Biocurious: Clinical trial readouts show road to approval can be as exciting as the destination
At the application stage, devices have a much higher chance of being approved than drugs
Investors can expect news from several companies with pivotal or late-stage trials
For a drug or device maker, there's no prouder moment than when a health regulator – especially the US Food & Drug Administration (FDA) – approves their product to be unleashed on unsuspecting patients.
It's like watching your kid graduate – and you can even tolerate the long-winded speeches.
But don't confuse this coming-of-age moment with being the ultimate share price catalyst.
For investors, the 'ker-ching' can be much earlier, such as with trial progress or even the FDA granting permission to begin a study.
For instance, PainChek (ASX:PCK) shares had a nice run last October, after a positive validation study that supported the pain measurement app maker's US approval application.
In late June Blinklab (ASX:BB1) shares soared after the autism test developer won ethics approval for a 1000-patient US trial.
In the case of devices, FDA device approval tends to be less of a dramatic moment than for a drug go-ahead, because the chances of success are much higher.
Most applicants avail of the 510(k) route, which means that a device only needs to be substantially equivalent to a legal equivalent.
According to the contract research organisation Bioaccess, the FDA processes around 10,000 510(k) applications annually, with an approval rate of around 90%.
Review times are also shorter: 120 days compared with 420 days for the de novo (new device) route.
Here are some device (or quasi device) plays with advanced trials – typically- pivotal ones – that could move the share price dial.
Emvision runs with Emu trial
EMvision Medical Devices (ASX:EMV) in enrolling up to 300 suspected stroke victims in a pivotal trial of its stroke detection device Emu, across six local and US sites.
Emu is a portable bedside scanning unit that's much lighter than a conventional computed tomography (CT) unit.
The company is also developing an even small version, First Responder. As its name suggests, this one's for ambulance use.
The trial sites are all high calibre research centres handling high stroke volumes.
The stroke patients will receive the standard of care and an Emu scan.
Given the device is a trail blazer, Emvision is girding for approval under the de novo route. After that, the company hopes the agency will approve First Responder approval under the 510(k) channel.
Emu/First Responder will determine whether a stroke is a blockage (ischaemic)or a bleed (hemorrhagic).
This will decide the type of treatment and it's crucial to get the diagnosis right.
The company expects a six-to-12-month recruitment period.
Micro-X also is on strike with strokes
Meanwhile, x-ray imaging house Micro-X (ASX:MX1) plans to launch trails of its portable stroke unit, Head CT, across three local hospitals in the current half.
The trials will entail suspected stroke victims being subject to standard CT imaging, then overlaid with the Micro-X scan that deploys a more effective 'cold cathode' method.
Aiming for 'several hundred' scans, the studies only need to prove that the Micro-X tech is just as good as the conventional ones,
Funded by $8 million from the Australian Stroke Alliance, the study supports a proposed 510(k) application next year, in view of a US launch in 2027.
The company expects the trials to run for nine months.
Micro-X had multiple applications for its tech, bomb and baggage screening.
As part of a 'strategy re-set' the company is focused on medical applications.
Micro-X has commercialised two mobile digital radiology devices: the first-generation Nano and a sturdier iteration called Rover.
Heart patients move like Jagger
In the past, heart patients too old or too sick for surgical aortic valve replacement – or open-heart surgery – in effect were given a death sentence.
Transcatheter Aortic Valve Replacement (TAVR) procedures enable malfunctioning valves to be replaced in a non-invasive, 20-minute procedure.
TAVR recipients include Arnold Schwarzenegger and Mick Jagger – and they're still rockin'.
TAVR also applies to replacing artificial valves that have an effective operating life of five years or so.
Anteris Technologies (ASX:AVR) is on track to commence a pivotal trial of its Duravr device in the current quarter, pending FDA approval.
The company says it's qualified 79 sites globally for the trial, which will enroll patients with a 'broad array of risk profiles'.
The trial will be designed to provide the 'primary clinical evidence' for the FDA to mull premarket approval.
In parallel, Anteris is pursuing European clearance.
More than Imagion-ation
Shares also can pop on the strength of trial approval alone.
In the drug/device sphere, Imagion Biosystems (ASX:IBX) awaits clearance to carry out a phase II study of its cancer imaging agent, Magsense for Her-2 positive beast cancers.
For use with magnetic resonance imaging (MRI), Magsense improves cancer detection by adding 'molecular specificity'.
In lay terms, this avoids painful, error-prone biopsies.
This month, Imagion formed an alliance with Michigan's Wayne State University School of Medicine.
In part, the institution's MRI gurus will help to devise an optimal dose to be used in the study.
Trip the light fantastic
Invion (ASX:IVX) highlights how the trial journey, rather than the destination can evoke investor excitement.
Invion is advancing photodynamic therapy (PDT) for tumor types including non-melanoma skin cancers and ano-genital cancers.
Someone has to do it.
The idea is that light-activated photosensitisers leave the healthy tissue unharmed, but zap the diseased stuff.
Thus, PTD is a promising non-toxic, non-invasive alternative to chemotherapy, radiation or surgery.
Invion shares early last December rocketed more than 300% after the company said it had enrolled its first patient in its Queensland based phase I/II skin cancer trial.
The adaptive study now is poised to enter is second stage.
The next Sirtex?
OncoSil Medical (ASX:OSL) is equated with a less developed version of the targeted liver cancer radiation treatment house Sirtex, acquired for $1.9 billion in 2018 by Chinese interests.
Relative commercial immaturity aside, Oncosil targets the difficult pancreatic cancer.
Oncosil is trialling its eponymous targeted treatment with the standard-of-care chemo, Folfirinix.
The study, TRIPP-FFX, has completed recruitment and investors should expect data in early 2026.
The study pertains to patients with locally advanced pancreatic cancer.
The trial has recruited 'at least' 88 patients across 15 local and European hospitals.
So - there you have it.
While bonanza share gains are never guaranteed, investors know where to look for surprise pit stops along the circuitous approval journey.
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