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CANARY BIOTECH & HEALTHCARE INVESTOR ROADSHOW
Wednesday 8 July 2015: iSonea will be presenting at the Canary Biotech & Healthcare Investor
Roadshow to be held on Wednesday 8th
July in Melbourne and Thursday 9th
July in Sydney.
The investor presentation is attached and the key messages for new investors are outlined below:
• Unique first mover advantage with its proprietary ARM™ technology to detect and measure
wheeze
• A multi-product portfolio in respiratory health not based on one product and thus lower risk for
investors.
• Core technology that has been used by world leading respiratory physicians and scientists.
• Forefront of digital/mobile health platforms that will change asthma care
• Huge global market with over 300 million people with asthma
• Asthma is a global burden for health systems
• Business turnaround by new Board and Management team
• Clear pathway forward to monetise the business
• Valuation potential Substantial transactions starting to occur in digital health
Leon L’Huillier
Chairman
+61 (0)3 9653 9321
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World’s First Digital Wheeze Detection Technology for the Management of Asthma
An Australian owned company with Israeli & Australian technology
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About iSonea®World’s First Digital Wheeze Detection Technology for the
Management of AsthmaiSonea is a medical device company with an innovative portfolio of
wheeze detection & measurement products that help patients &
physicians improve asthma management and reduce preventable
emergency room visits, hospitalisation & unnecessary worry &
suffering.
iSonea has unique leading edge acoustic sensors, proprietary
algorithms and software platforms to objectively detect and
measure wheeze, an important symptom of asthma.
Its latest product, AirSonea®, is a remote patient monitoring device
and app.
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Changing Asthma CareChanging Asthma CareChanging Asthma CareChanging Asthma Care
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Why Why Why Why investinvestinvestinvest now?now?now?now?The company is now well positioned to create shareholder value and has substantialvalue creation potential:
• Unique first mover advantage with its proprietary ARM™ technology to detect and measure wheeze
• A multi product portfolio in respiratory health not based on one product and thus lower risk for investors.
• Core technology that has been used by world leading respiratory physicians and scientists.
• Forefront of digital/mobile health platforms that will change asthma care
• Huge global market with over 300 million people with asthma
• Asthma is a global burden for health systems
• Business turnaround by new Board and Management team
• Clear pathway forward to monetise the business
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Valuation potential: Substantial transactions starting to occur in digital healthFor
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Have you noticed you’ve been wheezy, breathless or coughing lately? Are you
using your medication more? Is your asthma interfering with you usual
activities?
Asthma Australia Spring 2014 UpdateFor
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Asthma Symptoms
The main symptoms of asthma:
• Wheezing
• Shortness of breath
• A tight chest
• Coughing
When airways become inflamed, flow pressure changes
during respiration causing the airway wall to flutter. This
flutter results in acoustic energy, or wheeze. The flutter
or wheeze is a manifestation of airway flow limitation.
“If an infant presents with frequent and/or severe
episodes of recurrent wheezing they should be
diagnosed and managed as asthma, unless there is
evidence to the contrary.” Global Asthma Report 2014
Airflow Limitation
Changing Asthma CareChanging Asthma CareChanging Asthma CareChanging Asthma Care
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• iSonea continues to have a first mover advantage with its unique proprietary Acoustic RespiratoryMonitoring (ARM™) algorithm technology.
• Our ARM technology records airway sounds to detect continuous adventitious breath sounds andmeasure the extent of wheezing caused by airway obstruction. The measurement is presented asWheezeRATE™.
• iSonea devices work like a stethoscope utilising special contact microphones, or acoustic sensors, topick up breath sounds from the lungs at the windpipe (trachea), and in the clinical devices, the chest.
Actual wheezing event from an asthma patient, recorded with iSonea’s ARM technology.
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First Mover Advantage/Computerised Wheeze DetectionFirst Mover Advantage/Computerised Wheeze DetectionFirst Mover Advantage/Computerised Wheeze DetectionFirst Mover Advantage/Computerised Wheeze Detection
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The company’s portfolio of computerised wheeze detection products and apps
AirSonea®, WHolter™, SonoSentry™, WheezoMeter™, PulmoTrack™ and the
AsthmaSense ™ App
Have been approved by the Australian TGA and carry the European Union’s CE mark. All except AirSonea have US
FDA clearance
A MultiA MultiA MultiA Multi----Product Portfolio to Lower Risk for InvestorsProduct Portfolio to Lower Risk for InvestorsProduct Portfolio to Lower Risk for InvestorsProduct Portfolio to Lower Risk for Investors
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Health authorities universally agree effective tools to improve patient self-management of asthma arecritical.
“TheTheTheThe developmentdevelopmentdevelopmentdevelopment ofofofof robustrobustrobustrobust acousticacousticacousticacoustic devicesdevicesdevicesdevices forforforfor useuseuseuse atatatat thethethethe bedsidebedsidebedsidebedside –
as exemplified by electronic stethoscopes paired with small
convenient recorders and perhapsperhapsperhapsperhaps inininin thethethethe formformformform ofofofof aaaa smartphonesmartphonesmartphonesmartphone withwithwithwith
anananan appappappapp - may provide the long-awaited portable objective means to
record, analyse, and store lung sounds just as any other clinical
information is measured and stored. This development will make
sound tracking possible, further enhancing the usefulness of
auscultation.”
“Fundamentals of Lung Auscultation” by Abraham Bohadana,
M.D.Gabriel Izbicki, M.D.
& Steve S Kraman M.D. NewNewNewNew EnglandEnglandEnglandEngland JournalJournalJournalJournal ofofofof MedicineMedicineMedicineMedicine
370;9 NEJM:ORG FEBRUARY 20, 2014
AirSonea® Asthma Wheeze Monitor Device & App
The convenient and easy-to-use AirSonea device
connects via Bluetooth® with the asthma management
smartphone app to detect and measure wheeze.
The 30 second recording and WheezeRATE algorithm analysis
takes place within the app with measurements results displayed
on the smartphone screen. The results and actual sound files
are automatically uploaded to the
cloud servers so the entire history can be reviewed and shared
with doctors and other healthcare providers via secure email.
The app features asthma management diary features;
medication usage and reminders, and symptoms and triggers to
help asthma sufferers gain a better understanding of how their
condition affects them and importantly, help them better
adhere to their treatment plans. Further features including
weather conditions and pollen count are planned.
Remote (Home) Monitoring ProductsRemote (Home) Monitoring ProductsRemote (Home) Monitoring ProductsRemote (Home) Monitoring Products
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SonoSentry™1 (WheezoMeter™) and New
SonoSentry™ 2 Prototype. Standalone device
with inbuilt LCD screen.
iSonea has achieved the first clearance of an Over-
the-Counter (OTC) wheeze detection device in the
United States. With FDA clearance, the company
can market the device in the USA as an OTC
product without the need for the purchaser to
obtain a prescription from a medical practitioner.
Computation is performed on the device and a
phone, phone service or a server is not required
(however, there is additional value in being able to
extract information from the device to be placed
on a server).
iSonea is actively investigating the potential to
substantially lower the costs of production of
SonoSentry 2 to evaluate a commercial launch of
this product in China and developing countries.
Remote (Home) Monitoring ProductsRemote (Home) Monitoring ProductsRemote (Home) Monitoring ProductsRemote (Home) Monitoring Products
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WHolter™
Symptoms of asthma, including wheeze, are
generally worse at night and early morning.
The WHolter is designed for 8 - 24 hour home ambulatory
recording (nocturnal, wheeze, cough). This option of
monitoring Asthma patients and collecting data for a
period of time in their own home is important and has
excellent potential to develop service and consumables
revenues around it. WHolter uses PulmoTrack software
and currently connects to a PC via USB.
Next Step: upgrade to wireless capability and app
function
Home Monitoring: NocturnalHome Monitoring: NocturnalHome Monitoring: NocturnalHome Monitoring: Nocturnal
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PulmoTrack® Computerised
Wheeze Detection
PulmoTrack is iSonea’s foundation product,
designed for hospital/clinic-based real-time
monitoring of wheeze and cough in the
management of acute, severe asthma in the
ER and IC, and for Pediatric Pulmonary
Function Testing and Sleep Labs. The
PulmoTrack module has a wireless connection
to a PC.
In a recent study conducted at the Department of Neonatology, Charité University Medical Centre, Berlin, Germany, wheezes were detected
using the PulmoTrack® Model 2020. “….an instrument developed for continuous tracking and recording of breathing sounds and the
detection of wheezing. Computerised wheeze detection is feasible during the first year of life. This method is more objective and can be
more readily standardised than subjective auscultation, providing quantitative and noninvasive information about the extent of
wheezing”. Puder et al BMC Paediatrics 2014
Clinical/Hospital MonitoringClinical/Hospital MonitoringClinical/Hospital MonitoringClinical/Hospital Monitoring
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History of 14 clinical publications, using iSonea’s proprietary Acoustic Respiratory Monitoring (ARM™) technology.
JOURNAL OF ASTHMA
Vol. 41, No. 8, pp. 845-853, 2004ORIGINAL ARTICLE
Wheeze Detection: Recordings vs. Assessment of
Physician and Parent
M. L. Levy, 1,4,* S. Godfrey, 2,# A. Sheikh, 4 W. Hanekom, 5 Ambulatory Care
Nurses, 5 A. Bush, 6 and P. Lachman
1. Kenton Bridge Medical Centre, London, UK
2. Hadassah University Hospital, Jerusalem, Israel
3. Karmel Medical Acoustic Technologies Ltd., Yokneam Ilit, Israel
4. Division of Community Health Sciences, GP Section, University of Edinburgh, Edinburgh,
Scotland
5. Northwick Park Hospital, London, UK
6. Royal Brompton Hospital, London, UK
Core ARMCore ARMCore ARMCore ARM™ ™ ™ ™ Technology Research Published by World leading PhysiciansTechnology Research Published by World leading PhysiciansTechnology Research Published by World leading PhysiciansTechnology Research Published by World leading Physicians
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Two of the globally renowned physicians who have published on wheeze detection were keynote
speakers at recent major asthma conferences held in Australia during 2015
Globally Renowned Physicians Speak at Asthma ConferencesGlobally Renowned Physicians Speak at Asthma ConferencesGlobally Renowned Physicians Speak at Asthma ConferencesGlobally Renowned Physicians Speak at Asthma Conferences
Professor Andrew BushProfessor of Paediatric Respirology, Royal
Brompton Hospital, NHS Foundation Trust.
Faculty of Medicine, National Heart and
Lung Institute.
Dr Mark LevyRespiratory lead for the Harrow Clinical
Commissioning Group in Harrow, London.
Senior Clinical Research Fellow, University
of Edinburgh (2004-2014).
Professor Andrew Bush Dr Mark Levy
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iSonea’s Medical & Scientific Advisors are Internationally Respected iSonea’s Medical & Scientific Advisors are Internationally Respected iSonea’s Medical & Scientific Advisors are Internationally Respected iSonea’s Medical & Scientific Advisors are Internationally Respected
Professor Noam Gavriely, MD, D.Sc
He has been conducting basic and applied research on
pulmonary acoustics for over 25 years and is an
international authority in this field. He is extensively
published in various aspects of breath sounds, including the
1995 CRC press book on "Breath Sounds Methodology",
and holds multiple US and international patents on
phonopneumography and other aspects of breath sounds
monitoring. Dr. Gavriely received his M.D. and D.Sc. from
the Technion-Israel Institute of Technology and did his post-
doctoral fellowship at the Harvard School of Public Health
and the Brigham and Women’s Hospital.
Prof. Simon Godfrey, MD, PhD, FRCP, FRCPCH
is Emeritus Professor of Pediatrics at the Hadassah-Hebrew
University, Jerusalem. His major clinical interests are in
pediatric pulmonology and asthma. His main research
interests are in pediatric pulmonary physiology, infant lung
function, asthma, bronchial provocation and the application
of novel investigative techniques for the diagnosis and
management of pediatric pulmonary diseases. Prof.
Godfrey has published over 190 original papers, 16 books
and contributed numerous chapters to other books, in
addition to written editorials on pediatric pulmonary topics.For
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iSonea at Forefront of Explosive Field of Digital HealthiSonea at Forefront of Explosive Field of Digital HealthiSonea at Forefront of Explosive Field of Digital HealthiSonea at Forefront of Explosive Field of Digital Health• First wave: Fitness and wellness devices
The first wave of this trend is already evident in the rapid consumer adoption of wearable sensors and smartwatches which produce data related to physical activity, although of limited or little clinical value.
• Second wave: Digital health platforms for complex diseases
The second wave includes the monitoring of symptoms and behaviour in chronic disease management, such as wheezedetection and measurement in asthma, glucose monitoring for diabetics.
• Third wave: Big data
The third wave will come with algorithms and software that can sense and interpret multiple factors and conditions that couldimpact symptoms, in order to identify risks and issues alerts for avoidance. This aspect involves the collection and analysis ofBig Data from multiple sources, including the networks of device users.
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Smartphones provide an engine for this change: It is estimated that there will be 10 billion mobile devices in use
worldwide by 2016.
“We're all essentially surgically connected to our smartphones, and we're still in the early stages of
realising their medical potential.”
Dr. Eric Topol, Director, Scripps Translational Science Institute
#1 Most Influential Physician Executive in the USA, Modern Healthcare National Poll
Health conscious consumers are already embracing self-management and this is evident in the growth of wearable
fitness sensors such as Fitbit.
The continued shift toward accountable care will encourage the adoption of remote patient monitors
for chronic diseases like asthma, diabetes and cardiovascular illness, with the goal of keeping patients
out of the hospital, lowering costs and improving care.
Remote Patient Monitoring: Key Driver of GrowthRemote Patient Monitoring: Key Driver of GrowthRemote Patient Monitoring: Key Driver of GrowthRemote Patient Monitoring: Key Driver of Growth
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Traditional MonitoringPeak Flow Meters
Outdated technology, not suitable for
children, patient compliance poor and
considerable patient effort.
Respiratory Digital Health:
Asthma & COPDSensors, apps, text and analytics to
monitor and control symptoms.
Convenient, effortless, objective symptom
measurement - iSonea
iSonea has broad patents that could provide barriers to entry iSonea has broad patents that could provide barriers to entry iSonea has broad patents that could provide barriers to entry iSonea has broad patents that could provide barriers to entry
Digital Health Platforms Replace Outdated TechnologyDigital Health Platforms Replace Outdated TechnologyDigital Health Platforms Replace Outdated TechnologyDigital Health Platforms Replace Outdated Technology
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• 334 million people have asthma
• 14% of the world’s children experience asthma symptoms
• 8.6% of young adults (aged 18-45) experience asthma
symptoms
• Approximately 250,000 people die prematurely each year
from asthma. Almost all these deaths are avoidable (WHO
2007)
• China: Over 30 million but probably closer to 100 million
• USA: 25 million, 10% of children
• Europe: 30 million
• UK: 5 million
• Australia: 2 million
Huge Global Asthma MarketHuge Global Asthma MarketHuge Global Asthma MarketHuge Global Asthma Market
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The asthma burden to society is massive in terms of asthma
deaths, hospitalisation, emergency visits, missed days of
schooling and work.
In the USA, for example:
• 5,000 deaths per annum
• 2 million emergency department visits
• 500,000 hospitalisations
• 27 million missed days of school and work
Creates a burden cost of over $56 billion annually or $2,200
per person including both the direct and indirect medical
expenses associated with asthma, it is estimated that the
total cost is closer to $82.5billion annually, or $3,300 per
person.
Source: US department of Health and Human Services CDC 2014
Asthma is a Major Health BurdenAsthma is a Major Health BurdenAsthma is a Major Health BurdenAsthma is a Major Health Burden
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• Nearly half of adults with asthma in Australia had poor asthma control and 29% needed urgent health care for
asthma in the previous year according to a recent study published in Medical Journal of Australia. 3
• 49% of the people who had died in the UK from asthma in 2012 were being treated for mild or moderate asthma
when it is likely that many of these patients had poorly controlled, undertreated asthma. 4
• 48% of adults diagnosed with asthma who were taught how to avoid triggers did not follow most of this advice 5
• Medication adherence is poor. Data suggests approximately 30% of patients do not take their medications as
prescribed.
“Although written asthma action plans have been recommended in national guidelines for the management of asthma for over 20
years, the majority of people with asthma do not have one.”
Asthma in Australia 2011
The Australian Centre for Asthma Monitoring, Woodcock Institute of Medical Research
1. Centers for Disease Control and Prevention (CDC) : Asthma Statistics/Asthma Society of Canada,
2. Global Asthma Network: Global Asthma Report 2014
3. Medical Journal of Australia 202 (9) 18 May 2015: Asthma control in Australia: a cross-sectional web-based survey in a nationally representative population
4. Why Asthma Still Kills, The National Review of Asthma Deaths (NRAD) May 2014
5. Centers for Disease Control and Prevention, Vital Signs, May 2011.
Asthma is Poorly Controlled and New Tools are EssentialAsthma is Poorly Controlled and New Tools are EssentialAsthma is Poorly Controlled and New Tools are EssentialAsthma is Poorly Controlled and New Tools are Essential
Asthma is poorly controlled and new tools are needed to help patients.
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iSonea has conducted extensive market research in the US and Australia that shows our functional, user
friendly product line will meet the expectations of our customer base that includes parents and patients,
the medical profession, insurers, pharmacies and retailers.
Key Findings: Parents
• Parents of children with asthma are constantly worrying about their child’s health and wondering when the next
attack will occur and what will trigger it.
• They admit they could be more diligent and none feel like they are in complete control.
• They also find it difficult to articulate the severity of symptoms.
• ‘Asthma Guilt’ is pervasive. It’s a function of the pressure of day-to-day life overwhelming the best of intentions;
coupled with the more ‘reactive’ approach to an asthma attack rather than ‘proactive’ management. They also find
it difficult to articulate the severity of symptoms to doctors, a source of some frustration.
Adults
• Adults with Asthma (secondary market)… have more established knowledge of their asthma and “know if I’m
wheezing or not”. Certainly interested but not to the same degree as parents.
Market Research: AirSonea an Important Management ToolMarket Research: AirSonea an Important Management ToolMarket Research: AirSonea an Important Management ToolMarket Research: AirSonea an Important Management Tool
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Medical Professionals’ Interest in device: Intent to purchase the AirSonea® wheeze monitoring device ranged from
60% to 95% in the various studies.
iSonea also conducted qualitative in-depth interviews with key asthma experts and a quantitative study with a total of
100 Australian GPs including 50 Paediatricians who routinely treat asthma.
• Results found that 80% of GPs and 62% of Paediatricians in the study would recommend iSonea’s new mobile
wheeze monitoring system to their asthma patients. Providing additional scientific data on the technology would
increase the percentage of these recommendations.
• In general, the product was perceived as an important management tool for patients who would benefit form
more frequent home monitoring of asthma symptoms, which were characterised as 75% of patients with unstable
asthma and approximately half of all patients with stable asthma.
Key Findings: Medical ProfessionalsKey Findings: Medical ProfessionalsKey Findings: Medical ProfessionalsKey Findings: Medical Professionals
Physicians considered home monitoring of asthma “very important”, chiefly to assist in the management of asthma
treatment plans and ensuring medication adherence. They noted that historically, the use of peak flow meters and
diaries has been met with poor compliance and reliability.
*The Independent consumer research studies were conducted by Dectiva LLC, Procter & Gamble Tremor, Galaxy Research, Consilium and Sweeney EY
Research
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Business Turnaround by New Board & Management TeamBusiness Turnaround by New Board & Management TeamBusiness Turnaround by New Board & Management TeamBusiness Turnaround by New Board & Management Team
The new Board appointed in February 2014 has delivered major changes to turnaround the business
1. The business structure has been dramatically simplified, costs reduced and streamlined for clearer focus
2. A totally new software IT infrastructure has been developed to support the AirSonea device and app.
3. Cash burn reduced from near $900,000 pm to a forecast core underlying cash burn of around $240,000 pm.
4. Intellectual Property Portfolio consolidated
5. Leading globally respected scientific advisors appointed
6. Improved relationships with leading clinicians, healthcare professionals and peak Asthma bodies established
7. Broader focus on the whole portfolio of products to open up substantially more commercial opportunities
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The new Board appointed in February 2014 has delivered major changes to turnaround the business
1. Overall, the business structure has been dramatically simplified, costs reduced and streamlined for clearer
focus and accountability and more robust financial controls
• Management are now based in Melbourne, Australia and Haifa, Israel. Senior Management previously resided in
multiple locations including Maryland, Boston, San Diego and New York
• $2.5 million pa taken out of management and staff costs
2. A totally new software IT infrastructure has been developed to support the AirSonea device and app. Our new
software is more robust, scalable and secure. Micro-processing upgrades have addressed firmware bugs.
Further, it provides substantially faster analysis of breath recordings and an app with a more engaging user
interface. The failed launch in Australia indicated web and app problems and the engagement of multiple
service providers situated on four continents resulted in a high cost, over-engineered and incomplete IT
infrastructure.
Business Turnaround by New Board & Management TeamBusiness Turnaround by New Board & Management TeamBusiness Turnaround by New Board & Management TeamBusiness Turnaround by New Board & Management Team
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Net average monthly outgoing cash flows ($000)
433
542
240
881
605543
397
* Prior to finalisation of Quarterly 4C statement. Forecast underlying cash burn
3. Cash burn reduced from near $900,000 per month to a forecast underlying burn of around $240,000 per
month. Estimated cash balance of $2.9 million as at June 30*.
Business Turnaround by New Board & Management TeamBusiness Turnaround by New Board & Management TeamBusiness Turnaround by New Board & Management TeamBusiness Turnaround by New Board & Management Team
High R & D spend
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4. Consolidated Intellectual Property Portfolio: One service provider to ensure our patent strategy is implemented
and that our IP is secured in relevant jurisdictions.
5. Appointed leading globally respected scientific advisors: Prof Noam Gavriely & Prof Simon Godfrey
6. Established improved relationships with leading clinicians, healthcare professionals and peak Asthma bodies in
Australia and overseas.
7. Broader focus on the whole portfolio of products to open up substantially more commercial opportunities in both
the home/ambulatory market and in hospital and clinical settings.
Business Business Business Business Turnaround by Turnaround by Turnaround by Turnaround by New Board & Management TeamNew Board & Management TeamNew Board & Management TeamNew Board & Management Team
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The Wall
PartnershipUser Interface
R&D
Marketing
Two Bulls
App
Development
Grey
Innovation
Product
Development
Life is Digital
Web/Email
hosting
Refined
Manufacturing
China
EY Sweeney
Market
Research
Sterling
Medical
QA
USA
FAL Lawyers
Australia
Shartsis Friese
LLP, USA
Patents
DKC
Consultants
Finance &
Accounts
iSonea BoardExecutive
Chair
iSonea IsraelR&D, Medical &
Scientific
Advisory
iSonea Current PartnershipsiSonea Current PartnershipsiSonea Current PartnershipsiSonea Current Partnerships
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Building shareholder value through global and country partnerships either as joint ventures or sales
and distribution agreements remains our core objective.
Our pathway forward is two-fold and these steps are being managed in parallel
1. Commence commercial discussions with potential partners that include the worlds largest healthcare companies
2. Complete clinical trials on AirSonea overseas, especially in the important North American market
Clear Pathway ForwardClear Pathway ForwardClear Pathway ForwardClear Pathway Forward
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Fitness &
Wellness
DevicesThermometer
Weight Scale
Step Counter
Pulse Oximeter
Heart Rate
Monitor
Blood Pressure
Monitor
Baby Monitor
Chronic Disease
Devices
AirSonea
Wheeze
Monitor
Smart Inhalers
Blood Glucose
Monitors
Cardiology
Patient Self-
Management
Smartphone
Personal Computer
Personal Health
Diary
Internet
Healthcare System
Family Carers
Disease Management
Hospitals &
Healthcare
Providers
Insurance Companies
iSonea Potential PartnershipsMedical Devices & Disease Management
Philips, Omron, ResMed, GE Healthcare, CareFusion, Vectura,
Propeller Health, Alere, Care Innovations, Dexcom, Withings
Big Pharma
GlaxoSmithKline, AstraZeneca, Schering-Plough, Boehringer
Ingelheim, Novartis, Teva,
Smartphone/Portable Health Devices
Apple, Samsung, Xiaomi, Sony, Fitbit, Jawbone, iHealth Labs
TeleHealth
AT&T, Verizon, Telstra, Optus
Digital Platforms
Microsoft HealthVault, Qualcomm, Neusoft, Google, Yahoo
iSonea brings Digital Health Capabilities to Worlds Largest Healthcare CompaniesiSonea brings Digital Health Capabilities to Worlds Largest Healthcare CompaniesiSonea brings Digital Health Capabilities to Worlds Largest Healthcare CompaniesiSonea brings Digital Health Capabilities to Worlds Largest Healthcare Companies
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Trial 1:
The objective is to show AirSonea® is at least as accurate as a consensus of a panel of physicians and trainedexperts in detecting and quantifying wheeze. In the last few years, 14 successful clinical studies have beenconducted using iSonea's proprietary ARM™ technology on patients with obstructive airway disease.
Trial 2:
The objective is to study the efficacy of managing asthma in children during and after an acute attack using theAirSonea device to measure wheeze rate in an Urgent Care/Emergency Department setting.
The company expects Trial 1 to be completed by the end of October and Trial 2 by year end. However, thenumber of variables in clinical trials make it difficult to accurately predict completion dates.
Complete Two AirSonea Clinical TrialsComplete Two AirSonea Clinical TrialsComplete Two AirSonea Clinical TrialsComplete Two AirSonea Clinical Trials
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Valuation Upside: Transactions Now OccurringValuation Upside: Transactions Now OccurringValuation Upside: Transactions Now OccurringValuation Upside: Transactions Now Occurring
Fitbit: IPO: $8 Billion Valuation.
New fitness & wellness product Fitbit Surge tracks
GPS, continuous heart rate, all-day activity stats and
sleep, September 2014.
Xiaomi: iHealth’s small wellness business valued at
over $125million.
Asian smartphone giant, Xiaomi buys 20% stake in
Andon’s iHealth business for $25 million
Wellness Devices
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Dexcom market cap now $5.6 billionDexcom® Introduces Apps That Enable the First Ever Continuous Glucose Monitoring (CGM) on the Apple Watch™ Now
People With Diabetes and Caregivers Have Access to Life-Saving Glucose Data in a Convenient and Discreet Manner Right
from their Wrist
Dexcom continuous glucose monitor (CGM) provides patients the opportunity to track their glucose levels and trends righton their wrist with the Apple Watch™. Additionally, patients or "Sharers" can invite up to five people to view their glucoseinformation and send an alert when the sharer's glucose levels are outside the norm.
Continuous glucose monitoring is considered the most significant breakthrough in diabetes management in the past 40years.
Dexcom Stock Check
32
DexcomDexcomDexcomDexcomComplex Disease Device
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ResMed buys Irish Company, S+ in 2011 and launches consumer product
in America in 2014.
Peter Farrell: “We have a consumer app and device called S+. It tracks
every breath, gives you your sleep history. This is a consumer product. It
was written up in The Wall Street Journal as the best. We’ve sold
thousands. It will be here in 2015.”
The S+ monitors breathing patterns and body movements without
requiring uncomfortable wristbands, mattress strips or electrodes. The
system… allows consumers to log factors such as caffeine and alcohol
intake, as well as exercise, to analyze patterns over time and deliver
personalized sleep strategies.
The capabilities of the S+ go beyond those of fitness devices available on
the market because the S+ algorithm provides personalized suggestions
informed by more than two million nights of proprietary sleep data.
ResMedResMedResMedResMedComplex Disease Device
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Forward Looking StatementsCertain statements made in this presentation are forward-looking statements. These forward looking statements are not historical facts but rather are based on iSonea’s
current expectations, estimates and projections about the industry in which iSonea operates, and its beliefs and assumptions. Words such as "anticipates," "expects,"
"intends," "plans," "believes," "seeks,” "estimates,“ “guidance” and similar expressions are intended to identify forward looking statements and should be considered an at-risk
statement. Such statements are subject to certain risks and uncertainties, particularly those risks or uncertainties inherent in the process of developing technology and in the
endeavour of building a business around such products and services. These statements are not guarantees of future performance and are subject to known and unknown risks,
uncertainties and other factors, some of which are beyond the control of iSonea, are difficult to predict and could cause actual results to differ materially from those expressed
or forecasted in the forward looking statements. iSonea cautions shareholders and prospective shareholders not to place undue reliance on these forward-looking statements,
which reflect the view of iSonea only as of the date of this presentation. The forward looking statements made in this presentation relate only to events as of the date on
which the statements are made. iSonea will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events,
circumstances or unanticipated events occurring after the date of this presentation except as required by law or by any appropriate regulatory authority.
Forward Looking Statements & Medical Device RisksForward Looking Statements & Medical Device RisksForward Looking Statements & Medical Device RisksForward Looking Statements & Medical Device Risks
General Medical Device Risks
• Medical device R&D involves medical and scientific uncertainty and long lead times and there is no certainty that any particular event will occur within a certain time period.
• Technology changes in the medical device and digital health industry are accelerating and new technologies emerge.
• Market acceptance of medical devices is uncertain and can be impacted by difficulties in marketing, acceptance by patients and clinicians, delays in marketing and the
advancement of new competitive products.
• Medical device R&D and manufacturing activities require funding over a long period of time and more working capital is often required to complete development and
commercialisation of certain products.
• Government health regulations, which are subject to change, add uncertainty to obtaining approval to market medical devices.
• Obtaining, securing and maintaining rights to technology and patents are an integral part of securing potential product value and can lead to patent disputes.
• The loss of key personnel can have an adverse impact.
• Potential product liability risks and warranty claims are inherent in the manufacturing, marketing and use of human medical devices.
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iSonea Limited (ISN) is an Australian owned, public company listed on the ASX. It is a developer, manufacturer and marketer of medical devices for the diagnosis
and management of asthma and related chronic respiratory diseases.
Brief History
1996 - 2011: Company Beginnings
• In 1996 Prof Noam Gavriely M.D. D.Sc. founded company Karmel Medical Acoustic Technologies (KMAT) in Haifa, Israel. The company’s technology was based
on innovations in the field of pulmonary acoustics developed by Prof Gavriely. His translation research applied the basic physics of sound into medical and
nursing practice to enhance health outcomes and patient wellbeing.
• In 2006, KMAT (Israel) and Pulmosonix (Australia) were purchased by Salus Technologies, a listed Australian company. The group was renamed KarmelSonix
Ltd.
• In 2011, the company name was changed to iSonea Limited and a new Board of Directors and an American management team were appointed.
2011 - 2013: A major strategic error in September 2013
• A major strategic error was made in 2011 with the decision to rush the design, development, manufacture and launch in Australia of a portable monitoring
device, the AirSonea Asthma Wheeze Monitor and App. Successful FDA cleared clinical products were discontinued and the relationship with the foundation
professors in Israel terminated. The September 2013 online launch failed. The hype around smartphones and mobile health applications gave investors
unrealistic expectations of early success. The product had poor user experience and functionality, no brand recognition nor support from the medical
profession and the broader asthma community.
• This expensive and ill-conceived online launch in September 2013 had a serious impact on the company’s financial and cash position as sales revenue of only
$19k resulted.
2014: Company Turnaround
The company’s financial position was deteriorating rapidly and a new commercially experienced Board was appointed. The Board now comprises of : Mr. Leon
L’Huillier (Executive Chairman), Mr. David Ashmore, Mr. Ross Blair-Holt, Dr. Timothy Oldham and Mr. John Ribot-de-Bresac.
2015:
Appointed the company’s original medical and scientific leaders, Prof Noam Gavriely as consultant and Emeritus Prof Simon Godfrey as Senior Scientific Advisor.
AppendixBrief Company HistoryBrief Company HistoryBrief Company HistoryBrief Company History
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1. February 2013: AirSonea Australian launch foreshadowed
2. September 2013: AirSonea Australia launch
3. November 2013: CEO to step down
4. December 2013: Aggressive sales plan announced
5. Australian launch fails, AirSonea not submitted to FDA
6. New Board announced
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July 2012 July 2013 July 2014 July 2015
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Leon L’Huillier – Executive Chairman
Leon L'Huillier is an experienced Chairman, Company Director and Chief Executive with a strong background in the health sector and venture capital.
He has substantial experience across a range industries, government and the not for profit sector. He is a Deputy Chair of Australian Prostate Cancer
Research, a former Director and Audit Chairman of Woolworths Limited, and other listed public companies. He was Chairman of Repco Limited, one
of the most successful ventures of Archer Capital, a leading Australian VC firm.
Leon was foundation Chair of the Vision CRC at The University of NSW, a former Chairman of the Royal Children's Hospital Brisbane, former Chairman
of the Australian Health Ministers Advisory Council, a former Director of the National Health and Medical Research Council, St. Vincent's Hospital
Melbourne and the Microsurgery Foundation.
Qualifications: MBA, (Chicago), MPhil, (London), BCom (Hons) (Melbourne), FAICD
David Ashmore – Independent Non-Executive Director
David Ashmore is a Fellow of the Institute of Chartered Accountants, a Fellow of the Financial Services Institute of Australasia and a Graduate of the
Institute of Company Directors. He has over 40 years of professional assurance services experience and is a former senior partner at Grant Thornton
Australia and one of its predecessor firms and was a leader in the audit services division for many years.
Mr. Ashmore is an Independent Director and Chairman of Saferoads Holdings Ltd and holds a number of other private company directorships and
appointments as an independent member of Audit and Risk Management Committees.
Qualifications: FCA, GAICD, F.FIN
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Ross Blair-Holt – Independent Non-Executive Director
Ross Blair-Holt brings to the iSonea Board a number of skills, including strategic and structured decision making at all levels of finance expertise, business
processes, risk management, and governance. After working at General Credits Finance Company and Citibank until 1986, Ross has worked for the Bruce
Mathieson Group of private companies from 1986. He is currently Director and CEO of all these companies.
In addition, from 2004 to 2014, Ross was Chief Operating Officer of ALH Group, owner of 330 Hotels across Australia. ALH is owned 75% by Woolworths Ltd and
25% by Mathieson Group. Ross remains a Director of the ALH Group, as well as being a member of the ALH Audit and Risk Committee.
Qualifications: BCom (Melbourne), CPA
Dr. Tim Oldham– Independent Non-Executive Director
Timothy Oldham has more than a decade of direct life sciences business development, alliance management, market entry, and sales & marketing experience in
Europe, Asia and Australia. He is CEO of Cell Therapies Pty Ltd, a leading Asia Pacific provider of collection, manufacturing, delivery and distribution capabilities for
stem cell therapies and regenerative medicine and was President of Asia Pacific for Hospira, Inc. (2007 to 2012), having held a variety of senior management roles
with Mayne Pharma (2002 to 2007) prior to its acquisition by Hospira. These roles encompass the development and commercialisation of pharmaceuticals,
devices, biologics and cellular therapies.
Prior to this, Tim was an engagement manager with McKinsey & Co (1997 to 2001). He has been chairman of the European Generic Medicines Association
Biosimilars and Biotechnology Committee, a Director of the Generic Medicines Industry Association and a member of the Pharmaceutical Industry Strategy Group.
He is a also a Director of Acrux Ltd (ASX:ACR).
Qualifications: BSc (Hons), LLB (Hons), PhD, GAICD
John Ribot de Bresac – Independent Non-Executive Director
Mr. John Ribot-de-Bresac has extensive experience and a strong record of achievement as a senior executive across consumer facing businesses in the sport,
leisure and hospitality industries including in strategy development and implementation. Following a distinguished sports career where he received the Australian
Sports Medal, he was instrumental in the establishment of the Brisbane Broncos and Melbourne Storm, in executive Director roles, and as chairman of the
Brisbane Roar. Currently Mr. Ribot-de-Bresac serves as Director of Victorian Major Events Company, executive chairman of Queensland Clubs Management (QCM),
and owns hospitality venues throughout Queensland.
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