Dedicated HCPCS Billing Code for Arch Therapeutics’ AC5® Advanced Wound System Now In Effect

New code is expected to advance commercialization efforts in doctors’ offices and other outpatient settings

FRAMINGHAM, Mass., April 05, 2023 (GLOBE NEWSWIRE) — Arch Therapeutics, Inc. (OTCQB: ARTH) (“Arch” or the “Company”), a marketer and developer of novel self-assembling wound care and biosurgical products, today announced that the Centers for Medicare and Medicaid Services (“CMS”) Level II Healthcare Common Procedure Coding System (“HCPCS”) code dedicated to the Company’s AC5^® Advanced Wound System (“AC5”) went into effect on April 1, 2023.

The HCPCS code, A2020, establishes a new pathway for the reimbursement of AC5 and is expected to improve the ability of providers in outpatient facilities, including doctors’ offices, wound care clinics, hospital outpatient departments and ambulatory surgical centers, to seek payment from CMS and commercial payor networks throughout the country for use of the product.

Dan Yrigoyen, Vice President of Sales of Arch Therapeutics, said, “Since the announcement last month that CMS created a HCPCS code for AC5 Advanced Wound System, we have had new product inquiries by potential customers in offices and other outpatient facilities who previously indicated they were unwilling to order AC5 absent an available dedicated reimbursement code. We believe that A2020 will facilitate new and ongoing engagement with a growing number of interested potential customers in outpatient settings.”

AC5 was cleared as a medical device by the Food and Drug Administration (“FDA”) for the management of partial and full-thickness wounds, such as pressure sores, leg ulcers, diabetic ulcers, and surgical wounds.

“This now-effective AC5-specific code represents an essential element of our ongoing commercialization plan that we believe will help drive continued adoption and use of AC5 and increase opportunities to provide patients with improved outcomes for wound healing. While a code does not guarantee coverage or payment, its effectiveness marks a key commercialization milestone for the Company,” concluded Mr. Yrigoyen.

AC5 is a proprietary synthetic self-assembling wound care product designed to provide clinicians with multi-modal support and utility across all phases of wound healing. Once applied, AC5 conforms to a wound’s peaks and valleys prior to automatically assembling, thereby providing a different approach to manage challenging, irregular, undermined, and tunneling wounds. Case studies demonstrating that the use of AC5 can lead to improved outcomes, including limb salvage (avoided limb loss), even for patients who have not responded to alternative modalities, may be found here: https://www.archtherapeutics.com/technology/clinical-data.

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About Arch Therapeutics, Inc.
Arch Therapeutics, Inc. is a biotechnology company with a novel approach to stop bleeding (hemostasis), control leaking (sealant) and manage wounds during surgery, trauma, and interventional care. Arch is developing wound care and biosurgical products based on an innovative self-assembling peptide technology platform with the goal of improving healing outcomes for patients. Arch has received regulatory clearance to market AC5^® Advanced Wound System in the United States and AC5^® Topical Hemostat in Europe. Arch’s development stage product pipeline includes AC5-G™ for endoscopic resection of gastrointestinal tumors, AC5-V^® for hemostasis during vascular surgery and AC5 Surgical Hemostat™ for general surgical hemostasis, among others.^1,2

Notice Regarding Forward-Looking Statements
This news release contains “forward-looking statements” as that term is defined in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Statements in this press release that are not purely historical are forward-looking statements and include any statements regarding beliefs, plans, expectations, or intentions regarding the future. Such forward-looking statements include, among other things, references to novel technologies and methods, our ability to recruit additional field sales representatives and their effectiveness, our business and product development plans and projections, or market information. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the inherent uncertainties associated with developing new products or technologies and operating as a development stage company, our ability to retain important members of our management team and attract other qualified personnel, our ability to raise the additional funding we will need to satisfy our existing obligations and continue to pursue our business and product development plans, our ability to obtain required regulatory approvals, our ability to produce commercial quantities of our products within projected timeframes, our ability to obtain the inclusion of our AC5^® Advanced Wound System on targeted federal supply schedules, our ability to develop and commercialize products based on our technology platform, and market conditions, and our ability to establish additional commercialization partnerships and build a critical mass of field sales representatives. These forward-looking statements are made as of the date of this news release, and we assume no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements. Although we believe that any beliefs, plans, expectations, and intentions contained in this press release are reasonable, there can be no assurance that any such beliefs, plans, expectations, or intentions will prove to be accurate. Investors should consult all of the information set forth herein and should also refer to the risk factors disclosure outlined in the reports and other documents we file with the SEC, available at www.sec.gov.

Contact:
ARTH Investor Relations
Toll Free: +1.855.340.ARTH (2784) (US and Canada)

¹ AC5-G, AC5-V, and AC5 Surgical Hemostat are currently investigational devices limited by law to investigational use.
² AC5, AC5-G, AC5-V and associated logos are trademarks and/or registered trademarks of Arch Therapeutics, Inc. and/or its subsidiaries.

Email: investors@archtherapeutics.com
Website: www.archtherapeutics.com

or

Michael Abrams
Chief Financial Officer Arch Therapeutics, Inc. Phone: 617.431.2333
Email: mabrams@archtherapeutics.com