In this interview with Sanna Severins, COO of Hy2Care®, we explore:
- Her career journey: From chemical engineering to MedTech, following her passion for healthcare innovation.
- Hy2Care’s technology: A revolutionary hydrogel implant designed for cartilage repair, particularly in knee injuries.
- Current development phase: Ongoing clinical trials in the Netherlands and the company’s next steps in scaling up.
- Challenges ahead: Raising Series B financing, navigating regulatory hurdles, and developing a reimbursement strategy.
- Personal motivation: Sanna’s connection to rheumatology and her drive to make a meaningful impact in the treatment of osteoarthritis.
Sanna, you studied chemical engineering at Eindhoven University of Technology and then moved into marketing. What prompted that shift?
“When you start studying, your interests change. I always wanted to work in a chemical company, but I wanted to do the commercial side of it. At Eindhoven, we had the possibility to do a management certificate, which is now called entrepreneurship and management. So that’s what I did. I first went to Unilever, and they gave me the opportunity as a chemical engineer to move into consumer marketing. I liked it, but I missed the technical connection. So, then I went to DSM, where I had also graduated. I worked there for 15 years, first in pharma, and then in biomedical, where I fell completely in love with the MedTech industry.
You have worked for really large corporate multinationals before you started at Hy2Care®, a small startup. What made you think, “Okay, this is it”?
“Two things. One might sound very woolly, but I always believe that, as you can see in my career, I did what I believed in and where my heart was. I come from a family where rheumatology is a big topic—many people in my family have osteoarthritis. As a little girl, I wanted to be a rheumatologist. Hy2Care® is working closely with ReumaNederland (formerly the Dutch Rheumatism Foundation), which is one of our partners and supporters. So, for me, the circle is complete. I’m not a doctor, but I work in a company that is indirectly addressing osteoarthritis. It’s not curing the disease, but I believe our treatment, when applied early enough, can help prevent the huge wave of osteoarthritis patients we’re seeing, whether due to aging or inadequate treatment.
Can you tell us a bit more about the technology of Hy2Care®?
“It’s a hydrogel implant specifically designed for traumatic cartilage defects. So, for example, if you’re playing padel or football and hurt your knee, the knee swells up and doesn’t get better. You go to an orthopedic surgeon, and they detect a defect. Upon detection, they can insert our hydrogel implant. The implant looks like a two-component glue, and within 60 seconds, it forms a gel that sticks to the surrounding tissue. The structure is very open, like a sponge or membrane, allowing the person’s own cartilage cells to migrate into the implant and colonize the defect. Over time, the gel is bioresorbed, leaving behind healthy, functional cartilage in the joint. That’s how it works.”
And this technology can be applied to both knees and shoulders?
“We focus on the knee for now, as that is the biggest unmet need. The knee is where we felt a lot of impact during COVID, as elective treatments were postponed. Knee pain can seriously affect people’s lives, preventing them from exercising and leading to other health issues. So, we’ve prioritized the knee. Could we use this technology elsewhere? Yes, certainly; yet as we have to keep focus ourselves, we will explore developing other area’s with partners. Could we load the gel with medicines later on? Again, yes, we could, but for now, we are concentrating on the passive, cell-free implant.”
And at what stage of development are you currently?
“We’re in the clinical trial phase, and our ‘ACTIVE’ trial is running here in the Netherlands. The first human trial started with 10 patients, and now we have treated 45 patients with our gel. The 46th patient was scheduled for last week, but their defect was too large for our gel, which is designed for defects up to two square centimeters. Larger defects require cell-based therapies. We had already celebrated reaching 46 patients, so maybe we jinxed it Maybe we should run a lottery now. The first hospital that gets us the 46th patient wins a pie!*”
How many hospitals have joined the trial?
“Four hospitals are participating: Maastricht, Utrecht, Elisabeth-TweeSteden Hospital in Tilburg, and Martini Hospital, in cooperation with UMCG.”
“Traumatic cartilage damage in knees is a huge problem and a large market. How intense is the competition in this space?
“It’s a big market. The overall market for cartilage repair is about €4.5 billion, with our focus area being around €1 billion. The competition includes more established technologies like microfracturing, where small holes are drilled into the underlying bone to stimulate stem cell release. The drawback is that what grows back is scar tissue, which doesn’t have the same properties as cartilage and often leads to further treatment down the road. There are also cell-based therapies for larger defects, but they are very expensive—up to €40,000 per patient. Then, you have treatments like membranes or plugs, but these are very invasive and often require microfracturing as well. What sets us apart is that we insert a gel, which contains modified hyaluronic acid and dextran, creating an ‘edible house’ that the cells can build on without needing to break it down first.”
Reimbursement strategy is quite a big issue for start-ups. Do you have a strategy in place?
“Yes, we do. It’s very important to address reimbursement early on. Investors also ask about this, as it helps de-risk the investment. One of the biggest challenges is the so-called “valley of death,” where you have a CE mark, but you can’t sell because you don’t have reimbursement. In the Netherlands, we’re already talking to insurers and working with the Nederlandse Orthopaedische Vereniging (NOV) to get their advice. This will help us enter the market and start discussions with hospitals. We are also focusing on Germany, where there are some reimbursement codes available. And in the U.S., we’re conducting reimbursement studies to ensure that our clinical and commercialization strategy fits market entrance requirements.”
Apart from finding your 46th patient, what’s your biggest challenge in the coming period?
“We’re raising Series B financing, which is a challenge in the current climate, especially for MedTech and orthopedics, where you need long-term data. Another big challenge is obtaining the CE mark. The new MDR regulations lead to extended lead times to get to CE-mark.
You need the CE mark to sell in Europe, but the rules and regulations have changed, and there’s a backlog with the notified bodies. How are you dealing with that?
“Yes, that’s correct. We’re in a waiting period due to the backlog, but in the meantime, we’re preparing our data and working on amongst others securing second suppliers. This is where SBMC comes in, helping ensure we meet the necessary requirements for future expansion.”
*) Shortly after the publication of this article, the 46th patient was treated.
