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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

High volume, low cost sensors that can - and should - get wetmeptec.org/Resources/09 - Proteus KEYNOTE.pdf · High volume, low cost sensors that can - and should ... using the Digital

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Page 1: High volume, low cost sensors that can - and should - get wetmeptec.org/Resources/09 - Proteus KEYNOTE.pdf · High volume, low cost sensors that can - and should ... using the Digital

High volume, low cost sensors that can - and should - get wet

MEPTEC May 22, 2013

Mark Zdeblick, Ph.D.Co-Founder and CTO

Page 2: High volume, low cost sensors that can - and should - get wetmeptec.org/Resources/09 - Proteus KEYNOTE.pdf · High volume, low cost sensors that can - and should ... using the Digital

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

Page 3: High volume, low cost sensors that can - and should - get wetmeptec.org/Resources/09 - Proteus KEYNOTE.pdf · High volume, low cost sensors that can - and should ... using the Digital

Proteus Digital Health

HaywardWafer MEMS Fab

London, UKCommercial

3©2012 Proteus Confidential

HaywardAssembly

Redwood CityR&D

Page 4: High volume, low cost sensors that can - and should - get wetmeptec.org/Resources/09 - Proteus KEYNOTE.pdf · High volume, low cost sensors that can - and should ... using the Digital

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

Page 5: High volume, low cost sensors that can - and should - get wetmeptec.org/Resources/09 - Proteus KEYNOTE.pdf · High volume, low cost sensors that can - and should ... using the Digital

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

Page 6: High volume, low cost sensors that can - and should - get wetmeptec.org/Resources/09 - Proteus KEYNOTE.pdf · High volume, low cost sensors that can - and should ... using the Digital

Proteus Networks Therapeutic Systems

6©2012 Proteus Confidential

Networked pacing lead Networked medicines

Page 7: High volume, low cost sensors that can - and should - get wetmeptec.org/Resources/09 - Proteus KEYNOTE.pdf · High volume, low cost sensors that can - and should ... using the Digital

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

Page 8: High volume, low cost sensors that can - and should - get wetmeptec.org/Resources/09 - Proteus KEYNOTE.pdf · High volume, low cost sensors that can - and should ... using the Digital

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

Page 9: High volume, low cost sensors that can - and should - get wetmeptec.org/Resources/09 - Proteus KEYNOTE.pdf · High volume, low cost sensors that can - and should ... using the Digital

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

Page 10: High volume, low cost sensors that can - and should - get wetmeptec.org/Resources/09 - Proteus KEYNOTE.pdf · High volume, low cost sensors that can - and should ... using the Digital

Tablet Computer, Pills and Patch

10©2012 Proteus Confidential

Page 11: High volume, low cost sensors that can - and should - get wetmeptec.org/Resources/09 - Proteus KEYNOTE.pdf · High volume, low cost sensors that can - and should ... using the Digital

The Digital Health Feedback System

11©2012 Proteus Confidential

Page 12: High volume, low cost sensors that can - and should - get wetmeptec.org/Resources/09 - Proteus KEYNOTE.pdf · High volume, low cost sensors that can - and should ... using the Digital

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.

Page 13: High volume, low cost sensors that can - and should - get wetmeptec.org/Resources/09 - Proteus KEYNOTE.pdf · High volume, low cost sensors that can - and should ... using the Digital

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

Page 14: High volume, low cost sensors that can - and should - get wetmeptec.org/Resources/09 - Proteus KEYNOTE.pdf · High volume, low cost sensors that can - and should ... using the Digital

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

Page 15: High volume, low cost sensors that can - and should - get wetmeptec.org/Resources/09 - Proteus KEYNOTE.pdf · High volume, low cost sensors that can - and should ... using the Digital

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

Page 16: High volume, low cost sensors that can - and should - get wetmeptec.org/Resources/09 - Proteus KEYNOTE.pdf · High volume, low cost sensors that can - and should ... using the Digital

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

Page 17: High volume, low cost sensors that can - and should - get wetmeptec.org/Resources/09 - Proteus KEYNOTE.pdf · High volume, low cost sensors that can - and should ... using the Digital

• 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:

Page 18: High volume, low cost sensors that can - and should - get wetmeptec.org/Resources/09 - Proteus KEYNOTE.pdf · High volume, low cost sensors that can - and should ... using the Digital

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

Page 19: High volume, low cost sensors that can - and should - get wetmeptec.org/Resources/09 - Proteus KEYNOTE.pdf · High volume, low cost sensors that can - and should ... using the Digital

Thank you!

19©2012 Proteus Confidential

www.proteusdh.com