Anteris Reports Medium-Size DurAVR THV Outcomes from the EMBARK Study at TCT 2026

At 30 days, the medium-size valve cohort had no valve-related mortality or moderate or severe leakage around the valve.

Rhea-AI Summary

Anteris Technologies Global (AVR) reported 30-day outcomes for its Medium-size DurAVR transcatheter heart valve in 22 EMBARK Study patients. The patients had severe aortic stenosis and medium aortic annuli. Results were presented at TCT 2026.

The effective valve opening increased to 2.64 ± 0.19 cm2 from 0.8 ± 0.2 cm2 at baseline. Mean pressure gradient, the pressure difference across the valve, fell to 6.17 ± 1.40 mmHg from 45.5 ± 11.7 mmHg. At 30 days, there was no valve-related mortality, no moderate or severe leakage around the valve, and no moderate or severe prosthesis-patient mismatch, where the valve opening is too small for the patient's blood-flow needs.

The ongoing PARADIGM pivotal trial is actively enrolling and will include the Medium-size valve. It will compare DurAVR with commercially available transcatheter valves in a randomized study of safety and effectiveness.

Positive

• Minor pointEffective valve opening increased to 2.64 ± 0.19 cm2 at 30 days from 0.8 ± 0.2 cm2.
• Minor pointMean pressure gradient fell to 6.17 ± 1.40 mmHg at 30 days from 45.5 ± 11.7 mmHg.
• Minor pointValve-related mortality was zero at 30 days in the Medium-size DurAVR cohort.
• Minor pointModerate or severe leakage around the valve was absent at 30 days.
• Minor pointFreedom from moderate or severe prosthesis-patient mismatch was 100% at 30 days.
• Minor point. Forward-looking: it has not happened yet and may not happen.PARADIGM is actively enrolling and will include the Medium-size DurAVR valve.

Negative

• None.

News Explained

The release states that DurAVR is for investigational use only and is not available for commercial use or sale worldwide; the reported study outcomes therefore concern a product not offered commercially.

Key Figures

Patient cohort: 22 patients Effective orifice area: 2.64 ± 0.19 cm2 (baseline 0.8 ± 0.2 cm2) Mean pressure gradient: 6.17 ± 1.40 mmHg (baseline 45.5 ± 11.7 mmHg) +1 more

Patient cohort

22 patients

Medium-size DurAVR THV outcomes; 30 days

Effective orifice area

2.64 ± 0.19 cm2 (baseline 0.8 ± 0.2 cm2)

30-day results

Mean pressure gradient

6.17 ± 1.40 mmHg (baseline 45.5 ± 11.7 mmHg)

30-day results

Freedom from moderate or severe PPM

100%

Medium-annuli cohort; 30 days

Key Terms

effective orifice area, mean pressure gradient, paravalvular leak, prosthesis-patient mismatch, +1 more

5 terms

effective orifice area medical

"large effective orifice areas (EOAs)"

Effective orifice area (EOA) is the functional cross‑sectional area through which blood flows across a heart valve during ejection, measured under actual flow conditions rather than by the valve’s physical opening. Clinically it is estimated from Doppler echocardiography using the continuity equation (relating flow upstream and through the valve) and is reported in square centimeters; because it reflects flow contraction and velocity, EOA is typically smaller than the anatomical or geometric opening and changes with cardiac output and measurement technique.

mean pressure gradient medical

"single digit mean pressure gradient (MPG)"

The mean pressure gradient is the average pressure difference, expressed in millimeters of mercury (mmHg), measured across a cardiac valve or vascular narrowing during the relevant part of the cardiac cycle (typically systole for aortic or mitral valves). Clinically it is calculated by taking the time‑average of the instantaneous pressure differences (often derived from Doppler velocities using the Bernoulli relationship or from catheter measurements) and is used to quantify the degree of obstruction; it is distinct from the peak (maximum) gradient, which records the highest instantaneous pressure difference rather than the average over time.

paravalvular leak medical

"no moderate or severe paravalvular leak (PVL)"

A paravalvular leak is blood flow that escapes around, rather than through, a surgically implanted or transcatheter heart valve because the valve’s sealing interface against the patient’s native tissue is incomplete or has separated. It produces varying degrees of regurgitation and can cause symptoms or complications such as heart failure or red blood cell destruction (hemolysis); clinicians diagnose and grade it by imaging (usually echocardiography) and sometimes treat it with catheter-based closure or repeat surgery depending on severity.

prosthesis-patient mismatch medical

"freedom from moderate or severe prosthesis-patient mismatch"

A prosthesis‑patient mismatch occurs when an implanted prosthetic heart valve has an effective opening that is too small for the patient's body size, producing higher-than-expected blood‑flow resistance across the valve. Clinically it is assessed by the valve’s effective orifice area (EOA) indexed to the patient’s body surface area (EOA/BSA); lower indexed EOA values indicate a greater mismatch and correlate with higher transvalvular gradients and reduced valve hemodynamic performance. Valve label size alone does not define mismatch, because EOA varies by valve design and how the valve functions in a given patient; assessment uses echocardiography or measured EOA values and accounts for body size to determine whether a mismatch is present and how severe it is.

randomized controlled trial medical

"This prospective, randomized controlled trial (RCT)"

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.

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MINNEAPOLIS and BRISBANE, Australia, Nov. 01, 2026 (GLOBE NEWSWIRE) -- Anteris Technologies Global Corp. (“Anteris” or the “Company”) (NASDAQ: AVR, ASX: AVR) a global healthcare company committed to designing, developing, and commercializing cutting-edge medical devices to restore healthy heart function, today announced 30-day clinical and hemodynamic outcomes for the Medium-size DurAVR^® Transcatheter Heart Valve (THV) in twenty-two severe aortic stenosis patients with medium aortic annuli (aortic annulus area 492 ± 38 mm²). The DurAVR THV demonstrated single digit mean gradients, large effective orifice areas (EOAs), no moderate or severe paravalvular leaks and no valve related mortality, with 100% freedom from moderate or severe prosthesis-patient mismatch^* (PPM) in a cohort of medium annuli patients from the EMBARK Study.

The 30-day Medium-size DurAVR THV results were presented by Azeem Latib, MD during the Emerging Concepts and Innovations in TAVR session at the Transcatheter Cardiovascular Therapeutics (TCT) Conference in San Diego, California.

30-day Results Highlights

• DurAVR THV delivered a favorable hemodynamic profile with a large EOA of 2.64 ± 0.19 cm² (baseline 0.8 ± 0.2 cm²) and a single digit mean pressure gradient (MPG) of 6.17 ± 1.40 mmHg (baseline 45.5 ± 11.7 mmHg). 
• At 30-days, clinical safety outcomes were positive with no valve related mortality and no moderate or severe paravalvular leak (PVL).
• No moderate or severe prosthesis–patient mismatch was observed at 30 days.
  

“These are exceptional 30-day hemodynamics for medium annuli, with large effective orifice areas, single-digit gradients, and no moderate or severe PPM or paravalvular leak. That matters because prosthesis-patient mismatch is not just a small-annulus problem. A recent study in younger, lower-risk TAVR patients found PPM was associated with higher mortality and substantially more heart failure hospitalization at five years.¹ As TAVR moves to patients who will live with their valve for decades, this is the hemodynamic profile we designed DurAVR to deliver, and we look forward to PARADIGM confirming it in a randomized setting,” said Chris Meduri, M.D., Anteris Chief Medical Officer.

The DurAVR THV is being evaluated in the ongoing global PARADIGM pivotal trial (ClinicalTrials.gov ID NCT07194265), which is actively enrolling patients and will include use of the Medium-size DurAVR THV. This prospective, randomized controlled trial (RCT) is designed to evaluate the safety and effectiveness of DurAVR THV compared to commercially available transcatheter aortic valve replacements (TAVRs) in the treatment of severe aortic stenosis.

^{¹Suruga K, et al. Prosthesis-Patient Mismatch in Young and Low-Risk Patients After Newer Generation Balloon-Expandable Transcatheter Aortic Valve Replacement. JACC Cardiovasc Interv. 2025;18(12).}

^{*Prosthesis‐patient mismatch (PPM) happens when a prosthetic valve, after being implanted, doesn't have a large enough opening (EOA) to accommodate the patient's blood flow needs, based on their body size. The result is higher than expected gradients. PPM affects a significant proportion of transcatheter aortic valve (TAVR) patients, particularly patients with a small aortic annulus and has been associated with impaired long-term survival following surgical aortic valve replacement (SAVR).}

^{**As defined in VARC-3}

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.

DurAVR THV is intended for INVESTIGATIONAL USE ONLY. Not available for commercial use or sale worldwide. CAUTION—Investigational device. Limited by Federal (or United States) law to investigational use.

Forward-Looking Statements

This announcement contains forward-looking statements. 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	Investor Relations (US)
investors@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

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Anteris report for Medium-size DurAVR in the EMBARK Study?

Among 22 patients with severe aortic stenosis and medium aortic annuli, 30-day outcomes included no valve-related mortality and no moderate or severe leakage or prosthesis-patient mismatch. Mean pressure gradient was 6.17 ± 1.40 mmHg, and the effective valve opening was 2.64 ± 0.19 cm2.

How will Anteris assess DurAVR in the PARADIGM trial?

PARADIGM will assess whether DurAVR is not unacceptably worse than commercially available transcatheter valves on a combined measure of all-cause mortality, all stroke and cardiovascular hospitalization at one year. The trial plans approximately 1,000 patients in its All Comers Randomized Cohort, assigned 1:1 to DurAVR or commercially available and approved valves.