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June 13, 2016 Issue

The Most Powerful Name In Corporate News and Information


Biosensors for Real-Time Monitoring of Body Biochemistry



Ben Hwang, Ph.D., Chairman & CEO


Profusa, Inc.


Interview conducted by:

Lynn Fosse, Senior Editor, CEOCFO Magazine, Published – June 12, 2016


CEOCFO: Dr. Hwang, what is the overall concept behind Profusa?

Dr. Hwang: We have solved the fundamental problem that has plagued the continuous biochemical sensing industry for the last 30 to 40 years. For example, our cars and homes all have sensors inside that provide real-time information that tells you the health of your car and how it is performing. This has been the holy grail in the biology and medical space industry, which is to provide that same kind of insight, and to provide real-time biochemical information that streams outside of the body so the physicians and care providers could actually make a therapeutic or clinical decision. That has been very difficult to do because the body does not like anything foreign inside of it. Any of us who has ever had a splinter would know, no matter how small it is, the body mounts a very aggressive response against it. That response is called the “foreign body response.” Without it, from an evolutionary point of view, we would not be here. That said, from the biochemical sensing point of view, it really is a tough problem that has hampered the medical diagnostics industry for a long time. We basically solved that problem. In a nutshell, what we have is a very small sliver of an inert material that we put just under the skin and provides signals on real-time biochemistry to outside of the body. We have continuous sensor data over more than two years at a time, compared to the current best in class, which is about two to seven days.


CEOCFO: What is it made of? What is the science? How is it able to monitor?

Dr. Hwang: The little sliver of material that we put under the surface of the skin, when I say little, really is very small. It is about the width of four hairs and about the length of 3 millimeters. It is placed under the skin via a normal invasive procedure like a vaccine. The material is completely bioinert, so it is safe to the body, and it is constructed in a way that encourages the body to actually not “see” it. Basically, it is able to evade the body’s surveillance system so the body grows very healthy tissue throughout that tiny sliver of material. Now all we need to do is embed on that material fluorescence chemistry, which are chemical compounds that will emit light differently depending on what body chemical is bound to it. If you want to measure oxygen or glucose, for example, that chemistry could bind oxygen specifically, and every time the oxygen is bound to it that light comes off differently. Whenever you want to interrogate or get data, it is on a reader that is a wearable device like a Band-Aid or a watch that you put on the surface of your skin.


CEOCFO: Is information acquired continuously or might you set it up to acquire every three hours or every two days?

Dr. Hwang: It depends on the use case. There are certain applications and use cases where acquiring data continuously is needed so we can interrogate that sensor and get data as frequently as once every second, once every 5 seconds, or once every minute. You can set that however you want, depending on the application. Then, there are certain applications where reading it once a day or once a week is more than enough. In those applications, you just read it whenever you want.


CEOCFO: Would the person be reading the data themselves? Would info be transmitted to a medical provider?

Dr. Hwang: Once again, it really depends on the application. I think there are certain applications such as if you are a diabetes patients and you want to monitor your real-time blood glucose level. If you are an ultra athlete during training you want to make sure that you modulate your intensity so that you get the result you want. If you are a marathon runner, you do not want to burn off all of your energy in the first part of the race. Those types of applications would be continuous and most of the user interface. That data is used by the user. On the other hand, you can imagine applications in which a patient is discharged from a hospital and they have undergone some kind of surgical event where their wounds may not heal. In those applications, the physician would like to be able to get that data so that if there is anything that has gone wrong post surgically they could ask the patient to come in for timely intervention. Once again, the system is quite flexible and really is based on the application and how it is used for these use cases to determine the performance frequency and context.


CEOCFO: Although you have proven data, is the medical community skeptical?

Dr. Hwang: The short answer is no. There is a difference between skepticism as to whether it is going to work and whether it is helpful, and skepticism as to whether or not it will make an impact. I think are two very different types of question in skepticism. I think with the former, whether the technology will work or not, a degree of skepticism is healthy. We have demonstrated and proven it, we have published papers on it, and we have applied for and have received grants that are very competitive. We provide that kind of information and data to the community, and our partners and collaborators have no skepticism around the technology or the approach. I think what we have to prove is whether or not changing the paradigm of care with some of these patient populations to go from once a year chemical information to once a month, once a week, or continuous. Providing that stream of data at that greater frequency, would that make a difference in patient care and clinical outcome? I think the hypothesis is yes, but we have to prove it. I think there is a healthy skepticism in the medical community, and we welcome that body of work. We live in a resource constrained world. We live in a bandwidth constrained world, and in the resource and bandwidth constrained world sometimes more may not be better because the question becomes when should the decision be made with that additional data? What is that decision? Whether the ability to make that decision in real-time versus waiting for another week or another month makes a drastic difference in the outcome of that particular patient or in that particular disease population. I think for certain applications the answer would be a resounding yes, because there is a big body of clinical data and evidence to support that. In certain other applications, I think the jury is out and I think we are responsible to prove that case with our clinical collaborators to actually demonstrate that post-surgical monitoring of tissue reperfusion in wound care. Having a stream of data versus the current paradigm of looking at the patient at one-month, three-month, and six-month intervals makes a difference in clinical outcomes, and I think we have to prove it. It makes sense but we have to prove it.


CEOCFO: What is Lumee?

Dr. Hwang: Lumee Oxygen Sensing System™ is our first medical product. We have been at this now since 2009, and working hard on this from 2011. Lumee really is the culmination of those efforts over the last 5 years, and it is our first product aimed at the application of real-time continuous monitoring to help the vascular interventionalist determine whether or not your tissue is getting enough oxygen. The critical application here is for wound care and wound healing in a patient population where oxygen delivery to a local area is compromised, most likely either due to trauma or due to blood vessels being clogged, so that blood is not delivering the appropriate nutrients and oxygen to that particular area. The procedure to correct this is that the surgeon will open up one or more arteries and perform balloon angioplasty, or place stents within the vessel to keep it open in order to supply the tissue with oxygenated blood. Our sensors can help guide the surgeon before, during, and after the surgery to see whether or not that procedure has taken hold and has the desired outcome the surgeon is looking for. There is a really large clinical need. Doctors today do not have a good way to measure tissue oxygen. Right now there is a little bit of guesswork that goes on. While the care is improving and we have really incredibly skilled doctors working on this very big problem, the tools just have not been available to guide their decision making in real-time. That is what our Lumee sensor is going to do. It provides real-time information on how much tissue oxygen is in a particular area. So when a doctor opens up an artery and it has the desired outcome, the surgeon has very high confidence about the artery that they just opened up did the trick and they can stop. If the artery starts to close after the surgical procedure is done, which happens in about 30% of the cases, the physician could ask the patient to come back so they can intervene before any more tissue damage is done.


CEOCFO: Is that product available or still in development?

Dr. Hwang: We expect to have regulatory approval to market the product in Europe for the Lumee Oxygen Sensing System in June. The first step of introducing that product to the market is to conduct larger scale clinical studies to generate a larger body of clinical information. Then, introduce it to physicians, and explain how to use the product, and then slowly let that effort translate to a larger patient population throughout that market. We will follow that up with the U.S. regulatory approval process later this year.


CEOCFO: What do you understand about getting attention, perhaps from your previous experiences, to allow you to get this in front of the right people because the data alone is not going to do it?

Dr. Hwang: We think about that quite a bit obviously. Fundamentally, I think the premise has to be that your product and the solution that it provides to the patient population is going to do what you say it is going to do. You have to have a body of data that actually proves it. There are approaches that other companies will take and other products will take where you get the buzz before the data, as opposed to getting the data first and let the data generate the buzz. I think the latter approach, especially in the medical community where people’s health and lives are at stake, the entire industry is setup to prevent hype from overtaking reason and patient care, and good decisions. You have to start with the data and the information, and pick an area where you truly feel like you can make a difference. In other words, it is a large population of patients that are really suffering, that if you do not do it right the outcome is catastrophic and that there is a big clinical need so you are solving a problem. Getting physician engagement to help you and partner with you to develop not just the technology, but also the use case. How do you design it? How do you implement it in your workflow so that you are additive and not distractive to their workflow, and how they take care of patients? It goes to the bandwidth-limited portion of the barrier that I talked about earlier. I think you are well on your way when you can actually do that. The rest of it is getting the word out, going to conferences and such. When you do that with a good solid body of evidence in a big problem that needs to be solved, where there is no currently good available solution and partner with doctors so that you have the direct feedback and input from the physician during product development, that when using our technology, it does not take additional time, it does not take additional mind share, it does not take their staffs time away from what they are doing, then I think the rest just comes naturally. After that, I think most of the companies, when they have problems or at least the uptake in delays creep in, where it is unexpected most of the time, is not around the data to set the requirement for regulatory approval, but in not putting enough emphasis on designing the work flow and the product in a way that does not take too much time away from the surgeon or a nurse’s day. No matter how good a product is, if you are chewing up time just to use your technology, uptake is going to be very slow.


CEOCFO: Are you looking for funding or partnerships? Do you have what you need for the moment?

Dr. Hwang: We are always looking for partners that will accelerate our journey. We have been very fortunate. In 2008-2009, when the company was founded, clearly that was a terrible time to raise money around the world because of the macroeconomic environment. So we embedded into our DNA the pursuit of grant funding from government agencies, and continue to have very good success and a track record with it. Up until now, about 50% of the financial support that we have received is from government grants and another 50% from private equity investors. We have a very robust grant pipeline. Do we have enough? The short answer is yes, we have enough to do what we do. That said, we are impatient in the right way, which is I think what we have developed as a technology could benefit a lot of people. Developing newer products, as well as getting the product into the hands of as many people as possible who can benefit from it, really is our mission. To the extent that partnerships at larger companies, partnerships with companies who have expertise, knowledge, and infrastructure that we have not developed yet, as well as raising funds to help us accelerate those technologies, we’re always not just open but actively pursuing those conversations.


“We have solved the fundamental problem that has plagued the continuous biochemical sensing industry for the last 30 to 40 years… which is to provide real-time biochemical information that streams outside of the body so the physicians and care providers could actually make a therapeutic or clinical decision.”- Ben Hwang, Ph.D.


Profusa, Inc.



Ben Hwang, Ph.D.

(415) 655-9861







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