Portable & Scalable EEG
To develop an easy-to-administer Electroencephalography (EEG) in an acute setting to diagnose ongoing seizures (status epilepticus) in patients presenting to Emergency Room or in an Intensive Care Unit that is reliable, reproducible, economic, remotely accessible, and easily viewable.
AIM
To develop an easy-to-administer Electroencephalography (EEG) in an acute setting to diagnose ongoing seizures (status epilepticus) in patients presenting to Emergency Room or in an Intensive Care Unit that is reliable, reproducible, economic, remotely accessible, and easily viewable.
Background & Gap
Seizure is a medical condition when electrical activity inside the brain coordinates into hyper-synchronous rhythmic discharges originating from Cell bodies (grey matter) inside the brain that lasts longer than 3 seconds.
Status Epilepticus is a state where brain has ongoing seizures either intermittently or continuously lasting longer than 30 minutes without treatment (or longer then 5 minutes with treatment) where patient does not regain normal brain function.
Ongoing seizures may be obvious physically (clinical seizure or clinical status epilepticus) or may not be obvious (sub-clinical seizures or non-convulsive status epilepticus) with presentation mostly of confusion or poor responsiveness (Altered Mental Status). A clinical seizure (or status) may convert into (or be followed by) subclinical seizure (or non-convulsive status).
Electroencephalogram (EEG) is a record of electrical activity of the brain (typically of the first 8cm of the brain surface) captured on the scalp (skin of the head) through amplification (and filtering noise) that can help capture seizures (when involving more than 1$cm^2$ area).
The ability to obtain EEG immediately, with concerns of status epilepticus, is very valuable in clinical status and imperative in the sub-clinical setting.
Current techniques of obtaining EEG include closely attaching a highly conductive electrode to the scalp (skin on the head) in measured locations (distances) connected through a wire to a multi-channel amplifier (taking 8-20 electrodes) including noise filter and then displayed on computer through software with the ability to process and display the EEG in various ways.
Current limitations of the technology include training requirements for the technician (such as to understand electrode placement, troubleshooting poor signal from electrodes, and then recording the EEG for later viewing by physician), cost and difficulty in procuring recording equipment, material cost (disposables), remote access for physician to review, mobilization delays (calling in technologist from afar), etc.
Currently, long-term EEG recording during acute settings (longer than 30-minutes) is only available at a few hospitals in the whole country.
Requirements
A solution is to obtain long-term (1 hour or longer, ideally 24 hours or more) EEG recordings (with or without) using off-shelf components (solutions) that are;
affordable (economic)
technically simple (not requiring extensive technician training)
portable (can be transported from room to room, from one hospital to other)
reproducible (can be produced at scale in large quantities)
reliable (EEG results are at least 80% comparable to standard solution or ideally 95% comparable)
remotely accessible (troubleshooting and data review can be done remotely such as physician review)
easily viewable (dashboards)
Decision support system (quick screening to warn for potential ongoing seizure at bedside, without waiting for remote physician review)
Product-Market-Fit
Overall prevalence of epilepsy in Pakistan is estimated to be 9.99 per 1000 population. Highest prevalence is seen in people younger than 30 years of age. Only 27.5% epileptic persons in urban areas and 1.9% in the rural areas were treated with AEDs.
Status epilepticus is the second most common neurological emergency
Janszky J, Bone B, Horvath R, Suto Z, Szapary L, Juhos V, et al. Status epilepticus 2020. *Orv Hetil.* 2020;161(42):1779–1786. doi:10.1556/650.2020.31908.
Taking 1998 as baseline until the end of 2018, the compound average growth rate (CAGR) is 15.6%, with other variables remaining unchanged (Source: IMS Health Pakistan (Private) Limited.)
About 35 adult patients present annually (on average) to one hospital in Karachi with Clinical Status Epilepticus with a 12.5% mortality. A longer duration of status and longer interval to hospital presentation were found to be significantly associated with greater mortality in this study.
Currently no data exists for non-clinical status epilepticus in Pakistan. A study from Qatar reported 65 out of 250 patients in ICU with altered mental status when monitored on EEG had non-convulsive status.
Pakistan’s estimated population: 230 million
Seizure prevalence’s estimation in Pakistan: 2 million
Time-to-Market
12 months or so
MVP in 6 months
Beta testing and finalize design in 6 months
Traction shown by 18 months
Intellectual Property
As per approach:
Algorithm
Software (frontend or backend)
Device or modification
Revenue Models
Sales of device model:
Cost of EEG Machine in Pakistan - 150,000 - 250,000 (Chinese)
Supply costs monthly (disposables)
Technical services and maintenance
Software sales
Updates
Network - remote reading and dashboard
Fee for Service Model:
Per long-term EEG Cost : 15,000-50,000
Subsidy Model:
International Donations and Grants (Gates foundation, WHO, World Bank, USAID financing)
Pharmaceutical Companies collaborations (sales of AED)
Additional Revenue:
Data capture for AI and ML
Virtual Clinical Trials
Data for Pharmaceutical industry
Examples
