Memphasys Limited (ASX: MEM) has formally lodged Memphasys Felix regulatory submissions with the Australian Therapeutic Goods Administration (TGA) and India’s Central Drugs Standard Control Organisation (CDSCO). The dual submissions represent the final regulatory step before commercial activation in both markets, following the company’s CE Mark approval secured in December 2025.
The TGA submission seeks inclusion of the Felix™ System on the Australian Register of Therapeutic Goods, with approval expected by April 2026. The CDSCO submission initiates a review process anticipated to take approximately six months from lodgement. Both regulatory pathways leverage the clinical data, manufacturing standards and quality systems underpinning CE Mark approval.
These regulatory clearances would unlock commercial execution in two high-value IVF markets simultaneously, transitioning Felix™ from approved technology to revenue-generating asset across multiple jurisdictions.
What Is Regulatory Approval and Why Does It Matter for Medtech Investors?
Regulatory approval from bodies such as the TGA and CDSCO serves as the formal authorisation required before a medical device can be legally marketed and sold within a specific jurisdiction. For a medical device company, these approvals validate that a product meets the safety, quality and performance standards mandated by national health authorities.
The CE Mark approval provides the clinical and quality foundation for subsequent regulatory submissions in other markets. It demonstrates that the Felix™ System has met European Union conformity requirements, which many non-EU regulators reference when assessing device safety and efficacy. This creates a pathway for accelerated approvals in jurisdictions that accept CE Mark data as part of their evaluation process.
For investors, regulatory milestones function as de-risking events that convert pipeline products into commercial assets. A product without regulatory clearance cannot generate revenue, regardless of its technical merit. Approvals remove this barrier, enabling companies to activate commercial agreements, place devices in clinical settings and establish recurring revenue streams.
Three Markets, Three Pathways to Revenue
Memphasys is progressing regulatory and commercial readiness across three distinct markets, each with its own regulatory status and market opportunity. The company’s multi-jurisdiction strategy reduces dependency on any single market while providing near-term revenue visibility through structured commercial arrangements.
| Market | Regulatory Status | Expected Clearance | Annual IVF Cycles | Commercial Readiness |
|---|---|---|---|---|
| Australia | TGA submission lodged | April 2026 | ~60,000 fresh cycles | Advanced negotiations underway |
| India | CDSCO submission lodged | ~6 months | 300,000 (growing to 500,000-600,000) | Supply agreement executed |
| United Kingdom | CE Mark valid; MHRA registration in progress | Immediate pathway | ~75,000-80,000 | Partner discussions active |
Australia represents an attractive near-term market combining advanced clinical standards, high technology adoption and strong reimbursement frameworks. In 2023, approximately 103,556 assisted reproductive technology treatment and lab-only cycles were performed, including more than 60,000 fresh cycles where Felix™ has potential application.
India represents one of the largest global ART growth opportunities, with approximately 300,000 IVF cycles performed annually and forecast to grow to 500,000–600,000 cycles in coming years. Male-factor infertility contributes to around half of all cases, with ICSI penetration exceeding 70%, positioning Felix™ to support increased laboratory efficiency across India’s expanding clinic networks.
The United Kingdom represents one of Europe’s largest assisted reproductive technology markets, with approximately 75,000–80,000 IVF treatment cycles performed annually. The market combines NHS-funded treatment with a substantial private clinic network, supporting both initial console placement and recurring consumables revenue models.
India: Contracted Demand Awaiting Activation
Memphasys has executed a non-exclusive supply agreement with Andro Diagnostics, Coimbatore (part of the Andrology Center group), structured for activation upon CDSCO approval. The agreement provides contracted demand visibility and establishes a foundation for market penetration across India’s fragmented IVF clinic landscape.
The agreement includes the following commitments:
- Year 1 minimum: 1,800 Felix™ cartridges
- Year 2 minimum: 2,700 cartridges
- Quarterly delivery cadence post-approval
- Deployment across a network of more than 200 partner IVF clinics
Activation of this agreement is contingent on CDSCO approval, which has now been formally progressed through regulatory submission. The structured commitment provides revenue line-of-sight once regulatory clearance is secured, converting regulatory approval directly into measurable commercial activity.
UK Market Entry Without Additional Regulatory Delay
The United Kingdom’s transition framework allows CE Mark holders to sell medical devices without a UKCA mark during the current transition period. Memphasys is progressing the administrative requirements necessary to enable immediate commercial sales of Felix™ under this pathway.
The company is actively advancing four requirements for UK market entry:
- A valid CE Mark under EU MDR or IVDR (secured December 2025)
- Appointment of a UK Responsible Person (UKRP)
- Completion of MHRA device registration
- UK-compliant labelling, including UKRP details
The UK represents a substantial private IVF market with minimal regulatory friction under current transition rules. Male-factor infertility contributes significantly to treatment demand, and increasing utilisation of ICSI procedures creates a strong addressable use case for the Felix™ System within embryology laboratories. The market structure, combining NHS-funded treatment with a material private clinic presence, supports both console placement and recurring consumables revenue models.
Commercial Execution Roadmap
Regulatory clearance in Australia and India, together with completion of UK market entry requirements, would enable activation of existing and pending commercial arrangements, direct clinic-level sales of Felix™ cartridges, expansion of the installed console base and establishment of scalable, recurring cartridge revenue streams.
In India, the company has a formal commercial supply agreement in place, structured for activation upon receipt of CDSCO approval, providing a clear pathway to initial cartridge revenues.
In Australia, Memphasys is in advanced commercial negotiations with multiple parties, with discussions focused on distribution structures, console placement and cartridge supply arrangements. These negotiations are intended to enable rapid commercial activation following anticipated TGA approval.
In the United Kingdom, the company is actively engaging with prospective commercial partners and IVF clinics, with discussions progressing regarding distribution, console placement and cartridge supply arrangements. While no formal UK commercial agreements have yet been executed, these conversations are intended to ensure the company is well positioned to commence commercial activity promptly following completion of MHRA registration and related UK entry requirements.
CEO Commentary
“Our go-direct commercial and regulatory strategies are working hand in glove, delivering exactly what we committed to the market. More key regulatory submissions have now been lodged, contracted demand continues to build, and these approvals are expected to further accelerate growth in Felix™ sales as execution progresses,” said Marjan Mikel, Chair of the Commercialisation Committee.
Concurrent regulatory and commercial progress positions the company for rapid market penetration upon approvals. The structured approach across multiple jurisdictions creates multiple near-term catalysts while reducing execution risk through diversified market exposure.
What Comes Next for Memphasys
With regulatory submissions lodged, commercial readiness progressing and market entry pathways advancing across multiple jurisdictions, Memphasys believes Felix™ is entering a new phase of global commercial execution. The company faces several defined near-term catalysts that provide investors with clear milestones to monitor regulatory and commercial progress.
The TGA decision is expected by April 2026, based on regulatory advice and CE Mark conformity. The CDSCO review process is anticipated to take approximately six months from submission. In the United Kingdom, MHRA registration and UKRP appointment remain in progress, with completion enabling immediate commercial sales under the CE Mark transition framework.
The company has stated it will continue to update shareholders as regulatory reviews progress and as further commercial agreements and approvals are secured. Multiple near-term catalysts across three markets provide structured checkpoints for assessing execution against the company’s stated commercialisation strategy.
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