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IMPEDIMED LIMITED Investor Presentation 2018

Oct 16, 2018

65135_rns_2018-10-16_94bbf393-d601-4568-bdfc-4cb9222d75e0.pdf

Investor Presentation

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Annual General October 2018 Meeting

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Investor Presentation

ASX:IPD October 2018 Annual General Meeting

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www.impedimed.com

Annual General October 2018 Meeting

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Disclaimer

  • The material contained in this document is a presentation of general information about the activities of ImpediMed Limited (“ImpediMed”) current as at the date of this presentation. The information is provided in a summary form, does not purport to be complete and should not be relied upon as advice for investment purposes. This presentation does not take into account the investment objectives, financial position or needs of any particular investor. Independent advice should be sought before making any investment decision.

  • SOZO[®] is intended only for use in countries in which it has received regulatory approval or clearance. Inclusion of products and information does not imply any official medical advice, recommendation or warranty. The information provided is not a substitute for the advice of an appropriate health professional. This website can be accessed from countries around the world and may contain references to products that have not been granted regulatory approval or clearance in your country. You should consult your health professional for detailed information regarding ImpediMed’s products and their suitability for you, as well as the regulatory approval or clearance status of such products in your country.

  • To the extent permitted by law, no responsibility for any loss arising in any way (including by way of negligence) from anyone acting or refraining to act as a result of this presentation or its contents is accepted by ImpediMed or any of its officers, employees or agents.

  • The information in this presentation is subject to change and unless required by law, ImpediMed assumes no obligation to update this presentation or its contents for any matter arising or coming to ImpediMed’s notice after the date of this presentation.

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Forward Looking Statements

  • Certain statements in this presentation may constitute forward-looking statements or statements about future matters that are based on management’s current expectations and beliefs. The forward-looking statements in this release include statements regarding the timing of the launch of the next generation product, the ability of the new features to broaden the appeal of the product, and the ability of new product to meet the needs of the customer base, among others. These statements are subject to risks and uncertainties that are difficult to predict and are based on assumptions as to future events that may not prove accurate. Actual results may differ materially from what is expressed in this presentation.

  • There can be no assurance that any existing or future regulatory filings will satisfy the relevant authorities’ requirements regarding SOZO[®] nor can there be any assurance that SOZO[®] will be approved or cleared for all applications by any authorities for sale in any market or that they will reach any particular level of sales. In particular, management’s expectations regarding ImpediMed’s ability to commercialize SOZO[®] , including its estimates of potential revenues, costs, profitability and financial performance could be affected by, among other things, unexpected trial results, including additional analysis of existing data, and new data; unexpected regulatory actions or delays, or government regulation generally; its ability to maintain patent or other proprietary intellectual property protection; competition in general; government, industry, and general public pricing pressures; and additional factors that involve significant risks and uncertainties about our products, product candidates, financial results and business prospects. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected.

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Investment Highlights

  • Cancer Survivorship >US$1.8 Billion annually

  • Large and Attractive Markets Chronic Heart Failure >US$1.0 Billion annually • Successfully building high margin SaaS subscription business

  • • Highly disruptive non-invasive digital health platform for the clinical monitoring of fluid and tissue

  • Differentiated Advantages Robust patent portfolio with more than 40 families • Cloud based data of patient measurements allows for proprietary analytics and algorithm optimisation

  • • Lymphoedema – PREVENT Trial and Peer-reviewed Publications of 1,460 patients in 5 studies

  • Significant Body of Clinical Evidence CHF – Peer-reviewed Publications of ~250 patients in 5 studies • +400 Peer-Reviewed Publications using BIS for tissue and fluid monitoring across many chronic diseases

  • • FDA Clearance for the clinical assessment of unilateral and bilateral lymphoedema

  • Regulatory Clearances FDA Clearance for monitoring patients with CHF (clinical and at-home monitoring) • CE Mark for multiple indications including lymphoedema, CHF, renal failure

  • • Category I CPT Code[®] for lymphoedema

  • Reimbursement Existing codes for CHF and home monitoring • Our model fits the evolving US reimbursement environment (Fee-for-Service to Value Based Medicine)

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Major Achievements Last 12 Months

Growing Body of Clinical Evidence Strengthens BIS Value Proposition

  • Lymphoedema

  • PREVENT Lymphoedema Trial Top-line Results

    • 95% reduction in the progression to clinical grade lymphoedema

    • Bioimpedance spectroscopy (BIS) and L-Dex[®] suggested as the new standard of care for cancer survivors at risk of developing lymphoedema by Principal Investigator of PREVENT Trial

    • First PREVENT Trial paper published with outstanding initial data. The authors from the PREVENT trial concluded that L-Dex[®] is very sensitive in the assessment of sub-clinical lymphoedema in patients with a history of breast cancer and recommends an aggressive measurement protocol

  • 3 independent studies published showing significant reductions in progression to clinical grade lymphoedema

  • Multiple presentations of new clinical data on reduction of progression of lymphoedema presented at global medical conferences

  • Chronic Heart Failure

  • Correlation case study of SOZO[®] versus CardioMEMS™ (r=0.876) presented at 23rd World Congress on Heart Disease

  • Correlation case study and clinical utility of SOZO[®] to monitor CHF patients presented at American Heart Congress - CVD

Subscription-Based SOZO[®] Digital Platform Introduced

  • Since the launch of SOZO[®] $5.9 million of contracted revenue booked

  • 4 leading cancer institutions become SOZO[®] Centres of Excellence (University of Kansas, University Hospitals of Cleveland, Sharp Medical Center, and Macquarie University Hospital)

Guidelines Enhanced

  • American Physical Therapy Association (APTA) recommends L-Dex[®] testing for sub-clinical lymphoedema, expanding the use from current to existing cancer survivors (an 8 fold increase in potential patients)

New and Expanded Regulatory Clearances

  • FDA 510(k) clearance received for monitoring fluid in patients with chronic heart failure

  • FDA 510(k) clearance received for the clinical assessment of patients with bilateral lymphoedema (expands the potential patient population by more than 700,000 in the US annually)

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Corporate Overview

  • ASX listed (October 2007)

  • Operations in US (San Diego, CA), Australia (Brisbane) and Europe (Greece) (70 total staff)

  • Market capitalisation ~AU$165M (~379M shares on issue)

  • Cash on hand AU$27.2M (30 September 2018)

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Share Register Breakdown
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2%
23%
75%
Institutional
Private
Founder/Management
Substantial Shareholders
2%
23%
75%
Institutional
Private
Founder/Management
Substantial Shareholders
Allan Gray 17.0%
Fidelity (FIL) 7.5%
Starfish Ventures 6.8%
Kinetic Investment Partners 6.4%
Macquarie Group Limited 6.2%
Paradice Investment Management 6.1%

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October 2018

Business Highlights
















Key Stats (AUD $ Millions)
(Preliminary and unaudited)
Q4
FY18
Q1
FY19
Change
%
Change
Contracted Revenue Pipeline (CRP) $3.5 $4.7 $1.2 34%
Total Contract Value (TCV) $1.9 $1.4 ($0.5) (26%)
Annual Recurring Revenue (ARR) $1.3 $1.8 $0.5 38%
Medical Revenue $1.1 $0.9 ($0.2) (18%)
SaaS Revenue $0.1 $0.2 $0.1 100%

Key Points

  1. Q2 FY18 began transitioning business to SaaS subscription business model in conjunction with the introduction of the SOZO[® ] Digital Health Platform

  2. Contracted Revenue Pipeline (CRP) is the future period revenue amounts related to Total Contract Value (TCV) that are yet to be reported as recognised revenue

  3. Total Contract Value is the total value of customer contracts signed during the period including one-time and recurring revenue

  4. Annual Recurring Revenue (ARR) is the normalised amount of revenue reasonably expected to be booked for the next 12-month period based on existing signed contracts, and assuming installation upon sale

  5. Subscription revenue now accounts for 24% of the company’s quarterly medical revenue (up from 10% in the previous quarter)

  6. Strong customer and SaaS pipeline building

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SaaS Business Model ~~FY18 Revenue~~

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A$4,800,000 FY18 Revenue
A$4,200,000
A$3,600,000
A$3,000,000
SaaS business
model
A$2,400,000
introduced
A$1,800,000
A$1,200,000
A$600,000
A$0
Q1FY18 Q2FY18 Q3FY18 Q4FY18 Q1FY19
SOZO [®] begins shipping 510(k) Clearance
to US customers for bilateral LE
23 Oct 17 Apr
Medical Revenue Annual Recurring Revenue
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Contracted Revenue Pipeline

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BIS Technology is Non-invasive, and provides Fast, Accurate and Medically Meaningful Information

Low Frequency

Current passes around cells High Frequency Current passes through cells

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Advantages

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Accurate
Fluid

Fast

Sensitive

Fat
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Non-invasive
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  • Informative

• Actionable

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Muscle
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  • Medically Meaningful

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Bone
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~60% of the human body is made up of water

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SOZO[® ] - Next Generation BIS Digital Health Platform

  • SOZO[® ] has the potential to change health care by identifying early onset of disease states both in the clinic and at home, leading to improved patient outcomes

  • SOZO[®] is the world’s ONLY cloud-based, non-invasive, individualised fluid monitoring device with proven, peerreviewed accuracy for delivering medically meaningful results in as little as 30 seconds

  • SOZO[®] combines the technology of our world-renowned scientific and medical devices into a single digital health platform

  • SOZO[®] has multiple FDA clearances and CE Mark, with more clearances on the horizon

  • SOZO[®] is the only fluid measurement device with over 1,100 patients enrolled in a randomised controlled trial

  • SOZO[®] will take advantage of data collected for continuous improvement of care

  • SOZO[®] is poised to enter its first billion dollar plus markets (CHF and LE) with a SaaS model which allows for easy upgrades and entry in to other large markets

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• L-Dex [®] for assessing sub-clinical
unilateral and bilateral
lymphoedema
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• Chronic Heart Failure fluid
monitoring
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• Hydration status
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  • Extracellular fluid • Intracellular fluid • Total body water

  • Fat-free mass • Skeletal muscle mass

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• Protein and mineral content
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Initial Focus on Cancer Survivorship and Chronic Heart Failure

Cancer Survivorship

  • Cancer and its treatments have a huge impact on the body that often affect the quality of life after the disease

  • 1.7M new cases of cancer and 15.5M living cancer survivors in the US

  • 1 in 3 cancer survivors will develop lymphoedema as a result of their cancer treatment

  • SOZO[®] can assist with the early detection of lymphoedema and other aspects of patient management (nutrition, bone density, muscle wasting)

Addressable Market US$1.8 Billion annually

Chronic Heart Failure (CHF)

  • CHF is a progressive disease in which patients experience a permanent decline every time they have a major cardiac event

  • 6.5M CHF patients in the US of which 25% (1.6M) are classified as Class-III (moderate-tosevere)

  • CHF currently costs the US healthcare system >US $31B in hospitalisation costs alone

  • SOZO[®] can detect small changes in fluid levels that typically pre-empt a major cardiac event which may be avoided by adjusting medication

Addressable Market >US$1.0 Billion annually

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Cancer Survivors

  • More than 15.5 million in the US

  • More than 5 million patients suffering from persistent cancer related lymphoedema

  • 1 in 3 people will develop lymphoedema

  • Cancer survivors have a 15-fold increased risk of developing heart failure

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L-Dex[®] for the Early Detection of Subclinical Lymphoedema

Lymphoedema is a leading post-surgical complication for many cancer patients and greatly impacts quality of life. Simple and accurate measurement of fluid in limbs allows early detection and intervention

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L-Dex [®]
Stage 0 Stage 1 Stage 2 Stage 3
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  • Cancer treatment can damage the lymphatic system and result in fluid build-up in the extremities

  • It can become an irreversible, life-long, debilitating condition that progressively gets worse

  • L-Dex[®] detects the onset of lymphoedema very early, ~36 ml of fluid build up versus 200 ml+ for other approaches

  • L-Dex[®] has been clinically proven to detect sub-clinical lymphoedema up to 10 months before any visible symptoms

  • If detected at stage 0 or stage 1, the progression of lymphoedema can be prevented, and often reversed

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PREVENT Trial — Pre-specified Interim Analysis

Trial Design

  • Multi-centre, prospective, randomised controlled trial • 1,100 patients enrolled

  • Followed for 3 years

  • 10 medical centres across the US and Australia

  • Majority NCI designated cancer centres

  • To achieve a relative 20% improvement over the standard of care — a tape measure

Primary Aim

  • To determine if sub-clinical detection of extracellular fluid accumulation via BIS and subsequent early intervention reduce the rate of progression relative to rates seen using standard tape measurements

Interim Data

  • Early results demonstrate a 67% relative improvement in progression to persistent lymphoedema in the L-Dex arm compared to tape measure arm

  • Reflecting what others are seeing in their clinical practice

12 Month Interim Data from PREVENT Trial

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Patients n = 500 / 1,100
analyzed
Cancer patients
Trial arm CONTROL ARM TEST ARM
developing persistent
monitor with tape monitor with L-
lymphoedema each day
measure Dex®
>560
(n = ~250) (n = ~250)
Trigger N = 68 N = 41
events (27.2%) (16.4%)
requiring
N = 109
intervention
(21.8%)
The possible future,
<21 per day
Patients
developing N = 10 N = 2
67% relative
lymphoedema (14.7%) (4.9%)
improvement
after
intervention
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Independent Clinical Evidence Continues to Expand The North American market for compression therapy is estimated at over US$1 Billion, a 75% reduction in lymphoedema has the potential to create a favourable impact throughout the medical system

Investigator
Duration
Reported Outcomes
Percent
Reduction
Number of
Patients
Investigator
Duration
Reported Outcomes
Percent
Reduction
Number of
Patients
Investigator
Duration
Reported Outcomes
Percent
Reduction
Number of
Patients
Investigator
Duration
Reported Outcomes
Percent
Reduction
Number of
Patients
Investigator
Duration
Reported Outcomes
Percent
Reduction
Number of
Patients
Kilgore
2018
2014-2017 • 34% identified elevated L-Dex®followed by intervention
• 6% progressed to clinical stage disease versus reported incidence rate of 20-40%
82% 146
Whitworth
2017
2010 - 2016 • 12% identified elevated L-Dex®followed by intervention
• 3% progressed to clinical stage disease versus reported incidence rate of 10-50%
75% 596
Kaufman
2017
2010 - 2016 • 10% identified elevated L-Dex®followed by intervention
• 0% progressed to clinical stage disease versus reported incidence rate of 20-53%
100% 206
Laidley &
Anglin 2016
2008 – 2013 • 12% identified elevated L-Dex®followed by intervention
• 3% progressed to clinical stage disease versus reported incidence rate of 3.5-47%
75% 326
Soran
2014
2010 – 2013 • 33% identified elevated L-Dex®followed by intervention
• 4% progressed to clinical stage disease versus reported incidence rate of 36%
88% 186
Total Patients Evaluated 1,460

Multiple, independent, investigator-led clinical studies have reported significantly lower rates of persistent lymphoedema by monitoring patients with L-Dex[®] and intervening

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SOZO[®] Adoption Accelerating

SOZO[®] Worldwide Customer Base

  • 114 SOZO[®] customers

  • 71 U400 customers converted

  • 43 new institutions installed

  • 234 contracted SOZO[®] devices

  • Subscription contracts up to 3 years

  • Monthly subscription fee based on indication licensed and estimated initial patient volume

  • 12,800 patient assessments completed

  • 72% unilateral lymphoedema

  • 6% bilateral lymphoedema

  • 22% tissue analysis

Impact

  • Large cancer institutions contracting for greater number of devices (4:1)

  • Expanded testing due to device ease of use and subscription business model

  • Increasing patient testing

  • Protocol adoption and routine testing taking hold

  • Inquiries into new indications

  • Inquiries into tissue analysis

New Revenue Opportunities

  • Additional device sales to existing institutions

  • Expanded utilisation

  • Commercial payors

  • New indications and tests

SOZO[®] Patient Tests by Quarter 6,500

4,875

3,250

1,625 0 Q1'18 Q2'18 Q3'18 Q4'18 Q1'19

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New Centre of Excellence

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The University of Kansas Cancer Center

Evolution and Acceleration of SOZO[®]

  • Ranked as one of the nation’s leading cancer centres for eight years in a row (US News and World Reports)

  • One of only 70 National Cancer Institute (NCI) designated cancer centres

  • 5 SOZO[®] Digital Health Platforms installed at two Breast Surgery Clinics

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  • 9 additional SOZO[®] Digital Health Platforms are planned for six medical oncology sites (November 2018)

  • Accredited by the National Accreditation Program for Breast Centers (NAPBC)

  • Commission on Cancer (CoC) accredited

  • Considering adding additional SOZO[®] units

  • Expanding to pelvic cancers in January

  • Cancer patients to be tested following a disciplined protocol

  • They expect more than 2,000 newly diagnosed cancers patients per year to be enrolled in testing program

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Establishing SOZO[®] as Standard of Care

PREVENT Trial Update

  • Interim results under peer review

  • Submitted to key cancer publication

SOZO[®] Reimbursement Strategy

  • NCCN Guidelines[®]

  • Inclusion of formalised protocol and BIS technology

  • Commercial Payors

  • Present to key regional payors

  • Request formal technical review

  • Present to top national payors

Awareness Campaign

  • Physicians

  • Presentation of PREVENT data at key medical congresses and physician training meetings

  • Educational seminars expanded

  • Press release of PREVENT Trial results and success stories at key cancer centres

  • Institutions

  • Articles in key journals focusing on reducing costs and improving patient outcomes

  • Patients

  • Approach key patient advocacy groups to ensure members are aware of the PREVENT Trial interim results and where they can go for testing

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Chronic Heart Failure

  • Global pandemic affecting at least 26 million people worldwide

  • 1 in 5 people over the age of 40 will develop heart failure

  • Most common cause of hospitalisation of people 65 years and older

  • Overall global economic cost in 2012 was estimated at US$108 Billion annually

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CHF Overview

CHF is a chronic, progressive and debilitating condition

Among the most expensive diseases for the US Healthcare system

6.5M+ patients

US government funding bonuses and assessing penalties for physicians and hospitals that over/under perform

Reducing hospital stay and readmission is a major focus

and readmission is a US$31B+ hospitalisation costs alone major focus Assessing / monitoring fluid status is critical to the management of CHF patients

A change of fluid status may signal the need to increase/ decrease medication levels

Correct medication levels significantly reduce hospital stays and readmissions

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Role of SOZO[®] in Optimising Outcomes for CHF Patient Management

• Current practice is to monitor CHF patients daily for fluid burden in clinic and at-home

• Current monitoring methods have major shortcomings

Weight Scale • Inaccurate and rudimentary (although low cost ~US$150 per month)
Implantable Devices • Invasive and expensive ~US$25,000 (although accurate/precise)

SOZO[®] is uniquely positioned to replace current monitoring methods

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Precision/accuracy of implantable…

...at the cost of a scale

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US CHF Business Model

Initial Focus on Class III CHF Patients

  • Estimated at 25% of US 6.5 million CHF patients

  • Monitor and manage the disease progression for Class III patients

SOZO[® ] CHF Usage Model

  • Baseline reading to be performed in a clinical setting

  • Daily monitoring to continue in either a clinical or remote setting

SOZO[® ] CHF Revenue Model

  • Initial device purchase plus a per patient per month subscription model

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Preliminary Estimate of Initial US Addressable Market
Estimated initial patient population ~1.6 million
Preliminary estimated addressable per
annum US market based on US$60 per >US$1.0 Billion [1]
patient per month over 12 months
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  • Well established and growing in CHF market

  • Excludes revenue from initial device sales

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SOZO[® ] Non-invasively Correlates to CardioMEMS™ at a Fraction of the Cost

Case Study

  • Patient with advanced heart failure, implanted CardioMEMS™ device, multiple co-morbidities

  • Changes made in diuretic medication to keep fluid balance stable

  • Weight, mental acuity, as well as PA pressures were utilised to guide therapy

  • During the monitoring period patient experienced periods of dehydration and subsequent fluid overload

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r = 0.876

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Conclusion

SOZO[®] BIS measurements had a correlation coefficient of 0.876 with changes in diastolic pulmonary artery pressure as measured with CardioMEMS™ to detect fluid excess and impending congestion before hospitalisation

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Heart Failure Action Plan

SOZO[®] Regulatory Milestones

  • CE Mark achieved June 2017

  • FDA 510(k) clearance for fluid monitoring of patients living with CHF achieved December 2017

Clinical Data for Marketing Purposes

  • Working with world leading institutions on CHF trials

    • First data presented at 23rd World Congress on Heart Disease July 2018

    • Correlation case study and clinical utility of SOZO[®] to monitor CHF patients presented at American Heart Congress - CVD

  • Data from initial CHF studies has led to initiation of larger multi-centre study

  • Study commenced, first patient enrolled 9 October 2018

  • ~200 patients

  • Fluid measurements during hospitalisation for CHF and daily for 45 days after discharge (at-home)

  • Study will be catalyst for initiating broad market release

Favourable Reimbursement and Guidelines Regime

  • Reimbursement code established to pay providers to remotely manage patients

  • Current guidelines in place for daily monitoring of Class III patients for fluid burden in US

Broader Market Release

  • Targeted for 2H CY2019

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Annual General October 2018 Meeting Expected Milestones and Upcoming News Flow

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SOZO[® ] for Cancer

  • •PREVENT Trial interim results published •PREVENT educational seminars expanded •PREVENT Trial — additional publications •NCCN Guidelines[®] — The addition of a formal testing protocol and BIS technology •Podium presentations at major medical congresses •Private payors begin coverage of L-Dex[®] — catalyst for broad adoption in US •Continued strong growth in SOZO[®] SaaS subscription based business •Expanded indications for managing cancer survivors

  • SOZO[®] for Heart Failure •Release of additional CHF studies utilising SOZO[®] •Completion and results of larger multi-centre study •Commercialisation of SOZO[®] for CHF

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Appendix

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Annual General October 2018 Meeting Management Team Deep and Broad Commercialisation Experience

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Richard Carreon

Frank Vicini, MD Chief Medical Officer

Morten Vigeland

Chief Financial Officer

Managing Director and Chief Executive Officer

  • Joined September 2014

  • Joined April 2011

  • Joined July 2012

    • 20+ years in financial management in the medical technology industry
  • 25+ years as radiation oncologist

  • 30+ years experience

  • • Extensive experience in the medical device field and growth companies

  • • Previously Vice President at Medtronic (10 years)

  • Completed his fellowship at Harvard Medical School, has authored over 200 peer reviewed publications, and participated in 6 NIH clinical trials and the MammoSite Registry trial

  • Experience in med-tech

  • start-ups and emerging growth companies

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Dennis Schlaht

David Adams

Nancy Deisinger

SVP Ventures, Licensing & Corporate Development

SVP R&D and Technology

VP Human Resources

Joined July 2016 20+ years in human resources, including 10+ years in medical device, working with start-ups to Fortune 500 companies Previously AVP Human Resources at 3E Company

  • On Board November 2013 to August 2016

  • • Joined August 2016 • Background as medical device investment & business development executive

• Joined October 2007 • 30+ years in engineering development and product marketing • Previously Vice President of Marketing and Product Development at XiTRON’s Test and Measurement Business

  • 25+ years experience in tax, financial planning, and business development

  • • Previously Vice President, Integrations and Divestitures at Medtronic

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Catherine Kingsford

SVP Medical Affairs

  • Joined January 2007

  • 20+ years global clinical experience with medical devices

  • Previously worked as a cardiac scientist at several world-class medical institutions including St. Andrew's War Memorial Hospital, The Prince Charles Hospital, and Royal Brompton Hospital

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Shashi Tripathi

Chief Technology Officer

Joined July 2018 20+ years as a healthcare technology leader

  • • •

Previously SVP of Technology & Operations at New Century Health, where he oversaw all aspects of IT, project and product management, product development and operations

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Annual General October 2018 Meeting

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Board of Directors

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Scott R. Ward

  • MS, BSc Non-Executive Director

  • Joined July 2013

  • Venture capitalist with 30+ years experience in healthcare industry

  • Previously Senior Vice President and President of the Cardiovascular business of Medtronic

  • Chairman of the Board of

  • Creganna-Tactx Medical Devices and

  • Cardiovascular Systems, Inc.

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Gary Goetzke Juris Doctorate Non-Executive Director

  • Joined August 2016

  • 15+ years in senior management positions with medical device companies

  • Currently the Principle and Chief Executive Officer of Compass Medical Advisors, LLC

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Robert M. Graham

AO, FAA, FAHMS, MBBS, MD, FRACP, FACP, FAHA Non-Executive Director

  • Joined January 2018

  • Received medical training at the University of South Wales where he is now the Des Renford Professor of Medicine

  • Inaugural Executive Director, Victor Chang Cardiac Research Institute, Sydney Australia

  • 17+ years experience in US healthcare and currently a consultant physician in cardiovascular diseases

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Richard Carreon

Managing Director and Chief Executive Officer

Joined July 2012

  • 30+ years experience

  • Extensive experience in the medical device field and growth companies

  • Previously Vice President at Medtronic (10 years)

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Judith Downes

Non-Executive Director

  • Joined April 2017

  • 20+ years of accounting

  • and senior management expertise with large ASX listed companies

  • Previously a CFO at

  • Alumina Limited and CFO/ COO of Institutional Division, ANZ Banking Group Limited

  • Currently Board Chairman of Bank Australia Limited and Honorary Fellow of the University of Melbourne’s Faculty of business and Economics

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Donald A. Williams

Amit R. Patel

BAcy, CPA Non-Executive Director

MBA, BME Non-Executive Director

  • Joined March 2017

  • Joined March 2017

  • 35+ years in leadership roles serving the life science, biotech, and medical device industries

  • 8+ years in senior management positions

  • Currently on the board of

    • Vios Medical and
  • Currently the Audit Pillsbury United Committee Chair of Akari Communities •

  • Therapeutics, Alphatec Currently the CEO and Holdings, Marina Biotech, Co-Founder of Vios and Proove Biosciences, Medical and the Compensation Committee for Marina Biotech

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