ARCH THERAPEUTICS, INC. (OTCMKTS:ARTH) Files An 8-K Regulation FD DisclosureItem 7.01
On October 1, 2018, Arch Therapeutics, Inc. (the “Company”) issued a press release to announce that it had submitted a 510(k) notification to the U.S. Food and Drug Administration (the “Agency”) for its AC5ä Topical Gel (AC5) and has received acknowledgement from the Agency that the submission has been received. The text of the press release is attached hereto as Exhibit 99.1 and is incorporated by reference herein.
The disclosure under Item 7.01 (Regulation FD Disclosure) is incorporated herein by reference.
Item 9.01 | Financial Statements and Exhibits |
(d) The following exhibits are being filed herewith:
Arch Therapeutics, Inc. ExhibitEX-99.1 2 tv503807_ex99-1.htm EXHIBIT 99-1 EXHIBIT 99.1 Arch Therapeutics Announces 510(k) Submission to the U.S. FDA for AC5™ Topical Gel FRAMINGHAM,…To view the full exhibit click here
About ARCH THERAPEUTICS, INC. (OTCMKTS:ARTH)
Arch Therapeutics, Inc. is a development-stage company. The Company operates as a biotechnology company. The Company focuses on developing products to stop bleeding (hemostasis) and control leaking (sealant) during surgery and trauma care. The Company’s technology is based on a self-assembling peptide that creates a physical, mechanical barrier, which could be applied to seal organs or wounds that are leaking blood and other fluids. The Company’s primary product candidates, collectively known as the AC5 Devices (AC5), are designed to achieve hemostasis in surgical procedures. The Company’s product candidates rely on its self-assembling peptide technology and are designed to achieve hemostasis in skin wounds, and minimally invasive and open surgical procedures. The Company focuses on developing other product candidates based on its technology platform for use in a range of indications. As of September 30, 2016, the Company had not generated any revenues.