Bayer's Phase III REVEAL Study Supports PET Imaging for Cardiac Amyloidosis

An investigational PET radiotracer demonstrated high sensitivity and specificity for diagnosing cardiac amyloidosis in the Phase III REVEAL study, according to results presented at the European Society of Cardiology (ESC) Congress 2026 and simultaneously published in JAMA.

The multicenter, open-label, single-arm study evaluated iodine 124 evuzamitide (I-124 evuzamitide) in 170 adults with suspected cardiac amyloidosis at 18 US centers. The study met its primary endpoints for sensitivity and specificity based on visual PET scan interpretation by three independent readers.

Sensitivity ranged from 90% to 94% among the readers, while specificity ranged from 84% to 89%. Based on agreement between at least two of the three readers, I-124 evuzamitide achieved 94% sensitivity and 86% specificity.

The investigational tracer also demonstrated high diagnostic performance for the two major cardiac amyloidosis subtypes. For transthyretin amyloidosis (ATTR), majority-read sensitivity was 96% and specificity was 86%. For light-chain amyloidosis (AL), sensitivity was 95% and specificity was 86%.

“For people with cardiac amyloidosis, obtaining an accurate diagnosis can be challenging,” said Sharmila Dorbala, MD, REVEAL principal investigator, director of Nuclear Cardiology at Brigham and Women’s Hospital and director of Amyloidosis Research at Mass General Brigham Heart & Vascular Institute. “These challenges can lead to delays, underdiagnosis or misdiagnosis in the course of the disease.”

Participants received a single intravenous dose of I-124 evuzamitide followed by cardiac and partial-body PET/CT imaging 3 to 5 hours later. Images were independently interpreted by experienced cardiac PET physicians blinded to clinical data.

Among the 170 participants, 55 (32.4%) experienced at least one treatment-emergent adverse event through day 30. Eleven patients (6.5%) experienced a serious adverse event, none considered related to I-124 evuzamitide. Only one adverse event, fatigue, was considered related to the tracer. No deaths or treatment-related discontinuations occurred.

“Bayer is proud to present this new research on cardiac amyloidosis at ESC,” said Erin Bowman, MD, senior medical director of Molecular Imaging and Theranostics at Bayer. “The presentation of this data reflects our ongoing commitment to advancing research for patients affected by this disease.”

I-124 evuzamitide has received FDA Breakthrough Therapy Designation for PET imaging in patients with suspected or known cardiac amyloidosis, as well as Orphan Drug status for AL and ATTR in the US and EU. The agent remains investigational and has not been approved by any regulatory authority.