Several ASX medtechs are focused on the cardiac space. Pic: Getty Images
Health & Biotech
Cardiovascular diseases (CVDs) are the leading cause of death globally, responsible for the loss of ~17.9 million lives each year, according to the World Health Organisation (WHO).
The WHO says CVDs are a group of disorders of the heart and blood vessels and include coronary heart disease, cerebrovascular disease, rheumatic heart disease and other conditions.
“More than four out of five CVD deaths are due to heart attacks and strokes, and one third of these deaths occur prematurely in people under 70 years of age,” the WHO says.
According to the American Heart Association between 2017 and 2020, 127.9m US adults (48.6%) had some form of CVD, which accounted for 12% of total US health expenditures in 2019 to 2020, more than any major diagnostic group.
Behavioural risk factors of CVD include an unhealthy diet, physical inactivity, tobacco use and harmful use of alcohol, while environmental risk factors include air pollution. An increasing ageing population is also expected to further see the incidence of CVD rise.
Among this backdrop, the cardiology sector is emerging as one of the most profitable areas within healthcare, encompassing a broad range of products and services, including diagnostics, pharmaceutical and devices for treatment.
On the ASX there are several medtechs focused on the cardiac sector. Here are some turning heads of late.
This disruptive medical device company has developed the world’s only MRI compatible devices for performing cardiac ablations, where a catheter is guided into the heart to selectively destroy cells responsible for causing electrical disturbances resulting in arrhythmias (irregular heartbeats).
The procedure is currently done under X-ray guidance, known as X-ray fluoroscopy, with the problem being X-ray is good at showing hard structures like ribs and the catheter itself but can’t visualise soft tissue like the heart, making it hard for physicians to know they’ve done the ablation completely in the area causing the arrhythmia.
The long-term, first-time success rates can be as low as 50% with patients often requiring two to three procedures to permanently fix the arrhythmia with X-ray fluoroscopy also exposing patients and medical staff to radiation throughout the procedure.
IMR is succeeding in the long desire of clinicians to do cardiac ablations under the superior imaging capabilities of magnetic resonance imaging (MRI).
Protected by more than 90 patents, its equipment looks and feels the same as the ones physicians currently use for the procedure but are safe and effective for use inside the strong magnetic fields created by an MRI scanner.
IMR last week announced that the first real-time iCMR-guided cardiac ablation in the US has been performed at The Johns Hopkins Hospital in Baltimore as part of its Vision-MR Ablation of Atrial Flutter (VISABL-AFL) pivotal clinical trial supporting US Food and Drug Administration (FDA) approval of its products.
The VISABL-AFL trial for FDA approval is a repeat of the trial the company already did in Europe for CE Mark approval for atrial flutter, which showed 100% success at the three-month follow-up.
Johns Hopkins joins the trial following the Cardiovascular Institute of South Paris (ICPS) in June with more hospitals set to come on board shortly and IMR due to complete enrolment this calendar year with the aim to have FDA approval by mid-2025.
In Europe, where the company has already received regulatory approval for atrial flutter, it’s about to start the VISABL-VT clinical trial for its second indication, ventricular tachycardia (VT).
Vice president of corporate strategy Nick Corkill told Stockhead VT is a very serious condition, which can be deadly.
“The first time success can be as low as 40% and procedure times can be several hours,” he says.
“This is where we think MRI can add significant value as doctors can see the heart in real time with the goal of delivering therapy in a more precise manner and in much less time.”
Corkill says the cardiac ablation market has been estimated at over US$10bn pa and is growing rapidly.
“The strong growth we see in the market is partially due to the rising incidence as the population ages, but with only 5% of patients currently getting an ablation we see the potential for improving safety and efficacy outcomes to drive even faster growth as more patients elect to have the procedure,” he says.
“There has been significant investment in mapping technologies and devices to help doctors guide what they are doing when inside the heart. We think using an MRI in real-time for complex arrhythmias like ventricular tachycardia will significantly reduce procedure times as well as improve first time success.”
Established in 2003 in Silicon Valley, EBR has developed the WiSE Cardiac Resynchronization Therapy (CRT) system, which holds the distinction of being the world’s first “leadless” pacing system for heart failure.
EBR focuses on treating heart failure patients with ventricular dyssynchrony, where the right and left sides of the heart are out of sync. In these patients, the right side of the heart beats, but the left side lags.
The standard treatment involves placing a lead outside the left ventricle to pace both sides simultaneously, but these leads can sometimes fail.
Roughly the size of a cooked grain of rice, EBR’s ground-breaking WiSE technology employs proprietary wireless techniques to administer pacing stimulation directly to the heart’s left ventricle and overcome problems associated with current standard of care.
The device consists of more than 100 meticulously assembled miniature electrical components, each delicately arranged by hand before being compacted into its cylindrical rice grain-like shape.
EBR announced positive top-line data from its pivotal SOLVE -CRT trial at the Heart Rhythm Society’s May 2023 conference. Additionally, the company released positive results from the SOLVE randomised sub-study in September 2023, further reinforcing conclusions from the primary study.
The company recently announced that results from its SOLVE trial had been published in JAMA Cardiology, an international peer-reviewed journal.
JAMA Cardiology is a leading journal for clinical investigators, clinicians, and trainees in cardiovascular medicine worldwide.
EBR is using a modular approach for its pre-market approval (PMA) submission to the FDA and is on track to deliver the fifth and final module in Q3 2024.
The company says commercial readiness activities are underway, including fostering relationships with key US clinical sites in preparation for FDA approval targeted in Q1 2025.
This medtech is focused on commercialising its patented artificial intelligence platform that detects, diagnoses, and helps address coronary artery disease.
The company’s flagship Salix Coronary Anatomy (SCA), is a breakthrough technology that can detect vulnerable plaque biomarkers from a Coronary CT Angiography (CCTA) within minutes.
A vulnerable plaque is essentially a soft plaque that ruptures and causes clots to block arteries. The plaque is particularly unstable, and prone to produce sudden major problems such as a heart attack or stroke.
In its latest quarterly update AYA says it has moved into the final phase of its application process for US FDA 510(k) clearance for for SCA.
“During the quarter we requested a second Q-sub meeting with the FDA to validate and confirm the activity of recent months,” the company says.
“This process gives us a high level of confidence our application is on track for a successful submission.”
The company has also signed its third strategic agreement with a major hospital on the US east coast, specifically chosen for their expertise and market share in cardiovascular care.
“Over the past two quarters, Salix has been validated and integrated with our strategic partners in a non-clinical setting to prove our approach, meaning we can immediately move to sales with FDA approval,” AYA says.
The company says furthermore its first commercial agreement in Australia with Cardiac Centre NSW is now in full swing with first revenues to due Q1 FY25.
Founded in Australia, with a significant presence in the medtech hub of Minneapolis in the US AVR has developed the world’s first single-piece transcatheter aortic valve called the DurAVR THV for treating aortic stenosis (AS).
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 (AS) 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 more than 55,000 patients worldwide.
AVR 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.
During a visit to Australia in April to attend Sydney Valves 2024, a conference focused on the latest in structural heart interventions, CEO and managing director Wayne Paterson told Stockhead AVR’s DurAVR THV boasts a distinctive shape designed to emulate the performance of a healthy human aortic valve.
Paterson says the new class of biomimetic (mimics nature) valve was deliberately designed to address unmet clinical needs in the treatment of AS.
“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.”
In CY25, AVR is due to start a pivotal randomised clinical trial for DurAVR. In its latest quarterly report the company says it has received positive feedback from the FDA on key elements of the pivotal, registration study.
At Stockhead, we tell it like it is. While Imricor and EBR Systems are Stockhead advertisers, the companies did not sponsor this article.
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