Australia’s most read investor-focused magazine for ASX-listed Tech & Biotech stocks

In a market already teeming with fitness gadgets promising everything short of immortality, WHOOP has launched its boldest salvo yet with the arrival of WHOOP 5.0 and WHOOP MG in Australia. Promising to take wearables from glorified pedometers to pocket-sized longevity labs, this latest release could reset expectations around personal health tech.

Boston-based WHOOP—still private, cashed-up, and with Cristiano Ronaldo in their corner—has launched not one, but two devices tailored for the biohacking brigade and health-conscious everyperson alike. The WHOOP 5.0, alongside the new flagship WHOOP MG, is designed not just to measure performance but to help extend healthspan, that elusive grail of living well for longer.

“We’ve taken everything we’ve learned over the past decade and built a platform to help our members perform and live at their peak for longer,” said Will Ahmed, WHOOP founder and CEO. “We’ve held nothing back.” It’s a characteristically ambitious pitch from a company that has never shied away from high-performance rhetoric.

So what’s new? For starters, both devices boast a sleeker form factor—seven percent smaller—and a 14-day battery life, extendable to a month with the new Wireless PowerPack (included with Peak and Life memberships). Under the hood, enhanced sensors now capture biometric data 26 times per second, feeding WHOOP’s overhauled app experience.

But it’s the health features that steal the show. WHOOP MG comes with a medical-grade ECG sensor—think at-home heart checkups without the GP visit. Then there’s the new “Heart Screener”, which enables on-demand ECG readings and can detect signs of atrial fibrillation (AFib), a leading cause of stroke. Add to that Blood Pressure Insights (patent pending), giving daily systolic and diastolic estimates from your wrist.

The “Healthspan” feature, developed with the Buck Institute for Research on Aging, offers a twist on age: your WHOOP Age and Pace of Aging, based on nine health metrics. If your real age is 42 but your WHOOP Age says 35, congratulations—your lifestyle might just be adding years to your life, not subtracting them.

WHOOP has also stepped up for women’s health with hormone-linked insights across menstruation, pregnancy and perimenopause—something few wearables tackle comprehensively. And a revamped Sleep Score aims to nudge the sleep-deprived toward better nights.

On the fitness front, it’s no slouch either. With support for over 145 activities, from VO₂ Max tracking to strength-based muscular strain, WHOOP wants to be your performance coach and health adviser rolled into one snug wristband.

The pricing model is also noteworthy. WHOOP now offers three membership tiers for Australian users:

• WHOOP One: Fitness insights at $299 per year.

• WHOOP Peak: Deeper health and longevity features at $419 per year.

• WHOOP Life: The full suite, including medical-grade features, at $629 annually.

This tiered approach may appeal to both cost-conscious athletes and those chasing granular data and peace of mind.

Ronaldo—an investor and now official WHOOP evangelist—says the device helps him monitor and refine his habits. “It’s like a doctor on my wrist,” he said, adding a bit of star power to a launch clearly aimed at the global stage.

With mounting pressure on healthcare systems and consumers increasingly turning to proactive health tools, WHOOP's entry into the local market is timely. Whether Aussie consumers will buy into its data-heavy pitch en masse remains to be seen, but WHOOP 5.0 and MG mark a definitive step forward in the wearable tech arms race—not just tracking steps, but perhaps, rewriting the rules of ageing.

WHOOP 5.0 and WHOOP MG are available in Australia from May 9th via WHOOP.com.

By all accounts, Amplia Therapeutics (ASX: ATX) has reason to be chipper this week, as its flagship ACCENT trial in advanced pancreatic cancer has delivered a clinically significant result—fifteen confirmed partial responses (PRs), enough to claim superiority over chemotherapy alone.

In the biotech game, particularly in a field as daunting as pancreatic cancer, that’s no small beer.

Amplia’s ACCENT trial is assessing the company’s focal adhesion kinase (FAK) inhibitor narmafotinib (AMP945) in combination with the well-known chemotherapy duo gemcitabine and Abraxane. The trial, which commenced in January 2024, is now fully enrolled with 55 patients, 21 of whom remain on treatment. It is modelled after the MPACT study that originally validated the gemcitabine-Abraxane pairing.

According to the company, the fifteen confirmed partial responses—defined as tumour shrinkage exceeding 30% sustained over at least two months without new metastases—were enough to pass the pre-set efficacy threshold. That statistical line in the sand had been drawn at 15 PRs or complete responses (CRs) in the 50-patient cohort.

Notably, pancreatic cancer is infamous for its dismal prognosis and resistance to treatment, so even a partial response holds considerable weight. A complete response remains vanishingly rare.

CEO and MD Dr Chris Burns put it plainly: “We are extremely excited to have now recorded 15 confirmed partial responses in the ACCENT trial, demonstrating the benefit of adding narmafotinib to standard-of-care chemotherapy. With over 20 patients still on study we are hopeful that further PRs will be observed.”

That optimism may not be misplaced. If additional responses are clocked among the remaining patients, it would strengthen the already encouraging signal and bolster the drug’s case as a potential frontline enhancer.

The current ACCENT trial is open-label and single-arm, meaning there’s no randomised control group receiving chemotherapy alone. Instead, the company is benchmarking results against historical data, particularly from the MPACT trial published in the New England Journal of Medicine in 2013. While purists may grumble about the lack of a placebo arm, this approach is not uncommon in oncology—especially in indications where ethics would frown upon withholding treatment.

So far, the safety profile remains favourable. As noted in a prior April update, narmafotinib continues to be well tolerated, with adverse events in line with those expected from chemo alone. For a drug targeting a new biological pathway—FAK, which is overexpressed in pancreatic and other fibrotic cancers—that’s an encouraging sign.

For investors, the timing is propitious. Top-line data from the fully enrolled Phase 2a portion of the ACCENT trial is expected by mid-Q3 2025, making Amplia a stock to watch as the biotech reporting season heats up. It’s worth noting that the FAK space is garnering increasing attention globally, particularly in relation to solid tumours and fibrotic diseases.

Amplia’s approach targets the tumour microenvironment—essentially making the cancer’s ‘home turf’ less hospitable for growth and metastasis. It’s a promising frontier, and narmafotinib’s specificity and potency may give it a leg-up over first-generation FAK inhibitors.

That said, Amplia remains a development-stage biotech. Revenue is nil, and commercial success will hinge on successfully navigating further clinical trials, securing partnerships or licensing deals, and eventually wading through the regulatory minefield. The company will need to keep its powder dry—or top up the coffers—between now and a potential Phase 3.

Still, for a company that listed back in 2019 and has largely flown under the radar, Amplia is starting to make some serious clinical noise. If the forthcoming Q3 data echoes the current results, Amplia could soon find itself with more than just an encouraging acronym on its hands—it may have a pipeline-driving asset worth betting the house on. Or at least, worth watching closely.

No investment advice here—but keep your eyes on the ACCENT.

When it comes to cracking the U.S. healthcare reimbursement nut, even the most cunning of diagnostics outfits need a decent dose of patience, persistence and perhaps a prayer or two. Melbourne’s Lumos Diagnostics (ASX: LDX), purveyor of the rapid test darling FebriDx®, has just inched closer to the Promised Land — with a pair of Medicare wins that could open the floodgates for wider adoption of its ten-minute sniffle sorter.

Now, for the uninitiated, FebriDx is a clever little tool designed to tell the difference between bacterial and non-bacterial respiratory infections — the kind of call that determines whether your local GP reaches for antibiotics or not. It does so with a simple finger prick and within 10 minutes, giving it the kind of edge that’s catnip to emergency departments and primary care clinicians alike.

But having a test that works is only half the battle. In the Byzantine world of U.S. healthcare, getting paid is the real sport. And that’s where Lumos has just landed a couple of critical goals.

The company has secured reimbursement coverage from two of the seven Medicare Administrative Contractors (MACs) — Palmetto and Novitas — at the modest but respectable rate of US$41.38 a pop, effective April 2025. It’s a technical milestone, but one with big commercial implications.

Why? Because these MACs act as gatekeepers for Medicare, the U.S. government’s health safety net that covers about 20% to 24% of all test reimbursements. And more often than not, what Medicare covers, the private insurers — who pick up the tab for the rest — eventually follow.

To rewind slightly, FebriDx had already nabbed a spot on the 2025 Clinical Laboratory Fee Schedule via the somewhat unromantic-sounding PLA Code #0442U, thanks to the Centres for Medicare & Medicaid Services (CMS). That established a nationwide reimbursement rate, but didn’t guarantee anyone would actually get paid.

As Lumos boss Doug Ward put it, “It is extremely pleasing to achieve some early wins with two of the 7 U.S. Medicare Administration Contractors. This is an important and critical step in building the reimbursement framework to support clinical adoption for FebriDx®.”

Indeed, Doug. While those two wins won’t yet buy a private island, they’re the kind of beachhead that matters in the slow grind of healthcare monetisation. Negotiations are said to be “well progressed” with another three MACs — Noridian, WPS, and CGS — which, if landed, would mean Lumos has five of the seven in its pocket.

This isn't just about bureaucracy; it’s about building momentum. As real-world usage picks up, and clinicians begin seeing value in the test — both diagnostically and economically — insurers become more inclined to cover it. Lumos’ field teams are already doing the legwork, helping with insurance appeals, collecting clinician feedback, and documenting medical necessity.

There’s a kicker too. FebriDx is already cleared for both Moderately Complex and CLIA-Waived environments (those are U.S. regulatory categories for test complexity, not dodgy Sicilian resorts). Should Lumos secure a CLIA waiver, the test could shift more fluidly between healthcare settings without starting the reimbursement song and dance all over again.

Now, this isn't Lumos' first rodeo with FebriDx. The company has been on a long road with the product, having had previous bumps including regulatory hurdles and funding squeezes. But it’s now finding its stride, with this reimbursement progress acting as both validation and a commercial accelerant.

And lest we forget, the test is manufactured in the U.S., a patriotic plus that’s bound to sit well with lawmakers and job-conscious decision-makers in D.C.

The share market hasn’t exactly gone gaga over Lumos of late, but news like this could offer a flicker of light for investors seeking under-the-radar medtech plays with tangible catalysts on the horizon.

As is always the case in diagnostics land, success isn’t measured in test performance alone. It’s the bureaucratic dominoes that need to fall — and Lumos has just nudged two of them.

Now it’s a question of how fast the rest tumble.

In a move that might have been met with a shrug on the ASX boards this morning, but deserves a double take, Kiwi-Aussie medtech outfit TruScreen (ASX/NZX: TRU) has inked a significant public health pact in Vietnam. The initiative will see the company’s AI-powered cervical cancer screening device deployed across Ho Chi Minh City in a five-year push to screen 260,000 women—a scale that dwarfs anything in the company’s history.

It’s not every day that a small-cap straddling the ditch muscles into one of Southeast Asia’s most pressing health challenges. But that’s exactly what TruScreen’s done. The company has teamed up with the Ho Chi Minh City Public Health Association (HPHA) and its local distributor, Gorton Health Services, to tackle the country’s dismal cervical cancer screening rate, which sits at a mere 25% of the targeted demographic. The Vietnamese government’s goal? Hit 60% of women aged 30 to 54—a cohort that numbers in the tens of millions.

The official rollout began on 12 April with a ceremony attended by not just public health luminaries but also reps from the Australian Consulate and the Vietnam Cancer Association—illustrating just how seriously the effort is being taken. The device of choice is TruScreen’s own Ultra®, a portable, AI-enabled, real-time screening tool that does away with labs, pathologists, and the usual cytology rigmarole. It’s screening on the fly, no slides or stains required.

As TruScreen Chair Tony Ho, alongside HPHA president Dr Le Truong Jiang and GHS Vietnam CEO Mr Tran An Bao, put ink to paper, CEO Marty Dillon didn’t mince words on the mission’s stakes: “This program… may save the lives of over 2,600 mothers, daughters, sisters, wives and friends.”

It’s also a milestone for the company’s long-haul efforts in Vietnam. TruScreen’s technology was only added to the Vietnamese Ministry of Health’s official playbook in December 2023. Now it’s front and centre in one of the largest urban population centres in the region.

The broader Vietnamese market is tantalising. The country has 36 million women aged 18 to 65—TruScreen’s entire addressable demographic. Ho Chi Minh City, with 9 million people, is a launchpad. If all goes well, the model will be replicated across the nation and potentially across Southeast Asia. The company is already touting the program as a “reference site for neighbouring countries”.

Operationally, the plan is as meticulous as it is ambitious. Social workers will go door-to-door educating women and signing them up. The actual screenings will happen at district health centres and private clinics, supported by three major hospitals: Tu Du, Hung Vuong, and Ung Buou. Even the Ho Chi Minh City Women’s Union is lending a hand on the media front. It’s a full-court press.

From an investment angle, it’s worth noting that TruScreen is still far from blue-chip territory. But this partnership gives it something it has long lacked—scale and validation. For a medtech that has long spruiked its ability to leapfrog traditional screening methods in low- and middle-income countries, this is not just a commercial win but a proof of concept.

The device itself, TruScreen Ultra®, has a CE Mark, is TGA registered in Australia, and is already in use in 29 countries, including China, Russia, Mexico and Zimbabwe. In FY24 alone, over 200,000 tests were performed using the device—mostly on the back of single-use sensor sales. Now, with the 260,000-screening goal in Ho Chi Minh City alone, that annual figure could look modest.

What sets TruScreen apart is its tech’s agility. Unlike Pap smears or HPV tests which require samples, labs and follow-ups, TruScreen’s gizmo gives results on the spot using low-level optical and electrical stimuli. In a place where lab infrastructure is patchy and awareness about cervical cancer is low, that’s a genuine advantage.

And while the market hasn’t popped champagne on the news yet, this development should be watched closely. A successful run in Vietnam could open doors not just in ASEAN but also in public health procurement circles globally. For a small-cap often flying under the radar, this could be the announcement that finally puts it on the map.

As Dillon puts it, “This program… increases screening uptake amongst the women of Ho Chi Minh City.” It may also do the same for investor interest in TruScreen.

Anatara Lifesciences (ASX: ANR) has delivered the headline results from Stage 2 of its much-anticipated Phase II GaRP-IBS trial—and the outcome is a classic case of “glass half full” for investors and clinicians alike. While the trial failed to meet its primary efficacy endpoint of statistically significant symptom reduction in Irritable Bowel Syndrome (IBS) compared to placebo, the data paint a more nuanced picture, with secondary outcomes offering genuine reasons for cautious optimism.

Let’s address the gut-wrenching news first: the primary endpoint, a reduction in the IBS Symptom Severity Score (IBS-SSS), did not achieve statistical significance. The placebo cohort, true to type in IBS trials, showed a robust early response, with a convergence of scores between placebo and the GaRP treatment group by week 8. Despite this, those on GaRP recorded a consistent and sustained improvement, with a 45% reduction in symptoms—an outcome that, while clinically meaningful, didn’t cross the magic p-value threshold.

Executive Chair Dr David Brookes was candid: “Not reaching significance for the primary efficacy endpoint in any quality trial has to be a real disappointment... however the trial has still delivered significant findings.” Indeed, the silver linings start to emerge in the secondary endpoints, particularly the statistically significant improvement in anxiety scores (p=0.034 at week 8), contributing to a significant overall HADS (Hospital Anxiety and Depression Scale) improvement (p=0.025).

This is not just statistical hair-splitting. Anxiety is a well-recognised co-morbidity in IBS, and the gut-brain axis is increasingly seen as a legitimate therapeutic target. A reduction in anxiety without affecting depression (which remained in the normal range) points to a subtle but valuable benefit, potentially reflecting the microbiome-modulating properties of the GaRP formulation.

Even more telling is the result for the “Adequate Relief” metric—essentially a patient-reported perception of symptom improvement—which was highly significant at week 10 (p=0.004). In plain terms, more patients felt better on GaRP than placebo, and that feeling persisted two weeks after stopping the treatment. That’s a strong endorsement for a product aimed at a condition with few clear-cut treatment wins.

The modified intent-to-treat (ITT) analysis reinforced these findings, with GaRP delivering a 115-point reduction in IBS-SSS from baseline, compared to 80 for placebo. While not statistically definitive, the clinical impact—particularly in a population suffering moderate IBS—shouldn’t be dismissed.

On the strategic front, Anatara is now at a crossroads. The disappointment of missing the primary endpoint will inevitably cool some partnering enthusiasm sparked by Stage 1’s strong results, but the overall package—solid safety profile, clinically meaningful benefits, and signals of a gut-brain effect—remains intact.

Commercialisation paths are still on the table, with Anatara working to package its preclinical and clinical findings into a format more palatable for prospective partners. The GaRP product, composed of GRAS (Generally Regarded As Safe) ingredients, remains protected under current patent filings, and management is eyeing broader indications, possibly even within the nebulous but growing gut-brain health category.

Meanwhile, the anti-obesity project ticks along quietly in the background. Proof-of-concept studies are underway in mice at the University of Newcastle, exploring GLP-1 agonist-like effects using novel oral compounds. The company has allocated $250,000 to the initial studies, which are expected to yield results within six months. While early-stage and still under wraps, the obesity program could provide Anatara with a fresh commercial avenue, especially given current market enthusiasm around GLP-1s.

With its coffers buoyed by a $500,000 R&D tax rebate and operational costs trimmed (including a shift to part-time roles and non-executive board positions), Anatara is consolidating rather than retreating. Manufacturing and ingredient sourcing for GaRP are now on the back burner, with resources focused on data consolidation and strategic reorientation.

In summary, while the GaRP-IBS trial didn’t deliver a slam-dunk, it certainly hasn’t flatlined. The data offer tantalising hints of clinical relevance in a notoriously difficult therapeutic area. For investors and potential partners, it’s not a matter of if GaRP works—but how best to interpret and capitalise on the signals that it might.