Skip to main content

AI assistant

Sign in to chat with this filing

The assistant answers questions, extracts KPIs, and summarises risk factors directly from the filing text.

IMPEDIMED LIMITED AGM Information 2016

Nov 9, 2016

65135_rns_2016-11-09_daada4dd-d2f9-486a-ae76-9e71db2c9ed5.pdf

AGM Information

Open in viewer

Opens in your device viewer

==> picture [92 x 18] intentionally omitted <==

==> picture [195 x 36] intentionally omitted <==

Annual General Meeting ASX:IPD November 2016

==> picture [231 x 336] intentionally omitted <==

1

==> picture [92 x 18] intentionally omitted <==

==> picture [52 x 52] intentionally omitted <==

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. 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 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 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.

2

==> picture [92 x 18] intentionally omitted <==

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 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 commercialise 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 materialise, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected.

3

Investment Summary

==> picture [92 x 18] intentionally omitted <==

Proven, Proprietary Technology, IPD’s Bioimpedance Spectroscopy (BIS) - provides a simple, accurate, non-invasive system for precisely measuring and monitoring tissue composition and fluid status in a variety of disease states; scientific/clinical validation in a variety of disease states

Next Generation Platform Technology - SOZO™ is the world’s first connected health platform using patented BIS technology; human-centred design, enabling early detection and better management of chronic disease in both clinic and at-home settings

L-Dex[®] , Enables Early Identification of Lymphoedema - affects approximately 20% to 30% of cancer survivors and significantly impacts longterm outcomes

  • 55 leading US cancer centres already adopted - paving way for future revenue flow

  • US reimbursement in place - CPT[® ] Category I code currently enabling physicians to seek reimbursement of US$112 per patient assessment. Increased to US$124 effective 1 January 2017. Requires engagement with the local Medicare Administrative Contractors if and when necessary

  • Strong clinical endorsement - premier US cancer centres and clinicians in various post-approval trials

  • NCCN and ACS/ASCO Guidelines for Breast Cancer - lymphoedema management included for the first time in guidelines

Chronic Heart Failure (CHF), BIS Potentially Used as an Early Warning Indicator of Fluid Burden - positioning to pursue significant and compelling market opportunity in CHF

  • Established practices / guidelines - US daily monitoring of class III CHF patients for fluid burden, EU remote patient monitoring with CardioMEMS for unstable class III CHF patients in ESC guidelines

  • Established market - US 5.7 million CHF patients, EU 6.5 million

  • Established economic need - Hospital Readmission Reduction Program and Physician Quality Reporting System Bonus Program

  • Partnering with major institutions - Harvard Clinical Research Institute, the Mayo Clinic, Lancaster General, Atlantic Health, and Scripps Health

  • Reimbursement pathway - a reimbursement code has been established to pay providers to remotely manage patients

  • On track for regulatory clearance / approval CY2017 - CE Mark (early ’17) FDA 510(k) submission (early ‘17)

Strong IP Position - over 200 patents and patents pending

4

==> picture [92 x 18] intentionally omitted <==

Major Achievements Last 12 Months

  • CY 2016 Oct • 55 Leading Cancer Centres now using L-Dex on high risk breast cancer patients

  • AU$2.8 million Research & Development tax credit received

  • Mayo Clinic to use SOZO™in CHF study

  • • Study published on efficacy of L-Dex in clinical practice

  • Sep • Scripps to use SOZO™in CHF study

  • Aug • FDA releases draft guidance for “Use of Real-World Evidence to support regulatory decision making”

  • • Announced next generation device - SOZO™

  • • Mayo Clinic joint technology development agreement signed

  • Jul • Redox agreement signed expanding Electronic Health Record integration

  • • Vanderbilt to Begin Human Factors Testing of Next Generation Device

  • • Medicare announces 13% increase in L-Dex reimbursement

  • May • Mayo Clinic 5 year clinical trial agreement signed Feb • Successful AU$75 million private placement •

  • CY 2015 Jan Established noted US CHF advisory board • US commercial launch of L-Dex commences

  • Dec • Lymphoedema included in the American Cancer Society / American Society of Clinical Oncology guidelines

  • Nov Harvard Clinical Research Institution to lead ImpediMed’s pivotal CHF study

  • Oct Purchase key assets and intellectual property of Intersection Medical

5

==> picture [92 x 18] intentionally omitted <==

Corporate Overview

ASX listed (October 2007) Management Change July 2012 S&P/ASX 300 – added March 2015

==> picture [23 x 24] intentionally omitted <==

==> picture [27 x 26] intentionally omitted <==

Operations in US (San Diego, CA and Bloomington, MN), Australia (Brisbane) and Europe (Greece) (77 staff)

==> picture [24 x 21] intentionally omitted <==

Market capitalisation ~AU$520M (~374M shares on issue)

==> picture [25 x 25] intentionally omitted <==

Cash on hand AU$73.4M (30 September 2016)

==> picture [233 x 78] intentionally omitted <==

==> picture [233 x 78] intentionally omitted <==

==> picture [280 x 26] intentionally omitted <==

----- Start of picture text -----

SHARE PRICE PERFORMANCE
----- End of picture text -----

==> picture [279 x 182] intentionally omitted <==

SUBSTANTIAL SHAREHOLDERS SUBSTANTIAL SHAREHOLDERS
AllanGray 13.4%
Fidelity (FIL) 8.3%
Starfish Ventures 6.8%
UBS 6.5%
KineticInvestmentPartners 5.2%
ParadiceInvestmentManagement 5.0%

6

==> picture [92 x 18] intentionally omitted <==

Financial Year 2016

==> picture [256 x 58] intentionally omitted <==

==> picture [256 x 58] intentionally omitted <==

==> picture [256 x 58] intentionally omitted <==

==> picture [256 x 58] intentionally omitted <==

==> picture [256 x 57] intentionally omitted <==

==> picture [256 x 57] intentionally omitted <==

==> picture [188 x 16] intentionally omitted <==

----- Start of picture text -----

ONCOLOGY REVENUE (000’s)
----- End of picture text -----

==> picture [159 x 16] intentionally omitted <==

----- Start of picture text -----

MARKET CAP (millions)
----- End of picture text -----

==> picture [158 x 16] intentionally omitted <==

----- Start of picture text -----

CASH BALANCE (000’s)
----- End of picture text -----

==> picture [511 x 163] intentionally omitted <==

----- Start of picture text -----

$3,500 $90,000 $400
$2,625 $67,500 $300
$1,750 $45,000 $200
$875 $22,500 $100
$‐ $‐ $0
FY12 FY13 FY14 FY15 FY16 FY12 FY13 FY14 FY15 FY16 FY12 FY13 FY14 FY15 FY16
----- End of picture text -----

7

==> picture [92 x 18] intentionally omitted <==

Bioimpedance Spectroscopy (BIS) Technology

==> picture [388 x 23] intentionally omitted <==

----- Start of picture text -----

BIS Technology
----- End of picture text -----

==> picture [72 x 119] intentionally omitted <==

----- Start of picture text -----

Fluid
Fat
----- End of picture text -----

==> picture [63 x 9] intentionally omitted <==

----- Start of picture text -----

Low Frequency
----- End of picture text -----

==> picture [60 x 92] intentionally omitted <==

==> picture [150 x 128] intentionally omitted <==

----- Start of picture text -----

Unique Spectra
256 Frequencies
Impedance
----- End of picture text -----

==> picture [87 x 137] intentionally omitted <==

----- Start of picture text -----

Current passes around cells
High Frequency
Current passes through cells
----- End of picture text -----

==> picture [72 x 119] intentionally omitted <==

----- Start of picture text -----

Muscle
Bone
----- End of picture text -----

Advantages

  • Simple and sophisticated method for measuring fluid and tissue composition

  • A rapid, non-invasive system that provides highly

  • accurate data

  • The full frequency spectrum approach used by IPD provides the most accurate impedance information available about each of the fluid compartments of the body

  • No assumptions are made about the normal distribution of Extracellular Fluid (ECF) and Intracellular Fluid (ICF), something typically done by BIA devices and which does not hold true in many disease states where excess fluid exists

  • With accurate determination of each fluid compartment based on individual measurements, there is no need for the general, population-specific regression algorithms used by BIA devices

8

==> picture [112 x 26] intentionally omitted <==

Simple and Sophisticated Tool for Chronic Disease Management

What’s New

  • No longer requires gel backed electrodes

  • Patients no longer required to be prone when being tested

  • Testing no longer requires an examination room

  • Cloud based, HIPPA security compliant

  • Designed for improved workflow in clinics reducing testing time to seconds

  • Patient interface with healthcare provider

  • Integrates with patients medical records

  • Uniquely simple for easy patient use

  • Opens up the at-home market

  • SOZO™ designed to significantly expand our clinical footprint

Enhancements

  • 4 channels

  • Measures both sides of the body as well as full body

  • Segmental measurements

Other Opportunities

  • Clinicians/institutions regularly inquiring about SOZO™ for a variety of potential uses in disease states where measuring fluid is critical

==> picture [92 x 18] intentionally omitted <==

==> picture [76 x 262] intentionally omitted <==

==> picture [103 x 21] intentionally omitted <==

==> picture [88 x 5] intentionally omitted <==

==> picture [95 x 16] intentionally omitted <==

  • SOZO™ Fit sales to be targeted in select markets where appropriate

9

==> picture [92 x 18] intentionally omitted <==

==> picture [112 x 26] intentionally omitted <==

Patient

Centred Design

==> picture [279 x 401] intentionally omitted <==

Data Means Nothing without a Patient at the Centre

Patient Centred Design

Designed with over 15 years of patient and clinician based feedback to move SOZO™ from research based to inside and outside the clinic use.

Simple User Interface

With only seconds for each reading, the interface has been designed with speed and accuracy in mind. Whether it is inside of a clinic where accurate data is critical for decision support, or at home in the comfort of your own environment, SOZO™ is there to support and enable users on a daily basis.

Data that is Meaningful to Outcomes

Presentation of confusing data makes it difficult to make a good decision. The information gathered by SOZO™ is presented in a way that is personalised for each user. Each reading comes with a narrative about the patient, their progress and how to enhance their personal journey.

10

11

==> picture [792 x 335] intentionally omitted <==

----- Start of picture text -----

For Lymphoedema
in Cancer Survivors
----- End of picture text -----

with L-Dex for the Early Detection of Lymphoedema

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

==> picture [106 x 167] intentionally omitted <==

Cancer treatment can damage the lymphatic system and result in fluid build up in the extremities

If not treated, it can become an irreversible, life-long, debilitating condition that progressively gets worse

==> picture [222 x 167] intentionally omitted <==

L-Dex is able to detect the onset of lymphoedema very early, ~35 ml of fluid build up versus 200 ml+ for other approaches

SOZO™ is designed to be used both clinically and at-home

==> picture [133 x 168] intentionally omitted <==

If detected early, the progression of lymphoedema can be prevented, and often reversed

A simple compression sleeve worn for ~ 4 weeks is normally required after each elevated assessment

SOZO™ is not yet approved, cleared or registered for sale

12

==> picture [280 x 335] intentionally omitted <==

----- Start of picture text -----

Commercialisation
of L-Dex
Well on Track
----- End of picture text -----

==> picture [92 x 18] intentionally omitted <==

2015 - US Commercial launch of L-Dex commenced December 2015

2016 - National Launch

  • 55 (anticipate 65+ by end of CY) multi-disciplinary cancer centres utilising L-Dex in their high risk breast cancer programs

  • Integrating L-Dex into clinical work flow practices and systems

  • 2017 - Expansion Drivers

  • Reimbursement increase commencing 1 January 2017 (Potentially pushes testing time from December 2016)

  • Double customer base in top tier cancer centres

  • Continue to add NCCN Alliance Cancer Centres

  • Clinical and Study data generated globally to drive uptake

  • Private payors begin to cover

  • Expand to all cancer related lymphoedema in original CY2016 highvalue cancer centres

  • Commence at-home business

  • Apply to NCCN for inclusion of our technology (BIS) in cancer guidelines

  • Introduction of SOZO[TM] expected to drive acceleration of sales (testing takes seconds vs ~10 min)

2018 and beyond - Aiming to establish L-Dex as standard of care both clinically and at-home

13

==> picture [334 x 357] intentionally omitted <==

==> picture [92 x 18] intentionally omitted <==

==> picture [204 x 44] intentionally omitted <==

For CHF

14

==> picture [92 x 18] intentionally omitted <==

Heart Failure Large and Compelling Opportunity

Heart Failure

Is a chronic, progressive condition in which the heart muscle is unable to pump enough blood through to meet the body's needs for blood and oxygen. At first the heart tries to make up for this by:

  • Enlarging. When your heart chamber enlarges, it stretches more and can contract more strongly, so it pumps more blood. With an enlarged heart, your body starts to retain fluid, your lungs get congested with fluid and your heart begins to beat irregularly.

  • Developing More Muscle Mass. The increase in muscle mass occurs because the contracting cells of the heart get bigger. This lets the heart pump more strongly, at least initially.

  • Pumping Faster. This helps to increase the heart's output.

CHF is Among the Most Expensive Diseases for Medicare

  • Estimated 5.7 million people in the US suffer from heart failure

  • 870,000 newly diagnosed cases per year

  • Heart failure costs the US an estimated US$31 billion each year

  • By 2030 these costs are expected to increase to US$70 billion

  • 80% of these costs are spent on hospitalisation

  • Length of stay and readmissions have become major issues

“If this (BIS) technology has the ability to measure alterations in fluid levels accurately over time, it has the potential

to significantly improve the delivery of care for heart failure patients.”

-Dr. Roy Small

15

==> picture [92 x 18] intentionally omitted <==

CMS is Aggressively Addressing Escalating Costs

Chronic Care Quality Measures

Key CMS chronic care quality measurement programs includes Physician Quality Reporting System (PQRS): Provides incentives (0.5-2% bonus) to physicians and group practices.

Chronic care measures include:

  • Diabetes

  • Heart failure

Hospital Readmission Reduction Plan (HRRP)

HRRP penalises hospitals with relatively higher readmission rates for Medicare patients.

Relative measures so hospitals need to outperform against their peers.

Penalties are a reduction in payment of up to 3% for every Medicare patient for 12 months.

  • Coronary artery disease

  • Stroke management

  • COPD and asthma management

Readmission is to any hospital for any reason (“all causes”) within 30 days.

  • Current focus on:

  • Heart attack

  • Heart failure

  • COPD

  • Hip or knee replacements

44% of eligible providers earned an incentive in 2014, totaling $224 million

86% of the 9.5 million Medicare Readmissions resulted in penalties in 2014, totaling $420 million

16

==> picture [92 x 18] intentionally omitted <==

Current Heart Failure Monitoring Methods Inaccurate or Invasive and Expensive

The assessment of fluid burden is critical to the Current monitoring methods have major management of CHF patients shortcomings

  • Current practice is to monitor CHF patients daily for fluid burden in both a clinical and home setting

  • Compelling clinical evidence and support for the role of BIS in monitoring fluid burden in CHF patients

  • Weight Scale - inaccurate, unable to distinguish fluid increase from fat or muscle weight gain

  • Implantables - invasive and expensive $25k+

==> picture [633 x 199] intentionally omitted <==

----- Start of picture text -----

Device Method Measurement Brought on by
Weight Scale Weight gain 2 kilograms gained in 2 days Fluid burden
Intrathoracic Impedance Resistance Fluid burden
Implantables
PA Waveforms Cardiac Filling Pressure Fluid burden
----- End of picture text -----

17

==> picture [92 x 18] intentionally omitted <==

Optimising Outcomes for Heart Failure Patients

HF Classification % of Patient Population (est)
Class I 35%
Class II 35%
Class III 25%
Class IV 5%
  • Class III/IV HF patients account for the majority of the annual HF readmission and length of stay rates would have hospital readmissions

  • Reducing readmissions has a profound impact on the cost of care and improves the outcomes for these patients

  • BIS technology may be used as an early warning system for cardiac decompensation with the potential to optimise patient care and significantly reduce hospital readmissions

“BIS can detect and follow the changes in lung impedance in patients and is sensitive to extracellular volume. Since most patients with acute HF suffer not only from pulmonary edema but also from edema in the limbs, a combination of different segmental BIS measurements offers the best option to manage the course of disease.” - Weyer 2014

==> picture [325 x 154] intentionally omitted <==

Heart Failure HospitalisationHeart Failure Hospitalisation

==> picture [325 x 189] intentionally omitted <==

18

==> picture [92 x 18] intentionally omitted <==

Heart Failure Program Making Rapid Progress

In Progress

Targeted

Achieved

Regulatory

  • FDA 510(k) Submission

  • CE Mark anticipated

Clinical Research Studying Diagnosed Unstable CHF Patients

  • Scripps Health

  • The Mayo Clinic, Lancaster General Hospital, and Atlantic Health Systems

  • European study

  • Pivotal trial

Reimbursement

  • Reimbursement barriers are known and manageable as remote monitoring of CHF patients is well accepted by payors and providers

  • Technologies for early detection of fluid burden may result in significant cost savings to hospitals, accountable care organisations and integrated delivery systems trying to avoid costly readmissions due to CHF

Early CY2017 Early CY2017

Early CY2017

Early CY2017

Mid CY2017 Mid CY2017

CHF Advisory Boards

  • US Key Opinion Leaders

  • Harvard Clinical Research Institution

  • US Reimbursement

Key Partnerships

  • The Mayo Clinic joint development agreement

  • REDOX Electronic Medical Records Integration

  • Vanderbilt Human Factors Testing

Sophisticated Technology

  • SOZO[TM] Integrated platform

  • Chronic Disease Management Software Suite

  • Cloud based, HIPPA Security Compliant

19

==> picture [92 x 18] intentionally omitted <==

Noted Medical Advisory Board Providing Guidance

US Advisory Board Members and Clinical Research Team

Paul Friedman, MD - Vice Chair, Department of Cardiovascular Medicine, Medical Director, Remote Monitoring, Mayo Clinic

Roy Small, MD - FACC, FSCAI, Medical Director of Clinical Research, Lancaster General Hospital

J. Thomas Heywood, MD - Director, Heart Failure Recovery and Research Program, Scripps Health

Advising the company on study design, clinical utility, and implementation of hospital and remote patient monitoring for SOZO™

Andrew Accardi, MD - Chairman of Emergency Medicine, Scripps Memorial Hospital Encinitas

Laura Mauri, MD, M.Sc. - Chief Scientific Advisor, Harvard Clinical Research Institute; Recognised leader in the use of statistical methods in clinical

20

==> picture [92 x 18] intentionally omitted <==

==> picture [117 x 28] intentionally omitted <==

==> picture [70 x 23] intentionally omitted <==

----- Start of picture text -----

CHF
----- End of picture text -----

Potential CHF Business Model

  • Initial focus on Class III CHF patients

  • Estimated at 25% of US 5.7 million CHF patients

  • Goal is to monitor and manage the disease progression for Class III patients

  • Initial phase to establish SOZO[TM] CHF program in select key clinics

  • Baseline reading will be performed in a clinical setting

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

  • Initial device purchase plus a per patient per month subscription model well established and growing in CHF market

  • Phillips

  • Medtronic

  • St. Jude Medical

Preliminary Estimate of US Addressable Market

Estimated Initial Patient Population ~ 1.4 Million Preliminary Estimated Addressable Per Annum US Market > US$1.0 Billion* • Based on $60 per patient per month over 12 months

*Excludes revenue from initial device sales

21

==> picture [92 x 18] intentionally omitted <==

Important Milestones

Next 18 Months

Regular updates on L-Dex adoption and sales expansion

  • CE Mark for SOZO™

  • Geographical expansion

  • FDA clearance for SOZO™

  • Conversion and integration of SOZO™ into clinical practices (short-term resource focus)

  • Global studies drive adoption and expand reimbursement

  • Private payors to begin coverage of L-Dex

  • Progress on inclusion of lymphoedema in additional cancer guidelines

  • • Expand L-Dex business model into patients’ homes

SOZO™ CHF coming to market

  • Completion and reporting of feasibility studies

  • Completion and reporting of pivotal trial

  • CE Mark and FDA Clearance

  • SOZO™ CHF commercial launch

SOZO™ Technology platform advancements

  • Drives expansion into new synergistic technology opportunities under joint development agreements

  • Expands business development opportunities

22

==> picture [319 x 59] intentionally omitted <==

==> picture [127 x 49] intentionally omitted <==

“Innovation is at our core and will be the life-blood of our future”

23

==> picture [132 x 53] intentionally omitted <==

Appendix

24

Management Team Has Deep and Broad Commercialisation Experience

==> picture [116 x 139] intentionally omitted <==

==> picture [109 x 132] intentionally omitted <==

==> picture [110 x 132] intentionally omitted <==

==> picture [109 x 129] intentionally omitted <==

==> picture [109 x 125] intentionally omitted <==

==> picture [92 x 18] intentionally omitted <==

==> picture [108 x 137] intentionally omitted <==

==> picture [110 x 136] intentionally omitted <==

  • Frank Vicini, MD Morten Vigeland Jack Cosentino David Adams Ann Holder Catherine Kingsford Dennis Schlaht Chief Medical Officer Chief Financial Officer Chief Strategy Officer SVP Ventures, SVP General SVP Medical Affairs SVP Quality, R&D Licensing & Corporate Management and Technology

  • • Joined September 2014 •• 15+ years in financial Joined April 2011 •• Joined November 201520+ years experience Development and Operations •• Joined January 200720+ years global • Joined October 2007 • 25+ years as management in the in technology solutions • On Board November • Joined July 2015 clinical experience • 30+ years in • Completed his radiation oncologistfellowship at Harvard Medical School, has • Experience in med-medical technology industrytech start-ups and • Seasoned entrepreneur and medical device companiesand technologist •• Joined August 2016Background as medical 2013 to August 2016device investment & •• 20+ years experienceExtensive experience in the medical device field with focus on the • Previously worked as with medical devicesa cardiac scientist at several world-class • Previously Vice engineering development and product marketing authored over 200 emerging growth bringing innovative business development cardiovascular space medical institutions President of peer reviewed publications, and companies • Previously at solutions to market • 25+ years experience executive • Previously at Medtronic with several including St. Andrew's War Marketing and Product Development participated in 6 NIH Medtronic, Minntech in tax, financial years in the Cardiac and Memorial Hospital, at XiTRON’s Test and clinical trials and the Corp and LifeScience planning, and business Vascular Group more The Prince Charles Measurement MammoSite Registry trial Alley • Previously Vice development recently at the corporate level focused on building Hospital, and Royal Brompton Hospital Business President, Integrations new solutions and Divestitures at for disease management Medtronic

25

Board of Directors

==> picture [96 x 121] intentionally omitted <==

==> picture [96 x 119] intentionally omitted <==

Elizabeth Gaines Non-Executive Director

  • On Board since March 2016

  • Non-Executive Director of Fortescue Metals Group Ltd, NextDC Ltd and Nine Entertainment Co Ltd

  • Most recently the Chief Executive Officer, and previously Chief Financial Officer and Chief Operating Officer, of Helloworld

Cherrell Hirst AO FTSE, MBBS, BEdSt, D.Univ (Hon), FAICD Non-Executive Chairman

  • Scott R. Ward

  • Officer, of Helloworld MS, BSc

  • • A member of Chartered Non-Executive Director

  • Accountants Australia & New Zealand, the Australian • Institute of Company • Venture capitalist with Directors and Chief 30+ years experience in Executive Women

    • On Board since July 2013
  • On Board since 2005

  • Venture capitalist with 30+ years experience in healthcare industry

  • Appointed Non-Executive Chairman in Nov 2011

==> picture [96 x 122] intentionally omitted <==

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

  • Leading medical practitioner in breast cancer screening/diagnosis

  • Currently Chairman of Tissue Therapies Ltd and Non-Executive Director of Medibank Private Ltd

  • Chairman of the Board of Creganna-Tactx Medical Devices and Cardiovascular Systems, Inc.

Gary Goetzke Juris Doctorate Non-Executive Director

  • On Board since August 2016

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

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

==> picture [102 x 10] intentionally omitted <==

==> picture [102 x 33] intentionally omitted <==

==> picture [102 x 7] intentionally omitted <==

==> picture [102 x 4] intentionally omitted <==

==> picture [102 x 16] intentionally omitted <==

==> picture [102 x 45] intentionally omitted <==

==> picture [92 x 18] intentionally omitted <==

==> picture [92 x 117] intentionally omitted <==

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)

26