Per the 2/16/2017 PR, "Arch is maintaining current guidance regarding its aim to file a CE Mark for AC5 Topical Hemostatic Device™ as soon as possible and is continuing to work with its third-party partners to prepare requisite materials for submission to regulatory authorities. As previously stated, the planned 2017 regulatory filings would be the company's first, as there has not yet been a submission for approval of AC5 to any regulatory body".