Podcast Transcript

David Brühlmann [00:00:31]:
What happens when a scientific insight into how the body heals becomes a device you can actually implant in a patient? Today we’re taking a slightly different turn from our usual bioprocessing focus and stepping into MedTech.

My guest is Eva-Maria Balet, Co-Founder and CEO of Regenosca, who left the research benches of EPFL to tackle soft tissue repair. We’ll trace her journey from pure science to building a company.

Let’s dive in. Eva, welcome to the Smart Biotech Scientist. It’s good to have you on today.

Eva-Maria Balet [00:02:22]:
Thank you for inviting me. I’m looking forward to our conversation.

David Brühlmann [00:02:26]:
Let’s start with perhaps a bit of a controversial question. Eva, share something that you believe about translating life science research into real products that most people disagree with.

Eva-Maria Balet [00:02:38]:
I think one belief I hold, maybe a little controversially, is that starting with an exciting scientific discovery is not often the best model for creating real-world impact in life science.

There are typically two approaches. Either you discover something in the lab and then look for an application, or you start with a clear clinical need and design your research around solving it. I strongly prefer the second approach.

For me, being patient-centric is key. When you begin with a real unmet need, it gives your work direction and purpose, and it keeps you focused on meaningful outcomes rather than just elegant science. It also really helps when things don’t go as planned, which is often the case, because you stay motivated by the potential impact on patients.

At Regenosca, that’s exactly how we work. From the very beginning, we built interdisciplinary teams that included clinicians, so patient needs were embedded in the research from day one.

In my experience, that mindset makes all the difference in translating science into something that truly matters.

David Brühlmann [00:03:36]:
Tell us your story, Eva. How did you first start in science? What drew you into it, and then led you to EPFL and eventually to Regenosca? What were some interesting pit stops along the way?

Eva-Maria Balet [00:03:51]:
I have always been fascinated by life sciences, which is why I chose biotechnology. What really intrigued me was the idea that you can use cells or microorganisms as tiny factories and essentially program them to produce something valuable. That combination of biology and engineering really captured my curiosity early on.

Then, during my PhD at EPFL, I applied this mindset to tissue repair, working on scaffolds—temporary structures that support the body in regenerating tissue. What fascinated me most was that sometimes, by providing just the right support, you can significantly enhance the body’s own healing capacity.

David Brühlmann [00:04:26]:
That’s funny. When you’re saying that, I think we have a similar start to our careers. I studied at EPFL as well, and I was sitting in this biotechnology class when the professor told us that we could produce monoclonal antibodies in CHO cells. That also caught my attention. I thought, “Wow, this is amazing.“

Eva-Maria Balet [00:04:45]:
For me, it was the same. It was just fascinating.

David Brühlmann [00:04:50]:
What was the thing that eventually pushed you, shall I say, over the line from academic research into starting your own company? That’s quite a different ball game, isn’t it?

Eva-Maria Balet [00:05:00]:
When I was at EPFL doing my PhD and postdoc, I was always drawn to applied science where there’s a clear path toward clinical use. What ultimately pulled me from academia into entrepreneurship was the desire to see our work actually reach patients. The strong feedback from clinicians, along with the motivation of my co-founders, really reinforced that decision.

Today, I think I still benefit greatly from my scientific background, but I have learned to translate it into a broader context. Science taught me how to learn, how to deal with uncertainty, and how to iterate toward solutions. Those skills are actually incredibly valuable when you’re building a company.

David Brühlmann [00:05:38]:
Let’s start out simple. To understand what is the problem you’re solving with your company: you’re in the soft tissue repair space. What exactly is the problem you’re solving?

Eva-Maria Balet [00:05:51]:
Soft tissue repair is needed in many situations: after trauma, after the removal of diseased tissue such as cancer, or simply when tissue weakens over time and loses its ability to provide mechanical support. Today, surgeons have several options, but none of them is truly ideal.

On one side, there are synthetic meshes, such as those used, for example, in hernia repair or stress urinary incontinence treatment. These meshes provide excellent mechanical support. They are highly standardized and readily available. The downside, however, is that they remain permanently in the body, which can trigger inflammatory reactions or complications such as erosion.

On the other side, there are biological materials derived from human or animal tissue. These are generally more biocompatible, but they often come with challenges in terms of standardization, scalability, and consistent performance because they depend on donor tissue.

If no suitable product is available, surgeons often have to harvest tissue from the patient themselves, for example from the inner thigh. That means creating a second surgical site, with additional pain, risk of complications, and only a limited supply of tissue. So despite the many available tools, surgeons are still working with compromises. That’s exactly where innovation is needed.

David Brühlmann [00:07:02]:
And what kind of innovation did you develop? What kind of tissue are you now developing?

Eva-Maria Balet [00:07:09]:
The implant we’re developing is called TissueSpan. At the heart of TissueSpan, there’s a very simple idea. Instead of replacing tissue, we support the body in healing itself.

TissueSpan is a fully engineered collagen implant produced through a proprietary process that allows us to create a mechanically stable structure while preserving the natural bioactivity of collagen. That combination is really key. For the surgeon, it’s very straightforward: an off-the-shelf, ready-to-use implant for soft tissue repair.

Once implanted, the biology takes over. Cells from the surrounding tissue migrate into the scaffold, new tissue forms, and over time the implant is completely absorbed and replaced by the patient’s own tissue. In the end, there’s no permanent foreign material left inside the body.

What makes TissueSpan fundamentally different is that it combines the strengths of current solutions without their limitations. It’s standardized and scalable like a synthetic mesh, but it integrates naturally like a biological material, without relying on donor tissue or requiring a second surgical site.

David Brühlmann [00:08:12]:
How long does this process take? You implant this collagen-based scaffold, then cells eventually populate it, and finally it’s degraded. Are we talking about a few days, several months, or how does that work?

Eva-Maria Balet [00:08:28]:
We’re talking about months. Once TissueSpan is implanted, cell migration and cell infiltration start immediately. It then takes approximately three to four months for the implant to be completely absorbed. So there’s a balance between cell ingrowth, new tissue formation, and gradual implant resorption.

David Brühlmann [00:08:45]:
What are the underlying mechanisms that cause cells to migrate into it once it’s implanted? Is that driven by biology, or something else? How does that work?

Eva-Maria Balet [00:08:56]:
Imagine you have a wound, an injury, and the body has this excellent capacity to heal itself. But when the gap is too large, the body just doesn’t manage. What we do with the implant is provide a temporary bridge so the cells can migrate across the support and do what they naturally know how to do: regenerate tissue. It’s very important that TissueSpan is really just a structural support that enables cells to cross a gap that is too large for them to bridge by themselves.

David Brühlmann [00:09:26]:
Oh, that’s brilliant. That’s highly fascinating. So the biological process itself works. It’s just that the gap is too large. If I translate that into very simple terms.

Eva-Maria Balet [00:09:36]:
Yes, that’s exactly how I would describe it.

David Brühlmann [00:09:39]:
Excellent. And how do you produce these collagen-based implants?

Eva-Maria Balet [00:09:46]:
So you’d like to know a little more about manufacturing?

David Brühlmann [00:09:49]:
Yes.

Eva-Maria Balet [00:09:50]:
Manufacturing is actually a very sensitive topic for us, so I’ll stay at a high level. TissueSpan is based on a proprietary molding technology. We start with collagen as the raw material, process it through our molding technology, and at the end we obtain a mechanically stable implant that is sterile and ready for clinical use.

David Brühlmann [00:10:15]:
Translating this scientific discovery into a real medical device, as we all know, is quite a challenge. What were the biggest hurdles? Whether technical, scientific, practical, or perhaps more entrepreneurial—what were some of the challenges you faced?

Eva-Maria Balet [00:10:34]:
Bringing a scientific concept from the lab to something that can safely be used in patients is indeed a major step, and it requires a complete shift in mindset.

In research, the focus is on proving a concept. But for clinical use, everything needs to be reproducible, controlled, and aligned with strict regulatory requirements. One of our biggest challenges was translating our laboratory process into a robust and scalable manufacturing process.

That meant moving into a GMP environment and implementing full control over every step, from raw materials to in-process controls and final product testing, ensuring full traceability and consistent quality. It also required a highly interdisciplinary effort. We had to combine expertise from scientists, engineers, quality specialists, and regulatory experts to meet clinical and regulatory expectations.

Another key challenge was preserving the unique properties of our material while adapting the manufacturing process to industrial standards, because what works in the lab must work reliably every single time you produce it for a patient. In the end, innovation in MedTech is not just about the science—it’s about making that science reliable, scalable, and safe for every patient.

David Brühlmann [00:11:42]:
I’m curious. Your product is regulated as a medical device, so I imagine the regulatory requirements are much stricter than, for instance, those for a biologic drug. Or are they comparable?

Eva-Maria Balet [00:11:59]:
They’re really two different worlds. You have medical devices and you have drugs, and each has its own regulatory framework and standards. One thing I actually appreciate about the regulatory landscape is that it provides a structured framework with clear definitions and guidelines that help you classify your product.

At a high level, a medical device is defined by having a primary mode of action that is physical or mechanical, whereas drugs and biologics act primarily through pharmacological, immunological, or metabolic mechanisms. In our case, the primary function of TissueSpan is structural, which clearly places us in the medical device category.

I think it’s a useful exercise for every founder to work through this classification themselves because it forces you to understand your product in depth. But it’s equally important to validate your interpretation early with experts, whether they’re regulatory specialists, notified bodies, or authorities such as Swissmedic.

We’re very fortunate because one of our co-founders brings extensive regulatory expertise and leads this area. He has deep knowledge of the field and is also supported by a broader network when needed. That has been extremely valuable in navigating the regulatory pathway efficiently.

David Brühlmann [00:13:07]:
This is quite a challenging undertaking, especially in a startup environment where you don’t always have all the expertise at hand. So I’d be curious, Eva, what would you tell a founder who’s listening and is also trying to figure out how to navigate the regulatory landscape? What advice would you give them? What worked well for you during this process?

Eva-Maria Balet [00:13:31]:
I think what worked extremely well for us was having regulatory expertise in-house because one of my co-founders is a regulatory consultant. He’s used to navigating guidelines and standards, and he also has a broad overview of the applicable regulations and standards. That allows him to help us identify the best and most efficient regulatory pathway.

But I think if you don’t have that expertise in-house, there are many excellent regulatory consultants with deep experience. In that case, it’s very important to find a regulatory consultant you trust, bring them along on the journey early, and build a strong relationship so they can support you as effectively as possible.

David Brühlmann [00:14:08]:
Yeah, that’s definitely important. A leadership principle I love to follow is “Who, Not How,” which means it’s much better to have the right people—the right “who”—on your team or, as you said, working with you as consultants, than trying to figure out all the complicated things yourself. Especially on the regulatory side, it’s a very complex world if you don’t have the expertise, and mistakes can be very costly.

Eva-Maria Balet [00:14:36]:
I completely agree. No founding team can cover everything. That’s why it’s so important to build a broader ecosystem around you, whether that’s advisors, early team members, or board members who complement your skills and bring additional expertise. For us, the team composition was both intentional and organic.

Before founding Regenosca, I had already been working closely with my co-founders in the lab. So there was a strong foundation of trust, mutual understanding, and confidence in one another. What really united us was our shared belief in the technology and our deep collective understanding of it. At the same time, we brought different perspectives: clinical, regulatory, scientific, and entrepreneurial. I think that interdisciplinarity is one of our core strengths.

David Brühlmann [00:15:21]:
The leap from the lab bench to a device inside a patient is rarely a straight line. It’s built on inflection points, hard technical problems, and a clear view of what’s failing patients today. Eva-Maria’s perspective on that journey is one you’ll want to carry into Part Two. If this episode added value, please leave a review on Apple Podcasts or your favorite podcast platform. Thank you for tuning in, and I’ll see you in Part Two.