It’s been a rocky corporate journey for the ASX-listed Anteris Technologies over the years, but the heart device play holds rising hopes of cracking a $US11 billion ($14bn) global valve replacement market currently dominated by two US giants.
Until about six years ago heart patients too old or too sick for surgical aortic valve replacement – SAVR or open heart surgery – were told to go home and get their affairs in order.
A wonder of medical science, Transcatheter Aortic Valve Replacement (TAVR) procedures commuted that death sentence. Patients deemed unsuitable for grueling open-heart surgery could now have their dodgy valves replaced in a non-invasive procedure lasting about 20 minutes.
Initially, TAVR was restricted to older, high-risk patients. But in 2019, the US Food and Drug Administration (FDA) allowed TAVRs to be performed on lower-risk younger patients – and overnight the mean age of TAVR recipients tumbled from 85 to 73.
Arnold Schwarzenegger and Mick Jagger have both received one in recent years; with the latter reportedly back on stage within weeks.
But expanding the patient demographic has exposed a key problem: the artificial valves are not good enough to last the longer life expectancy of the younger recipients, some of whom are in their 60s.
According to Anteris chief executive Wayne Paterson, the existing valves are good for five years or so but eventually lose their efficacy because of the build-up of calcium deposits (aortic stenosis) and mechanical fatigue.
Formerly Admedus and before, Anteris is zeroing in on a solution with a threefold approach.
The first leg is its legacy product called ADAPT, which applies a patented treatment to the collagen bioscaffold material from which heart valves (and other surgical tissue) are made.
The second is its prosthetic aortic valve itself, called DurAVR (durable aortic valve replacement). As its name implies, the 3D one-piece valve is designed to last an expected lifetime of ten to 15 years, rather than the typical five-year expectancy of an 85 year old.
Paterson says traditional valves are made in three parts and connected by hundreds of sutures, which render them “mechanically compromised” and “anatomically incorrect.”
They also aren’t wide enough to meet the blood-flow requirements of younger patients who are likely to be more active.
The company’s third innovation is a guidance system called ComASUR, aims for a more reliable placement of the valves when inserted via a balloon catheter.
Invented in Australia by leading cardiothoracic surgeon Dr Leon Neethling, ADAPT is derived from collagen derived from local cattle (only Australian beef can be used as it is free of ‘mad cow’ disease).
While that in itself does not distinguish Anteris from its peers, Anteris claims superior performance in reducing the build-up of calcium deposits.
Being a xenographic material, the body will try to reject it. Given this danger, collagen makers seek to purge the animal material of all DNA, but trace amounts remain.
But the ADAPT technique eliminates all DNA, which causes the immune response (inflammation) that leads to calcification.
Anteris has reported positive results from its anti-calcification study, where its ADAPT treated tissue showed superior anti-calcification attributes compared with tissue used in the competitor valves of Medtronics and Edwards Lifesciences.
ComASUR, meanwhile enables an easier alignment of the commissures, the three points of the replacement valve that should align with the native valve.
“If you can land [the valve] it in the same place as the original valve you’ll get better blood flow,” Paterson says. “The problem is the clinicians are not able to do that consistently, or not at all.”
To date, animal studies have shown the feasibility of the use of the DurAVR valve, combined with the ComASUR guidance. The company is holding discussions with the FDA in view of initiating a human trial.
Management expects the study to be approved in the December quarter, with the company striving for US product approval by 2024 and European assent in 2023.
Meanwhile, seven patients have received the valves as part of a Europe-based SAVR study.
In order to prove superior valve efficacy, the overseers of a trial normally would need to wait ten to 15 years to assess the state of the implanted devices.
In the Anteris labs, test valves are attached to machines which compress 10 to 15 years of normal heartbeats into the space of months.
While the FDA requires a minimum test equating to 200 million heartbeats – the equivalent of about four years –Paterson reports “our valves have run to 750 million cycles and are still going strong”.
Paterson says that with ADAPT already used in 20,000 non-heart surgical repair procedures, Anteris has a multi-year head start in proving its anti-calcification credentials.
“We have ten years’ data in humans showing zero calcification,” he says.
To fund the ongoing work, Anteris recently secured a $20m funding package with Mercer Street Global Opportunity Fund LLC. The deal allows for initial $2.5 million and a further $4.05m realised (pre transaction costs) in the current quarter.
Anteris generated revenue of $7.07 million in the (first) December half, derived mainly from sales of its legacy patches (These assets were sold to the Massachusetts based Lemaitre Vascular Inc in 2019 for $36 million, but Anteris retaining manufacturing rights for three years.
“The next 12 to 18 months will be enormously exciting as we work to demonstrate the superiority of DurAVR against the current competitors, thus delivering physicians, patients and healthcare systems a life-saving product,” Paterson says.
With a mere $50 million market cap, Anteris could well be taken over ahead of gaining regulatory approval.
While shareholders will be the ultimate arbiters, Paterson hopes the company can continue to fly the flag for Australian medical innovation.
“Australia needs a global medtech company,” he says. “The ones we have are great, but we don’t have enough of them.”