If there is no number on the table, or soon will be, we cannot help you yet. If there is, the rest of this page tells you whether we are the right call.
• You are in a live financing conversation — a cap being proposed, a term sheet in hand, or a round opening this quarter.
• Your device is on an FDA pathway: Class II under 510(k) or De Novo, or Class III under PMA.
• You are somewhere between pathway definition and first-in-human, where the price is most contested.
• You would rather find the hole in your own numbers than have an investor find it.
• You are pre-prototype with no pathway view. The analysis would tell you things you cannot act on.
• You have under four months of runway. You need a bridge, not a positioning exercise.
• You are CE-mark first with FDA deferred. Our benchmarks and base rates are FDA-derived and will not price an MDR milestone honestly.
• You want a number that flatters a round you have already planned.
• You need someone to run your raise and open doors. That is not the service, and an occasional unpaid introduction is not a substitute for it.
An FDA device is a US asset, wherever you built it.
A company in Tel Aviv, Dublin, Eindhoven or Toronto pursuing a 510(k) is building an asset that will eventually be re-rated against what US Class II companies at that stage are worth. But the seed round is usually priced by local investors against local comparables.
Part of that discount is earned. Distance from the US market is real execution risk — clinical sites, reimbursement, commercial build, and probably a US restructuring somewhere ahead. Part of it is habit.
Separating the two is the work. Our benchmarks are keyed to FDA class and pathway, not to geography, so the analysis applies wherever you are incorporated.
Independent reads for angel groups and syndicates.
The same arithmetic runs from the investor’s chair. If your group is evaluating an early device deal and wants an independent read on the risk profile and whether the cap clears, that is a fixed-fee engagement per asset.
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