PROTEMBIS

The European Investment Bank (EIB) is providing €20 million in venture-debt financing to German medical-technology company Protembis to develop a next-generation device for protecting the brains of patients who undergo certain heart treatments.

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The funding is to support clinical trials, research, development and market access for the “ProtEmbo” cerebral embolic protection system. ProtEmbo is a filter device that deflects embolic material away from arteries to the brain during left-sided heart procedures including transcatheter aortic valve replacement (TAVR), countering risks including stroke and cognitive decline.

“This agreement demonstrates our commitment to supporting companies such as Protembis that aim to improve the health and well-being of European citizens. Their innovative technology, developed in Europe, will save patients who have to undergo heart surgery, from suffering grave side effects like cerebral embolic events”, said EIB Vice-President Nicola Beer.

The EIB accord with Protembis is supported by the InvestEU programme to trigger more than €372 billion in additional investment in new technologies until 2027. The deal is aligned with the InvestEU objective of promoting research, development and innovation.

“We are pleased to announce the signature of this agreement with the EIB,” said Protembis Co-Chief Executive Officers Karl von Mangoldt and Conrad Rasmus. “We would like to recognise the hard work, skill and professionalism of the EIB team while thanking our existing investors and our board for their unwavering belief in the benefits of this additional financing facility.”

TAVR is an x-ray guided procedure to replace an aortic valve that has narrowed and doesn't open fully. TAVR is minimally invasive, meaning it uses smaller incisions than open-heart valve surgery. Globally, around 430,000 patients with severe aortic stenosis are expected to be treated with TAVR by 2025.

A significant complication of TAVR is the risk of dislodging debris that lines the aortic arch and the old aortic valve. This debris can travel to the brain via three major arteries that originate in the roof of the aortic arch. It can block the smaller vessels in the brain and create lesions, which may cause stroke or contribute to acceleration of cognitive decline.

ProtEmbo is inserted during TAVR via the artery in the left wrist, and lines the roof of the aortic arch, shielding the brain from the dislodged debris.

In March 2024, Protembis completed a €30 million Series B financing round to advance a pivotal FDA approved Investigational Device Exemption study called the ProtEmbo trial. The trial will enrol between 250 and 500 patients undergoing TAVR in Europe and the US. The study aims to show the superiority of ProtEmbo by randomising against a hybrid control group: half of this control-group receiving no protection and half receiving the current predicate system called “Sentinel”.

Background information

The European Investment Bank (EIB) is the long-term lending institution of the European Union owned by its Member States. It makes long-term finance available for sound investment in order to contribute towards EU policy goals. Its key priorities are climate and the environment, development, innovation and skills, SMEs, infrastructure, and cohesion. It works closely with other EU institutions to foster European integration, promote the development of the European Union and support EU policies in more than 140 countries worldwide.

The InvestEU programme provides the European Union with crucial long-term funding by leveraging substantial private and public funds in support of a sustainable recovery. It also helps mobilise private investments for the European Union’s policy priorities, such as the European Green Deal and the digital transition. The InvestEU programme brings together under one roof the multitude of EU financial instruments currently available to support investment in the European Union, making funding for investment projects in Europe simpler, more efficient and more flexible. The programme consists of three components: the InvestEU Fund, the InvestEU Advisory Hub and the InvestEU Portal. The InvestEU Fund is implemented through financial partners that will invest in projects using the EU budget guarantee of €26.2 billion. The entire budget guarantee will back the investment projects of the implementing partners, increase their risk-bearing capacity and thus mobilise at least €372 billion in additional investment.

About ProtEmbo and Protembis. The ProtEmbo Cerebral Protection System is an intra-aortic filter device that protects the entire brain from embolic material liberated during transcatheter aortic valve replacement (TAVR). It is a low-profile non thrombogenic system that shields all cerebral vessels, delivered through the left radial artery for optimal placement and stability. This is an ideal access site enabling physicians to avoid interference with TAVR equipment typically delivered through the femoral artery.

Protembis is a privately held emerging medical device company that has developed the ProtEmbo^® Cerebral Protection System. The company strives to provide a simple and reliable solution to protect patients from brain injury during left-sided heart procedures, improving patient quality of life and reducing overall healthcare costs associated with brain injury during such procedures. The ProtEmbo^® System is currently undergoing clinical investigations.

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