STEMI DTU Randomized Control Trial Demonstrates for the First Time that a Combination of Delayed Reperfusion and Left Ventricular Unloading Does Not Increase Myocardial Infarct[...]

NEW ORLEANS - Johnson & Johnson (NYSE: JNJ) - March 28, 2026 - Randomized controlled trial (RCT) data presented at the American College of Cardiology (ACC) 2026 today and simultaneously published in the Journal of the American College of Cardiologydemonstrates for the first time that supporting the left ventricle (LV) with an Impella CP for more than 40 minutes prior to reperfusion does not reduce nor increase heart muscle damage, known as a myocardial infarction. Greater infarct size correlates to a higher risk of dying or developing heart failure, a condition that impacts more than 55 million worldwide¹. Findings from the trial support future studies on whether pre-PCI treatment with Impella CP opens a window of time that enables delivery of adjunct pharmacotherapies designed to reduce reperfusion injury.

STEMI DTU (ST-segment Elevation Myocardial Infarction Door-To-Unloading) RCT² is a mechanistic study investigating the impact of LV unloading on infarct size. The overall findings are neutral because the trial's primary endpoint did not demonstrate that LV support plus delayed reperfusion reduces heart muscle damage in patients with anterior STEMI without cardiogenic shock compared with PCI alone. The hypertensive nature of most anterior STEMI patients enrolled in the study may have limited the ability of Impella CP to reduce LV wall stress and unload the LV, thereby contributing to the neutral results.

"This is a landmark trial with novel insights that will impact future scientific discovery for years," said Gregg Stone, MD³, Professor of Medicine and Director of Academic Affairs for the Mount Sinai Health System, co-Principal Investigator, and presenter of the study at ACC 2026. "STEMI-DTU challenges the standard STEMI treatment paradigm that is focused only on rapid coronary reperfusion, a directive that has not changed in the last three decades. While this trial was neutral, the results raise intriguing possibilities about potential therapeutic approaches that combine mechanical circulatory support and pharmaceutical therapy."

Other novel findings from the study include:

• Older patients enrolled in the study (61+ years of age) demonstrated a trend towards reduced infarct size with LV support and delayed PCI (p=0.056). Over 75% of STEMI patients in the U.S. are over age 65⁴.
• Higher rates of bleeding and vascular complications in the treatment arm were not associated with increased mortality at 12 months.
• Compared to controls, pre-PCI TIMI blood flow was significantly improved after 30 minutes of Impella CP support and corresponded to an increase in coronary perfusion pressure. Coupled with 100% operator compliance with the treatment protocol, these observations suggest a period of patient stability on Impella CP support prior to revascularization that informs future clinical trials.
• Elevated lactate levels were correlated with larger infarct sizes across the total study population. This finding provides new insight into the clinical utility of a pre-PCI lactate level to identify patients at higher risk, despite clinical stability.

"STEMI DTU is the first clinical trial to test this novel and disruptive hypothesis and demonstrate the ability to stop the ischemic clock during infarct. More research is needed in older age, abnormal lactate subsets and the impact of concomitant beta blockade. We will continue to explore LV unloading impact without PCI in STEMI patients in future studies," said William O'Neill, MD², emeritus director of the Center for Structural Heart Disease at Henry Ford Health System and co-Principal Investigator of the study.

"During the period between Impella CP insertion and PCI, operators could bail out and perform PCI at their discretion based on patient stability. However, there was never a clinical need to begin PCI during this waiting period. We had 100% compliance. Many of my patients began to snore, suggesting that they were clinically stable enough to fall asleep. This suggests that pre-PCI LV unloading rested the heart without worsening the infarction," said Nima Aghili, MD, MPH², Interventional Cardiology, Advanced Heart Failure Specialist, Colorado Heart and Vascular and participating clinician in the study.

Johnson & Johnson leads in the science of LV unloading and is dedicated to the STEMI DTU research program. Future potential studies may combine Impella and adjunct pharmacotherapy to optimize loading conditions and improve myocardial salvage with LV unloading before PCI for patients suffering from a heart attack. Impella, the world's smallest heart pump, is inserted into the heart to temporarily take over the heart's pumping function, allowing the heart to rest and recover while maintaining the flow of oxygenated blood throughout the body.

About the STEMI-DTU RCT
The STEMI-DTU (ST-segment Elevation Myocardial Infarction Door-To-Unloading) RCT investigates whether combining primary left ventricular (LV) unloading plus a 30-minute delay before percutaneous coronary intervention (PCI) reduces infarct size compared to standard-of-care immediate perfusion with primary PCI in anterior STEMI patients without cardiogenic shock. Based on extensive preclinical research, the trial challenges the well-established standard of care that prioritizes immediate reperfusion in STEMI and deliberately tested whether LV unloading and delaying PCI could limit ischemia-reperfusion injury and reduce infarct size in a carefully selected patient population. The successful STEMI DTU pilot safety and feasibility RCT confirmed the safety and feasibility of a 30-minute LV unloading before reperfusion following an anterior STEMI. While the neutral results of the STEMI DTU pivotal RCT do not immediately impact clinical practice, the trial provides key new insights for the development of future clinical trials testing the potential clinical utility of LV unloading to reduce infarct size and improve outcomes for STEMI patients.

About Cardiovascular Solutions from Johnson & Johnson MedTech
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Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 related to Impella CP. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: competition, including technological advances, new products and patents attained by competitors; uncertainty of commercial success for new products; the ability of the company to successfully execute strategic plans; impact of business combinations and divestitures; challenges to patents; changes in behavior and spending patterns or financial distress of purchasers of health care products and services; and global health care reforms and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com, www.investor.jnj.comor on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.

Source: Johnson & Johnson

¹ World Heart Federation
² STEMI DTU Randomized Control Trial is a Johnson & Johnson sponsored study
³ Drs. Stone, O'Neill and Aghili were not compensated for their participation in this press release
⁴ Salari, N., Morddarvanjoghi, F., Abdolmaleki, A., Rasoulpoor, S., Khaleghi, A. A., Hezarkhani, L. A., Shohaimi, S., & Mohammadi, M. (2023). The global prevalence of myocardial infarction: a systematic review and meta-analysis. BMC cardiovascular disorders, 23(1), 206. https://doi.org/10.1186/s12872-023-03231-w

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