Anteris Technologies takes aim at the future of heart valve care

Our hearts rely on small but vital mechanisms to function: the valves that keep blood moving in the right direction. When these valves become damaged or diseased, the consequences can be serious to deadly.

Heart disease remains a pressing concern in Australia. According to the Heart Foundation (2024), heart disease kills one person every 18 minutes, equating to 79 persons dying of heart disease every day. Heart valve disease also becomes more common with age, affecting at least 10% of people aged 75 and older. Our heart valves open and close roughly 100,000 times a day, and this constant motion can stretch, thin, or stiffen the thin tissue flaps (leaflets) over time. Calcium deposits can also build up on the valve leaflets, causing them to stiffen and thicken in a process known as calcification.

The Baker Health Institute estimates 254,000 Australians are living with undiagnosed heart valve disease, a number that is expected to grow substantially to 336,000 in 2031, and to 435,000 in 2051.

Aortic valve disease is the most frequent cause of severe heart valve disease.

The aortic valve regulates the flow of oxygen-rich blood from the heart's left ventricle into the aorta, carrying it throughout the body. When the valve becomes damaged or diseased, the heart must work harder to maintain circulation.

One common result of this stress is aortic stenosis, where the aortic valve stiffens and narrows, restricting blood flow from the heart. This can cause chest pain, fatigue, and breathlessness, and may lead to heart failure if left untreated. Once developed, aortic stenosis reduces life expectancy and survival rates, making early diagnosis and treatment important.

The best treatment for patients often depends on individual factors, including age, anatomy, general health, and surgical risks. Doctors can treat heart valve disease with medication, surgery, or minimally invasive procedures. For patients with severe aortic stenosis, however, treatment may include several different methods. These include surgical aortic valve replacement (SAVR), an open-heart procedure that replaces the damaged valve, or transcatheter aortic valve replacement (TAVR/TAVI), which replaces the valve using a catheter inserted through an artery, usually in the groin.

The design and performance of replacement valves remain important areas of clinical research, with next-generation technologies increasingly focused on replicating the structure and function of a healthy natural valve.

Anteris Technologies Pty Ltd ( ASX:AVR , NASDAQ:AVR ) is aiming to address this issue with its DurAVR transcatheter heart valve, designed to more closely replicate the function of a healthy human aortic valve and help tackle aortic stenosis.

A new approach to heart help

Australian-founded structural heart company Anteris Technologies is developing new cardiac care solutions and operates across Australia, the United States, and Switzerland. Its lead product, the DurAVR Transcatheter Heart Valve (THV) differs from other technologies through its biomimetic design, which is engineered to mimic the shape and blood flow dynamics of a healthy human aortic valve. DurAVR is moulded from a single piece of bovine pericardial tissue and is designed to reduce calcification.

This approach could help restore more natural blood flow and improve valve performance. Anteris chief medical officer Dr Chris Meduri has described the clinical results as resembling a "pre-disease state", reflecting the company's focus on reproducing the function of a healthy heart valve.

Cardiac surgeon and medical researcher Dr Michael Reardon has also described the technology as a "structural heart holy grail", highlighting the potential significance of advances in heart valve design.

PARADIGM: Putting the DurAVR to the test

Building on earlier encouraging clinical findings, Anteris is evaluating DurAVR in the global PARADIGM trial. This is a "randomised, controlled study designed to assess the THV valve's safety and effectiveness against already commercially available transcatheter aortic valve replacement (TAVR) devices" (Cardiac Interventions Today, 2026).

The trial includes over 1,000 patients with severe aortic stenosis, equally allocated to either DurAVR or commercially available replacement valves. The primary results to be measured are deaths, stroke, and cardiovascular hospitalisation during the first year after the procedure. The study aims to determine whether DurAVR is as safe and effective as standard, already-approved heart valves.

PARADIGM Principal Investigator Dr Azeem Latio said the "early procedural experience with the DurAVR THV system has been highly encouraging". However, the trial's results will help determine whether DurAVR is as safe and effective as existing alternatives.

Anteris has continued to expand the international footprint of its PARADIGM trial, securing regulatory clearance to study its DurAVR® Transcatheter Heart Valve in patients with severe calcific aortic stenosis in both France and Germany in 2026. The authorisations allow the company to start up clinical centres and begin recruiting patients in two established European TAVR markets.

Both Germany and France offer access to a network of structural heart centres and experienced investigators. These clearances also broaden the trial's European presence and mark another step in Anteris's clinical and regulatory progress for the DurAVR device.

What comes next?

The treatment landscape for aortic stenosis continues to evolve, with ongoing research focused on improving valve durability, reducing complications, and expanding treatment options. Clinical trials such as Anteris Technologies' PARADIGM study help evaluate whether emerging technologies can deliver meaningful benefits compared with established treatments, while providing participants with structured clinical monitoring and follow-up.

For Anteris, the trial is a key step in determining whether DurAVR's biomimetic design can deliver comparable or improved outcomes for those suffering from Aortic Stenosis. The company's findings will help shape the medicine and biotech industry's path toward new treatments and help for those suffering with heart conditions.