Clinical Evaluation Finds Arch Therapeutics’ AC5® Advanced Wound System Effective in Healing Complex Chronic Wounds in Patients with Previously Unsuccessful Treatments and Significant Comorbidities

Rhea-AI Summary

Arch Therapeutics (OTCQB: ARTH) announced significant findings regarding its AC5® Advanced Wound System in a recently published study. The system showed improved healing in nonhealing wounds after just 3 to 6 applications, requiring only weekly clinic visits. The study highlighted that AC5® effectively interrupted the inflammatory phase and stimulated proper healing, particularly in patients with serious comorbidities. AC5® has received FDA marketing authorization and aims to reduce healthcare burdens while enhancing patients' quality of life.

Positive

• Marked improvement in wound healing with AC5® after 3 to 6 applications.
• Effective even in patients with significant comorbidities and previous treatment failures.
• Facilitates outpatient care, potentially reducing healthcare costs.
• FDA marketing authorization obtained for AC5® Advanced Wound System.

Negative

• None.

AC5® Advanced Wound System demonstrated notable improvement in healing after only 3 to 6 applications—with only weekly clinic visits and reapplication

FRAMINGHAM, Mass., Jan. 06, 2022 (GLOBE NEWSWIRE) -- Arch Therapeutics, Inc. (OTCQB: ARTH) (“Arch” or the “Company”), a marketer and developer of novel self-assembling wound care and biosurgical devices, today announced a study of its proprietary adaptive self-assembling barrier scaffold (aSABS) and peptide technology, AC5^® Advanced Wound System, demonstrated marked clinical benefit in patients with significant comorbidities and nonhealing wounds. The results of the study were published in the January 2022 issue of the peer-reviewed WOUNDS journal. The manuscript is currently available online here and is expected to be available in physical form later this month.

Clinical insights gathered from the study concluded that the use of aSABS:

• had a marked effect on wound healing by interrupting the stalled inflammatory phase, reducing the bioburden of infected wound tissue, and stimulating the progression of the wound through the proper biological sequence of repair
• contributed to fast-paced healing (3 weeks in some cases)—with only weekly clinic visits and reapplication
• resulted in the healing of wounds that have been persistently inflamed and infected and for which other advanced wound products and surgical debridement had been unsuccessful—even in patients with considerable systemic comorbidities
• may offer clinicians an alternative to high-acuity operating rooms by facilitating debridement and management of some complex wounds in low-acuity outpatient clinic settings
• improved patients’ quality of life and the at-home burden of wound care for both patients and their caretakers
• may provide a favorable effect on patient morbidity and mortality in wound management
• may reduce burden on the health care system
  

Together, the new study along with data presented by multiple key opinion leaders at recent wound care conferences highlight the versatility and benefit of AC5^® Advanced Wound System. “The insights may give new hope to patients suffering from chronic wounds,” explained Terry Norchi, MD, Chief Executive Officer of Arch Therapeutics. “Non-healing wounds can lead to cascading health problems, including amputation for many patients. These results may provide guidance to clinicians that can positively impact both patient outcomes and treatment costs,” said Norchi.

AC5^® Advanced Wound System received marketing authorization by the US Food and Drug Administration and is now commercially available. A comparable product, AC5^® Topical Hemostat, received a CE mark in Europe.

About Arch Therapeutics, Inc.
Arch Therapeutics, Inc. is a biotechnology company developing a novel approach to stop bleeding (hemostasis), control leaking (sealant) and manage wounds during surgery, trauma, and interventional care. Arch is developing products based on an innovative self-assembling barrier technology platform with the goal of making care faster and safer for patients. Arch has received regulatory authorization to market AC5^® Advanced Wound System and AC5 Topical Hemostat as medical devices in the United States and Europe, respectively. Arch's development stage product candidates include AC5-G, AC5-V and AC5 Surgical Hemostat, 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 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

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.

FAQ

What are the benefits of AC5® Advanced Wound System according to the recent study?

The study highlighted benefits such as marked improvement in healing after just 3 to 6 applications, effectiveness in patients with serious comorbidities, and facilitating outpatient treatment.

When was the study on AC5® Advanced Wound System published?

The study was published in January 2022 in the peer-reviewed journal WOUNDS.

What regulatory approval has AC5® Advanced Wound System received?

AC5® Advanced Wound System has received marketing authorization from the US Food and Drug Administration.

What is the stock symbol for Arch Therapeutics?

The stock symbol for Arch Therapeutics is ARTH.

How might AC5® Advanced Wound System impact healthcare costs?

AC5® may reduce healthcare costs by facilitating outpatient management of wounds, thus alleviating the need for more expensive high-acuity treatments.