Relatively new to High Tech Campus, STENTiT is a medtech startup aiming to revolutionize artery intervention. Born out of technology from Eindhoven University of Technology (TU/e) , the company found a natural home at High Tech Campus Eindhoven to grow its business and benefit from the Brainport community.

Bart Sanders is the CEO and Co-Founder of STENTiT. As an engineer at TU/e, he worked on a heart valve device that would eventually become one with the body. This project sparked his idea to use the same technology to develop regenerative endovascular implants, commonly known as stents. 

The company’s revolutionary stent is both absorbable and regenerative. The device has bioresorbable properties that trigger a natural healing response by the circulating blood cells and in time, the implant is replaced by new tissue that repairs the artery. The device is inserted with a catheter and provides temporary support to the artery as a stent, but in the long term, it actually restores the artery’s health in that spot.

“This regenerative component is something that the competition cannot do,” says Sanders. “Other stents initiate a scar tissue forming response that they temper by eluting drug from the device. The stent can be overgrown by scar tissue and this becomes worse and worse the longer the implant is in the body. Also, new problems can come up at that point in the artery again. We believe that if you can skew the initial immune response, you will have a favorable immune response – which is not scar tissue forming but healing tissue forming.”

It's all about the team

He was lucky enough to connect early on with leading stent expert, Professor Patrick Serruys, who saw potential in the technology. Professor Serruys joined the company to lend support as Medical Advisor and Chairman. Sanders was then able to bring business acumen to the team when Golo von Basum joined as COO, having already successfully introduced medical products to the U.S. market. STENTiT is now a small but effective team of ten, including quality and regulatory, system architect, R&D engineers, pre-clinical engineer and a business developer fully dedicated to get this device to the patient. 

The team received 1.8 million euros in seed funding last year, and with this early funding in place, the company is currently focused on further development of their product and clinical trials. 

“So far, we’ve proven our technology and regenerative nature of the device in pre-clinical trials. Next year, we’ll focus on moving towards first clinical trials to demonstrate the functionality of our stents in patients. This would be a very exciting and important milestone in our mission to improve patient lives. 

Clinical trials and where STENTiT enters the market

While stents are very often used to treat coronary disease, it is not the only application. In fact, stents are used all over the body, including in the legs and arms and in the brain for the treatment of aneurysms.

STENTiT will not target the cardiac market initially. Rather, its first approach will be to introduce the regenerative stent for the treatment of critical limb ischemia where the blood flow to the foot is severely compromised. Current treatment options are ineffective, and in 40% of these patients, amputation is the end result within six months.

“We're now focusing on peripheral indications below the knee. In the U.S. and EU, 250,000 amputations are being performed every single year. Here, physicians are screaming for better solutions to treat their patients. So far, only a 40-year old technology is being used called balloon angioplasty, in which a balloon is temporarily opening up the obstruction in the artery. However, this therapy is very ineffective. Within three months, 75% of the patients are already in need of a reintervention.”

But first comes the approval process, and for that, the U.S. these days is a more favorable environment for many medical device startups.

“The regulatory pathway is more predictable in the U.S. than in the EU at the moment,” Sanders said. Because of the implementation of the new European Medical Device Regulations, competent authorities are overloaded to recertify already existing products. This makes it difficult for startups to enter their queues with their new products to obtain certification. Let’s hope Europe will be able to fix this huge issue for their own benefit, to keep new innovations available for their patients.”

Sanders has experienced firsthand the difficulties of introducing a medtech device in the crowded stent industry. However, these industry dynamics and the large potential for STENTiT’s device go hand-in-hand.

“The stent business is a competitive domain,” he said. New generations of stents can really be disruptive and take over the older generations of stents to disrupt the status quo.

“Once you have something revolutionary in this domain, it can be super interesting,” Sanders said. “We hope to be the latest wave in this technology. We have all the proper ingredients in place to break that open and to become the new standard in endovascular treatment."