On 13 May 2026, NanoSanguis S.A.’s subsidiary entered into an agreement with SyVento sp. z o.o., formally launching the industrial development phase of NanOX 4 Kidney perfusion fluid. The total gross value of the agreement exceeds PLN 3.9 million.

The cooperation will be carried out under a contract development and manufacturing model, which is standard practice in the biotech and medtech sectors. This model will enable production in a specialised industrial environment compliant with ISO 13485 requirements and manufacturing practices appropriate for a GMP environment, while allowing NanoSanguis to retain full control over the technology, know-how and future development strategy.

A Key Development Milestone for NanOX 4 Kidney – From the Laboratory to Manufacturing

The transition to the industrial phase is one of the most important milestones in the product’s development. This innovative next-generation perfusion fluid, based on a synthetic oxygen carrier, is moving from laboratory research to process scale-up and manufacturing in accordance with the ISO 13485 quality standard. This phase paves the way for further preclinical and clinical studies, as well as future product certification and commercialisation.

NanOX 4 Kidney is being developed as a Class III medical device, the highest regulatory class. This means that it must meet the most stringent quality, technological and legal requirements under the Medical Device Regulation (MDR, EU 2017/745) and the ISO 13485 quality management system.

Comprehensive Development of the Manufacturing Process

The scope of cooperation covers comprehensive technological and regulatory activities, including:

• scaling up the manufacturing process,

• process optimisation and validation,

• manufacturing preclinical and clinical batches,

• analytical testing and quality control,

• preparing complete technical and quality documentation.

Work will be carried out in parallel across technology, analytics and documentation, enabling the ongoing identification of critical process parameters and the mitigation of technological and regulatory risks.

The outcome of the agreements will be the development and validation of the NanOX 4 Kidney manufacturing process, together with the production of preclinical and clinical batches. The work will also deliver a complete data package required for future conformity assessment, clinical trials and the certification of NanOX 4 Kidney as a medical device.

SUS Technology to Enhance Process Safety

The agreements provide for the use of modern SUS (Single-Use Systems) technology, which employs disposable process systems used in advanced biotechnology and the manufacture of sterile medical devices. This means transferring some manufacturing operations to a sterile, closed, single-use production system. SUS technology makes it possible to:

• reduce the risk of contamination,

• enhance process safety,

• improve the consistency of manufacturing parameters,

• simplify technology validation and scale-up,

• accelerate preparation of a process that meets quality requirements.

SUS technology offers particular benefits for sterile Class III medical devices, where quality control and manufacturing process stability are essential to the safety of future clinical trials and the commercial product. It is also regarded as a cost-effective and environmentally friendly solution.

High Quality and Regulatory Requirements

The technology and manufacturing partner was selected on the basis of stringent criteria, including:

• a certified ISO 13485 quality management system,

• compliance with the MDR (EU 2017/745),

• experience in manufacturing sterile Class III medical devices,

• GMP infrastructure,

• expertise in controlling critical process parameters.

The qualification process included two quality audits:

• 16 April 2026 – quality management system audit,

• 24 April 2026 – infrastructure and operational process audit.

Agreement Implementation Schedule

• From May to September 2026, the production installation is scheduled to be commissioned, the manufacturing process scaled up and optimised, and a pilot batch and optimisation batches produced. The latter will be used in large-animal studies.

• From October 2026 to July 2027, repeatable validation batches of the perfusion fluid are scheduled to be manufactured in accordance with GMP standards for stability studies and GLP-compliant preclinical studies.

• From November 2027 to July 2028, batches of the perfusion fluid intended for clinical trials are scheduled to be manufactured.

Analytical work will be carried out in parallel, focusing in particular on determining the fluid’s composition, validating analytical methods and assessing its physicochemical properties. This will include measuring the average particle size using Dynamic Light Scattering (DLS) and determining zeta potential using Laser Doppler Electrophoresis (LDE).

A Strategic Milestone for the NanOX 4 Kidney Project

Entering into cooperation with a technology and manufacturing partner marks the transition of the NanOX 4 Kidney project from the laboratory phase to an industrial environment that meets the highest quality and regulatory standards for Class III medical devices.

The manufactured fluid will be used in key studies planned as part of the product’s development pathway:

• studies involving isolated porcine organs, with completion estimated for November 2026;

• non-GLP studies using a porcine kidney autotransplantation model, with completion estimated for November 2026;

• GLP porcine autotransplantation studies, with completion estimated for September 2027;

• clinical trials in humans.

This is a strategic step bringing the technology closer to potential introduction into the medical market.

In line with the business plan, the availability of perfusion fluid manufactured to the ISO 13485 quality standard, successful completion of non-GLP autotransplantation studies and CE certification of the NanOX Recovery Box device represent a favourable point at which to enter into a partnering agreement.

About SyVento sp. z o.o.
SyVento is a Polish biotechnology company engaged in the research, development and manufacturing of innovative medicinal products and medical devices. It specialises in developing products based on nanotechnology and in aseptic filling processes. Founded in 2015, the company operates a modern research and manufacturing centre in Skawina, near Kraków. The facility includes, among other things, a GMP-compliant pharmaceutical manufacturing area and a non-GMP development area, with a combined floor space of more than 8,000 m².
SyVento is the first company in Poland authorised to independently manufacture, test and release for clinical trials therapies based on mRNA technology and lipid nanoparticles (LNPs). SyVento’s mission is to support the development of innovative therapies, from research through to clinical manufacturing, by providing integrated services and technology platforms for the pharmaceutical and biotechnology sectors.