Intelligence Feed event · Policy · 2026-10-20

    Anteris Secures German BfArM Regulatory Clearance for DurAVR PARADIGM Trial

    Question

    Anteris Secures German BfArM Regulatory Clearance for DurAVR PARADIGM Trial

    Direct answer

    Anteris Technologies obtained regulatory authorization from Germany's BfArM to initiate its global PARADIGM clinical trial. The study evaluates the DurAVR Transcatheter Heart Valve for severe aortic stenosis. This clearance activates patient recruitment at leading German cardiovascular institutions, expanding clinical data generation across the European Union.

    Original publisher
    Market Ontology
    Evidence through
    2026-10-20
    Published
    2026-10-20
    Revision
    1 · 2026-10-20

    Cite as: Market Ontology, “Anteris Secures German BfArM Regulatory Clearance for DurAVR PARADIGM Trial”, revision 1, evidence through 2026-10-20. https://marketontology.com/market-events/2026-10-20/anteris-secures-german-bfarm-regulatory-clearance-for-duravr-paradigm-trial-6bdd67

    POLICY
    Anteris Secures German BfArM Regulatory Clearance for DurAVR PARADIGM Trial
    Anteris Technologies obtained regulatory authorization from Germany's BfArM to initiate its global PARADIGM clinical trial. The study evaluates the DurAVR Transcatheter Heart Valve for severe aortic stenosis. This clearance activates patient recruitment at leading German cardiovascular institutions, expanding clinical data generation across the European Union.
    AVR
    Impact
    67
    OCT 20
    SIG
    AVR
    Anteris Secures German BfArM Regulatory Clearance for DurAVR PARADIGM Trial
    Anteris Technologies obtained regulatory authorization from Germany's BfArM to initiate its global PARADIGM clinical trial. The study evaluates the DurAVR Transcatheter Heart Valve for severe aortic stenosis. This clearance activates patient recruitment at leading German cardiovascular institutions, expanding clinical data generation across the European Union.
    → Regulatory clearance for clinical testing in Germany derisks AVR clinical development milestones, improving terminal valuation multiples.
    Impact
    Anteris Technologies obtained regulatory authorization from Germany's BfArM to initiate its global PARADIGM clinical trial. The study evaluates the DurAVR Transcatheter Heart Valve for severe aortic stenosis. This clearance activates patient recruitment at leading German cardiovascular institutions, expanding clinical data generation across the European Union.
    Affected
    AVR
    Transmission
    Regulatory clearance for clinical testing in Germany derisks AVR clinical development milestones, improving terminal valuation multiples.

    How this development reaches the affected companies

    AssetExposure and channelDirectionEvidence
    AVRregulatory approval derisking clinical pipeline progressionUp1-4wAnteris Technologies received BfArM regulatory clearance to initiate PARADIGM trial for DurAVR in Germany

    Does this development affect your holdings?

    Enter your holdings to check them against this and other recent developments, review the decision that matters most, then set a monitor.

    Check this development against my holdings

    Review your initial audit before choosing ongoing portfolio scanning at $79/month.

    What happened next

    Price follow-up pending — no stored daily closes for these assets yet.

    Closing prices from stored daily bars; returns measured from the last close on or before the event date. Not a recommendation.

    No verifiable public source recorded for this card.

    Related

    Check this development against my holdings

    See today's live cards

    Public pages are published 24 hours after the product shows them. Desk shows every catalyst, event and causal reading as it happens, mapped to your holdings.

    Open Desk — $399/month