FDA Waiting Room: For Aussie applicants, it’s (mainly) business as usual

• Despite myriad pressures under the Trump regime, the FDA’s drug and device approval process largely has been unfettered
• Telix Pharmaceuticals expects a company-making approval decision by the end of the month
• Painchek is among a string of device plays awaiting the agency’s assent

The US Food & Drug Administration’s (FDA) resources have been cut more times than Martin Scorsese’s then-edgy 1988 religious drama The Last Temptation of Christ.

Word from within the powerful agency’s imposing Maryland portals is that reviewers have struggled with their task of late because of lack of access to Zoom calls and similar everyday privations.

For a legion of Australian drug and device makers awaiting company-making FDA approvals in the Trump era, it’s a nervous time.

But need they be worried?

Business as usual

In most cases, the risk of rejection is the same as being struck by lightning.

The prevailing message is that despite mayhem at the agency, the approval process has not overly slowed unless the therapy is in a controversial realm (read: vaccines).

Rather like the Kyiv denizens carrying out their lives amid a barrage of missiles, it’s largely business as usual.

A couple of notable rejections aside – namely Replimune Group’s melanoma drug RP1, and see the Telix section below – so far this year the FDA has approved therapies for a range of cancers, autoimmune diseases, urinary tract infections and even menopausal hot flushes.

PainChek (ASX:PCK) CEO Phil Daffas says the FDA does a “superb” job under considerable pressure.

The developer of a digital pain assessment, Painchek awaits FDA clearance under the de novo (new) device pathway (see below).

“Their M.O. (modus operandi) has been nothing but guidance and support,” he says.

Aussie biotechs get the nod

ASX life science have-a-go heroes have found favour, especially in the devices and diagnostics realm.

In the drug space, the FDA last December greenlit Mesoblast’s (ASX:MSB) graft-versus-host disease stem cell treatment, Ryoncil.

In June, the agency approved CSL’s (ASX:CSL) home-grown Andembry, the world’s only prophylactic for hereditary angioedema.

Device-wise, the agency approved Orthocell’s (ASX:OCC) peripheral nerve repair tool Remplir.

It also waved through EBR Systems’ (ASX:EBR) groundbreaking left-ventricle assist device Wise and Nanosonics’ (ASX:NAN) next-gen medical probe steriliser, Coris.

“Everyone was getting nervous towards the end, but we were very fortunate not to be impacted (by the FDA changes),” Nanosonics chief Michael Kavanagh says.

“The Australian medtech industry should be proud, not necessarily [of] Nanosonics but Australia’s ability to do these types of things.”

Telix sweats on kidney imaging decision

Is the FDA poised to make us further proud?

Radiopharmacy giant Telix Pharmaceuticals (ASX:TLX) will know within three weeks whether the FDA has approved its kidney cancer imaging agent, Zircaix.

The stakes could not be higher for the $6.8 billion market cap Telix, given Zircaix could well present a bigger market than for Illuccix, its approved prostate cancer imaging agent.

So far at least, the FDA hasn’t come back with any queries.

Mind you, Telix hasn’t had its way on other fronts. The FDA in late April knocked back the company’s New Drug Application (NDA) for its brain cancer imaging agent, TLX101-CDx.

As Telix CEO Dr Chris Behrenbruch pointedly noted, this was despite “a robust consultation process prior to submission and during  review of the NDA”.

Painchek’s painless process

As with Telix, the FDA’s decision will be company making for Painchek.

Painchek’s eponymous app is used across 110,000 nursing home beds in Australia, the UK and Canada – an addressable market of 500,000 beds.

The US opens a market of three million beds, worth an estimated $100 million in annual recurring revenue.

Painchek’s FDA process started in 2019, when the company sought guidance on a supportive clinical trial (since successfully completed).

“The primary contact was the same person all the way through,” Daffas says.

Painchek lodged its review in November 2024, after two pre-submission meetings with the agency.

“They recommended a two-step process, with feedback after each step,” he says.

“That was very helpful guidance. If there was room for a misunderstanding it got clarified in those two meetings.”

Daffas says the FDA reps included experts in AI, privacy rules and cybersecurity and communications.

“Once again it’s very helpful for us, as it makes for a more robust product.”

Painchek expects an FDA decision around early October.

4D Medical breathes easy

The developer of algo-based lung images tools, 4D Medical (ASX:4DX), has ‘frequent flyer’ status with the FDA which has approved eight of its devices already.

These include its XV LVAS, which processes conventional X-ray scans “to provide rich, functional lung health detail not available via other modalities”.

4D is now waiting to hear from the FDA about CT.VQ, a ventilation perfusion imaging device.

The company dubs the FDA’s review as “well progressed”.

4D has filed under the 510(k) predicate device route. According to the company, last year companies waited an average 112 days for an FDA yeah or nay.

The current situation is “aligning well with our experience in previous applications”, the company says.

Artrya is back for seconds …

Artrya (ASX:AYA) says hard-to-detect coronary plaque is a key cause of heart attacks.

This was an uncontroversial proposition for the FDA, which in late March approved Artrya’s Salix Coronary Anatomy (SCA) platform.

The AI-enabled tool provides point-of-care detection of high-risk plaque, a key predictor of heart attacks.

Artrya has submitted for approval of a second device, Salix Coronary Plaque (SCP).

SCP will extend the use to patients who have undergone a coronary CT angiogram.

“Once cleared, [SCP] will enable us to deliver near real-time, AI-powered cardiac analysis to a large and growing market and unlock access to an established reimbursement code for plaque analysis,” co-founder (and now CEO) John Konstantopoulos says.

The company expects to hear from the FDA by the end of September.

… as is Echo IQ

As with Artrya, heart diagnosis peer Echo IQ (ASX:EIQ) is no stranger to the FDA.

In October last year the agency approved its EchoSolv AS, an AI-inspired device to detect aortic stenosis (narrowing of the heart valves).

Echo IQ now is eyeing consent for a second product, EchoSolv HF, to detect heart problems early.

It has teamed up with the esteemed Mayo Clinic to carry out a validation trial, the final requirement for FDA submission.

Mayo also has exclusive rights to use EchoSolv HF across its 30 hospitals and possibly even co-brand the product.

Echo IQ expects FDA approval by the end of the year.

Imricor goes modular

Still on matters of the heart, Imricor Medical Systems (ASX:IMR) is taking a Lego Masters approach to its maiden FDA application, for its cardiac ablation device, Vision-MR.

By this we mean that Imricor has submitted its FDA in separate modules (‘bricks’), to enable a rolling review.

Vision-MR is the only ablation catheter designed for use with a magnetic resonance imaging (MRI) scanner, as opposed to x-ray fluoroscopy.

The company last week said the second module was under review and it expects to submit the third module in the December quarter.

“We expect a steady string of 510(k) product submissions and approvals, which in turn helps accelerate the commercial launch across the US,” the company says.

In the March quarter European regulators re-approved Vision-MR, under tougher new rules.

The European gatekeepers also approved Northstar, “the world’s only MRI-native 3D mapping and guidance system.”

The FDA is also likely to approve Northstar in the current half. This will enable the company to start the initial rollout of its interventional cardiac magnetic resonance cardiac ablation labs.

Patience, please

Some applicants strike trouble with the FDA because they assume that reading the agency’s intentions is easy as a Golden Book, when in fact they can be harder to fathom than Ulysses.

As Telix’s brain cancer setback attests, being on the same page is crucial.

Amid the chaos of RFK Jr’s early days as health czar, in March your columnist warned that while FDA approvals were often company making, don’t expect quick returns.

That’s because shares may have run hard in anticipation of the happy event and profit takers move in.

Often, companies raise capital on positive news and this constrains the share price.

EBR did the rounds for $66 million in May and Mesoblast in January raised a monstrous $260 million.

FDA approval is only the first step to commercialisation: securing reimbursement and distribution network are just as important.

But without consent, companies aren’t even in the starting block to tackle the world’s richest – albeit more quixotic – healthcare market.

If anyone needs reminding, the US accounts for roughly half of the world’s healthcare expenditure.

At Stockhead, we tell it as it is. While Painchek is a Stockhead advertiser, the company did not sponsor this article.