First human tests for Stentit's solution against amputation risk

STENTiT has achieved a medical breakthrough with the first placement of its Resorbable Fibrillated Scaffold (RFS) in a patient with chronic limb-threatening ischemia (CLTI). This innovative, dissolvable stent not only provides immediate support to the vessels but also stimulates natural tissue regeneration. This allows the body to repair functional blood vessels on its own.

The VITAL-IT 1 study, taking place in Graz, Austria, will follow 10 patients over the next two years to evaluate the effectiveness of the RFS. CLTI, a serious cardiovascular condition, affects millions and leads to thousands of amputations every year. STENTiT, based at the High Tech Campus in Eindhoven and a former winner of a Gerard & Anton Award, aims to improve the standard of care for vascular problems with its regenerative technology, with an ambitious plan for future applications beyond CLTI.

Innovation in vascular care

Developing medical technologies that effectively address vascular conditions is crucial in the fight against amputations. STENTiT has positioned itself as a pioneer in the regenerative treatment space with its Resorbable Fibrillated Scaffold. This innovative solution not only provides temporary support for the artery wall but also promotes the body's own tissue repair, which is crucial for long-term healing and functional recovery. CLTI, a severe form of peripheral arterial disease, accounts for more than 250,000 amputations annually and affects an estimated 3.5 million people in Europe and the US.

The VITAL-IT 1 study, a groundbreaking clinical trial, aims to evaluate the efficacy and safety of the RFS. This non-randomized feasibility study, led by Prof. Dr. Marianne Brodmann, will include up to 10 patients suffering from chronic limb-threatening ischemia.

The first clinical data from the feasibility study should give a boost to the current €30 million Series A funding round. Positive study data could confirm the regenerative potential of the RFS. STENTiT has raised over €10 million in funding to date and is supported by NextGen Ventures, the Brabant Development Agency (BOM), Ten Cate Investment Company, and a group of informal investors. Additionally, €10 million in equity capital has already been secured for the Series A round from the European Innovation Council (EIC) Accelerator, a program of the European Investment Bank.

Regenerative properties

RFS is unique in its ability to stimulate arterial regeneration through the infiltration of the body's cells. During the process, the stent provides temporary support to the artery wall, after which it gradually dissolves, making way for newly formed tissue. This approach reduces the risk of complications and the need for reinterventions. The success of these techniques reinforces the vision of regenerative medicine to repair damage without the need for permanent implant material.