SCOTTSDALE, Ariz., Sept. 10, 2025 -- Imaging Endpoints (IE), the global leader in Imaging CRO technologies and services for oncology trials, announced the filing of a provisional patent application for its revolutionary AI enhanced Imaging Review Charter (IRC) system. This innovative AIRC System™ is designed to enhance highly customized IRCs for clinical trials, setting new standards in the industry.

Imaging Endpoints is the scientific leader in customizing and optimizing image acquisition and analysis for clinical trials in oncology, with the most sophisticated approach in the industry for ensuring clarification(s) and/or modification(s) of published criteria to enhance each unique clinical trial design. This advanced approach to image analysis has contributed to the Company's remarkable 95% marketing approval success rate across over 200 regulatory approvals supported.

The new AIRC System addresses long-standing challenges in trial imaging design by assisting in the assimilation of data for intelligent, tailored modifications and/or clarifications to standard oncology criteria while ensuring alignment to current regulatory requirements of the FDA, EMA and other regulatory agencies across the globe.

Key Features of the New AIRC System:

• Dynamic Customization: The system includes a customization module that integrates datasets from industry standards, published oncology criteria, Imaging Endpoints' library of analysis customizations, and trial information from the study protocol and experimental agent (such as mechanism of action), to generate dynamic IRC documents.
• Criteria Optimization: The System provides the largest dataset and leading method for the identification of specific criteria clarifications and/or modifications that are required to optimize image acquisition and analysis for each unique trial.
• Enhanced Regulatory Compliance: By integrating requirements, standards, guidelines and recent industry-wide findings of the FDA and other regulatory agencies globally, while more clearly describing criteria enhancements, the AIRC System helps to optimize adherence to regulatory standards while improving the efficiency of sponsor and Agency review.
• Increased Efficiency: The System utilizes AI to compile and integrate applicable data for IE's Physician, Scientific, Operations, and Regulatory experts to evaluate — enabling faster trial setup with highly reliable outcomes.

Doug Dean Burkett, CEO and President of Imaging Endpoints, commented on the innovation: "For over fifteen years, IE has been at the forefront of imaging CRO services within oncology. The filing of this patent marks another milestone in our commitment to Connect Imaging to the Cure™. This AI enhanced IRC System enhances the efficiency and effectiveness of oncology trials while further solidifying our industry leadership."

For more information, or a copy of Imaging Endpoint's recent white paper on criteria optimization, see Optimizing Imaging Response Criteria for Improved Outcomes in Oncology Clinical Trials

About Imaging Endpoints

Imaging Endpoints (IE) is passionately focused on its vision to Connect Imaging to the Cure. With a flawless global inspection record and a remarkable 95% marketing authorization success rate, IE has a proven track record of supporting successful regulatory submissions across the globe. IE's commitment to quality, innovation, rapid turnaround times, and operational excellence has positioned it as the global leader in oncology imaging.

Imaging Endpoints is the largest oncology Imaging CRO, with 8 offices strategically located across 6 countries including Scottsdale, AZ, Cambridge, MA; London, UK; Leiden, Netherlands; Basel, Switzerland; Hyderabad, India; and Shanghai, China.

IE is an affiliate of HonorHealth, one of the largest healthcare systems nationally, and Southwest Medical Imaging, Ltd. (SMIL/RadPartners), part of the largest private radiology group in the U.S.

For further media queries, please contact: IE.MediaRelations@imagingendpoints.com | Contact no. +1 480.314.3070.