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1 C-Pulse™: Innovative heart assist system for advanced heart failure September 2009 www.sunshineheart.com

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Page 1: C-Pulse™: Innovative heart assist system for advanced ...s3-us-west-2.amazonaws.com/brr-streamguys/files/SHC/2009_09_15... · This presentation may contain forward looking statements

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C-Pulse™: Innovative heart assist system for advanced heart failure

September 2009

www.sunshineheart.com

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This presentation may contain forward looking statements. Various factors could cause actual results to differ materially from these projections including timing, clinical results, financing availability, product sales and marketing or efficacy of products.

Although the Company believes that the forward looking statements are reasonable, it can give no assurances that the Company’s expectations are correct. All forward looking statements are expressly qualified in their entirety by this cautionary statement.

St Leonards (Sydney), NSW, Australia Tustin, California USA

Australian Securities Exchange (ASX): SHCU.S. Incorporation (Delaware)

www.sunshineheart.com

Caution: C-Pulse is an investigational device. The device is limited by federal (United States) law to investigational use only.

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Sunshine Heart, Inc. Vision

Sunshine Heart is dedicated todeveloping a successful

internationalheart assist device business

focused on improving thequality of lifefor people in

advanced heart failure(not end-stage heart failure)

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Definitions

Heart Failure: a progressive condition in which the heart can not pump enough blood to the body’s other organs. It results from damage to the heart muscle typically arising from a heart attack or virus.

C-Pulse™: Sunshine Heart’s system to assist the heart to pump blood to the other organs and to the native heart muscle. Therapy for advanced heart failure patients.

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Sunshine Heart, Inc: Company BackgroundTimeline2000: Australian Pty Ltd > Patents & ANZ Acute Patient Study2002: US Incorporation > Cuff Verification2004: ASX IPO > ANZ pilot study; Driver Development2006: Placement > Complete Driver Development2008: Rights Issue > FDA Feasibility Study initiation2009: Placement/Rights Issue > FDA Feasibility Study completion

Don RohrbaughCEO

William Peters, MD Founder, CTO/ CMO

Australia• CTO/ CMO• R&D: Engineers/Techs• Financial• Board of Directors• ASX listing

USA• CEO• Regulatory• Clinical / CRO• Operations • Outsourced Manufacturing

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Unique C-Pulse™ Heart Assist System

ECG Sense Lead

Extra-aortic Cuff

Battery Pack

Driver

Interface Lead

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Unique C-Pulse™ Heart Assist SystemHeart Fills - Cuff Inflates Heart Ejects - Cuff Deflates

to body

to heartreduce

workload

Simple implant:No heart-lung machineSmall chest incisionFast patient recovery / discharge

Non-blood contacting:No anticoagulationAvoids thrombus riskPatient disconnectable

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C-Pulse™ AdvantageUnique Heart Assist System►

Only non-blood contacting heart assist ►

Simple implant and quick patient recovery►

Only heart assist that increases coronary blood flow ►

Only heart assist that allows Freedom to disconnect►

Provides immediate and sustained symptom relief and an improved quality of life

All other heart assist devices: 24/7 Patient Connection Required

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C-Pulse™ Market Size

0200400600800

10001200140016001800

Patie

nts

(000

's)

NYHAClass I

NYHAClass II

NYHAClass III

NYHAClass IV

CRT PacemakersBSC GuidantMedtronicSt Jude

LVADs

CLINICAL NEED

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HF Therapeutic gap

SHC focus: Class III unmet clinical need

CRT; HF Pacemakers*

LVADs;BTT/ DT

HTX

Class III (Advanced) HF: 1.4 m (US); 90k (AUS)

Cl IV : 0.4 m (US); 15k (AUS)

Patient symptoms (fatigue, short of breath, dizziness, etc):<<<<<<<<< with mild exercise >>>>>>>>>> <<< at rest >>>

*CRT, CRT-D: +$3b global market

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Clinical Results to Date: ANZDemonstrated Benefits

Patient symptomatic reliefImproved Quality of LifeImproved cardiac functionNon-Blood contacting assistancePatient elective disconnect

Risk MitigationAorta CT Scan screeningMinimally Invasive ImplantSafe aortic wrap

Reported Clinical ResultsANZ: 6 + 5 patients

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US Feasibility Study: In Process

Intensity = Incidence of HF deaths

University Heart Failure Research SitesOhio State Medical Center

Northwestern School of Medicine

Penn State Hershey Medical Center

U of Alabama Birmingham Medical Center

Jewish Hosp, U of Louisville

U of Florida School of Medicine

Medical Advisors: MAB; DSMB; CEC; Steering Committee

Co-PIs: Drs William Abraham & Patrick McCarthy

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Glimpse into US StudyObservations to date

Patient relief of symptoms; no angina pain, easier breathing

Minimally invasive surgical procedure with short hosp stay

Improved Quality of Life with increased endurance, stamina and ability to enjoy activities

No adverse effects; ie. stroke, blood clots, other serious events

Patients able to successfully disconnect from device

Visible signs of improved circulation

US Clinical StatusUS: 4 >>> 20 patients

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Glimpse into US StudyPre- C-Pulse Patient Condition•Enlarged heart •Shortness of breath •Dizziness •Abnormal heart rhythm (arrhythmia) •Swelling (edema)•Optimum medications•Pacemaker implanted

Status• C-Pulse support despite arrhythmias• Pt #1: Bridge to transplant @ 4 mo• Pt #2: 6 mo tests in Sep/Oct

First two patients (60 and 54 yo)@ 3 months follow-up testing

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Glimpse into US Study

First Female patient (59 yo)@ 3 weeks post C-Pulse

Pre- C-Pulse Patient Condition•Enlarged heart •Shortness of breath •Dizziness •Optimum medications•Pacemaker implanted Status• Symptomatic relief•

Improved Physical endurance (shopping, social events, etc)• Can periodically disconnect (see photo)Women in Heart Failure•Typically longer survival rates•Higher incidence of hospitalizations•Overall poorer quality of life

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The Ohio State University ExperiencePre-op, post-op and 3 mo follow-up; patients and physicians

View videos on website

www.sunshineheart.com

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2008 2009 2010 2011 2012 2013 2014

Major Milestones

FDAFeasTrial

Clinical Reimbursement

CE Mark > Revenues (plan to be developed)

US $$

C-Pulse II: Development

FDAPivotalTrial

Follow-Up

FDAPMA

FDA Feas f-u

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C-Pulse™ Milestones (see Company Profile)Sunshine Heart Inc - Milestone Table

Event Timing Impact

FDA Feasibility Trial - Finish recruitment 1QCY10 Positive

FDA Feasibility Trial – Six month follow up 3QCY10 Positive

FDA Pivotal Trial Commence 4Q CY10 Positive

Submit for CE Mark Approval 4Q CY10 Positive

FDA Pivotal Trial- Finish recruitment 2QCY12 Very Positive

Pivotal Trial Follow Up 2QCY13 Positive

PMA application 3QCY13 Very Positive

Sales C-Pulse 1QCY14 Very Positive

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C-Pulse Pathway to Market►

Approval for EU/ Australia; CE MarkApplication with US data

Approval for US; FDA PMA US Feasibility; non-randomized; 20 pts, 6 sites, 6 mo follow-up US Pivotal trial; randomized; ~150 pts, 30 sites; 1 yr follow- upPMA approval

ReimbursementUS Clinical Reimbursement establishedCE Mark reimbursement for heart assist devices

Reimbursement received

First to market opportunity: Only Class III heart assist system in FDA trials

World’s first non-blood contacting heart assist system

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C-Pulse: Effective Business Model

* Rose E, et al (REMATCH), AHA 2002 ** Benchmarked to cost for simple CABG (Coronary Artery Bypass Grafting)

LVADs* Heart Transplant*C-Pulse

Device cost $ ~US$90,000~US$54,000

Operation time (hours) 4-8 3-6> 1

Length of Stay (days) 39* 183- 7**

Total Cost $ ~US$230,000*- $320,000 ~US$250,000~US$80,000

Procedure Cost $ ~US$140,000US$25,000**

Medicare, DRG 1 or 2: US$ 88 - 199k

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12 application families; more in process

Significant Intellectual Property Protection

Granted•

Heart Assist Devices, Systems, Methods•

Curved Ascending Aortic Cuff •

Fully implanted device •

Heart assist with aortic deformation Pending

Heart assist devices, systems, methods•

Balloon actuator•

Counterpulsation stent •

Wrap tensioning device/method•

Extra-aortic patch•

Percutaneous Lead Features •

Synchronous control system•

Trade Marks•

C-Pulse•

Sunshine Heart

Next generation C-PulseLife of patents: 2020 > 2023 > 2026 > 2027 >

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SHC Financials, Board and OwnershipFinancials (AUD): 30 JUN 09Cash $2.0mBurn Rate/ month (prior 6 months) 0.62mShares on Issue (as of 30SEP09)

292mTop 20 shareholders

>85%

Board of DirectorsMr Nicholas Callinan; ChairmanMr Donal O'Dwyer; Non-Executive Director Dr Geoff Brooke; Non-Executive DirectorMr John Brennan; Non-Executive DirectorMr Crispin Marsh; Non-Executive Director Dr William Peters; CTO and DirectorMr Donald Rohrbaugh; CEO and Director

Ownership:Venture Capital: 65%Institutional: 8%Biotech Funds: 6%Founders: 5%Other: 16%

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Rights Issue Information►

3 for 5 non-renounceable rights issue to raise up to $8.1 million

$0.04 per share (32.2% discount to closing price as of 11 September 2009)

Eligible Shareholders may apply for additional shares over and above their entitlement under the Top-Up Facility

Underwritten to $5.5 million by ABN AMRO Morgans

GBS Venture Partners and CM Capital have committed to take up their entitlement of approximately $4.2 million (approximately 51% of the issue)

Follows an Institutional Placement which raised $1.75 million (15% of issued capital)

The funds raised by the Placement and Rights Issue are expected to provide the company with sufficient funding to complete the 20 patient US FDA trial (expected to be completed 1Q 2010) and complete 6 month follow-up (expected to be completed 3Q 2010)

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Use of Funds (AUD 7.25-9.85m)Continue Feasibility enrollment and follow-up

Continue clinical reimbursement• Refine manufacturing• Prepare CE Mark application• Prepare for US Pivotal trial• Progress with C-Pulse II

• Additional Journal publications• Additional Patent applications

• Then, Pivotal Trial Financing

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Key Investment Considerations

Large unmet clinical need; first-to-market opportunity

Unique heart assist system: C-Pulse™

US clinical trial in process; with reimbursement

Experienced international team (Executives / Board)

Strong medical advisory and clinical site teams

Well-defined business model

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C-Pulse Goal: Improve QOL for Advanced HF Patients

Class III Patient Lifestyle•Tired, debilitating fatigue•Short of Breath•Dizziness•Swollen legs/ankles•Repeat hospitalizations•Poor Quality of Life despite optimal medical therapy

SHCVision

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C-Pulse™: Innovative heart assist system for advanced heart failure

September 2009

www.sunshineheart.com