CEREBROS

Every day, about 400 children lose their lives in India to HIE alone. These deaths can be prevented by providing improved physiology-based treatment during HIE at remote point-of-care for "intact survival". However, such system is not available in India and it is difficult to bridge the gap between rural clinics and good neonatal care units available in hospitals in townships. Hence providing an affordable brain monitoring system that enables neonatologists, who are also scarce in India, for early identification and management of HIE at point-of-care by CHWs. This solution is rapidly scalable and will be a paradigm-shift in neonatal care.

India has the highest number of neonatal mortalities in the world. As of 2015, 20% (1,201,000) of global under-five deaths occurred in India, meaning that one in every five global child deaths occurred in India. Hypoxic-ischemic encephalopathy (HIE) contributes to 20% of neonatal mortality and 50% of early neonatal mortality - 400 children losing their lives daily in India to HIE alone.

HIE is disproportionately high in rural area and among poor and tribal population. This reveals a unique vulnerable group who can benefit from improved physiology-based treatment during HIE at remote point-of-care for "intact survival". In fact, therapies like cooling can reverse the changes in HIE and improve survival in HIE if initiated within the window period. But currently no affordable point-of-care technology exists to detect and monitor HIE. Structural imaging (CT/ MRI/ Ultrasound) is far and few in India and healthcare resources, such as radiologists, neonatologists are scarce.

This twofold scarcity of technology and manpower causes "delayed detection and intervention” resulting in high mortality in HIE among neonates, especially in rural India. Hence providing an affordable brain monitoring system allowing early identification and management of HIE at point-of-care by CHWs will be a paradigm-shift in neonatal care.

CEREBROS - A novel, radical solution at the heart of which is a low-cost, portable, multimodal electroencephalography (EEG) and near infrared spectroscopy (NIRS), IoT (Internet of Things) device integrated with a tele-monitoring platform for continuous remote monitoring of cerebral hypoxia and seizures and early detection and management of HIE at point-of-care. The overarching objective of CEREBROS is to empower CHWs, such as an Accredited Social Health Activist (ASHA) or ANM (Auxiliary Nurse Midwifery) workers, in rural hospitals to identify propensity for brain injury in HIE (HIBI) early and ensure early physiology-based treatment for "intact survival" under the remote telemonitoring guidance of a neonatologist, such that neurological outcome is good.

The primary group of beneficiaries of this solution are the neonates suffering from HIE. If scaled globally, thousands of neonates can be saved every day thanks to early detection and treatment of HIBI.

The second group of beneficiaries are the neonatologists who are scarce in availability compared to the need in present. This technology will enable them to monitor multiple neonatal wards remotely via CHWs from one central location, and to provide live guidance to treat many HIE-positive neonates within short time duration.

We are working closely with neonatologists who have provided their valuable inputs in our prototype development stage and now are actively monitoring our prototype's clinical trial outcome.

The global Neonatal Mortality Rate is grave and if something can be done to reduce the loss and distress families suffer daily worldwide, we believe it must be done. Our solution not only helps in reducing NMR, but also is affordable and portable at the same time. It can be deployed in rural clinics with least manpower and transportation involved. Moreover, due to its remote monitoring feature, the system is rapidly scalable in nature, enabling neonates and their parents to access improved physiology-based treatment and guidance of experienced neonatologists from anywhere of the world at anytime.

Our solution is a novel radical innovation with no predicate yet available in the global market. There are a few companies (like Artinis) who use either one of our used imaging technology or both but it is targeted for adults in non-critical medical purposes. This makes us a trailblazer as our solution CEREBROS, EEG-NIRS joint imagine system, can provide a low cost, easy to use device and a novel biomarker in asphyxia by detecting the seizure episodes and cerebral hypoxia early in HIE, in order to save the lives of neonates. Moreover, the headband that contains the electrodes and sensors is shaped like a wearable and adjustable cap, unlike the hard and rigid headsets produced by other companies working in similar fields. Hence, it is portable and very easy to use by nursing staff, even by ANMs.

Most of the clinical systems available in the market uses only EEG data to detect and monitor HIE symptoms. However, EEG alone is not an accurate marker for HIE. Sometimes it can be false flags. NIRS on the other hand, can detect conditions that can occur during HIE. CEREBROS has the advantage of detecting HIE more accurately by this joint monitoring technology where EEG and NIRS data can be seen side-by-side, providing more comprehensive diagnostic data, to accurately detect HIE.

A pilot study was conducted in a medical college with SNCU serving rural population in West Bengal involving 20 neonates. The preliminary results show that combined NIRS-EEG parameters can detect HIE and detect clinically silent epileptic activity which are otherwise missed. Specifically, the preictal blood flow increases, as seen in an ovine model of perinatal hypoxia leads to an increase in the total haemoglobin concentration (detected using NIRS) that can be combined with the seizure-like features in EEG for online classification of HIE severity (B. Hagan (MS thesis under A. Dutta), Classification of Electroencephalogram in Ovine Model of Perinatal Hypoxia by Movement of the Autoregressive Model Parameters; https://ubir.buffalo.edu/xmlui...). This work was presented as a poster at International symposium on frontiers in development and molecular medicine 2019.

Our preliminary plan is to help the Neonatal Care System within India in our first few years. Our plan is divided into three phrases -

Firstly, CEREBROS can be integrated with newborn care corners, currently 14,000 such exist, roughly three or four per district, which provide immediate care for newborns to further improve their chances of "intact survival".

Secondly, CEREBROS will help in monitoring secondary brain injury in HIE at the special newborn care units (NCU). Currently, there are 548 such units across the country providing care for babies that have very serious conditions.

Thirdly, CEREBROS will empower 9 million ASHA workers of India who provide home visit for maternal and child care and can identify sick newborns and refer them to NCUs.

Once we achieve at least first stage of our primary goal, only then we wish to focus on helping the global Neonatal Care Sector, one country at a time, following the Medical Device Guidelines carefully.

Presently, we are at Clinical Trial Stage of our prototype. Once this is completed, we will move to Production stage.

Within 1-2 years, we expect to serve the Newborn Care Centers and NCUs in hospitals across India. In five years, we expect to cover Indian Neonatal Care Sector, and also expand to Bangladesh, Bhutan, Nepal, Pakistan, and also in Netherlands.

Right now, the main hurdle is the gestation period any medical device company faces because of Medical Device Regulations. This is accounted for and yet very harsh for startups who wish to help the medical sector.

We plan to fulfill every requirements of MDR thoroughly, and save the lives following the rules.

Full-time staff = 2

Part-time staff = 2

Our team consists of highly experiencedand knowledgeable professionals who have worked in and with the medical and technological fields, that our solution covers, extensively. They are dedicated to the end goal and wish to help in saving the HIE positive neonates earnestly.

1. IIMCIP - This branch of IIM focuses on incubating start-ups and assist them in their growth stage. We are working with IIMCIP to get help on our management work.

2. IIT Gandhinagar - IIT Gandhinagar has an excellent lab for testing our prototype. We are working with them for validation testing of our prototype.

Right now, we are at R&D stage. Once we enter production stage, we will do a Limited Model Release first to the hospitals we are tied up with. Once satisfactory results are met, we will enter the next stage of B2B with other hospitals and newborn care centers.

We are still in R&D Stage. Right now, our main financial sustainability is grants from research enthusiast bodies.