Emvision is flying high after initial testing of its portable stroke device. Pic via Getty.
Health Check: Emvision’s stroke detector takes to the skies
Health & Biotech
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- Emvision to launch remote stroke detection trial
- It’s a tricky market but biotechs are raising funds
- Imugene wins FDA fast-track status for cancer program
Ahead of a wider trial, Emvision Medical Devices (ASX:EMV) has taken to the air with initial proof-of-concept testing of its portable device to detect strokes and traumatic brain injury.
Under an existing ethics approval, the First Responder device was road – or air – tested in remote locations, in collaboration with the Royal Flying Doctor Service (RFDS) and the Australian Stroke Alliance (ASA).
“RFDS staff received preliminary training in the operation of the device and the scans were successfully completed under an existing ethics approval,” the company says.
“Pleasingly, First Responder demonstrated an ability to withstand the physical stress, environmental conditions and operational constraints unique to aeromedical retrieval.”
Emvision has applied for ethics approval for a study in which the RFDS will enrol at least 30 patients for an eight-week “usability and workflow implementation study”.
The backpack-sized First Responder is a lighter version of Emvision’s Emu.
Emu is a bedside device which itself is way less heavy than traditional computed tomography or magnetic resonance imaging scanners.
Emu also has been undergoing hospital testing.
The devices ascertain whether a stroke is a blockage (ischemic, the most common form) or a bleed (haemorrhagic).
The difference is not just academic, because treating bleed patients with anticlotting drugs – the remedy for ischemic strokes – can be fatal.
Strokes are best treated in the first hour – the so-called Golden Hour – post event.
In the company’s words: “rapid triage, transfer and treatment decisions are critical to minimise brain damage, disability and death.”
Strokes are the world’s second biggest killer, with 15 million cases a year (55,000 in Australia, or 150 per day). Five million of these patients will die and one third will have a permanent disability.
ASA co-chair and neurologist Professor Geoffrey Donnan says patients in rural and remote locations have 17% more strokes than urban dwellers and receive less specialist stroke care.
The company also intends to use Emu to scan acute suspected stroke cases attended by the Melbourne Mobile Stroke Unit.
The unit is the country’s only specialist service of its ilk.
Biotechs pass the hat
Defying difficult market conditions, multiple biotechs have been raising equity – mainly in small amounts.
The big daddy exception is heart-device maker Imricor Medical Systems (ASX:IMR), which is undertaking a placement for a minimum $70 million at $1.41 apiece.
Remarkably, that’s at no discount to Friday’s ‘frozen’ close before a trading halt.
The deal also has been done at a modest 3% discount to the average 30-day weighted price.
Oncology drug developer Chimeric Therapeutics (ASX:CHM) has launched a rights offer to raise $3.2 million at half a cent apiece, a 23% discount.
The shares come with a one-for-one option exercisable at 0.8 cents, by December 19 this year.
The maker of consumer products under the Hydralite brand, The Hydration Pharmaceuticals Company (ASX:HPC), raised $650,000 in a placement at one cent apiece and $610,000 more in a rights issue.
Lung imager 4D Medical (ASX:4DX) attracted $5.5 million in a placement, with a $7 million share purchase plan (SPP) closing yesterday.
The placement was stuck at 42.5 cents.
SPP subscribers will pay considerably less: a 2.5% discount to the average five-day price leading up to yesterday’s cut-off.
That price looks like 35 cents, or thereabouts.
It’s life in the fast lane for Imugene
Immuno-oncology drug developer Imugene (ASX:IMU) has been granted US Food & Drug Administration (FDA) ‘fast track’ status for one of its key programs.
The effort in question is Azer-cel, Imugene’s allogeneic (off-the-shelf) candidate for the blood cancer diffuse large B-cell lymphoma.
The therapy is based on Car-Ts, which are tricked-up versions of the body’s T-cells to enhance their cancer-fighting abilities.
FDA fast-track status allows for expedited development and review of proposed therapies addressing serious conditions with an unmet need.
Benefits include more frequent meetings with the FDA and the option of a “rolling review” of regulatory submissions.
This counts for something, especially the widespread concerns about FDA approvals being delayed because of the upheaval under new health czar Robert F Kennedy Junior.
As opposed to traditional autologous therapies that use the patient’s own bone cells, allogeneic treatments offer the benefit of large-scale manufacturing at a much cheaper cost.
The company says data to date from its ongoing phase 1b trial has shown “significant promise”, especially for patients who have failed multiple prior therapies.
“We are committed to working closely with the FDA to bring this important therapy to patients as efficiently as possible,” Imugene chief Leslie Chong says.
And speaking of trials, Opthea (ASX:OPT) shares are on voluntary suspension until next Monday, pending news about one of its two major phase III trials for wet aged-related macular degeneration.
Investors await with bated breath for that one.
Life in the closet at the FDA
Imugene might have to hold its FDA meetings in a broom cupboard, if reports of the agency’s back-to-the-office dictate are anything to go by.
Most of agency’s staff have been banned from remote working.
Our on-the-ground agent – in truth, the newsletter Stat – reports that one employee was assigned a storage closet in a district courthouse.
One staffer was told they would be sharing a conference room with around 70 people.
Some booked a stay at a nearby hotel to avoid a six-hour round commute.
Others are wondering whether the drinking water is safe after a Legionnaire’s disease outbreak a year ago.
Happy days! But at least they still have a job for the time being.
Meanwhile, the government reportedly has cut funding for an ongoing 30-year prediabetes and diabetes program.
The program is one of many National Institutes of Health programs that have been defunded.
But this one is baffling as JFK Junior’s agenda includes tackling chronic conditions such as … diabetes.
At Stockhead, we tell it is as it is. While Emvision and Imricor are Stockhead clients, the company did not sponsor this article
