How the first FDA-cleared cuffless blood pressure solution is paving the way to new remote monitoring technologies? – Interview with Dr. Eisenkraft, Chief Medical Officer of Biobeat

Cloud-based medical solutions for continuous non-invasive medical-grade remote monitoring lead a new chapter in healthcare by utilizing technology to enhance and significantly improve the effectiveness of patient care and make a major difference in health outcomes. We talked with Dr. Eisenkraft, Chief Medical Officer of Biobeat, a global leading bio-technology company, about their business model, the path to the development of the first FDA-cleared cuffless blood pressure solution and the future of continuous remote monitoring of patient’s vital signs area.

Connected digital health solutions – apps, wearables and tracking sensors have started a new era of healthcare with user-generated data being the core of patient-centered business models. Continuous non-invasive remote patient monitoring solutions are becoming key vehicles for significant cost savings for healthcare ecosystem by providing real-time, personalized patient data to the physicians and healthcare professionals, while helping patients stay out of the hospital and still get vital continuum of health care to prevent deterioration of a health condition. Monitoring of vital signs and other significant physiological parameters via advanced sensing and remote monitoring devices could potentially act as an early-warning digital solutions that allow healthcare providers detect, measure and record signs of a disease before a patient even feels any symptoms.

Recently, we had a chance to talk to Dr. Eisenkraft, Chief Medical Officer of Biobeat – one of the top global bio-medical technology company offering novel continuous non-invasive medical-grade remote monitoring devices. In his interview with us, Dr. Eisenkraft shares Biobeat’s business model, their global market penetration strategy and 3 use cases for their cutting-edge cloud-based medical solutions. During our discussion we also dive into the trends in the advanced medical remote monitoring space of the future, the future of hospitals and the factors that affect health insurers decision to enter a partnership with a healthcare provider.

Enjoy the interview.

Research2Guidance: As a short introduction to Biobeat, could you please share the story behind it and what is the service offering?
Dr. Eisenkraft: Biobeat is a bio-technology company, based in Israel, that has developed cutting-edge cloud-based medical solutions for continuous non-invasive accurate medical-grade monitoring of vital signs and other clinically relevant parameters. It provides end to end capabilities in a way that individuals now can be monitored, and medical care providers don’t necessarily have to be next to them.

Our team has designed and developed 2 novel medical-grade sensors / monitoring devices. The first is in the shape of a watch and the second is in the shape of a patch. Both devices play a key role in continuous care monitoring – hospital and community care, connecting home-based and hospital / medical centers.

In fact, FDA has recently granted a 510K Class II Medical Device clearance for Biobeat’s patch and watch for measurement of blood pressure, oxygenation and heart rate in hospitals, clinics, long-term care and at home, and we have also a CE mark approval, and the Israeli Ministry of Health approval as a hospital and home medical monitoring device.

Research2Guidance: What is your value proposition?
Dr. Eisenkraft: Biobeat’s watch is intended for chronically ill patients, who need to have a long-term monitoring device at home or in homecare facility. It provides real-time continuous monitoring for 3 days. After that the patient needs to recharge it for 2 hours and keep on using it.

The patch is more for in hospital or prehospital use. It is a single use up to 6 days device, at the end of the 6th day one simply discards it. The beauty of this medical device is that once it is attached to an individual’s body it starts working in a very simple way. Here again, the data is continuously monitored and transmitted in real-time to Biobeat app and to our cloud. Medical care providers, whether nurses and / or physicians, can see the data immediately upon collection.

Biobeat device can continuously monitor a list of vital signs and hemodynamic parameters including blood pressure, blood saturation, respiratory rate, heart rate, stroke volume, cardiac output, systemic vascular resistance, body temperature, steps, sweat and some more parameters. This is a non-invasive wireless wearable device. The derived data from the monitor can be transmitted continuously via e.g. Wi-Fi, BT, Cell, etc. and in real-time. It can be paired with any electronic medical records and be subjected to in-depth data analysis in order to form insights and recommendations of clinical significance to both healthcare providers and patients.

The healthcare provider doesn’t have to copy anything; everything is directly transmitted into the existing medical systems. For example, a nurse can see the information on a tablet, or in a nursing station screen. For each of the devices one can, and one should enter an alarm based on preset individuals’ parameters, so one also gets alerts once there is some discrepancy in the measurements. Within the app patients can tag when they take a specific drug. This is quite important because it allows the physician to understand after a few days / weeks, whether the treatment that has been prescribed really helps the patient or not.

Research2Guidance: I see, can you share with us some use cases?
Dr. Eisenkraft: We see several use cases here. The first is at hospitals use – the devices can be given to patients that currently have no kind of monitoring. Today, in the hospitals less than 10% of patients are being really monitored. To most of them 2 to 3 of the mentioned vital signs are taken 2-3 times a day. Like for example, blood pressure, heart rate, saturation and temperature; sometimes if the healthcare providers have the time, which most of the times they don’t, they also take the respiratory rate. With Biobeat the physician and the nurse have a continuous monitoring of all the vital signs of the patients, and everything is transmitted to the hospital system.

Another case is senior housing facilities. Most of the inhabitants of these facilities are not monitored. Once a deterioration of a health condition is determined it could be a bit too late to do something about it. Some of these people have chronic conditions or because they are elderly their health is not so stable, so, again this situation is perfect for a continuous non-invasive monitoring device. In this case we are talking about prevention and for the personnel to be able to react and intervene with the right approach when the parameters have worsened for the person.

After the hospital – connected home care is another use case. It is when a physician wants or needs to monitor a patient after being discharged from the hospital. At present, we are conducting a study in Israel. Since most of the patients stay in hospital for less than 6 days the basic idea would be when someone is feeling bad and a medic or a physician is coming to his home, the doctor can attach the patch to the patient and from that moment on the patient is being monitored. When the patient is in the hospital the data is immediately transferred to the hospital’s medical system, but the monitoring continues, and the physician can look at the data at any time and get the accurate essential measurements. Later within the 2-3 days after he is discharged home, he will still have the patch attached and he is still being monitored. The data now is transferred from the hospital to the specific HMO that the patient is related to. With Biobeat we can provide this whole continuous medical care with all the patients’ vital signs shared in real-time with the medical professionals. This could save lives and help patients have an idea of their health and have more control over the health outcomes.

Research2Guidance: What is your business model and who are your clients?
Dr. Eisenkraft: Our business model is B2B. We work with distributors that work with medical centers, HMO’s and insurance companies. Our devices are aimed at healthcare market players (medical centers, HICs, HMO’s, hospitals, etc.) that need to monitor patients either in hospitals or at home, whether because they were discharged early from hospital, are chronically ill, elderly living alone at home or patients who opt for home-hospitalization. HIC’s also have an interest to help their members to stay and be healthy. The continuous, accurate and reliable monitoring of physiological parameters outside the hospital setting in a mobile non-invasive way provided by Biobeat devices make a big positive difference in people’s lives.

As a company, strategically we have decided to channel our devices through distributors. We are looking for collaborations with them. We will provide to our partners a 24/7 support. The patient will get our devices through medical centers, HMOs or insurance companies.

The reason we are not interested in B2C market and selling directly to the patients is that most of the people don’t know exactly what to do with their vital signs data. A person needs a medical professional to look at all his parameters to understand and interpret the data and decide what should be done based on these vital signs.

Research2Guidance: Which countries are you concentrating on and why?
Dr. Eisenkraft: We are interested in the global market. Biobeat was founded in 2014 and as a medical bio-technology company, we needed to work on different regulation approvals. For any company in this space it is not enough to want to be a global market player. Regulation plays a key role to move forward.

First, we did some validation studies in Israel. So far, we have more than 10 different validation studies covering all our vital signs. At the moment, we still perform some of the studies. One should keep in mind that all the studies must be conducted taking into consideration different regulators’ demands, registrations, everything under the approval of the Institutional Review Board (IRB), etc.

We also got the CE mark certification of our vital signs’ measurements, which helped us be in Europe. We started selling our devices mainly in Scandinavia and its countries through a distributor. At present we look at different European hospitals and research institutes. Our devices present an interesting business case for these players, since for the first time one can relatively easy monitor all the vital signs that I have mentioned above for early detection of infections, all kinds of medical conditions in terms of hemodynamics and respiratory stability, etc.

In the USA we have just received FDA clearance for blood pressure, oxygenation and heart rate, as well as the transmission platform. This clearance opens huge opportunities for remote medical monitoring and now we have entered the US market in homecare centers. At present we have a pilot going on, as well as different collaborations with several governmental agencies interested in long-term monitoring. The aim is to have a better awareness of any biological emergencies and disease outbreaks using the Biobeat devices, and at the same time learning about the everyday wellness and level of stress of employees in different facilities and environments. We have a contract with an insurance company in the US and with several research agencies.

Presently, we also have entered local markets which include hospitals, HMOs and securities forces. The latter is not only in Israel, but all over the world, where the potential of monitoring casualties and even routine monitoring of security forces is of a demand.

Research2Guidance: Why did you enter first the Scandinavian markets and not Germany, when you planned your European market penetration?
Dr. Eisenkraft: Scandinavian countries were more open; we received the CE mark approval as is and after a relatively short period of experience the focus went into implementing the technology. We found that working with them was a bit faster. If we look at the German market, there are a lot of differences between their states and even though you have the CE mark approval you still have local regulations inside those states. For us as a relatively small company this is more challenging. We haven’t given up and we will work harder to cover all the requirements, but strategically first it makes sense to go where it is easier.

Research2Guidance: Can you please share some examples of partnerships that you have?
Dr. Eisenkraft: Sure. We were approached by DRIVe, a division within BARDA, one of the largest research authorities within the Department of Health and Human Services in the US. This division was looking for innovative solutions for some of the most troubling gaps they have now in public health and public security. When they saw our devices, they suggested to have a collaboration on the early detection of the flu. This year the flu seems to be quite devastating with numerous fatalities in Australia. Australia acts as a sentinel as the flu later appears within a few weeks in Europe and the US.

The DRIVe is very interested in using our devices. At present, we have 2 collaborations to monitor people’s health and understand the natural history of the flu. What is exactly happening physiologically in a person, who was exposed to the flu and starts being ill. The idea is to provide by the end of this collaboration an algorithm that will enable them the early detection of flu.

Another very interesting use case and potentially important partners are large Pharmaceutical companies. The reason is that more and more Pharma companies understand that probably in the near future regulators, especially the FDA, will demand during the clinical studies with new medications that these kinds of monitoring systems has to be used to better understand the effect of the drug on the user. Right now, we have several very nice collaborations with international Pharmaceutical companies that want to see and make sure that the drugs they make and provide, do help as they intend to. This is another very important field that we have entered.

The above example is mainly in the US market. However, there is a lot of interest in Europe too. Having in mind that most of the companies are global, I believe in the future we will have more international collaborations with all the global divisions. So far, these collaborations are mainly continental, for example in the US in several centers or in Europe in several centers.

Research2Guidance: What is the cost of the watch and the patch?
Dr. Eisenkraft: Biobeat devices enables cost-effective non-invasive monitoring solutions that can replace several other highly expensive monitoring devices. The wristwatch is currently around 1500 USD and as we move forward within the manufacturing this price will be reduced. The patch is currently worth 100 USD, but it will be reduced to about half the price once we start mass production.

Research2Guidance: Is the cost covered by the health insurance companies (HICs)?
Dr. Eisenkraft: We estimate that the cost could be covered by HICs. And we are already looking into several reimbursement codes in the US that are relevant for the use of such devices. It is similar in Europe, but we should consider the market nature there – the huge discrepancy and differences in country by country. We plan to tailor the relevant pricing and plan to each of these geographical areas.

Research2Guidance: In your opinion, how willing are health plans to offer digital preventative services and what factors affect their decision to enter a partnership with a healthcare provider?
Dr. Eisenkraft: We already see that. We have a collaboration with a health insurance company in the US and the aim of this collaboration is detecting stress among employees and not just to know that someone is in stress, but immediately intervene with the aim of helping the person to go over that, to be more relaxed and to understand what is disturbing him. This modest, but at the right time intervention could help the person stay healthier and be more productive at work. At the end the company, but also the individual will benefit from that. This is one of the major issues for the health insurance companies – to help their members be healthy and stay healthy and find a way to prevent chronic diseases.

I believe for health insurance companies it is important the solution to have some history of proven outcomes or validation studies, that clearly show how the device / digital solution helps a person to stay and be healthy. To stay engaged with the solution is also important to have a real long positive health effect.

Research2Guidance: Interesting. So, what are some of the ways that you in real-time can intervene with my stress? Will you offer me a specific meditation, or suggest a song to listen to or …?
Dr. Eisenkraft: You gave some beautiful examples. We are still working on that and definitely thinking of different options / solutions to address a certain condition. At present we don’t have a final package for that. We do have other packages like sleep laboratory and blood pressure holter that you can use at home and don’t need to go to a clinic.

In a similar way we can detect stress and based on that suggest different approaches, either go to a relevant personnel in your organization and talk to them, letting them help you with the stress situation that you are in; or use the vital signs that you can see in the application with different bio feedback maneuvers to relax yourself. Music can also be very helpful for certain individuals. So, there are so many possibilities and I guess the end product will allow the user to choose what he thinks is the best way of relaxing. The nice thing is that one gets an immediate feedback and if one sees that it doesn’t help, one can change to another way of dealing with the stress.

Have in mind that during the stress a lot of parameters are changing, e.g. blood pressure, heart rate, respiratory rate, and we can detect that. In the US the public relation we did is with blood pressure, because we are the first company that received an FDA clearance for blood pressure using this optic technique, which is very common, but we managed to upgrade it in a way that allowed us to get this clearance. We have 20 different vital signs and when you have the whole health picture you can really define the fingerprint of a specific medical condition. This could be stress, this could be an infection, this could be hypertension with maybe other vitals that are deranged. It helps to have a better understanding on what is happening in different medical conditions.

Research2Guidance: What about data privacy? Can you use the data you have gathered to have a different revenue stream in the future, for example to share it with research organizations or enter partnership for a specific study?
Dr. Eisenkraft: All these and more options are valid and on the table. The advantage of our system is that we don’t have any personal data of any of the users. We don’t have names, emails, social security numbers. We just have the serial number of the patch; the pairing to the specific patient is being done by the healthcare provider in the medical facility or at home. We don’t have any of this data. That is why we are 100% in compliance with the privacy and data protection regulation. Having such huge quantities of data will become powerful tool in the near future and probably all the different aspects you have mentioned could become relevant for us.

Research2Guidance: Who do you see as the key competitors?
Dr. Eisenkraft: We have several competitors. Biobeat team is in favor of this competition, because it drives us to be better. For example, we didn’t think about the patch originally. Our idea was to design a watch. Then we heard by different hospital representatives that they want / need a device that will be one time used with no fear of infection transmission between patients. We looked at some of the market players and understood that this is something that we should also offer. And this is how the patch came along. Competition is good.

Some of our competitors are Oxitone and Cnoga. Both companies have very nice devices, but we provide more vital signs that we monitor continuously. Our devices one can be used for a longer period, and they come also with all the system around to support. This means the application and the management system within the hospital. Despite this competition we are in a good place.

Research2Guidance: What challenges are you facing?
Dr. Eisenkraft: The main challenge is convincing the physicians and nurses that something like our devices are feasible. We have meetings in which medical professionals see how our devices work and they can’t believe it. They haven’t had something so simple that shows so many vital signs continuously, they don’t have to copy the data, and everything is transmitted into their system. I can tell you that everywhere we go, and in every meeting we have in a medical facility, the first thing we hear at the end of the meeting is “Please, leave the devices here”. Healthcare providers are enthusiastic, but on the other hand they go for it quite slowly. And this is the challenge that every new technology introduced to the healthcare market is facing. The decision process takes a lot of time. Whenever we meet with key opinion leaders that see and understand the potential of Biobeat devices there is a lot of excitement.

Research2Guidance: What trends do you see in the advanced medical remote monitoring area of the future?
Dr. Eisenkraft: I am confident that this market will keep on growing at a faster pace. The challenge is of having too many vital signs presented in numbers, so it is too much data. And I think the way to address this, and we are already doing that, is to combine advanced algorithms that will provide machine learning capabilities. In each given moment there could be huge numbers of people being monitored with our devices and we could keep gathering the data all the time. That is one of the powers of our technology. It is cloud based so no limit as to how many data points could be recorded, saved and analyzed.

I think the future goes from looking at dozens of vital signs to providing the caregivers with the bottom line – what is the condition, what you should do, what you should think of. Instead of giving 20 different vitals, we will tell the physician “he is dehydrated, or she has now stroke or is going to have a stroke”, all based on these vital signs. And that is why we are so interested in understanding the natural history of each disease, to follow it from the beginning, gather the data and keep updating our existing algorithms.

Research2Guidance: What is the future of hospitals?
Dr. Eisenkraft: I think if a patient should be admitted into the hospital, then he should be monitored, and I think Biobeat patch is the solution. You place it on the body and the patient will be monitored from that moment on. This will save a lot of costs of medical stuff taking vitals all the time in the currently relatively primitive way they do it. Based on the data that is gathered and transmitted to a patient medical record, physicians and nurses will get relevant and accurate data, not just numbers and this will become a very strong decision support tool when they have to decide on a treatment or operation or whether the patient should be discharged from the hospital.

Research2Guidance: What defines the success of a digital health solution?
Dr. Eisenkraft: I think a successful digital health solution is the one that can show and lead to a positive change / outcome on a bigger scale. And if it comes with a simplicity of use and the data is not just valid, but also it is presented in a way that physicians / nurses can do something with it and make a better-informed decision, this will be the most important thing.

Research2Guidance: What is next for Biobeat? Where do you see the company in the near future?
Dr. Eisenkraft: I think to answer this question, we first need to look at where we are now and what we have accomplished within a short period of time. As a small start-up company, we have managed to achieve a lot in less than 4 years. We have 2 different configurations, a whole system that provides end-to-end medical support and we have strong algorithms that become even stronger thanks to the data we gather all the time. The fact that we have more than 30 collaborations so far shows that even though it is difficult to enter this field, the healthcare market eco-system shows trust. We have more than one collaboration in a specific facility whether a medical center or an agency, so we build our name slowly, but surely by showing that the product is good, valid and provides things that were not available before. Biobeat team is very proud of that. Our aim is to keep moving forward.

In the near future, we plan to receive investments that will allow us to enlarge the scope of the manufacturing, to enter with our novel solutions new markets and reinforce our brand with different initiatives. In Europe we got the CE mark on all our vital signs, and we will continue to work with the FDA to clear additional parameters for our devices. Like in every bio-technology company, the team always works on the next generation, so we are working on different vitals that are currently not included in our devices. And I can tell you the road in front of us is really exciting.

Research2Guidance: Thank you for your thoughts and insights, Dr. Eisenkraft.

About Biobeat

Biobeat Technologies Ltd. is an Israeli-based technology company that has developed cutting-edge, cloud-based, continuous, wireless, non-invasive, accurate, medical-grade monitoring devices that measure and record vital signs and other physiologically relevant parameters. We have recently received FDA clearance and CE mark for our wristwatch and patch monitors. Measurements include continuous blood pressure, heart rate, saturation, respiratory rate, stroke volume, cardiac output, cardiac index, systemic vascular resistance, pulse pressure, heart rate variability, sweat, skin temperature, movement, and more. The patch also provides one lead ECG. The technology is based on reflective photoplethysmography (PPG), suitable for continuous and accurate cloud-based monitoring. Another important feature is that vital signs and parameters could be obtained even while in motion. Biobeat Technologies Ltd. fully owns the IP related to its technology. Our IP is diverse, and covers hardware design and sensor geometry, signal processing and filtration, led sensor design, and our pioneering algorithms. For more information visit: www.biobeat.cloud

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