Epistemic

The specific problem within the Horizon Prize we are working to solve is “Improve the rare disease patient diagnosis journey” and “Enhance efficiencies in clinical trials and research”.

According to the WHO, about 50 million people have epilepsy in the world, a rare disease. One third of this population does not respond to drugs or surgery. Epilepsy is a global disease with an unequal distribution. 80% of the affected individuals reside in low- and middle-income countries.

Patients can get severely hurt during a seizure, which limits their activities. Patients and their families often have a significant level of stress knowing a seizure can strike. Parents report they don’t sleep well at night and that they are afraid to leave their kids alone, or at school. Kids lose friends. Adults lose jobs. They experience varying degrees of social stigma and depend on the constant help of a caregiver.

Diagnose and treatment are also difficult, and many times inaccessible. Physicians face a great lack of information for treatment. They rely heavily on patients’ or caregivers’ reports, which are often inaccurate because of the time elapsed between doctor´s appointments. Besides, many patients don´t even have access to diagnose or treatment.

Therefore, offering tools to simplify diagnose and treatment and give more autonomy to the patients is of great importance.

Epistemic has a system with three products:

• Epistemic App: an electronic diary in which the patient or caregiver can register details of seizures, medications and daily habits.
• Epistemic Web: a platform in which the doctor can see the diary information.
• Aurora: a portable and wearable electroencephalogram device that is wireless, uses dry electrodes, has high fidelity and does not require a specialist to position electrodes to perform an exam

The app is useful both in the phase of diagnosis and treatment. Physicians can follow the symptoms, and also track the effectiveness of the treatment, and, therefore, enhance the treatment faster, reducing time. The Physician can also track the patient's evolution online, without requiring multiple travels or visits from the patient. Today we have 35,000 downloads of the app.

Aurora can be used for diagnoses in remote areas, where there are no specialists to position electrodes of conventional EEG (electroencephalogram). It can also be used at home by the patient, making the exam more realistic, in the natural environment of the patient.

Finally, the app can be used to track clinical trials. It can be used to collect the data from the patient in thorough detail.

Epistemic has a system with three products:

• Aurora
• Epistemic App
• Epistemic Web

Aurora is a wearable EEG device that uses 6 dry electrodes which are already positioned in positions F7, T3, T5, F8, T4, T6. Its format is that of a tiara that is weared like a sports headphone (battery behind the head) during the day, and backwards at night.

It reads the electric signals of the brain and transmits the data via Bluetooth. It also has a SD card to store the data, in case the Bluetooth connection is not available.

We tested the device compared to 3 different hospital EEG: Gtec g.USBamp RESEARCH, Meditron Vertex sc823 and Nihon kohden neurofax eeg-1200. In all cases, the fidelity of the signal captured by the Aurora was higher. We tested with known signals (sinusoid and square waves with frequencies and amplitudes in the range of EEG signals) and compared with a theoretic wave. Every time Aurora´s was the most similar to the theoretic wave. We also tested in humans in our own lab and are starting tests in a hospital with real patients.

The desktop app shows the signal being captured. We are enhancing it now to add filters and visualization of the signal in the frequency domain (FFT).

Epistemic App is a digital diary that is available in Android and has more than 35,000 downloads. Data is inputted by the patient or caregiver through a sequence of multiple choices questions. It includes questions about a seizure (time, intensity, duration, symptoms, aura, bruises, and others), medication (both rescue mediations and treatment medications) and daily habits (menstruation, sleep, exercise, humor, bowel function, food intake). It also has a free text box to insert any relevant information. Exercise and sleep data can be collected automatically via a smartwatch from any brand.

Groups of questions can be eliminated from the questionnaire in the configuration section, in case the user finds it to long. More personalized questions such as symptoms and aura, can have its multiple choice answers configured by patient.

The app can be used for diagnosis and treatment. It can answer questions like: Are the symptoms compatible with epilepsy? What is the frequency of seizures? Is the patient following the prescribed treatment? Is the medication working? Is the number of seizures decreasing? Is the patient using too much rescue medication? Is any daily habit interfering with seizures?

The information of the app can be seen in graphs. However, for the doctor, we built Epistemic Web, which facilitates making correlations with seizures and other information collected by the app. The physician has access to the patient's data if the patient shares it. The physician can visualize the whole history of the patient, but the information is available for 30 days only. After 30 days, the patient has to share again, so we have data protection.

We are currently performing a trial with 100 patients being followed by neurologists with the objective of inserting artificial intelligence in the app. The idea is the app can make reports for the physicians and give a chance of having a seizure that day and give tips to the patient to reduce seizures with daily habits, like “exercise today, you have less seizures when you exercise”. During the trials, doctors are analyzing whether the apps forecasts, reports and tips are relevant.

The target population is patients with epilepsy, their caregivers, and neurologists treating epilepsy. Those living in less privileged countries and territories can benefit the most.

Aurora is a wearable device, easy to position and to use. It has a single on/off button, and a software that can be installed in a computer. The software is more relevant to the health professional. If the electrodes are not making contact, there is an alarm. Therefore, it can be used by non-specialists.

It can be used for diagnoses or follow-up exams in remote areas, where there are no specialists to position electrodes of conventional EEG (electroencephalogram). It can also be used at home by the patient, making the exam more realistic, in the natural environment of the patient. It is also much cheaper than a conventional EEG. Aurora is not yet in the market, but we estimate a selling price of US$1.500,00.

Hence, Aurora makes EEG exams easier and more accessible. This impacts lives tremendously because more people can be diagnosed and treated, and even in areas that do not currently offer this kind of exam.

Epistemic App is useful both in the phase of diagnosis and treatment. It´s a tracker of the patient’s evolution. At first the physician may ask the patient to fill in the diary for a certain period to make a more precise diagnosis. After, the patient should continue using it so the physician can evaluate the adherence to treatment, the effectiveness of the medication, and whether the patient has other triggers to seizures that can be treated simply by a change of habits. Today we have more than 35,000 downloads, and 3,000 active users in the last month. However, we believe this can be expanded greatly, because of the benefits it has impacting lives of not only patients with epilepsy, but also of caregivers.

Epistemic Web is where physicians access their patients’ diary history. It is configured in the form of graphs that can be zoomed or aggregated to make it easier to find correlations between sizes and medications, and seizures and habits. Thus, giving more information to the physician to enhance treatment.

Diagnosis and treatment can also be done remotely, decreasing costs, and giving access to patients in in areas not attended by a neurologist.

A better treatment results in less seizures. Patients can be more independent from their caregivers, performing tasks they don’t today because they can get hurt during a seizure. Patients and caregivers that cannot work can go back to the job market increasing the family´s income. Children that stay at home can go back to school.

Finally, the system can be used for clinical trials. It is a wonderful tracker, so it can be used to gather a great amount of information about patients during the trial.

The whole solution was developed engaging patients, caregivers, and health professionals. I detail this engagement in other questions.

We at Epistemic have the principle, value and goal of improving the quality of life of people with epilepsy, especially the most needy and vulnerable. To do this, we are guided by the ideas and agendas of the communities we serve, listening to their voices, understanding their needs and wishes, and involving them in the development and improvement of our solution. We have partnered with health professionals that are both clinical doctors and researchers. They work in public hospitals and are filiated to a university. And they have showed an interest, from the beginning, on developing the best tools with Epistemic. They have the knowledge of cutting-edge solutions for epilepsy. Furthermore, their patients are the most in need, and some of them have also cognitive problems. During the development of Epistemic App, we made a monthly visit to the Hospital of Unicamp, to check with health professionals whether the information we were gathering with the app was relevant to diagnosis and treatment, and we made several tests of usability with the different patients. We would come back to the company every time with loads of feedback, and with those we adjusted the app and went back with the new solution to the hospital again. This cycle was repeated several times.

We also participate of several events related to epilepsy such as Purple Day every year, a day to increase awareness about the disease, and several congresses, both national and international. We were awarded with 9 prizes. 2 international prizes in social entrepreneurship: the Cartier Women’s Innitiative Awards and

Fundación MAPFRE Awards for Social Innovation, and Epilepsy´s Foundation Prize. Other awards were in Brazil: Pfizer, Fundación Everis and Hospital Sírio-Libanês, Samsung Creative Statups, Inova Unicamp, Finep Mulheres Invadoras, FMUSP.

Another form of approaching the community is by calling patients with epilepsy for group marketing research in the company or over the phone. Our fist market research with thorough analysis of patients’ and caregivers’ bios was done early on, at the beginning of our project.

We have a close relationship with people with epilepsy and their caregivers through various channels: In person at events promoted by the Brazilian Epilepsy Association (ABE), through our social media pages, by whatsapp and email from the company, as well as Focus Group in person at our headquarters in São Paulo. We also act as vectors of reliable and updated information about the disease, promoting discussions about breaking stigma and prejudice though several campaigns. We want our technologies to be accessible and useful to all people who suffer from epilepsy, and that is why we are always looking for innovation and improvement of our solutions. 

We are in the phase Pilot with Epistemic App and Web. They are in the market and are wonderful products as they are. We have 35,000 downloads, but still very few paying users. We need to go through trials to build its artificial intelligence and make it a unique diary worldwide. And for that we need funds. US$ 150,000 is a lot of money in Brazil and will help us go through it.

The trials consist of 100 patients compromised in filling the app at least once a day, even in days they don´t have seizures. To understand what triggers the seizures in different patients, we need also to understand what happened in days they don´t have seizures. Each patient will have an assigned neurologist to follow up his/her treatment, at least once a month. The physician will not only treat the patient, but also evaluate conclusions taken by our system about cyclicity of seizures, triggers and daily forecast of the probability of the patient having a seizure that day. For that, we need the project to run for at least one and a half years to collect enough information to continually train the AI model. Therefore, the minimum number of consultations from neurologists will be around 1,500. The prize would cover that, and certifications for Aurora.

Aurora is in prototype phase. We have the device: electronics, mechanics and software. It was tested with great success. We are as we speak preparing the product for industrialization: building molds and adapting electronics for automatic test points. We have a small production in the company that can produce up to 1,000 devices a year, so that will be sufficient for the first lots sold. The product as it is can be sold for non-medical uses such as meditation and research, for example. However, for medical use we need to certify it in Brazil, and later in other countries. The prize would be useful to pass this phase too.

Aurora is also going through clinical trials, that will be detailed in other questions.

We also believe the prize can help us with the barrier of contacting public healthcare providers in more than on country.

Paula Gomez leads all initiatives mentioned in the question about how the team relates to communities, and she is the one to represent Epistemic in international events, such as:

• INSEAD Social Entrepreneurship Programme (Course in social entrepreneurship) (ISEP) (France)
• The Epilepsy Foundation of America annual conference (USA)
• International Congress on Mobile Devices and Seizure Detection in Epilepsy (Denmark)
• International Conference on Artificial Intelligence in Epilepsy and Neurological Disorders (USA)
• Congress of The Brazilian Institute of Neuroscience and Neurotechnology (BRAINN) (Brazil)
• The Cartier Women’s Initiative Awards (Singapore) (Social Entrepreneurship Prize)
• Fundación MAPFRE Awards for Social Innovation (Madrid) (Social Entrepreneurship Prize)

Most international congresses in epilepsy have a day dedicated to the patients. They serve as a means of education in the area, and for us participants to connect with the patients.

In Brazil we connect more deeply making part of clinical encounters, such as the Epilepsy Clinic of Hospital das Clínicas from Unicamp, and IPq (Neuropsychiatry encounter promoted by USP monthly).

Paula is a fomenter of encounters with the community within the company, and she always does meetings to take conclusions after every event.

Here I focused on each technology used to show how we create the product that has the impact I mentioned in some of the other questions.

The technology used for the Aurora:

• Dry electrodes - they improve the EEG exams because they do not use a conductive gel, which is messy, and they run through the hair, having no need of any shaving. This makes the product ideal to use at home.
• The positions of the electrodes are fixed, therefore there is no need of a specialized professional to fix the electrodes in the correct positions.
• Electrodes only capture signals, they do not apply any voltage on the patient, making it safe to the user.
• Bluetooth low energy and an internal SD Card, making storing exams easy.
• High precision analog converters, to make the signal captured by Aurora high fidelity.
• A USB-c port to recharge the battery.
• Flexible electronics to follow the contour of the product.
• Mechanics using flexible and rigid resins to increase adaptability to the head while still being comfortable.

We use all this technology to build a new and innovative product.

 Aurora can catalyze broader impacts because it can be used in other applications such as meditation, cognitive impairment, and sleep. This can catalyze other players to develop new applications using our hardware, impacting the market for mental health solutions.

Epistemic App:

• Developed in React Native to enable migration to other operating systems. Today it is available for Android, and we are working on the iOS version.
• Uses a sequence of questions to help the patient input information easily. It also has a free text to insert any information the patient sees fit and is not addressed by the questions.
• Some questions can be customized for each user. For example, the question about symptoms can have as answer choices only the symptoms that patient usually has.
• It synchronizes with any smartwatch to capture some of the information in the epilepsy journal automatically.
• Users can input information even when the app is used offline, with no wi-fi or cellular network available; a benefit that can be used in remote areas or for patients that have no internet at home.
• Has a control for medication. It gives alerts in the correct timing to take the medication through notifications, in which the patient can respond whether they have taken the medication, without the need of opening the app. In case the patient does not respond, another 2 notifications are sent to remind the patient.
• In case the patient does not want to answer all the questions, she/he can go to settings and choose the ones to keep, making the questionnaire shorter and easier to fill in.
• Artificial intelligence in development to impact even more the patient’s life.
• Gamification to encourage app usage, and to promote donations.

The app can catalyze broader impacts when used, for example, by hospitals in clinical trials.

We categorize in UN goal 3 – Good Health and Wellbeing

Our goal is to reach as many people as possible. The more people using Aurora and Epistemic App, the higher the impact in their lives. We want to help patients with epilepsy have a better quality of life, which includes increasing their knowledge about themselves, having less seizures and being better inserted into society, be it by getting a job or being able to ride a bicycle.

A year from now we want to expand and have more significant numbers of patients, expanding to Spanish speaking countries (our app today is available in Portuguese and English). Our goal is to have more than 100,000 users for the app, and to have Aurora certified having its first sales. The financial goal is to become financially viable, still with our very lean team. And finally, we aim at having Epistemic’s App in iOS (today we only have the Android version).

In the next 12 months we also plan to have developed gamification, to make inputting information in the app more fun, and to encourage inputs every day, even on those days the patient did not have a seizure. And finally, have developed an artificial intelligence so that the app can give tips that can help the patient have less seizures (tips about habits, like sleep and exercise, never about medication). This will help immensely the quality of life of patients (and caregivers). Another feature possible with the artificial intelligence is to give daily forecasts to the patient about the probability of her/him having a seizure that day. And the third one would be to make reports to the health professional through Epistemic Web.

Five years from now we aim to be present in several countries of The American and African´s continents. We should have 1.000.000 users of the app, and 2.000 units of Aurora sold yearly.

Today we don´t have a significant budget, and Aurora is not yet in the market. Therefore, for now we measure number of downloads of the app, number of users in the last three months. Besides, we analyze the journey of the patients in the app with google tools: what screens they use the most, average of inputs per user per month and others.

As we mentioned, we are at the beginning of clinical trials of the app to be able to collect information both through the patient and her/his health professionals to train a model of artificial intelligence. The first step is to evaluate the app through a standardized scale used worldwide to evaluate specifically apps with medical applications. 63 different neurologists are evaluating the app as we “speak”. The name of the scale is MARS (Mobile Application Rating Scale). So that is a measure too.

As we expand the number of users, we can also measure the results in closed communities, like:

• Average number of seizures of some closed groups of frequent users’ patients in the first year, and the same measure with the same patients one, two and three years later.
• Number of exams and medical appointments in some closed groups of a remote area before introducing Aurora and Epistemic App, and after 1, 2 or 3 years.
• Number of injuries treated in some hospitals or local clinics due to epilepsy before Aurora and Epistemic App, and one, two and three years later.

The closed groups should be, for example, a remote city, big enough to have several cases of epilepsy. Because more than 1% of the population has epilepsy (and the percentage is larger in low- and middle-income countries), the community does not have to be so big. 

Impact on patient and caregiver:

• Less people with epilepsy unattended by professional healthcare professionals
• No need to travel to distant cities
• Better quality of life
• Less seizures
• More insertion in society and labor market

Health professionals:

• No need to have EEG training to perform and electroencephalogram exam
• More information to enhance diagnosis and treatment
• Possibility of providing care in remote areas

Research

• Epistemic App as a tracker of clinical trials
• With both Aurora and Epistemic App we are building an enormous database of patients with epilepsy (several biomarkers of seizures, medication and habits) that can be used for research of triggers or medications

Other players:

• Aurora can be applied for several other uses:  exams for other diseases, monitoring for mental health diseases, monitoring for cognitive issues, meditation, and other. And this encourages third parties to develop this applications using Aurora.

This was answered in "What makes your solution innovative and sustainable?"

Our team is highly qualified. We have 7 PhDs.

The internal full-time team is composed of 4 partners and 8 staff. We have people specialized in: artificial intelligence, app development, hardware, software, mechanics, physics, marketing, sales, finance and management. We can also produce Aurora in-house for small scales.

Our part-time partnerships are primarily 2 groups or health professionals from the 2 best universities in Brazil: the neurology group of UNICAMP, and that of USP. The group is composed by neurologists, nurses, psychologists and technicians.

We also have two major contractors for design, both of Aurora and Epistemic App/Web.

In the solution presented in this application we have been working for 4 years now. At first only the partners worked on the project. We then received our first governmental grant and expanded the team to 4 partners + 2 staff. Then we started receiving prizes and more grants, which helped us finish our products. 

At Epistemic, we strive to create an inclusive and diverse environment throughout our recruitment process. Our team consists of a small group of 12 individuals, including 4 women and 2 individuals from black backgrounds. While we acknowledge that there is still a predominance of white males, we are proud to say that our distribution percentage of diversity exceeds that of the market and universities. Furthermore, we have previously welcomed members who identify as homosexual.

The leadership team is composed of two women and two men.

We make no distinction in advances in the career in the company. It is only based on performance.

Besides, it is a very jovial company, with a great atmosphere, with all being friendly to each other and collaborating.

Most importantly, we work for inclusion. We work to enhance quality of life and include patients in the society.

Value Proposition of Epistemic App and Epistemic Web:

• Patient and caregiver: achieve better quality of life, better treatment that leads to less seizures, more autonomy from caregivers, self-knowledge of the illness and triggers, change of habits to have less seizures, be seen by specialized neurologists even if they are not available within a feasible distance, make EEG exam at home, go back to the job market, do sports, ride a bicycle or drive a car.
• Physician: have much more information for a better understanding of the patient’s condition, triggers, effect of medication and adherence to treatments; see, diagnose and treat patients that live in remote regions, see results of EEG exams without the need of seeing the patient physically.
• Pharmaceuticals, health insurances and telemedicine: better treatment leads to less cost of hospitalization, clinical trial tracker, study effectiveness of medication and adherence to treatment, increase number of medical appointments with telemedicine.

Business Model: We are still experimenting business models. For now, our business model is:

• Epistemic App: all input and visualization of records up to the last 30 days are free. We have two subscriptions: PRO and VIP. With the PRO (For US$1,00/month) the user has access to the whole history of records, and with the VIP (US$2,00/month) the user can share data with physicians with no limitations. Free users pay for a one-time fee to share (US$6,00) the data.
• Epistemic Web: free
• Aurora is not in the market yet but will probably have a HAAS model.

We are now campaigning to sell to pharmaceuticals or health insurances. We have had success contacting them and having meetings, and they showed much interest. However, the corporate timing is very different from the timing of startups.

What would really help would be good to generate both more impact and revenue is to sell to public health services.

Up until now we have kept the company running well with grants and prizes and we have funds to continue for several months. But we need to start having significant revenue to become financially sustainable. To keep the same team, rent and other expenses, we need to reach revenues of around yUS$35,000.00 monthly or US$420,000,00 annually.

For that, considering only the app, we would need around 25,000 subscriptions, what would lead to around 500,000 users. This would need a considerable investment in marketing.

Public health services could benefit from the app because less people would need to be hospitalized or have emergencies. And a smaller price can be applied so it reaches more people. Reaching public health services is our next and main goal. This would help making the maximum on impacting people’s lives.

Aurora will be soon in the market. If sold, our price would be around US$1,500.00. Expenses would be greater because of costs of goods sold, so we would need to sell 50 EEGs per month. We are considering leasing the product or charging per exam. However, we have not gone in depth in this analysis to set a price and understand the number of licenses of exams needed.

We know that we will have a mix of revenues from the App and from Aurora.

We have received:

• Investment from the 4 partners
• Grants from FAPEPS (Fundação de Amparo à Pesquisa do Estado de São Paulo) and CNPq (Conselho Nacional de Desenvolvimento Científico e Tecnológico) e  and Fundep (Fundação de Desenvolvimento de Pesquisa), all  Brazilian development agencies. Total: ~US$550,000
• Prizes in money from Cartier, Epilepsy Foundation of America, Hospital Sírio Libanês e Fundação Everis (Brazilian hospital and Spanish foundation) and Samsung. Total: ~US$250,000
• We currently have revenues from 50 subscribers of the app. Total ~US$60/month (we are just at the beginning of sales)
• Interest from 4 pharmaceuticals (Aché, Torrent, Hypera, Roche), 1 laboratory (Fleury), and one from food industry (Danone) that offers ketogenic diets, used to treat epilepsy. They all showed interest in providing the VIP subscription to their network of physicians or patients. But we are still in negotiations. Big corporations have a timing very different from that of a startup.
• We plan to contact public health systems. That is our next move.
• Start sales or licensing, or hardware as a service with Aurora. We will start with non-medical uses (university research and meditation) until we have the certifications needed for medical use.