NanoGroup S.A., a Polish biotechnology company listed on the Main Market of the Warsaw Stock Exchange, has announced its project development roadmap for 2026–2027. The plan focuses, among other areas, on the final stage of certification for the NanOX Recovery Box, an innovative transplantology device designed for mechanical kidney perfusion outside the human body.
A key milestone will be the audit by the notified body TÜV NORD, scheduled for 2026, followed by obtaining CE marking no later than the first quarter of 2027. Completion of these stages will significantly reduce project risk and open the way for commercialisation of the technology on the European market. The Group’s projects are aligned with the global normothermic machine perfusion market, whose value is expected to grow more than fourfold to USD 9.04 billion by 2034, at a CAGR of 18.1%. This underlines the strong scaling potential of the technology and the attractiveness of the segment.
“2025 was a moment of transition for us from the phase of building foundations to the phase of consistent strategic execution. Today, we have a complete technological, financial and regulatory base that allows us to enter the most demanding stage of development: clinical and regulatory validation and preparation for the commercialisation of the comprehensive NanOX system,” comments Przemysław Mazurek, President of the Management Board of NanoGroup S.A.
In 2026, NanoGroup is focusing on the implementation of key stages of the certification process, including the completion of engineering studies, biocompatibility tests, and GLP and non-GLP studies. At the same time, GMP production standards are being developed, which will be necessary for future scaling and market entry.
The NanOX system is the technology with the greatest partnering potential within the Group. It is an innovative system for extracorporeal kidney perfusion, consisting of the NanOX Recovery Box and the NanOX 4K Perfusion Set. After the presentation of the prototype and the start of engineering work, the project entered the formal regulatory pathway under MDR (EU) 2017/745, which is a key element of technology de-risking.
“Our goal is no longer only to develop the technology, but to successfully guide it through the regulatory pathway and create repeatable commercialisation models. We want consistent execution, not innovation alone, to be the key source of long-term value for NanoGroup shareholders,” added Przemysław Mazurek.
Another project being developed in parallel is NanOX 4 Kidney, the first perfusion fluid designed with oxygen transport in mind. It offers the potential to change the paradigm of transplantology: from merely slowing down processes to actively maintaining proper metabolism in the organ. Following positive results from an autotransplantation study in 2025, the project has entered a phase of intensive preclinical validation.
Key development activities for 2026 have been divided into two stages. In the first half of 2026, the company plans to select a contract development and manufacturing organisation, choose the target fluid variant for certification studies, and select a contractor for non-GLP studies covering isolated organs and autotransplantation models.
In the second half of the year, the company plans to manufacture the first batches of material in a non-GMP standard and under conditions compliant with the ISO 13485 quality management system for medical devices, a quality standard similar to GMP principles. It also plans to carry out non-GLP studies on isolated organs and in autotransplantation models. This stage will conclude with the completion of studies in a pig autotransplantation model under non-GLP conditions and confirmation of the ability to effectively manufacture NanOX 4 Kidney Fluid under ISO 13485-compliant conditions.
It is worth noting that portfolio diversification and stable financing remain important elements of NanoGroup’s strategy. In 2025, the Group secured PLN 24.8 million in grant funding for projects and PLN 24.5 million in capital from a Series N share issue. Financial institutions, including investment fund companies, also joined the shareholder base, strengthening the Group’s investor base.
The objective of NanoGroup’s development strategy for 2026–2028 remains to build one of the three largest biotechnology groups in Poland by market capitalisation, develop at least 10 projects, and conclude at least two significant partnering agreements generating recurring revenue. At the same time, the company is focusing on technologies with high market potential and a relatively short path to commercialisation.
Recently, the company has also increased its exposure to the value-added medicines segment through a PLN 7.5 million investment in Auxilius Pharma S.A. and strengthened its competencies in diagnostics and targeted therapies through the acquisition of an aptamer platform.
The projects carried out by the Group fit into the global trend of dynamic growth in the normothermic machine perfusion market, whose value is expected to increase from USD 1.7 billion in 2024 to USD 9.04 billion in 2034, representing a CAGR of 18.1%. This trend confirms the significant scaling potential of the technology and the attractiveness of the segment in which the Group operates.
The coming quarters will be a period of transition for NanoGroup from intensive technological development to advanced regulatory validation and preparation for commercialisation, while continuing to expand its project portfolio and build international partnerships.
Source: CEO.com.pl
