- Anteris has developed the world’s first, single piece transcatheter aortic valve called the DurAVR™ THV
- The DurAVR THV is the only TAVR to demonstrate near normal flow consistently in aortic stenosis patients
- Device developed in collaboration with leading global interventional cardiologists and taps into a US$10 billion market
Anteris Technologies will use this year to prepare for a pivotal registration trial as the cardiac device company looks to revolutionise treatment of aortic stenosis (AS), a potentially fatal heart disease with a growing, multi-billion dollar market.
Founded in Australia, with a significant presence in the MedTech hub of Minneapolis in the US, Anteris Technologies (ASX:AVR) has developed the world’s first single-piece transcatheter aortic valve called the DurAVR THV.
The DurAVR THV was developed in collaboration with leading interventional cardiologists and cardiac surgeons globally and has been shown to restore normal (pre-disease) aortic blood flow in aortic stenosis patients.
The DurAVR THV is crafted from AVR’s patented anti-calcification ADAPT tissue technology, which has a track record of more than a decade in clinical use and has been distributed to over 55,000 patients worldwide.
Stockhead recently caught up with CEO and managing director Wayne Paterson on his visit to Australia to attend Sydney Valves 2024, a conference focused on the latest in structural heart interventions.
How does the DurAVR THV work?
To understand how the DurAVR THV works, it’s essential to comprehend the pivotal role of an aortic valve in the body’s cardiovascular system, as well as the specific condition that the device is treating.
Paterson says the aortic valve regulates blood flow from the left side of the heart to the body. The left ventricle (one of four heart chambers) pumps blood from the lungs through the aortic valve to the rest of the body.
“During heart contractions, the aortic valve opens, allowing oxygen-rich blood from the left ventricle to enter the aorta, the main artery,” he says.
“Aortic stenosis is the abnormal narrowing, thickening, and stiffening of this valve, hindering blood flow.”
Paterson says AS is a common, serious, and potentially life-threatening condition, predominantly affecting older people, with treatment involving a minimally invasive transcatheter aortic valve replacement procedure (TAVR or TAVI) or surgery to repair or replace the faulty aortic valve.
He says one in eight people aged over 75 show moderate to severe AS and it is fatal for 50% of patients if untreated for two years with still only ~15-20% of severe cases treated.
“This is the only Australian company in the space,” Paterson says.
Out-pacing competition
Paterson says AVR’s DurAVR THV boasts a distinctive shape designed to emulate the performance of a healthy human aortic valve. This new class of biomimetic (mimics nature) valve was deliberately designed to address unmet clinical needs in the treatment of aortic stenosis.
He says AVR’s initial clinical studies reported results which demonstrate >30% superiority versus current therapies when compared to similar sized valves.
“The space commercially is projected to be US$10 billion by 2028 and there are two main companies out there – Edwards Lifesciences, with approximately 65% of the US market, and Medtronic, both US companies,” he says.
“There’s been no innovation in valve design for a decade and we are the first new class of product in this space in 10 years and we have robust IP around all aspects of our design innovation.”
The latest data includes 30-day results for all 28 patients treated in the First-In-Human Study (Cohorts 1-4) in addition to 30-day results for all 15 patients treated in the US Early Feasibility Study.
“We now have 50 patients in total treated with DurAVR THV across Europe and the US and it’s the only product in this space giving a pre-disease curative blood flow,” he says.
“The way clinicians diagnose and calibrate the severity of aortic stenosis is the mean gradient.”
Paterson says a healthy state mean gradient range is 5-10 mmHg and that is the treatment objective.
“When patients present with symptoms, they are probably at about 20-25mmHg and when they’re very symptomatic they’re at 40-50 mmHg, which is the marker for severe disease,” Paterson says.
“We’ve treated patients with gradients as high as 80-90 mmHg, but 40-50 mmHg is bad, and a lot of damage is being done because the pressure is so high across the aorta and the opening has narrowed so much.”
He says that extra pressure can lead to stroke or heart attack, peripheral damage of blood vessels and can lead to problems with the heart’s left ventricle, the heart chamber responsible for pumping oxygen rich blood to tissues all over the body.
“The more pressure that builds up, the more work that the left ventricle is doing because it does all the pushing, so it gets bigger like a muscle working out,” he says.
“But when the left ventricle gets too big it can stop working so instead of being more effective because it’s getting strong, it is getting weaker leading to heart failure.”
“There was a real need for a product that takes a patient out of the disease state as the current ones bring patients back to mild disease before the valves start to degrade and the condition goes back to moderate and severe, so it’s a repeated cycle.”
AVR is now approaching the start of a pivotal registration trial, which the company anticipates beginning in 2025.
Experienced board and leadership plus strong support
Paterson joined AVR in 2014 as a NED and later became chairman. In 2017 he became CEO and MD after an extensive global career in pharmaceuticals in Asia Europe, and the US.
Paterson has also been on the board of other NASDAQ-listed biotech companies and says the board and leadership team of AVR has extensive experience in getting to market medical pharmaceuticals and devices.
“We are fortunate enough to work with an advisory board comprising some of the biggest centres in the US including Cleveland Clinic, Columbia and others so the guys that do thousands of TAVR procedures currently designed this product,” he says.
He says the clinicians are highly regarded in their field globally with enormous influence in the field.
Furthermore, AVR has strong support from major health care funds, with its biggest investor Perceptive Advisory a major hedge biotech fund in the US and L1 a joint US /Australian fund.
“In New York where we spend a lot of our time there are very dedicated healthcare funds with deep global knowledge and expertise in this space,” he says.
“Some of these funds will invest on the ASX and we have some great names on our register.”
Part of Canada’s Special Access Program
AVR’s device has been used in successful Valve-in-Valve (ViV) procedures through Health Canada’s Special Access Program (SAP).
SAP facilitates the provision of life-saving technologies not yet commercially available in Canada when no other alternatives are suitable.
Paterson says a ViV procedure becomes necessary for patients when their existing bioprosthetic aortic valve starts to fail due to calcification or structural decline.
In such instances, a new heart valve must be inserted within the malfunctioning valve.
These patients are at a heightened risk for further surgical interventions and require a minimally invasive treatment option.
‘Results that look like a pre-disease state’
Interventional cardiologist and AVR chief medical officer Dr Chris Meduri says DurAVR THV is “really is a different class of technology”.
“With DurAVR we are seeing clinical results that look like a pre-disease state, with excellent hemodynamic performance and good laminar flow,” he says.
“In addition, it is incredibly easy to use.”
Professor of medicine at Columbia University Rebecca T. Hahn has also praised the AVR technology.
“The hemodynamics are so fantastic yet it has the ease, reliability, and accuracy of the balloon expandable valve,” she says.
“It combines all those things in a really well-designed valve.”