NanoGroup S.A. is beginning preparations for the potential entry of its flagship NanOX System project into the U.S. market. The Company has appointed a dedicated project team led by Dr Habil. Tomasz H. Zastawny, a life sciences executive with 28 years of international experience in medical technology development, FDA regulatory processes and commercialisation.

The team will assess the NanOX System’s readiness for development in the United States, potential regulatory pathways, the technology’s competitive position, and possible cooperation and commercialisation models.

NanOX is a proprietary system designed for the ex vivo preservation and regeneration of organs for transplantation. It comprises, among other components, the NanOX Recovery Box, a perfusion fluid and a proprietary perfusion protocol. In February this year, the NanOX Recovery Box entered the European certification phase, while NanOX 4 Kidney is currently at an advanced stage of preclinical development.

The potential of the market in which NanOX is being developed is illustrated by the scale of kidney transplantation in the United States. In 2024, 28,492 kidney transplants were performed in the U.S., while 147,091 people were on the waiting list. These figures indicate the persistently high level of unmet need and highlight the importance of technologies that support more efficient utilisation of available organs. Source: SRTR, 2024 Annual Data Report.

“NanOX is at an important stage of development. We are preparing the technology both for the next stages of development and for potential entry into the U.S. market. Appointing a dedicated team led by someone with such extensive experience in the development, regulation and commercialisation of medical technologies in the United States will help us prepare thoroughly for this process.”

The Team’s Experience

The team will be led by Dr Habil. Tomasz H. Zastawny, who has 28 years of international experience in the life sciences sector, spanning biotechnology, pharmaceuticals, contract research organisations (CROs) and medical technologies. He has worked with, among others, the FDA, EMA and PMDA, and throughout his career has been responsible for clinical and regulatory development, technology transfer and the commercialisation of innovative solutions. He is currently President of the Management Board and co-founder of the U.S. biotechnology company Armora Bio. Previously, he held positions including Chief Drug Development Officer at PRA/PAREXEL, Senior Vice President at Rakuten Medical and Chief Development Officer at Adial Pharmaceuticals. He is also a member of the Supervisory Board of NanoGroup S.A.

Preparing NanOX for potential entry into the U.S. market forms part of NanoGroup S.A.’s strategy to develop its proprietary technologies and commercialise them globally. This strategic direction is reinforced by the investment agreement with Auxilius Pharma S.A. and the integration process initiated between the two companies. Together, these developments are expanding the Group’s capabilities and expertise in the U.S. market while creating new opportunities for the development and future commercialisation of medical technologies in the United States.