Regulatory and Commercial Roadmap
Felix™ System
Memphasys is progressing a robust global regulatory and commercialisation strategy for the Felix™ System, aimed at bringing this novel sperm separation technology to market across key jurisdictions.
Clinical Evidence and Submissions
Memphasys has completed a clinical trial of the Felix™ System. Positive trial data, supported by an extensive literature review, which forms the basis of submissions to major regulatory bodies including:
- CE Mark – European Union,
- Therapeutic Goods Administration (TGA) – Australia, and
- Central Drugs Standard Control Organisation (CDSCO) – India.
CE Mark (EU MDR 2017/745) – APPROVED December 2025. The Felix™ System has received CE Mark certification under EU MDR 2017/745, granting full commercial access across the European Economic Area and enabling rapid entry into CE-recognised markets including the Middle East, India, and Asia-Pacific.
TGA / ARTG (Australia) – APPROVED February 2026. The Felix™ System received TGA registration on 9 February 2026, two months ahead of the previously guided timeline. Felix™ is included on the Australian Register of Therapeutic Goods and is available for immediate commercial sale across Australia.
UK MHRA – REGISTERED 2026. The Felix™ System is registered with the UK Medicines and Healthcare products Regulatory Agency (MHRA), providing immediate commercial access to the UK market.
Regulatory approvals are no longer a gating factor – they are now accelerating commercial rollout.
Commercial Launch
- End of FY2025 – Commercial launch in Europe
- Beginning of FY2026 – Commercial launch in MENA and Australia
- Beginning of FY2026 – Commercial launch in India
- Beginning of FY2026 – Commencement of offshore manufacturing
United States Regulatory Outlook
Memphasys has completed a pre-submission meeting with the U.S. Food and Drug Administration (FDA) for the Felix™ System. Based on initial feedback, the device is likely to be classified as a novel Class II device requiring a de novo submission. The U.S. regulatory strategy continues to evolve in parallel with progress in other jurisdictions. The regulatory strategy in the US will move forward with commercial partnerships in place.
Strategic Partnerships
In parallel with regulatory activities, strategic partnership discussions are underway to support regional distribution and commercial scaling.