1. Executive Overview:
Predictive Neuro Stimulation
Jerry Hudson - Principal & Managing Partner, Consilium Healthcare Strategy Group
(Consultant and Authorized representative)

2. PNS (Predictive Neuro-Stimulation)
Why it is a game changer !
Medical Opportunity Identified:
Can individuals with intractable types of seizures find relief where drugs and surgery have not
worked for them?
 Prevention: Identifies and suppresses seizure-related neurological activity 4-12
minutes before the onset of the seizure state, without any discomfort during the process.
(The individual would never know that a seizure was about to even occur)
 Accuracy: Data, in a 10 patient analysis, demonstrated the system was 86% accurate in
detecting seizures
 Efficacy: PNS has proven to stop the oncoming seizure effect 100% of the time in
initial patient population
 Eliminates and/or reduces common side effects associated with VNS and Medications
(AEDs)
 Gives Clinicians a new (better) treatment option in a market with limited choices
 Better quality of life for the patient!!!
Great opportunity to invest in a classic “Disruptive Technology” that can grow into a self-sufficient
company, or be acquired by one of current dominant market players

3. Assumptions:
 2.2M people in the U.S.
suffer from Epilepsy.
 Approximately 1M do not
benefit from drug
treatment and thus would
be candidates for device-
based therapy
 Current ASP for a device-
based (VNS) implant is
$20K/unit (with leads)
==================
 Possible Expansion into
“Overall Market”, another 1.2M
potential patients as device
therapy evolves
Market Opportunity
(Size and Potential)
Photo from www.epilepsyfoundation.org/getinvolved/

4. Key Factors to Consider
 Target Rich U.S. Epilepsy Niche Market - $20 Billion ; Worldwide - $520 Billion
 Predictive – Patient unaware of either seizure or stimulation events
 Less Invasive than some alternatives; Neuropace complete system in brain
 Device operable only when sensing onset of an event; saves battery life
 Potential for early diffusion / acceptance in marketplace.
 Potential for Early FDA Approval via 510K or CE Mark
 Disruptive Technology ?????

5. Reimbursement News !!!!!
 …………..The new technology add-on payments provide additional
reimbursement for technologies that are inadequately paid under the diagnosis-
related group (DRG) system, which provides reimbursement based on the
average cost of all the therapies in the DRG. To qualify for the bonus
reimbursement payment, the new technology must represent "an advance in
medical technology that substantially improves, relative to technologies
previously available, the diagnosis or treatment of Medicare beneficiaries," CMS
explains on its website.
The maximum add-on payment is the DRG payment plus 50% of the estimated
costs of the new technology; the actual add-on payment varies for each
hospital. It lasts for two to three years--the amount of time it takes to collect
and reflect data on the new technology's cost in the DRG payment through
recalibration of the average payment………………..
Source from “Fierce Medical Devices” and CMS website

6. Other Neuro Stimulation Innovations
• Ambulatory Seizure Monitoring Device
The ambulatory seizure monitoring system can be utilized as a mobile health device that reports neural behavior away from a hospital, making it
possible for the user to stay at home, and primary care personnel in order to monitor a patient’s seizure activity in order to provide deeper analysis of
the patient’s condition and apply personalized intervention techniques. The Ambulatory Seizure Monitoring device is a device that has been
developed with the objective of acquiring a portable, clean EEG signal and transmitting it wirelessly to a handheld device for processing and
notification. This device is comprised of four phases: acquisition, transmission, processing, and notification. During the acquisition stage, the EEG
signal is detected using EEG electrodes; these signals are filtered and amplified before being transmitted in the second stage. The processing stage
encompasses the signal processing and seizure prediction. A notification is sent to the patient and designated contacts, given an impending seizure.
• The Portable Neurodynamics System
• Portable EEG device that captures event-related potentials (ERP) were captured via an (a) EEG cap using eighteen electrodes
(b) Bundled wire connections were inserted into the (c) A/D convert and amplifier.
• EEG data analysis will be accomplished through analog/digital conversion of signals, in order to process EEG data as it relates to
differing levels of cognitive states.
• Bottom display features a device that can interface with laptops, tablets, and smart phones.
• Used for triage of brain states after initial traumatic brain injury in order to provide a quick assessment of location and degree of
damage to the brain based on neural activity.
• MobiCare 20/20
The MobiCare 20/20 wearable health monitoring device provides biosensor interfaces from multiple biosensor sources which enables
continuous monitoring of a variety of human vital signs, i.e. Heart Rate, Glucose Levels, Body Temperature, Blood Pressure, Perspiration,
as well determine location of at-risk patients (GPS) and Gyroscopic measurement – determine if patient is lying down for an extended
period of time and has other vital signs signaling patient illness. These captured attributes will provide solutions to different scenarios
where the patient’s health is stressed and needs immediate attention. Several scenarios will be developed to provide a range of
patient health statuses which can be reported to health care providers. An implementation of an intelligent correlation methodology
will show the real-time interrelationships between specific events, services and devices that interact with each other. Our systems
architecture will store and secure and report critical patient analysis of the health attributes from the patient’s reporting devices.
BCISim Inc. – Proprietary Devices