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    Date submitted
  • 04-Sep-2017

Low-cost,Portable Brain Scanner

Abstract

Neurological diseases resulting in Brain damages are major causes of death & disability as most neurological issues are not apparent (no external injury, minimal change in cognition & mood).So they are ignored at onset. Even care-providers, including Physicians, often misses correct & timely diagnosis for neurological issues at point-of-care(POC). They currently screen such patients by physiological observation at POC, which is subjective & training dependent. Only, in case of severe symptoms, they refer the patient for a Brain Scan. But stroke, seizures, traumatic brain injuries(TBI), Hypoxic Ischemic Brain Injury(HIBI), Hypoxic Ischemic Encephalopathy( HIE) are potentially fatal due to short therapeutic window (e.g.: In Ischemic Stroke the definitive treatment of thrombolysis should be administered within 4.5 hrs ).

But commonly used brain-scanners (CT/MRI) are least penetrative at POC as they are non-portable and very costly (significant capex for device & infrastructure and high opex resulting expense to cross $1 mn ) .They need skilled operators and specialist (radiologist, neurologists) to interpret the report. This two fold scarcity of technology & manpower is causing patient with neuro-emergency and disorders to miss timely and correct diagnosis and preclude them benefiting from advances in neurological therapy, where early diagnosis is critical of therapeutic success.

Our solution CEREBROS aims to bridge the above two gaps at POC by empowering any onsite care-providers, such as, Paramedic, Health Workers, Nurse, Physicians including Rural Doctors in developing countries.At the heart of CEREBROS is an easy-to-use, low-cost, portable, non-invasive, multi-modal (Near-infrared spectroscopy (NIRS) and Electroencephalography (EEG)) brain scanner in the form of a wearable headset with proprietary embedded system optimized using "smart" algorithms. The device is IoT (Internet Of Things) enabled integrated with Tele Neuro-Monitoring platform to provide early screening & triaging of neurological diseases at POC along with continuous brain status monitoring. The platform interfaces in real-time with local medical emergency system to provide timely retrieval & intervention at POC and/or at the nearest hospital with appropriate facilities within golden hour.

Intro Video (2 mins) : https://youtu.be/N-YzBVqg2Ok

Use cases: http://bit.ly/4usecase

Public Health Impact: http://bit.ly/HealthImp

Video

Original YouTube URL: Open

Introduction Video

Photos

Additional Questions

Who is your customer?

CEREBROS BENEFICIARIES, USERS and CUSTOMERS In any healthcare system, beneficiaries are often different from customers and customers may be different than users. For CEREBROS also, the same concept applies and as such beneficiaries, users and customers are defined as following: Beneficiaries: Patients with neurological disorders and diseases (e.g: Brain Stroke and Seizures among adults, Traumatic Brain Injury among accident victims, Hypoxic-Ischemic Brain Injury-HIBI or Hypoxic Ischemic Encephalopathy- HIE among neonates, infants and children , Neurodegenerative disorders such as Alzheimer and other dementias among Geriatric population) Users: Any and all type of Healthcare providers ( e.g: General and Family Physicians which includes AYUSH Practitioners and Rural Doctors in India, Specialist Physicians such as Neurologist, Geriatrician, Pediatrician and Neonatologist, Nurses including Auxiliary Nurse Midwifery (ANM) who are responsible for delivery in developing countries such as India, Emergency Medical Technicians (EMTs) and Paramedics and Other allied health workers, such as Physiotherapist and Community Health Workers ( e.g. Accredited Social Health Activist (ASHA) in India). Customers: The customers will vary based on the specific country’s healthcare system. But the customers can be classified in two broad categories - A. Government Healthcare and B. Private Healthcare. Epidemiological Study and Survey among Users: The need of the beneficiaries ( Neuro-emergency patients) and the gaps for the problem is well documented in Neurological Epidemiology studies. One of them in India has been done by our Co-Founder Dr. Das . In 2012, Neurologist Dr.Das published a seminal paper "Neurologic Disability:A Hidden Epidemic for India"(Neurology.2012;79:2146–47) where he identified emerging epidemic of neurological disability in India, affecting 3.5 million people annually. We have also done a survey among the Users and Customers, specifically among the Neurologists with following survey result: 1. Only a very small number of Neurologist (10%) mentioned using EEG as the only point-of-care device for brain scanning, but that only for Epilepsy purpose. 2. 100% responders mentioned the need of a point-of-care, portable brain scanning technology for early screening and triaging of neurological emergencies, such as Stroke, TBI, HIBI, HIE as well as for brain function status for Neurodegenarative disorders, such as Vascular Dementia. 3. 100% responders agreed “continuous brain monitoring” will be added benefit. 4. The few neonatologists that participated in the survey, all agreed that, in case of HIE and HIBI among neonate, the early screening and any physiology-based treatment like hypothermia at remote point-of-care for "intact survival" under continuous brain monitoring by ASHA worker or ANM nurse will be a huge public health impact. The CUSTOMERS of CEREBROS can be broadly described in three categories/groups according to the disease / beneficiaries and the deployment modality as explained below. Category I. Beneficiaries: On-site brain scanning for early screening and triaging of Neurological Emergencies ( Stroke and Seizures, Traumatic Brain Injury and Trauma etc) among all age groups : Users and Customers: Medical Care Providers, who don’t have brain scanning technology due to high capex and opex of current technologies. Example of such customer segment in India and other emerging economies (e.g: China, Brazil, South Africa) as well as developing countries in Asia, Africa, Latin America, which have similar healthcare system are : A. Emergency Care-Providers: Any and all emergency care-providers, specifically the ones who attend the patient first ( e.g: Ambulance and EMT, Highway Patrol and Paramedics, Fire Engine and Fire Fighters, Local Emergency Room (ER), Small County and General Hospitals, General and Family Physician and clinics), who cannot afford to have a CT/MRI Scanner (and the costly resources), can easily buy the low-cost CEREBROS and can do a quick scan to detect neuro-emergency and identify it’s severity. Due to country specific Healthcare system, facilities and resources the specific end users and the customer will be different. As example, in India (and in most developing countries), in absence of a country wide federal emergency system like 911 type system, the customer will vary significantly, both from Government and Private Sector. The primary customers will be: 1. National Ambulance Service ( a.k.a. 108 Service ) which is executed by the State Government and financially supported by Central Government and State Government jointly under the National Health Mission project (Details: http://nrhm.gov.in/nrhm-components/health-systems-strengthening/emri-patient-transport-service.html) . Several of the 108 service is executed under a PPP model, where private organizations, such as GVK EMRI in 14/15 states (http://www.emri.in/our-presence/ ), ZHL in 5 States (http://zhl.org.in/our-services/ambulance-services/dial-108.html ) or BVG India in Maharasthra (http://bvgindia.com/emergency-medical-service/) etc, operates the Emergency Service on behalf of the government. 2. National Highway Authority of India(NHAI) which has deployed several Highway Patrol vehicles and Ambulances in different stretches of India (http://www.nhai.org/listofstretch.htm ) 3. City based emergency systems - Kolkata Medical Emergency System(Private) or CATS in New Delhi(Government) or ZHL in Mumbai (Private) as well as City Municipal Corporation Ambulances. 4. Private Ambulance organization with small fleets of ambulances (1 to 10 ambulances) – In Kolkata Itself, there are 110 such organizations which operate approximately 350 ambulances across the city that includes Greater Kolkata and Howrah. 5. Local Fire Engines primarily run by local government authorities (such as, City Municipalties, Block , Sub-Divisions and District fire department) B. Government owned Public Health System which works under a tiered step-by step “Referral Model”: Government Health Centers ( Rural Sub Center - SC, Primary Health Centres- PHCs, Block Primary Health Centres – BPHCs) and Government Hospitals (e.g.: Rural Hospitals - RH, Sub-divisional Hospitals - SDH, District Hospitals - DH and Tertiary Hospital/Medical Colleges – TH/MC) works under a referral system. It refers any neuro-emergency to the next level. The path of referral is as following - SC => PHC => BPHC => RH => SDH => DH => TH / MC. The Neuro-department, which can provide proper intervention is mostly located in the TH / MC in Tier I cities. As such it’s a waste of time to follow the path of referral for a patient, who had internal brain injury. In-fact, for certain cases, like an onset of stroke or seizure, instead of sending to the Tertiary Multi-Specialty Hospital in the Tier I city, it will be ideal to send the patient to a Stroke Ready, Neuro-Specialty hospital which may be in a closer Tier II or Tier III city. But it’s also true that for optimal resource utilization, proper screening and triaging of the neuro-emergency is needed at point-of-care. As such, CEREBROS will diagnose a neurological emergency at point-of-care, wherever the patient shows up first – it can be the PHC or may be the Rural Hospital or the Emergency Room of the Sub-divisional hospital. Based on the type and severity of the neurological emergency the patient will be referred to the nearest Tertiary and/or Neuro-specialty hospital with appropriate facility, instead of following the path of referral . C. Private HealthCare facilities: Private Nursing Homes, Small Hospitals, Diagnostic centers in urban and rural areas, which cannot afford to have CT/MRI machines and don’t have access to skilled technicians can also deploy CEREBROS and do a proper screening and triaging, followed by referral to the appropriate nearest hospital as explained above. D. Large Private Hospital network, who works under a Hub and Spoke model: The hub (The multi-specialty hospitals in city, such as Apollo Healthcare, AMRI, NH Hospitals) can deploy CEREBROS at the spokes (the centers in Tier II, Tier III cities and in rural areas) as the point-of-care screening tool for early detection, thus reducing time for intervention (The triage process). They can also use CEREBROS as the first line of defence in their own Ambulance fleet as well as in their Emergency Room (ER) where the Patient is admitted first. This ER can be physically located with the Hospital or can be at another place – Whatever be the situation, the ER is always overcrowded. Generally the patient showing maximum distress, gets the maximum attention – which can be for a painful but not life threatening condition, while a patient with a brain injury might have internal bleeding but not showing any apparent external symptom – This TBI patient will invariably end up at the end of the queue for a CT/MRI. With CEREBROS, any nurse, including the non-clinical staff, also can do a quick scan and decide the severity. E. Neuro-emergencies causing brain injury in War zones: In a conflict area (e.g: war zone, border area), blasts causes many internal brain injury and trauma. But the severity varies significantly based on the proximity. Most of the stations and outposts have only few air-ambulances. The Military can deploy CEREBROS in these Military out-posts. A quick scan with CEREBROS will decide which soldier should be evacuated first and taken to the Trauma center asap. F. Remote construction sites, mining area and offshore places (both Government and Private Corporations) – Again, though due to the nature of the job, these areas have high probability of of accidents causing brain injury, generally brain scanning facilities are not available in the vicinity due to remoteness of the job sites. As such, these are ideal candidate for CEREBROS deployment. G. Private organizations / institutions/ company can deploy CEREBROS, if they consider the economic loss, due to delayed or no diagnosis of a brain injury occurring on site, resulting in disability or death. Not to mention the lawsuit and other intangible losses (brand value etc.), associated with such incidences. Specifically, manufacturing company, sports facilities in schools/colleges, recreational facilities where TBIs are quite common, will be greatly benefitted. It can be used by anyone with a little training – thus a coach in a football field, a colleague in a shop floor, a life-guard in an Amusement Park can use CEREBROS. They can be like a first responder in a brain injury situation with CEREBROS - very similar to AED, in case of a cardiac arrest. H. Finally, specifically in India and developing countries, where individual General Physician including Rural Doctor, who attends the patient first in a neurological emergency, will be a prolific user of CEREBROS, if the service is provided at an affordable pay-per-scan model. (The scan will be is 1/10th - 1/20th of the cost of CT or MRI) Category II. Beneficiaries: Continuous Brain Status Monitoring for Hypoxic Ischemic Encephalopathy (HIE) / Hypoxic Ischemic Brain Injury (HIBI) among Neonates and Children: Users and Customers in India (and other developing countries) are both from Government and Private sector, but due to the public health impact in Neonatal Mortality Rate (NMR) and Infant Mortality Rate (IMR) reduction, the Government Health Department will be the primary customer : As such, for this specific neurological disorder (HIE and HIBI) among neonate and infants, we will specifically target the National Health Mission ( the combined National Rural Health Mission/NRM and National Urban Health Mission/NHUM), that has special emphasize in Maternal and Child Health. We are collaborating very closely with the "National Task force in hypoxic ischemic brain injury (HIBI)”. HIBI has been identified as one of the "silent epidemic" by Indian Government and thus this task force has been convened in AIIMS under the aegis of Department of Biotechnology (DBT). The task force has also identified the primary reason for neonate mortality in HIBI is "delayed detection and presentation for intervention". CEREBROS being the only portable, point-of-care, non-radioactive solution that can provide continuous brain status monitoring among all ages, including neonates, once validated in the clinical study, will be deployed as the "de-facto" solution for early detection of HIBI all across India. The specific places of such deployments will be: A. RMCH (Reproductive, Maternal and Child Health) centres that includes Sub Centres, Primary Health Centres and Block Primary Health Centres – Used by ASHA, ANM as well as General Physicians B. Government Hospitals, namely Rural Hospitals, Sub-divisional and District Hospitals which works as the referral center for the Government Children Hospitals and the Tertiary Multi-Specialty Hospitals and Medical Colleges in nearby cities – Used by Nurse and Physician including Pediatrician. C. Government Child Hospitals that includes Sick Newborn Care Units (SNCU), Neonatal Intensive Care Unit(NICU), Paediatric Intensive Care Unit(PICU) for continuous brain status monitoring. Also the Private Healthcare sector will deploy CEREBROS at the following point-of-needs: A. Private Paediatric Clinics and Nursing Homes as well as smaller hospitals in Tier II, Tier III and Rural areas, which do not have neonatologist, can deploy CEREBROS to screen onset of HIE/HIBI and upon diagnosis, can refer them to the nearest SNCU/NICU/PICU (Government or Private) B. In-fact, the Private, large Tertiary Children Hospitals in Tier I cities (such as Institute of Child Health(ICH), Kolkata, the premier Pediatric and Neonatal Institute and Hospital in Eastern India) are of the opinion that, with a low number of neonatologist even in these Hospitals, CEREBROS will be a game changer to manage HIE/HIBI. CEREBROS can be deployed in the Emergency Room of these large children hospitals to screen children with HIE/HIBI as well as on the bedside for continuous brain function monitoring. C. Finally, General and Family Physicians, AYUSH Practitioners and Pediatrician in the communities can use CEREBROS in their clinic or during home visit to detect onset of HIE/HIBI. Category III. Beneficiaries: Patients with Neurodegenerative conditions such as Dementia or patient undergoing Stroke rehabilitation. Users and Customers: Healthcare Providers, who primarily caters to the geriatric population at home as explained below. Due to increase in life-expectancy, we have seen a significant increase in geriatric population who needs to be served at their home. The home healthcare is likely to grow to reach $368 Billion by 2020 from $270 Billion in 2016 at a CAGR of 8%. In Asia, specifically in India and China, rising patient awareness and an expanding middle class causing a double digit annual growth in Home-Healthcare. In India alone, Home based medical care market is expected to grow at a CAGR of 18% to reach US $6.2 Billion by 2020 from the current $3.2 Billion. CEREBROS is uniquely poised to service this home health care market. A. Private Home Care Providers who provides proactive clinical care as well as recuperative clinical care at home , specifically rehabilitation services (e.g: Portea, TribecaCare, Arogya HomeCare, Nightingales, Care24 and many more ) B. Multi-Specialty/Tertiary Private Hospital which provides continuity of care at home (e.g.: Apollo in all of its centers, Woodlands Hospital, and Medica Hospital in Kolkata etc. ). C. Care-providers who visits patient at home, such as Physiotherapists, Nurse, can use CEREBROS to report the Brain status of the patient to the treating Neurologist. Due to ease of use of CEREBROS, any family member, with minimal training, can also do the same. D. Neuro-Specialty Hospitals, both Government and Private, can use CEREBROS in OPDs(Out-patient ) and IPDs(In-Patient department /beds) for evaluation and continuous monitoring of Brain function among elderly patients. E. Finally, individual Physicians, Geriatric Specialists or Neurologists will be a prolific user of CEREBROS to understand the Brain Status function of their elderly patient. Customer Segments in Developed Countries As mentioned earlier, in parallel to deployment in India, we will apply for FDA (US) and CE (EU) approval. Once FDA approval and CE certification is obtained, we will position CEREBROS as the de-facto solution for 1. Point-of-care brain scanning for neuro-emergency screening and triaging and 2. Continuous Neuro-Monitoring platform. A. In other developing or Low Middle Income countries (LMIC), with similar healthcare setup, similar set of beneficiaries, users and customer, as explained above will be using CEREBROS. B. In Developed Countries: While the beneficiaries will be similar, due to more standardized healthcare delivery model, the users, customers/ customer channels will be different. As example, the primary customer or primary channel of deployment, in US will be the Healthcare Insurance companies while in UK, it will be the NHS (National Health Services). In Developed countries, the Users and/or the Customers can be broadly described as following: A. Emergency Systems – Most developed countries have well established , standard federal emergency system – e.g.: 911 in North America, 999 in UK, 112 in EU, 119 in Japan, 000 in Australia etc. B. Vast, sparsely populated rural areas (country side) of US, Australia and certain European countries where neuroimaging facilities and trauma centers are far and few, will be immensely benefitted from CEREBROS deployment. CEREBROS can be deployed in the Health-Centres, General Hospitals, County Hospitals which do not have any neuro-imaging facilities. C. Hospitals, including Trauma Centers, Stroke Ready Hospitals and Neuro-Specialty Hospitals, who have brain scanners (CT/MRI) in their main facility can use CEREBROS at point-of-need, such as • In their own Ambulance fleet which works with the local emergency system (e.g: 911 in US or 999/112 in UK )deployment - Paramedics and EMTs can use CEREBROS onsite for neuro-emergency diagnosis and also for continuous neuro-monitoring during transportation. • In Emergency Room(ER), where the Patient is admitted first, CEREBROS can be used as a quick brain scanning tool ensuring point-of-care screening and prioritizing by the busy ER staff. D. Private organizations and Public places: Similar to AED deployment, CEREBROS can be deployed in private organizations and facilities (Specifically, manufacturing companies, sports facilities and recreational facilities where Traumatic Brain Injuries (TBIs) are quite common) as well as Public places and Institutions. While for deployment in private places, no governmental policy is required, but a federal governmental level policy to deploy CEREBROS in public places and in certain facilities (e.g.: Manufacturing Shop floor Or Certain Contact Sports), will surely help in the adaptation of CEREBROS. The use of CEREBROS across public and private spaces will save many neuro-emergency patients, very similar to how AED saves many cardiac-emergency patients. CEREBROS can be used by anyone with a little training – thus a coach in a football field, a colleague in a shop floor, a life-guard in an Amusement Park can use CEREBRO and notify 9-1-1 appropriately. They can be the first responder providing intervention in a brain injury situation with CEREBROS - very similar to AED, in case of a cardiac arrest.. E. Screening in Military Aid Stations, remote construction sites, mining area and offshore places: With a heavy deployment of Military and Navy globally, the remote Military Aid Stations and Offshore stations can use CEREBROS effectively to screen and prioritize which soldiers with brain injury will be evacuated first. This deployment prioritization issue, with only one air-ambulance and multiple TBI patients, is most evident in Military. In a conflict area (e.g: war zone), blasts causes many internal brain injury and trauma. But the severity varies significantly based on the proximity. Most of the stations and outposts have only few air-ambulances. A quick scan with CEREBROS will decide which soldier should be evacuated first and taken to the Trauma center asap. F. Finally, owing to changing family landscape, favorable demographics, increasing disposable incomes, and quest for better preventive care, the home healthcare, which currently represents a small chunk of the overall healthcare industry, is likely to grow immensely in the years ahead. Due to sparsely populated areas with elderly people, who are mostly staying alone and confined at home, the Health Systems of Developed Countries ( US, EU, Australia, Japan) are introducing Home based clinical care enabled by tele-health. As such, currently, not having any commercial POC device for Brain status monitoring at home presents huge potential for commercialization, not only in India, but globally, including US and Europe. Obviously, the approval and certification process (FDA and CE) along with higher marketing and operational cost will require a different Go-to-market (GTM) strategy in each of these regions, specifically in US and Europe. Outside the above customers the two other areas in Developed countries, who will be significantly impacted (financially and clinically), are: 1. Decision of Air Ambulance deployment in Civil Area: One specific area of cost-saving and optimal usage of medical emergency service is the Air Ambulance cost deployment. As mentioned in this article (http://airmedical.net/resource/air-ambulance-flight-cost/) “The cost of air ambulance flights can range widely, from five digits all the way up to six.”. Regarding insurance covering the cost, it varies widely - From not paying anything ( In Montana where insurance denied the full bill as an out-of-network air-ambulance was used https://goo.gl/rO0kgU ) OR denying to pay most of the bill of $47,182 to Mr Kendall, a rancher in Pearce Arizona, though he used an in-network air-ambulance, as according to insurance air-ambulance was not required (https://goo.gl/Y8PmwO). The common thread in all these individual incidents point out two things – • The nature and severity of the brain injury dictates if the patient needs to go to a Trauma center, what level and whether an air-ambulance is required or not. • If the brain injury is screened earlier along with the severity, a road ambulance can take the patient to the right level (Level I to V) of Trauma center within golden hour Early screening and triaging of Brain Injury at point-of-care is the answer, which is provided by CEREBROS. Finally, the Air-Ambulance industry itself is going through a topsy-turvy time as expressed in the NY Times article (https://goo.gl/Y8PmwO), which points to a supply-demand mismatch, rising cost, sustenance issues. We are not claiming that CEREBROS is going to solve the Air-Ambulance industries supply-demand and financial problem. But within the Brain Injury domain, we can have a significant impact. Because the patient’s with brain injury is the most prolific users of Air-Ambulance and an optimal deployment of air-ambulance is the need of the hour. A quick scan with CEREBROS on-site will detect the severity of the brain injury very early in the process, based on which the EMT can decide deployment of air-ambulance, effectively providing an optimal utilization of the ambulance services. 2. A new area of application: Continuous Brain Monitoring: Finally for all the above customer channels, CEREBROS is going to provide a completely new service. Due to our proprietary sensor-fault tolerant algorithm which has excellent sensitivity and specificity under noise (moving ambulance including air-ambulance), CEREBROS will be able to continuously monitor the brain showing the neurovascular coupling status during transportation. If a radiologist is on-board he/she can monitor it or this can be transmitted to the neurologist in the Neuro Hospital. This continuous monitoring of brain status during Neuro-emergency is not commercially available with any current technology. Few clinical trials are on with CT Scan fitted ambulances, but the high costs and more importantly the high radiation exposure in CT Scan is not making it a clinically feasible option. Formatted document: http://bit.ly/Cust-User

What problem does this idea/product solve or what market need does it serve?

The Problem: Neurological diseases are major cause of death and disability globally. The major culprits like stroke, seizures, intracranial haemorrhages, traumatic brain injuries(TBI), Hypoxic Ischemic Brain Injury (HIBI)/ Hypoxic Ischemic Encephalopathy(HIE) are potentially fatal if remain untreated. 90% TBI and stroke patients miss ideal treatment due to missed/late diagnosis while 20% Neonatal death is due to non-diagnosis of HIBI/HIE. Timely diagnosis of Neuro-emergencies depends on accessibility to neuroimaging facilities (e.g.: CT and MRI). But they are least penetrative at point of care, as they are non-portable and stationary (only available in “Scan Centres”), significantly costly ( $150K - $1mn / INR 2-7 Cr just for devices, expensive infrastructure and high on-going operational expense) and needs skilled technicians and physicians (neurologists) to interpret the report. As such, one CT scan costs anywhere from $500 to $2500 while the cost of single MRI scan is usually between $1000 to $3500 in US and in India CT scans costs INR 3000 while MRI ranges between INR 6000 – INR 10000. Unfortunately, India has one of the lowest numbers of neuroimaging facilities (1 MRI for million population and 98% Care-Providers don’t have access to any neuroimaging). Also in India, with 3000 neurologists serving 1.2 billion, neuro-emergencies are often not diagnosed early. This two fold scarcity of technology and manpower is causing patient with neuro-emergency to miss timely and correct diagnosis and preclude them benefiting from advances in medical management and neurological therapy, where early diagnosis is critical of therapeutic success, resulting in higher mortality and morbidity. And it’s not only India, it’s a global problem, as no affordable, point-of-care neuroimaging technology that can provide continuous brain-status monitoring is currently available. The only point-of-care neuroimaging technology that is available in the market, “CT Scanner fitted Ambulances” costs more than USD 1 million with high operational costs, thus not available to the masses in developed countries also. Further, the underlying technology being radioactive X-ray, they cannot provide continuous brain monitoring due to radiation risk. Please refer the documents below for detail: CEREBROS Introduction Documents: Pitch Deck: http://bit.ly/Pdeck-V5 Use cases: http://bit.ly/4usecase Public Health Impact: http://bit.ly/HealthImp Social Impact: http://bit.ly/CERSOC Market Size: http://bit.ly/CER-Market

What attributes will make this idea/product successful? Why do you believe that those features will create success?

CEREBROS™: CEREBROS is a comprehensive end-to-end (360 degree) solution consisting of an IoT (Internet-Of-Things) device integrated with a AI (Artificial Intelligence) based Tele Neuro-Monitoring platform in cloud to provide : 1. Early screening and triaging of neurological emergencies (e.g: Stroke and Seizure, Traumatic Brain Injury-TBI and Brain Trauma, Hypoxic-Ischemic Brain Injury-HIBI or Hypoxic Ischemic Encephalopathy- HIE among neonate etc.) 2. Evaluation and continuous brain status monitoring for any neurological disorders at point of care and during transportation and 3. Timely retrieval and intervention at point-of-care or at the nearest appropriate health center, so that patients’ are benefited from advances in neurological interventions, which need to be administer within golden-hour or as early as possible. At the heart of CEREBROS is a low-cost, portable, radiation free, non-invasive, multi-modal (Near-infrared spectroscopy(NIRS)+Electroencephalography(EEG)) brain-scanner in the form of wearable headset with embedded system optimized using "smart" algorithms. The device is simple to use and can be used by not only General Physicians but by any minimally trained health care-providers such as AYUSH Practitioners, Rural Doctors, Paramedics and EMT (Emergency Medical Technician), Nurse (ANM, GNM) as well as Community Health Workers (e.g.: ASHA workers) As example - Based on the severity classification of a TBI case, the patient should be transported to a Level I, Level II or Level III Trauma Center , while for a Brain Stroke the patient should be transported to the nearest Stroke Ready Hospital (SRH), capable of 24 X 7 Intravenous Thrombolysis and/or Vascular Intervention/Intra-arterial Thrombolysis. The patient will be under continuous, remote monitoring under the SRH, so as soon as the patient arrives, the appropriate stroke management for the patient, can start without any delay - as "Time is Brain"(In a Stroke, per minute we loose 1.9 million Neurons, 14 billions Synapses and 3.1 week of accelerated aging). In case of a Neonate (just-born), showing any sign of discomfort in a remote, rural Maternal and Child Health (MCH) delivery center can undergo a quick non-invasive, radiation free scan using CEREBROS and if Hypoxic Ischemic Encephalopathy(HIE) is detected, the community health worker or nurse can provide structured, multimodal delivery of treatment like hypothermia under the remote, continuous tele-monitoring guidance of a neonatologist,, while the baby is transported to the nearest NICU (Neonatal ICU) In India, the service will be deployed under an affordable Software-As-A-Service(SaaS) based model, for deeper penetration across Governmental Health System and Private Health Care Providers resulting significant societal and public health impact. CEREBROS BENEFITS & INTEGRATED INNOVATION CEREBROS platform envisions to create a paradigm shift in neuroimaging and brain scanning market globally which will change how (multi-modal), when (continuous and remote) and where (point-of-care) brain scans are done by seamlessly interfacing with different healthcare delivery systems in real time, empowering any and all type of healthcare providers. We are taking an “Integrated innovation” approach. As defined by Grand Challenges, “Integrated Innovation is the coordinated application of scientific/technological, social and business innovation to develop solutions to complex social challenges. This approach does not discount the singular benefits of each of these types of innovation alone, but rather highlights the powerful synergies that can be realized by aligning all three. Integrated Innovation recognizes that scientific/technological innovations have a greater chance of going to scale to achieve national and global impact and sustainability if they are developed from the outset in conjunction with appropriate social and business innovations.” As such, the CEREBROS product is being developed as an integrated innovation, consisting of scientific/technological, social and business innovation, for an end-to-end solution (360 Degree solution) for Neurological Emergencies, specifically for Brain Stroke and Seizure among Adults, Traumatic Brain Injury (TBI) and internal brain injury/trauma among accident victims, Hypoxic Ischemic Brain Injury (HIBI) and Hypoxic Ischemic Encephalopathy (HIE) among Neonates, Infants and Children. A. Technology Innovation: Portability: CEREBROS device is a highly miniaturized customizable electronics device for simultaneous high precision acquisition of electrophysiological (EEG) and optical (NIRS) signals. Dual-mode ( NIRS + EEG ) technique is built within the device resulting better sensitivity and specificity where Multi-Modal System incorporating other bio-signals and Physiological Observation: For definitive diagnosis and severity classification of neurological emergency situations, other bio-signals, such as, ECG/EKG, PPG, PULSE OXIMETRY, BLOOD PRESSURE and physiological observations are equally important. These conventional systemic measures along with NIRS + EEG signals are important to build a phenomological model to determine the signature of the neuro-glial-vascular interaction and dysfunction leading to prognosis of neurological diseases and disorders. Our solution ensures this through a point-of-care, easy to use interface which captures 1. other bio-signals (mentioned above) from multiple devices manually or automatically and 2. Patient’s Clinical data and relevant physiological observation done by the onsite care-provider. Wearable, Easy to Use Device: Ergonomic design of the wearable headset with pre-configured built-in sensors. The sensors placement is done using an optimal whole head montage for EEG/NIRS joint imaging. This will enable any minimally trained health care provider to use the product at point-of-care. Blue Tooth enabled, Power-efficient system running Compressed sensing (CS) algorithm with adaptive scheme to avoid data loss for fast imaging which will be leveraged for super-resolution imaging for forehead as well as for whole-head imaging and abnormality localization. This embedded system will also help in efficient usage of power thus ensuring longer battery-life, specifically during continuous neuro-monitoring. Continuous and Remote monitoring of Brain Function: Unlike CT/MRI, both NIRS and EEG technologies being radiation free, non-invasive and the device being designed as a wearable headset, continuous brain monitoring is possible. . Operator Independence at onsite: CEREBROS will empower any and all healthcare provider on-site. Starting from Community Health worker, Paramedic, Nurse, General Physician (including Rural doctors and Alternative Medicine doctors in Developing countries), can use CEREBROS at point-of-care. B. Social Innovation (Deployment Model): Physician Touch: Healthcare in India (and Globally) is Physician dependent. Patient feels comfortable, when they have some interaction with Physician, specifically specialist. Based on need, using our tele-health platform, audio-video interaction between remote physician and the patient can be established. Built-In Intervention, providing end-to-end (360 Degree) solution: Unlike current models of diagnostic, we will have built in intervention within the operational model, providing an end to end solution to the end user, the patient. The intervention will be either onsite (e.g: In case of a HIE onset in a neonate the community health worker or nurse can provide structured, multimodal delivery of treatment like hypothermia under the remote, continuous tele-monitoring guidance of a neonatologist,, while the baby is transported to the nearest Neonatal ICU ) and/or the nearest hospital with appropriate resource and facilities (e.g: In case of a Stroke diagnosis, transporting the patient to the nearest Stroke Ready Hospital (SRH) with Thrombolysis facility and Neurosurgeon while keeping the Stroke unit in the SRH ready for intervention by providing them real time brain status of the patient). Thus, not only CEREBROS will ensure the clinical “golden hour” criteria, but will empower the local Healthcare providers to act rapidly and with urgency, saving many lives in case of neuro-emergencies. This will further result in gaining trust among the common people as well as among all typed of local health care-providers, including general physicians, Rural doctors, Alternate Medicine Practitioners, thus providing deeper penetration in the community and in the public health system, impacting the bottom of the pyramid population. C. Business Innovation (Operation and Revenue/Commercialization Model): Multi-Tiered Hub and Spoke Model for operation -Several local Spoke(s) which will work as the Point-Of-Care Emergency Service Provider as Level –I spoke ( e.g.: Local Medical Emergency System (Private or Government), it’s ambulance and paramedics, Rural and General Hospitals, Nursing Homes, Diagnostic centres without scanning facilities and finally the General Physicians, Nurse, ASHA workers etc. ] will have multiple levels of supports which are : • Few local Hub(s) which will work as the first level –II Intervention Center(s) • City based Regional Hub(s), generally Multispecialty or Neuro-Specialty Hospitals and/or Intensive Trauma Center , which will work as the Level-III Interventional Center • The Central Arogya MedTech Hub which will be the central tele-monitoring and guidance centre Affordable, SaaS (Software as a Service) based Revenue Model: The customers benefits are - • Minimal to Zero Capital Investment in device, infrastructure etc compared to half a million to more than a million dollar investment for setting up a “Brain Scan Centre”. • No costly operational cost, such as radioactive material, skilled technicians, infrastructure maintenance and office overheads. • Pay-per-screening based model for certain markets and customers o e.g: In India for the public healthcare system as well as for the private independent healthcare providers. These independent private healthcare providers in India ( General Physician including Alternate Medicine practitioners and Rural Doctors, Small Hospitals, Nursing Homes, Diagnostic Centres, Pharmacies) can charge a minimal service fees and still it will be much cheaper for the patient compared to the current cost of CT/MRI and they need not to travel to the city. They will bring quality clinical service at an affordable cost to their patients including the rural, hard-to-reach and poor, bottom of the pyramid population – At the same time, can be financially benefitted. Considering these private providers being one of the important spokes in the community, the service of CEREBROS will be sustained and scaled in a bottoms-up approach. As such, CEREBROS which does not require any specialized skill-set for operation, is one-of-its-kind to provide a low-cost, portable and real-time ability to estimate brain tissue oxygenation and to detect neurological emergencies, such as stroke and any brain injuries. By bridging the technology and manpower gap, it will empower community health workers of public health system as well as private health providers for rapid screening and triaging. It will thus drastically improve the two major hurdles for neurological emergency, improve detection rate and reduce diagnostic waiting period, not only in India but also globally. CEREBROS is going to revolutionize the global brain scanning and monitoring market by providing a point-of-care solution which is economical and scalable. Competitors and our advantage: http://bit.ly/Competitor-Adv Benefits and Integrated Innovation: http://bit.ly/Ben-Innov

Explain how you (your team) will execute to make this idea/product successful? What gives you (your team) an advantage over others already in the market or new to this market?

CEREBROS Operational/Business Model: The CEREBROS platform envisions to create a paradigm shift in neuroimaging and brain scanning market which will change how (multi-modal), when (continuous and remote) and where (point-of-care) brain scans are done by seamlessly interfacing with different healthcare delivery systems in real time, empowering the healthcare providers, such as 1. Medical Emergency & Trauma care: Onsite screening and triaging by paramedic followed by continuous brain status monitoring during transportation to Hospital 2. Rural and Community health: Neuro-Emergency detection at community level by Primary Care Physicians including AYUSH practitioners, Nurse as well as Community Health Worker 3. Continuous Brain Status monitoring for high-risk patients, such as Neonatal suspecting HIBI, Stroke Patients undergoing neurological rehabilitation etc. In India we are taking an “Integrated innovation” business model approach, as defined by Grand-Challenges (http://www.grandchallenges.ca/funding-opportunities/integrated-innovation/), providing end-to-end solution for Neurological emergencies. Here is a detailed explanation on how CEREBROS device & platform will work in tandem to achieve the above in India. ( Note: Though the below mentioned model is explained keeping Indian Healthcare system in mind, but it can be applied to any similar Healthcare delivery model, where neurological treatment facilities and resources are far and few and mostly concentrated in major cities. As such not only in developing countries, the same model is applicable in developed countries, such as North America/Europe/Australia too ): A. Tele-health based remote diagnosis and integration with local Medical Emergency System: The CEREBROS wearable head-gear will work as an IoT (Internet Of Things) device using intuitive, easy-to-use, multi-lingual, audio-video enabled Smartphone App which will: 1. Integrate with proprietary cloud based Tele Neuro-Monitoring platform to provide point-of-care diagnosis remotely and if needed, continuous monitoring during transportation. 2. Interface with local Medical Emergency System to satisfy “Sense” ( Nearest Hospital with appropriate facilities and resources as well as availability ), “Reach” ( Nearest Ambulance / Vehicle for retrieval ) and “Care” ( Hospital being ready with timely and appropriate intervention), the three cardinal pillars of Medical emergency. Thus, once diagnosed, the service provider with the help of nearest Ambulance will be able to transfer the patient to the nearest Hospital with neurology management facilities and resources within golden hour. Also, the neurologists in the Hospital will be ready so that no time is lost upon arrival of the patient in the Emergency. B. Unique 360 degree model of deployment providing maximum impact to the patient :The current model of diagnostic ends at the “Scan-Center” – it’s up-to the patient (and his/her family) to decide where to go and how to go. As explained above, we will have built in intervention within our operational model, providing an end to end solution (360 degree) to the end user, the patient. The intervention should be done as locally as possible, as close to patient’s home. Upon diagnosis at point-of-care by the CEREBROS platform, the patient and the care-provider attending the patient, are guided to the Hospital ensuring the following criteria: a. It should be the nearest from patient’s location b. It should have appropriate resource and facilities (e.g: A Stroke Ready Hospital with Thrombolysis facility and Neurosurgeon) c. It should have availability to accommodate the patient C. (Tele)-Consultation: In India, patient feels comfortable, when they have some interaction with a specialist physician, specifically during neurological emergencies. Using our tele-health platform we will enable this interaction remotely - though for better resource utilization, care-provider with increasing level of expertise ( such as Community Health Worker < Paramedic < Nurse < General Physician < Pediatrician < Neonatologist (for Neonate and Children ) < Neurologist < Neurosurgeon etc.) , will be introduced gradually under a closed, bi-directional, decision tree based system running AI software and machine learning algorithms. As example, in case of a suspected Stroke, along with the NIRS+EEG combined signal, the onsite care-provider provides patient’s medical history including physiological observation ( e.g.: F.A.S.T for Stroke : http://www.stroke.org/understand-stroke/recognizing-stroke/act-fast) which is transmitted from handheld to cloud server. The data is processed and analysed using proprietary algorithms, which is assessed by the care-provider remotely. If needed, the remote care-provider can also use built-in audio-video facilities in the CEREBROS platform (and the handheld) to observe and interact with the patient, thus providing the human-touch that most patients in India crave for. D. Multi-Tiered Hub and Spoke Model for operation: a. Several local Spoke(s) which work as the Point-Of-Care Emergency Service Provider as Level –I spoke ( e.g.: Local Medical Emergency System (Private or Government), it’s ambulance and paramedics, Rural and General Hospitals, Nursing Homes, Diagnostic centres without scanning facilities and finally the General Physicians, Nurse Practitioners etc.] b. Few local Hub(s) which work as the first level –II Intervention Center(s) c. City based Regional Hub(s), generally Multispecialty or Neuro-Specialty Hospitals and/or Intensive Trauma Center , which will work as the Level-III Interventional Center d. The Central Arogya MedTech Hub which works as the central tele-monitoring and guidance centre. CEREBROS Product Pipeline and GTM Business & operational Model: http://bit.ly/Bus-Ops Product Pipeline: http://bit.ly/2rLcBJK Go-to-Market and Revenue Model: http://bit.ly/GTM-Rev CEREBROS Team: Our Team, our strength: Our team members come from a diverse background of neurology, public health, engineering & business management and compliments each-other. They bring together several years of experience of product development (lab to market ready) in the area of Bio-medical & neurology that has significant impact in community health. CEREBROS™ is being developed by Medical Emergency Doctor and Neurologist, Emergency service provider and Health Entrepreneurs, who are themselves the end-users, in collaboration with Biomedical Engineer specializing in Neuroimaging and Computer Scientist specializing in Artificial Intelligence and himself a social entrepreneur. We experience the need, understand the technology, the human factor and the regulation bottle-necks that are key in translating a point-of-care medical technology from lab to market. While on one hand we are running our R&D in collaboration with leading neuro institutes(e.g: SUNY Buffalo, INRIA France), we have also established presence in emerging countries (e.g: India) that includes a large pool of patients, rising government funding and increasing R&D investment which is crucial for running the pivotal clinical study for regulatory approval. While on one hand, in neuro-emergencies, by providing early screening and triaging to the nearest neuro-hospital, CEREBROS will have impact among 5 million (3.5 million TBI + 1.5 Million Stroke) patients in India, on the other hand by providing diagnosis and monitoring of HIE/HIBI among neonates and children at point-of-care, CEREBROS will make a significant impact in overall neonatal survival, first in India and then globally, because HIBI/HIE contributes to 20% of neonatal mortality. As obvious, this level of impact is only possible as the device is an IoT enabled device integrated with a tele neuro-monitoring platform. CEREBROS and its tele- neuro-monitoring platform with its highly affordable SaaS based model can reach the remotest part of India given the widespread telecommunication penetration in “Digital India”. As such the only infrastructure that is must for CEREBROS is having reliable Internet connection. As we will be using compressed sensing algorithm, and only data (no image etc) will be transmitted, 2G connection is good enough, which is mostly available in each nook and corner of India. With India government's Digital India endeavour, increased spending in public health and proliferation of private health care providers, the environment is ripe for a tele-neuro platform, at the heart of which, is a first-of-its-kind unique low-cost brain-scanner that will be a paradigm shift in how(multi-modal), when(continuous and remote) and where(point-of-care) brain scanning is done. In India, this will usher in a new era of Digital Health in Neurological domain which will be perfect match for the ongoing "Digital India" drive. Though radical, as we are closely collaborating with Government Health departments in multiple public health projects including medical emergency and neonatal and infant mortality, we envision a quick adoption of the CEREBROS solution in Indian Public Health system. Further, once proven in such a large patient pool in India, obtaining FDA and CE approval will be easier - thus CEREBROS has the potential to gain the bulk market share of neuro-emergency diagnostics within 5 years globally. Team & Partners: http://bit.ly/CerTeam Letter of supports: AIIMS, New Delhi - Padmashree Dr (prof) MV Padma (HOD Neurology II): http://bit.ly/AIIMSSup Institute of Child Health, Kolkata - Dr.I.Bhattacharjee (Professor) and Dr Jaydeb Ray (HOD): http://bit.ly/ICH-Sup University of Buffalo - Dr.A.dutta (Prof Bio Medical Engineering ): http://bit.ly/ADuttaSup Cadence - Mr J Ahuja (MD, Cadence India): http://bit.ly/Ahuja-Rec Mission Arogya (for community health)- Dr T Mahapatra (Medical Research Director) : http://bit.ly/MA-Sup Kisholoy (Pediatric and Neonatal ICU) – Dr Mirza (NICU Incharge) : http://bit.ly/DrMirzaSup Achievements and Awards In 2017,  We won the 1st Runners up in India’s premier social enterprise challenge “Tata Social Enterprise Challenge” for CEREBROS o https://www.telegraphindia.com/1170210/jsp/calcutta/story_135006.jsp o http://www.tatasechallenge.org/events/event-contest/?y=2017  One of the 5 start-up showcased in Bengal Global Business Summit 2017 with our product CEREBROS ( https://youtu.be/648eNspd29I )  We have received an Equity Investment for INR 25,00,000 ( INR 25 Lakhs, approx. USD 40,000) in the form of early-stage funding/seed funding from one of the leading Social Impact Investor of India: “Villgro” (http://villgro.org/about-us/ ). The investment has been made under the “Innovative Ventures and Technologies for Development (INVENT)” program and supported/funded by Technology Development Board (TDB), India and Department for International Development (DFID), UK. (http://villgro.org/invent/)  Just received INR 49,80,000 ( INR 49.8 Lakh, approx. USD 80,000) grant under Government of India’s flagship, Biotechnology Industry Research Assistance Council, “SPARSH” program for Geriatric Healthcare ( http://www.birac.nic.in/desc_new.php?id=110 )  CEREBROS has been selected as one of the winner of the Grand Challenges Explorations India being conducted by Bill and Melinda Gates Foundation and BIRAC. Waiting final round  We have been selected as one of the finalists (final stage 4/5) in the Innovation competition being conducted by Network 18 ( http://www.firstpost.com/venture/ ) .  In collaboration with IIT Gandhinagar have obtained another grant from BIRAC, for our other product "MindEye" (Early screening of Dementia in community) under the "CRS" program (http://www.birac.nic.in/desc_new.php?id=218) Earlier recognitions and grants ( 2015 June to 2016 Dec):  Cadence India provided a small grant of INR 6 lakhs for carrying out the prototype development for such a novel, Make-in-India technology that can have global impact. (Please refer the following letter of support - http://bit.ly/CadAIIMS)  Just with our concept, in 2015, Arogya MedTech with CEREBROS, was one of the 110 semi-finalist out of 3007 applicants in the world's largest business idea competition 43N in Buffalo, New York, just for the concept o https://goo.gl/kJozYy o https://www.buffalorising.com/2015/07/43north-announces-110-semifinalists/  In 2016, CEREBROS has been selected to move to the 2nd round of the prestigious United States–India Science & Technology Endowment Fund (USISTEF) grant o http://www.usistef.org/pdf/USISTEF-Shortlisted-Applications-Stage-I.pdf).  We had been selected as an incubatee in India's premier Technology Incubation Center, Indian Institute of Management, Calcutta, Innovation Park (http://www.iimcip.org/) at Joka, Kolkata, India. It is setup under the Department of Science and Technology (DST) of Govt of India (Equivalent to NIH/NIST of US). IIMC-IP is one of the oldest Incubation center of India under DST and the first in eastern India which has been recognized as Technology Business Incubators (TBI). In 2016, we had also completed the product prototype, lab tested it along with completed limited clinical study. As the prototype has been developed, we don't have any requirement to be physically located in this Incubation center.