Epistemic

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, in many cases, patients don´t have access to treatment in their home towns. They have to travel long distances do go to health centers. Treatment requires a frequency in consultations with doctors, what makes it even harder. Besides, many patients don´t have access to diagnose or treatment at all.

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 to address this issue:

• Epistemic App: an electronic diary in which the patient or caregiver can register details of seizures, medications, daily habits and medication alerts.
• 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. This can be done remotely, through Telemedicine in a health facility nearby with internet access. The app works offline, so the patient can use it anywhere. The Physician can also track the patient's evolution online, without requiring multiple travels or visits from the patient. Today we have 47,000 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 is easy to wear and adjust to the size of the head, and uses dry electrodes, which do not require the use of conductive gel

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 for diagnosis, treatment, and auto knowledge for patients living ir remote areas without specializes health professionals.

Aurora is a wearable EEG device that uses 8 dry electrodes which are already positioned in positions F7, F8, T7, T8, P7, P8, FC3 and FC4. Dry electrodes do not require the conductive paste that is usually used in EEG exams in hospitals and clinics.

It also has sensors to measure temperature, oxygenation of the blood, and heart beats.

Its format is that of a ring with and additional strap on the top of the head with a turning buckle for adjustment.

The device reads brain electrical signals, transmitting data via Bluetooth. Additionally, it features an SD card for data storage, useful if Bluetooth isn't available, particularly for lengthy exams lasting 5 to 7 days.

We conducted tests comparing the device to three different hospital EEG machines: the Gtec g.USBamp RESEARCH, Meditron Vertex sc823, and Nihon Kohden Neurofax EEG-1200. Across all tests, the signal fidelity captured by the Aurora had less noise than the others. Using known signals (sinusoidal and square waves within EEG signal ranges), we compared them with a theoretical wave. Consistently, Aurora's waveform more closely matched the theoretical one.

We have built 6 prototypes of Aurora, in different versions. We are now working on our last version, to be ready in June, that has minor electronic improvements and a more significant change in mechanics, to make it more comfortable and offer a better fixation.

The desktop app shows the signal being captured. We are enhancing it now to add visualization of the signal in the frequency domain (FFT) and a feature of seizure counting using AI. However, the basic functionality is already working.

Data from Aurora is transmitted to the health center where it can be analyzed by a specialist.

Epistemic App, accessible on Android and iOS, serves as a digital epilepsy diary. Patients or caregivers input data through a series of multiple-choice questions covering seizures (time, intensity, duration, symptoms, aura, bruises, etc.), medication (both rescue and treatment), and daily habits (menstruation, sleep, exercise, mood, bowel function, diet). Additionally, a free-text box allows insertion of relevant details. Exercise and sleep data can be automatically collected via any smartwatch brand.

Users can customize the questionnaire by eliminating question groups deemed lengthy. Moreover, they can configure multiple-choice answers for personalized queries like symptoms and aura.

It also has a medication alarm. Answers of medication intake are done directly on the notification, with no need of opening the app.

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?

  For the doctor, we built Epistemic Web, in which the physician has access to the whole history of the patient.

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 longer and 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$3.000,00.

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 follow up the adherence to treatment, the effectiveness of the medication, whether the patient has other triggers to seizures that can be treated simply by a change of habits, and, most importantly, if seizures are decreasing. The benefits not only affect patients with epilepsy, but also caregivers.

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

We are going to implement a clinical trial that will teste whether using Epistemic system in two remote cities in the state of São Paulo, Brazil, can:

The health center will be in the city of Ribeirão Preto, in partnership with Dr. Frederico Nakano, a neurologist from USP University (the most important university in Brazil). We will perform the tests in SUS, the Brazilian governmental health system. These test will start in August 2024.

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.

The use of the solutions for the purposes presented in this project is unique. 

Epistemic is dedicated to enhancing the lives of people with epilepsy through the use of technology, particularly the most vulnerable, by collaborating closely with the communities they serve. Partnering with healthcare professionals, including clinical doctors and researchers affiliated with a university, we prioritize the development of cutting-edge solutions tailored to patients' needs. Regular visits to public hospitals, such as the Hospital of Unicamp, facilitated continuous feedback loops, ensuring the Epistemic App's relevance to diagnosis and treatment. Through iterative cycles of development and adjustment based on professional and patient input, Epistemic remains committed to providing effective tools to improve epilepsy management and support those in need. We also publish relevant and verified information in our social media, in which we have around 3,500 followers.

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. The most relevant for us being The Congress on Mobile Health and Digital Technology in epilepsy. We were awarded with 11 prizes national and international. 2 international prizes in social entrepreneurship: the Cartier Women’s Initiative Awards and Fundación MAPFRE Awards for Social Innovation.

However, 2024 for us is the year we are implementing 3 parallel clinical trials with the community.

The first clinical trial was already described. It is going to be done in the SUS system (Sistema Único de Saúde) and will address costs for the health system. We will prove that Epistemic´s System brings cost reduction. This will be carried out in USP Ribeirão Preto with the lead of Dr. Frederico Nakano.

The second clinical trial is already approved by the Ethics’ Committee, and will be performed at UNICAMP, in Campinas. Prof. Dr. Ferando Cendes and Prof. Dr. Clarissa Yasuda are the medical leads. It will answer two questions:

The third clinical trial will test Epistemic App and help build our AI for the app. We have written the project, and we are waiting for the Ethicals’ Committee approval. Medical leads are Dr. Lécio Figueira and Dr. Laura Guilhoto, both professors at USP and UNIFESP respectively. These tests will follow patients that use the app continuously and are followed by neurologists every 3 months to evaluate the effectiveness of the treatment, and whether the app helps improve treatment. The test will answer the following questions:

We are working with the best health researchers in the country, and they all work for the public health system, in which the most vulnerable patients are treated.

Aurora: Incorporating the most advanced hardware, this device achieves an unprecedented level of miniaturization, maintaining high fidelity and significantly reducing noise interference compared to traditional hospital electroencephalograms. The promising results were validated by tests carried out in the laboratory with known signals and comparing results with Nihon and Gtech´s equipment, and Aurora showed to have the cleanest signal and the one most faithful to the original signal. During clinical trials we will be able to test in humans.

We have already made 6 Aurora prototypes, each one more elaborate than the last, and the next one will be the final one. The latest version will not bring as many changes as the previous ones. We have been working on version 7 for a while now and will have it reay by June 2024. Therefore, we consider we are in prototype stage.

Epistemic App/Web: The initial version of the application is available for download in the Google Play and Apple Store stores, compatible with Android and iOS systems, respectively. Furthermore, the Web platform can be accessed through our website (https://www.epistemic.com.br/physicians_home). Currently, the system works like an epilepsy diary, allowing patients to record information about their seizures, medications and daily habits. Meanwhile, doctors can view this data in an organized way through the Web platform. The system already provides several benefits for the treatment of epilepsy, and we have 3.000 active users in the last month. However, we consider we are in prototype stage of the unique in the world app with AI and Gamification.

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 47,000 downloads, but still very few paying users. Clinical Trials will help as build its artificial intelligence and make it a unique diary worldwide.

Aurora has a few more months to total completion. We can start the first phase of clinical trials only with the electronics, which should be developed by May 2024. So, it is in the prototype phase.

We will perform 3 clinical trials this year. We have some funds for the trials through government grants. However, we do not have the funds yet to pay all the health professionals that will participate in the trials. US$ 150,000 is a lot of money in Brazil and will help us go through them.

The prize would help cover certifications for Aurora, so that, after the clinical trials, it can be sold as a medical device.

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

Today we do not have a system that, combined with telemedicine, can provide diagnosis and monitoring of patients with epilepsy in remote areas anywhere in the World. And this is not just a problem for low and medium development countries. We were at the International Congress on Mobile Health and Digital Technology in Epilepsy in 2023, in Switzerland, where we heard reports about long EEG tests, which can last up to 7 days, in England. They cannot reach remote areas because technicians must go to patients' homes daily to replace disconnected electrodes and change the equipment's memory card.

The Aurora can be used for longer exams at home. It has enough storage space to keep 7 days of the patient's EEG and can be put on and off by the patient themselves (for example, at bath time).

There are three other apps in the international market: Epilepsy Journal, Helpilepsy, and Epsy. The Epistemic App is the only:

- Brazilian

- That connects with a smartwatch automatically collecting sleep and physical activity information

- Which is part of a complete system of diagnosis and treatment of epilepsy.

- And certainly, the only one that will have Artificial Intelligence to generate intelligent reports for healthcare professionals, and health tips for patients (never proposing to substitute the physician but helping in autocare).

We interact with healthcare professionals and patients throughout the development of the application. It has been heavily tested for understanding and ease of use.

The system's AI will be built throughout the App's Clinical Tests. We will have 120 patient committed to filling out the diary daily. With this data we will train our machine learning algorithm so that it can conclude about: what are the seizures triggers, whether the patient's seizure have any pattern (cyclicality), whether the medications are being effective, whether adherence to treatment is high, and finally, whether the algorithm is a good predictor of seizures. All these conclusions will be shown on Epistemic Web, in the form of a report, for doctors to further help with treatment. In the Epistemic App we will use the algorithm to give recommendations to the patient, tips like “How about you go to sleep early today, you have already been sleeping badly for 3 days”, for a patient who we know has sleep as a trigger for seizures.

There are other wearable EEGs with foreign technology on the market, such as Muse and those from Emotiv. Most of them are used for other purposes, such as sleep monitoring, meditation and gaming. And they are not certified by the FDA and ANVISA. The idea is for Aurora to be certified by ANVISA after clinical tests to be medical equipment. However, it is not a worldwide innovation by itself.

Aurora uses dry electrodes (does not use conductive paste like hospital electrodes), is easy to place, adjustable to different head sizes, and easy to clean. All of this makes the exam easier in locations without specialists.

Therefor, Epistemic System is innovative in application.

Our biggest goal is to help bring epilepsy care to more people. All impacts below are important to reach our main goal.

Impact:

• Accessibility: The introduction of a portable EEG and a mobile epilepsy monitoring application makes the technology more accessible to populations in remote areas.

• Equitable Access to Healthcare: By allowing remote monitoring and testing in remote areas, the solution promotes equitable access to healthcare, benefiting marginalized populations and remote communities in general.

• Remote Monitoring: The solution allows remote monitoring of patients' epileptic activity, which is especially important in regions where healthcare infrastructure is limited. This allows doctors and healthcare professionals to closely monitor patients' progress, even from a distance.

• Accurate Personalized Treatment: With the ability to record and analyze data in detail, Epistemic System can help in identify individual patterns. This can lead to more accurate diagnoses and more personalized treatments for patients.

• Cost Reduction: By facilitating remote monitoring the solution can contribute to reducing costs. This includes costs related to frequent doctor visits, transportation to health centers, and hospital stays. Aurora is significantly lower priced compared to traditional hospital EEGs, contributing to reduced costs associated with EEG exams.

• More precise treatment: The development of artificial intelligence for analyzing EEG data and integration with telemedicine platforms can drive advances in these areas. This includes improvements in automatic seizure detection, intelligent reporting and clinical decision-making support.

• Increased efficiency: Exams become more efficient due to the elimination of the need for extensive preparation time, in addition, doctors have quick access to all necessary data through Epistemic Web, speeding up consultations. And with “seizure counting” the doctor can report an exam in less time.

• Reduction in emergencies and hospitalizations: With more effective treatments provided by technology, patients tend to have fewer epileptic seizures, resulting in a reduction in medical emergencies and hospital admissions.

• Increase in quality of life: less seizures have a direct impact in quality of life.

• Health promotion: The combined use of EEG and the Epistemic App offers innovative, complete and low-cost tools, becoming great allies of the healthcare system in promoting the prevention and effective treatment of epilepsy.

• Increased work activity: with fewer crises, patients can return to the job market.

• Reduction in Travel: By allowing exams at home and remote monitoring, the solution can reduce the need for patients to travel to health centers, resulting in lower emissions of pollutants related to transport.

• Patient Empowerment: The ability for patients to monitor their own health through the mobile app promotes patient empowerment by allowing them to actively participate in their own care and make informed decisions about their health.

• Empowerment of Healthcare Professionals: Technology can also empower healthcare professionals by providing more accurate and up-to-date information about patients' health status, allowing for better clinical decision-making and more effective care delivery.

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.

Goals in a 1 year:

• Aurora ready and functioning: 40 final prototypes produced.
• Have our 3 clinical trials running: 250 patients using our products.
• Number of Active users of Epistemic App: 6,000.
• Number of Aurora´s in use: 20.
• Certification of Aurora in process.
• Proof of Concept in process in at least 2 Brazilian municipalities (independent of clinical trials) within SUS (public healthcare system).
• AI of Epistemic App developed and tested (not yet implemented).
• Gamification implemented.
• Translation of Epistemic App to Spanish.

Goals in 5 years:

• Clinical Trials finished, at least 6 publications with results.
• Epistemic will have reached breakeven.
• Number of Active users of Epistemic App: 200,000.
• 100 Brazilian municipalities within SUS using Epistemic System.
• ANVISA, Health Canada and FDA approvals, certification approvals in another 5 small and medium income countries
• Market presence in at least 5 countries
•  Impact measurements and goals:
  • Number of people in remote areas being cared for by Epistemic System: T>3,500.
  • Number of people in remote areas that have been inserted in the job market: M/T>20>#/span###
  • Number of people in remote areas that have reached zero seizures in the last 12 months: Z/T > 50>#/span###
  • Reduction in the travels to health centers > 40>#/span###
  • Reduction in the number emergencies and hospitalizations > 30>#/span###

The technology used for the Aurora:

• Dry electrodes made in house - 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 in remote areas.
• 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.
• Artificial Intelligence in the software to mark the times of the seizures (seizure counting) to speed up the doctor´s work in reporting the exam.
• Developed in React Native to enable migration to other operating systems. Today it is available for both Android and iOS.
• Uses AWS (Amazon Web Services) for the backend and data bases.
• Uses a questionnaire to help the patient input information easily. It also has a free text slot 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 and aura can have as answer choices only the symptoms and auras 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.

Aurora can catalyze broader impacts because it can be used for exams of other diseases.

Epistemic App:

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

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 3 groups or health professionals from the 3 best universities in Brazil: the neurology group of UNICAMP, UNIFESP and 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 5 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 increase the team and have the infrastructure of a development lab. 

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 3 women and 3 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 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 System:

• 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.
• National Health Systems: a wider population with access to diagnosis and treatment, better treatment leads to less cost of hospitalization, increase number of medical appointments with telemedicine, EEG exams with a lower cost (Aurora costs much less than conventional EEGs).

Business Model

• Individuals: can subscribe to use the app
• Private sector: 
  • Pharmaceuticals, health insurance, food specialized in ketogenic diets: they can benefit from knowing effectiveness of medications (their own or from competitors), can offer the diary as a benefit for their pool of doctors, can follow effectiveness of diets. We offer the app for a large number of users at a discount.
  • Laboratories: we offer Aurora for exams at home
• National Health Systems: this sector is our main goal since they can reach unattended remote areas. We can offer a free app for the entire population at a fixed and discounted price. Aurora is sold.

Up until now we have kept the company running well with grants and prizes we have won. Brazilian government believes in our products. It has awarded us with several grants: Grants from FAPESP (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

We have also received 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. A total of 10 prizes.

We do not currently generate enough revenues to be sustainable. Our greater bet is Government Health Services. That is where we can generate greater impact and have a greater scale. For now, we only have a few app subscribers. We have many users (Around 47.000 downloads), but only a few are payers. We don´t believe pursuing this path will lead us to sustainability.

We have started a work of contacting key stakeholders in health departments of local municipalities, pharmaceuticals, insurance companies and laboratories. We are already creating awareness.

There is also a new law for public procurement of startups. It helps public bids to be faster and easier and allows governments to hire startups for a short period of 12 months to develop proof of concept. 

We are also starting 3 clinical trials which intend to not only prove the quality and effectiveness of our system, but also prove that it can bring savings to the health system. These results will be very important to help sell to governments.