XELTIS BV

Their core work

Xeltis is a Dutch medical technology SME specializing in in-situ tissue engineering for cardiovascular implants — specifically heart valves that the body regenerates naturally after implantation. Their core technology enables the body's own cells to populate and replace a biodegradable scaffold, eliminating the need for donor tissue or lifelong anticoagulation. In the HybridHeart project they contributed to developing a biocompatible, soft-actuated artificial heart combining tissue engineering with soft robotics; in SimInSitu they are applying in-silico simulation platforms to validate tissue-engineered heart valves before clinical trials. They bridge materials science, cardiac surgery, and computational modeling to bring next-generation heart implants closer to clinical use.

What they specialise in

How they've shifted over time

In their earlier H2020 work (HybridHeart, starting 2017), Xeltis was focused on the physical device: building a soft-actuated artificial heart using tissue engineering scaffolds, soft robotics, and wireless energy transfer — a highly exploratory, FET-funded effort. By 2021, with SimInSitu, the focus shifted from device fabrication toward computational modeling, in-silico testing platforms, and formal verification and validation of tissue-engineered heart valves — signaling a move from proof-of-concept hardware toward regulatory-ready clinical evidence generation. The trajectory is clear: from physical prototype to digital validation, which is typical of a company preparing for CE marking or clinical trials.

Xeltis is moving toward computational clinical trial platforms and regulatory validation, suggesting they are preparing their tissue-engineered heart valve technology for formal clinical and regulatory approval pathways.

How they like to work

Xeltis participates exclusively as a consortium partner — never as coordinator — suggesting they contribute specialized technology or clinical expertise rather than leading project management. With 17 unique partners across just 2 projects, they operate in medium-to-large consortia (averaging ~8-9 partners per project), which is consistent with the multidisciplinary nature of medical device development. This profile fits an SME that plugs in as a technology owner or clinical knowledge holder, letting academic or larger industrial partners manage coordination.

Xeltis has built a network of 17 unique partners across 7 countries through just 2 projects, indicating broad European reach relative to their small project count. Their collaborations span research excellence and health sectors, pointing to a mix of academic research groups and clinical or industrial partners.

What sets them apart

Xeltis occupies a rare niche: they are one of very few SMEs in Europe combining proprietary biodegradable scaffold technology (endogenous tissue restoration) with the computational validation expertise needed to take that technology through clinical trials. Unlike academic groups that study tissue engineering theoretically, Xeltis is a product-oriented company with a specific clinical target — heart valves — and a clear path toward regulatory submission. For a consortium needing a credible industry partner who owns the core IP and understands both the biology and the regulatory requirements, Xeltis is an unusually well-positioned collaborator.

Highlights from their portfolio

• SimInSitu
  Largest EC contribution (€640,000) and the most forward-looking project — building the in-silico validation infrastructure that could accelerate regulatory approval for the entire class of tissue-engineered heart valves.
• HybridHeart
  A rare FET-funded project combining soft robotics, wireless energy transfer, and tissue engineering to develop the first fully biocompatible artificial heart — an exceptionally ambitious target for an SME.