PAD the Silent Killer and How DermaVasc™ Makes a Difference

An interview with Dr. Irene Jaffee and CEOCFO Magazine

Published – October 1, 2021

CEOCFO: Dr. Jaffe, you were appointed CEO of Dermaflow, LLC in November 2010. How has the company and its vision developed under your leadership? Has there been any changes to your approach or in product development?

Dr. Jaffe: I was one of three founders of Dermaflow. We had known each other before from various entrepreneurial efforts and we all both trusted and respected each other. We all had different complementary skill sets. These encompassed areas of engineering and technology development, business acumen, business strategy, R&D, and technology management. The latter is more descriptive of myself. Dermaflow has what is known as a platform technology, which means that we have developed tools that can address many applications.

The challenge was and is selecting the application or applications that would be an ideal pick based on timeliness, existing need and gaps in the market and market readiness to adopt. This is the vision that I have evolved together with my team to where we are today. We have made some false starts but luckily before we went too far out on a limb with that, we recognized and acknowledged that, also seeing that some of the applications that we thought to target early on had a lot of value but they did not meet a strict enough litmus test. We learned over time to be more rigid with the criteria we posed in order to have the best market fit. The keyword is market fit. We cannot emphasize enough how important that is. In a way, we have come full-circle because the vascular application which we have developed which we call, DermaVasc™, which is simply taken from the name of the company Dermaflow, we took off the flow suffix and put in Vasc for vascular; had its beginnings as one of the initial targets we tested and at that time our technology, the prototypes and the market were not right to address that in the way we are doing today. It is interesting how these things evolve.

CEOCFO: Before we talk about your product offering, would you tell us about the market and need for non-invasive dermal blood flow monitoring?

Dr. Jaffe: Peripheral blood flow is known by numerous other names as well. One of the names is dermal blood flow and that is where the name of the company Dermaflow comes from. Another one is skin blood flow, another is capillary blood flow and the last one is microcirculation. They all are words that describe the same thing. We are talking about blood flow in your smallest blood vessels, your capillaries, which are located directly below your skin, only about one to three millimeters, so very close to your epidermis. This actually allows a window into measuring changes in the capillary blood flow using appropriate sensors on the skin and is totally non-invasive. The flow in the capillaries is of prime importance because it will allow the blood to reach over the trillion cells of your body and bring them oxygen and nutrients and remove the waste products. Without this the body would die. That is the importance of peripheral blood flow.

The periphery of your body and the blood flow there is the first area where changes in blood flow occur when a deterioration sets in, whether it pertains to an acute condition or a chronic condition. Therefore, being able to measure these changes in a simple and cost-effective way is paramount to maintaining your health and well-being. Many people do not realize that, they think about their larger vessels, arteries, heart attacks and the like that but they do not realize that their smallest vessels are very important. In order to assess your peripheral blood flow specifically for a certain condition or disease state, there needs to be an established correlation between the measurement of peripheral blood flow and the disease state, and that essentially is what Dermaflow is all about.

In the specific market we are addressing today, the peripheral vascular market, we look for early signs of deterioration in the blood flow in the lower limbs, which can lead to PAD (Peripheral Arterial Disease). About 50% of PAD subjects are asymptomatic, meaning they have no symptoms and there is a huge number of people that are not aware that their peripheral vascular condition is deteriorating. This is not being routinely screened nor monitored today and it needs to be. All of this is part of the Dermaflow and DermaVasc™ mission.

CEOCFO: Would you tell us about your non-invasive peripheral blood flow measurement product, the DERMAVASC™, the PERICHEK™, and the PERICHEK MULTI™? Why is peripheral blood flow measurement important? What does it indicate?

Dr. Jaffe: PAD is a silent killer of which many people that have the early manifestations of this disease are not aware at all. If PAD continues silently until the disease is full-blown or nearly full-blown, then it is much more difficult to stop the implications, which can be as severe as amputation of a limb or even death. Just to throw out a statistic which published in a conference that was in June of this year: Most individuals, especially women, are very aware of breast cancer and how that can be a real killer if not detected early, well it might be interesting to note that PAD kills three times more women in the US than breast cancer. This is a little-known fact. PAD is one of the chronic diseases that for whatever reason has not achieved the notoriety that it should, based on the importance and the implication of the disease, so that is what we are trying to remedy at DermaFlow.

Furthermore, so many prevalent chronic conditions which exist today, like high blood pressure, diabetes, obesity, high cholesterol, smoking, advanced age and inactivity all can lead to PAD. This probably encompasses ~70% of the adult US population today. Just as blood-pressure is routinely monitored today because over time the healthcare space understood the importance of that parameter and monitoring it, PAD also needs to be routinely monitored and it is not. To address this, Dermaflow has developed DermaVasc™ a method, a tool or device based on peripheral blood flow, which directly address at home, in the clinic and in the hospital, this parameter of assessing the status of your lower limbs as regard to PAD. We are especially interested in the home or the remote Over-the-Counter (OTC) market. The reason for that is that our vascular experts tell us repeatedly that by the time a person is referred to a vascular clinic, his disease is typically much more advanced. We want to detect the disease before that stage; that is the way to invoke change.

Based on the development of our proprietary PERICHEK™ sensor technology, which can measure local peripheral blood flow throughout the body including in the lower limbs, we realized that we can enhance this by adding a second technology that works together with PERICHEK™ to stimulate the blood flow in the leg artificially. By stimulating the blood flow, we are essentially teasing out changes in flow that may not be seen otherwise. Thus, allowing us to be even more accurate in looking at changes in the peripheral blood flow which can then be related to the beginning of PAD disease, as PAD is typically a disease of the insufficiency of circulation in your lower limbs.  

CEOCFO: Is there an age that this is more prevalent?

Dr. Jaffe: Yes there is. The probability of having PAD as you age increases sharply.

There are a number of chronic conditions referred to earlier, however, that can lead to PAD at earlier ages.

Who has these chronic conditions?   If you look broadly, it is about 70% of the adult population today in the US and elsewhere as well. That is a huge percentage of the population.

CEOCFO: Why non-invasive? Why is that important?

Dr. Jaffe: Non-invasive is extremely important especially if you wish to have your device operating from the home by non-professionals. It makes it so much easier not only for the caregiver or the user, but it also allows for an easier and quicker implementation into the market with lower cost and less regulatory burden and that today is a prime factor. If you have an innovation that can truly address gaps in the market, you want to be out there as soon as you can.

CEOCFO: How does your product differ from what is in use today?

Dr. Jaffe: Lower limb circulation issues are measured in the clinic today by a variety of different devices and technology, foremost of which is known as ABI (Ankle-Brachial Index). It measures blood pressure differences between the upper body and the lower body with the help of a cuff, very similar to the blood-pressure cuffs that we are all so familiar with today. The technique has been around for decades, although obviously improved over time. It is still considered a type of gold standard but it has many problematic issues and limitations. ABI, nor the other relevant clinical tools mentioned are NOT being used today to screen broadly for PAD, nor would they be suitable for home use, and that is the key to fully and comprehensively addressing this chronic disease.

As we see it the bigger issue is early detection both in the home and in primary care physician offices. We regularly attend and sit on patient panels. Currently many of them are virtual. We talk to patients throughout the world but mostly in the US and Europe. We hear from the PAD patients and we hear their stories. They relate to us that had they had such a tool as DermaVasc™, long before they were actually diagnosed with PAD, a tool that would have indicated and alerted them in a much earlier time- frame, they believe they would have been in a far better place today. DermaVasc™ would have allowed them to take measures and lifestyle changes to improve their conditions as early as possible.

This is the space where DermaVasc™ differs. It will address home monitoring for all those that are high-risk that are not aware of their PAD disease state. As I previously mentioned, probably 70% of adults in the US fall into this category. It will also allow those that are already diagnosed with PAD, tools to monitor their disease at home and gauge how changes in their lifestyle especially exercise and diet are influencing their lower limb vascular status. It will give them an incentive to do better which many of them today claim they do not have an incentive, or they do not have anything that shows them that by changing something, they can do better. It also includes PAD patients that have had interventions like stents put into their arteries. Inevitably, stents have to be replaced but you can help yourself in the meanwhile by doing exercise and eating healthy. DermaVasc™ is a tool to span home and clinical use and facilitate a paradigm shift in the way PAD is being handled and managed in the US and elsewhere. That is our belief.

CEOCFO: Is there a difference in your products depending on the settings, whether it be hospitals in-patient, out-patient or home?

Dr. Jaffe: We are placing a lot of initial emphasis on home products, for reasons that I have already mentioned. We are adamant to catch early disease state before anyone has to go to a hospital clinic. What we believe is also an advantage, is that the technological concept behind all of our products whether at home or in the clinic is really the same. The difference is maybe as far as a few features or the way the software will portray results, whether at home or in the clinic.

Obviously at home, you want to make it easier for the nonprofessional. In the clinic, you are dealing with physicians so you can make it a bit more technical. These product differences whether for home or clinic will follow over to cost for the different settings, so clearly the most inexpensive products will be for the home and we are working hard to make those products that can also be bought out-of-pocket if need be because not everyone has the proper insurance. The more expensive but still not expensive products will be for the clinic and the hospital.

CEOCFO: Is the in-home product easy to use if you are an elderly person?

Dr. Jaffe: We are taking that into consideration, so the way we envisioned our at-home product is that there will be a simple what we call the ‘traffic light indication.’ There will probably be two forms but one form will be visual so anybody no matter their age will be able to follow whether there is a green light lit up, yellow, or red. Those lights will conform to simple indications like, for example: your legs are looking good or you might want to think about some lifestyle changes or perhaps you should be going for a check-up at the doctor.

For those who wish to see a more sophisticated portrayal or result, there will be Bluetooth connection to smart devices such as your phone, cell phone, or tablet and you will be able to see it that way. Eventually with the clinical products, there will be a way to transfer that data via the cloud where at least your primary care physician can take a look at your measurements as well. Initially as to your point, ease-of-use, we are looking at visual type of traffic light indication for our elderly and perhaps less technologically efficient users.

CEOCFO: Where are you in the process; still in development or with products on the market?

Dr. Jaffe: We are not on the market. We do have advanced prototypes and we also are currently in discussions with three different partners regarding final development manufacturing and commercialization. We are hoping initially to be in the OTC market and eventually in the clinic as well.

CEOCFO: Are you fully funded for your growth in product development and commercialization or looking for investors and partners?

Dr. Jaffe: Dermaflow is considered an early-stage pre-revenue company because we do not yet have our products on the market and we are not yet selling them. In order to facilitate our commercialization plan for the OTCs, the over-the-counter home products and eventually setting the stage for a follow-on clinical product we do need further investment. We believe part of this will come from collaborating with corporate partners with whom we are already engaging but further investment will be needed to get our products into the market and change the current paradigm for PAD, which is still tremendously underserved. We welcome hearing from angel investors or syndicated angel groups, family offices, early-stage VCs and other appropriate private equity venues who believe that healthcare innovation is a priority.

CEOCFO: Why is the success of Dermaflow important to patient health and an important company to watch?

Dr. Jaffe: Dermaflow was founded in order to utilize measurements of peripheral blood flow and early detection for a broad platform of chronic and acute diseases and conditions. Early detection may allow for disease prevention or at the very least for not allowing further deterioration, which could greatly impact quality of life and even lead in some cases to early death.

COVID had been instrumental in showing how important home health monitoring is. It can be implemented easily and can become part of our daily lives to vastly improve our health. This is what Dermaflow with DermaVasc™ is poised to accomplish with lower limb circulation and vascular health. We together with our vascular exports see clearly the wide breadth of advantages for the consumers, the patients, and the health system as a whole.