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Anteris Technologies Announces First Patients Treated in DurAVR THV Global Pivotal Trial (the "PARADIGM Trial") MINNEAPOLIS, United States and BRISBANE, Australia 27 October 2025: Anteris Technologies Global Corp. ( Ante

Key Takeaway: Anteris Technologies has announced the successful enrollment and treatment of the first patients in the DurAVR Transcatheter Heart Valve (THV) global pivotal trial, known as the PARADIGM Trial, which is aimed at assessing treatment options for severe calcific aortic stenosis. This trial is a significant step towards advancing the DurAVR THV towards commercialization and is expected to generate the required clinical evidence for its effectiveness. The PARADIGM Trial will enroll approximately 1,000 patients and will provide comparative data against existing transcatheter aortic valve replacements. Anteris plans to expand the trial to additional regions including the United States, Europe, and Canada.

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POSITIVE FACTORS

  • First patients treated successfully in the PARADIGM Trial, marking a significant milestone.
  • The initial experience with the DurAVR THV System has been very positive according to Prof. Dr. Ole De Backer.
  • Anteris is expanding treatment options for patients with severe aortic stenosis through this trial.
  • The trial aims to provide robust comparative evidence which could transform patient care.

Full Press Release Details

Anteris Technologies Announces First Patients Treated in DurAVR THV Global Pivotal Trial (the "PARADIGM Trial")
MINNEAPOLIS, United States and BRISBANE, Australia 27 October 2025: Anteris Technologies Global Corp. (Anteris or the Company) (NASDAQ: AVR, ASX: AVR) a global structural heart company committed to designing, developing, and commercializing cutting-edge medical devices to restore healthy heart function, today announced the first patients have been enrolled and successfully treated in the DurAVR Transcatheter Heart Valve (THV) global pivotal trial for patients with severe calcific
aortic stenosis (the "PARADIGM Trial"). The procedures were performed by Prof. Dr. Ole De Backer at, The Heart Center, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
"We are proud to be the first enrolling center for this important trial," said Prof. Dr. De Backer. "Our initial experience with the DurAVR
THV System has been very positive, and we look forward to providing definitive comparative evidence which could transform patient care."
"With the first patients now randomized in the PARADIGM Trial, we are actively generating the clinical evidence required to advance the DurAVR
THV toward commercialisation, expanding treatment options for aortic stenosis patients," said Anteris Chief Medical Officer, Chris Meduri, M.D. "This head-to-head study will provide robust comparative evidence across all surgical risk groups, which
we believe will differentiate our platform based on efficacy, safety and ease of use."
The PARADIGM Trial builds on Anteris' existing clinical data set of 130 patients successfully treated with the DurAVR THV, including
de novo (first time) aortic stenosis cases, valve-in-valve (ViV) patients and complex anatomies such as bicuspid aortic valve patients. Anteris aims to drive the global PARADIGM Trial through the addition of further countries and sites in the near
term, with planned expansion across the United States, Europe and Canada. Management believes strong enthusiasm from investigators is expected to translate into efficient recruitment and timely study advancement.
About the PARADIGM Trial
The PARADIGM Trial is a prospective randomized controlled trial* (RCT) which will evaluate the safety and effectiveness of the DurAVR
THV compared to commercially available transcatheter aortic valve replacements (TAVRs).
This head-to-head study will enroll 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 (ClinicaTrials.gov ID NCT07194265). The planned expansion across other geographies
includes additional cohorts.
*A Premarket Approval (PMA) application requires a high level of clinical evidence to demonstrate reasonable assurance of safety and effectiveness
for the intended use. Randomized controlled trials are generally considered Level 1 evidence, the highest level for determining the effectiveness of interventions in evidence-based medicine given RCTs mimimize bias and allow a clear comparison
between treatment groups.
Anteris Technologies Global Corp. (NASDAQ: AVR, ASX: AVR) is a global structural heart 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 Transcatheter Heart Valve (THV), was designed in partnership 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 planned expansion of the PARADIGM Trial, the results of
the PARADIGM Trial, the quotes from Prof. Dr. De Backer and Chris Meduri, M.D, the contours of the PARADIGM Trial, and the expansion of the PARADIGM Trial to other countries and cohorts. 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, 2024 that was filed with the SEC 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:
Investor Relations Investor Relations (US)
investor@anteristech.com mchatterjee@bplifescience.com
Debbie Ormsby Malini Chatterjee, Ph.D.
Anteris Technologies Global Corp. Blueprint Life Science Group
+61 1300 550 310 | +61 7 3152 3200 +1 917 330 4269
Website www.anteristech.com
X @AnterisTech
LinkedIn https://www.linkedin.com/company/anteristech

Frequently Asked Questions

What is the DurAVR THV global pivotal trial?

The DurAVR THV trial, known as the PARADIGM Trial, evaluates the safety and effectiveness of the DurAVR Transcatheter Heart Valve for severe aortic stenosis.

Who performed the initial procedures in the PARADIGM Trial?

Prof. Dr. Ole De Backer at Copenhagen University Hospital performed the initial procedures.

How many patients will the PARADIGM Trial enroll?

The trial aims to enroll approximately 1,000 patients in a randomized cohort.

What technology does the DurAVR THV utilize?

The DurAVR THV utilizes ADAPT tissue, an FDA-cleared material aimed at minimizing calcification.

What does the PARADIGM Trial compare the DurAVR THV to?

It compares the DurAVR THV against commercially available transcatheter aortic valve replacements.

Last updated: Oct 28, 2025