Caristo Congratulates Abcentra for First Patient Dosed Successfully in Phase 2b 'FORTIFY' Clinical Trial Evaluating Orticumab in Patients with Cardiovascular Disease

'FORTIFY' Selects FAI-Score^™ as Primary Outcome Measure, and Caristo as Worldwide Imaging Core Lab for Coronary Inflammation and Plaque Measurement and Monitoring

STAMFORD, Conn. and LOS ANGELES, Sept. 16, 2025 /PRNewswire/ -- Caristo Diagnostics, on a mission to transform the diagnosis and treatment of cardiovascular disease, today, congratulates Abcentra for the successful dosing of the first patient in the FORTIFY clinical trial (https://clinicaltrials.gov/study/NCT06927739), and announces Caristo's role as FORTIFY trial's worldwide imaging core lab. For the FORTIFY clinical trial, Caristo oversees all coronary inflammation and plaque measurement and monitoring, as well as contributes to patient selection through its proprietary CaRi-Heart^® and FAI-Scor™e technologies.

The FORTIFY clinical trial (Focused Orticumab Research for Treating Inflammation in Coronary Arteries; NCT06927739) is a multi-center, randomized, placebo-controlled, double-blind trial designed 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. A total of 240 adults with a history of type 1 MI and elevated Fat Attenuation Index (FAI) Score — determined using Caristo's CaRi-Heart technology — are being enrolled at 40 sites in the U.S. and Europe.

Caristo's core laboratory responsibilities for the FORTIFY trial include:

• Certifying and training each clinical site to ensure high-quality coronary computed tomographic angiography (CCTA) imaging
• Supporting patient enrollment by identifying eligible candidates based on elevated coronary inflammation as measured by FAI-Score, an AI-powered imaging biomarker that is an independent predictor of future major adverse cardiovascular events
• Conducting baseline and follow-up analyses for all randomized patients at 24 weeks
• Quantifying coronary inflammation using CaRi-Heart technology, which leverages the FAI-Score
• Providing comprehensive cardiovascular risk calculations, plaque analysis using CaRi-Plaque™, image quality control, and radiation dose optimization

"We chose Caristo because their cutting-edge imaging technology allows us to measure coronary inflammation with unprecedented precision," said Christopher Farina, CEO of Abcentra. "This will be vital to confirming orticumab's potential to address coronary inflammation, one of the root causes of heart attacks."

"Pharma and biotech sponsors are increasingly turning to Caristo to help select trial candidates and evaluate how both coronary plaque and inflammation — two critical and independent predictors of heart attack risk — are affected by a trial drug," said Frank Cheng, CEO of Caristo Diagnostics. "We are proud to partner with Abcentra on FORTIFY and to support their groundbreaking work in developing targeted anti-inflammatory therapies with FAI-Score chosen as the primary outcome endpoint."

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. Backed by leading hospitals and scientists, Caristo is on a mission to save lives through early detection and personalized prevention. For more information, visit caristo.com.

About Abcentra:

Abcentra is a clinical stage biopharmaceutical company pioneering targeted therapies for cardiovascular inflammation. The company's first-in-class monoclonal antibody, orticumab, targets oxidized LDL to quell persistent inflammation within atherosclerotic plaques, offering a novel approach for patients at risk of recurrent cardiovascular events. For more information, visit abcentra.com.

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