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Armis Biopharma develops Next Generation Protection against Incumbent and Evolving Biological and Chemical Threats
Theodore E. Ziemann
Chairman and CEO
Armis Biopharma, Inc.
Interview conducted by:
Lynn Fosse, Senior Editor
Published – November 30, 2020
CEOCFO: Mr. Ziemann, what is the overall vision behind Armis Biopharma?
Mr. Ziemann: Armis Biopharma is focused on protecting humans, animals, and the environment from harmful pathogens and chemical agents. Armis’ proprietary Veriox® technology is effective against incumbent and evolving mutations of viruses, bacteria, spores, fungus, and for neutralizing chemical warfare agents, when designed for specific purposes.
CEOCFO: What is the science behind Veriox®?
Mr. Ziemann: Veriox is a peracid (peroxyacid) technology that is a very effective antimicrobial. It literally destroys the pathogens. It is also effective in destroying certain chemical warfare agents.
CEOCFO: How does it work?
Mr. Ziemann: Basically, it breaks through the surface of the microbe and destroys the contents of the cell. From that perspective, it is very different from a systemic antimicrobial or antibiotic, because those have to work inside your bloodstream and they specifically go after different functions of the microbes. That is why they are not effective against all the microbes and it is also why microbes develop resistance to them over time. It would be extremely difficult for pathogens to develop resistance to Veriox® because rather than interrupt their ability to reproduce, it literally destroys them.
CEOCFO: Why does it work?
Mr. Ziemann: It works because it destroys the organism. As a result, it is very effective against resistant organisms which I am sure you have heard about, like MRSA (Methicillin-
CEOCFO: What was involved in the development? What was the basic idea and what did you need to go through to come up with something that can actually do the job?
Mr. Ziemann: Armis Biopharma was originally a company (Chata Biosystems) that primarily produced chemicals for pharmaceutical laboratories. One of our customers used a technology to separate X and Y chromosomes from cattle semen. Their machines were getting bacterial contamination. They had been using a sodium hypochlorite solution that was causing corrosion of their machines. They asked us to develop a product for that application which was not corrosive or flammable. We jointly developed an effective product for this use and patented it.
Once we developed it our board started asking questions about whether this product would be effective in killing mutated, antibiotic resistant pathogens like MRSA and Clostridium difficile. Our chief technical officer at the time started doing research looking for a technology that would kill C. difficile, because that was the bacteria that was a significant health risk and very difficult to kill. First, he did a lot of academic research. He then eventually developed the Veriox® technology in our laboratory. We tested it and found that it was extremely effective against c. difficile and many other pathogens. Later, the U.S. military tested it and found that it was effective against certain chemical warfare agents.
CEOCFO: What have you developed so far?
Mr. Ziemann: Our products are based on this type of technology. In June of this year we launched a product called ArmiClenz™, which is an EPA registered surface disinfectant killing 99.999% of bacteria, 99.9% of viruses and is also on the EPA’s COVID List N. This product is designed for use on hard, no-
In December, we are planning to launch ArmiVET™ wound wash for animals.
We also received a grant from the National Institute of Health (NIH) for $2.1 million to develop a product for decontamination of chemical warfare agents on skin. We have been given approval for the first phase of work on that grant for $423,048 and have initiated toxicology studies.
CEOCFO: Would you tell us how the product you just announced works?
Mr. Ziemann: VeriFixx™ is a medical device designed for fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe and mallet toe. VeriFixx™ is designed to make surgical corrections of this kind more accessible to patients through shorter time to ambulation, shorter overall recovery time and reduced pain.
It is to be used when one of the minor toes is crooked, either hooks down or up and it is ugly. In some people it also causes pain when walking. The product would be inserted in the toe to straighten it for cosmetic purposes and/or to prevent discomfort. Our product is designed to give you faster recovery from the surgery and to prevent rotation.
Right now, competitive products are prone to not offer the same type of stability that our product does. We believe that VeriFixx™ will make the surgical correction much more acceptable to patients in need due to significantly shorter recover time than the current 6 weeks before being able to walk normally and up to one year before full recovery.
CEOCFO: That seems different from some of your other offerings. How did you come up with the idea to develop VeriFixx?
Mr. Ziemann: VeriFixx™ was developed to demonstrate the unique mechanical design and the titanium coating on PEEK (Polyether Ether Ketone) as an improved small bone implant. In the future we want to apply an antimicrobial coating to the device to help reduce potential infections. This will require an additional registration. We believe that our Veriox® technology can be an effective antimicrobial when applied as a coating to the device. The ultimate goal is after demonstrating the technology on a small implant that it could safely be applied on a wide variety of larger orthopedic implants, such as hip joints and knee joints to reduce infection during and immediately after the procedure. As an example, if a hip replacement becomes infected the implant has to be removed, the infection eliminated, and then the implant re-
CEOCFO: With almost limitless opportunity, how do you decide where to focus your efforts?
Mr. Ziemann: Yes, there are limitless urgent needs. We initially wanted to register more complicated products, but what we finally decided on was to register EPA (Environmental Protection Agency) registered products, and to register 510(k) medical devices. They still require a great deal of work in terms of proving the safety and the efficacy of the technology, but it is not as costly as trying to develop and register a drug for example. We know that the technology is very effective, so it is then a matter of choosing what fits with our registration priorities.
In the case of the chemical warfare agent decontamination product, there is interest from the US Military, as well as to protect the civilian population from a mass casualty event. In those cases, we were able to get grants. The first one that I mentioned to you was through the NIH for the civilian population. Another grant for wound decontamination was approved by the DOD, pending the 2021 military budget.
CEOCFO: When you are speaking with the right people, do they understand the technology? Are they skeptical? What is the feeling when you are introducing Armis?
Mr. Ziemann: Biological and chemical threats are increasing and becoming harder to defeat. This is well understood by those who serve the medical, food production, and food processing communities as well as the military.
I think that potential customers and partners are excited about the ability to easily kill difficult pathogens, but also because of the relative safety of the technology, and the fact that it is an environmentally friendly material. It does the job and then breaks down into water, oxygen, and carbon dioxide, and doesn’t leave a residue. We do not have a complex chemical that hangs around, so that is a big deal. There is no chlorine or ammonia in our chemistry.
We do face competition from other products, for example with our chemical warfare decontamination product, there is a product made in Canada that we would compete with. However, it does not have the environmental safety that our product has. Further, we have equal or better efficacy, and our cost is very competitive.
Originally, the technology was expensive, and so we were very focused on medical applications, but now that we have found a way to produce the product at a much lower cost, it opens many doors in surface disinfection, as well as chemical warfare decontamination.
CEOCFO: How do you gain attention? How do you reach out to the people that should know about what you are doing?
Mr. Ziemann: We hope that interviews such as this will bring attention to our company. Since we are small it is more difficult to gain attention. That said, we have contacts with some of the major companies who would be interested in our technology and the military, both for the chemistry itself, as well as in the medical device arena. For the first product, ArmiClenz™ surface disinfectant, we are reaching out to distributors and retailers and we hope to get this product into the big box stores, as well as Amazon. Those are the consumer products. Customers can also order directly from our www.armiclenz.com website. Two products in development (human wound wash and spore killer) will be marketed to the medical community and nursing homes. With the medical device, our intention is to work with large medical device companies who may want to either license or purchase the technology.
CEOCFO: What is the key to staying focused when you have so much going on and so many possibilities?
Mr. Ziemann: The key is to continue working on our core Veriox® technology. This is the platform with the most solutions to large needs for a very effective disinfectant that is also in the safest rating category. That is our prime objective and so we utilize outside contractors to help us in areas where we do not have internal expertise. For example, for EPA and FDA registrations we use consulting companies, because that is what they do, and that takes a lot of the load off of us.
For manufacturing, our approach at this point has been to utilize custom manufacturers who have expertise and scale and can produce the product efficiently for us. It prevents us from having to raise large amounts of capital for hardware.
CEOCFO: Final thoughts? What might someone miss when they first look at Armis Biopharma?
Mr. Ziemann: Our senior team has worked in key positions for very large companies before getting involved in Armis, so we have great diversity of experience, solid areas of expertise, and good contacts. We have been a development company, but about two years ago I made the decision to strengthen our focus on bringing products to market faster, and we are starting to see results. ArmiClenz™ was commercialized and VeriFixx™ cleared by the FDA, with ArmiVET™ coming by year end 2020. VeriCyn™ wound wash is planned for 2021, and products for oral health, medical and nursing home disinfectants and products for decontamination of chemical warfare agents are expected shortly thereafter. We have an excellent portfolio. We have a very efficient organization, because we only have a few employees, and utilize contractors as necessary. We are looking for partners to help us commercialize our technology.
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“Biological and chemical threats are increasing and becoming harder to defeat.”
Theodore E. Ziemann