NanoSanguis has taken delivery of the first two production units of the NanOX Recovery Box. The devices have already been commissioned and tested by the NanoSanguis team. In early September, they will be shipped to El Prat de Llobregat, near Barcelona, where they will be used at the certified Versa Biomedical S.L. facility as part of a preclinical study programme evaluating the NanOX 4 Kidney kidney perfusion solution in a large-animal model.

NanOX Recovery Box on the Path to Certification

The NanOX Recovery Box is a Class IIb/IIa medical device designed for controlled kidney perfusion during the transplantation process. It enables perfusion across the full temperature range and monitors key process parameters, including perfusate temperature, oxygenation level, pH, pressure and flow. NanOX Recovery Box is the first Polish transplant medicine device of its kind and is currently undergoing an advanced certification process, which is expected to be completed in the first quarter of 2027.

From the second quarter of 2027, the device is expected to be available for use in human organ transplantation procedures. Before then, between September and December 2026, it will be used in the largest preclinical study programme to date involving the NanOX 4 Kidney perfusion solution.

Studies in Barcelona

The preclinical study programme will comprise two groups of experiments:

• IKP (Isolated Kidney Perfusion) – up to 26 experiments involving isolated porcine kidneys, including a control group.
• ATX (Kidney Autotransplantaion) – up to 32 experiments in a porcine kidney autotransplantation model, including a control group.

The isolated kidney perfusion (IKP) study reproduces, ex vivo, the conditions associated with kidney transplantation from a donor after circulatory death (DCD). The protocol includes a 30-minute period of organ ischaemia, followed by 12 hours of subnormothermic perfusion at 25°C using the NanOX Recovery Box and NanOX 4 Kidney solution, subsequent reperfusion and post-procedure assessment. The control group will undergo the procedure using the current market-standard approach with Belzer MPS perfusion solution.

The autotransplantation (ATX) study is a more extensive surgical procedure designed to replicate kidney transplantation from a DCD donor. It includes a 30-minute period of organ ischaemia, followed by 12 hours of subnormothermic perfusion at 25°C using the NanOX Recovery Box and NanOX 4 Kidney solution. The animal’s contralateral kidney is then removed, and the perfused kidney is transplanted in its place. Postoperative kidney function is subsequently monitored over a 14-day observation period. The programme aims to obtain 12 successful study outcomes using the NanOX solution, with additional procedures permitted in accordance with the research protocol.

Successful completion of the studies will provide key preclinical evidence for NanOX 4 Kidney through the demonstration of reproducible results in an autotransplantation model. This represents a further development milestone following the first successful autotransplantation performed in July 2024. Since then, the Company has finalised the perfusion solution formulation and is completing the transfer of its manufacturing process, including scale-up, to Syvento sp. z o.o.

The autumn study programme will be conducted at Versa Biomedical S.L. in El Prat de Llobregat, near Barcelona, Spain. Versa Biomedical is a specialised contract research organisation (CRO) and one of Europe’s most experienced centres conducting studies using porcine models. The facility has more than 12 years of experience and has completed over 200 projects for clients from 14 countries.

Following delivery of the devices to Barcelona, the NanoSanguis Development Team will train the designated operators and provide support throughout the preclinical study programme.

The IKP study is scheduled to commence in September.

In the group photo, from the right:

Wojciech Frąckowiak (Lead Researcher), Piotr Mierzejewski (Vice President of the Management Board of NanoGroup S.A.), Kornel Prystupiuk, Daniel Kopeć, Daria Szeląg, Julia Zakrzewska-Borzęcka, Paweł Pacek, Marek Sutkowski (NanOX Recovery Box Development Team)