Arch Therapeutics Launches Multi-Site Clinical Study for AC5® Advanced Wound System

Rhea-AI Summary

Arch Therapeutics (OTCQB: ARTH) has launched a multi-site clinical study to enhance the adoption of its AC5® Advanced Wound System for treating complex wounds. The study aims to enroll up to 60 patients across six sites, focusing on wound closure as a primary endpoint. This initiative completes recent commitments under a reimbursement strategy aimed at increasing sales in doctors’ offices and wound care clinics. Dr. Brock Liden will serve as the primary investigator, signaling a promising step for Arch’s future revenue growth.

Positive

• Launch of multi-site clinical study for AC5 to enhance sales opportunities.
• Study aims to improve payor adoption and product awareness.
• Dr. Brock Liden serves as the primary investigator, indicating strong medical backing.

Negative

• No significant financial metrics mentioned that would assure immediate revenue impact.

Expected to Accelerate Sales Opportunities in Doctor’s Office and Wound Clinics

FRAMINGHAM, Mass., Sept. 07, 2022 (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 it has launched a multi-site clinical study (the “Study”) to accelerate payor adoption and differentiate the key benefits of AC5^® Advanced Wound System (“AC5”) in treating challenging wounds. The Study is expected to enroll and treat up to 60 patients at six sites with a primary end point of wound closure. The launch of the Study completes the near-term commitments listed in the Company’s recently announced reimbursement initiative to accelerate sales opportunities for AC5 in doctor’s offices and wound care clinics.

Dr. Brock Liden, a board-certified podiatrist, attending physician at the Circleville Foot & Ankle Center, and expert lecturer on wound care, podiatric medicine, surgery, and practice management, has agreed to serve as the primary investigator (“PI”) for the Study. As the PI, Dr. Liden will be responsible for overseeing all critical elements of the Study. "AC5 is a new step forward in the exciting synthetic skin substitute or cellular tissue product area.  I believe it is the only flowable synthetic skin substitute on the market and offers a unique application technique for difficult-to-treat wounds. I always seek better treatment options for patients with complex acute and chronic wounds, and AC5 has shown great promise in early use. As such, I am excited and honored to serve as the Primary Investigator for this Study,” stated Dr. Liden.

“The Study supports our near-term revenue prospects by gaining amplified exposure for AC5 Advanced Wound System in doctor’s offices and wound care clinics, and our long-term revenue prospects by creating opportunities for data sharing with payors and wound care clinicians—building product awareness and demonstrating better outcomes, while potentially lowering the cost of care for the more than 7 million people in the U.S who live with a chronic wound,” stated Dan Yrigoyen, Vice President of Sales of Arch Therapeutics.

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

^{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.}

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 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)
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

FAQ

What is the purpose of the clinical study launched by Arch Therapeutics?

The clinical study aims to accelerate payor adoption and showcase the benefits of the AC5 Advanced Wound System in treating challenging wounds.

How many patients will be enrolled in the clinical study for AC5?

The study is expected to enroll and treat up to 60 patients across six sites.

Who is overseeing the clinical study for AC5?

Dr. Brock Liden, a board-certified podiatrist, will serve as the primary investigator for the study.

What are the expected outcomes of the AC5 study?

The primary outcome is wound closure, which will help demonstrate better treatment options and support future sales.

What market impact could the AC5 study have?

The study may enhance product awareness, improve treatment outcomes, and potentially lower costs for managing chronic wounds in the U.S.