27-05-2025
Health Check: Optiscan perfects ‘dial a pathologist' platform; 4D Medical probes further FDA approval
Optiscan's telepathology streaming software enables surgeons to have secure real-time access to pathologists – no matter where they are in the world
4D Medical's device probes the lung's innards without the nasties
Painchek signs a US distributor ahead of expected US approval
Optiscan (ASX:OIL) and its Canadian tech partner Prolucid Technologies have advanced telepathology streaming software enabling a surgeon to seek the counsel of a remote pathologist during an operation.
And that could be very remote.
The software has advanced to minimum viable product stage: when a product meets the minimum use requirements but can be tweaked further.
The cloud-based software enables pathologists to review high-resolution images, generate reports and collaborate within secure settings.
The software 'essentially brings the pathologist into the heart of the operating theatre and bridges the gap between surgery and pathology,' says Optiscan CEO Dr Camile Farah.
'This platform is a potential game changer for global digital pathology, with particular relevance to regional, rural and remote healthcare settings where access to pathology expertise is limited.'
Eliminating microscopes
Naturally, the software is compatible with Optiscan's medical devices, which are based on the company's proprietary confocal laser endomicroscopy, or CLE.
CLE eliminates the age-old and unreliable method of analysing tissue samples under a traditional microscope.
The magic involves a single optical fibre in a probe projecting laser light on to live tissue treated with fluorescent dye.
This creates real-time digital microscopic images at a magnification 1000 times that of computed tomography or magnetic resonance imaging scanning.
CLE avoids the need for painful biopsies.
Optiscan is carrying out a 50-patient breast cancer trial at the Royal Melbourne Hospital and Frances Perry House.
This is in view of an eventual US Food & Drug Adminstration (FDA) approval submission.
The telepathology project now will focus on validating the platform in real-world uses, incorporating user feedback and 'preparing for broader clinical deployment'.
Optiscan shares surged 13% this morning.
4D Medical vies for a further FDA approval
4D Medical (ASX:4DX) CEO Dr Andreas Fouras says the lung imaging house has a 'once in a generation' opportunity to improve healthcare with its latest tool subject to FDA perusal.
"We have an incredible opportunity whereby existing lung diagnostics are failing us," Fouras told an investor webinar this morning.
4D yesterday said it had lodged a marketing approval application for its software, which probes the innards of the lungs as an adjunct to computed tomography (CT) scans.
The key selling point of the CT:VQ software is that it enables data and visualisations to be extracted from a routine CT scan, without the need for any radiotracer or contrast agent.
VQ scans evaluate both the airflow (ventilation) and blood flow (perfusion) in a patient's lungs.
We're not sure why they are known as 'VP' scans, but let's move on.
The CT:VQ test creates images that show how well air and blood are distributed throughout the lungs.
This helps doctors identify areas where there might be an imbalance between ventilation and perfusion.
Fouras said existing methods were logistically challenging, slow and expensive.
The most widely used, a single camera scan called planar scintigraphy produces grainy and flat images.
VQ scans diagnose several lung conditions, including primarily pulmonary embolism (blood clots in the lungs), chronic thromboembolic pulmonary hypertension, chronic obstructive pulmonary disease and asthma.
The current process consists of two scans. These are a ventilation component involving inhaling a material with contrast agent, followed by injection of a radioactive contrast to assess blood flow.
Fouras said one million VQ scans were done in the US annually 'and we intend to capture every one of them.'
In old naval parlance, that's known as a clean sweep.
Burgeoning US portfolio
If CT:VQ is approved, 4D Medical will have nine cleared products in the US, as well as six each in Europe and Australia.
Fouras notes the company's lung ventilation analysis software tool LVAS attracts public reimbursement of UD$650 ($1000) per scan.
He reckons CT:VQ should fit neatly into this code.
CT:VQ is subject to an ongoing 80-participant study of lung health with the US Department of Defense.
Under the FDA's protocols, the agency decided within 90 days.
But this typically extends to 120 days accounting for follow-up review time with the applicant.
4D shares surged 17% after Monday's announcement but were a tad off today.
Painchek lines up US distributor
The developer of the world's first mobile phone-based pain assessment and monitoring tool, PainChek (ASX:PCK) has signed up a US distributor ahead of anticipated FDA approval in the current quarter.
Painchek already has a dominant share of the Australian aged-care market with its eponymous device and a substantial UK beachhead as well.
But as is the norm, the US offers the greatest opportunity.
The company cites a local market of 220,000 aged-care beds and 540,000 in the UK, equating to an annual value of $11 million and $26 million annually.
But the US has 1.7 million beds, for an annual value of $100 million.
Painchek's non-exclusive agreement is with Eldermark Software, which provides care management systems in the US (and Canada) to more than 116,000 clients.
Using facial recognition and AI, the device detects pain in patients unable to enunciate their discomfort, such as dementia suffers.
Painchek also has its eyes on the larger, 400 million strong pre-verbal kids' market.
'The financial impact cannot be quantified at the time of entry into the agreement, as it is a reseller agreement based on Eldermark's best efforts to promote Painchek's technology within its existing client base,' Painchek says.
Elsewhere, to date, Painchek has signed contracts up with around 1800 aged care facilities, with more than ten million pain assessments carried out to date.
Neuren chair decries weak share price
Neuren Pharmaceuticals (ASX:NEU) chairman Patrick Davies says he is 'frustrated and disappointed' by the company's marked-down share price that not reflect the company's success with its approved US Rett syndrome drug, Daybue.
Addressing the company's AGM this morning, Davies said Neuren had hauled in $445 million of royalties from its partner Acadia in 2023 and 2024 – in effect pure profit.
Neuren shares have declined from their $25 peak in late 2023, to as low as $8.70 in mid-April.
While the shares have improved since, management contends the $1.7 billion market cap hardly reflects Neuren's progress across at least three other add-on indications.
One of them – for Phelan-McDermid syndrome – is entering phase III stage.
Neuren's cash has swelled to $341 million.
'It was only a few years ago that we had to work really hard to raise fresh capital of $20 million to support our growth plans,' Davies says.
