Evidence
What we know, and how we know it.
Published literature for the problem. Internal pilot data for the solution, labeled as internal. We do not present one as the other.
The problem
| Figure | Claim | Basis |
|---|---|---|
| Every 90 seconds | Frequency of IO placement in the United States | Innovo internal estimate, extrapolated. Not a published figure. |
| Up to 50% | First-pass attempts that experience complications | NEJM and out-of-hospital cardiac arrest literature |
| -$300 | Kit cost wasted per failed attempt | Innovo estimate from list pricing of consumables |
Source links are attached to each specific claim in the clinical summary, available on request.
I-Optic internal pilot
100%
First-attempt placement
Fifteen participants, ten with medical training and five without, placed an IO using I-Optic with no prior exposure to the device. Every participant succeeded on the first attempt.
The finding worth noting is not the percentage. It is that the lay cohort performed the same as the trained cohort, which is what you would expect if the reticle and the locked vector are doing the work that experience normally does.
This was an internal pilot run by Innovo, not a controlled clinical trial, and it is not a claim of clinical efficacy. The I-Optic Trainer is intended for skills training and is not cleared by FDA for clinical use; a 510(k) for clinical indication is in progress.
Regulatory and intellectual property status
| Device | Class | Patent | Availability |
|---|---|---|---|
| T-Band | Class I, 510(k) exempt | Utility patent awarded | Shipping today |
| I-Band | Class I, 510(k) exempt | Patent pending | Shipping today |
| I-Optic Trainer | Class II, 510(k) in progress for clinical use | Patent pending | Available for training |
Next step