BrainCapture's BC-1 Solution

Epilepsy is a neurological disorder in which brain activity becomes abnormal, causing seizures or periods of unusual behaviour, sensations and sometimes loss of awareness. It is the most common neurological disorder, affecting more than 50 million people worldwide and contributing to 1% of the global disease burden. Nearly 80% of people living with epilepsy (PLWE) live in low-and-middle-income countries (LMICs) (WHO, 2022). This unequal distribution is partly explained by risk factors like perinatal injury, head trauma, tropical diseases and central nervous system infections, which are common in low-income regions (Muhigwa et al., 2020). These risks are further exacerbated in rural areas (Matuja et al., 2001).

While epilepsy can occur at any age, it disproportionately affects children under the age of 10. Globally, the age-standardized prevalence of active epilepsy shows a peak in the 5-9 age demographic, with approximately 374.8 [280.1-490.0] cases per 100,000 children. Additionally, children account for the most severe form of epilepsy and the majority of epilepsy-related fatalities, with years lived with disability (YLD) peaking in the 5-9 age demographic, and years of life (YLL) lost due to epilepsy peaking in the under 5 demographic (GBD Epilepsy Collaborators, 2016).

While numerous studies have indicated that neurological disorders are on the rise in LMICs, there is still a deficit in comprehensive and up-to-date data on the true epidemiological burden and impact of these conditions for countries like Kenya. A review of 35 studies published between 2003-2018 estimated the prevalence of lifetime epilepsy in children (0-17 years) in Kenya to be 21-41 per 1,000 (Samia et al., 2019). Another publication reported the crude prevalence of lifetime epilepsy, including adults, to be as high as 31 per 1,000 in one heavy-burden region (Kariuki et al., 2021). Due to factors like social stigma, inconsistencies in diagnostic criteria and fragmented data collection, the above estimates may underreport the true scale of the problem.

According to the World Health Organization (WHO), 70% of PLWE could live seizure-free if properly diagnosed and treated with accessible and affordable anti-seizure medication. Early diagnosis and treatment of epilepsy has a pronounced effect on improving quality of life and reducing the risk of premature death among PLWE (Steenkiste et al., 2019). Moreover, epilepsy frequently develops in childhood, where diagnosis delivers even more significant benefits as treatment allows a seizure-free childhood and adolescence, leading to more positive learning and social-engagement experiences.

The diagnosis and management of epilepsy can be particularly challenging in low-resource settings, where access to specialized healthcare is limited and gold standard diagnostic equipment like electroencephalogram (EEG) machines are prohibitively expensive. Even when equipment is available, there are very few qualified EEG technologists to operate it and even fewer neurologists to interpret EEG recordings. Kenya for instance has an estimated 24 neurologists, most of whom are based in urban settings, serving a population of more than 53 million (Myer et al., 2016). As a result of these barriers, PLWE in LMICs often receive delayed or inaccurate diagnoses, which can have serious consequences for patients and their families.

BrainCapture has developed an affordable diagnostic solution (BC-1) that enables portable, medical-grade EEG-based diagnoses without a neurologist or EEG technician onsite. The BC-1 consists of:

• a CE marked, low-cost device for capturing EEG recordings, consisting of an amplifier and electrode cap;
• a proprietary smartphone application that can guide a non-expert to perform a medical-grade EEG recordings; and
• a cloud-based telemedicine solution that allows secure transfer of patient data to be read by a remote expert and relayed back to the clinicians at the point of care.

BrainCapture’s approach to EEG can massively increase the availability of epilepsy diagnosis globally by re-engineering the EEG diagnostic for easy adoption by the facilities that bring healthcare to the majority of the people on the planet. With a unique combination of hardware, software, AI tools and remote diagnostic services, our solution offers several benefits over the existing standard-of-care:

Affordability: The BC-1 device is priced significantly lower than traditional EEG machines, making it financially accessible for health systems in LMICs. Our main competitors include EEG equipment from traditional manufacturers like Nihon Kohden, Cadwell and GE Healthcare. These cost $20,000-$35,000 per machine, compared to $5,000 for the BC-1. Moreover, health facilities must hire qualified EEG technologists to handle conventional EEG equipment, significantly increasing their operational costs.

Portability and Simplicity: Designed for use in remote settings, the BC-1 is portable, battery-operated and engineered for durability. This ensures that it remains functional and reliable even in the harshest of environments, reducing the burden of frequent repairs and specialized handling.

Ease of Use: The BC-1 circumvents the need for a specialized on-siteEEG technologist. Our studies confirm that non-specialists can successfully generate high quality EEG recordings after minimal training.

Cloud-Based Telemedicine Platform: Our solution includes a telemedicine platform that allows for remote diagnosis and management by specialists, mitigating the issue of sparse neurological expertise. Our hub-and-spoke model significantly enhances the solution's scalability, enabling rapid expansion and integration into diverse healthcare settings.

Diagnostic Accuracy and Reliability Powered by Artificial Intelligence: BrainCapture is actively working on integrating advanced AI models to analyse EEG data, making it possible to deliver consistent and dependable precision diagnostics in settings lacking specialized neurological expertise.

Rapid Turnaround of Diagnostic Results: The BC-1 provides rapid turnaround of diagnostic results (within 2 hours), which is crucial for timely medical intervention and improved patient outcomes, especially in emergency and acute care scenarios. 

How it works:

Setup and Recording: A healthcare worker places the electrode cap on the patient’s head. The BC-1 device, connected to the cap, amplifies and records the electrical activity of the brain.

Data Transmission: Via a proprietary smart phone app, the recorded EEG data is sent to a cloud-based remote server where it can be accessed by specialists.

Analysis and Diagnosis: Specialists analyze the EEG data to identify patterns that may indicate neurological abnormalities. 

Feedback and Reporting: The diagnosis and suggested treatment protocols are sent back to the local healthcare provider via the same cloud platform.

Learn more about the BC-1 from our product video.

Target Population

The BC-1 solution is designed to serve populations in LMICs where the burden of epilepsy is high and healthcare resources, particularly for neurological care, are severely limited. To date, the BC-1 has been successfully deployed in Kenya, and it will soon be launched in the Philippines and Indonesia (by Q3 2024). We have plans of expanding to 35 countries by 2030, with the goal of reaching all segments of PLWE, regardless of their age, gender or socioeconomic status.

The population segment that will benefit the most from the BC-1 is children, as epilepsy disproportionately affects this demographic. Globally, we have the opportunity to serve an estimated 300-375 patients per 100,000 children in the 5-9 age group alone (GBD Epilepsy Collaborators, 2016). This amounts to hundreds of thousands of children for a high-burden country like Kenya with more than 20 million children under the age of 14. Similarly, the Philippines has a significant burden of epilepsy, with approximately 1 million Filipinos living with epilepsy and only 20 epileptologists in the whole country (Moalong et al., 2020).

These patients are currently underserved due to the following barriers:

• Neurological specialists are rare and often concentrated in more developed urban settings, leaving a significant portion of neurological patients undiagnosed or misdiagnosed. 
• Conventional EEG machines are expensive and require substantial initial investment and maintenance costs, making them unaffordable for many hospitals and clinics in these regions. 
• There is a significant shortage of trained healthcare professionals who can perform and interpret EEGs, which limits the capacity for neurological diagnostics.
• The physical distance from healthcare facilities that do offer neurological services can be a significant barrier, requiring patients to travel long distances for diagnosis and treatment.

The BC-1 will address these needs in the following ways:

• Improving Accessibility: The portability and ease of use of the BC-1  allow it to be deployed in remote and rural healthcare settings where traditional EEG services are unavailable. This capability significantly expands access to neurological diagnostics for millions of patients.
• Reducing Costs: By offering the BC-1 at a fraction of the cost of traditional EEG machines, our solution makes neurological diagnostic tools accessible to a broader range of healthcare facilities. This affordability also extends to lower operational costs, as the device does not require highly specialized personnel for its operation.
• Training and Empowerment: The BC-1 comes with comprehensive training programs designed for non-specialists. This approach empowers local healthcare workers at all levels of healthcare to perform EEG tests, thereby decentralizing and democratizing access to essential neurological diagnostics.
• Facilitating Continuity of Care: The BC-1 telemedicine platform allows for continuous remote monitoring and consultation, ensuring that patients receive ongoing care and management without the need for frequent travel.

Impact on Lives

The BC-1 device will directly and meaningfully improve the lives of PLWE by enhancing their access to accurate neurological diagnostics and treatment. This will ultimately contribute to reducing the morbidity and mortality associated with epilepsy, as well as alleviating the economical and emotional strain on patients and their families. 

BrainCapture is deeply ingrained in the communities it serves. Our approach to advancing neurological care is participatory, involving local communities in the implementation of our projects. This not only ensures cultural sensitivity but also contributes to the long-term success and sustainability of our solution. Our commitment to community engagement sets us apart from other innovators in this space, fostering a sense of ownership and trust among those who benefit from our services.

One of BrainCapture’s co-founders, Dr. Farrah Mateen, is a senior neurologist with over a decade of experience implementing innovative neurological solutions and building capacity for neurological care in low-resource settings including Guinea-Conakry, Tanzania and Bhutan. Other key team members, including our Chief Commercial Officer, Business Development Manager and Lead EEG Technologist either hail from or have extensive experience working in Kenya, underscoring our commitment to the local context and ensuring agility in addressing the needs of our target market.

In our mission to democratize neurological care, we acknowledge the diversity of the regions we operate in. BrainCapture aims to adapt its services to local cultures and languages, ensuring that our technology is not just accessible but also resonates with the communities we serve. The planned integration of local languages like Swahili and Tagalog in our smartphone application is just one example of our commitment to inclusion. 

Moreover, our EEG technologists and customer support staff are recruited locally, which aligns with our mission of capacity building and ensures more effective and timely communication with our end-users. We maintain a continuous feedback loop with our customers and technical team to provide adequate support and proactively address any technical or usability issues that might arise.

Additionally, we collaborate closely with local stakeholders, including healthcare professionals, community leaders and patients, to co-create solutions that are contextually relevant and responsive to community needs. For instance, we have several ongoing applications with the Centre for Infectious Disease Research in Zambia, aimed at acquiring funding that will enable us to adapt the BC-1 to neonates, with a focus on enhancing the diagnosis of hypoxic ischemic encephalopathy, a neurological condition which poses a significant burden to newborns in this setting. We also have an IRB-approved clinical study, involving 200 patients, that will be implemented by the Aga Khan University Hospital in Nairobi, Kenya some time in Q3 2024. Finally, we have an ongoing market feasibility study with Buena Suerte, a local medical equipment distributor in the Philippines, that is scheduled to conclude in October 2024. 

In our pursuit to integrate AI capabilities into the BC-1, we are committed to ensuring that our approach to model design and implementation is community-centered. By actively engaging with and leveraging the diverse datasets extracted from local communities, we will be able to develop AI models that are fine-tuned to the specific health profiles and epidemiological trends of the communities we serve. This data integration strategy will also ensure that our AI algorithms are not only technically robust but also culturally and contextually appropriate, increasing the efficacy of our technology.

BrainCapture has successfully completed many concrete steps towards launching and growing the BC-1 solution:

• The company was legally incorporated in Denmark in 2019 and licensed to operate in Kenya in 2022.
• We have a fully functioning, CE-marked device that meets all medical standards and has undergone successful testing by both experts (for recording readability) and non-experts (for usability).
• We are compliant with all regulatory requirements and have obtained a certificate of ISO 13485:2016 compliance from a notified body, as well as marketing authorization from the Kenya Pharmacy and Poisons Board.
• We have ongoing applications for market authorization in Indonesia and the Philippines. We also have an ongoing market feasibility study in the Philippines, and have completed other pilot studies, including one in the United Arab Emirates. 
• We have engaged a manufacturer in Poland capable of producing the BC-1 hardware at scale, our pilot batch, consisting of our first 50 BC-1 units was delivered in November 2023.
• In 2020, our team secured a €1M grant from Eurostars followed by a €2M Accelerator Grant from the European Innovation Council (EIC) in 2021. The EIC grant includes an additional €3.5M equity investment component that matches qualified investors. Alongside these substantial grants, we have garnered several smaller grants, including a $50,000 award from the Epilepsy Foundation in 2023.
• We have a patent pending on our approach to an automated recording quality software tool that will inform a user of the quality of a recording in real time.
• We have over 160 medical facilities in five countries under LOI and are in discussions with 3+ distributors representing many more markets.
• Since launching in Kenya in late 2023, we have installed 10 BC-1 devices at healthcare facilities, trained more than 50 healthcare staff to perform EEG testing and are currently generating 100-120 neuro diagnostic results per month.

BrainCapture is applying to MIT Solve because we recognize the unique platform it provides for collaboration, mentorship and access to a diverse network of experts and leaders across various fields. While funding is essential, our primary goal in applying to Solve is to leverage the expansive ecosystem of partners, resources and opportunities that can propel the BC-1 solution to greater heights and broader implementation. The visibility gained from the accelerator will also further spotlight our mission. BrainCapture is eager to contribute to and grow within this vibrant community, driving forward our shared goals of innovation and social impact.

The main areas of support we aim to obtain through our participation in the MIT Solve Challenge are:

• Technical Enhancement and Scalability: While our device is currently effective, we seek to continuously improve its technical capabilities and scalability. Solve can connect us with technology partners and academic institutions that can provide expertise and collaboration in areas such as AI, cloud computing and hardware optimization. These connections will increase our capacity to evolve the BC-1’s functionality, ensuring it can be scaled sustainably.
• Market Access and Expansion: Expanding into new markets within LMICs presents a complex array of regulatory, logistical and market penetration challenges. Through Solve, we hope to gain insights and support from other innovators and businesses who have successfully navigated similar challenges. This support could include mentorship on navigating regulatory environments, forming strategic partnerships and tailoring marketing strategies to diverse populations.
• Legal and Regulatory Navigation: As we expand, understanding and complying with the varied legal and healthcare regulations in different countries is a significant challenge. Solve’s network of regulatory experts and global innovators can provide guidance and share best practices, helping us streamline our entry and operation in new markets while maintaining compliance.
• Cultural Sensitivity and Localization: Ensuring our solution is culturally sensitive and appropriately localized is crucial for its success in diverse settings. We anticipate that Solve’s global community will offer valuable perspectives and advice on cultural adaptation, helping us refine our approach to training, community engagement and overall solution deployment.
• Sustainability and Impact Measurement: To ensure the long-term sustainability of our project, we seek guidance on establishing robust impact measurement frameworks and sustainability models. Solve’s resources in these areas can help us articulate, measure and communicate the impact of our solution more effectively to stakeholders and funders.

The BC-1 solution is innovative in several key aspects that align with user needs in our target communities:

Affordability and Accessibility: The BC-1 device is cost-effective, priced at only $5,000, compared to the $20,000-$35,000 range for conventional EEG machines offered by leading competitors such as Nihon Kohden and GE Healthcare. This dramatic reduction in cost makes the BC-1 accessible to health systems in LMICs with a high burden of neurological disorders, addressing the critical financial barriers that these regions face.

Simplicity and Portability: Designed for remote and resource-constrained settings, the BC-1 is portable and battery-operated, capable of performing 30 EEG recordings on a single charge. Its robust design is suitable for challenging environments, ensuring reliability where other medical devices may fail.

Ease of Use: The device can be operated by non-specialists after minimal training, which is a significant shift from the norm where EEG operations require specialized neurotechnologists. This feature is particularly crucial in regions where highly trained medical specialists are rare.

Scalability through Cloud-Based Services: By leveraging smartphone technology and a cloud-based telemedicine platform, the BC-1 enables remote EEG monitoring and consultation, overcoming barriers of distance and neurological expertise in resource-limited settings.

Rapid Turnaround of Diagnostic Results: BrainCapture ensures swift interpretation of EEG recordings by offering dedicated EEG readers, who deliver results with optimal speed and efficiency, typically within a turnaround time of just 2 hours. This is particularly essential in acute and emergency situations.

Pricing Strategy: A per-test fee of approximately $25 USD covers our remote diagnostic services. This fee structure significantly undercuts the average rate of $40 (6,000 KES) charged for an onsite EEG technologist in Kenya. In a commitment to accessibility, we employ a sliding scale strategy, tailoring fees to suit diverse market conditions. For instance, in more economically developed regions like Manila, Nairobi and Nakuru, slightly higher rates will apply. These adjusted fees in relatively affluent areas serve to subsidize costs for underserved regions such as Kilifi in Kenya and Bayugan in the Philippines, ensuring equitable access to our services across all communities.

Diverse Use Cases: While our primary target for the BC-1 is epilepsy diagnosis and monitoring, the versatility of EEG technology extends far beyond this singular application. EEG has proven invaluable in the investigation and diagnosis of a wide spectrum of neurological disorders, including stroke, traumatic brain injury, migraines, cerebral palsy, Alzheimer's disease and other dementias. Recognizing the multifaceted capabilities of EEG, we intend to leverage the BC-1 technology to address a broad range of neurological conditions, thereby maximizing its impact on improving healthcare outcomes in underserved communities.

Integration of Artificial Intelligence (AI) Models: Planned enhancements to the BC-1 include the integration of AI algorithms, which will revolutionize the diagnostic process by providing real-time feedback to operators and streamlining interpretation. By harnessing AI capabilities, the BC-1 can significantly improve the efficiency and accuracy of neurodiagnostic procedures, empowering healthcare workers with advanced tools for early detection and intervention. 

BrainCapture’s theory of change outlines a clear pathway from specific activities to desired outcomes, supported by empirical evidence and data from initial deployments. This framework not only demonstrates the potential impact of the BC-1 on improving neurological care in LMICs but also highlights the sustainable change it can bring to healthcare systems in these regions.

Key Activities and Inputs

• Deployment of the BC-1: Introducing an affordable, portable and easy-to-use EEG device tailored for low-resource settings.
• Training Local Healthcare Workers: Providing comprehensive training programs to enable non-specialists to operate the BC-1 effectively.
• Remote Diagnosis through a Cloud-Based Telemedicine Platform: Leveraging smartphone technology and a telemedicine platform to transmit EEG data and connect local healthcare providers with specialists for remote diagnostics and ongoing patient management.
• Integration of AI: Enhancing diagnostic accuracy and enabling real-time feedback through advanced AI algorithms.

Immediate Outputs

• Increased Access to Neurological Diagnostics: By deploying the BC-1 in remote and underserved communities, more individuals have access to essential neurological assessments.
• Empowerment of Local Health Workers: With training and technology, local health workers are equipped to perform neurological diagnostics independently, reducing reliance on scarce neurological specialists.
• EEG Datasets: Collection and harmonization of EEG data for diagnosis and monitoring of neurological disorders.
• Improved Diagnostic Accuracy and Speed: AI integrations and cloud-based analyses provide quick and accurate diagnostics, facilitating timely medical interventions.

Longer-Term Outcomes

• Reduction in the Treatment Gap for Neurological Conditions: With better access to diagnostics, more individuals receive timely and appropriate treatments, potentially reducing the prevalence and severity of untreated neurological disorders.
• Improved Patient Outcomes: Prevention of complications, disabilities and fatalities associated with untreated neurological conditions.
• Capacity Building in Local Healthcare Systems: Training and empowering local healthcare workers create a more robust healthcare system, enhancing overall medical care capacities.
• Economic and Emotional Well-being: As individuals receive correct and timely diagnoses and treatments, this reduces the overall economical and emotional strain to them and their families.

Evidence Supporting Links

• Research on Diagnostic Accessibility: Numerous studies from entities like the World Health Organization and the Global Burden of Disease Collaborators highlight the disparity in access to neurological diagnostics in LMICs and its impact on health outcomes. By providing an affordable and easy-to-use device, BrainCapture addresses this critical barrier.
• Pilot Project Outcomes: Initial deployments of the BC-1 device have shown increased diagnostic rates. For example, pilot programs in Kenya demonstrated that local health workers could effectively use the BC-1 after minimal training, resulting in a significant increase in patients screened for epilepsy and other neurological conditions.
• AI Efficacy Studies: Research on AI in medical diagnostics has shown that AI can significantly enhance the accuracy of diagnostic tools, reducing human error and improving patient outcomes. Our initial tests with the BC-1 device confirm that AI integration has the potential to increase readability and reduce false negatives and positives in EEG readings.
• Feedback from Local Healthcare Providers: Interviews and continuous feedback from users of the BC-1 device has provided qualitative evidence that the technology is both effective and valued in the target communities.

Impact Goals

• Increase Access to Neurological Care: Significantly enhance access to accurate and timely neurological diagnostics for at least 1 million people in low-and-middle-income countries by 2028.
• Improve Neurological Health Outcomes: Reduce the incidence and severity of untreated neurological symptoms, such as epilepsy seizures, by 30% in the communities served over the next 5 years.
• Improve Quality of Life: Enhance the overall well-being and daily functioning of individuals with neurological disorders and their caregivers by alleviating symptoms, reducing treatment burden and promoting social inclusion and participation in community life.
• Strengthen Local Healthcare Systems: Build the capacity of at least 2,500 healthcare facilities by providing the technology and training needed to conduct and interpret EEGs autonomously.
• Cost Reduction: Reduce the economic burden associated with epilepsy by decreasing the number of unnecessary hospital visits and optimizing treatment plans. Patients will be able to minimize costs associated with delayed and ineffective treatment, such as travel expenses for medical referrals and lost wages.
• Job Creation: Central to our scaling plans is the recruitment of local EEG technologists to provide remote diagnostic services. This will not only enhance our capacity to serve more patients but also contribute to job creation within the healthcare sector. 

Measuring Progress Towards Impact Goals

• Number of BC-1 Devices Deployed: Tracks the distribution and operational status of BC-1 devices in target regions, serving as a direct indicator of increased access to diagnostic tools.
• Number of EEGs Performed: Measures the utilization rate of deployed devices, providing data on how many individuals are receiving neurological assessments due to the availability of the BC-1.
• Diagnostic Accuracy and Patient Outcomes: Compares baseline health data before BC-1 deployment to post-intervention outcomes, assessing improvements in diagnosis accuracy and subsequent health outcomes, including reduced frequency and severity of seizures, improved cognitive and emotional development in children, and reduced morbidity and mortality from neurological conditions.
• Quality of Life Assessment: Utilizes standardized scales such as the Quality of Life in Epilepsy (QOLIE-31) to quantitatively measure physical, mental and social well-being.
• Caregiver Burden Scale: Utilizes validated instruments such as the Zarit Burden Interview (ZBI) to assess the impact of caring for individuals with neurological disorders on caregivers' emotional, social and physical well-being.
• Healthcare Worker Training and Capability: Quantifies the number of healthcare workers trained to use the BC-1 device and evaluates their proficiency levels over time, indicating capacity building within local healthcare systems.
• User Satisfaction: Utilizes surveys and feedback mechanisms, including net promoter score, to assess the satisfaction levels of both patients and healthcare providers with the BC-1 technology, impacting the solution’s acceptance and sustained use.
• Community Health Impact: Monitors broader health metrics within the community, such as the rate of hospital admissions for neurological issues and the average time to diagnosis of neurological conditions, reflecting the overall health impact of the solution. 
• Incremental Cost-Effectiveness Ratio: Compares the cost of deploying the BC-1 solution against the cost of deploying traditional EEG equipment, considering the additional health benefits gained, such as the number of avoided hospital admissions or improved diagnostic accuracy.

The BC-1 is powered by innovative EEG (electroencephalography) technology combined with telemedicine infrastructure. EEG is a non-invasive technique that records electrical activity in the brain, providing valuable insights into neurological health.

Hardware

The BC-1 hardware consists of a robust and portable amplifier, capable of connecting to electrode caps of various sizes for infant, paediatric and adult patients. In addition to its small size, the amplifier has a rechargeable battery, enabling easy deployment of the technology in settings with space constraints and unstable power supply.

EEG signals are gathered by the electrode cap and transmitted via the amplifier to a smartphone application. The smartphone app is connected to the amplifier by Bluetooth and relays EEG signals to the cloud for remote interpretation.

Software

The BC-1 utilizes a smartphone app that serves as a user interface for operating the device and transmitting EEG data to a cloud-based platform. The app is designed to guide non-specialized healthcare staff through the electrode placement process and signal quality checks, ensuring high-quality EEG recordings. This allows operators with only basic training to be able to use BC-1, making the device’s use in remote settings with critical healthcare staff shortages possible.

At the end of the EEG testing session, the smartphone app transmits EEG data to a cloud-based platform, where it can be accessed for remote analysis.

Telemedicine Platform

An integral part of the BC-1 solution is its cloud-based telemedicine platform, which facilitates:

• Remote Diagnosis: EEG data captured by the device is uploaded to the cloud, where specialists from anywhere in the world can access and analyze the information, providing expert diagnosis and treatment recommendations remotely.
• Data Management: The BC-1 platform manages patient data securely, adhering to local and international data protection regulations, ensuring patient confidentiality and data integrity.
• Data Harmonization: The BC-1 platform has the potential to facilitate data harmonization in communities with sparse and fragmented data collection systems. For instance, we intend to explore integration with existing institutional and national health information systems, allowing for seamless data flow and improved patient management across different healthcare services.
• Data Security and Privacy: Our cloud-based platform is compliant with the European Union’s General Data Protection Regulation (GDPR) and the United States’s Health Insurance Portability and Accountability Act (HIPAA) requirements. For instance, the platform’s backend mimics data structuring and pseudo-anonymization software used for multi-site randomized clinical trials. Our platform employs encryption protocols and access controls to safeguard patient information during transmission and storage. This ensures that data integrity, patient privacy and diagnostic accountability are preserved at every step of the way.

AI-Enhanced Usability and Diagnosis

Our continuous learning algorithms will help refine the BC-1’s capabilities over time, improving diagnostic accuracy and diagnostic speed with each use. Leveraging EEG datasets collected from diverse populations in our target communities, our AI models will be tailored to recognize neurological patterns specific to the demographics and common conditions of the regions in which they are deployed, ensuring culturally and regionally relevant diagnostics.

Evidence supporting the efficacy of the BC-1 includes:

Proof of Concept

Investigations for a portable EEG machine began in 2011 at the Technical University of Denmark (DTU), shortly resulting in the Smartphone Brain Scanner (SBS). By 2013, the SBS had demonstrated immense potential and achieved Technology Readiness Level 4 (TRL4 - component and/or process validation in a lab environment), culminating in a seminal paper on the design, implementation and evaluation of the first fully portable EEG brain imaging system (Stopczynski et al., 2014).

Field Testing

Between 2014-2019, the transformative potential of SBS as a diagnostic tool for LMICs was further explored through field validation studies. In collaboration with neurologists at Harvard Medical School, including a BrainCapture co-founder, a new generation of SBS was tested in Bhutan (McKenzie et al., 2017) and Guinea (Williams et al., 2019), demonstrating optimal safety and accuracy for detection of epileptiform abnormalities in 307 paediatric and adult participants. The early prototypes of the SBS served as crucial building blocks and laid the foundation for development of the BC-1, which was ultimately released in 2021.

Usability Testing

BrainCapture has successfully validated the usability of the BC-1 with both expert and non-expert users. Approximately 93% of the recordings obtained from our usability study were of a readable quality, thus suitable for epilepsy detection. 

Regulatory Approvals

Before wide-scale deployment, the BC-1 received certification from relevant regulatory bodies, including ISO 13485:2016, CE marking as a Class IIB medical device, and marketing authorization from the Kenya Pharmacy and Poisons Board, attesting to its quality, safety and effectiveness. 

User Feedback

Continuous feedback from users of the BC-1 is routinely collected and analyzed to monitor its performance in real-world settings. This feedback has consistently indicated high satisfaction rates among healthcare providers, citing the device’s reliability, ease of use and the quality of diagnostic information it provides.

List of Relevant Publications 

Currently Published

• Grego G. Deployment of a real-time quality control algorithm and visualization of EEG recordings for embedded platforms (2022). 
• Sokolov, et al. Smartphone EEG Diagnostics for Epilepsy Patients in the West African Republic of Guinea (2020). This paper demonstrates the validity of a Smartphone Brain Scanner prototype upon which the BC-1 system was based.
  
• McKenzie et al. Validation of a smartphone-based EEG among people with epilepsy: A prospective study - Scientific Reports. Nature. 2017 April 3. doi: 10.1038/srep45567.
  
• Stopczynski et al. (2014) The Smartphone Brain Scanner: A Portable Real-Time Neuroimaging System. PLoS ONE 9(2): e86733. doi: 10.1371/journal.pone.0086733  
  
• Williams et al. Smartphone EEG and remote online interpretation for children with epilepsy in the Republic of Guinea: Quality, characteristics, and practice implications. Seizure 2019; 71: 93–99.

Submitted for Publication

• Submitted for publication in 2023, this paper was written with Sandor Beniczky, one of the world’s leading epilepsy researchers and Head of the Clinical Neurophysiology Department at the Danish Epilepsy Center. The study proves the usability of BC-1 by non-expert healthcare workers.
• Scheduled for publication in Q3 2024, the BC-1 will be listed in the WHO Compendium of Innovative Health Technologies for Low-resource Settings (2024)

BrainCapture has 8 full-time staff and 3 part-time staff. We frequently engage contractors to support our short-to-medium term objectives. For instance, we currently have 4 local contractors, under our partner Buena Suerte, supporting our launch in the Philippines.

Our team has been working on this solution since 2011, when our future co-founders began investigations for a portable EEG machine at the Technical University of Denmark (DTU). The product development journey spanned a decade of continuous iteration and refinement, culminating in the release of the BC-1 solution in 2021. Formalizing our commitment, BrainCapture was legally incorporated in Denmark in 2019, with an operational entity established in Kenya in 2022. This was quickly followed by regulatory approval, with the BC-1 technology receiving market authorization from the Kenya Pharmacy and Poisons Board in 2023 and CE mark in early 2024.

BrainCapture recognizes that a diverse, equitable and inclusive workforce is crucial for fostering innovation and effectively serving the diverse communities that benefit from our BC-1 device. Our commitment to these values is reflected in our hiring practices, workplace policies and the ongoing efforts to enhance the diversity and inclusivity of our team.

Leadership Diversity: Our leadership team includes members from various cultural, geographical and professional backgrounds, including those with direct experiences in the communities we serve. For example, one of our co-founders, Dr. Farrah Mateen, brings over a decade of experience working in diverse neurological care settings across multiple continents.

Global Representation: We have key staff from a variety of countries and backgrounds, reflecting the global nature of our mission. This diversity enhances our ability to understand and adapt to the cultural nuances of the regions in which we operate.

Recruitment Strategies: We are committed to further diversifying our team by recruiting from a broader range of countries, focusing particularly on regions where we have significant operations. This includes using diverse job advertising channels and establishing partnerships with local collaborators to help us identify and attract talent from the communities we serve. For instance, in the Philippines, we are working closely with our local implementing partner, Buena Suerte, to build a dedicated marketing and tech support team.

Professional Development: We ensure equitable access to opportunities for professional growth and advancement within the company, with a particular emphasis on empowering local employees in our operational countries to assume leadership roles.

Inclusive Workplace Culture: We actively foster a culture of inclusion where all team members feel welcomed, respected and valued. 

Community Engagement: Our commitment to diversity, equity and inclusion extends beyond our internal operations to how we engage with and impact the communities we serve. We ensure that community voices are heard in the development and deployment of our technologies, particularly through participatory design processes.

Aligned with our impact goals, our business model emphasizes B2B sales, where devices are sold to private and public sector health providers via distributors, who already have established good relations with our target customers.

Our primary customers are hospitals, clinics and health facilities in LMICs that require affordable and reliable neurodiagnostic tools. With the BC-1, these facilities benefit from improved neurodiagnostic capabilities, leading to better patient care and outcomes, along with increased revenues.

The direct beneficiaries are patients in underserved regions who will now gain access to timely and quality neurodiagnostic services. This will empower them to receive appropriate treatment and support, ultimately improving their health outcomes and quality of life. Due to the lower operational and capital costs, the BC-1 will increase access to EEG testing, which will enable patients in need to receive neurodiagnostic services at a lower cost.

BrainCapture has two revenue streams: (1) BC-1 device sales and (2) BC-1 telemedicine services. For our distribution partners, CAPEX will secure part of their profit, but they will also share revenues from the pay-per-test telemedicine service fees. This dual stream of revenue will incentivize distributors to not only generate new sales, but also provide technical support and maintenance for the already deployed devices. Driven by this symbiotic partnership and our shared values, distributors will serve as champions of EEG accessibility, amplifying our reach with exponential impact.

The BC-1 offers a compelling value proposition at a competitive price of $5,000 per unit, which is only 1/5th of the average cost of traditional EEG equipment. Moreover, by eliminating the need for onsite EEG technologists and significantly improving the turnaround time for diagnostic results, the BC-1 provides an affordable and efficient solution for health facilities with limited human resource to meet the demand for testing. 

The high demand for the BC-1 solution is driven by the critical lack of neurological care and diagnostics in many LMICs, compounded by the increasing burden and awareness around neurological health needs.

BrainCapture has a hybrid of funding sources, including grants, private equity investments and product revenue. To date, we have raised approximately $4 million in total funding, including $850,000 USD in equity investments. Notable grant contributions include a €1 million award from Eurostar and a €2M accelerator grant from the European Innovation Council (EIC). The grant includes an additional €3.5M equity investment component that matches qualified investors. We have also received smaller grants from entities like the Epilepsy Foundation ($50,000), Innowwide ($65,000) and Roddenberry Foundation ($15,000) to help us launch and scale our product in Kenya and the Philippines.

Our business model consists of two revenue streams: (1) BC-1 device sales and (2) BC-1 remote diagnostic services. With an average price of approximately $20 USD per EEG test, and an average of 25 tests per health facility per month, each health provider stands to contribute at least $3,000 USD per year to our annual recurring revenue (AAR). Our projected total revenue for 2024 is $250,000 USD, and we expect to breakeven by 2025 with 100 customers.

Evidence of our success so far includes our initial device sales in Kenya and the Philippines, establishing a solid market presence. We are actively engaged in negotiations with more than 8 distributors representing diverse markets, which will further expand our global footprint. Our telemedicine service is currently facilitating 80-120 EEG tests per month, indicating strong demand and ongoing operational success. Additionally, we have secured letters of intent from 160 potential customers across five countries, with sales expected to finalize promptly upon receiving the necessary national regulatory approvals. This momentum underscores our effective market penetration strategies and the robust demand for our the BC-1.

Our strategic plan to attain financial sustainability includes scaling operations to 3-4 new countries annually over the next 5 years. We project significant growth in both our revenue streams as we expand into these new markets, aiming to reach 1.2 million patients across more than 2,000 health facilities. By 2028, we expect a combined total of $15 million from hardware sales and telemedicine services. To diversify our revenue base and enhance our financial stability even further, we are considering additional revenue streams. These include leveraging the BC-1 device for clinical data capture and analytics services targeted at neurological research institutions, academic partners, pharmaceutical companies and government agencies. 

As we expand our operations, we will rely on our revenue streams and equity capital to sustain our growth trajectory. However, we remain committed to actively pursuing grants that closely align with our mission, as this will help subsidize the cost of the BC-1 device, allowing us to expand our reach and maximize our impact.