Rocko - my concern does not lie with adoption by the SAB. Titan is a fledgling company about to fight for market share in a space that has been monopolized since 2001. Not all prospective targets are early adopters and willing to put their political capital on the table for a device that has not been validated appropriately through bypassing human trials.
No human trials = short term gain for the long term pain. The growth of the organization is dependent on it - trust me. Data collection is a key component in building a solid foundation.
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