Imagine a tiny, dissolvable scaffold placed inside a clogged leg artery to keep it open. Instead of staying there forever like a metal tube, this one slowly disappears over a year as the body repairs the artery itself. It's like a temporary support beam that vanishes once the building is strong enough to stand on its own.
Current treatments for below-the-knee critical limb ischemia have high failure rates, with 73% of cases seeing artery re-blockage within 3 months and 25% of patients facing amputation.
A bioresorbable nanofiber stent that dissolves within 12 months. The project delivered a frozen design and clinical-grade production batches.
If you are a medical device provider dealing with the 73% restenosis rate of current treatments — this project developed a regenerative nanofiber stent that dissolves within 12 months to prevent long-term complications.
If you are a clinic dealing with the 25% of BTK-CLI patients who end up requiring amputations — this project developed a bioresorbable stent that promotes natural healing to reduce limb loss.
If you are a biotech firm dealing with the limitations of drug-eluting stents — this project developed a first-in-class nanofiber structure that reconstructs arteries from the inside out without needing drugs.
Based on available project data, specific pricing is not listed, but the company has mapped health economics and started a global reimbursement strategy to ensure commercial viability.
Yes, the project has already scaled up production to create clinical batches for testing and the first clinical trial.
The project has filed new patents and registered a trademark for RFS to protect the technology before CE-mark and FDA approval.
The Clinical Trial Application (CTA) has been submitted to the ethical committee, and the goal is to obtain CE-mark and FDA approval.
The project runs until 2025-11-30, focusing on clinical trials and design optimization for longer lesions before market launch.
The project is led by a single SME, STENTiT BV from the Netherlands, which holds 100% of the industry ratio. This lean structure suggests a highly focused commercial drive, as the company is managing everything from R&D and patent filing to clinical trial applications and reimbursement strategies internally.
Contact STENTiT BV in the Netherlands
Contact us to explore licensing opportunities for bioresorbable nanofiber technologies.
