The StentUp project focuses on the clinical and industrial scaling of the Resorbable Fibrillated Scaffold (RFS) developed by STENTiT. This technology offers an innovative solution for treating Peripheral Arterial Disease, a common condition with rising incidence due to aging populations and increasing rates of diabetes. To bring this technology to clinical application, STENTiT is collaborating closely with the Smart BioMaterials Consortium (SBMC), which recently established state-of-the-art cleanroom facilities in Eindhoven. STENTiT’s production process is being implemented within SBMC’s GMP-compliant infrastructure. This implementation includes the installation and validation of equipment, preparation of quality documentation, and integration into SBMC’s ISO-certified quality management system.

What the project works on

The StentUp team focuses on several key steps that bring the technology closer to patients:

• Expanding the range of RFS implant sizes, so the solution can support more patient anatomies.
• Scaling up production, taking the technology from laboratory prototypes to pilot manufacturing.
• Translating the technology into stable, repeatable processes ready for regulated medical production.
• Building quality and certification pathways in preparation for future clinical use.
• Producing an early clinical-grade batch, essential for the next phase of testing.
• Carrying out process development and manufacturing in SBMC’s GMP cleanrooms, designed specifically for the development, production and quality assurance of advanced biomaterials and implantable devices.
• Sharing knowledge within the regional ecosystem, connecting engineers, scientists and clinicians working on regenerative medicine.

Why it matters

If successful, the RFS could increase the quality of life for patients around the world. For the region, StentUp reinforces the strong position of Brainport as a leader in high-tech biomedical innovation.

Supported by partners

The project is co-funded by EFRO/OPZuid, with additional support from the Dutch national government and the Province of North Brabant.