The NanOX Recovery Box is an innovative device for kidney perfusion outside the human body. Developed as part of the NanOX System, it provides a way to store and monitor organs that is unavailable on the market today.

Combined with NanOX 4 Kidney fluid, it has the potential to revolutionize transplantation, significantly increasing the donor pool – saving tens of thousands of lives each year.

Research and development plan

The device’s research and development plan is being implemented according to the schedule.

The leading subcontractor for the work is the Wroclaw-based A4Bee, which has reproduced the prototype in 2024 near-production conditions. The final version of the device, which meets current standards and uses certified components, is currently being made.

In the first half of the year, documentation and design work was completed.

By the end of 2025, we plan to:

1. Prepare perfusion sets for biocompatibility studies (by the end of August), which will last until the end of the year.

1. Produce two copies of the target device and disposable perfusion sets (September/October).

1. Conduct engineering tests at an accredited body (October).

Certification

We plan to start the certification process in January 2026.

Certification documentation is currently being completed. In February 2025, our subsidiary, NanoSanguis, implemented a Quality Management System (QMS) in accordance with the ISO 13485 standard for medical devices – the same system is implemented at A4Bee.

In December, the clinical evaluation (Clinical Evaluation Report) will be ready, along with the results of the biocompatibility tests of the perfusion set. After that, all documentation will be submitted to the selected notifying body.

Patent

In September 2024, we filed a patent application with the Polish Patent Office for “Organ perfusion device and organ perfusion container” (No. P. 449924).

In May 2025, we received a preliminary positive evaluation of our invention from the Patent Office. The state of the art report confirms that “the invention meets the requirement of uniformity, the requirement of industrial applicability, the claimed solution was disclosed clearly and comprehensively against the background, (…) and therefore meets the statutory requirements of the inventive step.”

The patent granting process takes approximately 24 months. In September 2025, we plan to extend patent protection to designated markets throughout Europe and/or around the world.

New visuals

Completion of the design phase also means target visualizations of the device – they are in the gallery below the text. First photographs – in the fall.

We encourage you to monitor your progress regularly – #StayNanoTuned!