Thinking ahead – ASX MedTech leaders

Here’s the fourth instalment of our series on the fascinating ASX cohort of medical device developers.

ImpediMed (IPD, 8.1 cents)
Market capitalisation: $83.8 million
Three-year total return: -52.7% a year
Analysts’ consensus target price: 14 cents (Thomson Reuters)

You would not know it from the share price performance over the last few years, but Brisbane-based ImpediMed has put some world-class technology in the clinic. ImpediMed’s bio-impedance spectroscopy (BIS) devices non-invasively measure a patient’s total body water and extracellular and intracellular fluid volumes – and tissue composition – to help doctors assess and treat chronic diseases. The BIS measurement takes less than 30 seconds.

Fluid imbalance has significant clinical implications, and detailed knowledge of fluid levels can tell doctors a lot.

ImpediMed produces a range of medical devices, which are approved for sale in the US by the Food & Drug Administration (FDA) and CE-Marked for sale in Europe. The flagship product is the SOZO digital health platform aimed at multiple indications, including heart failure, lymphoedema (limb swelling caused by a lymphatic system blockage, most commonly caused by lymph node removal or damage due to cancer treatment) and protein calorie malnutrition.

Using ImpediMed’s BIS technology, SOZO measures 256 unique data points over a wide spectrum of frequencies from 3 kHz to 1000 kHz. The SOZO fluid analysis for lymphoedema helps doctors in the early detection of lymphoedema in the arms and legs. It utilises ImpediMed’s proprietary L- Dex lymphoedema index, which is 80% sensitive and 90% specific in detecting sub-clinical lymphoedema. If detected, the progression of lymphoedema can be prevented – or even reversed, by wearing a compression sleeve. If not treated, it can become an irreversible, life-long debilitating condition that gets progressively worse. Early detection of lymphoedema using SOZO allows early treatment, which prevents progression to serious disease. 

The SOZO fluid analysis for heart failure provides an objective measure of fluid overload in heart failure patients. It uses ImpediMed’s HF-Dex heart failure index which is a measure of extracellular fluid as a percent of total body water: the reading is analysed against guidelines and the appropriate fluid volume found in healthy people. HF-Dex also includes an assessment for patients with end-stage renal disease (ESRD). 

SOZO – which can be assessed remotely – allows doctors to easily and accurately assess changes in a patient’s condition, get earlier diagnoses, alert them to the need for intervention, through a non-invasive test. It is a software-as-a-service (SaaS) product, which generates ongoing revenue from subscribers.

Last month, pharma giant AstraZeneca signed a $2 million deal to lease 175 SOZO devices, across 20 countries, as a Phase II trial to measure fluid volume in patients with heart failure and chronic kidney disease. AstraZeneca has used ImpediMed’s BIS technology for a number of years to measure subjects’ fluid volumes in their clinical studies, but this is their biggest order. The pharma giant is conducting a Phase II trial of two drugs in heart failure patients who also have chronic kidney disease, which will run over 18 months.

HeraMED (HMD, 14.2 cents)
Market capitalisation: $21 million
Three-year total return: n/a
Analysts’ consensus target price: n/a

A scary experience in 2011 with he and his wife’s third pregnancy was the spark for David Groberman, founder and chief executive officer of HeraMed, to develop a digital pregnancy monitoring solution. One day, his wife was convinced that their baby had stopped moving in the womb: the couple raced to a clinic, but it took hours to get the baby checked, and hours for the result to come. It was good news – but Groberman was amazed that it took so long.

The outcome was HeraBEAT, a medical-grade foetal heart rate monitor, and a fully integrated smartphone app that monitors foetal heartbeat in the home to hospital standards. The device incorporates a portable ultrasound Doppler device that makes it reliable, safe to use and proven, while amplifying its accuracy and efficiency.

HeraBEAT has been extended into HeraCARE, a digital (SaaS) platform designed to be a new model of care for women throughout pregnancy. The digital platform will deploy AI powered algorithm and combination of a digital platform and smart connected devices to assist expecting mothers as well as healthcare professionals in better managing their pregnancy care, with a focus on personalised, continuous and proactive home-oriented solution, transforming the doctor-patient relationship from today’s episodic, visit-centric and inconvenient healthcare to a future of home-based, continuous “connected health.” HERABeat was approved for use in the US as a clinical medical device in November 2019.

The Israeli-based company announced a major partnership in September 2019, a deal with the world-famous Mayo Clinic in the US to join forces to co-develop a new platform – Mayo was impressed with how HERAMed could augment its OB Nest digital pregnancy platform. HERACare was built out of this collaboration: in July 2020, the Mayo Clinic invested US$100,000 in HERAMed, buying 1.19 million shares in the company.

Last month, HERAMed signed a Letter of intent with leading US provider of virtual care, eCare21, to integrate its technology into the eCare21 platform.

Recently, the FDA approved foetal heart rate monitoring for home use. COVID-19 has galvanised the fast-track adoption of digital health: governments, insurers and providers are increasingly adopting and reimbursing innovative “telehealth” solutions. The rise of telehealth could lead to a permanent shift in healthcare: HMD is banking on maternity care representing a big opportunity within telehealth. The company is a loss-maker, but is pregnant with potential.

Respiri (RSH, 22.5 cents)
Market capitalisation: $147 million
Three-year total return: +84.2% a year
Analysts’ consensus target price: n/a

Formerly known as iSonea, Respiri is a medical technology company that develops devices and mobile health applications to improve the management of chronic, costly respiratory disorders.

Respiri’s technology is to designed to make the process of how asthma patients and their physicians monitor and manage their asthma much more efficient. The company’s wheezo asthma management tool – which is currently being launched – is an eHealth app combined with a simple, easy to use, hand-held device, which records the user’s breathing over a 30-second period and analyses the recording for wheeze. The app also allows users to track other important asthma symptoms, triggers, medication usage, location-specific weather and environmental factors (pollen, pollution, air quality).

It is also a SaaS product. The device and app make up a secure, cloud-based mobile health platform that records wheeze and other clinically relevant asthma symptoms, compiling crucial information about triggers, symptoms and events. Patients can easily share their data (wheeze recordings, symptoms, triggers, medication use) with their healthcare professionals to facilitate shared decision making. 

wheezo has CE-Mark approval for sale in Europe, and is approved by the Therapeutic Goods Administration for sale in Australia: Respiri has filed a 510(k) application – a medical device application – with the US FDA.

Respiri is certainly targeting a substantial market – in 2019, 11.2 of Australians had asthma, according to the Australian Institute of Health & Welfare (AIHW). 45.3% of patients have poorly controlled asthma. Asthma affects quality of life, productivity at work and school, and can lead to devastating outcomes: in 2017, says AIHW, 441 Australians died as a result of their asthma. The World Health Organisation (WHO) says more than 340 million people worldwide suffer from asthma.

Wheezo also looks to be capable of playing a role in the management of other severe respiratory diseases, such as chronic obstructive pulmonary disease (COPD). 

Again, Respiri is a loss-maker, and investors are backing wheezo to make a global splash.

James Dunn

James is an experienced senior journalist and host of The Inside Network's industry events.