Stock Markets
iRhythm Technologies Announces Results of GUARD-AF Trial
- 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
PACS Group expands with acquisition of 53 healthcare facilities
FARMINGTON, Utah – PACS Group, Inc. (NYSE: PACS), a prominent holding company in the post-acute healthcare sector, has completed the acquisition of 53 healthcare facilities from Prestige Care, notably expanding its operational footprint. The transaction introduces PACS to the Pacific Northwest and adds five new states to its portfolio, including Alaska, Idaho, Montana, Oregon, and Washington.
The acquired facilities encompass a mix of skilled nursing, assisted living, and independent living units, amounting to 2,511 skilled nursing beds and 1,334 assisted and independent living units across the eight states. This strategic move not only extends PACS’s geographical reach but also marks its entry into the senior living vertical, increasing its senior living communities from 16 to 37.
Jason Murray, Chairman and CEO of PACS, emphasized the company’s commitment to operational excellence and enhancing the quality of life for more individuals through their care model. The acquisition is seen as a synergy of cultural alignments between PACS and Prestige, aiming to leverage local knowledge and elevate healthcare services.
Josh Jergensen, President and COO of PACS, highlighted the mission-driven approach and the goal to provide resources to empower local leaders and staff. Scott Mortensen, Vice President of Ancillaries at PACS, reiterated the company’s value on the legacy of care established by Prestige and the intention to maintain the foundational ethos of love in care provision.
The integration process is being managed with a focus on continuity of operations, as PACS works closely with Prestige leaders. The expansion is a significant step for PACS as it continues to grow as a legacy company and a leader in post-acute care.
Investors should note that statements regarding the anticipated benefits of the acquisition and its strategic fit contain forward-looking projections and are subject to risks and uncertainties. These may include challenges in integration and potential expenses related to the acquisition. PACS has not provided any endorsement of the forward-looking statements and encourages investors to review its filings with the U.S. Securities and Exchange Commission for a more comprehensive understanding of risks involved.
This article is based on a press release statement from PACS Group, Inc.
In other recent news, PACS Group has initiated a public offering of 13.9 million shares, with the completion contingent on market conditions. The offering is managed by several financial institutions, including Citigroup, J.P. Morgan, and Truist Securities. Recent developments also include an upward revision of PACS Group’s 2024 guidance following a second-quarter adjusted EBITDA of $99.7 million, surpassing expectations. This performance has been attributed to successful mergers and acquisitions, with projections to add over 50 facilities in the third quarter of 2024. Analyst firms Oppenheimer, Stephens, and Macquarie have raised their share price targets for PACS Group, maintaining positive ratings. Additionally, PACS Group has made significant changes to its board committees, including the appointment of Evelyn Dilsaver as a Class II director. These updates provide insight into the latest activities at PACS Group.
InvestingPro Insights
In light of PACS Group’s recent expansion through the acquisition of healthcare facilities, the company’s financial metrics and analyst outlook provide a clearer picture for investors. With a market capitalization of $5.94 billion, PACS is positioning itself as a significant player in the post-acute healthcare sector. The company’s revenue growth is notable, with a 29.08% increase in the last quarter, reflecting its aggressive expansion strategy and potential for increased market share.
InvestingPro Tips suggest a positive outlook for PACS, with net income expected to grow this year and four analysts having revised their earnings upwards for the upcoming period. This optimism is mirrored in the company’s stock performance, with a strong return over the last year, including a significant 66.3% price total return. Moreover, PACS’s strategic moves seem to be well-received by the market, as indicated by the large price uptick over the last six months.
However, investors should be aware of the company’s valuation multiples. PACS is currently trading at a high earnings multiple with a P/E ratio of 47.51 and a Price/Book ratio of 10.45, which may suggest a premium price for its shares. Additionally, while PACS does not pay a dividend, the company’s growth trajectory and profitability may compensate for the lack of direct income return for shareholders.
For those seeking more in-depth analysis and additional insights, there are 13 more InvestingPro Tips available for PACS at https://www.investing.com/pro/PACS, which could help investors make more informed decisions.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.
Stock Markets
Cintas stock soars to all-time high, reaches $812.58
Cintas Corporation (NASDAQ:), a leader in the professional uniform and business supplies industry, has reached an all-time high, with its stock price soaring to $812.58. This milestone reflects a significant surge in the company’s market value, marking a remarkable 63.07% increase over the past year. Investors have shown growing confidence in Cintas’s business model and its ability to expand its services across various sectors, contributing to the company’s robust financial performance and this record-setting price level. The all-time high serves as a testament to Cintas’s strategic initiatives and operational excellence, which have consistently driven shareholder value and solidified its position in the market.
In other recent news, Cintas Corporation reported higher-than-expected earnings per share for the fourth fiscal quarter, with net income reaching $414.3 million. The full-year revenue hit an unprecedented $9.6 billion, marking a significant milestone for the company. Looking ahead, Cintas has projected it will surpass $10 billion in annual revenue for fiscal 2025.
Several analyst firms have updated their assessments of Cintas. Redburn-Atlantic initiated coverage with a Neutral rating and a price target of $670, citing the company’s consistent growth and high incremental returns on capital. Meanwhile, Truist Securities reaffirmed its Buy rating, increasing its price target to $850, and Baird downgraded the stock from Outperform to Neutral but raised the price target to $775.
In other corporate developments, Cintas announced a four-for-one split of its common stock, marking the company’s first stock split since 2000, aimed at increasing share ownership accessibility. The company also announced that two of its board members, John Barrett and Gerald Adolph, will not be seeking re-election at the company’s 2024 annual meeting of shareholders.
Furthermore, Cintas announced a significant increase in its quarterly cash dividend and a new share repurchase program, authorizing the repurchase of up to $1.0 billion of its common stock. These are among the recent developments for Cintas Corporation.
InvestingPro Insights
Cintas Corporation’s (CTAS) recent stock price achievement is complemented by a host of positive indicators that underline the company’s financial health and market position. According to InvestingPro data, Cintas boasts a substantial market capitalization of $81.81 billion, underscoring its significant presence in the industry. Furthermore, the company’s gross profit margin stands at an impressive 48.83% for the last twelve months as of Q1 2023, highlighting its efficiency in managing costs and generating revenue.
Investors considering Cintas will find that the company has maintained a consistent record of dividend payments for 32 consecutive years, showcasing its commitment to returning value to shareholders. Additionally, the stock has experienced a high return over the last year, with a 63.96% price total return, aligning closely with the increase mentioned in the article. These financial strengths are reflected in the company’s robust operating income margin of 21.56% for the same period, which indicates strong operational performance.
For those seeking deeper insights, there are 21 additional InvestingPro Tips available, which provide a comprehensive analysis of Cintas’s performance and future outlook. Among these, the company’s ability to cover interest payments with its cash flows and its liquid assets exceeding short-term obligations suggest a stable financial footing. Moreover, analysts have revised their earnings upwards for the upcoming period, reflecting optimism about the company’s prospects. To explore these further, interested readers can visit InvestingPro for a detailed perspective on Cintas’s financial metrics and expert analysis.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.
Stock Markets
JPMorgan stock slumps as interest income warning rattles market
By Nupur Anand and Pritam Biswas
NEW YORK (Reuters) -JPMorgan Chase shares fell more than 7% after the president of the largest U.S. bank tempered the outlook for its earnings from interest payments as interest rates are expected ease.
President and Chief Operating Officer Daniel Pinto said forecasts for net interest income (NII), or the difference between what the bank makes on loans and pays out on deposits, were overly optimistic.
The Federal Reserve is widely expected to lower its key policy rate by at least 25 basis points at its Sept. 17-18 meeting, kicking off a monetary easing cycle that would lead to smaller-than-expected increases in banks’ interest income.
“NII expectations are a bit too high,” Pinto told investors at a conference in New York, without providing a revised estimate. “Next year is going to be a bit more challenging.”
JPMorgan had forecast in May its NII would rise to $91 billion this year as interest rates remained elevated, excluding its markets division.
“The commentary about too much optimism on NII for 2025 from the management has rattled the market,” said Chris Marinac, director of research at financial adviser Janney Montgomery Scott.
“There are incremental worries around the economy and the political climate,” which are likely to contribute more volatility in shares over the next two months, he said.
JPMorgan shares fell as much as 7.5%, their worst daily drop since June 2020. The stock is at its lowest in over a month, at $202.45.
JPMorgan’s total investment banking fees could climb by 15% in the third quarter, Pinto added.
The bank’s profit rose to a record in the second quarter, buoyed by a 46% jump in investment banking revenue. Rivals including Citigroup and Wells Fargo also reported strong gains in investment banking.
Revenue from JPMorgan’s newly merged commercial and investment bank unit also jumped to a record $35.5 billion in the first half.
Trading revenue is expected to be flat or rise 2% in the third quarter, while volumes for mergers and acquisitions will probably stay steady, Pinto said. That compares with a 10% trading revenue increase in the second quarter.
The prediction echoes more subdued guidance from Goldman Sachs for trading revenue to likely fall 10% in the third quarter. Citigroup estimated on Tuesday that markets revenue would probably drop about 4%.
Bank shares fell after the Fed outlined on Tuesday a sweeping overhaul to ease two major draft bank capital rules following intense industry lobbying against the U.S. central bank’s proposal to set aside more capital for different businesses.
The draft rules required the biggest U.S. lenders to hike their capital by around 19%. A major rewrite lowered the level to 9%, but analysts said that failed to meet market expectations.
“I thought these changes will be positive for the bank, but clearly the street was looking for a bit more,” said Stephen Biggar, banking analyst at Argus Research.
“Banks are down across the board, but the larger the bank, bigger the hit and that could also be impacting the JPMorgan stock.”
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