Polish biotechnology company NanoGroup is moving into the next stage of development of its NanOX 4 Kidney technology for extracorporeal kidney perfusion. The first two production units of the NanOX Recovery Box have been commissioned and tested and are due to be transported to a research centre near Barcelona in early September.
The devices will be used at Versa Biomedical in El Prat de Llobregat in a new preclinical programme scheduled to run from September through December 2026. The studies are designed to generate repeatable data from large-animal models before the technology advances further along the clinical-development pathway.
NanoGroup’s subsidiary NanoSanguis is developing both the NanOX 4 Kidney perfusion fluid and the Recovery Box system used to control the organ-perfusion process.
Two complementary preclinical study programmes
The autumn programme will include two types of experiments: isolated kidney perfusion (IKP) and kidney autotransplantation (ATX). The IKP phase is expected to begin in September and may include up to 26 experiments using isolated porcine kidneys, including a control group.
The protocol is intended to reproduce ex-vivo perfusion associated with kidney transplantation after circulatory death. It includes a 30-minute period of kidney ischaemia followed by 12 hours of subnormothermic perfusion at 25°C using the NanOX Recovery Box and NanOX 4 Kidney fluid.
The control procedures will use MPS Belzer solution, allowing researchers to compare the experimental technology with an established market standard.
Autotransplantation will test post-operative kidney function
The second part of the programme is more complex. The ATX study may include up to 32 porcine kidney autotransplantation experiments, including controls.
Following the same 30-minute ischaemia period and 12-hour perfusion stage, the treated kidney will be transplanted back into the animal. Researchers will then observe post-operative kidney function for 14 days.
The programme is designed to obtain 12 successful study outcomes for NanOX 4 Kidney, with additional procedures possible under the research protocol.
Recovery Box moves toward CE certification
The NanOX Recovery Box is designed to provide controlled kidney perfusion across a broad temperature range while monitoring parameters including perfusion-fluid temperature, oxygenation, pH, pressure and flow.
The device is currently undergoing certification, with NanoGroup expecting CE certification in the first quarter of 2027. The first production units will therefore already be used during the preclinical-development phase.
The upcoming studies follow an earlier successful kidney autotransplantation performed in July 2024. Since then, NanoGroup has selected the target formulation of the perfusion fluid and begun industrial development and manufacturing work with SyVento.
The company aims to complete the current non-GLP research programme in isolated-organ and autotransplantation models around the end of 2026 and beginning of 2027. The Barcelona studies will be an important test of whether the results can be reproduced consistently as the technology moves closer to potential clinical use.
