Dieses Interview stammt vom 13 November 2003 auf www.wallstreetreporter.com
WSR: Could you start with an overview of the company?
ABI: Ambri stands for Australian Membrane Biological Research Institute. It's a spinout from the largest research organization in Australia called CSIRO, Commonwealth Scientific & Industrial Research Organization. It's broadly a biotechnology and nanotechnology company. It was listed on the Australian Stock Exchange in August 2001, ticker symbol ABI. We are located in Sydney, Australia. We have 65 employees with seven Ph.Ds., a number of Masters, and 32 Bachelors degrees. The technology is protected by over 80 patents and we have 55 pending. Our website is www.ambri.com, and our vision is to increase shareholder value by building businesses based on membrane and biosensor technology with a major focus currently on the point-of-care diagnostics market.
WSR: What can you tell us about the market opportunity and potential for the company in the point-of-care diagnostics business?
ABI: The point-of-care diagnostic business is one aspect of our strategic direction. I'd like to emphasis that there is enormous potential, I believe, in this technology in other areas. So, let me answer your question in terms of the specific space of point-of-care. The In vitro Diagnostics (IVD) market comprises of basically two large segments. There is the clinical chemistry segment, or the laboratory base segment, and the point-of-care segment. Point-of-care means that you can turnaround the diagnostic tests particularly quickly at the patient bedside or in the home, and it is useful in time critical medicine. A good example of this would be people who present with chest pain in the emergency department and the physician wants to know very quickly whether that chest pain is due to a coronary event or an occlusion. There are various markers in the blood that can be identified reasonably quickly with a test or a product called Troponin, and if proved positive, it gives the physician a clearer indication of the triage of that patient.
The point-of-care diagnostic market also includes blood glucose monitoring. Worldwide, it's approximately a $7 billion to $8 billion market growing at around 10% per annum. However, there are segments like the cardiac and congestive heart failure segment that are growing above that. Fifty to sixty percent of the global point-of-care market is in the United States. We believe it's a significant opportunity for Ambri. For example, some of our potential competitors are generating revenues of above US$100 million per year with the application of six to seven tests in that market space, with market shares varying between 5% and 40%. And we believe our platform technology can compete effectively in that space.
WSR: What are the major advantages of working with this technology?
ABI: The Ion Channel Switch is the core technology; it's protected by a number of patents as I alluded to. The difference with this system is that it is a digital platform system. It is comprised of a self-assembling lipid bi-layer that is assembled and anchored to a gold substrate and has channels created in it using a molecule called Gramacidin. That sounds very complex, but in fact, what this technology is doing is mimicking a nerve cell or a cell membrane in the body, and the channels can open and close according to the presence of an analyte or something that you are trying to detect. When you close the channel, the current drops; when you open the channel, the current increases. So, this is a very fine-tuned digital technology. The advantages of this technology over our competitive technology is, one, it's digital; two, it's miniaturizable, and three, we can put in an array. Now, we can put 200 tests on a very small slide and that can all be hooked up digitally. The other major advantage with this is that it can be used for a broad range of tests such as immunoassay, electrolyte, and other molecular diagnostics. So, we see this as a true platform technology for this industry.
WSR: In terms of product offering, tell us about the SensiDx™ System.
ABI: The product offering consists of a number of things. We have focused on the biosensor and the 80 patents around that, but surrounding this technology there needs to be a delivery system. As you know, in marketing, technology needs to be put in a delivery system that meets customer needs. So, we house the biosensor in a thing called a cartridge. The biosensor is only a small dot like a pinhead; you can hardly see it. It is housed in a sophisticated cartridge that can be put into a machine or an analyzer that can draw blood across the heads of the biosensor and enable the digital connection to proceed. The real advantage of our system in terms of use by the customer is that it all can be done without any exposure to blood. The blood is drawn into a vacucontainer and that vacucontainer remains sealed through the whole process and once removed from that machine, it can be used for other analyses. So, the nice thing about our system is you can take a sample and stick it into the SensiDx System, get a reading, and then that container can get forwarded to central pathology for a confirmation test if you wish. I think those are some of the key advantages of our technology. We have produced about 20 of these devices and we have a production facility for making the cartridges, albeit at low volume presently.
WSR: What is your strategy to ramp up towards commercialization?
ABI: One of the key things with this technology is the enormous complexity of it. As you can imagine, we have 80 patents protecting it. So, we have to assemble this in a multistep process. Currently, it takes 10 to 12 detailed steps to manufacture a biosensor. A gold surface is placed on a plastic base in a reducing atmosphere, the first layer chemistries anchor to the gold, a second layer self assembles to the first layer and then we add other chemistries to attach receptor molecules. So, manufacture is a complex electrical, chemical, and biochemical process. One of the critical issues from our point of view is process control and manufacturing. At this stage for ramp up, we are concentrating on statistical process control because we have been through most of the difficult research questions. We are now into the advanced development and scale up for the manufacturing side of things. So, that's our focus. We want to go from 10 cartridges today to 75 cartridges per day in the next few months and to be able to assemble those into the delivery system, which is the cartridge, and to be able to store them so that they can be sent to hospitals. Our plan is to demonstrate that we have the performance characteristics in the biosensor that will demonstrate critical commercial requirements by about May 2004, and then by February 2005, have a market launch in the Australian market. The product will be the SensiDx analyzer and cartridge systems, which will have two tests in the Australian market.
WSR: What can you tell us about major collaborations, partnerships, or alliances in the biosensor space?
ABI: In November last year, we were very fortunate to sign a licensing agreement with Dow Corning and Genencor, two large U.S.-based companies that themselves have a joint venture called Biosensor Enterprises Limited. Biosensor Enterprises Limited is looking at new technology developments using silicon-based and biotechnology products such as monoclonal antibodies, fragmented antibodies, molecular diagnostics, and so forth, for a variety of markets. They have licensed this technology for all markets outside of human professional, i.e. bioterrorism, food detection, and home consumer use. The great thing about this alliance between Ambri and Biosensor Enterprises Limited is that we are doing combined R&D. They are developing the next generation of Ion Channel Switch or Biosensor Technology with much improved performance in terms of stability that they will require in their market space. Fortunately, we have access to these improvements and similarly, they have access to our improvements. So, we are working very closely with these U.S.-based organizations to develop the technology and it's going very well.
WSR: What are the funding and capital needs of the company going forward?
ABI: The best way to look at that and answer this question is historically, I believe, if you look at pure point-of-care plays in the U.S. market. There are a number of those; Biosite (BSTE) is one that is listed on the Nasdaq, another is i-STAT. They have a long development history and certainly, funding order of magnitude of about US$100 million will be required from start to finish, to globally commercialize POC products and start generating significant revenues. If we look at the money that has been being spent on this technology to date, including prior to ASX listing, we believe we are at the development stage of this project. There has been some AUS$50-60 million spent on this project to date. So, we are getting closer to a commercialization goal, but to develop a global company that matches those other companies, certainly there is more money that needs to be raised.
WSR: And as far as it relates to near-term milestones, what would you highlight for our audience to keep on our radar screens?
ABI: Our web site regularly posts progress on our advance to key milestones. So, we have a milestone, a commercially viable technology set for May of next year. Our press release to the ASX on November 10, 2003, detailed the progress and steps toward that goal. This will be an on-going process where we monitor exactly where we are versus plan and communicate this to the market place. That is certainly a good way to follow the progress to the organization. But I think also what we need to look at here is the enormous potential of this technology outside of the point-of-care area, and I don't think that's been clearly relayed today in this interview.
WSR: Then tell us about the applications of the technology outside of that point-of-care market space.
ABI: My background is from medical devices, and I have a great interest in medical device implantables. While we have patent positions on using this self-assembling nanotechnology for neurogenesis or nerve growth, and there are possibilities there where we can actually stimulate nerve growth by using some of the patent applications that we have here. We also have the possibilities through the digitization and microarray capabilities of this technology for human implantable biosensors in the body that can act as sentinels for markers that may be detrimental for future health. So, metastasis or the return of a cancer or a particular metabolite that indicates a byproduct of a genetic problem may be detected with an implantable miniaturized biosensor array. This technology has the capability of doing that, and that to me is an enormously exciting market, and we haven't even really touched on that, although we are interested now in exploring those opportunities with potential licensing and alliance partners. The other area is, of course, as a clinical chemistry based technology. We are focusing on point-of-care, but certainly the large players are looking for broad-based platform technologies that can analyze a wide range of potential analytes such as immunologicals, electrolytes, and molecular diagnostics. And we believe that our platform could serve that function for a large player as well.
WSR: What is your vision and what emerging trends do you see here that will shape the way in which Ambri Limited capitalizes on this opportunity?
ABI: To me, fully demonstrating that this platform technology has a broad-based application across a wide range of analytes is the technology vision. Once that has been established, we believe it will be very difficult for other players to match this in a cost-effective way. And so, the vision from our point of view, is focusing very much on the technology development, but bearing in mind that we need to get a product as quickly as possible into a market space. Being a small play like Ambri is, we need to bite off segments; we need to be a niche player in terms of using that technology. So, we have to develop novel new markers that we can put on the biosensor, so that we can find a place in the marketplace where there aren't too many other people at the same time.
WSR: In closing here, why we should continue to track and follow this company in the near-term and beyond?
ABI: I think that is covered by our licensing partners, Dow Corning and Genencor, and their statement to us. They searched the world in a detailed due-diligence program to find a biosensor technology. They came up with two or three biosensor technologies that were available, but when they evaluated the Ambri Biosensor Technology, they discovered it was one of the most advanced technologies with the best patent protection that they could find. In a way, I think that emphasizes the value proposition of the technology. The value proposition that we have is that the market place is looking at different sorts of technologies to answer the one problem. We believe that we can use this as a true pioneering nanotechnology that can actually provide solutions over a wide range of clinical and non-clinical problems in a cost-effective manner.
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