"The WD-40 of Biotech" $ARTH

that is actually quite fascinating from a medical standpoint, it makes perfect sense that it is a device.  I'll have to dig into it to see if I think it is a good investment. 

One of the 200+- applications for AC5 is Pressure Ulcers or Bedsores:

Number affected: 2.5 million patients per year.

Cost: Pressure ulcers cost $9.1-$11.6 billion per year in the US. Cost of individual patient care ranges from $20,900 to 151,700 per pressure ulcer. Medicare estimated in 2007 that each pressure ulcer added $43,180 in costs to a hospital stay.

Lawsuits: More than 17,000 lawsuits are related to pressure ulcers annually. It is the second most common claim after wrongful death and greater than falls or emotional distress.

From Government Website:

www.ahrq.gov/professionals/systems/hospital/pressureulcertoolkit/putool1.html

Arch Therapeutics ARTH Dr. Norchi INTERVIEW --

Arch Therapeutics’ President and CEO, Terrence Norchi, Featured on “Small Cap Spotlight” Podcast Discussing First Product, Clinical Trial Significance, CE Mark Process, and Other Items

August 18, 2016



Small Caps Podcast on Arch Therapeutics

www.archtherapeutics.com/news/media/detail/1222/arch-therapeutics-president-and-ceo-terrence-n
orchi


Other MISC postings from SA


Electric Phred , Contributor

Here are some of the musings of a vascular surgeon buddy with whom I share the release:

"... . . . the big deal is that it is safe in humans. The 41% faster hemostasis in nice, but so what. No one would use this kind of product on a skin lesion excision. Now they can move forward with additional studies using it for where it could have a HUGE impact.

With more major bleeding, this really looks revolutionary. ALL the other topical hemostatic agents rely on the clotting cascade. This is a sealant that (if you watch the rat video) you can get results in actively bleeding surfaces. So I think cardiac, vascular trauma and ortho surgeons would love it. Also could use in an outpatient wound clinic setting where they do a lot of wound debridements (excising slough and dead tissue from chronic inflamed wounds). One could do a much more aggressive (better) debridement and not have to wait forever holding pressure while the bleeding stops.

...I do appreciate your reaching out to me on this. I'm rather fascinated by this stuff. I think I'd use it like crazy if I had it."

OK so he likes it but I still haven't convinced him to buy the stock. But he's convinced me to hold mine (or perhaps engage in more panic buying if we go back to the 50's) One of the values of SA is reaching out to practices like this and sharing their observations.

Bill in Shanghai

20 years ago I was the Canadian distributor for a collagen product, Avitene, used for hemostasis (to stop bleeding) tinyurl.com/hj8... the product takes minutes to work but it was a highly successful product that surgeons counted on because it worked. Bleeding during surgery is a serious and potentially life threatening factor of surgery. Avitene sold in 1990 for $30 for a small sheet and price was never an issue. AC5 works in seconds, once on the market there will be fast conversion. Surgeons need this and will use it as soon as a bleed is identified. Arch Therapeutics IMO is a strong buy

Another Article

www.massdevice.com/arch-therapeutics-touts-1st-human-novel-blood-control-device/

Regarding margins on AC5----$ARTH I have spent a fair amount of time trying to determine this so let me try and add some color.

So from the current company presentation:

“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. ”

“Potentially high margin novel products.” So what does potential “high margin” mean per my estimates?

At scale I estimate $ 400-$500 typical sale per application (2cm by 2cm area) with my estimated calculated cost (based upon discussions with several experts in the field–these shall remain confidential) of anywhere from 5% to 20%. So profit margins of anywhere from 80 to 95%. The key word is “scale.” I believe the profit margins will tend to the high side.

Look at the cost of pressure ulcers or bedsores–Do you think Arch can do better than $20,900 to $151,700 per pressure ulcer ?? Per Bedsore !

Number affected: 2.5 million patients per year.

Cost: Pressure ulcers cost $9.1-$11.6 billion per year in the US. Cost of individual patient care ranges from $20,900 to 151,700 per pressure ulcer.

Lawsuits: More than 17,000 lawsuits are related to pressure ulcers annually. It is the second most common claim after wrongful death and greater than falls or emotional distress

Could This Device Offer Faster Bleeding Control?


www.mddionline.com/article/could-this-device-offer-faster-bleeding-control-08-24-16

Posted in Research and Development by mthibault on August 24, 2016

Arch Therapeutics' AC5 Topical Hemostatic Device was found to be safe and faster at controlling bleeding than standard treatment in a small trial. What makes this technology unique?

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Marie Thibault



It's so far, so good for the AC5 Topical Hemostatic Device.

Recently released topline data from a small study has shown the solution is safe and achieved hemostasis of skin wounds 41% faster than standard treatment. AC5-developer Arch Therapeutics is planning to use these study results in a CE Mark application for the device.

The AC5 device doesn't look like your typical device. It is a slightly viscous liquid that Terrence Norchi, MD, president and CEO of Arch Therapeutics, compares to the consistency of alcohol-based hand sanitizer. Still, the product is expected to be regulated as a device because of its unique technology. Norchi told MD+DI that the topical AC5 consists of self-assembling peptides that interact with the highly charged environment of a wound to build itself into a physical barrier over the wound.

AC5 is being regulated as a device in Europe and is likely to be viewed similarly by FDA. Norchi pointed out, "It's that self-assembly that has allowed us to go down the pathway of being a medical device rather than a traditional drug . . . A device is something that requires for its primary effect neither metabolic activity nor chemical activity of the body. The fact that [AC5] will self-assemble out of body, without being metabolized, that it will do so in your pasta sauce, is very supportive of this being a device."

The 46-patient study was the first to test AC5 in humans. Each patient in the study had at least two skin lesions that were removed under local anesthetic. Each patient received both treatments—one on each wound—wounds were randomized to treatment with AC5 or standard therapy with a sham application of saline with a syringe. The primary endpoint assessed safety through 30 days post-procedure. Neither the control group or AC5 group had any serious adverse events and the two groups had similar safety results, according to a company press release. Importantly, a secondary endpoint evaluating wound healing found no evidence of AC5 having any detrimental impact on healing.

Time to hemostasis was measured as a secondary endpoint. Wounds treated with AC5 had a statistically significant faster median time to hemostasis—41% faster than wounds in the control group (p<0.001). "We’ve seen ranges from 10-15 seconds to half a minute to certainly under a minute. We're not looking at times north of a minute," Norchi said.

Study principal investigator Jack Kelly, MD, a plastic, reconstructive, and aesthetic surgeon and professor of surgery at Galway University Hospital in Galway, Ireland, said in the release, "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."

The study excluded patients with major underlying conditions like active malignancies, pregnancy, or organ failure. But, of the 46 patients studied, 10 were on one antiplatelet product. Data from that subset of patients will be analyzed to determine whether they experience a similar desired hemostatic effect with AC5, Norchi said. "Those patients tend to bleed more. Our underlying mechanism of action being self-assembly should be relatively agnostic to somebody's coagulation cascade and bleeding tendencies."

Kelly noted AC5's ease of use. "We are encouraged by how patients responded to the unique formulation of AC5 and how easy it was for a clinician to use," he said in the release.

Norchi echoed this sentiment. He pointed out that AC5 doesn't require cold storage and is simple to prepare, with the current formulation just requiring doctors to mix the powder with water and apply it using a syringe.

"I recall doing some animal surgery once with a human surgeon." Norchi said. "She looked at me after using [AC5] for the very first time and said, 'This stuff is beautiful.' I think to use it is to really appreciate it."

Arch Therapeutics anticipates that this study data will be published in a peer-reviewed journal and plans to use the data as part of its CE Mark application. That regulatory submission is slated at earliest by the end of 2016. As for plans in the United States, Norchi said the company tentatively intends to file an FDA submission in 2017, but cautioned that "submission is a coordination of a number of activities beyond just the clinical trial."

This study is just the beginning of the trials Arch Therapeutics plans to conduct. The company is focused on building a broad set of products, Norchi said, including an internal hemostatic device for surgical procedures, products for chronic cutaneous ulcers, prevention of surgical adhesions, and various form factors of its technology.

"If a surgeon or health care provider sees bleeding, he or she can pick our product off the shelf. That's the goal," Norchi said.

Marie Thibault is the managing editor at MD+DI. Reach her at marie.thibault@ubm.com and on Twitter@medtechmarie.

Arch CEO is a MD, MIT MBA and Former Portfolio Manager at Putnam $4 Billion Healthcare Fund.

Old but informative perspective on Norchi—the timing of trials off but at this time it matters little Arch has already now had its first successful human trial. 

www.youtube.com/watch?v=GRktlyx5ALk

The Burden of Bleeding

Bleeding is common in both open and laparoscopic surgery and can result in 30-50% of procedure time spent controlling bleeding

Visual Surgery Field loss resulting in increased error risk

Increased length of hospital stay

Use of expensive resources (blood transfusions cost $500 to $ 1,000 unit)

Can result in abnormal healing and adhesions

Hematomas and seromas formation in surgery wounds

Antithrombotics (blood thinners) increase bleeding risk



"The clear field of vision (AC5 product is clear liquid) provided could cut procedure time in half as well as provide vastly increased likelihood of excellent outcome post-surgery."


Arch Therapuetic AC5 Surgical Hemostatic Device

Attributes of AC5

Synthetic peptide

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)

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”
Bioasborbable

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



Next Generation Medical Technology

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.

Arch Therapeutics ARTH Presentation Today --



The meat is on Page 16--wish Dr. Norchi spent the whole time on it. AC5 (200 +- applications) is but one of many products.... note discussion of the expanding pipeline


wsw.com/webcast/rrshq26/register.aspx?conf=rrshq26&page=arth&url=http://wsw.com/webcast/rrshq2
6/arth/index.aspx

ir.archtherapeutics.com/press-releases/detail/480

Arch Therapeutics Provides Corporate Update at the 18th Annual Rodman & Renshaw Global Investment Conference