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Lynn Fosse, Senior Editor
Steve Alexander, Associate Editor
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Christy Rivers -
Chief Executive Officer
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Interview conducted by:
Lynn Fosse, Senior Editor, CEOCFO Magazine, Published – November 11, 2019
CEOCFO: Mr. Ashery, what is the idea behind Nobio™, Ltd?
Mr. Ashery: The idea behind Nobio is to solve a major problem which affects our lives every day, which is infections and unwanted bacteria. The traditional way of preventing infections with materials called antimicrobial have a serious limitation; in fact, several limitations. One is that they are short term; the other is that they can be toxic and the third is that they can cause resistance. Our technology can actually do the same job, but without these negative effects. In other words, in can act permanently, it does not have toxicity, it does not induce resistance and it can be applied across many areas of life in materials that we use from medicine and dental and consumer products; all those things that could potentially cause infection. We can enable to manufacture all these things in a way that they will never get contaminated by bacteria.
CEOCFO: Would you please explain the approach in laymen’s terms?
Mr. Ashery: It is nano technology, so it is going to be a bit difficult to do it very, very simply, but I will do my best. We designed nano particles that can be impregnated into a range of materials at the time of the manufacturing of the product. Essentially, you get a product which has these antibacterial properties, which means that bacteria, if it contacts it, will die. For example, if we go to medical devices like implants, implants can get infected. It can be infected during surgery. It can be infected after they are already in the body and that can cause serious complications. It can even cause death. It could cause the need to remove the implant, and that means two more surgeries and the cost and the suffering for the patient is enormous. If this implant was manufactured with our material it is very unlikely to get infected. It is hard to say absolute things, but let us say that the risk would be significantly lowered.
CEOCFO: What is it about your material that can prevent an infection?
Mr. Ashery: That is because all the traditional bacterial materials were soluble. In other words, they dissolve and they release some toxic molecules that goes into the bacteria and kill it. We have actually developed a solid. It is non soluble, so it does not release. It always stays where we put it and it always remains affective for a lifetime, forever. That is really the paradigm change, the revolution, so to speak, in this area.
CEOCFO: What is it made out of?
Mr. Ashery: There is a variety of different options. The concept though, is the particle, which is, you would call it, the vehicle or the carrier. It is coated with a high volume of functional groups which do the killing and they are covalently bound. That means it is a very strong chemical bond, which means that it will not be released in normal conditions. The particle allows us to create a very high concentration of the antibacterial effect, at a focal point, and when the bacteria comes in contact it is very effective against it.
On the other hand, it allows us to anchor it in the host material and when they mix those particles with the material at the production stage, it essentially becomes part of the matrix of the material and whatever we make of it; if we make an implant, if we make a tube, if we make a dental filling. In fact, the first products to be on the market next year, which got FDA clearance, are a line of tooth filling materials. The main reason that these fillings fail and need to be replaced multiple times is bacteria. That is also why we eventually lose our teeth and the main reason we go to the dentist. Therefore, it is a huge problem that affects each and every one of us.
CEOCFO: Why dental first?
Mr. Ashery: This started in dental. There is a little legacy here. That is because the people who developed this technology were actually coming from the dental world and trying to solve one of the biggest problems in dentistry. As I said, we lose our teeth and we go to the dentist because of the bad bacteria that settles on the teeth, between the teeth or inside those cavities, and keep producing acid that cause the tooth’s decay. Then after several times we have to do a root canal and after that can be infected the tooth has to be extracted, gone, we lose one, two, three and sometimes a whole jaw. Twenty percent of Americans above sixty-
Today we are working with many companies in the medical device area and with consumer products, I mentioned implants and there are several other examples like contact lenses, sanitary products; everywhere that you have moisture and humidity, you have bacteria. If it is a setting that could become a contamination and could cause infection, that is a serious problem. If it comes in contact for an extended time or many people are exposed so there can be transmission, from one person to another. Therefore, it really affects many areas of life, as I said in the beginning. Dentistry is one big area and then medical devices is another. Then there are many consumer products, baby products and personal hygiene products. This could really be in many different products and materials. Water systems is another example.
CEOCFO: Have similar approaches been attempted in the past?
Mr. Ashery: Yes. Traditionally antimicrobials were soluble materials. That is how people were thinking in this area. All the molecules that were designed to kill bacteria were; again, the notion was that they were released, whether we are talking about antibiotics as one example, metal ions, like silver and copper and mercury. All of these metals are used in different places, also to prevent contamination, because they corrode in the presence of oxygen and moisture and then they release those ions that can hurt and kill the bacteria. However, the overriding or the common problem with all of these is as I said in the beginning; they wane, they deplete. It is like a battery. Once you release there is an end, an expiration for that. Also, they are non-
But the biggest problem today, and people maybe do not talk about it enough, is the antimicrobial resistance. Bugs are getting resistant. That means that they are not sensitive anymore to existing antimicrobial treatments, and quite rapidly, faster than we are developing new drugs or new antibiotics, so they are kind of gaining on us. Some predictions are that in three decades more people will die from resistant bacteria than from all cancers combined.
CEOCFO: What sets your approach apart?
Mr. Ashery: There have been efforts, but what we have come up with, and this is our uniqueness, is the particles concept. People have tried to take antimicrobial molecules and bond them covalently to surfaces. Let us put it this way; it is not very practical to do. It really limits how you can apply it, from the engineering standpoint of it. Our concept of putting them on the particles and mixing it in with the raw material is something that pretty much mimics the standard processes in the industry, when you talk about the plastics industry or other polymers industries.
From a production and implementation standpoint, it is a very standard thing, but also much more affective, because the particle allows to concentrate a lot of activity at one focal point. Therefore, think about it, if I were to take little nails and throw them on the floor and you walk over it, it is not going to hurt much, you are not going to feel that. However, if I stack them one on top of the other you are going to step on one and it is going to injure you badly, and this is exactly what happens when we put all of these at one focal point. When the bacteria comes close it really burns a whole in the membrane. That is why it is very lethal and we can use overall very little of this material to get the effect that we want.
CEOCFO: What has been the response from the medical and dental communities, from people in general when they learn what you have done? Has there been some skepticism?
Mr. Ashery: Yes. In a sense, because it kind of goes against the traditional microbiology. People have been conditioned to always think about antimicrobial as a soluble material, because it goes out and into the bug to kill it. This is where we came up with a different approach. I would agree with that, that their initial reaction is skeptical. However, we have done a lot of research. There are more than twenty scientific publications, three clinical trials, a bunch of animal studies and different situations with implants and different materials and so on. Therefore, there is a very significant body of scientific data.
We now have four products that are FDA approved. Let us say that we have gone and made some way in having data and credentials, also for the scientific community, so people are starting to get this. Now we have products approved for dentistry and we are preparing to launch this in the beginning of next year, in the first or second quarter of 2020 and we are really just in operational preparations now. However, we are also working with many major companies in the medical device industry. It is easy to test. You do not have to go through a very elaborated scientific discussion. You just come in and we make it together with them and they test it and they see that it is working. That is probably the easiest way to convince them.
CEOCFO: For the Infinix™ products that you are going to be launching next year; what do you need to do in the interim? Will you be working with partners? Will you be manufacturing? What is going into the prep for launch?
Mr. Ashery: We are on the commercialization. There is interest from several major commercial entities, distributors or even manufacturers with strong commercial platforms that would really love to sell this brand or to integrate the technology into their materials. We are happy to work in both ways. Our vision of is for this technology to be available to everyone, so it could be within the Infinix™ brand or it could be with other peoples’ products, because it is compatible with all. Therefore, this would be through a combination of these distributors and manufacturing partners.
For the distributors, we will have to manufacture it because this will be our formulations and for that, we are not going to set up our own production lines, because there are many contract manufacturers out there. We just have to pick one that is good. Right now, we are in discussions with several and I believe we will finalize that also in the next few months. We just got our FDA clearance in September, so it’s only a month since then. Now, all of these things are happening, both on the operations and the manufacturing and the commercialization. We are also in discussion with some strategic investors who would like to partner with us and finance the roll out of this technology. A lot of things are happening right now.
CEOCFO: With so many potential areas to use what you have developed, how do you stay focused? It seems that almost every industry could make use of what you have?
Mr. Ashery: In my job as a CEO, I spend a lot of the time saying no to things, because of exactly that; to stay focused. We started at dental and right now this is the main area and we are focused on getting that portfolio of products into the market. This is our number one priority. Parallel to that, a small part of the organization is working with several partners, only on the implementation of the technology into their products or materials. That is not taking a huge amount of resources from us. In fact, it could be one engineer or material scientist in the company who works with two to three to four products of such partners and we have about ten of them. Therefore, it is another part of the activity, and our focus on dental is not distracting from what the other people are doing.
About seventy plus percent of the organization is focused on the dental and the others are supporting those partnerships. Nevertheless, I think it is important to do, because, long term, I think the vision for the company is not a dental company. It is going to be an antibacterial technology company and the technology will be applied in all of those different areas. We want to get started with those things and not just wait, because time is important, especially for young companies. However, the main focus from the operational standpoint is on dental.
CEOCFO: What surprised you as Nobio has grown to where you are today? What surprised you about how the technology works from the concept to actually getting FDA approvals and actually seeing it work?
Mr. Ashery: I have been involved with several startups and sometimes, especially in the early days, things do not always work consistently. I think that is the issue, because people discover something, they are very excited about this, but it is not very robust. It needs more development, more refinement, until it can really work consistently and deliver the results, be ready for prime time, to put in the hands of customers. Many companies rush too fast, because of different constraints such as finance or whatever, could be over-
This is the fourth company that I’ve been involved with and I have seen situations like this. Therefore, I came here expecting this to be the same, but I was pleasantly surprised. The concept here is simple, but it is a very robust thing and it is really working very well. It was also surprising that we can actually move quicker than I thought we would. The company is only four years old, but it really started to run when I joined, because of my industry background. Previously it was more focused in on the research. However, turning that to product and getting it to the market is kind of what I was hired to do, and getting four products approve by the FDA; I think that is good time, generally speaking.
CEOCFO: Why is Nobio Ltd an important company?
Mr. Ashery: It is going to help humanity in various areas. There are some great investment opportunities out there that are, nonetheless, confined to one aspect of life. Although we are talking here about health and preventing particular group of disease, infectious diseases, the risk is everywhere. It could be at home, it could be in a hospital, it could be when we eat something, when we are in public places, and I think it is just going to make the world a healthier place; less risks for health when we go about and live our lives. That is what got me excited. It is that you are not working on a widget or some application which is very specific, but this is something that could really have a broad impact and I like that idea a lot! I think that is something that everybody; you tell them about this technology, they always have a personal experience they can relate to and I think that is what makes it fun to be here in this position.
Nobio Ltd., Biofilm Prevention, Anti-
“The traditional way of preventing infections with materials called antimicrobial have a serious limitation; in fact, several limitations. One is that they are short term; the other is that they can be toxic and the third is that they can cause resistance. Our technology can actually do the same job, but without these negative effects. In other words, in can act permanently, it does not have toxicity, it does not induce resistance and it can be applied across many areas of life in materials that we use from medicine and dental and consumer products; all those things that could potentially cause infection.”-