Hi Gekko, Remember that they only have an IDE for a pilot study. They will need to lodge another IDE for the pivotal study they will need the data from to lodge for market approval. The pivotal study (if approved by FDA) will likely cost them upwards of $15-20 million, require 300+ subjects and take 3-5 years to complete. They are therefore probably still the better part of another decade away from generating any revenue in the states...if the product is proven to work that is.
Hi Gekko, Remember that they only have an IDE for a pilot study....
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