Germany-based Protembis has raised $30m in a Series B funding round to initiate a pivotal clinical trial of its intra-aortic filter device. 

Co-led by Sweden-based Segulah Medical Acceleration, Italy-based XGEN Venture, and Germany-based TechVision Fund, as well as other investors, the funding round will support the enrollment of the PROTEMBO investigational device exemption (IDE) trial (NCT05873816). 

The ProtEmbo Cerebral Protection system is a specialised intra-aortic filter designed to safeguard the brain from embolic material (small particles that can travel through the bloodstream) released during medical procedures. The device, introduced via the left radial artery, shields all cerebral vessels, and allows healthcare professionals to prevent any disruption to TAVR equipment typically administered through the femoral artery.  

The cardiovascular device company secured US Food and Drug Administration (FDA) approval for the trial in October 2023.  

The multi-centre, randomised, study will compare the safety and efficacy of the ProtEmbo Cerebral Embolic Protection device to a hybrid control in 500 patients undergoing a transcatheter aortic valve replacement (TAVR) procedure. Half of the group will receive no cerebral embolic protection (CEP) while the other half will receive the Sentinel CEP from Boston Scientific.

The primary endpoint of the trial is the occurrence of major adverse cardiac and cerebrovascular events (MACCE), assessed after 30 days, with neurological events adjudicated by stroke neurologists. 

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TAVR procedures involve the replacement of a diseased aortic valve with a man-made valve. According to a model on GlobalData’s Medical Intelligence Center, the TAVR market is set to generate $4.7bn in the US in 2030.  

In the announcement accompanying the funding, Protembis’ co-CEOs Karl von Mangoldt and Conrad Rasmus said: “It reflects the fact that the field of cerebral embolic protection is buoyant and that future growth will be driven by younger and lower risk patients who have zero tolerance for brain injury risk when selecting to undergo transcatheter aortic valve replacement.” 

In September 2023, EnCompass Technologies received conditional IDE approval from the FDA to begin the US pilot study of its F₂ cerebral embolic protection (CEP) system.