With FDA and EU Marketing Authorizations in Hand, 2020 and 2021 Can Be Catalyst Years for Arch Therapeutics

New York, New York--(Newsfile Corp. - September 22, 2020) -  Arch Therapeutics, Inc. (OTCQB: ARTH) has cleared significant hurdles to commercialize its AC5 Advanced Wound System and AC5 Topical Hemostat.1 In particular, two events position the company to create substantial value-creation by turning milestones into catalysts.

The first event happened in March of this year with the U.S. Food and Drug Administration (FDA) providing clearance to market its novel AC5 Advanced Wound System, which is viewed as offering an incredibly different approach to the management of partial and full-thickness wounds, such as pressure sores, leg ulcers, diabetic ulcers, and surgical wounds.

The second much-anticipated event was announced in April with the company disclosing receipt of the C.E. (Conformité Européenne) mark for AC5 Topical Hemostat. The C.E. mark provides authorization to commercialize AC5 Topical Hemostat in Europe, both as a dressing and to control bleeding in wounds.

The US and European labels are slightly different, but the underlying products, including the peptide and kit components, are the same. Arch envisions that surgeons in the US and in Europe would use both products in comparable wounds. Examples include those that require an acute surgical intervention, such as debridement (surgically removing necrotic tissue that may otherwise interfere with healing), those that are otherwise complicated, or those in patients who have underlying medical problems that could present challenges for wounds.



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Pioneering Novel Treatments

Arch is pioneering an innovative self-assembling technology platform. The company's goal from the start was to create solutions to make care faster and safer for patients. Its Dermal Sciences business addresses wounds in the skin with the products mentioned above. Its Biosurgery business is developing products for use in surgery and other applications within the body.

Both AC5 Advanced Wound System and AC5 Topical Hemostat can be used during in and out-patient procedures.2 Importantly, AC5 offers a new alternative to existing wound-care regimens. Its advantages include being a clear dressing that conforms to irregular wound geometry and can protect tissue in acute and chronic complicated wounds with utility across all phases of the wound healing continuum. AC5 utilizes a proprietary synthetic peptide that self-assembles, or builds itself, into a contiguous physical-mechanical seal on tissue, where it becomes a nanofiber scaffold with similarities to the body's native extracellular matrix. This activity can occur even in patients taking blood thinners. It helps protect wounds while creating an environment that enables them to heal. Interestingly, the products are regulated as medical devices even though they are made of peptides.

Its effectiveness is supported by treatment experts who have long demanded better treatment options. AC5 checks off multiple boxes to meet those demands. Further, by keeping focused on what the markets want, Arch expects the earliest adoption for the device will be to help treat complicated acute surgical wounds and wounds that require better debridement and wound bed preparation.

The pandemic has brought attention to the fact that many patients have wounds that would normally be cared for in an operating room which they cannot access in the current environment. Arch has described observations by surgeons who were able to care for challenging diabetic foot ulcers, pressure ulcers, and other complicated wounds in their clinic by using AC5 Advanced Wound System along with sharp debridement, relying on the products' inherent and constructive features.

The recent marketing authorizations represent the next steps to realizing its strategic ambitions. Arch expects its other development-stage product candidates to present future upside in additional multi-billion-dollar markets.

Despite the possible pandemic-related market weakness, the enthusiasm being generated from Arch's powerful platform opportunity is notably high. The company is better positioned than ever before to capitalize on its AC5 self-assembling peptide platform.

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1 AC5 and associated logos are trademarks and/or registered trademarks of Arch Therapeutics, Inc. and/or its subsidiaries.

2 AC5 Advanced Wound System and AC5 Topical Hemostat have received regulatory authorization for commercial marketing as medical devices in the USA and EU, respectively.

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