Designing the first drug-eluting TAVR platform for the entire aortic regurgitation continuum, including infective endocarditis.

Infective endocarditis is a bacterial infection of the heart valves. Bacteria from the bloodstream settle on a valve leaflet, form vegetations protected by a biofilm and can destroy the leaflet, which may cause aortic regurgitation.

About 45,000 people in the US develop infective endocarditis each year, around 30,000 of them on the aortic valve. In Germany, around 11,000 patients are diagnosed each year.Sources: Chen et al., Front Med 2022 (GBD 2019); Selton-Suty et al., Clin Infect Dis 2012

It has one of the highest mortality rates in cardiology. With Staphylococcus aureus, 28% of patients die in hospital and 42% within one year, and 20–40% suffer an embolic stroke or cerebral ischemia.Sources: Cahill et al., JACC 2017; Østergaard et al., J Am Heart Assoc 2022; Eur Heart J 2019

Standard therapy is four to six weeks of intravenous antibiotics, often followed by surgical valve replacement. Antibiotics alone cannot reverse the valve destruction, surgery in active endocarditis carries a mortality of 20% or more, and many high-risk patients are denied surgery.Sources: Figulla HR, Cardiovasc Revasc Med 2023; Figulla HR, Seidel RA, Lauten A, in: Transcatheter Aortic Valve Implantation, 2nd ed., CRC Press 2024

No. There is currently no approved transcatheter valve for patients with active infective endocarditis of the aortic valve. devie medical is developing a drug-eluting TAVR platform designed for this patient group; it is an investigational device and not available for sale.

Conventional TAVR valves anchor against a calcified annulus, which is typical of aortic stenosis. In aortic regurgitation there is usually no calcium, so anchoring becomes a major challenge and the valve may migrate. The first dedicated transcatheter AR valve was FDA-approved only in 2026.

A drug-eluting TAVR valve is a transcatheter aortic valve that also delivers medication locally. In the devie concept, bioabsorbable antibiotic films on the valve skirt are designed to release high-dose antibiotics directly at the site of infection, to complement systemic antibiotic therapy.

devie is developing one TAVR platform in two configurations. Configuration A, without drug delivery, is designed for chronic and acute aortic regurgitation. Configuration B, with an antibiotic-eluting skirt, is designed for infective endocarditis. The skirt is a module on the same frame, not a separate design.

devie's grippers are designed to engage the native aortic leaflets. As the self-expanding frame expands, the leaflets are secured between the grippers and the stent frame, which provides calcium-independent anchoring.

The devie valve combines three mechanisms. Securing the infected leaflets between grippers and frame aims to immobilize bacterial vegetations and is designed to prevent embolism; the antibiotic-eluting skirt is designed to penetrate the biofilm locally; and the new pericardial leaflets are designed to restore aortic valve function, all in one transcatheter procedure.

The devie valve uses dry bovine pericardial leaflets that come pre-loaded on the delivery system. This means no rinsing and no loading in the cath lab, with a lower target delivery profile.

No. The devie valve is an investigational device in preclinical development. It has not been approved or cleared by the U.S. Food and Drug Administration (FDA), is not CE-marked and is not available for sale in any market.

The platform targets the entire aortic regurgitation continuum: chronic AR, acute AR, infective endocarditis of the aortic valve and the prevention of endocarditis after TAVR. All indications are under development and not approved.

devie medical GmbH is a medical device company based in Jena, Germany, developing the first drug-eluting TAVR platform for the entire aortic regurgitation continuum, including infective endocarditis. The name stands for drug-eluting valve to treat infective endocarditis.

devie was founded by structural heart innovators and clinicians: Dr. Laura Figulla (CEO), Prof. Hans R. Figulla, MD (CSO), founder of JenaValve, Occlutech and TricValve, and Prof. Alexander Lauten, MD (Medical Advisor), co-inventor of TricValve. Dr. Raphael A. Seidel is CTO.

devie holds 9 patent families with more than 45 patents and applications in 6 jurisdictions: the US, EU, UK, Switzerland, China and Canada.

devie is supported by public funding from the Free State of Thuringia and the European Union (EFRE/ERDF) and by the investor bm|t beteiligungsmanagement thüringen. P&F Products & Features GmbH, Vienna, is its R&D partner.

Strategic partners, investors and clinicians can reach devie at info@deviemedical.com or +49 3641 637 43 81. Bench and preclinical data and the full IP position are available under NDA.