Pre-Seed
Also known as: Level 2, Pre-Seed Stage, Proof of Concept Funding
The second funding level in the GAITS Funding Readiness Framework — early-stage investment to validate a proof of concept and define the path to a Seed round, where the primary risk is technical and clinical feasibility.
Full Definition
Pre-Seed is Level 2 of the GAITS Funding Readiness Framework. At this stage, the team has moved beyond scientific exploration and is focused on demonstrating technical and clinical feasibility — showing that the approach works in a controlled setting and that there is a credible path to a prototype or first-in-human study.
Funders at Pre-Seed stage include angel investors, seed-stage health innovation funds, and government proof-of-concept programmes. The primary risk being evaluated is whether the technology can work in a clinically meaningful format, not whether it can scale. Commercial questions are secondary: funders want to see a team that understands the clinical problem, has a viable technical approach, and can execute early development work.
Typical instruments include SBIR/STTR Phase II (US), Innovate UK Biomedical Catalyst and NIHR i4i Product Development Awards (UK), EIC Transition grants (EU), and early angel or seed-stage venture capital. Teams should have preliminary data, a defined regulatory pathway, and a plan for the next major validation milestone.
A team developing a wearable continuous glucose monitor has bench data showing the sensor performs within acceptable accuracy ranges in vitro. They apply for a Pre-Seed grant to fund a first-in-human pilot study in 20 participants. The application demonstrates a credible technical approach, a defined regulatory classification (Class II medical device), and a primary endpoint focused on sensor accuracy versus a reference standard. The funder is evaluating feasibility and early clinical signal — not market size or commercial model.