The European Investment Bank (EIB) is providing €20 million in venture debt financing to German medical technology start-up Protembis. The company plans to use the money to advance the development of a novel system that protects the brain during certain cardiac procedures.
Specifically, the funds are intended to enable clinical trials, research, development and the market launch of the ProtEmbo embolism protection system. ProtEmbo is a filter device that prevents embolism particles released during left-sided heart surgery, transcatheter aortic valve implantation (TAVI), from entering the arteries supplying the brain. The aim is to prevent risks such as strokes or loss of cognitive abilities.
EIB Vice-President Nicola Beer said: “This agreement underlines our commitment to companies like Protembis, which are committed to the health and well-being of people in Europe. With its innovative technology developed in Europe, Protembis will protect patients from serious complications such as cerebral embolism.”
The EIB financing is supported by the InvestEU programme, which aims to stimulate more than EUR 372 billion in additional investment in new technologies across Europe by 2027. The agreement supports InvestEU’s objective of promoting research, development and innovation.
Karl von Mangoldt and Conrad Rasmus, Managing Directors of Protembis: “We are delighted to announce the signing of this agreement with the EIB. We would particularly like to highlight the hard work and the high level of competence and professionalism of the EIB team. At the same time, we would like to thank our existing investors and our Advisory Board for their firm support of this additional financing.”
TAVI is an X-ray-guided procedure to replace a narrowed aortic valve that no longer opens completely. Since the operation is minimally invasive, the access points are smaller than in open-heart surgery. By 2025, around 430,000 patients worldwide with severe heart valve defects are expected to be operated on using this procedure.
A major risk is that particles deposited on the vessel walls of the aortic arch and the old aortic valve become detached. These particles can then enter the brain via three large arteries that branch off from the upper vessel wall of the aortic arch, where they can block the narrower brain vessels, damage tissue and lead to a stroke or loss of cognitive abilities.
ProtEmbo is inserted through the artery in the left wrist for TAVI. The filter covers the upper vessel wall of the aortic arch and thus protects the brain from dissolved particles.
In March 2024, Protembis closed a Series B financing round of 30 million euros to advance the approval study “The PROTEMBO Trial” following the approval of the Research Product Exemption (IDE) by the US FDA. It is expected to include 250 to 500 patients undergoing TAVI in Europe or the USA. The randomized study aims to demonstrate the superiority of the ProtEmbo system over a hybrid control group: Half of this control group receives no embolism protection, and the other half receives the comparable, already approved product “Sentinel”.
ProtEmbo and Protembis: The cerebral protection system ProtEmbo is an intra-aortic filter that protects the entire brain from embolic particles that may be released during transcatheter aortic valve implantation (TAVI). It is a low-profile, non-thrombogenic system that shields the brain vessels. For optimal placement and stability, it is delivered via the left radial artery. This means it does not conflict with the TAVI system, which is normally inserted via the femoral artery.
The cerebral protection system ProtEmbo ® was developed by Protembis GmbH. The medical technology start-up wants to offer a simple, reliable solution to protect against brain injuries during left-sided heart surgery to improve the quality of life of patients. This also reduces the health costs that brain injuries entail during such procedures. ProtEmbo ® is currently undergoing clinical trials.
