false 0001537561 0001537561 2023-09-13 2023-09-13

 

 

 

 

 

Date of Report (Date of earliest event reported): September 13, 2023

 

(Exact name of registrant as specified in its charter)

 

 

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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

 

 

 

 

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).

Emerging growth company ☐

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

 

 

On September 13, 2023, Arch Therapeutics, Inc. (the “Company”) issued a press release providing a commercialization update on the Company’s first product, AC5® Advanced Wound System (“AC5”). AC5 is cleared by the Food and Drug Administration for the management of partial and full-thickness wounds, such as pressure sores, leg ulcers, diabetic ulcers, and surgical wounds. AC5 is a synthetic self-assembling wound care product that provides clinicians with multi-modal support and utility across all phases of wound healing.

 

Since the Centers for Medicare and Medicaid Services (“CMS”) established A2020, a Level II Healthcare Common Procedure Coding System (“HCPCS”) code dedicated to AC5, both orders and payments for submitted claims have accelerated.

 

Since the April 1, 2023, effective date of A2020, average monthly order volume for AC5 has grown significantly, increasing over four-fold when compared to average monthly order volume from the first calendar quarter. The Company can already confirm reimbursement through paid claims in various regions of the country and continues to make progress on its efforts to expand coverage and optimize payment policies with both commercial payors and contracting administrators for CMS.

 

While coverage and payment decisions by payor can vary, and total revenue remains modest relative to our long-term expectations, the increase in order volume, reimbursement trends, and the number of providers using AC5 in their respective practice settings exceeds management’s internal targets for this point in the process.

 

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.

 

 

(d) The following exhibits are being filed herewith:

 

 

 

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.