Every year, half a million people in Europe and the United States undergo knee cartilage surgery. About eighty percent of the cases involve post-traumatic osteoarthritis. Osteoarthritis develops slowly after the cartilage in the knee has been injured due to an accident or a fall, for example. These cases often concern young people who are not yet eligible for a new knee. A prosthesis only lasts fifteen to twenty years and fitting a second prosthesis still carries too many risks. This is why orthopaedic surgeons usually opt for a prosthesis just for patients around the age of sixty. The upshot: Many younger people, often between the ages of forty and sixty, have constant pain in their knees. This hampers them in their daily lives.
Hy2Care has come up with a solution for this. The University of Twente spin-off is developing an injectable gel to fill and eventually repair the damage to cartilage so as to prevent that injury from developing into osteoarthritis. “The body is unable to properly repair cartilage damage itself, so we need to lend a hand,” says Marcel Karperien, founder and CSO of Hy2Care. He spent years doing fundamental research at various universities, which is how he eventually stumbled across this special gel’s effect.
The gel is injected into the damaged area of the joint during minimally invasive surgery, such as keyhole surgery. “You can compare it to a two-component adhesive,” Karperien states. To begin with, the gel is liquid. During the injection, two components are mixed together and a chemical reaction then takes place. This causes the gel to become solid and adhere to the cartilage surface. The gel fills the defect in the cartilage up to the edge.
Growing new cartilage
The gel is made up of, among other things, sugar polymers, a substance that also occurs naturally in cartilage. Likewise, the chemical reaction that takes place to make the gel stick to the cartilage is also a natural process. “This makes it a safe system. Obviously, the body has to be able to tolerate the substances and their chemical reaction well,” says Karperien. “In fact, the gel facilitates the ingrowth of cartilage cells. This way, new cartilage is formed while the gel slowly breaks down. Over time, the defect is completely repaired and filled up with new cartilage.”
Outcome for young people
This technology could eventually be used not just in knees, but also in other joints, such as ankles, hips and shoulders. “The joint must be accessible via minimally invasive surgery. We need to be able to inject the gel into the joint properly. If this is can be done, then this technology can be a solution,” he says. “We are initially focusing on the knee because this is where a relatively large number of people are affected; thirty percent of all osteoarthritis is knee osteoarthritis,” Karperien states. “Post-traumatic osteoarthritis also often affects relatively young people. They become restricted in their sports options and daily activities. This technology would really be a godsend for them.”
The aim is for Hy2Care’s gel to completely restore cartilage. “But if the gel can delay the problems for ten to fifteen years, then I’ll already be very satisfied,” he goes on to say. After that period of time, people often qualify for a prosthesis.
Osteoarthritis in horses
The spin-off has already proven the effect of the gel in the knees of horses, where damage has been shown to heal well. “Horses, like humans, are susceptible to osteoarthritis. This could not be treated up until now, as it is not possible to implant a prosthesis in horses,” he explains. Osteoarthritis causes pain when walking, which is why horses no longer want to walk. At some point, this means that a horse will have to be euthanized after the onset of osteoarthritis. Karperien: ” We would like to use the technology for humans as well as animals in the future.”
The first treatments in human patients will be carried out this year. “To do this, we held a major investment round three years ago,” Karperien says. Back then, the company raised a total of 5.5 million euros, over 3.5 million of that from investors and almost two million in subsidies. “ReumaNederland played an important role in this as a catalyst,” he says. Studies on e.g., toxicity of the gel were carried out with funds from the initial investments.
The gel will be used this year on the first ten patients. If all goes well, the company will be another step closer to obtaining a CE mark, a certification that is obligatory for bringing medical devices to market. “The clinical trial will provide the ultimate proof of the effectiveness of the treatment using the injectable hydrogel in humans. We are therefore really looking forward to this,” says Karperien. A second round of investments will ensue to enable the treatment to be carried out on a larger group of patients. “After that, the product will be ready for the market, roughly in 2024.”
Hy2Care is not the only company working on developing a gel to repair cartilage. NC Biomatrix, a spin-off of the Eindhoven University of Technology, is working on a similar technology for intervertebral discs. “It’s good that there are multiple studies in this area and that several companies are trying to bring this to market,” Karperien adds. “I imagine that not every patient is the same and therefore more than one technology is needed for different treatments.”
University support is crucial
In the researcher’s opinion, it is especially important that the technology works well and that the product is affordable. “Then these kinds of products will definitely find their way to the market,” he contends. Except that this is not such an easy path. “The university has played an important role in the development process,” Karperien notes. “For one thing, the company would not have existed without the supporting role of the business developers.” This enabled the young company to use the lab spaces at the university, for a fee, and they received advice on various things such as legal and financial matters.
“It’s really fun to be involved with a spin-off,” he states. “It’s a totally new world that I have learned an awful lot from.” Karperien is mainly concerned with the scientific development aspect within the company. “It is very different from doing fundamental research at the university. It’s much more application-oriented.” Which is precisely where his passion lies. “I’ve done a lot of fundamental research, and I’m very happy with that. But I know that this is only going to contribute a very small amount towards better products and treatments for patients. In the spin-off, we are still doing research, but also bringing it straight to the patient,” he points out.
“That didn’t happen as much twenty years ago. In those days, we only wrote in papers that technology was promising when it came to the treatment of certain diseases. Now we are actually going to prove it,” he adds. His biggest dream: “I think it would be fantastic if the technology developed in my laboratory could actually help patients. And that is going to happen!”