Health Check: ‘Historical milestone’ as FDA approves second Artrya heart device

• Artrya shares surge up to 42% on FDA clearance of the company’s Salix Coronary Plaque device
• Sonic Healthcare joins CSL in the healthcare sin bin
• Universal Biosensors calls in the corporate undertakers

Artrya (ASX:AYA) has won US Food and Drug Administration (FDA) approval for a second heart disease detection device, thus paving the way for attractive per-scan fees.

The agency has given the nod to the company’s AI-powered Salix Coronary Plaque (SCP) module, for the “near real time, point of care assessment and management of coronary artery  disease”.

Artrya lodged the application under the 510(k) predicate device route only on June 16, so it was a quick turnaround from the stretched FDA.

High-risk plaque is a key indicator of heart disease, yet it’s often missed by current surveillance means. Put bluntly, for half of these patients the initial symptom is death.

SCP will provide clinicians with a highly detailed assessment of coronary artery plaque in under ten minutes.

The device will integrate with FDA-cleared Salix Coronary Anatomy (SCA) platform, which has been sold in the US since July.

SCA analyses data from computed tomography (CT) scans, so is not so real time-ish.

Expanding revenue

Artrya says the latest approval will “greatly expand the revenue opportunity with current and future customers”.

Getting to the pointy end of things, SCP is eligible for category one reimbursement of US$950 per assessment (for Artrya’s customers).

“We are thrilled to have received clearance …  which opens up a much greater revenue opportunity for us in the US, our largest market,” trills Artrya co-founder and CEO John Konstantopoulos.

Artrya is tackling the US market via partnerships with mid-sized hospital groups.

The first of these, Tanner Health, signed a deal to use SCA in July.

Northeast Georgia Health and Cone Health followed suit.

Petra Capital analyst Tanu Jain dubs the SCP approval as “another historic milestone” for Artrya that “material changes” the company’s prospects.

SCP accounts for more than 70% of the firm’s forecast US revenues for Artrya: $100 million by June 2029.

And there’s more: the company expects the FDA to approve a third device – Salix Coronary Flow – early next year.

Sonic shares don’t boom

Sonic Healthcare (ASX:SHL) has become the second healthcare giant to disappoint this week, following CSL’s (ASX:CSL) damp squib on Tuesday.

The company’s shares tumbled around 10% this morning after the pathology (and radiology) services giant reported a 7% boost in full-year earnings to $514 million.

Revenue gained 8% to $9.64 million.

Surely punters would be happy with a single digit increment in these challenged times?

But it was the usual story of the profit falling short of consensus expectations, of around $530 million.

RBC Capital Markets says the result was “disappointing”. But to be fair, the market expectations were above what management itself was guiding.

Sonic now has guided to underlying earnings (EBITDA) of $1.87-1.95 billion for the current year, compared with $1.725 billion in 2024-25.

That’s an 11% improvement at the midpoint, but once gain investors had chalked in a bit more.

Last month Sonic completed the purchase of LADR, one of Germany’s top five lab groups, for around €423 million ($760million) in a cash and scrip deal.

Given LADR turned dover €370 million last and generated €50 million, the acquisition should add some Panzer grunt to current year performance.

No pain, some gain at Medical Developments

Purveyor of the well-established Penthrox front-line pain relief device, Medical Developments International (ASX:MVP) has managed a $100,000 full-year profit.

While that seems modest, it’s a welcome turnaround on the previous $41 million loss.

The previous underlying loss (EBIT) improved to a $48,000 deficit after the previous $11.6 million shortfall.

A.k.a ‘the Green Whistle’, the Penthrox analgesic dispensers are a common sigh on sporting sidelines, when stricken players hobble off sucking the devices.

The company’s overall revenue gained 18% to $39.1 million, with pain management (Penthrox) turnover surging 23% to $26.2 million.

(The company also glean handy revenue from selling respiratory devices such as asthma spacers.)

Management reports “pleasing growth” in Europe and the UK.

Locally, Penthrox revenue gained 26% to $15.4 million and the devices now account for 43% of the hospital segment.

There’s a big missing piece to the company’s global jigsaw.

Despite the ubiquitousness of Penthrox, US authorities refuse to approve it for historical reasons.

Another one hits the rough

Universal Biosensors (ASX:UBI) has called in KPMG’s kindly voluntary administrators after failing to execute an urgent funding deal with an entity related to a director, Craig Coleman.

The company had reported first-half revenue of $2.76 million, down 11% and a $10.48 million loss.

The June 30 cash balance stood at less than $2.2 million.

In the words of David Copperfield’s Mr Micawber – a business consultant ahead of his time – “annual income twenty pounds, annual expenditure twenty pounds nought and six, result misery”.

The company said the administrators’ current intention was “to continue to trade UBS whilst an urgent assessment of trading is undertaken and options for its sale and, or recapitalisation are explored”.

For the time being, the administration pertains to the local arm of the US-incorporated entity.

Universal shares closed on Tuesday at 1.4c, ascribing a $5.4 million market cap.

Over a convoluted 20-year listed history, Universal commercialised bio-chemical sensor technology for applications including blood coagulation, wine testing, water impurities and canine glucose levels.

Sadly, the sector’s casualty wards are filling.

Last December Genetic Technologies entered voluntary administration. In December the company sold its key asset – its Genetype business – to Rhythm Biosciences (ASX:RHY) for $625,000.

In May this year, medical cannabis play Ecofibre gave up the struggle and called in administrators. As did Cryogenic sample labelling play, Bluechiip.

A slew of other biotech microcaps faces a similar fate if they don’t raise funds pronto. But your columnist is too much of a gentleman to name them.

Kiwi snore buster guides to “very strong” conditions

Ahead of its AGM later today, Kiwi based ResMed (ASX:RMD) rival Fisher & Paykel Healthcare (ASX:FPH) has guided to 31% profit surge in the current (September) half, with revenue up 13%.

This equates to earnings of around NZ$200 million and turnover of $1.075 billion.

CEO Lewis Gradon points to “very strong” conditions across the homecare and hospital products group.

The former includes continuous positive airway pressure pumps and masks for sleep apnoea; hence the rivalry with Resmed.

Earlier this month, Resmed disclosed June (fourth) quarter revenue of US$1.3 billion, up 10% and a US$380 million net profit, up 30%.

CEO Mick Farrell reported “robust global demand for our market-leading sleep and breathing health devices, as well as our expanding digital health ecosystem.”

The hospital group sells devices such as humidifies and masks.

Gradon refers to an “ongoing critical change” to hospital therapies which has provided a tailwind.

RFK ‘rhetoric’ linked with Atlanta shooting

In the latest missive from our overworked Washington desk, hundreds of health workers are imploring health secretary Robert F Kennedy Junior to tone down his rhetoric on vaccines after a fatal shooting.

Earlier this month, a gunman opened fire at the Centers for Diseases Control and Prevention’s Atlanta HQ, killing one policeman.

The assailant, who then shot himself, reportedly believed the Covid-19 jab had made him sick.

In a letter, more than 750 current and former federal health workers described JFK Jr as “complicit in dismantling America’s public health infrastructure and endangering the nation’s health by repeatedly spreading inaccurate health information.”

The uber department, Human Health Services said the protests were an attempt to politicise a tragedy by conflating “widely supported public health reforms with the violence of a suicidal mass shooter”.