With the healthcare debate at center stage of national discourse, determining a system that can reign in exorbitant costs for medical treatment is at the forefront of the conversation. For that reason, there is a greater awareness that focusing on early detection and disease prevention is a better answer for creating a sustainable system long term. It’s also why so much of the innovation happening in the life sciences space is now coming out of the burgeoning Medtech segment.
Newer medical technologies are empowering healthcare providers to help patients more effectively, diagnosing diseases more accurately and rapidly than before. In many cases, the methods today are more efficient and less invasive, resulting in patients more willing to undergo preventative tests and screenings. This eliminates a huge barrier for clinicians.
A prime example of this is Breathtec Biomedical (BTH:CNX) (BTHCF), which is developing best-in-class breath analysis devices for the early detection of infectious and life threatening diseases, such as lung and breast cancers, Alzheimer’s and Parkinson’s disease, tuberculosis, diabetes, liver disease and more. The foundation of Breathtec’s technology based on FAIMS, which serves as an ion filter that only detects molecules of interest. While breath analysis currently exists in limited form in the market, most devices are benchtop models that cannot be used at the point of care. The fact of the matter is there isn’t a solution at the point-of-care level, which is key for reducing the time and cost of diagnosis and give clinicians the tools to better help their patients.
In early March, Breathtec provided a corporate overview of its current programs—the continued development of its FAIMS technology as well as NaNose device, which is currently in clinical trial in Surrey, BC.
Equities.com had the opportunity to speak with Guy LaTorre, CEO of Breathtech Biomedical, to gain more insight on the company’s progress and strategic timeline, and key milestones over the next 18 months as it focuses on bringing its handheld breath analysis devices to market.
EQ: Breathtec Biomedical is a leading innovator in breath analysis devices for the purpose of early detection of infectious and life threatening diseases. Most notably, the company is developing technology that can harness the power of lab analysis into the form of a handheld device. From a big picture standpoint, how could this potentially revolutionize the market?
LaTorre: There has been significant interest in the use of breath analysis as a point-of-care tool to allow for early detection of diseases, but the field really hasn’t reached its full potential yet. The problem is no one has been able to produce a handheld device that is both sensitive and accurate in its ability to detect the volatility in the compounds of the breath associated with diseases. There have been a number of approaches that people have taken in capturing breath samples at the point-of-care, then sending them to the laboratory for analysis, using sophisticated equipment like a mass spectrometer, which is a huge device that sits on a counter top.
Those types of approaches have significant potential but there really hasn’t been anything built and clinically proven to look at the point-of-care. So, during the design process, we looked at what others have done and technical issues they have tried to overcome in building a handheld breath analysis device based on High-Field Asymmetric Waveform Ion Mobility Spectrometry (FAIMS) technology. We learned a lot from that and, as a result, we are designing a device that has the sensitivities and reproducibility required to work clinically. We hope to commercialize the product that is portable and easy-to-use and, of course, clinically validated–which will finally deliver on the promise of breath analysis as a clinical tool.
EQ: The significance of a handheld breath analysis device could be enormous for clinicians. What would some of the most noticeable benefits be with a portable device versus the current technology they are using now?
LaTorre: The point-of-care approach really lends itself to rapid results. So, for example, a clinician can make a decision at the point-of-care during the office visit as opposed to having to wait the five days for laboratory results, which is currently what’s happening. This will reduce the time and cost of diagnosis and allow for immediate treatment and better patient outcomes.
EQ: In March, Breathtec provided some significant updates on the stages of its technology development. To start, your flagship FAIMS platform has now completed the developmental testing phase and is starting its performance testing phase. What were some of the things you learned during this process that helped you improve upon the technology going forward?
LaTorre: Well, during the design process, we learned a lot about addressing the types of challenges that are required to get a technique like FAIMS from the benchtop to a handheld device. That includes how we optimize the design and components to achieve that high degree of sensitivity and reproducibility required for clinical use. But we’ve also learned a lot about the miniaturization process and have been able to miniaturize the electronic components as well as the FAIMS cells that we use to allow for us to make a truly portable device. We have made some major advances in our new V2 prototype verses our earlier V1 prototype, including reducing its size by more than tenfold.
So, we’ve moved quite a bit over the last six to eight months in our quest to develop this technology.
EQ: When you’re talking about creating a handheld device, miniaturizing the technology by tenfold is very significant. Breathtec has said that these tests will help set the stage for the company to enter clinical trials with the device in the second half of 2017 and in 2018. You’ve also said you have identified a clear path to market. Can you provide us with some details on the longer-term strategy with the FAIMS device?
LaTorre: I would be glad to. We conducted an analysis to look at the regulatory and clinical requirements to get the technology to market in both Canada and the US. We’ve determined that we would need to conduct a pilot clinical study, which will occur later in the fall of this year. It will probably start by mid-fourth quarter of this year, but maybe a little bit earlier. This study will confirm the clinical performance and the utility of the device and help us determine what the size of our next clinical study will be.
We will also captured user data during this first study and get feedback from clinicians who used the device in a clinical setting to better design the device for their use. If that study is successful, and we expect it to be, then we’ll enter into our second study– called a pivotal clinical study, which will start in mid-2018. The results of this study will be used for the regulatory submission to the FDA and to Health Canada, which will occur before the end of 2018. If all that goes well, we have the potential to put the product in the marketplace in the first half of 2019.
Wehad this regulatory analysis done by two separate regulatory experts. They’re both very good at what they do and we feel assured with the recommendations. Of course, we need to have a pre-submission request with the FDA to confirm our path, which we will do in the next coming months.
EQ: Breathtec also provided an update on the company’s clinical study of its NaNose technology, which is being done at Innovation Boulevard in Surrey. Breathtec said the study has provided a significant new understanding of the technology. Can you elaborate on that?
LaTorre: We’ve learned a lot about the NaNose device, its technology, how it works and what its potential is. We’ve also done a regulatory and clinical analysis to get the technology to market. So, the clinical study in Vancouver is ongoing. Please remember we have licensed this technology and did not do the development work ourselves so we have a lot to learn. We’ll continue to learn more about the technology and see what’s its clinical utility is as we continue to conduct the clinical study in Vancouver and we’re very hopeful that it meets the requirements for clinical use.
EQ: Can you shed some light on your strategic roadmap for NaNose, from a clinical and regulatory standpoint, as well as bringing it to market?
LaTorre: Absolutely. As with the FAIMS technology, we conducted the regulatory analysis for the US and Canadian markets, and what the regulatory consultants have confirmed is that there are similar pathways to the approval and commercialization process. So, the plans will also require a pilot clinical trial and a pivotal clinical trial of a certain size and performance data just like the FAIMS technology for us to obtain a regulatory path and clearance. The timelines for both are pretty much the same. So, the timeline I mentioned earlier with regards to the FAIMS technology is also doable for the NaNose technology.
EQ: So the coming 18 months will be a critical time to watch Breathtec and its development. To your credit, the company has been very communicative to the investment community about the progress you’re making along the way. With that said, what are some important takeaways you would like investors to consider as they kind of track your progress through this year and beyond?
LaTorre: I think that the first thing that I would want to do is thank our investors for their support and assure them that we’re making significant progress in developing our breath analyzer. The goal is to finally make point-of-care breath analysis a reality and to give them a great return on their investment. What we’re trying to accomplish is to develop a tool that can be used to detect multiple disease states by using the same device, which opens the door for its use on millions of patients with many different disease types. So, there is an enormous addressable market and significant revenue opportunities in our future.
We will also be working in the field of infectious diseases as it relates to public health and try to reduce the overuse of antibiotics through differentiating between bacterial and viral infections like we’re doing in our Vancouver clinical study on the NaNose. We’re also working with microbiologists and epidemiologists to see if there is a potential to help stop the spread of infectious diseases at our borders that are a significant issue to the US and beyond. So, I believe that our future is very bright. I think the technology that we’re developing will have enormous clinical applications and will really deliver on the promise of breath analysis for clinical use.
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