Wh Why are y are we he e here? re? Lead smart watch technology - - PowerPoint PPT Presentation

Wh Why are y are we he e here? re?

Longer term: provide wrist-based hospital-grade diagnostics anywhere Lead smart watch technology for LO LONG NG TERM TERM, CONTINUOUS, COMFORTABLE monitoring

• f

life-critical functions at MEDICALLY CERTIFIED SENSITIVITY AND SPECIFICITY LEVELS, in order to track:

Arrhythmia Atrial Fibrillation Bradycardia Tachycardia Cardiac Arrest Heart Failure Blood Pressure Skin Temperature Pulse Rate Respiratory Rate Oxygen Saturation Blood Glucose Activity Tracking Calories Burned Galvanic Skin Response Mental Stress Sleep Analysis Broad Health & Wellness

HEART CONDITIONS VITAL SIGNS WELL-BEING METRICS

Do we we ne need d an anoth ther r sm smar artw twatc atch h

• r medica

ical l we wear arab able? le?

Do we we ne need d an anoth ther r sm smar artw twatc atch h

• r medica

ical l we wear arab able? le?

FDA/CE clearance for medical diagnostics Continuous measurement 7/24 High reliability & accuracy in motion Long-term measurement Comfortable and hassle-free

We We need need anot anothe her r sma mart rtwa watch! tch!

FDA*/CE* clearance for medical diagnostics Continuous measurement 7/24 High reliability & accuracy in motion Long-term measurement Comfortable and hassle-free

Long-term monitoring is the only known effective solution for heart arrhythmias

*In process

Ou Our val r value ue pr prop

• pos
• sit

itio ion

Ou Our val r value ue pr prop

• pos
• sit

itio ion

Breakthrough and patent- protected sensor technology to achieve: Smartwatch technology combining state-of-the-art electronics, optics, mechanics and software algorithms to deliver a long-term, non-invasive solution

• Long-term, continuous, medically

certifiable measurement accuracy levels for heart arrhythm hmia ia as well as vital signs in all day-to-day conditions

• Non-inflating, medically certifiable

absolute blood press ssur ure measurement

Four Unique & Proprietary Technologies

Optical PPG with record accuracy, low false alarm rate and motion resistance

IP: 1 patent application

Optical PPG

Electronics cancelling ECG & PPG artifacts noise emanating from finger movements

PPG ACCELEROMETERS ARTIFACT

Fingers movement Accelerometers do not sense fingers movement Artifact sensor detects movements very accurately

IP: 3 patent applications

Four Unique & Proprietary Technologies

ECG & PPG artifact canceler

IP: 3 patent applications

Electro-mechanical sensor for blood pressure measurement over the radial artery

SYSTOLIC

DIASTOLIC

887 measurements | Mean error = 0.33 STD = 3.0 887 measurements | Mean error = 0.22 STD = 2.1

FDA requirements: Mean error < 5 mmHg STD = 8 mmHg

mmHg = millimeters of Mercury

Four Unique & Proprietary Technologies

Electro-mechanical sensor

Software algorithms for precise vitals measurement based on multi-sensors

Four Unique & Proprietary Technologies

Software algorithms

Pr Prod

• duc

uct t Ha Hard rdwa ware re

Blood Press ssure ure clip clip Smart artwat watch ch

CardiacSen Sense Smart rtwatch atch Conn nnectivity tivity Ec Ecosystem tem

Patient Big Data & AI Analytics for early detection

• f critical events through

digital health applications such as Apple HealthKit and Google Fit

CardiacSense Cloud Offline data Instantaneous Real- Time data in case of event detection

Patient reports

Offline data Big Data & AI Analytics Cloud Offline (Full Disclosure) and Real-Time (Event) data Monitoring Center Cloud Offline data Hospital Electronic Medical Records Cloud Real-Time data Offline data CardiacSense Watch Cradle

Ma Mark rket et Op Oppo port rtuni unity ty

Atria ial l Fi Fibril illati lation

• n (AF)

F) De Detect ection ion

Regula lar pulse se Atrial ial Fibr brillatio illation

The cost of AF- relat ated ed stroke kes

(in the U.S.)

12 12

$B

Long g term monito itori ring ng is the only y known n effec fective ve solution

• n for

heart rt arrhyt rhythmi hmias as

X5

AF increa reases ses the risk k

• f stroke

ke by 5x and stroke ke severit rity y by 5x

(in the U.S.) .)

The leading ing techn hnology

• logy for long-

term m AF F diagnos gnosis is is invasi sive ve and costly y

$

Source for $12B: Natale, A. &, Jalife, J (Eds). (2008) Atrial Fibrillation: From Bench to, (p. 13), NJ: Humana Press

DETECTION DIAGNOSIS MANAGEMENT

Ad Addr dres essa sable ble Ma Mark rket et Si Size ze

Atrial Fibrilla rillation tion (AF) ) Detec ection tion

General Population Consumer wearables High Risk Asymptomatic Risk factors: stroke, age, hypertension, heart failure, diabetes, etc. Symptomatic Initial Diagnostics Post-AF Procedures Ongoing Management U.S. Arrhythmia opportunity (Annual patients in millions)

DETECTION DIAGNOSIS MANAGEMENT

Ad Addr dres essa sable ble Ma Mark rket et Si Size ze

Atrial Fibrilla rillation tion (AF) ) Detec ection tion

General Population Consumer wearables High Risk Asymptomatic Risk factors: stroke, age, hypertension, heart failure, diabetes, etc. Symptomatic Initial Diagnostics Post-AF Procedures Ongoing Management U.S. Arrhythmia opportunity (Annual patients in millions)

Ma Mark rket et Op Oppo port rtuni unity ty

Bl Blood

• d Pressure

ssure (BP BP) ) Me Measure surement ment

Hypertension is a cardiovascular condition that affects 75 million lion American adults Pre-hypertension affects another 75 million lion American adults

46 46% 20 20%

Hypertension can lead to coronary heart disease, stroke and even death. It is sometimes called the ”SILENT NT KILLER”

Do not have it under control Not aware are to be having this condition

51 51

$B

Frequ quen ent t monito itorin ring g is effec ectiv tive to detect hypertension and receive preventative medical treatment or a prescription medication Current home blood pressure monitors are used occasion sionally ally, if at all. In addition, they are inflatable, subject to inacc ccuracies uracies due to movemen ment, position, time of day, size of blood pressure cuff, lack of calibra ibratio tion, “white coat syndrome” and patient error

Pot

• ten

enti tial al Busi sine ness ss Mo Mode dels ls

Sales of Cardiac diacSense ense smartwat rtwatch ches es

via distributors* to medical channels (subscription model): Hospitals, Assisted Living Centres, Mobile Cardiac Outpatient Telemetry (MOCT) centers (e.g. CardioNet, Preventice Solutions)

*Distributors provide services of marketing, sales, logistics, regulatory, and legal. Manufacturing is

• utsourced to medically-certified partners

Sales of Blood

• d Pressure

essure clips

(to watch manufacturers)

Strategic tegic partne tnersh rship ip between

CardiacSense and leading consumer wearables and/or medical equipment companies

SENSITIVITY / SPECIFICITY (DAY-TO-DAY CONDITIONS) STILL ONLY CONDITION 20-40 40-60 60-80 80-100 SPOT CHECK SPOT CHECK EVERY 2 HRS. < 2WEEKS < 1 MONTH < 3 YEARS MONITORING DURATION CONTINUOUS

Co Comp mpet etitio ition

Atria ial l Fi Fibril illati lation

• n (AF)

F) De Detect ection ion

Alivecor Fibricheck Apple 4 iRhythm Zio Medtronic Reveal Linq Holter CardiacSense

Co Comp mpet etition ition

Blo lood

• d Pressu

ssure re (BP) P) Measur suremen ment

Continuous

as long as in a specific position

Once every 15 min

for a full day

Spot-check

30-50 measurements

Spot-check

200 measurements

+++

Non-inflating

++

Non-inflating

+

Inflating cuff

inside a watch

• Inflating cuff
• ver the wrist

Heart arrhythmias, breathing rate

• Heart rate

Heart rate $80 $198 $500 $100

CardiacSense BP clip HealthSTATS Bpro Omron HeartGuide Microlife wrist W100 Monitoring duration Comfort level Integration with

• ther functionalities

Unit price

Eldad Shemesh Chief Executive Officer

• Former VP Engineering, Spacecom
• Former Head of satellite and space systems branch,

Israel Air Force

• B.Sc., M.Sc. in Electrical & Electronics Engineering, Tel

Aviv University

Daniel Naor Board Director

• Former McKinsey partner, Europe & North America
• PepsiCo senior executive, North America
• B.Sc., M.Sc. in Electrical Engineering & Computer

Science, M.I.T.

• MBA, INSEAD European Business School
• Prof. Boris Spector

Optics Design Leader

• Leading 20 electro-optical projects
• PhD in Optics from Russian Academy of Sciences,

Siberian Branch – Novosibirsk

• Senior Scientist and lecturer at the (EE) electrical

engineering faculty, Technion Israel

• Prof. Sami Viskin

Chief Medical Officer (Arrythmia)

• Boston Scientific, Advisory Board
• Director, Cardiac Hospitalization, Tel Aviv

Medical Center, Israel

• Expert on atrial fibrillation
• 140+ publications in peer reviewed journals
• MD, Tel Aviv University, University of California

San Francisco

• Prof. Giris Jacob

Chief Medical Officer (Blood Pressure)

• Director, Internal Medicine, Tel Aviv Medical

Center, Israel

• MD / PhD, Technion - Israel Institute of

Technology

Liat Shemesh Chief Operating Officer

• Experienced operations professional with

strong start-up experience in high-tech companies

• B.Sc. in Chemistry, Tel Aviv University
• M.Sc. in Chemistry, State University of New

York, Syracuse

• Former VP R&D, G Medical Innovations
• B.Sc., Electrical (Electronic) Engineering, Technion -

Israel Institute of Technology

• MBA, Tel Aviv University

Meni Itzhak VP Research & Development Israel Makov Senior Advisor

• Former President & CEO, Teva

Pharmaceuticals

• B.Sc. in Agriculture and an M.Sc. in

Economics, the Hebrew University in Jerusalem

Team

The clinical trial includes

24 patients

based on the following criteria

Completion of the first clinical trial is expected by Marc rch, , 2019

96%

• r higher

Sensitivity FDR

False Discovery Rate

Correlation coefficient R Regression line slope

1± 0.02

Bland-Altman 95% limits of agreement

Average (±tolerance) ± 1.96*SD: 0 (±5) ± 100

2%

• r lower

90%

• r higher

PPV

Positive Predictive Value

80%

• r higher

The pass criteria for the clinical trial are

Skin color r 2 each from Fitzpatrick skin types 5 and 6 (dark) Age Age 2 each from older than 65 and younger than 30 Body Mass s Index 2 each from obese and underweight categories Drivers ivers 4 patients that drive during trial Hairiness s leve vel l 4 patients with high level of hairiness level to assess light transmission A-fib ib 4 patients diagnosed with A-fib

First st Cl Clini nical cal Tr Trial for

• r AF

AF de detec ectio tion by by PPG PPG a and nd/or

• r ECG

CG for

• r FDA Cl

A Clea earanc ance

Roa

• adm

dmap ap

CURRENT

2019

2020-2021

2022

Smartwatch beta version

Current t

(Non FDA)

A-Fib Cardiac Arrest HR HRV ECG FDA A & CE for A-Fib FDA A & CE Bradycardia FDA A & CE Tachycardia

1st

st generati

ation

• n

FDA A & CE Blood Pressure FDA A & CE Cardiac Arrest FDA A & CE Respiratory Rate Patient Big Data & AI Analytics

2nd

nd generati

ation

• n

FDA A approval l for SPO2 over the wrist FDA A approval l for Heart Failure Galvanic Skin Response Patient Big Data & AI Analytics

3rd

rd generat

ation

• n

Smartwatch commercial version Blood pressure clip commercial version Adding SPO2 sensor

Strategic partnership options

26

Mi Mile lesto stones nes

Successful finalization of preliminary trial for A-Fib Successful finalization of pivotal trial for A-Fib CE clearance for A-Fib FDA clearance for A-Fib Manufacturing of first batch

• f commercial watch

FDA clearance for Tachycardia and Bradycardia FDA clearance for blood pressure FDA clearance for breathing rate

2019 2020 2021

Q

1 2 3 4 1 2 3 4 1 2 3 4 Finalization of clinical trial for FDA clearance of Blood Pressure FDA clearance for Cardiac Arrest

Investment tment round nds and Sub-roun rounds Amount unt raised d ($K) Pre Pre-mo money ney valuation ($K) Comme ment nt

2010-15

1,426 Shift t to medi dical

2016

May 2016 474 4,184 Private investors December 2016 26 5,025 Private investors

2017

May 2017 200 5,225 AY Electronics Ltd. June 2017 1,000 6,000 Public and private investors October 2017 513 10,000 Public and private investors

2018

March 2018 1,524 12,000 Public and private investors December 2018 2,000 20,000 On going Total l 2016-2018 18

5,737

Grand d total l 2010 to date

7,163

Fun undraisin raising Hi Histor tory y to Date

Other r source rces s of income me

Source Amount unt ($K) Israel Chief Scientist 292 Joint program with Korean Chief Scientist 300 NRE from different programs 150 Customer licensing 150 Total 892 892

Cardiac rdiacSen Sense se Dev evel elopmen pment t Costs ts (in $K)

2019 2020 2020 2021 2021

Total tal

Q3 Q3 Q4 Q4 Q1 Q1 Q2 Q2 Q3 Q3 Q4 Q4 Q1 Q1 Q2 Q2 Q3 Q3 Q4 Q4

G&A

187 202 226 241 256 256 256 286 286 286 2,482

R&D

635 659 738 738 738 738 738 738 738 738 7,197

Clinical

265 265 395 395 395 395 395 395 395 395 3,690

Commercial

112 127 150 165 175 195 199 199 199 199 1,720

SOM* Development

330 330 330 330 330 330

• 1,980

Production of first 7,000 watches for clinical trials

100 100 100 100 100 100 100 100 100 100 1,000

Contingencies

100 100 100 100 100 100 100 100 100 100 1,000

Inflation @3%/year

61 62 63 63 109 111 111 111 691 1,729 1,783 2,100 2,131 2,157 2,177 1,897 1,929 1,929 1,929 19,760

Total l Per Year

3,511 8,565 7,683

*System-on-Module 28

Strate rategic gic partnershi tnerships ps

Potentia ial l Strate ategic ic Partne ner r and d Estimated mated 2018 Sales s of Their r Device ices Impa pact t of Cardi diac acSense nse techno nolo logy gy Apple

$10B Smartwatches Premium pricing + additional volume

Samsung

$2B Smartwatches Premium pricing + additional volume

Fitbit

$1B Smartwatches Premium pricing + additional volume

Omron

$1B Inflatable Blood Pressure Monitors Existing business substitution

Medtronic

$1B Insertable Cardiac Monitors Existing business substitution

Example: Apple Watch premium of $100 over 30M units = $3B per year

Econ

• nomi
• mics

cs of

• f CardiacSen

Sense se smartwa watch tch to me

• medical

l cha hannel el

(subsc scri ript ption

• n model)

2020 2020 2021 2021 2022 2022 2023 2023 2024 2024

10 100 200 300 800 8,000 16,000 24,000 ($0) ($200) ($2,000) ($4,000) ($6,000) ($1,843) ($2,032) ($2,811) ($3,671) ($4,533) ($1,843) ($1,432) $3,189 $8,329 $13,467

2020 2020 2021 2021 2022 2022 2023 2023 2024 2024

Units (in K) 5 20 70 120 180 Cumulative Units (3 years) 5 25 95 210 370 Revenue (in $K) $1,400 $6,500 $24,100 $49,800 $84,600 Variable Costs ($500) ($2,000) ($7,000) ($12,000) ($18,000) Fixed Costs ($6,723) ($6,381) ($8,313) ($11,060) ($14,722) Profit ($5,823) ($1,881) $8,787 $26,740 $51,878

Econ

• nomi
• mics

cs of

• f B

Blood

• od Pressure

sure clips to w

• watch

h manufa facturers urers

Smartwatch sales price $100 per unit Subscription fee for 36 months minimum $15 per month Smartwatch cost $100 per unit Development costs increase after 2021 10% growth Distributor support 10%

• f revenue

Blood Pressure clip sales price $80 per unit Blood Pressure clip cost $20 per unit

30

In Concl clusion usion

• There is an unmet need for long-term medical monitoring of heart

conditions (such as arrhythmia) and vitals (such as blood pressure)

• Current smartwatches do not provide such capabilities, despite the

hype

• CardiacSense has a clinically proven technology to address these

needs in a watch form-factor

• FDA and CE clearances for heart arrhythmias are expected by Q4,

2019

• FDA and CE clearances for blood pressure monitoring are expected

by Q4, 2020

• Commercialization is expected to commence in H2, 2020
• Discussions with leading consumer wearable and medical equipment

companies are ongoing

• We are seeking to raise $20M of funding to support this game plan

THANK YOU!

Eldad Shemesh, CEO

eldad@CardiacSense.com +972.54.7000.824

CardiacSens Sense Apple le Comme ment nts Application AF detection Irregular rhythm suggestive of AF Apple not approved for AF detection due to low performance Monitoring type Continuous Spot-check, once every 2 hours Apple constrained by high power consumption Time to detect AF/irregular heart rhythm up to 5 minutes Up to 48 hours Sensitivity 97% 79% Apple info submitted to the FDA Specificity 97% 71% Apple research on the net Operating time 4 days 1 day CardiacSense with System-on-Module has one month

• perating time per charge

Can monitor diagnosed AF patients Yes No Major issue for Apple as this is a 6 million people market in the US alone Can detect finger movements Yes No Apple does not have the artifact sensor Can detect Cardiac Arrest Yes No Apple does not have the artifact sensor Medical device clearance Yes No Apple received the clearance for software in the cloud/mobile/watch only

36

Tec echnical ical Per erfor formance mance Comp mparison arison

FDA Re Regul ulato atory ry Strateg rategy y & Timel meline ine

CardiacSense is striving to have FDA clearance for heart arrhythmias detection by its smartwatch

FDA clearance for AF detection by PPG and/or ECG

Target for clinical trials: Sensitivity = 100%, Specificity = 93%

▪ Following the Pre-Submission process, and successful clinical trials in 2016 at the Tel Aviv Medical Center in hospital conditions, the company has started its clinical trial for FDA approval through the DeNovo route. This consists of two clinical trials at ambulatory conditions:

• Preliminary trial: 24 people partitioned to 6 groups

(Skin color, Age, BMI, Driving, Hairiness level, A-Fib) ▪ Primary endpoint: Beat by beat correlation between PPG and ECG ▪ Timeframe: trial will be completed on March 2019

• Pivotal trial: 100 people at one hospital in the US (Cleveland Clinic) and

three different hospitals in Israel ▪ Primary endpoint: AF detection ▪ Timeframe: trial will be completed by July 2019 ▪ CE mark is expected in Q3 2019, and FDA clearance is expected in Q4 2019 ▪ Subsequently, CardiacSense will conduct extensive clinical trials with Cleveland Clinic as well as

• ne of the biggest HMOs in Israel (Maccabi)
• Over 1,000 people will be monitored for more than six months in a study focused on

health in the community ▪ Primary endpoint: proving that CardiacSense system can reduce A-Fib treatment cost, hospitalizations, and percentage of strokes ▪ Timeframe: trial will be completed in 2020

FDA Re Regul ulato atory ry Strateg rategy y & Timel meline ine

CardiacSense is striving to have FDA clearance for heart arrhythmias detection by its smartwatch

FDA clearance for additional heart arrhythmias detection, such as Bradycardia and Tachycardia

• Results from preliminary clinical trial (beat to beat correlation)

will be used in this trial for detection of additional arrhythmias

• Expected clearance route: 510(k)
• Timeframe: 2020

FDA Re Regul ulato atory ry Strateg rategy y & Timel meline ine

CardiacSense is striving to have FDA clearance for heart arrhythmias detection by its smartwatch

FDA clearance for continuous measurement of absolute blood pressure

• During the past year CardiacSense has been collecting data at the

Tel Aviv Medical Center in a clinical trial to mature its technology

• Additional clinical trial will be conducted with 15 people in the US
• Expected clearance route: 510(k) (Tonometry)
• Timeframe: 2020

FDA Re Regul ulato atory ry Strateg rategy y & Timel meline ine

CardiacSense is striving to have FDA clearance for heart arrhythmias detection by its smartwatch