BERLIN, Germany / WHIPPANY, N.J., May 7, 2026
Bayer announced positive topline results from the pivotal Phase III REVEAL study evaluating its investigational PET radiotracer iodine 124 evuzamitide for the diagnosis of cardiac amyloidosis, a severe and frequently underdiagnosed heart disease. The study successfully met its primary endpoints for both sensitivity and specificity, demonstrating strong diagnostic performance using PET/CT imaging and potentially advancing a major breakthrough in non-invasive cardiac amyloidosis detection.
The investigational imaging agent, also known as AT-01, is designed to help clinicians visualize amyloid protein deposits in the heart using positron emission tomography computed tomography (PET/CT). Bayer stated that the positive Phase III data could support future regulatory submissions with the U.S. Food and Drug Administration (FDA) and other global health authorities as the company strengthens its position in precision molecular imaging and cardiovascular diagnostics.
Phase III REVEAL Study Meets Key Diagnostic Endpoints
The REVEAL study was an investigator-initiated multicenter Phase III clinical trial led by Brigham and Women’s Hospital evaluating the efficacy and safety of iodine 124 evuzamitide in patients with suspected cardiac amyloidosis. The trial enrolled 170 adults across 19 medical centers in the United States, making it one of the largest advanced imaging studies conducted in this disease area.
Participants received a single intravenous dose of the investigational PET radiotracer followed by PET/CT imaging conducted several hours later. Independent expert readers evaluated the scans while blinded to patient clinical information. Diagnostic performance was then compared against standard-of-care amyloidosis diagnoses determined by independent clinical adjudication panels.
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According to Bayer, the imaging agent achieved strong sensitivity and specificity in detecting cardiac amyloidosis through visual scan interpretation. Researchers believe the radiotracer could potentially become one of the first highly reliable non-invasive diagnostic imaging tools capable of both identifying and excluding cardiac amyloidosis in clinical practice.
The company plans to present the complete study findings at an upcoming scientific congress while continuing regulatory discussions regarding potential approval pathways.
Cardiac Amyloidosis Remains Difficult to Diagnose
Cardiac amyloidosis is a progressive condition caused by abnormal accumulation of misfolded amyloid proteins within heart tissue, leading to stiffness, impaired cardiac function, heart failure, and increased mortality risk. The disease is frequently underdiagnosed or misdiagnosed because symptoms often overlap with other cardiovascular disorders.
Experts estimate that the disease affects approximately 400,000 patients worldwide, although the true prevalence may be significantly higher due to delayed diagnosis. Current data suggest patients often experience diagnostic delays lasting between two and four years after symptom onset, during which irreversible cardiac damage may occur.
Researchers involved in the REVEAL study emphasized that a sensitive and quantitative PET imaging test could significantly improve early disease identification, distinguish cardiac amyloidosis from other causes of heart failure, and potentially differentiate between amyloid subtypes when combined with laboratory testing. The imaging technology may also help physicians monitor changes in cardiac amyloid burden over time and evaluate therapeutic response.
Bayer Expands Precision Imaging and Radiology Pipeline
The investigational radiotracer forms part of Bayer’s broader expansion strategy in precision molecular imaging and radiology innovation. The company acquired iodine 124 evuzamitide and related amyloid imaging assets from Attralus earlier in 2026, strengthening its radiology development pipeline focused on serious cardiovascular and systemic diseases.
The compound has already received both FDA Breakthrough Therapy Designation and Orphan Drug Designation in the United States and European Union for amyloidosis-related imaging applications.
Industry analysts believe advanced molecular imaging technologies could transform future cardiovascular disease management by enabling earlier diagnosis, more precise risk assessment, and personalized treatment planning. Bayer’s latest clinical data further highlight growing investment in AI-assisted radiology, PET imaging, and precision diagnostics as healthcare systems increasingly prioritize early disease detection strategies.
Source: Bayer press release
