Our Roadmap

A clear path from concept
to clinical impact.

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Concept & Feasibility

Clinical need validated. Core technology concept established. IP landscape assessed. Founding team assembled.

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Preclinical Validation

Current phase

Prototype development. Bench-level biosensing validation. IP filing.

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First In Human Studies (Q3-Q4 2026)

Pilot clinical study. Safety and performance data. Signal validation and optimisation. Finalising design for manufacturability. ISO 13485 QMS implementation and preparation for applicable IEC 60601, EMC and FCC testing.

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Validation Studies (Q1-Q2 2027)

FDA pre-approved validation studies to compare the device against current gold standard both in pregnancy and in labour.

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Regulatory Submission

FDA submission via 510(k) pathway. CE marking under EU MDR.

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Commercial Launch

US and European market entry initially. Health system partnerships.

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