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iRhythm Technologies Announces Results of GUARD-AF Trial

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  • 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.

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Allbirds stock touches 52-week low at $7.65 amid market challenges

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In a challenging market environment, Allbirds Inc. (NASDAQ:) stock has recorded a new 52-week low, dipping to $7.65. The eco-friendly footwear company has faced significant headwinds over the past year, reflected in a substantial 1-year change with a decline of -55.8%. Investors have shown concern as the brand navigates through a competitive retail landscape and supply chain issues, which have pressured the stock to its current low. The company’s efforts to rebound will be closely watched by market participants looking for signs of a turnaround or further indications of industry-wide pressures.

In other recent news, Allbirds disclosed its Q3 2024 financial results, reporting a net revenue of $43 million. This figure reflects a downturn due to reduced unit sales and transitions to a distributor model in certain regions. Despite these challenges, the company managed to increase its gross margin to 44.4%, attributed to lower freight costs and improved inventory management.

The company also launched two new products, the Tree Glider and Lounger Lift, which have been positively received by consumers. Allbirds revised its full-year revenue guidance to between $187 million and $193 million and anticipates an adjusted EBITDA loss of $75 million to $71 million.

Additionally, Allbirds has signed two new international distributor agreements, expanding its reach in Latin America and Europe from mid-2025. The company’s management, led by CEO Joe Vernachio and CFO Annie Mitchell, remains optimistic about future growth, driven by forthcoming product launches and strategic marketing efforts.

InvestingPro Insights

Allbirds Inc. (BIRD) continues to face significant challenges, as reflected in its recent stock performance and financial metrics. According to InvestingPro data, the company’s revenue growth has declined by 22.67% over the last twelve months as of Q3 2024, with a quarterly revenue decline of 24.89% in Q3 2024. This aligns with the InvestingPro Tip that analysts anticipate sales decline in the current year.

The company’s financial health is also concerning, with an operating income margin of -48.08% for the same period. An InvestingPro Tip highlights that Allbirds is quickly burning through cash, which is particularly worrisome given the current market conditions.

Despite these challenges, InvestingPro Tips indicate that Allbirds holds more cash than debt on its balance sheet and its liquid assets exceed short-term obligations. This could provide some financial flexibility as the company navigates its turnaround efforts.

For investors seeking a more comprehensive analysis, InvestingPro offers 17 additional tips for Allbirds, providing a deeper understanding of the company’s financial position and market performance.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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Quipt Home Medical stock hits 52-week low at $2.55

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Quipt Home Medical (TASE:) Corp. (QIPT) stock has reached a new 52-week low, trading at $2.55. This latest price point marks a significant downturn for the company, which has experienced a 46.87% decline over the past year. Investors are closely monitoring the home medical equipment provider as it navigates through a challenging period marked by this notable decrease in stock value. The 52-week low serves as a critical indicator for the market, reflecting investor sentiment and potential shifts in the company’s financial health and operational performance.

In other recent news, Quipt Home Medical Corp has been making notable strides despite facing several challenges. The company’s third fiscal quarter report revealed a steady increase in revenue, reaching $64 million, a 6.1% rise from the previous year. The customer base also expanded by 9%, serving 153,223 unique patients, and adjusted EBITDA grew by 2.7% to $14.2 million.

Benchmark revised its stock price target for Quipt Home Medical, reducing it to $7 from the previous $9, but maintained a Buy rating for the stock. This adjustment was influenced by several factors including the expiration of Medicare’s 75/25 rate relief, a diminished Managed Care contract, and the repercussions of the Change Healthcare (NASDAQ:) cyberattack. However, the firm predicts that Quipt could achieve an 8%-10% organic growth rate by the second quarter of fiscal year 2025.

In the face of these challenges, Quipt Home Medical has reported a 9% increase in resupply revenue for sleep therapy and supplies, which accounts for half of the company’s revenues. The company’s management has also indicated an active mergers and acquisitions pipeline, which could provide further growth opportunities. These are the recent developments that investors should keep an eye on.

InvestingPro Insights

Despite Quipt Home Medical Corp. (QIPT) hitting a new 52-week low, InvestingPro data reveals some interesting insights that may provide context for investors. The company’s revenue growth remains strong, with a 29.31% increase over the last twelve months as of Q3 2024, reaching $244.23 million. This growth suggests that QIPT continues to expand its market presence in the home medical equipment sector.

However, profitability remains a concern. InvestingPro Tips highlight that QIPT has not been profitable over the last twelve months, with a negative P/E ratio of -24.61. On a more positive note, analysts predict that the company will become profitable this year, which could potentially reverse the stock’s downward trend.

The current market valuation implies a strong free cash flow yield, according to another InvestingPro Tip. This could indicate that the stock may be undervalued at its current price, especially considering that it’s trading near its 52-week low. Investors looking for a deeper analysis can find 7 additional InvestingPro Tips for QIPT, offering a more comprehensive view of the company’s financial situation and market position.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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Muslims who voted for Trump upset by his pro-Israel cabinet picks

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By Andrea Shalal

WASHINGTON (Reuters) – U.S. Muslim leaders who supported Republican Donald Trump to protest against the Biden administration’s support for Israel’s war on Gaza and attacks on Lebanon have been deeply disappointed by his Cabinet picks, they tell Reuters.

“Trump won because of us and we’re not happy with his Secretary of State pick and others,” said Rabiul Chowdhury, a Philadelphia investor who chaired the Abandon Harris campaign in Pennsylvania and co-founded Muslims for Trump. Muslim support for Trump helped him win Michigan and may have factored into other swing state wins, strategists believe.

Trump picked Republican senator Marco Rubio, a staunch supporter of Israel for Secretary of State. Rubio said earlier this year he would not call for a ceasefire in Gaza, and that he believed Israel should destroy “every element” of Hamas. “These people are vicious animals,” he added.

Trump also nominated Mike Huckabee, a former Arkansas governor and staunch pro-Israel conservative who backs Israeli occupation of the West Bank and has called a two state solution in Palestine “unworkable”, as the next ambassador to Israel.

He has picked Republican Representative Elise Stefanik, who called the UN a “cesspool of antisemitism” for its condemnation of deaths in Gaza, to serve as U.S. ambassador to the United Nations.

Rexhinaldo Nazarko, executive director of the American Muslim Engagement and Empowerment Network (AMEEN), said Muslim voters had hoped Trump would choose Cabinet officials who work toward peace, and there was no sign of that.

“We are very disappointed,” he said. “It seems like this administration has been packed entirely with neoconservatives and extremely pro-Israel, pro-war people, which is a failure on the on the side of President Trump, to the pro-peace and anti-war movement.”

Nazarko said the community would continue pressing to make its voices heard after rallying votes to help Trump win. “At least we’re on the map.”

Hassan Abdel Salam, a former professor at the University of Minnesota, Twin Cities and co-founder of the Abandon Harris campaign, which endorsed Green Party candidate Jill Stein, said Trump’s staffing plans were not surprising, but had proven even more extreme that he had feared.

“It’s like he’s going on Zionist overdrive,” he said. “We were always extremely skeptical…Obviously we’re still waiting to see where the administration will go, but it does look like our community has been played.”

The Trump campaign did not immediately respond to an email seeking comment.

Several Muslim and Arab supporters of Trump said they hoped Richard Grenell, Trump’s former acting director of national intelligence, would play a key role after he led months of outreach to Muslim and Arab American communities, and was even introduced as a potential next secretary of state at events.

Another key Trump ally, Massad Boulos, the Lebanese father-in-law of Trump’s daughter Tiffany, met repeatedly with Arab American and Muslim leaders.

Both promised Arab American and Muslim voters that Trump was a candidate for peace who would act swiftly to end the wars in the Middle East and beyond. Neither was immediately reachable.

Trump made several visits to cities with large Arab American and Muslim populations, include a stop in Dearborn, a majority Arab city, where he said he loved Muslims, and Pittsburgh, where he called Muslims for Trump “a beautiful movement. They want peace. They want stability.”

© Reuters. FILE PHOTO: Richard Grenell, a top advisor to former U.S. President Donald Trump and former Acting Director of National Intelligence, speaks to the attendees of a Muslims and Bangladeshi Americans for Trump  outreach event in Hamtramck, Michigan, U.S. November 2, 2024.  REUTERS/Rebecca Cook/File Photo

Rola Makki, the Lebanese American, Muslim vice chair for outreach of the Michigan Republican Party, shrugged off the criticism.

“I don’t think everyone’s going to be happy with every appointment Trump makes, but the outcome is what matters,” she said. “I do know that Trump wants peace, and what people need to realize is that there’s 50,000 dead Palestinians and 3,000 dead Lebanese, and that’s happened during the current administration.”

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