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Re: volatility magnet post# 7516

Wednesday, 11/01/2017 7:57:39 PM

Wednesday, November 01, 2017 7:57:39 PM

Post# of 10346
Short version $ARTH Elevator Pitch.

Arch Therapeutics –Symbol ARTH

Arch is a small public company with a medical device pathway, relatively low capital requirements and potentially high margin novel products targeting large growing markets.

· Company owns a product called AC5 with over 200 potential applications for controlling bleeding (hemostasis) and body leakage (sealant) during surgery, trauma care or wound care. Many of the 200 potential applications are addressing Billion $ markets. Arch is being called the “WD-40” of Biotech. Arch has a tiny market cap of approximately $ 100 million.

· A few of the potential applications for AC5 are Pressure Ulcers or Bedsores (USA 2.5 million patients a year), Diabetic Foot Ulcers (1-1.5 million patients in USA each year),Burn victims (500K patients per year in USA), etc.

· Scientists at Massachusetts Institute of Technology invented this universal fix-all hemostat that works in a few seconds as compared to competitor products that may take as long as minutes.

· CEO of Arch, Terrence Norchi, is a MD, MIT MBA and Former Portfolio Manager at Putnam’s $4 Billion Healthcare .

· AC5 is a clear liquid classified as a medical device. How is that possible? AC5 when applied has no metabolic or body interaction and acts merely as a physical mechanical barrier.

· As a medical device, not a drug, AC5 needs one clinical trial for approval in each market.

· AC5 is a noncoagulant hemostatic agent. There are no other noncoagulant hemostasis agents on the market. Thus AC5 works in the presence of BLOOD THINNERS! Only one that does.

· ARCH completed a very successful human clinical trial in Europe and will apply for the CE Mark and upon approval will be selling product in Europe in 2017 with a yet to be announced joint venture partner. Also in 2017 ARTH will complete a US trial and file for FDA approval.

· In 2015 Arch executed a research collaboration agreement with CÚRAM Centre for Research in Medical Devices in Galway, Ireland to deploy resources in Ireland to advance Arch’s technology, ranging from early stage research to late stage development and human clinical trials. For each one Euro that Arch contributes to an annual maximum of 250,000 € to its own R&D activities within CÚRAM, CÚRAM will contribute two Euros up to an annual maximum of €500,000 to those same activities, made possible by its grant funding from Science Foundation Ireland (SFI).

· Anytime a hole in the body occurs one needs to worry about bleeding, leaking and contamination to mitigate infection. Arch’s AC5 to address these needs. Arch intends to transform the landscape of interventional healthcare with products to seal and protect leaking and bleeding tissue.

· The clear liquid stops bleeding in SECONDS compared to minutes for most of the product’s competitors. The market for AC5 is unthinkably large: Every soldier in the world will need a bottle of AC5, every policeman in the world, every ambulance, every gun club, every ER in the world, every first aid kit in every office and manufacturing plant in the world, every person on blood thinners, etc.

· The Company’s product, AC5, a liquid peptide, should result in faster, safer, simpler surgery with substantial savings in time of surgery.

· AC5 is a disruptive technology with multiple uses in large market cap areas that has been proven to be very safe and very efficacious in human testing.

· There are many other hemostatic agents, but:

* They all rely on using the patient’s blood,

*They all take minutes to stop bleeding, not seconds

*None of them create a clear seal that a surgeon can see through

* None of them work just as well on people on blood thinners

* None of them work in every situation where bleeding has to be stopped

Arch’s AC5 product solves all these problems.

· Dr. KSS has called AC5 “possibly one of the best medicine inventions of all time…a noncoagulant hemostatic agent” and that the Company’s family of peptides “are truly among the most remarkable biochemical inventions of all time.”

· Arch’s successful human clinical study in Europe was conducted by Dr. Jack Kelly, Dr. Kelly, Principal Investigator of the human clinical study, and a plastic, reconstructive and aesthetic surgeon and Professor of Surgery at Galway University Hospital, Galway, Ireland, said, “These study results indicate significant potential for AC5 in the treatment of bleeding skin wounds. The safety and efficacy outcomes for AC5 in this study were impressive and reassuring. While possessing a safety profile at least as good as that of the control group, AC5 was associated with a clinically significant improvement in time to hemostasis. We are encouraged by how patients responded to the unique formulation of AC5 and how easy it was for a clinician to use.” Profile of Dr. Kelly http://jackkelly.ie/surgeon-profile

· Dr. Terrence Norchi the CEO of Arch comment regarding the AC5 +- 200 applications plus new potential product pipeline. “My view is that they’re all big, and there’s lots of them and that’s why we’re pretty excited.”

· Arch 2017 Planned Milestones 1) Submit and receive 510(k) for US commercialization FDA 2) File and receive CE Mark for EU commercialization 3) File IDE (Investigational Device Exemption) for internal surgical clinical trial 4) File additional patent applications 5) Establish commercialization strategy 6) Provide preclinical data on pipeline programs

· Top Manufacturers of Hemostasis Products

1) Johnson & Johnson

2) Abbott Laboratories

3) Baxter International Inc.

4) Becton Dickinson

5) CR Bard Inc.

6) CSL Behring LLC

7) Grifols Worldwide