Arch Therapeutics Provides Corporate Milestone Update, Including Anticipated Filing of 510(k) for AC5(TM)
FRAMINGHAM, MA–(Marketwired – Feb 16, 2017) – Terrence Norchi, MD, CEO of Arch Therapeutics, Inc. ( OTCQB : ARTH ), developer of innovative materials as hemostatic and wound care devices, provided a corporate update during a live webcast this morning at 10:45 a.m. ET at the RHK Capital 2017 Disruptive Growth & Healthcare Conference in New York City. Replays of the live webcast can be accessed here: http://www.investorcalendar.com/event/11170. The presentation slides are available for download at: http://ir.archtherapeutics.com.
During the presentation, Dr. Norchi announced that the 510(k) filing for external use of AC5™ will be further advanced to mid-2017 from the previously announced target of late 2017.
Dr. Norchi said, “Our anticipated 510(k) filing focusing on external skin applications should present a nearer-term opportunity for AC5, compared to the company’s prior plan of filing a Premarket Approval Application (PMA) for all uses in the United States. 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. Our intent to file a PMA for internal use after completing related human clinical work remains intact.”
Dr. Norchi additionally reported that the company’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 (specifics are undisclosed). Preclinical research is ongoing with various partners, an approach that has the advantage of managing costs and engaging relevant experts. The company expects to advance the best product candidates further along the development cycle.
Per the company’s recent Form 10-Q, Arch received proceeds from warrant exercises of approximately $350K during the prior calendar quarter and approximately $150K during January 2017. Further, the company continues to internalize certain roles and resources that were previously fulfilled by consultants, as part of Arch’s ongoing strategy to manage costs and build an effective development team. For example, Arch has hired a VP of Medical and Technical Marketing as well as a Quality Manager, and has started to add expert advisors in military procurement and R&D as part of plans for future commercialization of AC5.
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.
About Arch Therapeutics, Inc.
Arch Therapeutics, Inc. is a medical device company developing a novel approach to stop bleeding (hemostasis) and control leaking (sealant) during surgery and trauma care. Arch is developing products based on an innovative self-assembling materials technology platform with the goal of making surgery and interventional care faster and safer for patients. Arch’s flagship development stage product candidates, known as the AC5 Surgical Hemostatic Device™ and AC5 Topical Hemostatic Device™, are being designed to achieve hemostasis during surgical, wound and interventional care.
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