InvestSMART

Memphasys Limited (ASX:MEM)

ALERT: Price-sensitive ASX Announcement for MEM
Current share price for MEM : $0.004 -0.001 (-20%)+
Announcement
Release
25 Sep 2026 9:35AM
Price at Release
$0.005
Full Release
download
Summary
Memphasys Limited (ASX: MEM) announced that a Board reassessment of the US regulatory strategy for its Felix™ Sperm Separation System has identified a potentially faster and more cost-effective route to FDA clearance by pursuing the established 510(k) pathway instead of the previously expected De Novo pathway, based on the identification of a legally marketed device believed to be a suitable predicate. The Company plans to undertake a Pre-Submission (Q-Submission) engagement with the FDA to obtain feedback on the proposed predicate, regulatory approach, testing requirements and supporting evidence ahead of a targeted formal submission in Q1 calendar 2027. Memphasys said the US is a major long-term opportunity, with about 500 clinics providing assisted reproductive technology services, 435,426 ART cycles reported across 457 clinics in 2022, and an estimated US$5.9 billion IVF market in 2025 representing around 20% of global IVF revenue. The US program will be ringfenced and progressed in parallel with the Company’s existing commercialisation efforts, while its immediate focus remains on accelerating Felix™ adoption, cartridge sales, repeat orders and recurring revenue across Europe, Australia and New Zealand, Asia and MENA; the announcement also noted ongoing commercial momentum, including additional repeat orders from existing partners and clinics in Italy, the UK and MENA.
Key Points
  • Memphasys identified a potential expedited FDA pathway for Felix™ through the 510(k) process instead of the previously contemplated De Novo pathway.
  • The revised strategy is based on the identification of a legally marketed device that Memphasys believes may serve as an appropriate predicate.
  • The Company will begin a Pre-Submission (Q-Submission) process with the FDA to seek feedback before making a formal regulatory submission.
  • Memphasys is targeting a formal FDA submission in Q1 CY2027, subject to FDA feedback and any additional required work.
  • The US IVF market was estimated at approximately US$5.9 billion in 2025, representing about 20% of global IVF market revenue.
  • The US opportunity includes around 500 ART clinics and 435,426 ART cycles reported across 457 clinics in 2022.
  • Memphasys said the US regulatory program will be strategically ringfenced and will not displace its near-term commercial priorities.
  • The Company remains focused on accelerating Felix™ adoption and revenue generation across Europe, Australia and New Zealand, Asia and MENA.
  • Memphasys reported continued commercial momentum, including additional repeat orders from partners and clinics in Italy, the UK and MENA.
  • Felix™ is described as a patented sperm separation technology that uses electrophoresis and size-exclusion membranes to isolate viable sperm cells for assisted reproduction.
IMPORTANT NOTE: This information is autogenerated and has not been reviewed for accuracy or completeness. You should refer to the full announcement here for further information.