Regulatory and Commercial Roadmap
Felix™ System
Memphasys is executing a global regulatory and commercialisation strategy for the Felix™ System across major assisted reproductive technology markets.
Regulatory clearances achieved
- European Union: CE Mark certification under EU MDR 2017/745, achieved in December 2025.
- Australia: included in the Australian Register of Therapeutic Goods in February 2026.
- United Kingdom: registered with the Medicines and Healthcare products Regulatory Agency.
- Thailand: Thai FDA approval achieved in August 2026, enabling the commercial agreement to move into launch.
- Vietnam: registration achieved in August 2026, triggering an initial 600-cartridge commercial order.
- Türkiye: registration achieved in September 2026, followed by the first commercial sale.
These clearances support the accelerating commercial rollout of Felix™ across Europe, Australia, the United Kingdom, the Middle East and South-East Asia.
India
Memphasys is progressing the regulatory pathway with India’s Central Drugs Standard Control Organisation. Commercial supply under the Company’s Indian agreement remains subject to the required regulatory approval.
United States regulatory outlook
Memphasys has completed a pre-submission meeting with the US Food and Drug Administration. Based on initial feedback, Felix™ is expected to require a de novo submission as a novel Class II device. The US regulatory strategy will progress alongside suitable commercial partnerships.
Commercial rollout
Felix™ has a 31-country commercial reach and more than A$4.2 million in publicly announced minimum contracted sales. Commercial activity includes Europe, Australia, the United Kingdom, MENA, Japan, India and South-East Asia.