Innovation Developed by UT Health Sciences Research Program Passes Landmark Trial for Cardiac Amyloidosis

Jonathan Wall, PhD, assistant dean for Research and director of the Amyloidosis and Cancer Theranostics Program in the College of Medicine - Knoxville, worked with his colleagues in partnership with the UT Research Foundation to advance their cardiac amyloidosis imaging tool through a successful clinical trial.

A new diagnostic tool developed at the University of Tennessee Health Sciences may soon make it significantly easier for physicians to detect cardiac amyloidosis, a progressive and frequently underdiagnosed disease caused by abnormal protein deposits in the heart.

The tool is a novel imaging technology, a radioactive molecule that, when injected into a patient and scanned, lights up amyloid deposits in the heart, making a disease that was once nearly invisible on imaging clearly visible for the first time.

Bayer announced on May 7, 2026, that the Phase 3 REVEAL study - a large, multisite clinical trial evaluating the molecule's performance - confirmed that the investigational PET imaging tracer iodine-124 evuzamitide detected cardiac amyloidosis with strong sensitivity and specificity in patients with suspected disease. The tracer was evaluated across 19 U.S. centers against standard clinical diagnosis methods.

Cardiac amyloidosis has historically been difficult to diagnose because its symptoms closely resemble those of more common forms of heart failure. Patients often spend two to four years moving between specialists before receiving an accurate diagnosis, by which point significant, sometimes irreversible organ damage may already have occurred. Until recently, clinicians lacked a broadly effective molecular imaging tool to directly identify and quantify amyloid deposits across disease subtypes.

Iodine-124 evuzamitide was developed by Jon Wall, PhD, and colleagues in the Amyloidosis and Cancer Theranostics Program at the UT Health Sciences College of Medicine - Knoxville. Working in partnership with the UT Research Foundation, Dr. Wall, Emily Martin, PhD, Steve Kennel, PhD, Alan Stuckey, and Tina Richey co-founded a UT startup to advance the technology toward clinical application. The company, now Attralus, Inc., shepherded it through clinical development. The compound was subsequently acquired by Bayer AG, which announced topline results of the Phase 3 REVEAL study.

"Our first-in-human study of iodine-124-evuzamitide, performed at UT Medical Center in collaboration with the Cancer Institute and the Department of Nuclear Medicine, brought patients from all over Tennessee and the U.S.," Dr. Wall said. "We are so grateful for the enthusiastic involvement of the patients and their families, without whom we could not have achieved this milestone and hopefully approval of this imaging agent by the FDA."

The tracer is designed to visualize amyloid deposits throughout the body with greater precision than existing diagnostic approaches, giving clinicians a direct molecular window into a disease process that was previously difficult to see clearly in living patients.

"Dr. Jon Wall and his team's groundbreaking research has opened the door to earlier, more precise detection of cardiac amyloidosis, offering new hope to patients and families facing this devastating disease."

Dr. Maha Krishnamurthy

More than a clinical milestone, the REVEAL study results represent a potential turning point in how cardiac amyloidosis is found and treated. Investigators believe the technology could eventually help clinicians monitor disease burden over time and distinguish between amyloid subtypes, capabilities that could meaningfully expand its role in patient care.

"This work began with a simple but important question," said Jessica Snowden, MD, vice chancellor for Research at UT Health Sciences. "How do we make an invisible disease visible early enough to truly help patients?"

"Dr. Jon Wall and his team's groundbreaking research has opened the door to earlier, more precise detection of cardiac amyloidosis, offering new hope to patients and families facing this devastating disease," said Maha Krishnamurthy, PhD, president of the UT Research Foundation. "The UT Research Foundation is honored to have played a role in helping this breakthrough move from the university into clinical development."

Cardiac amyloidosis remains significantly underdiagnosed worldwide, despite growing recognition of the disease and its substantial impact on heart failure outcomes. Earlier and more accurate diagnosis could open the door to timely intervention and more personalized treatment strategies.

The trajectory of iodine-124 evuzamitide - from academic research to startup, to acquisition, to a successful Phase 3 trial - illustrates the growing power of academic-industry partnerships in translating scientific discovery into patient benefit. It also reflects a broader shift in medicine toward precision diagnostics, using highly targeted molecular tools to detect and characterize disease in ways that were not previously possible.

"We continue to work on new ways to diagnose and treat systemic amyloidosis, which is a devastating disease impacting more patients every year," Dr. Wall said. "Taking the imaging agent form the lab to a successful Phase 3 study was possible by working with biotech partners and now Bayer. We are excited that our amyloid-binding imaging agent has passed this major milestone and we hope that this innovative approach will soon be clinically available to help all patients with amyloidosis."