Arch Therapeutics (Symbol ARTH) Commercialization is Knocking
How could a clear liquid be classified as a medical device that is on verge of commercialization after receiving FDA approval in 2019 ??
The company that owns this medical device is run by a CEO who is a MD, MIT MBA and Former Portfolio Manager at Putnam $4 Billion Healthcare Fund. Dr. Terrence Norchi is the Founder of Arch Therapeutics and the largest shareholder.
Per Dr. Norchi: “The commercial opportunity is significant and enduring.”
With only eight employees for the last six years Dr. Norchi has led Arch to commercialization.
Dr. Norchi Presentation is here:
The clear liquid stops bleeding in SECONDS compared to minutes for most of the product’s competitors. It will be widely used in surgery, EMS situations, every soldier, every policeman, every ambulance and every person on blood thinner.
The patented clear liquid is regulated as a medical device, NOT a drug, and therefore only needs ONE clinical trial for approval.
There are over 200 potential applications for this clear liquid medical device! 200 !! What’s really exciting is that the US market alone for hemostats to stop bleeding is a $5 BILLION market. This clear liquid is far superior to what is on the market now yet the total market capitalization of the company owning it is only $ 80 million today.
The clear liquid medical device is owned by Arch Therapeutics (ARTH) and is a noncoagulant homostatic agent called AC5. There is no other noncoagulant homostatis agent on the market. Thus AC5 works in the presence of BLOOD THINNERS! Only one that does.
AC5 is used to stop bleeding (hemostasis) and control leaking (sealant) during surgery, trauma care or wound care. As a medical device, not a drug, AC5 needs one clinical trial for approval in each market.
The 200 potential applications for AC5 include many billion $ markets—Arch has a TINY market cap of only $ 55 million with Arch’s AC5 receiving FDA approval December 17, 2118 allowing for the product to be marketed for external applications.
Arch External Applications 1) Diabetic foot ulcers..1 to 1.5 million patients year Annual US Healthcare system cost $11 billion 2) Pressure Ulcers (bedsores) 2.5 million patients year Annual spent on wound care products exceeds $ 15 billion 3) Adhesions 2.5 million patients/year US Form after 70-90% of major absominal surgery & 50-100% of women after pelvic surgery Market growing 15% year Need: Cover, protect, promote moist environment, enable healing Opportunity $ 1 to $2 Billion 4) GI Sealant 2-15% leak rate in anastomoses Significant morbidity and mortality. Significant reoperation rate with added expenses. Opportunity $.5 million to $ 1 Billion and potentially greater 5) Burns 500K patients/year in US Plus many more.
Arch is adopting a multiple selling partner marketing strategy in 2019.
Here is the stock price:
Faster, Safer, Simpler Surgery
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.
Scientists at Massachusetts Institute of Technology invented this universal fix-all hemostat that works in a few seconds.
AC5 is the first universal hemostatic agent and sealant product with applications ranging from plastic and general surgery to wound care and trauma care. There is no other competing product that can be used as a universal hemostatic agent.
The Company’s product, AC5, a liquid peptide, should result in faster, safer, simpler surgery with substantial savings in time of surgery.
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 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.
Surgical “biomaterials” for hemostasis and sealant are out of date. Surgical (and trauma) patients are at significant risk for morbidity and mortality from bleeding and/or leaking body fluids. While surgical techniques, instrumentation and technology have made tremendous strides over the last couple of decades, the majority of hemostatic agents and sealants that surgeons rely on to help stop bleeding and seal leakages have not kept up.
Attributes of AC5
Clear liquid, squirted or sprayed-- Can see and operate through it
Conforms to irregular wound geometry
Physical mechanical barrier (no metabolic activity or chemical activity with the body-reason it is classified as medical device)
Classified as Medical Device in Europe because of no interaction with the body
No sign of interaction with human cell receptors or cell kinase enzymes
Stops bleeding promptly
Faster time to stop bleeding versus five different popular marketed products
Blood thinner agnostic—only hemostasis product that is.
Efficacy even in presence of “blood thinners”
Natural amino acids, non-animal
Enables normal healing
Non-cytotoxic, non-pyrogenic, non-irritant, non-sensitizer
Stores at room temperature
Indefinite shelf life
Simple, effective, versatile, safe universal
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. Norchi 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."
"The clear field of vision provided could cut procedure time in half as well as provide vastly increased likelihood of excellent outcome post-surgery."
Arch’s AC5 peptide can be formulated in combination with a variety of other drugs or compounds, including antibiotics, vasoconstrictors, anesthetics, chemotactic factors and thus be used as a delivery agent. AC5 is a platform rather than a single product.
Posted to help in your due diligence research.