Polish perfusion technology enters an advanced stage of preclinical validation in kidney transplantation.

NanoGroup S.A., a Polish biotechnology company listed on the main market of the Warsaw Stock Exchange (WSE), has announced that its subsidiary, NanoSanguis S.A., has entered into a package of three agreements with Spanish contract research organisation (CRO) Versa Biomedical SL to conduct advanced preclinical studies of the NanOX 4 Kidney perfusion fluid in a large-animal model. The agreements enable the project to advance to the preclinical validation stage, which will generate data required for further research leading towards certification and the preparation of clinical trials in humans, while significantly reducing the project’s technological risk. The agreements represent another important milestone in the development of next-generation technology for ex vivo kidney perfusion.

NanOX 4 Kidney is a next-generation perfusion fluid being developed by NanoSanguis S.A. for ex vivo kidney perfusion. The technology is based on a synthetic oxygen carrier and is being developed with the aim of meeting the regulatory requirements for Class III medical devices. The project is supported by the European Funds for a Modern Economy programme under the SMART Path and aligns with the global trend towards active organ perfusion technologies designed to improve organ quality and enable functional assessment before transplantation.

The package of agreements with Versa Biomedical covers two non-GLP study programmes and one programme conducted in compliance with Good Laboratory Practice (GLP). The total maximum remuneration under the agreements amounts to EUR 1,214,150.11.

The total comprises:

• 174.249,52 EUR – remuneration for Part I, covering non-GLP studies involving isolated porcine kidneys with reperfusion. Start date: 17 July 2026;
• 330.907,63 EUR – remuneration for Part II, covering non-GLP studies using an autotransplantation model. Start date: 1 September 2026;
• 708.992,96 EUR – remuneration for Part III, covering studies using an autotransplantation model in accordance with GLP standards. Part III will be launched after NanoSanguis S.A. has assessed the results obtained in the earlier stages and submitted the relevant declaration in accordance with the terms of the agreement.

The programme has been designed as a sequential process for generating preclinical data in a large-animal model, enabling a comprehensive assessment of the safety and efficacy of the NanOX 4 Kidney perfusion fluid.

The agreements were concluded following completion of the contractor qualification process, which included a review of documentation and an audit of the research organisation.

In the Management Board’s assessment, signing the agreements with a CRO specialising in preclinical research represents another milestone in the development of NanOX 4 Kidney and marks the start of advanced validation in a large-animal model. This transition to preclinical functional verification is important for the project’s further regulatory pathway, the reduction of technological risk and the creation of project value.

The autotransplantation study is a complex large-animal experiment designed to replicate kidney transplantation from a donor after circulatory death (DCD). It includes a 30-minute period of ischaemia affecting one kidney, followed by 12 hours of perfusion under subnormothermic conditions (25°C) using the NanOX Recovery Box and NanOX 4 Kidney perfusion fluid. The kidney is then transplanted, followed by 14 days of postoperative monitoring to assess its function. The programme aims to obtain 12 successful outcomes in the autotransplantation model, with additional procedures potentially performed in accordance with the study protocol.

The programme addresses one of the key challenges in modern transplantation: the structural shortage of organs amid a growing number of patients awaiting transplants. The machine perfusion segment is one of the fastest-growing areas of transplant medicine, focused on improving organ quality and availability before transplantation.

The next step in the project will be to deliver two NanOX Recovery Box devices to Versa Biomedical in Spain, train the research team and implement operating procedures. Once these preparations have been completed, the preclinical studies will begin according to schedule.

NanoGroup S.A. will keep the market informed of key project milestones, including device delivery, completion of research team training and progress across the programme.

In this way, the Group is advancing the entire NanOX 4 Kidney development pathway—from formulation selection through preparation of the manufacturing process and research infrastructure to advanced preclinical and clinical studies that will form the foundation for further regulatory development and potential commercialisation.

Transplantation at a Turning Point: Perfusion Technologies Are Changing the Rules of Organ Transplantation

Market data indicate that kidney transplantation remains the most frequently performed type of solid-organ transplant worldwide. In 2024, approximately 1,259 kidney transplants were performed in Poland, around 20,729 in the United States and 45,000–50,000 globally. At the same time, the number of patients awaiting transplantation far exceeds the availability of organs. In Poland, approximately 20,900 people are receiving dialysis; in the United States, the figure is around 550,000, while millions of patients worldwide have end-stage kidney disease. At current levels of transplant capacity, meeting the existing need for kidney transplants in Poland could take more than a decade.

The machine perfusion technology market is growing rapidly. According to Precedence Research, the global normothermic machine perfusion (NMP) market is projected to grow from USD 1.71 billion in 2024 to USD 9.03 billion in 2034, representing a compound annual growth rate (CAGR) of 18.1%. This reflects growing demand for advanced methods of organ assessment and preservation.

The Group continues to make progress in developing organ perfusion technologies that align with the global trend towards improving the quality and availability of organs for transplantation and represent one of the Company’s key strategic development areas.