Heart disease is far and away the planet’s biggest killer, making up 30% of all deaths worldwide.
It’s a sobering statistic – and some feat given that we’ve just been through a pandemic that, according to the World Health Organization, killed an extra three million people above the global average mortality rate in 2020.
We know the reasons. Like its rival, cancer, heart disease is non-communicable and firmly connected to a range of lifestyle factors such as diet, exercise, alcohol consumption and smoking, making it preventable in theory.
But given the current health trajectory around the world towards sedentary lifestyles and a lack of access to healthy, fresh foods, this disease is not going anywhere.
And unlike many cancers, it can be hard to detect and therefore suddenly fatal. The human heart is also a difficult thing to repair.
These and other reasons make the heart an intriguing and lucrative subject for a raft of clinically focused companies.
In this article:
- Enormous unmet medical need
- Lifestyle factors
- What can be done?
- Detecting the problem
- Treating the disease
Enormous unmet medical need
Heart disease is an umbrella term covering a range of conditions targeting the structure and function of the heart. It includes coronary heart disease, arrhythmias, heart failure and valve disease.
The likelihood of getting heart disease comes from a complex mix of genetics, demographics and lifestyle factors, and it can be difficult to detect.
This disease profile means that there is a wealth of potential preventative, diagnostic and treatment options waiting to be discovered for a killer that presents a market opportunity of US$6 billion for heart valve replacements alone – a figure estimated to grow to US$10 billion by 2028.
And this is the market for treating only 15% of patients – based on incidence prevalence data – so capturing only those who are diagnosed before they die.
If you look at the total market, it's a crazy number like US$30 or 40 billion, if you could treat everybody, which is of course what you want to do.
"The problem is early intervention. Firstly, there’s a bottleneck between the GP, the cardiologist and the surgeon,” says Anteris Technologies Ltd (ASX:AVR, OTC:AMEUF) CEO Wayne Paterson.
“Secondly, while early diagnosis for any disease is beneficial, a lot of the patients we’re talking about here are less likely to go to their physician when they should.”
Paterson talks of an awareness problem – of people who die from ‘sudden’ heart attacks who may well have had symptoms for a long time but ignored them.
“It's a huge unmet medical need.
“My view, based on my background in the pharmaceutical industry, is that you want to be treating 40 to 50% of patients with a fatal disease where you can as an industry, so there's a lot to be done.
“It's already a huge market at 15%. But there are many more patients out there, and patient awareness needs to go up.
“Companies such as ours need the help with the bottleneck in the system with the physicians to make sure patients can get treatment.”
Lifestyle factors
Epidemiologists think that one in eight elderly patients – above the age of 70 – have this disease.
But two twin demographic shifts are happening to compound the problem. The number of people older than 70 is increasing as populations start skewing older across the developed world.
At the same time, the age profile for heart disease is getting younger and younger.
In the last two decades, people under 40 who are having heart attacks have become a growing cohort. Between 2006 and 2016, heart attacks in this age group have increased by 2% each year.
The reasons are complex. High rates of obesity and high blood pressure among younger people – from age 35 to 64 – are putting them at risk for heart disease.
According to the CDC, almost 50% of all Americans have at least one of the top three risk factors for heart disease: uncontrolled high blood pressure, high cholesterol and smoking. And these conditions and behaviours are appearing at younger ages.
What can be done?
With all the variables at play, there is room for lots of clinical research to be done into heart disease.
“You've got this mega-trend of ageing populations, coupled with patients being kept alive longer because of medical interventions that have improved so much,” Paterson says.
“And on the back of that, you've got a lot more cardiac disease due to lifestyle factors. There are multiple factors that mean that this market, and this problem medically, is just going to keep growing and growing, as we are seeing now.”
Some biotechs working in the space choose to focus on prevention. For others, like Artrya Ltd (ASX:AYA), early intervention is the key.
Still others, like Anteris, are working on the mechanics of heart itself – and making impressive progress.
Work is also being done to understand co-morbidities, such as coronary vulnerability during cancer treatment.
An example of this is Race Oncology Ltd (ASX:RAC)’s preclinical research, revealing that the company’s asset Zantrene protects from anthracycline-induced heart damage, while acting in tandem with anthracyclines and inhibitors to improve their ability to target cancer.
Detecting the problem
For a problem where one Australian is dying every 13 minutes of a heart attack, the solution would appear to be proactive screening, if such a procedure were accurate, efficient and cost-effective.
But to do this would be impossible without an enormous strain on the health care system and a much higher rebate through the Medicare schedule. Or would it?
Artrya is a medtech company that developed the Salix system that identifies a strong predictor of heart disease in patients – soft or vulnerable plaque in the coronary arteries – using artificial intelligence.
The company believes that AI is the material breakthrough in preventative heart health.
Vulnerable plaque is not easily identified with the naked eye and not generally reported, because the clinicians that are qualified to do this are highly specialised, scarce and time-poor.
Artrya’s Salix system can identify the plaque and report its location and severity within minutes of a simple CT or CCTA scan being conducted on a patient.
“Artrya’s Software as a Medical Device, the Salix Coronary Anatomy AI technology, quickly analyses cardiac CT scans to assist clinicians in accurately determining the extent of atherosclerotic plaque,” says CEO Mat Regan.
“While current medical practices to report coronary artery disease focus on calcification and narrowing of coronary arteries, Salix’s breakthrough technology maps vulnerable plaque and other coronary biomarkers. Vulnerable plaque is the silent killer, the reason so many people suffer heart attacks with no warning signs.
"Salix can provide an automatically generated report within minutes, with much less human intervention. By reducing treatment costs per patient Salix will aid public health systems and health insurers.”
Currently, there is only 56-69% agreement between expert readers in identifying vulnerable plaque with the naked eye.
In addition, the process takes a long time because of the difficulty of it, and there’s an interpretive layer, so different clinicians will interpret it in different ways.
By contrast, the software is running above the expert readers at more than 70% accuracy, which will increase over time as the AI learns and improves.
This accuracy and efficiency will in theory allow patients undergoing a CCTA scan to get a vulnerable plaque reading in their report.
Once those at risk are identified, clinicians can then prescribe action, which might entail lifestyle changes such as diet or exercise, or drugs. The patient can then be proactive in minimising their risk of heart attack.
Treating the disease
As mentioned earlier, the human heart is difficult to repair. Over time, science has made progress in this area of medtech, with the use of bio-mechanical, bio-prosthetic and now bio-memetic valve replacement technologies that have been put into the body through invasive open heart surgery and, more recently, using catheters.
“We’re making a biomimetic heart valve – so called because it is 3D-molded to mimic the heart valve found in the human body,” says Anteris Technologies’ Wayne Paterson, whose company has created the DurAVR Transcatheter heart valve. “It looks and behaves like the valve it is supposed to replace.”
Earlier attempts at valve replacements, Paterson says, were akin to replacing a human arm with an octopus tentacle.
What’s more, unlike older valves that were made to last long enough to see out the last years of an elderly patient’s life, these valves are made to last a lifetime and are suitable for use in the younger cohort of patients doctors are now seeing.
Anteris’ valve also performs well in terms of blood flow, which is critical to prevent heart attack – the medical need replacement valves are supposed to meet.
The valve is delivered by catheter into the body, which means there is no need to ‘crack the chest’ for open heart surgery, a much more traumatic and invasive procedure that often leaves older patients dead on the table.
These breakthroughs – in preventative heart health, early detection and understanding co-morbidities and treatments to prevent fatality – will no doubt be welcome additions to the medtech landscape in the fight against the world’s number one cause of death.