No. You need your existing operating theatre, an andrology lab (the same setup as IUI), and an embryologist with microscopes to load the device and assess embryos. You do not need an embryology cleanroom, incubator bank, HEPA filtration or continuous air monitoring.
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.
EVEA™ is designed to reduce laboratory infrastructure and hands-on embryo-culture requirements. Staffing needs depend on your existing programme, patient volume and local clinical requirements. Eve assesses this during feasibility review.
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.
EVEA™ device (per cycle), clinical protocols, hands-on staff training, quality systems, regulatory documentation, and ongoing technical support.
Operating theatre, andrology lab, embryology staff, 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) pathway. Requirements in other markets are assessed separately with local regulatory authorities.
Published studies of intravaginal culture have reported clinical pregnancy rates of 35–55% per cycle across different patient populations. Outcomes vary by patient age, indication and embryo characteristics. These are published IVC literature results, not EVEA™-specific data.
EVEA™ is an investigational medical device under development. Eve is planning a 50-patient clinical evaluation to establish EVEA-specific safety and clinical performance.
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.
There is no upfront $500K–$1M+ lab build. Eve charges per cycle. Costs depend on local healthcare market, patient volume and specific deployment configuration.
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 and no debt service on a $1M lab build. 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.
Schedule a call →