Ikonisys Group Renews Agreement as European Authorized Representative and Importer for Novodiax’s CE IVD-Certified Real-Time Immunohistochemistry Technology in Oncological Diagnostics and Organ Transplant Safety

Regulatory News:

Ikonisys SA (Euronext Growth Paris: ALIKO), a company specializing in the early and accurate detection of cancers through a unique fully automated solution for medical analysis laboratories, is pleased to announce that Hospitex has renewed its contract as the European Authorized Representative and Importer for Novodiax. Novodiax, a U.S.-based company specialized in immunohistochemistry, is the exclusive provider of CE IVD-IHC (in vitro diagnostics and immunohistochemistry) medical devices for real-time oncological diagnostics on tissue samples. With its innovative platform, Novodiax ensures the safety of organ transplant procedures by screening for potential malignancies in real time.

Under this partnership, Ikonisys Group will oversee importation, warehousing, regulatory compliance, and technical support for Novodiax’s groundbreaking technology, ensuring swift access for healthcare providers across Europe. This technology delivers rapid oncological insights into donor tissues, allowing transplant teams to make informed decisions regarding organ suitability, thereby reducing the risks of post-transplant malignancy.

Moreover, Ikonisys has strengthened its position in Europe by securing exclusive distribution rights for the Italian market through its Italian subsidiary, Ikonisys Srl. This strategic move consolidates the Group's role as a European representative and importer and enhances its ability to provide localized support, streamline operations, and accelerate market access in Italy. With direct distribution in a key European market, Ikonisys is set to increase brand visibility, foster closer relationships with customers, and drive growth across the region.

Current Landscape of the Organ Transplantation in Europe

Organ transplantation is a vital component of healthcare in Europe, with approximately 34,000 transplants performed annually. Demand continues to rise, as over 150,000 patients are currently on transplant waiting lists across the continent. In 2023, Europe recorded more than 7,000 kidney transplants, 4,000 liver transplants, and 2,500 heart transplants. This substantial increase highlights the urgent need for safe and reliable diagnostics in these procedures. Rapid diagnostic tools, such as Novodiax’s technology, can significantly impact decision-making, especially since up to 5% of organ recipients face the risk of post-transplant malignancies.

Novodiax’s innovative IHC technology facilitates faster and more accurate diagnostics, improving the quality and safety of transplantation procedures by ensuring each organ’s compliance with rigorous oncological safety standards before transplantation.

Strategic Alignment with Ikonisys Group’s Global Vision

This partnership fully aligns with Ikonisys Group’s strategy to establish itself as a global leader in next-generation cancer diagnostics. The agreement with Novodiax is a pivotal step toward achieving Ikonisys Group’s vision of becoming a world-class provider in the evolving field of oncology diagnostics.

About Novodiax

Novodiax is a biotechnology company specializing in the development and commercialization of rapid, high-quality immunohistochemistry (IHC) and immunocytochemistry (ICC) diagnostic assays. Known for their innovative ultra-fast testing platforms, Novodiax focuses on providing pathologists and clinicians with tools that significantly speed up diagnostic workflows, delivering results in minutes instead of hours. The company’s flagship products, which include novel ihcDirect® and ihcSlide™ systems, utilize proprietary technology to offer reliable, real-time diagnostics in clinical and research settings. By enabling faster and more efficient diagnostic processes, Novodiax aims to improve patient care and support precision medicine across a wide range of applications, from oncology to infectious diseases.

For more information: https://www.novodiax.com/

About Hospitex

Hospitex is the world leading company for cytology standardized monolayer preparations. With CYTOfast it re-invented cytological diagnostics. Hospitex offers a full range of integrated solutions aimed at streamlining diagnostic processes in cytology. The global shortage of expertise in pathology requires tools and technologies that enable diagnostic safety, efficiency and capacity building. In this area, Hospitex is recognized as the precision diagnostics player in cytology.

For more information: https://www.hospitex.com/en/

About Ikonisys

Ikonisys SA is a cell-based diagnostics company based in Paris (France), New Haven (Connecticut, USA) and Milan (Italy) specialized in the early and accurate detection of cancer. The company develops, produces and markets the proprietary Ikoniscope20® and Ikoniscope20max® platforms, fully-automated solutions designed to deliver accurate and reliable detection and analysis of rare and very rare cells. Ikonisys has received FDA clearance for several automated diagnostic applications, which are also marketed in Europe under CE certification. Through its breakthrough fluorescence microscopy platform, the company continues to develop a stream of new tests, including liquid biopsy tests based on Circulating Tumor Cells (CTC).

For further information, please go to www.Ikonisys.com

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