Break it Down: EBR gets approval for WiSE in reimbursement scheme
In this episode, host Tylah Tully takes a look at EBR Systems (ASX:EBR), which has received preliminary approval from the US Centers for Medicare and Medicaid Services (CMS) to participate in the Transitional Pass-Through (TPT) reimbursement scheme.
The scheme encourages hospitals to adopt breakthrough technologies that deliver clear clinical benefits but aren't yet covered under standard Medicare payments. and will drive adoption for EBR's WiSE CRT System.
Watch the video to learn more.
While EBR Systems is a Stockhead advertiser, it did not sponsor this content.
Originally published as Break it Down: EBR gets approval for WiSE in reimbursement scheme
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News.com.au
11 minutes ago
- News.com.au
Biocurious: with fresh grant funding, Emvision's Emu stroke device won't take a step backwards
A fresh $5 million government grant takes Emvision's cumulative non-dilutive funding to $25 million The company is trialing its Emu stroke detection device with a view to FDA clearance The lightweight variant First Responder could give ambulances rapid stoke detection capabilities With US biotech grant funding under pressure, drug and device developers need to delve more deeply for sources of valuable non-dilutive capital. Happily, numerous programs are still available for Australian life sciences plays willing to do their homework. In the case of stroke and traumatic brain injury (TBI) detection device developer Emvision, grant funding and partnerships have underpinned the company since it was formed in 2017. Co-founder and CEO Scott Kirkland puts the running tally at $25 million. This month, Emvision was awarded a $5 million Australian Government Industry Growth Program Commercialisation and Growth Grant. The funding is to accelerate development of Emvision's portable brain scanner, First Responder. Other funding sources have included the Australian Stroke Alliance, the NSW Medical Devices Fund and – we kid you not – the Modern Manufacturing Medical Products Manufacturing Translation Stream Project. Take nothing for grant-ed Kirkland says applying for grants takes significant time and management focus – and companies usually need to kiss a lot of frogs. 'You really need to dig around on the guidelines and look at what they have funded previously,' he says. 'But there are plenty of opportunities where objectives are boosting domestic manufacturing, creating engineering roles, generating IP and tackling the big health and societal burdens.' In the case of the US, the military complex can fund programs of specific interest, such as TBI assessment. The company is likely to progress TBI – a 'significant unmet need' – via a collaboration or grant. The Golden Hour As far as 'big health societal burdens' go, Emvision is tackling the need for more portable – and thus faster – ways to detect a stroke. The first 60 minutes post-event is known as the Golden Hour. But even the second hour – dubbed, you guessed it, the Silver Hour – is vital. 'With a stroke, time is brain,' Kirkland says. 'The faster it is diagnosed and treated; the more of the brain function that can be saved'. If treated early, a clot is softer and more treatable via clot-busting drugs or surgical removal of the blockage. In the US, a study of Mobile Stroke Units (MSUs) with a CT (computed tomography) scanner reported 33% of patients being treated in the first hour. This compared to just 3% for the normal ambulance arm. 'If you can bring the diagnostics tools to the patients, you save a lot of time to achieve better functional outcomes and less disability,' Kirkland says. Different strokes for different folks Clinicians and paramedics need to know whether the stroke is a blockage (ischaemic) or a bleed (haemorrhagic) as different treatments apply. To date, patients have been imaged with bulky, centralised scanners in hospitals. Emvision is developing a portable bedside scanner – Emu – which can be moved bed to bed on a cart. These units weigh about 100 kilograms, compared with a few tonnes for a typical CT unit. A trained healthcare professional can operate Emu, whilst a CT requires a radiographer. In a regular neurological intensive care unit, Emu's ability to hop from bed to bed is better than carting fragile patients to radiology. Emvision hopes Emu will pave the regulatory pathway for First Responder, its backpack-sized version for use in road and air ambulances and remote locations. On trial Emvision's work currently revolves around a pivotal trial for Emu, to support US Food & Drug Administration (FDA) clearance under the De Novo (novel device) pathway. The company hopes this will pave the way for First Responder approval under the less arduous 510(k) predicate device route. The US trial sites consist of New York's Mt Sinai, Florida's Mayo Clinic and Houston's Memorial Hermann Texas Medical Centre. A west coast site is pending. Locally, the trial has enlisted the Royal Melbourne Hospital and Sydney's Liverpool Hospital. They are all high calibre research centres handling high stroke volumes. The study aims to enrol up to 300 suspected stroke victims, who will receive the usual clinical care along with an Emu scan. Overlaying that, Emu then determines whether the stroke is a bleed or not, with a primary endpoint of at least 80% sensitivity and specificity for haemorrhage detection. Sensitivity is the ability to detect positive results, while specificity is the ability to discount false positives. The patients might have a different 'stroke mimic' condition, such as a migraine or epileptic seizure. 'We are seeking to also demonstrate that a 'mimic' does not confound our algorithms,' Kirkland says. Never a step back with Emu In an earlier domestic trial called Emview, Emu achieved 92% sensitivity and 85% specificity for bleed detection in a smaller cohort. For blockages, the results showed 95% sensitivity and 85% specificity. Kirkland says CT is good for detecting bleeds, with a 90-99% sensitivity. Without the use of contrast agents, it's less so for blockages (30-70%). (About 80% of stroke cases are blockages). Kirkland says while CT (or MRI) scans provide the 'ground truths', Emu's performance doesn't need to be identical to these machines. Especially in the case of First Responder, operators will use them where traditional neuroimaging is unavailable. Eyeing the US market While strokes afflict 15 million people annually – one-third fatally – there are fewer than 50 dedicated Mobile Stroke Unit ambulances globally. (Melbourne hosts two of them). That's because they cost upwards of $1 million to set up and a similar amount to operate annually. First Responder could provide every ambulance with a stroke and stroke type detection function. The US market eclipses anywhere else: 60,000 road ambulances – half the global tally – and 1500-1800 air ambulances. Post approval, Emvision's initial focus is likely to be in the expanded 'stroke belt' of southern states including Texas and Florida. For lifestyle and other reasons, the incidence of strokes there is much higher than the rest of the country. First Responder takes to the skies Alongside the Emu study, Emvision expects First Responder pre-hospital studies to get underway with the Royal Flying Doctor Service (RFDS), a Melbourne MSU and a standard road ambo. 'The initial focus is on feasibility, usability and how it fits into the workflow,' Kirkland says. 'In parallel, we are doing product development translation from advanced prototypes to commercial production units.' To date, RFDS scanning of healthy volunteers in real-world conditions has confirmed First Responder's durability. The company is obtaining ethics approval to scan actual RFDS patients. A cost-effective solution In theory, Emu and First Responder should walk off the shelves, given the age-old problem they promise to solve. But for cash-strapped healthcare systems, cost is always a factor. Kirkland expects an Emu to cost around $US175,000 – about a third of the price of a decent CT machine. First Responder is likely to be half or a third of the cost of an Emu. The company also expects to charge US$25 per Emu scan and US$50 per First Responder scan for a 'consumable'. This single-use item is a liquid that flows through a silicon membrane used to adjust to varying head sizes. 'We think we have a compelling, cost-effective solution,' Kirkland says. Kirkland says chasing grants requires patience as the process winds from initial application to presentations, due diligence and contract negotiations. 'I won't give away too many secrets because there are still a lot of grants we want to apply for."
News.com.au
12 minutes ago
- News.com.au
Inside content creator's $2.7m dream home switch
Controversial online personality Annie Knight splashed $2.7m on a 'forever home' after making $600,000 from an extreme six-hour stunt. The big-ticket purchase of a four-bedroom house with a pool is a big upgrade from her previous most expensive investment, an acreage home bought for $1.37m in August last year. Knight has now listed the earlier purchase, a Gold Coast house she had rented at $1100 a week, for sale. 'I bought the house of my dreams that doesn't need any renovating in a different area,' she said. 'So then I decided to sell the home I bought last year since I'd bought that with the intention of renovating and living in it. 'As an investment property, it just didn't make sense.' The 28-year-old, who was this week ranked in the top 0.01 per cent of creators on an online subscription platform, earlier revealed she had leveraged $600,000 in profit from a one-day filming event involving 583 people. 'When I say this is my dream home I mean it. It is so, so perfect, so much space, huge backyard, a pool.' While her purchase of the new four-bedroom house is yet to settle, Knight has listed her Currumbin Waters property for auction on August 22. The Tierney Drive home has three bedroom and two bathrooms over a 4,388 sqm bushland parcel, and is marketed by Coastal agent Emisha Canning. 'Tucked away at the end of a quiet street, this sun-dappled hideaway feels more like a secret treehouse than a suburban home,' the listing states. Features include high ceilings, timber floors and large windows framing a green outlook. An open-plan kitchen and dining zone flow to outdoor decking, while the main bedroom has an ensuite and there's also a study nook. The home's location was described as 'a quiet, family-friendly pocket where the bush meets the sea, just 10 minutes from Currumbin's surf breaks and rockpools, with local shops and sporting facilities all within easy reach'. Knight said the house had been rented last year, with the tenants since vacating ahead of the sale. PropTrack data shows house prices in Currumbin Waters were up 7.1 per cent over the past 12 months to a median of $1.2m. Knight retains another local investment property.
News.com.au
an hour ago
- News.com.au
Fitness coach exposes 5 fitness industry secrets
It seems that Instagram nowadays is flooded with ripped physiques and TikTok is full of 'What I eat in a day' videos. As a result, the impact of fitness influencers on Aussies' eating habits and body image has never been stronger. Recent research from The Butterfly Foundation revealed that 59 per cent of Australians say diet and fitness content on social media affects how they see themselves, while 63 per cent admit to comparing their appearance to what they see online. But behind the aspirational, time-stamped videos showing 'A day on my plate,' experts warn of a darker side to this wellness wave – one that encourages disordered eating, confusion, and unattainable ideals. Here are five little-known secrets about the fitness industry that experts want you to know. 1. 'Clean eating' and 'diet resets' are often restriction in disguise The language people use to talk about dieting is constantly evolving, and there are some common phrases gaining popularity that you should be aware of, as they might not mean exactly what they suggest. According to eating disorder therapist Jaime Dimarco, 'Using the term 'clean eating,' 'healthy eating,' and 'diet reset' are just more acceptable ways creators let their followers know they are heavily restricting their intake because they have body image issues'. While an influencer's fans might look to their diets for inspiration, Ms Dimarco says that behind the scenes, many 'have hormone issues, are malnourished and struggle with a silent eating problem'. Ms Dimarco, who has been an eating disorder therapist and recovery coach for five years, says that any diet where specific foods are completely avoided (unless for medical reasons) is simply 'fearmongering'. She points out that frequent and public vilification of certain food groups – such as carbs, meat, sugar, and fat – can contribute to widespread disordered eating. 'The truth is, no foods can actually cause health issues on their own … excessive amounts consumed can (just like anything in life),' she explains. Melissa Wilton, Head of Communications and Engagement at the Butterfly Foundation, echoes this, saying that such messaging 'can have a negative impact on our body image and relationships to food, eating, and exercise, because these posts invite comparison, and many people feel guilt or shame if their own intake or exercise regimes doesn't match up'. Certain wellness trends, she explains, are often 'diet culture in disguise' and can promote the idea that a smaller body weight and size equals health, with food being categorised as 'good' and 'bad'. This, in turn, can perpetuate the harmful 'thin ideal,' fatphobia, weight stigma, body dissatisfaction, and a disordered relationship with food. 'Dieting is the most common form of disordered eating, and the act of starting any diet increases the risk of an eating disorder developing in young people by five times,' she says. 2. Supplement promotions often focus solely on profit Scroll through any fitness influencer's page, and you'll likely see discount codes for supplements promising miraculous results. But nutritionist and qualified online coach Max Dimarco (who is married to Ms Dimarco and whose businesses work closely together) urges people to look beyond the tempting deals. 'Many influencers promoting supplements, especially those with larger followings, do so for commission on each sale, not because they genuinely care or even understand what they are promoting,' Mr Dimarco, who has 13 years in the industry, says. 'There is no such thing as a fat-burning supplement. It's just an appetite suppressant, typically triggered by caffeine. Yes, a long black could do the same.' He adds that top-tier influencers are often paid significant sums upfront to promote certain supplement brands, while micro-influencers might do it for free products and the validation of being associated with well-known brands. 'Most of these influencers couldn't tell you what's in the supplement or its supposed benefits,' he claims. 'They post the script provided for a video but are easily exposed when replying to followers' comments.' 3. Yes, many people still heavily edit their photos Even those who seemingly 'have it all' feel pressured to edit their images, Ms Dimarco reveals – even in a world where people are more aware than ever of photo editing. She explains, 'The need to edit photos usually comes from body dysmorphia or the desire to keep up with other influencers who also edit their images. 'It is so accessible now, and because technology is so advanced, an image can be enhanced within seconds. Many influencers have become so skilled at editing that their followers can't even tell the difference.' However, this illusion may drive followers, often young and impressionable girls, to adopt overly restrictive diets in an attempt to reach the same standards as their favourite influencer. 4. Not all coaches are qualified to give nutrition advice The online coaching industry is booming, but Mr Dimarco warns that many have limited credentials. 'Many give out personalised nutrition advice to clients without the proper qualifications, which is actually illegal,' he explains. 'A coach offering nutrition coaching or meal plans must be registered as a qualified Nutritionist or Dietitian. Most coaches out there don't have these qualifications.' He advises to watch out for red flags, such as generic meal plans, calorie targets, or strict restrictions, and to always verify a coach's credentials before committing. Also, if a coach provides nutritional advice without asking about your menstrual cycle, digestive health, hydration, or mental health related to training and eating, Mr Dimarco says to steer clear. 'They are neither qualified nor educated enough to give health advice,' he warns. 'This can lead to hormone issues, eating disorders, and toxic habits.' 5. Performance-enhancing supplements are widespread The myth of a 'natural' transformation is everywhere but may be seriously misleading, as many fitness influencers secretly use performance-enhancing substances. Mr Dimarco says, 'It's more common than most realise. I'd estimate over 90 per cent of popular fitness influencers use them. 'What was once considered a very 'taboo' subject is now becoming normal.' He says there is an increasing number of women using these substances, who claim their results are just due to standard supplements. 'There are many female influencers promoting their body changes as 'hard work' or because they started taking creatine. I've been in the industry long enough to see the signs from a mile away,' he reveals. 'When you see someone with a dramatic transformation in a short time – especially a huge change in their glute to waist ratio – it's obvious. 'This is often accompanied by skin issues like severe acne or a deepening voice.' The hidden use of these enhancements worsens the already unrealistic standards in the fitness community.
