Periodic Reporting for period 1 - EX-STENT (THE NEXT STENT GENERATION: A FIRST-IN-CLASS REGENERATIVE NANOFIBER STENT TO RECONSTRUCT ARTERIES FROM THE INSIDE OUT)
Período documentado: 2023-09-01 hasta 2024-08-31
Below-the-knee critical limb ischemia (BTK-CLI) is a severe form of peripheral arterial disease (PAD), affecting around 3.5 million people in the EU and US. It causes chronic pain, non-healing wounds, and a high risk of amputation, significantly reducing patient quality of life and straining healthcare systems. The current standard of care is still balloon angioplasty (POBA), which often results in complications such as elastic recoil, requiring many reinterventions. Conventional stent designs can cause scar tissue formation and increase the risk of thrombosis and amputations. Therefore, there is an urgent need for a safer, more effective solution. Our innovative regenerative stent, made entirely from bioresorbable fibers, addresses this gap by promoting natural vascular healing, preventing elastic recoil, and avoiding long-term complications. This stent resorbs within 12 months and does not require drug elution, ensuring smooth blood flow and minimizing risks of thrombosis or scar tissue formation. This EIC Accelerator project will optimize the stent’s design, and conduct clinical trials to demonstrate its safety in humans. The project will also focus on developing stents for longer lesions. The ultimate goal is to deliver a clinically proven regenerative stent that reduces amputations, improves patient outcomes, and offers interventional radiologists a superior treatment option for BTK-CLI, paving the way for widespread clinical adoption and market approval.
During RP1 of the EX-STENT project, STENTiT finalized the stent design freeze. Production was scaled up to create clinical batches for testing and the first clinical trial. The Clinical Trial Application (CTA) was submitted to the ethical committee for approval, ensuring readiness for human testing. Simultaneously, R&D began on longer implants, expanding the stent's applicability to more complex arterial lesions. These steps move the project closer to delivering a breakthrough solution for BTK-CLI patients.
New patents have been filed, a trademark for RFS has been registered, insights on health economics have been mapped, and first steps in global reimbursement strategy have been taken, all in order to safeguard commercialization after CE-mark and FDA approval is obtained.