Regenerate or restore? Rethinking cartilage repair
Dr. Alex Roth, founder and CSO of Avalanche Medical
“We are targeting patients who are more suitable for a restorative procedure than a regenerative one.”
For patients with cartilage damage in the knee, treatment options are not always straightforward. Especially for middle-aged patients, there is a gap: regenerative treatments may no longer provide a durable solution, while a total knee replacement comes too early.
Dr. Alex Roth, founder and CSO of Avalanche Medical, wants to fill that gap. The company is developing a synthetic cartilage implant for focal cartilage defects in the knee, specifically aimed at patients with declining regenerative capacity.
During the Great Small Talk Show on bone and cartilage regeneration, we spoke with him about restorative medicine, the road from research to clinical product and what it takes to build a medical technology company.
What problem are you trying to solve?
“Orthopaedic surgeons face a real treatment gap, particularly in patients between 40 and 60.
Biological regenerative therapies can have limited longevity in these patients. Symptoms and pain may return, requiring another surgery. But these patients are often not yet suitable candidates for a total knee replacement either.
People sometimes talk about that as getting a ‘new knee’, but it certainly isn’t. For a middle-aged patient who is still very active, a knee replacement may not meet their functional demands. And replacing knees at a younger age also increases the lifetime risk of revision surgery and complications.”
So you don’t necessarily see regeneration as the answer?
“For this particular patient population, we think restoration may be a better approach.
Our implant is made from a compliant synthetic material that approximates the mechanical properties of native cartilage. It has very low friction against cartilage and is designed to be durable.
So rather than asking the patient’s body to regenerate damaged cartilage, we aim to restore its function with a synthetic implant. That’s why we increasingly talk about restorative rather than regenerative medicine.”
What made you decide that this research should become a company?
“The ambition to bring this technology to patients was there right from the start. We saw a large unmet clinical need, a potential business case and limitations in the treatments currently available.
We also had prior experience with the material. The same material had already been investigated for a synthetic meniscus replacement. That gave us proof-of-concept data suggesting that it could be suitable for use in the knee joint.”
How close are you to clinical application?
“We hope to start clinical trials in approximately two years. We are now basically at design freeze and preparing a pivotal animal study with a device that is substantially equivalent to the one we ultimately intend to use in the clinic.
We’ve developed the product in the laboratory, transferred manufacturing to qualified partners and optimised the implant design. Now we’re preparing for final verification.”
That sounds almost like a smooth journey.
“It certainly isn’t! One of the biggest challenges is putting together the right team. A medical device development programme requires expertise in many different areas, and as a small company with limited resources you can’t have all of that permanently under one roof.
The technical development is also expensive. We manufacture the implant using injection moulding, so every physical iteration requires tooling and substantial upfront costs. We therefore use computational modelling to optimise the design before producing it.
And we’ve built a joint simulator to test durability. I sometimes compare it to an IKEA chair tester. It just keeps going through the same movement cycle, again and again. In our case, it mimics the gait cycle to see how the implant performs over time.”
What do you need from an innovation ecosystem?
“Access to the right expertise at the right moment.
At one stage you may need knowledge about developing a quality management system or structuring your regulatory file. Later, you suddenly need expertise in packaging or sterilisation.
As a startup, you don’t want to reinvent every wheel yourself. Being able to draw on a network of specialists is extremely valuable.”
How important is it to involve clinicians during product development?
“Very important. Pieter Emans is one of the co-founders of Avalanche Medical and was one of the initiators of the original public-private research collaboration.
I still shadow him in the operating room every once in a while. We’re not only developing the implant, but also the surgical instruments needed to place it. Those tools have to be intuitive and user-friendly.
We also bring Pieter into cadaver labs to test different solutions. That first-hand user feedback is extremely valuable. Something can work perfectly from an engineering perspective, but ultimately a surgeon has to be able to use it.”
And what about patients?
“They should be involved, and our funders also require us to involve them. But it isn’t always easy.
You have to find the right patients and ask the right questions. At the moment we also rely strongly on clinicians such as Pieter to represent patients’ interests. It’s certainly an area in which we can still improve.”
What would you tell researchers considering starting a company?
“If you are resilient, if you like challenges and if you want to challenge the status quo every single day, entrepreneurship might be right for you.
But it certainly isn’t a nine-to-five job. There are sacrifices. In a startup, that can mean not getting paid for a while, giving up job security or even not being able to get a mortgage for a certain period of time.
You really have to believe in what you’re doing and be resilient enough to keep going.”
From regeneration to restoration
Avalanche Medical’s journey shows how much has to happen between a promising biomaterial and a product that can actually be used in the clinic. The material has to work, the implant has to survive repeated loading, manufacturing has to be reliable and surgeons need tools that work in practice. At the same time, a startup has to navigate quality, regulatory requirements and clinical validation.
For Roth, that doesn’t mean having every capability inside one company. It means finding the right expertise at the right moment and keeping the clinical need at the centre of development.
And in this case, that clinical need leads to an interesting shift in perspective: sometimes the best solution may not be to regenerate what was lost, but to restore what the patient needs.
Rethinking Bone and Cartilage Repair
Bone and cartilage are closely connected, yet repairing them presents very different challenges. Progress depends not on a single breakthrough, but on bringing together a better understanding of damaged tissue, new regenerative technologies and clinical experience.
In this series of three interviews, we explore bone and cartilage repair from three different perspectives: research, clinical practice and innovation. Together, they show where the field stands today, what is holding progress back and what it may take to bring new solutions closer to patients.
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