In this interview, Sandro Matter, the company's co-founder and CEO, explains how TisMet™ offers a unique advantage over traditional materials like titanium or PEEK. He discusses the material's development, regulatory challenges, and applications in sports and trauma medicine, along with wider trends in biomaterials.

Supertrends: Welcome to the Supertrends interviews. Today my guest is Sandro Matter. Sandro has a PhD in materials science from ETH, and he is a co-founder and currently the CEO of a biomedical startup, Kairos Medical. Hello, Sandro.

Sandro Matter: Hello.

Supertrends: So, maybe let's start by you explaining what exactly you do at Kairos Medical.

SM: At Kairos, we are developing and commercializing a new material for orthopedic and surgical use.

Supertrends: And your flagship product is this TisMet™. Could you explain what this product actually is?

SM: TisMet™ is the brand name for our material. From this material, we are developing several applications and product solutions that will be commercialized under Kairos Medical or other brands. We work with magnesium alloys, and since there are many different types, we wanted a brand name that represents our very special alloy. TisMet™ (short for Tissue-Metal) is our chosen brand name because it reflects the specialized nature of the material.

Supertrends: And what makes your magnesium-based material different from other materials available on the market?

SM: Surgical procedures and medical applications that involve implants rely on the specific characteristics of materials. Every new material introduced into this space has enabled surgeons to develop new procedures or treatment concepts. We believe magnesium is a material that can open new doors for further developing current treatment protocols in the clinic. Every material has its own unique characteristics. For example, a wooden table and a metal table look different because their mechanical properties are distinct. This difference allows you to do things with wood or metal that you couldn’t do with the other material. That’s exactly what we’re doing today.

Supertrends: And as I can imagine, not every material can be used as a biomaterial for surgery. So what are the basic characteristics a material must have to be considered a biomaterial?

SM: Most biomaterials we know were discovered by accident and later improved for their medical purposes. For example, polymethyl methacrylate is a polymer whose components could be carcinogenic and generate high temperatures during setting. However, this material has been used to cement hip stems into human bones, providing great surgical performance over the past few decades. The same happened with stainless steel and later titanium. The first implants made from steel corroded in the human body, and it was a Swiss company, Institut Straumann, that helped develop stainless surgical steel 316L using their expertise from watch material development. Similarly, titanium’s use as an implant material has a Swiss legacy, with groundbreaking research by Prof. Steinemann and Perren at the AO Research Institute in Davos in the late 70s and 80s. Sometimes, it’s a matter of timing and the availability of materials.

It’s only in the past 20 years that we’ve started designing and engineering materials specifically for surgical use. Magnesium, in particular, is a physiologic element, and it’s known for its health benefits. People take magnesium supplements for well-being. On average, every adult has about 30 grams of magnesium in their body. Magnesium is a well-known physiological element, but it’s also a metal. I know this sounds a little strange, since the bones— which contain about 60% of the body’s magnesium— are not metal. And yet, this is how it works. Welcome to materials science.

The idea behind using magnesium is that it can replace materials like titanium. Titanium is a fantastic material for surgical implants; it’s strong and provides excellent outcomes. Surgeons like it a lot. But once titanium is placed in the bone, it does not degrade and remains there forever unless it is surgically removed. The material we've developed combines the strength of a metal with the advantage of biodegradation, so there’s no need for a second operation to remove it.

Supertrends: Okay, so essentially, once it’s in the body, it will degrade over time, and there will be no trace left behind. So, one of the biggest benefits for the patient is that they don’t need an extra surgery to remove it.

SM: Yes, exactly. That’s one of the biggest benefits. As people get older, if you have a surgical intervention with an implant in your 50s or 60s, the chance of needing another treatment in your 70s or later is very high. So, if you already have titanium in your bones and later need an artificial joint, for example, you’ll have to deal with the titanium remnants, which could complicate things. Our material eliminates that issue, allowing for greater flexibility in future treatments.

We also treat many hand and foot surgeries. In these cases, implants that were not explanted might cause problems due to mobility limitations, lack of space in shoes, and sometimes pain. The expectations for treatment outcomes are rising with patients.

Take a knee prosthesis, for example. Twenty or more years ago, patients thought that getting a knee replacement at 60 meant the end of activities like skiing or biking. Today, it’s not even a question—treatment modalities have improved so much. Patients have higher expectations today, and clinical treatments are improving as we treat a growing aging population.

Supertrends: We’ve already touched on the applications, but could you summarize three main applications you see for this product?

SM: We are pursuing applications in sports medicine, particularly for anchors and other types of fixation, where an implant is designed to degrade and disappear once the tissue has healed. We have also envisioned trauma applications—particularly in foot and ankle indications, but also for hand surgeries, where small fragments or smaller screws are used. For example, in the hand, or even in the head region, one would like to avoid a second incision and explantation. Finally, we are exploring applications in soft tissue treatment and other areas, such as biliary stents.

There are many potential meaningful applications for TisMet®. That’s actually one of our challenges—selecting the right applications. With so many ideas for what we can do with this material, the key to success is focus.

Supertrends: It’s a good problem to have, I guess! It’s always better to have too many ideas than not enough.

SM: Exactly. We believe in our vision, this is essential.

Supertrends: How does the medical community view this product? Is it already available on the market? Are people using it in clinical settings yet?

SM: We founded the company in 2022 and are still in the preclinical phase, having built up industrial production and become a medical device manufacturer under ISO 13485 accreditation. Our first-to-market product received FDA Breakthrough Designation last year, and we expect to receive market approval in the near future.

Supertrends: Nice. And what are the biggest challenges you face when introducing such a product to the biomedical market?

SM: Since this is a new class of material, we’re essentially starting from scratch. Traditional medical device companies rely on commercially available materials and then design their particular products. We start much earlier in the process. We manufacture our material ourselves using our own custom technology, followed by the complete manufacturing process we have developed—material and process innovation across the entire value chain of an implant.

On the other hand, alongside the hard work, it has been a pleasure to develop this material because the feedback from the clinicians testing our prototypes has been very rewarding, reinforcing our vision to provide a solution with differentiating clinical value.

Supertrends: So scaling up the process was quite challenging because it’s so important for biomaterials to maintain consistent quality.

SM: Yes, exactly. As a small company, we faced many challenges, but we have excellent partners, collaborators, and, in particular, investors who share our vision and have supported us through every step. Developing not only a new material but also scaling up its production, creating new devices from this material, and then manufacturing them industrially is quite a challenge.

Supertrends: From a regulatory standpoint, is it difficult to get approval for a new biomaterial?

SM: There are both technical and political aspects to consider. Technically— or rather scientifically— it’s fine, but one needs to generate a lot of in vivo and in vitro data, which takes time. The political part is harder to control. The EU has introduced new legislation, and during a five-year transition period, only 15% of existing products received a new CE mark under the MDR. You can imagine how this affects new innovations. In contrast, in the US, we received Breakthrough Designation, allowing for greater FDA support to bring such innovations to patient treatment more quickly. No surprise that 99% of startups and new products seek first-market access in the US rather than the EU, which risks becoming a 'desert' for new technologies over time if major changes don’t occur. Meanwhile, the US represents 50-60% of the global orthopedic market today.

Back to your question: In the US, new technology is welcomed, while in Europe, one faces an exhaustive and expensive regulatory pathway, which disadvantages small and mid-sized medical device companies.

Supertrends: That sounds really frustrating. It's sad that there are medical solutions that people need, but they’re held up by these regulatory hurdles.

SM: These are regulations that were introduced by the scandal after using low-cost oil in silicone breast implants in France. However, in my view, it’s a mentality thing. In Europe, it is believed that having a super tedious legislation helps to prevent fraud, which is highly questionable, in my opinion. As a result, we observe that way over 90% of new devices or technologies seeking approval are going to the US first, not with Europe anymore. In the past, the situation was reversed, leading to the creation of many medical device companies in Europe, and to my knowledge, European patients did not face high risks as a result. We joke sometimes, asking why beds have never been banned, since most people die in bed. But who knows—such a law might already be underway.

Supertrends: Is it easier when, for example, the product is already approved in the States? Does it then make it easier in Europe if they see that the product was already approved there, or does it make no difference?

SM: It’s easier from the perspective that you’ve already gathered clinical data, in addition to the fact that, business-wise, the US market is much more interesting and important for survival than any market in Europe. This data will help you in the approval process in Europe, because in Europe, everything requires clinical data. Even a product that has been on the market for years without any conflicting vigilance data needs to present clinical data under the new legislation. So, the typical approach most companies take today is to go to the US first, and then bring the clinical data back to Europe for those markets where they believe they can also expect appropriate reimbursement, which is another important issue. That’s the next part of the geographical challenge.

Supertrends: Okay, let’s move on to another topic: sustainability. I’ve read a bit about your product, and I understand it could contribute to sustainability because you don’t use rare-earth materials. Is that correct? Could you elaborate on how your product could support sustainability in your sector?

SM: Well, we never thought of sustainability as a major driver for our project. However, we are not using rare-earth elements because we believe they are not needed from a biomechanical or chemical perspective. The fewer components, the better.

Additionally, we don’t know exactly what happens with rare-earth elements after the material has degraded. Do these elements leave the body or not? There is some contradictory information on this, so we thought it would be better to avoid them if possible.

The initial idea from the surgeons was to develop an implant material for children, because with growing children, you often need to remove implants that don’t degrade as their bones continue growing. A fixed implant could inhibit bone growth. So, the first idea was to develop treatments for children.

When we started focusing on children, we also thought—if we can avoid rare-earth elements in the material, that would be great. After all, children have a lifespan of another 70 or 80 years, and we don’t want to introduce any risks related to elements we don’t fully understand. That was one of the main drivers for the project years ago when material scientists began developing TisMet®.

Supertrends: Okay, so the original idea was to help children avoid the stress and risks of additional surgeries. I never really thought about how challenging it could be to deal with implants in growing children.

SM: Indeed. We started with children in mind, and then we realized that this could also be beneficial for adults. Sometimes, innovation takes unexpected turns. But from a sustainability point of view, it certainly makes things easier for us. We’re not dependent on raw material sources that are questionable, which simplifies both the manufacturing process and our ability to control product quality.

Supertrends: What are the long-term goals for Karios Medical? Where do you see the company in five or ten years?

SM: The plan is to build a proper medical device company focused on this material, as we have gained extensive expertise in manufacturing and producing it. We want to establish a real center of competence for this type of material and the products made from it. Our goal is to find partners with whom we can commercialize and establish TisMet® products in the clinical space.

Supertrends: That sounds like a plan. If we could now take a broader view, as you are an expert in biomaterials and material science, are there any emerging trends in biomaterials that you find especially interesting or exciting?

SM: Yes, I can speak about the medical space, as that’s what I’ve focused on for the past 30 years. Looking a little bit at the past and then moving forward, there are three key streams of development that I would highlight. One trend has certainly been the whole regulation process and simplifying portfolios, although we know that bureaucracy tends to grow over time — that seems to be a law of life.

But when we talk about the things that are clinically needed, the first big trend is certainly digitalization. This includes things like patient data management, individualized treatment plans, and personalized medical products. It means you have digitization, followed by calculations or simulations, and then tailored treatment. One specific area that’s being debated right now is navigation in surgery. The big question is: Does navigation make treatments safer or cheaper over time? That’s a major ongoing debate. Even though we started talking about navigation over 20 years ago, the personalization of medicine — even in the pharmaceutical space — hasn’t been fully realized. While there’s been some progress, much of it is still in the R&D phase.

Trend number three is related to tissue replacement, which we’re still not great at. For example, in the U.S., the use of tissue bank products — where human bone and other tissues are processed — is still very common in clinics. When it comes to biomaterials, biological regeneration is something we’ll see coming back in the future. With our own material, and also through competitor activities, we do observe a certain 'comeback' effect.

In terms of newer materials enabling new treatments, that’s definitely happening. But it’s also quite a challenge. For example, polylactic acid, which has been used for bone regeneration over the past 20 years, has essentially fallen short of the expectations we had 25 years ago when this material platform first entered the field. However, these materials are still being used because they are commercially available; you can buy them from chemical suppliers by the kilogram. But materials like ours, for instance, you cannot buy. The investments needed to manufacture this type of material at scale are a critical factor at the beginning. That’s why orthopedic companies are reluctant to take on that risk. But overall, we’re seeing a return to biological materials and regeneration, and that’s definitely a trend.

Supertrends: There’s a lot of discussion around bioprinting these days. For bioprinting of human tissue, a scaffold is required, among other things. And this is where biomaterials come into play, right? To support this process?

SM: Absolutely. But if you look at the underlying materials used for these scaffolds, the range of materials is still fairly limited, I would say. You have different forms and shapes, like fibers, meshes, gels, and hydrogels — lots of different types of materials. But when it comes to the underlying material, it’s still quite basic. You can imagine doing different types of things in this area. Biological functionalization is still an issue. So, it’s shifting a bit from pure mechanics to bioengineering.

On the other hand, there’s also the cost issue, right? No one wants to pay three times more for a product. Human tissue bank-based products, for example, already have a certain price, and people are hesitant to pay much more unless the new product is significantly better clinically. And that has always been the hard proof at the end.

Supertrends: Thank you for those insights into the trends. Is there anything else you’d like to add at the end of our discussion - something we didn’t touch on, or something you think is important and worth mentioning?

SM: It’s interesting to look at the role Switzerland has played in this space. Switzerland is home to the AO ASIF Foundation, the largest surgical association worldwide, still today. Most people aren’t aware of this. However, within this research community, Switzerland and its technology companies have been crucial. They helped pioneer stainless steel for medical use, and then later introduced titanium in the late '70s. And now we’re bringing in a new material like TisMet™, which feels like a natural continuation of this legacy.

If you think about how many years have passed in between, it demonstrates that innovation and its implementation into patient treatment routines can take quite a long time.

Supertrends: Yes. Thank you, Sandro, for all the insights. It was really interesting talking to you.

SM: Thank you.

The interview, conducted on 4 November 2024, was part of Supertrends' “Interviews with Experts” series. Please note that the transcript may have been lightly edited for editorial reasons.