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Tuesday, November 29, 2022

Arch Therapeutics Inc (OTCBB:ARTH) Surges On Reversal

Arch Therapeutics Inc (OTCBB:ARTH) is making an explosive move up since reversing off $0.1632 lows. ARTH has come back down to where it started after a run-up in recent months that peaked at $0.391 in July.

The stock was the subject of a significant promotion last summer shortly after hitting the bb’s from The Bedford Report, The Paragon Report and Five Star Equities.

Arch Therapeutics Inc (OTCBB:ARTH) is a medical device company developing a novel approach to stop bleeding (hemostasis) and control leaking (sealant) during surgery and trauma care. Arch is developing products based on an innovative self-assembling peptide technology platform to make surgery and interventional care faster and safer for patients. Arch’s flagship development stage product candidate, known as the AC5 Surgical Hemostatic Device (TM), is being designed to achieve hemostasis in minimally invasive and open surgical procedures.

According to Arch, the Company intends to transform the landscape of interventional healthcare with products to seal and protect leaking and bleeding tissue. Arch’s solution elegantly controls the movement of these fluids and substances.

Arch’s products are currently progressing in preclinical development. The first product, AC5 Surgical Hemostatic Device,™ is designed to achieve hemostasis in minimally invasive (laparoscopic**) and open surgical procedures.

AC5™ stops bleeding promptly. Unlike many competitive products, it conforms to irregular wound geometry, allows for normal healing, and helps maintain a clear field of vision directly into the wound area.

In April the Company announced an independent third party has obtained favorable data from a preclinical animal study that compared the hemostatic activity of AC5 with a popular and commercially available branded fibrin sealant that is indicated for use in controlling bleeding.

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In the study, full thickness penetrating wounds were surgically created in rat livers, which are highly vascularized parenchymal organs, and then either AC5(TM) or the fibrin sealant was applied in order to stop the bleeding. The time to hemostasis (TTH), which is the time required to stop bleeding, was measured. The average TTH after application of AC5 was significantly less than 30 seconds. The average TTH for the fibrin sealant was approximately 50% longer.

The study group intends to submit the data for publication, at which time additional details would be made publicly available. This animal trial was conducted as part of an ongoing series of studies comparing AC5 with currently marketed hemostatic products that are used in surgical procedures.

CEO Terrence W. Norchi, MD said “AC5 has again shown promising results. Data from the preclinical studies conducted to date indicates that AC5 has favorable efficacy when compared to a number of other popular hemostatic agents. Furthermore, data to date continues to support that it is both easy to use and non-toxic. Compared to the products on the market that are sourced from humans or animals, AC5 is instead manufactured synthetically from amino acids that are not derived from humans or other animals, and therefore, would not be expected to carry that particular risk factor.”

On December 16 ARTH said it has received clearance to initiate a human clinical trial from a regulatory authority in Western Europe.

The randomized controlled single-blind investigation is designed to assess safety and performance of AC5(TM) in bleeding wounds created during the course of a dermatological procedure in fewer than 50 patients. The endpoints include product related adverse effects, with a planned patient follow-up assessment 30 days following the procedure, and time to hemostasis. A portion of the patients will be taking a therapeutics dose of an antithrombotic medication (commonly referred to as a “blood thinner”) during the study period.

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Currently trading at a $20 million market valuation ARTH does have $782,000 in the treasury, no revenues to date, a high burn rate and rising short term debt. But ARTH is an exciting story in small caps; they are the developer of the AC5 Surgical Hemostatic Device(TM) (“AC5(TM)”), a novel product aimed at controlling bleeding and fluid loss in order to provide faster and safer surgical and interventional care. Once also has to be excited by the favorable preclinical data from an independent study of AC5 Surgical Hemostatic Device(TM) versus a popular Fibrin Sealant as well as the Company’s ability to raise capital. We will be updating on ARTH when more details emerge so make sure you are subscribed to Microcapdaily so you know what’s going on with ARTH.

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Disclosure: we hold no position in ARTH either long or short and we have not been compensated for this article.

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