High volume, low cost sensors that can - and should - get wetmeptec.org/Resources/09 - Proteus...
Transcript of High volume, low cost sensors that can - and should - get wetmeptec.org/Resources/09 - Proteus...
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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
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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
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Proteus Digital Health
HaywardWafer MEMS Fab
London, UKCommercial
3©2012 Proteus Confidential
HaywardAssembly
Redwood CityR&D
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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
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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
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Proteus Networks Therapeutic Systems
6©2012 Proteus Confidential
Networked pacing lead Networked medicines
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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
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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
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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
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Tablet Computer, Pills and Patch
10©2012 Proteus Confidential
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The Digital Health Feedback System
11©2012 Proteus Confidential
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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.
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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
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45
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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
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55
60
65
70
75
Neuropsychiatric Patient: Disrupted Sleep Patterns
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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
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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
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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
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• 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:
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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
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Thank you!
19©2012 Proteus Confidential
www.proteusdh.com