Arch advances 510(k) filing for AC5 hemostat
Arch Therapeutics (OTCQB:ARTH) announced that the 510(k) filing for external use of the AC5 Topical Hemostatic device would be advanced to mid-2017 from the previously announced target of late 2017.
"Our anticipated 510(k) filing focusing on external skin applications should present a nearer-term opportunity for AC5, compared with the company's prior plan of filing a Premarket Approval Application (PMA) for all uses in the U.S.,” CEO, Dr. Terrence Norchi, said in a statement.
“We anticipate that the potential benefit from an earlier 510(k) filing is significant in terms of business opportunity and technology validation, and consequently, we have concentrated some internal resources to focus on this objective,” he added. “Our intent to file a PMA for internal use after completing related human clinical work remains intact."
Arch’s preclinical pipeline includes several product applications with high medical need: care of chronic cutaneous wounds and burns, prevention of surgical adhesions, sealing gastrointestinal anastomoses and ophthalmology. Preclinical research is ongoing with various partners.
Dr. Norchi said Arch is maintaining current guidance about its aim to file a CE Mark for the 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.