Ann: LBT begins key U.S. trial of APAS technology, page-38

Any pathology product (like pharmaceuticals) must have demonstrated its efficacy before it can be sold.
Without such a demonstration its unsaleable.
The USA Food and Drug Administration (FDA) is the pre-eminent approval authority.
If approval for a product is obtained through the FDA then approvals elsewhere will be much easier to obtain. It's like dominoes, knock one over and the rest will follow.
I agree it's frustrating, because it's time consuming, but, like any company in the medical field nothing seems to be happening until approval is gained.

Then there'll be movement at the station.