citing unresolved issues over wages, staffing and schedules.

The five-day strike, which began on Friday and closed Starbucks cafes in Los Angeles, Chicago and Seattle, will expand to Columbus (WA:), Denver, and Pittsburgh through Saturday, the union said in a statement.

This is the latest in a series of labor actions that have picked up pace across service industries following a period when workers at manufacturers in the automotive, aerospace and rail industries won substantial concessions from employers.

At Starbucks, the Workers United union, which represents employees at 525 stores across the U.S., said late on Thursday that walkouts would escalate daily, and could reach “hundreds of stores” nationwide by Christmas Eve.

“It’s estimated that 10 stores out of 10,000 company-operated stores did not open today,” Starbucks said, adding that there was no significant impact to store operations on Friday.

Around 20 people joined a picket line at a Starbucks location on Chicago’s north side, buffeted by snow and wind, but cheering in response to the honking horns of passing cars.

A few confused customers tried to walk into the closed store before strikers began chanting, but union member Shep Searl said the reaction had been mostly positive.

Searl said 100% of the unionized workers at the Starbucks location in Chicago’s Edgewater neighborhood were participating in the strike, and according to the workers, they have been subject to numerous unfair labor practices including write-ups, “captive-audience” meetings and firings.

The union member said they made about $21 an hour and added, “that would have been a great wage in 2013”.

It is an inadequate wage, the baristas said, given inflation and the high cost of living in a large city, especially since they rarely get 40-hour work weeks.

WORKERS SNUB OFFER

Negotiations between the company and Workers United began in April, based on an established framework agreed upon in February, which could also help resolve numerous pending legal disputes.

The company said on Thursday it has held more than nine bargaining sessions with the union since April, and reached more than 30 agreements on “hundreds of topics”, including economic issues.

The Seattle-headquartered firm said it is ready to continue negotiations, claiming the union delegates prematurely ended the bargaining session this week.

The union, however, said in a Facebook (NASDAQ:) post on Friday that Starbucks had yet to present a serious economic proposal with less than two weeks remaining until the year-end contract deadline.

The workers’ group also snubbed an offer of no immediate wage hike and a guarantee of a 1.5% increase in future years.

“Workers United proposals call for an immediate increase in the minimum wage of hourly partners by 64%, and by 77% over the life of a three-year contract. This is not sustainable,” Starbucks said on Friday.

In response to Starbucks’ statement on the proposals, Michelle Eisen, a Starbucks barista and bargaining delegate, said, “Starbucks’ characterization of our proposals is misleading and they know it. We are ready to finalize a framework that includes new investments in baristas in the first year of contracts”.

Separately, the baristas’ union said on Friday that it filed a new labor practice charge against the coffee house, alleging Starbucks “refused to bargain and engaged in bad faith bargaining” over economic issues.

Hundreds of complaints have been filed with the National Labor Relations Board (NLRB), accusing Starbucks of unlawful labor practices such as firing union supporters and closing stores during labor campaigns. Starbucks has denied wrongdoing and said it respects the right of workers to choose whether to unionize.

WORKING ON A TURNAROUND

Last month, the NLRB said that Starbucks broke the law by telling workers at its flagship Seattle cafe that they would lose benefits if they joined a union.

“It’s (the strike) taking place during one of the busiest times of the year for Starbucks, which could magnify its impact while bringing unwanted public scrutiny into the company’s labor practices,” Emarketer analyst Rachel Wolff said.

The coffee chain is working on a turnaround under its newly appointed top boss, Brian Niccol, who aims to restore “coffee house culture” by overhauling cafes and simplifying its menu among other measures.

“Given how much Starbucks is already struggling to win over customers, it can ill afford any negative publicity – or impact to sales – that the strike could bring,” Wolff said.

The Starbucks workers’ strike comes in the same week as Amazon.com (NASDAQ:) workers at seven U.S. facilities walking off the job on Thursday, during the holiday shopping rush.

There were 33 work stoppages in 2023, the most since 2000, though far lower than in past decades, data from the U.S. Bureau of Labor Statistics showed.