Everything hospital partners need to know about EVEA™, deployment and partnership.
No — but you do need a compact, clean embryology room. EVEA™ requires a laminar-flow workstation, one CO₂ incubator, microscopes, and a qualified embryologist for loading and assessment. What it is designed to reduce is the scope of sustained-culture cleanroom infrastructure: HEPA/HVAC, positive-pressure AHU, and the multi-unit incubator bank for open-dish culture.
Potentially. If you already run IUI, you have the theatre and basic lab setup required. Suitability depends on your specific theatre layout, andrology lab capabilities and local clinical requirements. Eve conducts a feasibility assessment during initial consultation.
Around one FTE can support roughly 2,000 IVC cycles — compared with 2–4 FTEs for the same volume of conventional IVF. Hands-on hours per cycle are modelled to drop from ~6.8 to ~2.8. Eve assesses specific staffing needs during feasibility review. Operational figures reflect Eve modelling, not clinical-trial data.
Indicative timeline: 4 months. Months 1–2: Feasibility assessment, staff training, protocol development. Month 3: Regulatory documentation and quality systems setup. Month 4: First clinical cycle. Actual timeline depends on your regulatory pathway and site readiness. Eve modelling; illustrative.
EVEA™ device (per cycle), clinical protocols, hands-on staff training, quality systems, regulatory documentation, and ongoing technical support.
Operating theatre (existing), andrology lab (existing), a compact clean embryology room (~30 m², one-time build), reduced-scope embryologist time, existing IUI programme, patient access, and clinical leadership.
Regulatory requirements depend on your jurisdiction. In Malaysia, Eve is working through the Medical Device Authority (MDA) Class B re-use pathway. Requirements in other markets are assessed separately with local regulatory authorities.
Published studies of intravaginal culture have reported clinical pregnancy rates of 40–50% per cycle across different patient populations. Outcomes vary by patient age, indication and embryo characteristics. These are published IVC literature results on the method, not EVEA™-specific data.
EVEA™ is an investigational medical device under development. It is not approved, cleared, or available for sale in any jurisdiction. Eve is planning a 50-patient clinical evaluation in Malaysia to establish EVEA-specific safety and clinical performance, completing Q3 2027.
No. EVEA™ occupies the clinical space between IUI and full IVF. It addresses good-prognosis patients and cases suitable for in-vivo culture. Complex cases escalate to conventional IVF, expanding clinical capacity rather than competing with it.
Yes. After culture, the embryologist assesses embryo quality. Selected embryos transfer; surplus embryos can be cryopreserved using standard protocols.
Activation capex for the hospital is estimated at ~$65–110K — versus $500K–$1M+ for a conventional IVF lab. Eve charges per cycle thereafter. Actual figures depend on your existing infrastructure and local costs. Eve modelling; illustrative.
Eve earns recurring revenue per EVEA™ cycle run. As you treat more patients, Eve grows. Both parties' incentives are aligned: better clinical outcomes drive more cycles and more revenue.
There is no upfront sunk cost on a $1M lab build and no debt service on it. You only pay for cycles actually run. The model aligns incentives: we both benefit from clinical success and patient volume growth.
No obligation. Just a quick review of fit for your institution.
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