Health Check: Compumedics isn’t dozing on the job after crucial US assent for its single-use home sleep test

• Compumedics shares surge up to 13% after FDA approval of its Somfit D device
• Don’t miss out on an options windfall, warns 4D Medical
• Amplia doses first patient in follow-on pancreatic cancer trial

Brain diagnosis house Compumedics (ASX:CMP) has won US Food & Drug Administration (FDA) approval for the company’s single-use sleep home-testing device.

The assent is nothing to yawn about: the company says it will double its US addressable market to US$240 million, consisting of four million home sleep tests annually.

Somfit monitors for conditions such as sleep apnoea and insomnia.

Compumedics already is marketing its multi-use version: a round sensor that patients wear on their forehead.

The gizmo collects physiological data that is transmitted to a sleep professional.

The FDA approved the reusable Somfit in May, as well as a more sophisticated variant, Falcon.

The single-use component is an adhesive gel electrode, with the sensor placed on top.

The market is moving to single use, for hygiene and convenience reasons.

While still popular, re-usable units need to be sent to – and back from – the customer and then cleaned.

Compumedics reckons it can snare 10-30% of the US home sleep testing market by June 2027.

Locally, Compumedics has been selling Somfits since early 2023, via the Philips-owned Australian Professional Sleep Services.

Thus far, the company reckons it has secured more than 75% of the local pharmacy-based home sleep market.

Last month Compumedics reported overall revenue of $51 million for the year to June 2025, up 3%.

The order book grew to a record $63.4 million, up 22% while underlying earnings grew 9% to $2.9 million.

Sleep (and related software as a service) revenue accounted for $30.2 million of total sales, up 88%. Of this, Somfit contributed $6.7 million.

4D reminds investors of options windfall

We don’t normally cover options exercise notices, but we will make an exception for this week’s biotech hero 4D Medical (ASX:4DX).

The lung imager reminds investors that listed options exercisable at 55 cents expire on October 1.

A week ago, the options weren’t in the money and most holders wouldn’t have bothered to exercise them.

This morning the stock traded as high as $1.46, a 200% gain on the week.

4D issued the free oppies on a one-for one basis, in its $13.9 million  capital raising in February.

This effort consisted of $5.5 million in a placement at 42.5 cents and $8.4 million in a share purchase plan at 36 cents apiece.

The option expiry terms were either February 28 2026, or 30 days after the FDA approving 4D’s lung perfusion imaging tool CT:VQ.

The company announced the latter on Monday, followed by the granting of US public reimbursement on Wednesday.

If all the options are exercised, the company will raise $22 million.

The news for option holders gets even better.

That’s because on options exercise they get one share and one ‘piggyback’ option, exercisable at 75 cents by February 29, 2028.

Amplia doses first patient

Speaking of hero stocks, Amplia (ASX:ATX) has dosed the first patient in its keenly awaited, follow-up pancreatic cancer trial.

The phase Ib/IIa study tests Amplia’s candidate narmafotinib (AMP-945). The trial combines the so-called FAK inhibitor with the standard of care chemotherapy, Folfirinox.

FAK (focal adhesion kinase) is not a cuss word, but a protein over-expressed in pancreatic cancer, one of the deadliest tumours.

Enrolling patients with newly diagnosed metastatic pancreatic cancer, the open-label trial is taking place across two local sites and four US cancer centres.

The trial expects to enroll 12 patients across four doses (three participants each).

Part A of this trial is a dose escalation effort, exploring the safety, tolerability and pharmacokinetics of increased daily administrations.

Amplia expects to complete this leg by March 2026.

The second stage – yep, Part B – takes the two best doses and tests them for safety, tolerability and efficacy. The company aims for at least 20 patients.

Amplia shares went on a tear after its ongoing Accent trial resulted in a response rate of 31% relative to chemo alone.

Unexpectedly, the trial recorded two ‘complete responses’ (in effect a cure).

Accent combines narmafotinib with different chemo agents: gemcitabine and Abraxane.

A cocktail of four chem drugs, Folfirinox is the preferred pancreatic cancer chemo in the US and most of Europe (but not in older patients because of toxicity issues).

Previous preclinical (animal model) studies showed the the narmafotinib/ Folfirinox combo improved survival in animal models of pancreatic cancer compared to Folfirinox alone.

Between early June and early July Amplia shares popped from five cents to a peak of 36 cents, on the back of the dare-to-dream Accent results.

In July the company raised $27.65 million in a placement at 23 cents apiece and then $2.65 million in a share purchase plan at 18 cents a pop.

It’s nice to get money through the door, but the raising crimped the share price.

Mesoblast enters $76 million funding option

Convertible note issues often are as popular as a flatulent astronaut, but Mesoblast (ASX:MSB) holders have given the initial thumbs-up to the stem cell developer’s proposal to issue such hybrid instruments to two key holders.

At its “sole discretion”, Mesoblast will issue US$50 million ($76.8 million) of unsecured notes to shareholders Gregory George and William Gueck.

If availed upon, the funds would repay or reduce current secured debt and support working capital.

The notes mature in five years, at which time the holders can convert to ordinary shares at around $2.50 –  a circa 120% premium.

Mesoblast has entered a commercial era, with its graft-versus-host therapy Ryoncil finally approved – and selling – in the US.

Mesoblast shares were around 5% higher this morning.

US eyes fast-track approval for ultra-rare diseases

Our overworked Washington desk is having a Mental Health Day, having hallucinated about orange-hued apparitions one time too many.

So, today’s missive from Gilead comes courtesy of Endpoints News, which reports the health czars are mulling a streamlined process for ultra-rare diseases.

Under the proposed Rare Disease Evidence Principles, gene therapy developers targeting ultra-rare populations would be able to seek approval based on a single-arm study (no placebo group).

In April, new FDA Commissioner Marty Makary flagged a review of the process.

But the idea was championed by former Center for Biologics Evaluation and Research director Peter Marks, with the help of two key Senators: one Democrat, one Republican.

Ah, bipartisanship! Those were the days.

The measure would apply to a genetic defect that affects fewer than 1000 Americans, so we’re talking uber rare.

The disease also must cause significant disability or death, with no adequate alternative therapies.

Your slightly addled columnist is not aware of any ASX biotechs that would benefit immediately from the measure – but we stand to be corrected.