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A day on from Memphasys confirming CE Mark approval for its Felix™ System, the initial headlines are giving way to something more important: perspective.

Yesterday’s announcement was rightly framed as a regulatory breakthrough. But with the benefit of distance and context, it is becoming clear that this milestone does more than unlock a market. It reshapes the company’s trajectory, its risk profile, and the way investors should think about what comes next.

For long-standing shareholders, this matters.

From “Someday” to “Now”: Closing a Long Regulatory Chapter

For much of the past six years, the idea of Felix™ achieving regulatory approval in an established market such as Europe oscillated between ambition and frustration. There were moments when the path seemed clear, and others when shifting regulations, particularly the introduction of Europe’s Medical Device Regulation (MDR), made the goal feel like a mirage.

CE Mark approval brings that chapter to a close.

Under MDR, approval is no longer a procedural hurdle. It is a structural validation of a device’s clinical evidence, manufacturing systems, quality controls and long-term compliance framework. Many devices never made the transition. Felix™ has.

With that approval now secured, Felix™ moves from being a technology seeking permission to operate, to one authorised to scale.

Why the Timing Matters More Than the Approval Itself

In isolation, regulatory approval is important. In context, it is transformative.

What distinguishes this moment from earlier phases in the Felix™ story is that CE Mark approval has arrived after the company completed the hard work of commercial preparation.

Multi-year, volume-backed commercial agreements were already signed, including binding minimum purchase commitments. Clinics were trained and operationally prepared. Manufacturing had scaled to support early commercial demand, with cost-of-goods materially reduced. Early cartridge orders were already flowing.

This sequencing changes the investor equation.

Instead of approval triggering a new round of planning, it immediately activates revenue pathways. For investors, this shifts Felix™ from a regulatory-dependent asset to a commercially executing platform.

What This Means for the Next 6-12 Months

From an investor perspective, the focus now shifts decisively from whether Felix™ can be commercialised to how quickly it scales.

Over the coming quarters, investors should be watching for:

• Recurring revenue visibility as contracted cartridge purchases under binding agreements begin to flow through

• Clinic utilisation data, particularly early adoption patterns in Europe and the Middle East and North Africa

• Margin progression, driven by improved manufacturing efficiency and higher cartridge volumes

• Sales cadence, rather than one-off announcements

Importantly, revenue growth from Felix™ is not expected to be linear. Adoption in IVF clinics typically follows a curve - initial onboarding, workflow integration, then expanding utilisation once confidence and familiarity are established.

CE Mark approval removes the gating factor that previously prevented this curve from starting.

The Strategic Optionality Now in Play

Beyond near-term revenue, CE Mark approval introduces strategic optionality that simply did not exist before.

It enables immediate commercial activity not only across Europe, but also in CE-recognising Middle East and North Africa jurisdictions, including markets such as Qatar where Felix™ can now be sold immediately.

It also provides a recognised regulatory foundation for progression in India and Australia, both of which represent large, strategically important IVF markets. Regulatory timelines in these jurisdictions are now materially shortened due to mutual recognition pathways.

Finally, regulatory de-risking increases Felix™’s attractiveness as a platform asset. Once a device is approved under MDR and generating contracted revenue, it becomes easier to expand distributor discussions, negotiate broader regional partnerships and attract strategic interest from larger IVF or medtech groups.

While none of these outcomes are guaranteed, CE Mark approval is a prerequisite for all of them.

Why Long-Standing Shareholders Should Frame This Differently

For shareholders who have lived through earlier iterations of the Felix™ story, scepticism is understandable. Promising technology does not always translate into commercial success.

What has changed is the alignment.

Felix™ now sits at the intersection of regulatory certainty, contracted revenue with binding minimum purchase commitments, operational readiness and clinical validation.

This is the first time all four have existed simultaneously.

As a result, investor risk has shifted away from regulatory approval and towards execution - a fundamentally different challenge, and one that can be measured quarter by quarter.

From Development Asset to Commercial Platform

Felix™ is no longer best understood as a single product approaching market. It is better viewed as a commercial platform built around a repeat-use consumable model, targeting a clearly defined, global IVF workflow.

With approximately 418,000 ICSI cycles annually in Europe alone, and immediate access to selected Middle East and North Africa markets, the addressable opportunity is both visible and actionable. Each clinic represents a recurring revenue opportunity rather than a one-off sale.

That dynamic changes how investors should think about scale, predictability and long-term value creation.

Looking Ahead: What Success Now Looks Like

In the months ahead, success will not be defined by regulatory announcements. That work is largely done.

Instead, success will be measured by consistent cartridge order flow against contractual minimums, expanding clinic penetration, improving unit economics and disciplined commercial execution.

These are the markers of a company transitioning from promise to performance.

From Mirage to Momentum - With the Road Now Visible

For years, Felix™ sat just beyond reach - scientifically credible, clinically validated, but constrained by regulatory gravity.

As of yesterday, that constraint has been lifted.

CE Mark approval does not guarantee success, but it finally allows success to be pursued without structural barriers. For investors, this is the moment where imagination gives way to observation, where execution can be tracked, assessed and valued.

The mirage is gone.
What lies ahead is momentum, and for the first time, a clearly visible road forward.

In a much-needed post-Christmas cheer, Brisbane-based biotech minnow AnteoTech (ASX:ADO) has announced a US$185,000 (~A$275,750) order from the Serum Institute of India (SII), alongside a raft of updates underscoring a strengthening pipeline and growing traction in global life sciences markets.

The order, slated for dispatch on 5 January 2026, forms part of an existing five-year supply agreement and marks a promising close to what’s been a strategically pivotal year for the company. The icing on the agar plate? SII is also set to evaluate a new AnteoBind™-enabled ELISA prototype, potentially unlocking access to a market segment valued at over US$21 billion globally.

CEO & Managing Director, Merrill Gray

While the dollar value of the order may seem modest in biotech terms, the real story lies in the qualitative strides AnteoTech is making. CEO Merrill Gray described the announcement as a result of “increased customer engagement by the Company’s Life Sciences Team,” noting the shift toward value-added products and deeper integration into the supply chain of major diagnostics players.

Gray’s emphasis on moving “up the value chain” isn’t just boardroom speak. AnteoTech is no longer content to supply additives to other people’s tests; it’s now eyeing a central role in two of the biggest immunoassay formats on the market - ELISA and CLIA (chemiluminescent immunoassays). The company is in early-stage discussions with a major global life sciences player to co-develop a CLIA diagnostic using its next-gen AnteoBind™ NXT platform.

The comparative studies are compelling: AnteoBind™ NXT has been shown to reduce antibody consumption while halving processing time compared to conventional tosyl chemistry - a ubiquitous method in CLIA test production. These cost and performance gains will be detailed in a forthcoming white paper due early 2026.

Backed by a June 2025 strategic reset, AnteoTech has ramped up its sales and marketing engine. It’s chalked up approximately A$70,000 in fresh revenue from Japanese customers - no small feat given prior stagnation in that market - and initiated 10 new product evaluations across Europe, North America, Asia, and India. The latter is particularly strategic, with the company leveraging leads from Trade and Investment Queensland and planning a boots-on-the-ground tour in February, including a BioAsia conference appearance and meetings with Indian partners.

Scientific validation continues to accumulate. Three peer-reviewed publications in the past quarter have praised the versatility and performance of AnteoBind™ across diagnostic applications, reinforcing the company’s push into point-of-care solutions and next-gen formats such as Luminex and lateral flow assays.

In essence, AnteoTech is quietly reinventing itself from a niche supplier to a core enabler in the diagnostics ecosystem. If successful in embedding its technology as an essential component in ELISA and CLIA formats, the revenue upside could be materially transformative.

But as always with biotech, execution is key. The coming year will be critical as AnteoTech moves from pilot studies and evaluations to real-world deployments and purchase orders.

For now, investors can take heart that the company is doing more than just talking up its tech - it's starting to sell it too.

In a fitting end to the calendar year, ASX-listed Metallium (ASX: MTM) has kicked off commissioning at its Texas Technology Campus, known as “Gator Point,” following a successful and safe maiden chlorine flash using its proprietary Flash Joule Heating (FJH) process.

It’s a milestone that not only underscores Metallium’s engineering chops but marks a crucial de-risking event in the company’s US ambitions, as it progresses toward full-scale operations in critical and precious metal recovery from e-waste.

Flash, Bang, Commissioning Begins

The first chlorine flash - effectively a hot and fast chemical reaction enabled by Metallium’s FJH tech - was completed without drama and in line with design parameters. This marked the first integrated operation of the FJH-chlorination process at the Texas site. For a company built on lab-tested tech, this real-world performance is a critical validation.

Metallium’s Managing Director & CEO, Michael Walshe, was quick to praise the team, saying:

“The successful completion of our first chlorine flash is a defining milestone… It confirms that the core FJH process is operating as designed under real operating conditions and marks the formal start of commissioning at Gator Point, exactly as planned”.

Demo Line Up and Running

If the FJH reactor is the engine, the three-crucible demonstration line is the test track. Now fully commissioned (both dry and wet), this line will serve a multi-purpose role: feedstock qualification, process optimisation, and customer or partner demonstrations. Think of it as Metallium’s own in-house test kitchen - with scalable recipes.

Permit in Pocket, Systems Online

One of the more significant behind-the-scenes wins was securing the Texas Commission on Environmental Quality’s Permit-by-Rule, granted on 5 December 2025. This green tick allows operations to proceed without further regulatory hurdles - no small feat given the complexity of chemical processing infrastructure in the US.

Commissioning is also advancing across broader systems: utilities, feedstock prep, environmental controls, gas-scrubbing, and safety circuits are all on the go as part of a structured roll-out over the coming months.

On Track for 8,000 TPA by Q3 2026

This isn’t just tinkering at the edges. Metallium’s game plan is a staged ramp-up to 8,000 tonnes per annum of printed circuit board (PCB) e-waste throughput, expected by the third quarter of 2026. Gold, copper, silver, and tin are the initial targets, with a gallium/germanium line in advanced planning - pending feedstock supply.

The company says it’s in advanced negotiations for long-term PCB supply deals. These offtake agreements are critical to securing the volume and quality of material needed to make the economics work.

Walshe summed it up:

“Securing high-quality, contracted feedstock is a critical pillar of our operating strategy as we scale toward 8,000 tonnes per annum of inbound PCB capacity”.

Strategic Site, Scalable Tech

Gator Point isn’t just a plant - it’s the prototype for Metallium’s broader US rollout. Built on a modular backbone, the site is designed for expansion, replication, and commercial deployment. It also acts as a demonstration and licensing hub for the company’s tech, putting Metallium squarely in the camp of US-based players looking to secure domestic supply chains for critical metals.

And given the site's location in an industrial corridor with access to logistics, utilities and skilled labour, it’s well-placed to anchor future build-own-operate projects across the US and potentially further afield.

The Bigger Picture

While the company still has hurdles to clear - feedstock contracts to finalise, further systems to commission, and product streams to optimise - this announcement positions Metallium as more than just a tech hopeful. With its Flash Joule Heating method now in operational motion, the company is edging into rarefied territory: a small cohort of next-gen critical-metals recyclers actually building plant and moving towards revenue.

There’s still a road ahead, but with sparks now flying at Gator Point, Metallium has turned the key on a potentially transformative phase of its journey. Investors will be watching closely to see if this flash of promise turns into a full-blown commercial burn.

Just before the year’s curtain call, ASX-listed Weebit Nano (ASX:WBT) has dropped a tech-sector zinger with the announcement of a licensing agreement with none other than Texas Instruments (TI) - a giant in the global semiconductor industry.

The deal sees TI adopt Weebit’s resistive random-access memory (ReRAM) technology into its advanced process nodes for embedded processing semiconductors. While commercial returns may be some time off, the partnership itself marks a major credibility win for the Israeli-Australian outfit.

As with many things in chip land, it’s what’s under the hood that counts. Weebit’s ReRAM is a type of non-volatile memory (NVM), meaning it retains data without power - a necessary feature for embedded systems in everything from IoT sensors to automotive ECUs. ReRAM is also faster, more scalable, and more power-efficient than legacy flash memory, which is fast approaching its physical and economic limits.

According to the announcement, the agreement encompasses intellectual property licensing, technology transfer, design, and qualification of ReRAM in TI’s process technologies. While the financial terms and potential royalties remain undisclosed - "not known at this time," per the filing - the strategic implications are clearer than ever.

Amichai Ron, Texas Instruments

“We are excited to collaborate with Weebit Nano to integrate ReRAM memory technology into our process technologies and products,” said Amichai Ron, Senior VP of TI’s Embedded Processing unit. “The collaboration will enable our customers to get access to industry-leading NVM technology in performance, scale, and reliability”.

From Weebit’s perspective, this isn’t just another handshake - it’s a marquee validation.

“TI is one of the world’s foremost integrated device manufacturers, producing tens of billions of chips every year,” said CEO Coby Hanoch. “This agreement is another strong signal that the industry is moving towards ReRAM as the successor to flash memory in SoC designs”.

That “successor to flash” narrative is one Weebit has been building steadily, positioning its ReRAM as a fab-friendly solution that avoids the costly equipment overhauls required by other next-gen memory technologies. With the ability to endure high temperatures (qualified to AEC-Q100 150°C), ReRAM is particularly well-suited to automotive and industrial-grade applications.

Still, investors looking for near-term revenue will need to be patient. The company has flagged that production orders and royalty payments are not expected until the medium term - and only at TI’s discretion. But in the notoriously cautious semiconductor sector, where adoption cycles can span years, a foot in the door at Texas Instruments is no small feat.

Weebit’s shares have ridden waves of investor enthusiasm over recent years, as the company has steadily progressed from lab-stage R&D to commercial traction. With licensing deals already in place with SkyWater Technology and Leti, and now this high-profile tie-up with TI, the company is methodically laying the groundwork for what could become a serious revenue pipeline.

While there’s no crystal ball in semiconductors - let alone ASX microcaps - Weebit’s latest deal cements its standing as a technology licensor that’s being taken seriously by the biggest names in the game.

For Memphasys (ASX: MEM), Europe has long been a stated priority. Today, that ambition translated into execution, with the company securing its first European commercial supply agreement - a five-year deal that provides an immediate entry point into the Italian IVF market, underpinned by committed purchase volumes and a clear pathway to scale.

The agreement, struck with Centro Fertilita Assistita (CFA Italia), marks Memphasys’ first commercial foothold in mainland Europe. Under the terms, CFA has committed to minimum purchases of 7,500 Felix™ cartridges over five years, equating to a contract value of at least €525,000, or approximately A$925,000.

CFA Italia team members meeting with clients

The purchase schedule is deliberately front-loaded, with 3,000 cartridges to be acquired across the first two years, followed by 1,500 cartridges annually thereafter. For a consumables-based medical technology model, that structure provides early revenue visibility and establishes a recurring demand profile beyond initial device deployment.

But while the contracted volumes matter, the stronger signal lies in what followed.

Ahead of any contractual obligation - and prior to CE Mark approval - CFA has already placed an initial order for 500 Felix™ cartridges, valued at A$62,500. Revenue will be recognised in the current quarter, with cash receipt expected in the next. In a sector where procurement decisions are often cautious and incremental, an early commercial order speaks louder than expressions of interest.

That order followed direct, in-market engagement, training and clinical onboarding - precisely the hands-on commercial strategy Memphasys has been executing across its priority regions. The approach is designed to shorten adoption cycles and move clinics from evaluation to utilisation, rather than waiting for regulatory milestones to do the heavy lifting.

Felix™ is positioned as a replacement for traditional centrifugation techniques used in sperm preparation, which can expose cells to mechanical stress and DNA damage. Using electrophoresis and size-exclusion membranes, the system delivers a faster, gentler and more standardised sperm selection process - attributes that resonate in high-throughput IVF laboratories.

 Italy provides a meaningful proving ground. It is one of Europe’s largest assisted reproductive technology markets, with close to 97,000 ART procedures performed in 2022. IVF accounts for the majority of that activity, reflecting both sustained patient demand and significant clinical throughput.

 CFA operates across a network of clinics performing thousands of IVF cycles annually and maintains established commercial relationships beyond its own facilities. As part of the agreement, CFA will actively engage this broader network to promote and sell Felix™, creating the potential for volumes to exceed minimum contracted levels over time.

 That scalability is central to Memphasys’ European strategy. While the agreement locks in baseline demand, it is intended as a launch platform rather than a ceiling.

 CE Mark approval is anticipated in early 2026, at which point Felix™ can be deployed across Europe without restriction. By securing a committed partner and early commercial orders ahead of regulatory activation, Memphasys positions itself to accelerate adoption rather than build momentum from scratch post-approval.

 The Italian agreement adds to existing commercial arrangements in Japan, India and the Middle East, reinforcing a strategy focused on contracted, repeatable revenue in clinically significant markets.

 For investors, the takeaway is less about the headline number and more about the pattern emerging beneath it: early orders, minimum commitments and partners with both clinical credibility and distribution reach.

 In medical technology, progress is rarely announced in advance. More often, it shows up quietly - one purchase order at a time.