Health Check: 4D Medical wins ‘historic’ FDA clearance for lung imaging tool

• 4D Medical shares gain up to 40% on FDA lung imaging device approval
• Lumos wins US funding for kids’ flu-versus-virus trial
• ‘Spend money to make money’: the lesson from the last-minute reporters

In an “historic moment in respiratory diagnostics”, the US Food & Drug Administration (FDA) has approved 4D Medical’s (ASX:4DX) ventilation perfusion device, CT:VQ.

The news sent 4D shares soaring up to 40%.

4D Medical describes CT:VQ as “the world’s first and only non-contrast, CT-based ventilation-perfusion imaging technology”.

The CT bit refers to computed tomography.

A VQ scan is a specialised nuclear medicine procedure that evaluates both airflow (ventilation) and blood flow (perfusion) in the lungs.

The test creates images showing how well airflow and blood flow are distributed throughout the lungs, helping doctors identify areas of imbalance.

VQ scans are primarily used to diagnose pulmonary embolism (blood clots in the lungs), a potentially life-threatening condition.

By showing areas of poor ventilation or altered blood flow, CT:VQ can help evaluate other conditions such as asthma and chronic obstructive pulmonary disorder.

CT:VQ does not require potentially hazardous contrast agents.

The company says because CT:VQ piggybacks off an extensive base of 14,500 US CT scanners, it can be used in rural and smaller healthcare facilities lacking nuclear medicine infrastructure.

4D Medical assesses the initial addressable market of US$1.1 billion – one million scans at an average reimbursement rate of about US$1150 per scan.

“4D Medical believes it can rapidly capture a significant part of this market, and over time expects to displace 100% of all nuclear VQ scans.”

The company estimates the global opportunity at US$2.6 billion.

Intriguingly, ProMedicus (ASX:PME) has taken an interest in supporting CT:VQ by advancing $10 million of hybrid debt/equity to 4D Medical.

An entrée to a wider collaboration, such as a distribution tie-up?

Pro Medicus gets good ATO news

Did someone say Pro Medicus?

The giant-slaying local hero today said it had won ‘authority to operate’ (ATO) from the US Department of Veterans Affairs. This opens the way for the mega organisation to use the company’s cloud-based Visage 7 imaging tool.

The clearance means that Visage 7 has successfully “demonstrated, documented, tested and validated rigorous federal security controls”.

Pro Medicus CEO Dr Sam Hupert says achieving the ATO has been “years in the making”.

It enables the company to create its first reference site, in view of other parts of the network migrating to the cloud.

At this stage, it’s hard to quantify the importance of achieving the ATO.

Given the US veterans’ health sector is bigger than Australia’s entire healthcare sector, we suspect it’s a big deal. Investors this morning weren’t getting too excited, though.

We BARDA test the kids, too

And still on the topic of US government funding, Lumos Diagnostics (ASX:LDX) has won a US$6.2 million package to undertake a paediatric trial for its bacterial-versus-viral test, Febridx.

The benefactor is the US disaster preparation agency, the Biomedical Advanced Research and Development Authority (BARDA).

The FDA has approved Febridx for adult use, but Lumos is undertaking a trial to enable administration by medical staff such as receptionists and nurses.

The process is known as a Clinical Laboratory Improvement Amendments  (CLIA) waiver.

The add-on paediatric trial will enable Febridx to be used in CLIA-waived settings for  kids aged two to 12.

Lumos expects to launch the study in the current quarter, in time for the US cold and flu season.

CLIA waiver would expand Lumos’s addressable market 15-fold, to more than US$1 billion a year across 270,000 clinical sites.

The point-of-care Febridx uses fingertip blood to detect bacterial-versus nonbacterial infections in around ten minutes.

Also yesterday, Lumos said it had won a US$1.5 million, follow-on contract to develop a test for a rare newborns’ disease called phenylketonuria.

The funder is the New Jersey-based Aptatek Biosciences.

Imricor lodges FDA paperwork

Imricor Medical Systems (ASX:IMR) has lodged an FDA approval submission for its Vision-MR diagnostic catheter for cardiac ablation.

Vision-MR is the first such catheter that can be guided by real time magnetic resonance imaging (MRI).

MRIs produce superior imaging and don’t entail radiation, unlike current unlike x-ray fluoroscopy guidance.

Last month, Imricor lodged a 510(k) submission for North Star, its accompanying 3D-mapping and guidance system.

“With North Star and the diagnostic catheter now both under FDA review, we are advancing toward our objective of delivering a fully integrated, radiation-free platform to US physicians and patients,” CEO Steve Wedan says.

Cardiac ablation addresses heart arrhythmias, or irregular heartbeats, manifested in right-side atrial flutter or left-side atrial fibrillation or ventricular tachycardia (rapid heartbeat).

Administered via a catheter through the vein, cardiac ablation uses electric impulses to scars abnormal heart tissue. This blocks irregular electric signals and restores a normal heartbeat.

European regulators approved Vision-MR in 2020. But as is the commercial reality of the med device space, companies need FDA approval to make a buck.

It’s a (results) wrap

Before we move on to savour the delights of Spring, here’s a sample of Friday’s biotech reporters ahead of the end-of-August cut off.

We’ll stick with the revenue producers.

In its “banner year”, Mesoblast (ASX:MSB) reports full-year revenue of US$17.2 million, 191% higher.

This income reflected inaugural US net sales of US$11.3 million from the company’s Ryoncil, a stem cell treatment for paediatric graft-versus-host disease.

After years of trying, Mesoblast won FDA assent for the treatment last December.

Mesoblast also reported a US$102 million loss compared with a previous US$88 million deficit. This resulted in end-of-year cash of US$162 million.

Botanix Pharmaceuticals (ASX:BOT) also reported revenue of US$5.75 million, up 857%. This derived from maiden US sales of Sofdra, the company’s treatment for excessive underarm sweating.

Botanix lost US$86 million compared with a US$32 million shortfall previously.

This reflected the costs of making Sofdra inventory, building a distribution platform and the usual sales and marketing.

Pot stock Althea Group’s (ASX:AGH) revenue slipped 23% to $23 million, although the loss narrowed from $32 million to $8.3 million.

Bear in mind Althea has exited the overly competitive medicinal cannabis sector, in favour of the THC-infused beverage market in the US and Canada.

Yes! There is such a thing.

The bevvies arm, Peak Processing managed revenue of $15.5 million, up 27% and narrowed a $3 million underlying loss to $1.7 million.

Profitable EZZ eyes US market

EZZ Life Science (ASX:EZZ) grew revenue slightly to $66.8 million, while net profit dipped 3% to $6.73 million.

The company grew its range of health and wellness product range by 15, to 68.

Two-thirds of EZZ sales derived from mainland China, but EZZ has just entered the US market via online channels.

The maker of asthma puffer compliance devices, Adherium (ASX:ADR) saw its revenue slip 23% to $817,237. The company’s $12.68 million loss compared with $10.3 million of red ink last time around.

As of June 30, Adherium was down to a mere $43,255 of cash, but a $4.3 million rights issue in July gave some – er – breathing space.

A provider of ‘hardware’ for lateral flow testing devices (including Febridx), Atomos (ASX:AMS) revenue of $32.6 million and narrowed a previous $15 million loss to $10 million.