Bart Sanders, ceo STENTiT
STENTiT, one of the initial members of SBMC, develops a treatment of patients suffering from critical limb ischemia that had the potential to precent thousands of amputations worldwide. With CEO, and co-founder Bart Sanders, we delved into the latest news regarding the development of regenerative stents and the establishment of a thriving enterprise.
Most people associate stents with cardiovascular applications, particularly around the heart. But you’ve focused on peripheral artery disease. Why?
“It’s an interesting story. We discovered a technology at the University of Eindhoven, where tubes made from fibers could be implanted inside the artery to act as a stent, providing instant support to the vascular wall, while enabling the potential to reconstruct the artery from the inside-out. Question than comes, where do you start to proof the technology as a start-up in this huge space? All over the body stents are being placed. Most people think about the heart, but this market is quite saturated. And although we could still provide a lot of benefit to the patient in this space, clinical trials take very long to proof the benefit to current stent alternatives. Therefor our first target market is in the peripheral space below-the-knee. Here, the clinical need is much higher as too many people still loose their limbs today due to a lack of effective treatment options. This makes it that besides the big impact we can have for these patients, also timelines for clinical trials are shorter which ultimately would lead to faster market access.
Specifically, we’re talking about legs, correct?
“Yes. People that suffer from a progressive form of peripheral artery disease have an occlusion in their arteries in the (lower) leg. These obstructions make it difficult for blood to enter the foot. As these patients walk, or exercise, oxygen depletion to the muscles is creating a lot of pain for which they need to pause and take a rest to get rid of the pain. In Dutch it’s called “Etalagebenen” as while strolling through the shopping mall, they literally need to pause to ease the pain while taking a look at the shopping windows. If left untreated, the vascular occlusion progresses making it even more difficult for nutrients to reach the foot. This may result into open wounds or even ultimately into an amputation. Because of a lack of effective treatment options, still 250.000 amputations are being performed every single year.
Are there currently no stents available for peripheral artery disease?
Techniques to advance guidewires, balloons and stents through a small incision all started decades ago in the space of the heart and underwent major evolutions of further sophistication over time. Now, we see that these techniques also start to become available in the peripheral space below-the-knee. As the field is emerging, still no stent is available in this space in the US today.
So, your vision is for all stents in the body to be regenerative. Is that correct?
“Absolutely, that’s our ultimate goal. We believe regenerative stents offer the best solution for various indications.”
How it works
STENTIT develops a stent that is placed in vessels that have an occlusion. Physicians typically advance conventional guide wires, over which a balloon delivery system is introduced. On top of the balloon a stent is mounted. What sets STENTiT’s stent apart is that it is entirely composed of bioresorbable nanofibers. It acts as an endovascular band-aid, capable of not only opening the artery to instantly restore blood flow but also reconstructing the artery from the inside out.
How do you decide which indication to pursue next? Is it driven by potential profits, patient impact, or a desire to sell the company?
“It’s a complex decision that takes multiple factors into account. Firstly, we need to ensure that physicians genuinely want our product for a specific indication, as there must be a demand in the market. Then, we assess the market size and patient population to determine the potential to address clinical needs. Additionally, we consider the readiness of our technology for that particular indication. Some require extensive research and development, while others need less. It’s a balancing act to find the right indication.”
You mentioned facing challenges early on when people didn’t believe in your vision. How did you find the motivation to overcome these challenges?
“My passion for what I do fuels me. I genuinely love the work I do. Growing an entire company starting off from an initial idea that could save patient lives and then to see it grow, gives me a tremendous amount of energy. Despite facing skepticism and numerous rejections, my belief in the potential benefits for patients keeps me going. For me it’s all about making that difference.”
Looking ahead, what do you anticipate as your biggest challenge in the next year?
“Our most significant challenge in the coming year is the transition to use our device in the first human patients. This is an exciting yet daunting step, as the translation of our technology to a human patient has never been tested before. It’s a pivotal and exciting moment for us.”
Managing the parallel processes of R&D and preparing for clinical trials can be challenging. How do you navigate this?
As a first-time technical founder, you need to find people around you with complementary competencies. In my case I needed people that could support us turning prototypes into products. People how knew how to set-up a quality management system, supply chains, handling regulatory and clinical topics and so on. I am very fortunate to have found these great people joining the team and to see how the entire company went through a great transformation because of them.
Congratulations on securing €12.5 million from the European Innovation Council. Was the application process strenuous, and do you have any insights to share?
EIC Accelerator is a great financial instrument in Europe to support promising high-impact companies with the necessary funding to de-risking the proposition and speed-up time to market. As the instrument also comprises a EUR 2.5 million non-dilutive grant component, many start-ups all over Europe apply. This makes it very competitive where success rates are around just 3-5%. You need to have a crystal-clear story and strategy how your solution is solving a huge unmet need, where the EIC would be a game-changer to make it into a success. Also, it helps to seek for external support in the writing phase, as these applications also come with a lot of rules and paper work.
Could you shed some light on the accelerator process, considering that others may not be familiar with it? Any tips or lessons learned from the application to management?
“Certainly. The accelerator process typically comprises three phases. Initially, you submit a pitch, which includes a video and a brief application to assess your eligibility. Following that, you complete a more extensive application that involves crafting a comprehensive business plan, detailing both the technology and the business potential. Many companies either make it past this stage or they don’t. If you progress, you’ll have to pitch to the decision-makers. The focus during the pitch is predominantly on the business aspect, how you plan to generate revenue. The process is rigorous, and they test your business acumen.”
Did you enjoy the pitching process?
I did, but they really put you to the test. If you reach this stage, different people already evaluated the impact, unmet need and technological potential. Now they want to make sure that the money will be spent well, and that management has a clear and solid plan in place to make it into a success.
You were one of the initial members of the consortium and have also embarked on a collaboration with Corbion and Vivolta. How has that been going?
“I’m delighted with the collaboration. Our three parties, each with unique expertise, work closely together in a complementary fashion. I appreciate that SBMC played a significant role in fostering this collaboration. It’s fantastic to witness this happening in our region, where we all learn together and reap the benefits of our joint efforts. The project is progressing smoothly, and we are happy that SBMC could foster this collaboration.”
Is there any advice you’d like to offer SBMC based on your experiences in the consortium?
“What SBMC has done remarkably well to promote collaboration and built solid long-term relations among companies in the region. They’ve provided the funding and facilities needed to facilitate these collaborations. This has been instrumental in promoting progress and synergy within the region.”
