Anteris Advances Global PARADIGM Trial Expansion with German Regulatory Clearance

Anteris expects German site activation to increase access to eligible patients and accelerate PARADIGM enrollment.

Rhea-AI Summary

Anteris Technologies Global (AVR) received full German regulatory clearance to recruit patients for its global pivotal PARADIGM heart valve trial. Clearance from the German Federal Institute for Drugs and Medical Devices enables recruitment at German centers for patients with severe calcific aortic stenosis. Anteris expects German site activation to increase patient access and accelerate enrollment.

The randomized trial will compare DurAVR with commercially available, approved transcatheter heart valves in approximately 1,000 patients, assigned 1:1. It will test whether DurAVR is not worse than the comparator on a combined measure of death from any cause, all stroke and cardiovascular hospitalization at one year after the procedure.

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Positive

• Moderate pointFull German regulatory clearance enables PARADIGM patient recruitment at German centers.
• Minor point. Forward-looking: it has not happened yet and may not happen.German site activation is expected by Anteris to increase eligible patient access and accelerate enrollment.

Negative

• None.

Key Figures

Trial enrollment: approximately 1,000 patients Randomization ratio: 1:1 Primary endpoint follow-up: 1 year post procedure

Trial enrollment

approximately 1,000 patients

PARADIGM All Comers Randomized Cohort

Randomization ratio

1:1

DurAVR THV versus commercially available approved THVs

Primary endpoint follow-up

1 year post procedure

PARADIGM primary composite endpoint

Historical Context

1 past event · Latest: Jun 08

1 event

1. Jun 08

   regulatory clearance

   24h Move

   -3.1%

   French clearance authorized recruitment at French centers for the same DurAVR PARADIGM pivotal trial.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

transcatheter aortic valve replacement, randomized controlled trial, non-inferiority, all-cause mortality, +1 more

5 terms

transcatheter aortic valve replacement medical

"transcatheter aortic valve replacement (TAVR) market"

A minimally invasive procedure that replaces a damaged aortic heart valve by guiding a folded replacement valve to the heart through a thin tube (catheter) inserted in a blood vessel, avoiding the need for open‑chest surgery. It matters to investors because it shapes demand for medical devices, hospital services and reimbursements, impacts patient recovery times and complication rates, and can materially influence sales, margins and regulatory risk for device makers and healthcare providers — like swapping a worn door using a narrow hallway instead of tearing down a wall.

randomized controlled trial medical

"a prospective randomized controlled trial"

A randomized controlled trial is a research method that tests the effects of a new idea or treatment by randomly dividing participants into two groups: one that receives the treatment and one that does not. This approach helps ensure that the results are fair and unbiased, providing clear evidence about whether the treatment actually works. Investors value such trials because they offer reliable information that can influence decision-making and reduce uncertainty.

non-inferiority medical

"assess non-inferiority on a primary composite endpoint"

A non-inferiority trial is a type of clinical test designed to show a new treatment is not meaningfully worse than an existing standard by more than a pre-set, acceptable amount. Think of it like proving a new smartphone model has battery life close enough to the leading model while offering other advantages; for investors, a successful non-inferiority result can clear the way to regulatory approval and market uptake even when the new option isn’t superior in headline effectiveness.

all-cause mortality medical

"all-cause mortality, all stroke and cardiovascular hospitalization"

All-cause mortality is the total number of deaths from any cause within a defined group over a specific time period. For investors, it is a broad safety and outcome measure used in clinical trials and public-health studies—like counting everyone who leaves a club for any reason—because higher or lower all-cause mortality can influence regulatory decisions, product reputation, long-term liability and market value.

cardiovascular hospitalization medical

"all stroke and cardiovascular hospitalization at one year"

An episode in which a patient is admitted to a hospital primarily for a heart or blood‑vessel related condition, such as heart failure, heart attack (myocardial infarction), unstable angina, stroke, serious arrhythmia, or other acute cardiovascular events. In clinical trials and regulatory disclosures it is used as an outcome or endpoint and is counted only when the hospitalization meets the study’s predefined criteria (for example, specific diagnoses, need for overnight stay, or adjudication rules), so the exact inclusion rules can vary by trial or dataset.

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MINNEAPOLIS and BRISBANE, Australia, Oct. 19, 2026 (GLOBE NEWSWIRE) -- Anteris Technologies Global Corp. (“Anteris” or the “Company”) (NASDAQ: AVR, ASX: AVR) announced today that it has received full regulatory clearance from the German Federal Institute for Drugs and Medical Devices (BfArM) for the DurAVR^® Transcatheter Heart Valve (THV) global pivotal trial for patients with severe calcific aortic stenosis (the “PARADIGM Trial”). This clearance enables Anteris to initiate patient recruitment at leading German centers and represents an important step in expanding the PARADIGM Trial’s European footprint.

Germany is Europe’s largest and most established transcatheter aortic valve replacement (TAVR) market, with an extensive network of experienced structural heart centers and investigators. Activating sites in this high-volume environment is anticipated to increase access to eligible patients and accelerate enrollment in the PARADIGM Trial. 

“Germany’s scale, clinical expertise and established TAVR infrastructure create an important opportunity to advance enrollment and extend PARADIGM’s reach across leading international TAVR markets,” said Wayne Paterson, Vice Chairman and Chief Executive Officer of Anteris.

The Company continues to execute its global clinical strategy through coordinated site activation and patient enrollment across the United States and Europe. Germany’s inclusion strengthens the trial’s European presence and adds meaningful scale to the PARADIGM Trial.

ENDS

About the PARADIGM Trial

The PARADIGM Trial is a prospective randomized controlled trial which will evaluate the safety and effectiveness of the DurAVR^® Transcatheter Heart Valve compared to commercially available transcatheter aortic valve replacements (TAVRs).

This head-to-head study will enrol approximately 1,000 patients in the ‘All Comers Randomized Cohort’ with 1:1 randomization of patients who will receive either the DurAVR^® THV or TAVR using commercially available and approved THVs. The PARADIGM Trial will assess non-inferiority on a primary composite endpoint of all-cause mortality, all stroke and cardiovascular hospitalization at one year post procedure.

For further information, please refer to ClinicalTrials.gov NCT07194265.

About Anteris

Anteris Technologies Global Corp. (NASDAQ: AVR, ASX: AVR) is a global healthcare company committed to designing, developing, and commercializing cutting-edge medical devices to restore healthy heart function. Founded in Australia, with a significant presence in Minneapolis, USA, Anteris is a science-driven company with an experienced team of multidisciplinary professionals delivering restorative solutions to structural heart disease patients.

Anteris’ lead product, the DurAVR^® THV, was designed in collaboration with the world’s leading interventional cardiologists and cardiac surgeons to treat aortic stenosis – a potentially life-threatening condition resulting from the narrowing of the aortic valve. The balloon-expandable DurAVR^® THV is the first biomimetic valve, which is shaped to mimic the performance of a healthy human aortic valve and aims to replicate normal aortic blood flow. DurAVR^® THV is made using a single piece of molded ADAPT^® tissue, Anteris’ patented anti-calcification tissue technology. ADAPT^® tissue, which is FDA-cleared, has been used clinically for over 10 years and distributed for use in over 55,000 patients worldwide. The DurAVR^® THV System is comprised of the DurAVR^® valve, the ADAPT^® tissue, and the balloon-expandable ComASUR^® Delivery System.

Forward-Looking Statements

This announcement contains forward-looking statements, including statements regarding the expectation that this regulatory clearance enables patient recruitment in Germany. Forward-looking statements include all statements that are not historical facts. Forward-looking statements generally are identified by the words “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “budget,” “target,” “aim,” “strategy,” “plan,” “guidance,” “outlook,” “may,” “should,” “could,” “will,” “would,” “will be,” “will continue,” “will likely result” and similar expressions, although not all forward-looking statements contain these identifying words. These forward-looking statements are subject to a number of risks, uncertainties, and assumptions, including those described under “Risk Factors” in Anteris’ Annual Report on Form 10-K for the fiscal period ended December 31, 2025 that was filed with the Securities and Exchange Commission and ASX. Readers are cautioned not to put undue reliance on forward-looking statements, and except as required by law, Anteris does not assume any obligation to update any of these forward-looking statements to conform these statements to actual results or revised expectations.

For more information:
Global Investor Relations investors@anteristech.com Debbie Ormsby Anteris Technologies Global Corp. +61 1300 550 310 | +61 7 3152 3200	Investor Relations (US) mchatterjee@bplifescience.com Malini Chatterjee, Ph.D.       Blueprint Life Science Group +1 917 330 4269

Website         www.anteristech.com
X                 @AnterisTech
LinkedIn         https://www.linkedin.com/company/anteristech

FAQ

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What does German clearance allow Anteris to do in the PARADIGM trial?

Full regulatory clearance from the German Federal Institute for Drugs and Medical Devices allows Anteris to initiate patient recruitment at German centers. PARADIGM evaluates DurAVR in patients with severe calcific aortic stenosis.

What will Anteris's PARADIGM trial measure?

PARADIGM will assess non-inferiority, testing whether DurAVR is not worse than commercially available, approved transcatheter heart valves on a combined endpoint of all-cause mortality, all stroke and cardiovascular hospitalization at one year after the procedure. Approximately 1,000 patients will be assigned 1:1 to the two treatment groups.