September 16, 2025 — Leads & Copy — Caristo Diagnostics congratulates Abcentra on the successful dosing of the first patient in the FORTIFY clinical trial. Caristo will serve as the worldwide imaging core lab for the trial, overseeing coronary inflammation and plaque measurement and monitoring, while contributing to patient selection through its CaRi-Heart® and FAI-Score™e technologies.
The FORTIFY clinical trial, formally known as “Focused Orticumab Research for Treating Inflammation in Coronary Arteries,” is a multi-center, randomized, placebo-controlled, double-blind trial. It aims to evaluate the efficacy of orticumab in reducing local coronary inflammation in patients with a history of type 1 myocardial infarction (MI) and elevated coronary inflammation. The trial plans to enroll 240 adults across 40 sites in the U.S. and Europe, all of whom have a history of type 1 MI and an elevated Fat Attenuation Index (FAI) Score as determined by Caristo’s CaRi-Heart technology.
Caristo’s responsibilities include certifying and training clinical sites to ensure high-quality coronary computed tomographic angiography (CCTA) imaging. Additionally, the company will support patient enrollment by identifying eligible candidates based on elevated coronary inflammation, as measured by FAI-Score. They will also conduct baseline and follow-up analyses for all randomized patients at 24 weeks, quantify coronary inflammation using CaRi-Heart technology, provide comprehensive cardiovascular risk calculations and plaque analysis, and ensure image quality control and radiation dose optimization.
Christopher Farina, CEO of Abcentra, said Caristo was selected because its imaging technology allows for measuring coronary inflammation with unprecedented precision. Frank Cheng, CEO of Caristo Diagnostics, added that pharmaceutical and biotech sponsors are increasingly turning to Caristo to help select trial candidates and evaluate the effects of trial drugs on coronary plaque and inflammation.
About Caristo Diagnostics: Caristo Diagnostics is a global leader in AI-powered heart disease detection. A spinout from the University of Oxford, Caristo’s award-winning technology is transforming cardiovascular care by identifying hidden heart attack risks before symptoms appear.
About Abcentra: Abcentra is a clinical stage biopharmaceutical company pioneering targeted therapies for cardiovascular inflammation.
Contact:
Frank Cheng, CEO of Caristo Diagnostics.
