Regulatory & Validation Pathway

Developed as an in vitro diagnostic medical device (IVD):

- CE-IVD pathway under IVDR (EU)

- FDA 510(k) Class II submission planned

- Clinical performance studies scheduled following prototype validation

Business Model

A scalable reader + disposable strips diagnostic platform, supported by:

- Recurring strip purchases

- Clinical software licensing

- B2B / B2B2C integrations with fertility & endocrinology clinics

- Long-term expansion to digital health and ISF-monitoring systems

We work with clinical researchers, academic labs, and industry partners to bring quantitative hormone diagnostics into everyday care.

CEO – Elvina Juršėnaitė

Business strategy, company building, partnerships, investment.

CTO – Kotryna Gasiulytė

Diagnostics, biosensors, clinical pathways, translational R&D.