Felix Finds Fertile Ground: Memphasys Races Toward Global IVF Rollout

Reproductive biotech hopeful Memphasys (ASX: MEM) is shifting from promise to execution, with a string of regulatory lodgements and fresh orders positioning its flagship Felix™ System for commercial lift-off across multiple continents. From regulatory filings in Australia and India to anchor-client adoption in Qatar, the company’s dual-pronged strategy - clinical credibility paired with go-direct sales execution - appears to be bearing fruit.

Regulatory Milestones: Approvals in Sight for Australia and India

Memphasys has filed its long-anticipated regulatory submissions with the Australian Therapeutic Goods Administration (TGA) and India’s Central Drugs Standard Control Organisation (CDSCO). TGA approval is expected by April 2026, while Indian clearance is anticipated within six months - timelines which would enable commercial sales in two highly strategic markets.

Both submissions build on the company’s CE Mark certification, granted in December 2025, allowing Memphasys to leverage existing clinical data and quality systems to fast-track approval pathways.

UK Sales on the Fast Track via CE Mark Pathway

While others navigate the regulatory fog post-Brexit, Memphasys is taking the express lane. Under the UK’s transitional framework, devices with valid CE Mark approval can be sold without the UKCA mark - provided certain registration and labelling requirements are met.

The company is currently completing MHRA device registration, appointing a UK Responsible Person, and preparing UK-compliant labelling. With no formal UK sales agreements signed yet, discussions are actively progressing with IVF clinics and potential distributors.

Indian Deal Locked and Loaded, Pending CDSCO Tick

On the subcontinent, Memphasys has secured a non-exclusive supply agreement with Andro Diagnostics of Coimbatore. The deal includes a minimum of 1,800 cartridges in the first year, scaling to 2,700 in Year 2, distributed across a network of over 200 clinics.

Activation is contingent on CDSCO approval, but demand fundamentals are compelling: India performs around 300,000 IVF cycles annually, projected to grow to as many as 600,000, with male-factor infertility implicated in roughly half.

MENA Momentum: Qatar’s IVF Giant Commits to Felix™

In what could be a pivotal endorsement, Hamad Medical Corporation (HMC) - Qatar’s leading fertility institution - has begun ordering Felix™ cartridges for clinical use. The initial demand clocks in at around 100 cartridges per month, equating to 1,200 per annum. HMC alone covers nearly half of the minimum annual volume required under Memphasys’ distribution deal with International Technical Legacy (ITL).

This makes HMC the first major institutional reference customer in the MENA region - a critical foot in the door for broader adoption.

Follow-On Demand and Wider Middle East Traction

The MENA story doesn’t end with Qatar. ITL has placed an additional follow-on order for 200 cartridges, reflecting demand from clinics across the UAE and elsewhere in the region. According to Memphasys, late-stage contractual discussions are underway with prospective clients in five additional MENA countries.

Each target clinic is capable of generating A$100,000–A$300,000 in annual cartridge revenue, offering substantial scale potential.

Execution Strategy Backed by Boots on Ground

Adding to this momentum, Associate Professor Hassan Bakos, Memphasys’ Director of Clinical Partnerships, is on his second visit to the region in two months. The trip, backed by ITL, includes optimisation support at HMC, clinic onboarding meetings and a prominent presence at an ART conference in Egypt - a market forecast to exceed US$500 million in IVF spend.

Commercial Countdown Begins

Chair of the Commercialisation Committee Marjan Mikel summed it up succinctly: “Our go-direct commercial and regulatory strategies are working hand in glove... contracted demand continues to build, and these approvals are expected to further accelerate growth in Felix™ sales as execution progresses”.

Indeed, with regulatory filings in motion, cartridge orders building, and commercial talks advancing across three continents, Memphasys appears to be entering the revenue-generating phase of its global push.

Investors won’t have to wait long to see whether Felix™ can make the leap from clinical promise to commercial success - the true test lies just ahead.