NanoSanguis S.A., a company within the NanoGroup S.A. group, has completed the selection process for the NanOX 4 Kidney perfusion fluid formulation. The decision was based on the results of research and development work conducted to date, including ex vivo studies on isolated rat kidneys using a DCD model (donation after circulatory death).

The selection of the formulation marks an important project milestone, reducing technological risk and enabling the transition to the next phase of preclinical development in a large-animal model.

NanOX 4 Kidney is an innovative next-generation perfusion fluid based on a synthetic oxygen carrier and designed for ex vivo kidney perfusion. The project is being developed as a Class III medical device and represents one of the Group’s key programmes in the field of transplantation.

Studies conducted by the Medical University of Gdańsk included ex vivo perfusion as well as biochemical, metabolomic and histopathological analyses. Compared with the reference solution MPS Belzer, NanOX 4 Kidney demonstrated a more favourable functional profile in a subnormothermic perfusion model. Observations included higher oxygen consumption, lower lactate concentrations and more favourable changes in the adenine nucleotide pool, alongside positive trends in histopathological assessments.

In view of the current direction of development in organ perfusion technology and the results obtained to date with NanOX 4 Kidney, the Company anticipates that further development of the technology may also include the use of the fluid as a standalone perfusion product, without requiring a functional link to a dedicated device within a single system. This approach could increase flexibility in the project’s future regulatory and commercial pathways and broaden its potential applications.

Reaching this stage confirms the project’s progress, reduces technological risk and enables the Company to focus on the next phase of preclinical studies.

Two series of non-GLP studies in a large-animal model are planned for later this year. According to the current schedule, studies involving isolated porcine organs and an autotransplantation model are expected to be completed in November this year.