An investment-ready validation strategy for a liquid-biopsy diagnostics venture
A diagnostics venture with two credible product concepts and promising early data needed to become fundable — which meant sequencing scientific risk, not just presenting it.
Investors were being asked to fund a science programme with no visible risk-reduction milestones. The clinical validation path, the regulatory route and the raise were being planned separately, so no single gate could be pointed at as proof the venture was de-risking.
We restructured the plan into explicit de-risking gates, each tied to a validation result, a clinical partner commitment and a funding tranche. Building the clinical network came first — commitments from clinics are the evidence that turns a validation plan into a credible one.
- —Staged validation plan with explicit de-risking gates
- —Clinical partner network build-out across 50+ clinics
- —Regulatory pathway assessment under MDR
- —Pre-seed round scoping, use of funds and milestone map
- —Investor materials tying each tranche to a validation gate
Letters of intent were secured for both product concepts and more than fifty clinics engaged, supporting a scoped €750k pre-seed round where each tranche unlocks against a named validation milestone.
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