ASX medtechs poised to transform healthcare with upcoming catalysts in 2024

In 2024 several ASX medtech companies have upcoming catalysts as they strive to innovate healthcare
Primary results of EBR’s SOLVE trial expected to be published in a leading peer reviewed journal in coming months
ImpediMed is focusing initially on the US market and has five key goals for the next 12 months

Recent years have marked significant milestones for ASX medtech firms, showcasing groundbreaking advancements at the intersection of cutting-edge technology and healthcare.

Medical technology encompasses technologies that diagnose, treat and enhance individuals’ health and wellbeing, spanning from low to high-risk medical devices, according to the Asia Pacific Medical Technology Association (APACMed).

These innovations empower healthcare professionals to deliver more accurate and timely care, ultimately enhancing patients’ quality of life.

READ: ASX medtechs poised to transform healthcare with upcoming catalysts in 2024 – Part 1

Several ASX medtech companies are poised for a promising year ahead, with upcoming catalysts. Here’s some more we’ve noticed.

EBR Systems (ASX:EBR)

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.

The company was described by early investor and well-known venture capitalist Mark Carnegie as having potential to “be as big as Cochlear” when it made its IPO in 2021.

Roughly the size of a cooked grain of rice, the ground-breaking WiSE technology employs proprietary wireless techniques to administer pacing stimulation directly to the heart’s left ventricle.

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.

To date more than 500 patients have been implanted with the tiny WiSE device, including some approaching 10-year anniversaries.

EBR achieved a key catalyst in May 2023, announcing positive results of its pivotal SOLVE-CRT (SOLVE) trial at the Heart Rhythm Society’s (HRS) 2023 conference in New Orleans.

The randomised results were presented at Asia-Pacific HRS in September 2023.

Senior vice-president of business development Andrew Shute says EBR is expecting the primary results of the SOLVE trial to be published in a leading peer reviewed journal in the coming months.

The company is using a modular approach for its pre-market approval (PMA) submission to the US Food and Drug Administration (FDA).

“The fifth and final module is on track to be submitted in Q3 2024,” Shute says.

“This is significant as it starts the FDA’s period for review, and we are targeting approval in Q1 2025.”

Shute says EBR is also planning expansion of its office and manufacturing facility in Silicon Valley.

“We are in the process of identifying a new facility close to our existing office,” he says.

“As we approach commercialisation we require a larger facility to host the planned expansion of our corporate and commercial teams and importantly increasing our existing manufacturing space and capability to meet future demand for our product.”

ImpediMed (ASX:IPD)

Founded and headquartered in Brisbane IPD is a world leader in the design and manufacture of medical devices employing bioimpedance spectroscopy (BIS) technologies for use in the noninvasive clinical assessment and monitoring of fluid status and tissue composition.

In 2017, IPD launched SOZO, which is the only FDA-cleared BIS solution for the clinical assessment of lymphoedema.

SOZO aids in the early detection of secondary lymphoedema, provides fluid status for patients living with heart failure and allows measurement and tracking of various body composition parameters.

Clinical use of SOZO is backed by PREVENT, the largest randomised controlled trial (RCT) for lymphoedema prevention in breast cancer patients, in which 92% of patients with early detection using BIS and intervention did not progress to chronic lymphedema.

The PREVENT trial recruited 1200 breast cancer patients across 10 centers with data showing that patients can develop breast cancer-related lymphoedema from a few months to three years after treatment, emphasising the need for careful screening for years following treatment.

Interim CEO and MD Dr Parmjot Bains says 2024 is gearing up to be transformational for IPD, which is initially focusing its efforts on the US market with five key goals for the next 12 months including:

Ensuring every new US breast cancer patient can access early lymphoedema prevention through focused sales execution
Delivering world-class customer experience and rapid implementation
Expanding reach for all cancer patients (pelvic, melanoma) at risk of leg lymphoedema
Reach break-even through acceleration of revenues and management of expenses and maximise shareholder value.
Develop innovative partnerships to accelerate patient impact into existing and new patient populations.

“In April 2024 we implemented a range of organisational changes that will support increasing sales, reducing costs and defining our longer-term product roadmap and commercialisation strategies,” Bains says.

IPD announced the appointment of Tim Benkovic to the role of senior vice president sales and customer success, based in the US and other organisational changes in April.

“This team has the necessary skills and experience in sales, marketing, medical affairs, R&D, finance and operations and I am confident we are well positioned to accelerate the growth of this business,” Bains says.

“We have a strong and growing sales pipeline and I’m excited about our prospects ahead.”

Anteris Technologies (ASX:AVR)

AVR will use 2024 to prepare for its global, pivotal registration trial as it aims to transform the treatment landscape for aortic stenosis (AS), a potentially life-threatening heart condition with a lucrative, expanding market.

AS occurs when there is a narrowing of the aortic valve in the heart, restricting blood flow from the heart to the body’s main artery, the aorta, and subsequently to the rest of the body. Following the onset of symptoms ~50% of AS patients do not survive more than two years.

Originating in Australia, with a notable presence in the MedTech hub of Minneapolis in the US, AVR has taken a deliberate approach to solving a critical unmet medical need by creating the first new class of transcatheter aortic valve in over a decade, known as the DurAVR THV.

The DurAVR THV uses a single piece of ADAPT tissue to create a more ‘human-like’ valve designed to meet the needs of today’s younger and more active AS patients.

Developed through collaboration with top interventional cardiologists and cardiac surgeons worldwide to address current treatment gaps, the DurAVR THV has demonstrated its ability to restore normal aortic blood flow in patients suffering from AS.

CEO Wayne Paterson told Stockhead with the ADAPT platform having shown best in class data over more than 10 years in thousands of patients, the company capitalised on the proven strengths of the material and decided to address an unmet medical need in a serious (and fatal disease).

“In a disease that cannot be treated with any drug, physicians are faced with replacing the aortic valve as the only solution,” he says.

“The existing therapies don’t actually take the patient back to a pre-disease state.”

“Anteris has developed the first new class in this therapeutic area in 10 years by capitalising on its platform strengths.

Paterson says with more than 60 patients treated so far in the US and Europe, AVR is not only seeing the best results of any product in the disease, but its proprietary device is also simple for physicians to use.

AVR is currently gearing up for the pivotal registration trial with clinical trial site selection underway and a staged scale up in manufacturing planned for the remainder of CY24.

Patient enrolment into the pivotal trial is forecast to start in CY25 with clinical trial sites across the US, Europe, and Australia.

The pivotal study, which forms a critical step in the successful registration and subsequent commercialisation of the DurAVR THV, will build on AVR’s initial clinical study results which demonstrate >30% clinical superiority to the market leader as measured by the defining haemodynamic (blood flow) disease parameters, effective orifice area (EOA) and mean pressure gradient (MPG).