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Re: divea post# 8617

Tuesday, 10/02/2018 4:15:49 PM

Tuesday, October 02, 2018 4:15:49 PM

Post# of 10348
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.