There are issued to be very concerned about. For one, the ARTH press release did not use the word hemostat; instead spoke of wound care more generally. Was this deliberate?
FDA required a specific biocompatibility study of the ACG Gel, apparently using volunteers. It is important to note that this was not a standard clinical study in that it was not treating wounds per se. ARTH did need to supply AC% Gel for the study, even if it was not in final product packaging. So there is a AC5 formulation.
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