GMP Cleanrooms

STENTiT becomes first launching customer in SBMC’s new GMP Cleanrooms

October 31, 2025

Bart Sanders STANTiT

Eindhoven, October 31 2025 – SBMC proudly announces STENTiT as the first company to enter its brand-new GMP-compliant cleanroom facilities at Cureon, the new innovation center for medtech and biotech at the High Tech Campus in Eindhoven. This milestone marks the official launch of SBMC’s cleanroom services and supports STENTiT in accelerating the clinical translation and industrial upscaling of regenerative vascular implant technology.

STENTiT, a MedTech SME from Eindhoven, is developing the Resorbable Fibrillated Scaffold (RFS) – a novel regenerative stent designed to not only keep blood vessels open temporarily but also stimulate natural tissue restoration. This innovative technology offers the potential for safer, more effective, and more sustainable treatment of Peripheral Arterial Disease (PAD), reducing the risks for amputations  and lowering healthcare costs.

By moving into SBMC’s GMP-compliant cleanrooms on the High Tech Campus, STENTiT can produce larger clinical batches of its implants under strict quality-controlled conditions. This step is critical for upcoming pivotal trials and for securing regulatory approval in both Europe and the United States.

The project is co-funded by EFRO/OPZuid, with additional support from the Dutch national government and the Province of North Brabant. This combined investment recognizes the importance of strengthening the regional life sciences and health sector and accelerating promising biomedical innovations toward patients. By enabling first-of-its-kind collaborations between pioneering startups and specialized GMP production facilities, the funding strengthens the position of Southern Netherlands as a leading hub for biomaterials innovation and regenerative medicine.

Jan Rietsema, CEO of SBMC, explains: “Having STENTiT as our launching customer perfectly illustrates why SBMC was founded: to bridge the critical gap between breakthrough biomaterials research and clinical application. Our cleanroom facilities, combined with our quality management expertise, provide companies like STENTiT with the infrastructure they need to scale safely and efficiently.”

Bart Sanders, CEO of STENTiT, adds: “This collaboration saves us the time and costs of expanding our own cleanroom, while giving us immediate access to certified facilities. It enables us to quickly produce the larger batches required for following clinical trials. By accelerating this clinical pathway, we can stay focused on bringing our regenerative stents to patients.”

Starting with STENTiT, SBMC’s cleanrooms will be available to other biomedical startups and SMEs, providing scalable GMP production capacity in a service model that supports the entire ecosystem for medical innovation in the region.

European Union
OPZUID
Provincie Noord Brabant

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