OXURION : Axiodis CRO, the French subsidiary of the Oxurion Group, announces a dual AI-driven strategic initiative to transform clinical trials

September 16, 2025 at 12:00 PM EDT

• Launch of digital twins and virtual patients to accelerate and enhance clinical trials
• Integration of AI modules into Exagis, Axiodis' proprietary eCRF solution

Leuven, BELGIUM, September 16, 2025, 6:00 PM – Oxurion NV (Euronext Brussels: OXUR) announces that its subsidiary, Axiodis CRO, specialized in clinical data management, is developing two major strategic initiatives incorporating artificial intelligence (AI) to accelerate and secure clinical trials.

These initiatives are fully aligned with Oxurion Group's technological roadmap, which aims to build a leading European hub dedicated to intelligent clinical data.

Digital twins and virtual patients: toward augmented clinical research

In partnership with a specialized provider, Axiodis CRO is launching a program centered on digital twins and virtual patients. The goal is to simulate the progression of human diseases, refine inclusion criteria, enhance patient safety, and significantly reduce the duration of early trial phases. This hybrid approach paves the way for more predictive and ethically sound clinical trials.

Exagis enhanced by AI: more reliable data, streamlined workflows

At the same time, Axiodis CRO is progressively integrating AI modules into its proprietary electronic Case Report Form (eCRF) solution, Exagis. This modernization is built around three key pillars:

Automated quality control of data entry;
Intelligent validation of coding, particularly through the use of standardized terminologies such as MedDRA (Medical Dictionary for Regulatory Activities) for adverse events and WHO-Drug for medicinal products, enabling automated, consistent, and regulation-compliant coding;
Predictive annotation of CRFs (Case Report Forms), through algorithms that can automatically suggest fields to complete, validate, or correct based on collected clinical data, thereby improving the quality and consistency of captured information.

“With Exagis, we want every study to benefit from increased accuracy without operational overload. AI strengthens our promise: data reliability, ease of use, and regulatory compliance,” said François BARTHELEMY, CEO of Axiodis CRO.

This strategy is part of an ongoing improvement approach for Exagis, an internally developed, HDS-certified, multilingual, and interoperable solution. The AI modules are designed to adapt to the specific needs of trial sponsors while complying with CDISC standards and EMA/FDA requirements.

A shared vision with Oxurion: building a pan-European clinical-data continuum

The integration of Axiodis within Oxurion aims to build a technology-driven ecosystem focused on enriched clinical data. The ambition: to optimize study design, automate quality control, and ensure reliable regulatory submissions. This strategy reinforces Oxurion's (Euronext Brussels: OXUR) position as a key player in clinical data in Europe and opens new commercial opportunities with pharmaceutical and biotech sponsors.

About Axiodis CRO

Founded in 2006 in Toulouse, Axiodis CRO is a French clinical research company specializing in biometrics. With over 15 years of experience, Axiodis offers a comprehensive and customized service portfolio for clinical trial management. The company currently supports more than 20 academic and industrial partners across France and Europe. Further information is available at www.axiodis.com.

About Oxurion

Oxurion NV (Euronext Brussels: OXUR) is a company specializing in acquiring majority stakes in promising European pharmaceutical subcontractors. Oxurion's ambition is to build an integrated group of subcontractors serving healthcare players. The Group's headquarters are based in Leuven, Belgium. More information is available at www.oxurion.com.

Important information about forward-looking statements

Certain statements in this press release may be considered “forward-looking”. Such forward-looking statements are based on current expectations, and, accordingly, entail and are influenced by various risks and uncertainties. The Company therefore cannot provide any assurance that such forward-looking statements will materialize and does not assume any obligation to update or revise any forward-looking statement, whether as a result of new information, future events, or any other reason. Additional information concerning risks and uncertainties affecting the business and other factors that could cause actual results to differ materially from any forward-looking statement is contained in the Company's Annual Report. This press release does not constitute an offer or invitation for the sale or purchase of securities or assets of Oxurion in any jurisdiction. No securities of Oxurion may be offered or sold within the United States without registration under the U.S. Securities Act of 1933, as amended, or in compliance with an exemption therefrom, and in accordance with any applicable U.S. state securities laws.

Additional Disclaimer

The planned investment in digital assets (such as Bitcoin and Ethereum) exposes the company to specific risks related to volatility, regulatory uncertainty, and cybersecurity. These factors may significantly affect the expected performance of the investments.

For further information please contact:

Oxurion NV
Pascal Ghoson
Chief Executive Officer
Pascal.ghoson@oxurion.com

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OXURION : Axiodis CRO, the French subsidiary of the Oxurion Group, announces a dual AI-driven strategic initiative to transform clinical trials

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