Biocurious: with fresh grant funding, Emvision's Emu stroke device won't take a step backwards

News.com.au

a day ago

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."