A Netherlands medical device company develops game-changing child heart surgery innovation—a valve that grows as the child gets older, saving them from further operations

Children born with heart malfunction face as many as seven operations over the years, because the implanted devices that keep them alive don’t get bigger as the children grow. They also suffer from an inflammatory response and a lifetime of strong medication, because traditional pulmonary implants are made of animal material which the body tries to reject.

But Xeltis, a medical device company based in the Netherlands, has developed a biodegradable polymer-based prosthesis which enables the patient’s body to build a new heart valve around it in a one-off intervention that may grow with the child, saving pain and heartache for the babies and their families, as well as the cost of multiple operations and care.

“Xeltis uses the body’s own mechanisms to heal,” says Eliane Schutte, the company’s chief executive officer. “The body creates cells inside and outside the device and eventually the device breaks down to be replaced by healthy tissue. Because it is your own tissue, it can grow with the body.”

The European Investment Bank has funded Xeltis to take its innovative products from clinical testing to manufacturing and marketing of its devices. Xeltis is developing the most advanced polymer-based restorative devices for cardiovascular treatment using self-healing implant technology based on the Nobel Prize-winning supramolecular chemistry research of Professor Jean-Marie Lehn, who works with Xeltis as a scientific adviser. 

During the pandemic, Xeltis needed funding to continue development, including the final stages of clinical testing for its devices prior to their approval by regulators.

The EIB was able to support Xeltis through financing available under the European Guarantee Fund, an EIB Group initiative in partnership with EU Member States to support European companies whose business was impacted by the COVID-19 pandemic.

The €15 million EIB investment enabled Xeltis to continue to develop its pulmonary valve device which aims to address congenital heart defects in children, as well as two other devices—artificial vessels for coronary bypass and hemodialysis access grafts that grow into a body tissue port for the dialysis needle. These are principally for use in older adults, for which there is a large potential market.

Living devices repair hearts, blood vessels and allow haemodialysis for chronic kidney disease 

“EIB involvement meant that Xeltis could fund development of three applications in parallel, rather than just choosing one,” says Antoine de Lachaux, an EIB loan officer who helped structure the financing. “It allowed them to accelerate development and therefore get devices faster to market, and enable patients to have access to these amazing applications. EIB investment is really critical to establish a clear proof of concept through a pivotal study in a first indication and thus attract additional investors.”

What heart problems do Xeltis devices solve?

• Xeltis’ pulmonary valve device addresses congenital heart defects in children
• Xeltis is developing cardiovascular products for older adults for which there is a large potential market, as cardiovascular disease is responsible for 31% of deaths globally
• Xeltis’ devices, which improve hemodialysis access, have the potential to help people with chronic kidney disease that affects 9% of the global population

For Xeltis, the loan structure and timing was ideal. Companies developing medical devices need a lot of financing, but until the products pass all clinical trials they are seen as unproven and too risky to find backers easily. The European Guarantee Fund is intended for small companies with higher risk profiles.

“Xeltis advanced existing technology and pushed it forward,” explains Auvo Kaikkonen, Senior Life Science Specialist in EIB’s Projects Directorate. “The challenge is to attract cells and then provide structure for stability. This is the neat combination that Xeltis has achieved.

“The polymer acts as a scaffold for heart valves and arteries. Then the cells grow on it because the material is cell-friendly.

“The EIB wants to support fantastic science and it is financially feasible,’’ says Kaikkonen.

Off the shelf options for human body parts

Xeltis has developed a library of polymers that are engineered to be implanted and then replaced by healthy tissue as the polymer device, which also acts as a scaffold, is absorbed by the body. This therapeutic approach is called Endogenous Tissue Restoration. The patient’s natural healing system develops tissue that pervades Xeltis’s device, forming a new, natural and fully functional blood vessel or heart valve within it. As restoration occurs, Xeltis implants are gradually absorbed by the body.

The different polymers have adjustable parameters, which can alter how long it takes for the polymer to be absorbed into the body. A valve takes more time to be completely replaced by patient’s own tissue than a blood vessel, for example, because it is a more complex structure.

“Xeltis manufactures all the parts,” says CEO Schutte. “We do everything onsite in the Netherlands with our team of thirty-five people, which is growing to forty staff this year. We have proved that we can make the devices. Now we will see if our work translates to clinical use, beyond testing.”