A self-contained device that moves the embryo-culture phase in-vivo, with the protocols and quality systems to run it anywhere — positioned as the middle layer between IUI and IVF.
EVEA™ occupies the clinical and economic space between intrauterine insemination and full conventional IVF — a lower-infrastructure path to embryo culture for indicated, good-prognosis patients. It does not replace IVF; cases it cannot serve escalate to IVF, expanding the funnel rather than competing with it.
Widely available, low success per cycle — many patients escalate.
Higher success per cycle than IUI, no embryology cleanroom, deployable in hospitals without a full IVF lab.
Major-city centres, full embryology lab — the backstop for complex cases.
Oocyte retrieval and sperm preparation in the clinic — standard egg collection.
Gametes loaded into the self-contained EVEA™ device; culture proceeds in-vivo over 3–5 days. No incubator bank, no cleanroom.
Device retrieved; the embryologist recovers and assesses embryo development in-clinic.
Selected embryo transferred; surplus embryos may be cryopreserved.
Conventional IVF cultures embryos in open dishes for 3–5 days, requiring a HEPA-filtered cleanroom, a bank of CO₂ culture incubators and continuous air-quality monitoring. EVEA™ moves that phase in-vivo — removing the single most infrastructure-heavy constraint in ART. IVC still uses an operating theatre, an andrology lab and microscopes; it removes the cleanroom, not all lab equipment.
No HEPA-filtered lab build, no continuous air monitoring, no dedicated embryology space — the single largest barrier to deploying ART outside major cities.
No bank of CO₂ culture incubators for open culture. The multi-day open-culture environment disappears entirely.
Substantially fewer embryologist-hours per cycle than a conventional ART centre — easing the specialist-staffing constraint.
Single-use, manufactured to ISO 13485 (Freudenberg Medical, LOI signed), supplied per cycle.
Standardised loading, retention and assessment protocols, with a structured clinical training programme delivered before first cycle.
QMS scaffolding deployed with every activation, jurisdiction-aware.
Malaysia MDA Class B predicate route; Hong Kong patent filed with a positive CNIPA search report; China standard-patent route within the priority window. A freedom-to-operate opinion has been obtained for Malaysia, our lead market.