Felix Early Thai FDA Approval, Commercial Launch Accelerates

Key points

• Thai FDA approval enables earlier commercial sales
• Exclusive three-year distribution agreement with IVF Envimed
• Additional 100-unit order placed by IVF Envimed

Full summary

Memphasys Limited (ASX: MEM) announces that the Felix System has received early approval from the Thai FDA, enabling commercial sales and distribution across Thailand. The approval activates a three-year exclusive distribution agreement with IVF Envimed Co., Ltd. The agreement has a minimum contracted value of approximately A$430,500. IVF Envimed has placed an additional order for 100 Felix cartridges and three consoles, following an initial order of 100 cartridges and three consoles. Thailand is a significant market for assisted reproductive technology (ART), with over 20,000 to 30,000 IVF cycles annually across 110 registered IVF clinics.

Guidance

Year 1 revenue expected to exceed contracted minimum of $75,000

Outlook

Focus on delivery of first-quarter order, training, and clinic onboarding. Further updates expected on new commercial agreements.