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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
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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.
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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
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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
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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
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$0.04 per share (32.2% discount to closing price as of 11 September 2009)
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Eligible Shareholders may apply for additional shares over and above their entitlement under the Top-Up Facility
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Underwritten to $5.5 million by ABN AMRO Morgans
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GBS Venture Partners and CM Capital have committed to take up their entitlement of approximately $4.2 million (approximately 51% of the issue)
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Follows an Institutional Placement which raised $1.75 million (15% of issued capital)
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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
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Large unmet clinical need; first-to-market opportunity
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Unique heart assist system: C-Pulse™
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US clinical trial in process; with reimbursement
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Experienced international team (Executives / Board)
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Strong medical advisory and clinical site teams
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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