Arch Therapeutics (OTC:ARTH) said today it submitted a 510(k) application to the FDA as it seeks approval for tis AC5 topical gel designed for hemostatic and wound care, seeking an indication for external wounds.
The Framingham, Mass.-based company said that it will still seek regulatory approval for its other AC5 products, designed for internal use, through the FDA’s premarket approval process.
“This is an important milestone for Arch. As previously shared, we planned to request 510(k) clearance in the middle of 2017 for the external use AC5, which is a significant acceleration from original expectations of seeking U.S. regulatory approval through the PMA process, and we have met that goal. This achievement illustrates the ability of our team to execute on our development and regulatory strategies,” prez & CEO Dr. Terrence Norchi said in a prepared statement.
Arch Therapeutics said that it is continuing to focus on product development and regulatory clearances, and that it is working to scale up production for commercial availability in the 2nd half of 2018.
“This 510(k) submission, which incorporates recommendations provided by the FDA during pre-submission communications, is the culmination of the collective effort and success of our team in completing important biocompatibility, toxicology, preclinical, and clinical studies. Simultaneously, we continue to make progress on our preclinical pipeline, including several product applications with high unmet medical needs,” Dr. Norchi said in a press release.
In February, Arch Therapeutics priced a direct offering, looking to float 10.2 million units at 60¢ per share and bring in approximately $6.1 million for the company.