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High volume, low cost sensors that can - and should - get wet
MEPTEC May 22, 2013
Mark Zdeblick, Ph.D.Co-Founder and CTO
Physician and
Proteus Snapshot
• Based in Redwood City, CA; operations in Hayward, CA and London, UK
• R&D initiated in 2003
• Over $100 million in equity financing to date (Carlyle, Essex Woodlands, Kaiser Permanente, Medtronic, Novartis, Otsuka, ON Semiconductor, Oracle, others)
• 110 employees in a unique organization
• Novel integrated circuit, MEMS and sensor design for custom medical applications• Signal processing and software development for intra-body communication• Product design, development and manufacturing from bench to clinic to market
2©2012 Proteus Confidential
Physician andNurseRemoteConnectivity
PersonalMedicalRecords
PatientSupportGroupConnectivity
• Product design, development and manufacturing from bench to clinic to market• Mobile applications software development• User experience for sustained consumer behaviour change
• Strategic product partnerships with global industry leaders
• All technology developed in-house: 500+ patent filings, 100+ patents issued
• WEF Technology Pioneer and Wired Magazine Top 10 Technology Breakthrough
• First products using the Digital Health Feedback System due to launch in early 2013 under the Helius brand
Proteus Digital Health
HaywardWafer MEMS Fab
London, UKCommercial
3©2012 Proteus Confidential
HaywardAssembly
Redwood CityR&D
Healthcare is growing sector of economy
US Healthcare as a percentage of GDP[1]
Rising Healthcare Costs are a Challenge to Society
4©2012 Proteus Confidential
Challenge: Deliver better care to more people for less money
[1] data © OECD www.oecd.org
In 2012, the US Postal Service delivered…
160 B pieces of mail
40% of worldwide total
Cost: $65.2B or ~$0.40 / item[2]
… while the World-wide-web delivered…
135 T emails among
Networking electronics enable lots more for less
5©2012 Proteus Confidential
135 T emails among
3.4 B email accounts[3]
Cost ~ $0.10 / 1000 emails[4]
Healthcare: it’s your turn to get networked!
[2] about.usps.com
[3] www.radicati.com
[4] http://aws.amazon.com/ses/#pricing
Proteus Networks Therapeutic Systems
6©2012 Proteus Confidential
Networked pacing lead Networked medicines
Evolution of a Networked Pacing Lead
Electrode
Networked Lead
Bench and animal testing validated 10 Years
implanted pacing at 10 V
7©2012 Proteus Confidential
ChipSkinprotected IC
Welded ChipPod
Electrode Node
Lead
Directional Pacing Reduces Side Effects
8
10
12
14
16
18
20C
ap
ture
Vo
ltag
e
Unacceptable low voltage phrenicnerve capture
using conventional ring electrodes
Proteus directional pacing avoids phrenic nerve capture at maximum output (implant has 10V maximum)
Elimination of Cardiac - Phrenic Nerve Stimulation Using Intraband Approach
Proteus directional pacing createslarge margin of safety and
increases therapeutic window
8©2012 Proteus Confidential
band-band band-coil intraband
0
2
4
6
8
Cap
ture
Vo
ltag
e
Phrenic Nerve
Cardiac Capture
Proteus directional pacing maintains favorable cardiac threshold (intraband can be steered for ultra-low V capture)
Acute Cardiac Canine Study0.5 ms Pace Pulse, Lead Positioned for Phrenic
Capture
increases therapeutic window
Percent of People with Type 2 Diabetes
<4%
4%
5%
7%
9%
>12%
Global Rise in Chronic Disease; Global Spread of Mobile Technology
9©2012 Proteus Confidential
Personal
Medical
Records
> 99% chance of sending a message within 20 minutes
Percent of People with Cell Phone Coverage
Source: International Telecommunications Union 2010
Tablet Computer, Pills and Patch
10©2012 Proteus Confidential
The Digital Health Feedback System
11©2012 Proteus Confidential
Tracking Adherence Enables Carer to Identify Patients Who Need Help
Good Adherer
A patient who takes pills at the same time everyday.
No adherence intervention needed.
Heart rate
Consistent daily dosing
12©2012 Proteus Confidential
Missed dose
Inconsistent dosing - amount and time
Poor Adherer
A patient who skips pills some days and has inconsistent dosing time. Reminders or other interventions may be beneficial.
Tracking Physiology Enables Carers to Identify Problems Early
Normal Walking Unstable Walking
13©2012 Proteus Confidential
Healthy Volunteer: Regular Sleep Pattern
16 17 18 19 20 21 22 23 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16
20-APR
21-APR
22-APR
23-APR
24-APR
25-APR
26-APR
27-APR
28-APR
29-APR
Time of Day
Date
(12A
M) S
leep S
core
35
40
45
50
55
60
65
70
75
16 17 18 19 20 21 22 23 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16
30-AUG
31-AUG
01-SEP02-SEP
03-SEP04-SEP
05-SEP06-SEP
07-SEP08-SEP09-SEP10-SEP
11-SEP
12-SEP13-SEP14-SEP
15-SEP
16-SEP17-SEP
18-SEP19-SEP
20-SEP
Time of Day
Da
te (
12
AM
) Sle
ep
Sc
ore
35
40
45
50
55
60
65
70
75
Neuropsychiatric Patient: Disrupted Sleep Patterns
Correlation of Adherence and Physiology Provides Actionable Insight
Self-titration of furosemide
Engineering View of Individual Patient Data from Heart Failure Study
Adherence
Behavior
14©2012 Proteus Confidential
Orthopnea/disrupted sleep Lying flat/restful sleep
Behavior
Physiology
What is the Ingestible Event Sensor?
Active layersThin-film layers activate and power the IES using stomach electrolytes
Active layersThin-film layers activate and power the IES using stomach electrolytes
Integrated CircuitModulates / pulses the current flow to encode information stored in it
Integrated CircuitModulates / pulses the current flow to encode information stored in it
15©2012 Proteus Confidential
Edible Skirt diskInsulating edible material, enhances detected voltage by creating a larger “virtual dipole”
Edible Skirt diskInsulating edible material, enhances detected voltage by creating a larger “virtual dipole”
Communication through body tissueElectric field is detected by a receiver worn on the patient’s skin
Communication through body tissueElectric field is detected by a receiver worn on the patient’s skin
Ingestible Event Sensor – Active Layers
Anode -Magnesium layer
Cathode - Cuprous Chloride layer
Upon ingestion,
gastric fluid
activates
the devices
16©2012 Proteus Confidential
• Active layers fulfill multiple functions to enable a simple, scalable design:• Activation – turn on device in the presence of gastric fluid to allow an ingestion event to
be detected
• Power – together with gastric fluid, form a battery that powers the device
• Communication – information is encoded in the modulated current from the electrodes
• Deposited via wafer-scale MEMS process at Proteus’s fab in Hayward, CA
Mg(s) + 2 CuCl(s) → 2 Cu(s) + 2 Cl- + Mg2+ Eo = 2.5 V (OCP = 1.6 V)Overall Reaction
• Preclinical assessment• 75 studies completed in canine and porcine models
• Multiple studies evaluating Mechanical, Electrical, and Chemical safety
• Ingestible Event Sensor excreted in stool
• No gastrointestinal accumulation, blockage, or injury observed
• Toxicology• 14-day oral gavage study in rodents
Ingestible Event Sensor - Safety and Toxicology Assessment
17©2012 Proteus Confidential
• 14-day oral gavage study in rodents
• No Ingestible Event Sensor related toxicity up to a 1000X maximum daily dose
• No dose-response in any clinical parameter
1. G. Moon, H. Hafezi, J. Frank, T. Robertson, and B. Costello, "Pre-clinical experience with an edible sensor system for electronically confirming oral pharmaceutical therapy", presented at the American College of Clinical Pharmacology, Sept 14, 2010
2. K.Y. Au-Yeung, T. Robertson, H. Hafezi, G. Moon, L. DiCarlo, M. Zdeblick, and G. Savage, "A Networked system for self-management of drug therapy and wellness", presented at the Wireless Health 2010 Conference, Oct 6, 2010
References:
Digital Medicines Define Trillion Sensor Universe
Therapeutic Area
Number of Patients
Doses Per Day Digital Doses per Year
TB 2 B 4 3T
Chronic pain 2 B 2 1T
Elderly 545 M 4 800B
HF / HTN 1 B 2 730B
Mental health 300 M 3 329B
Diabetes 285 M 2 208B
18©2012 Proteus Confidential
Diabetes 285 M 2 208B
HCV 170 M 2 124B
Epilepsy 50 M 2 37B
Alzheimer’s 30 M 2 22B
HIV 3 M 3 3B
MS 2.5 M 2 2B
Transplant 300 K 3 300M
Thank you!
19©2012 Proteus Confidential
www.proteusdh.com
