Arch Therapeutics, Inc. (“Arch” or the “Company”) provided an update regarding its reimbursement strategy for the use of AC5® Advanced Wound System (“AC5”), specifically regarding its use in doctor's offices and wound clinics. This segment represents its third targeted selling channel and is expected to expand upon the Company's first two selling channels: government facilities and non-government hospital operating rooms, which are currently supported by Lovell Government Services and Centurion Therapeutics, respectively. Specific action items related to the Company's reimbursement initiative in doctor's offices and wound clinics include the following: Sunsetting the Pilot Program.

The previously announced Pilot Program (the “Pilot”) delivered on its objectives and is set to begin a natural wind-down process as the company transitions to its next stage of the reimbursement life cycle. The Pilot yielded patient data and payor responses across a wide array of healthcare systems, expanded access to multiple providers, generated clinical data, and tested various coding options that, together, helped guide the development of the Company's HCPCS application to request a category specific code for AC5. Leveraging New Temporary Code for Synthetic Skin Substitutes.

Effective April 1, 2022, CMS authorized the use of A4100 as a temporary code to facilitate the reimbursement of doctor's offices and wound clinics for the use of synthetic skin substitutes. The Company has begun the process of advising providers to submit claims under this new code as the Company pursues a permanent HCPCS code. Filing a HCPCS Application.

The Company expects to submit its HCPCS application for specific coding to Centers for Medicare and Medicaid Services (“CMS”) in the coming weeks. HCPCS is a collection of standardized codes for medical procedures, products and services that facilitate the submission and processing of insurance claims for Medicare and other health insurers. Launching a Multi-Site Clinical Study.

Building on the progress of the Pilot program, clinical outcomes (including published case studies), and observations from key opinion leaders, the Company is planning to launch a multi-site clinical study in the third calendar quarter of 2022. The study is expected to enroll and treat up to approximately 60 patients at six sites, with the primary end point of wound closure. This study is intended to accelerate payor adoption as well as differentiate and highlight the key benefits of AC5 in treating hard to heal wounds.