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Clinical observations from Germany on C-Pulse Prof. Thomas Krabatsch, MD, PhD Director of Mechanical Circulatory Support, German Heart Center Berlin (DHZB), Germany German Heart Institute Berlin and CardioCentrum Berlin TCT 2013

Disclosure Statement of Financial Interest I, Thomas Krabatsch, DO NOT have a financial interest/arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this presentation.

Modern management of systolic heart failure with reduced EF Heart Failure Treat Cause Tx/MCS Fluid restriction +/- Diuretics Other Drugs ICD/CRT Aldosterone Antagonists Beta Blockers ACE Inhibitors NYHA III NYHA III/IV NYHA IV NYHA IIIb/IVa INTERMACS 7 6 5 4 3 2 1

European Society for Cardiology 2012 Guidelines for Acute and Chronic Heart Failure Table of Contents : Full Text (ESC Clinical Practice Guidelines) Preamble Introduction Definition and diagnosis The role of cardiac imaging in the evaluation of patients with suspected or confirmed heart failure Other investigations Devices and surgery Prognosis Pharmacological treatment of HF-REF (systolic heart failure) Pharmacological treatment of HF-PEF (diastolic heart failure) Non surgical device treatment of HF-REF (systolic heart failure) Arrhythmias, bradycardia and atrioventricular block in patients with HF-REF and HF-PEF Importance and management of other comorbidity in HF-REF and HF-PEF Acute heart fialure Coronary revascularization and surgery, including valve surgery, ventricular assist devices and transplantation Holistic managment, including exercise training and mutidisciplinary management programmes, patient monotoring and palliative care

Class I— No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or angina. Class II—Slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or angina. Class III—Marked limitation of physical activity. Patients are comfortable at rest. Less than ordinary activity causes fatigue, palpitation, dyspnea, or angina. Class IV—Inability to carry on any physical activity without discomfort. Symptoms of heart failure or the angina syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased. NYHA Classification

LVAD / HTX NYHA II NYHA III NYHA IV NYHA IVa NYHA I 3.5 million European patients in NYHA class III1 1 million European patients in NYHA class III with CRT1 Despite OMT and current treatments all-cause mortality rate for advanced HF with reduced EF at 3 years remains ~30% Indicating the need to continue seeking new treatment options2 Device treatment options for patients with moderate to severe heart failure 1. SHAPE (Study Group on Heart Failure and Perception in Europe) & The World Heart Failure Society 2. Loh, John C. et al. (2013) Temporal Trends in Treatment and Outcomes for Advanced Heart Failure With Reduced Ejection Fraction From 1993 -2010: Findings From a University Referral Center. Circulation Heart Failure, May 2013. 411-419.

LVAD / HTX NYHA II NYHA III NYHA IV NYHA IVa NYHA I For patients that need more than optimal medical therapy C-Pulse®, a device designed to provide symptomatic relief with the potential to halt disease progression Addressing the existing treatment need US Pivotal Counter HF™ Trial currently enrolling. CAUTION: C-Pulse is an Investigational device. The device is limited by Federal (or United States) Law to Investigational use only.

Ambulatory Extra-Aortic Counterpulsation C-Pulse System

C-Pulse® System Cuff Percutaneous Interface Lead Driver Programmer wireless connection 2.6 kg driver + battery (7-8 h)

C-Pulse® Counterpulsation Therapy C-Pulse System: Placed outside the bloodstream (no anticoag., no hemolysis, no vWD, no thrombosis) Allows patients the ability to disconnect for short periods of time (e.g. for personal hygiene) May be placed minimally invasively C-Pulse System is designed to: Increase coronary blood flow Decrease afterload Increase cardiac function

Multi-center, prospective, open label observational study, 50 Patients, 15 European Centers Study objective: The study is designed to observe the clinical outcomes of heart failure patients treated with C-Pulse® System according to the approved indications and contraindications. Regulatory status: CE Mark Inclusion Criteria = intended use According to the CE mark authorization, patients with the following conditions can be included: Patient is 18 years or older Patients with moderate to severe ambulatory heart failure [American College of Cardiology/American Heart Association (ACC/AHA) Stage C; NYHA Class III/IV ambulatory], who are refractory to optimal medical therapy. Patients who are non-responders to CRT pacemaker therapy Patient has signed and dated the investigation informed consent form Options HF C-Pulse® System European Multicenter Study

Options HF C-Pulse® System European Multicenter Study Exclusion Criteria (Contraindications) According to the CE mark authorization, patients with the following conditions (contraindications) have to be excluded: Evidence of significant ascending aortic calcification Moderate or severe atherosclerotic aortic disease Ascending aorto-coronary artery bypass grafts Any history of aortic dissection Patient has severe mitral valve incompetence, grade 4+ Patient has moderate to severe aortic valve incompetence, grade 2 - 4+ Patient has systolic blood pressure less than 90 or greater than 140mmHg Investigated parameters Quality of life (Kansas City) 6-min-walk test Left ventricular ejection fraction Adverse events

The Berlin Referral System Cardiologists in practice Identify potential patient Long-term follow-up Cardio Centrum Berlin Outpatient Heart Clinic Options HF Study Site Screening Prepare pt. for implantation Follow-Ups DHZB Experienced VAD center Implant procedure Intensive care

DHZB C-Pulse® Experience 4 male patients implanted 54 years, 54 years, 63 and 51 years of age All classified ACC/AHA stage C All patients on OMT 3 patients - NYHA class III and INTERMACS level 5 1 patient - NYHA ambulatory class IV and INTERMACS level 4

Current State: German C-Pulse® Experience Duration of support: Dated 19 October 2013 5 patients implanted as part of the Options HF C-Pulse® post market clinical study 415 total days of C-Pulse therapy 4 patients continue on C-Pulse therapy, all at home The second patient (implanted 14 June 2013) developed tachycardia with worsening heart failure 12 hours after surgery without stabilization under medication. Tachycardia prevented optimal C-Pulse support Further deterioration due to sepsis caused by pneumonia Implantation of a left ventricular assist device 5 days after index procedure

Patients in Germany 16 Berlin Patient - 114 days LVEF 25 to 35% 420 Patient days in Europe No Exit Site Infections No re-hospitalizations due to HF High compliance – Only disconnect for battery change High satisfaction from physicians and patients

Berlin Patient Results Presented at ESAIO in ScotlandSeptember 13th in cooperation with Dr. Holger Hotz from Cardio Centrum* Early Clinical Results Patient 1** Idiopathic dilated cardiomyopathy Patient 3 Ischemic cardiomyopathy Baseline Follow-up Baseline Follow-up RVEF 35% 50% (10 days) 35% 40% (12 days) LVEF 25% 40% (3 months) 20% 35% (7 weeks) NYHA III III (6 weeks) III II (6 weeks) 6 MHW 183 m 145 m (6 weeks) 240 m 418 m (6 weeks) *H.Hotz1, A. Schults1, T. Krabatsch2, M. Reinhartz1, H. Siniawski2, E.M. Delmo Walter2, R. Hetzer2 (2013) The Berlin experience with the first three C-Pulse® implants in Europe 1. Cardio Centrum Berlin, Germany 2. Deutsches Herzzentrum Berlin, Germany **Reduced distance is explained due to muscular weakness and lack of motivation due to cancer diagnosis

Most recent Patient Implanted at DHZB: The patient feels excellent, he says it is "a miracle" how good he feels. He would recommend this device to everybody with similar heart problems. He can now walk 500m to the next grocery store and do shopping and then cook for his family. Patient Feedback

Surgical implantation without cardiopulmonary bypass was successful in all patients No stroke, myocardial infarction, major bleeding or major infection due to the device No rehospitalisation for worsening HF SUMMARY - Early Results H.Hotz1, A. Schults1, T. Krabatsch2, M. Reinhartz1, H. Siniawski2, E.M. Delmo Walter2, R. Hetzer2 (2013) The Berlin experience with the first three C-Pulse® implants in Europe 1. Cardio Centrum Berlin, Germany 2. Deutsches Herzzentrum Berlin, Germany 1:2

 The C-Pulse® heart assist system is easy to implant without the need for cardiopulmonary bypass The C-Pulse system can improve cardiac function C-Pulse seems to be a promising therapeutic option for patients with moderate to severe heart failure Conclusion

Can C-Pulse® Use Lead To Left Ventricular Recovery? Andrew Kao, M.D., F.A.C.C. Associate Professor of Medicine University of Missouri-Kansas City Transcatheter Cardiovascular Therapeutics San Francisco, CA October 29, 2013

Disclosures .Presentation based on data from single center experience (St. Luke’s Mid America Heart Institute, Kansas City, MO) - C-Pulse® feasibility study .Caution: C-Pulse® is an investigational device. This device is limited by federal (US) laws to investigational use only

Proposed Treatment Algorithm for Advanced HF Adapted from Stevenson LW et al. J Heart Lung Transplant 2009;28:535-541 Interagency Registry of Mechanically Assisted Circulatory Support OHT DT C-Pulse®  Profile Description 1. Critical cardiogenic shock 2. Progressive decline on inotropic support 3. Stable but inotrope dependent 4. Resting symptoms home on oral therapy 5. Exertion intolerant 6. Exertion limited 7. Advanced NYHA Class III symptoms

Advantages of C-Pulse® Therapy .Easy to manage – “On-Off” concept .Cardiac assist device, not life-sustaining .Extravascular device – no need for anticoagulation .May be performed via mini-thoracotomy – faster recovery period

C-Pulse® 1 Week

Likelihood of Ventricular Recovery 0 5 10 15 20 OHT VAD MAHI C-Pulse® Additional 33% partial recovery INtERMACS Quarterly Statistical Report 6/13

Tales of Recovery

Patient #1 .45 yo man with 10 year history of familial dilated cardiomyopathy .History of DVT/PE but intracranial hemorrhage from coumadin – thus not VAD candidate .Cannot walk more than a few feet .Prescribed oxygen by local MD .Hemoptysis due to pulmonary edema .Diffusely diaphoretic

Patient #1 .Echo LVEF 10% .8/10 Right heart cath – RA 7, PA 52/23/34, PCWP 14, CO/CI 4.1/1.7 .8/10 C-Pulse® implantation .Discharge postop day 4 .1 month visit – walked around air show 3- 4 hours! – NYHA I since then .6 month RHC – RA 10, PA 35/13/23, PCWP 13, CO/CI 5.9/2.7

Patient #1 .9 months – asked for Cialis .1 year echo – LVEF 20% .2 year echo – LVEF 21% .Preop – 140 mg Lasix a day .5 months postop to now – no Lasix .12/12 (28 months) – PIL explant .Remains NYHA I

Patient #1 C-Pulse® Usage 0 20 40 60 80 1 3 6 12 18 24 28 Months % Use

Patient #1 - Lessons .Patient clearly INTERMACS profile 4 at baseline .Hemodynamics significantly improved by 6 months (60% improvement in cardiac index) .No diuretic requirement since 5 months .“Cialis” at 9 months .11% usage at 1 year .Successful PIL explant 28 months

Patient #2 .36 yo with 10 year history of LBBB .Finally diagnosed with HF 3 years prior .Echo LVEF 21% .Effort limitation at 3 blocks .Too well for OHT .Peak VO2 19 ml/kg/min, 42% of predicted

Patient #2 .Recently completed second master’s degree .Wanted to do anything possible to regain quality of life and return to work force .NYHA class III .Intermacs profile 7 .C-Pulse® placement 4/12 .Postop fevers ? Pericarditis .Discharge POD 7 .Pre discharge echo EF 45%!

Patient #2 .Excellent compliance 75-85% .7/13 – PIL issue necessitated C-Pulse® off for 48 hours – no symptoms .8/13 Stable on C-Pulse® 1:1 – given stability, decreased to 1:2 .9/13 Stable on 1:2 – no symptoms - C-Pulse® turned off .10/13 Follow up echo pending – asymptomatic off C-Pulse®

Patient #2 Serial LVEFs 0 10 20 30 40 50 Pre 0.25 1 15 16 17 Months Off x 48 hrs 1:2 x 1 month

Patient #2 - Lessons .Patient clearly INTERMACS profile 7 at baseline – HF treated 3 yrs prior but probably present for 10 yrs .Significant sustained improvement of LVEF by 7 days postop .Gradual “wean” 1:1 to 1:2 without symptoms .Serial echos during weaning process showed no change of LVEF

Patient #3 .61 yo man s/p anterior STEMI 7/01 – LAD drug-eluting stent .Post MI LVEF 30% .LVEF 20% 2007 – ICD placement .2/10 – LLL nodule – biopsy non small cell, negative metastatic workup .LLLobectomy .Incidental finding of bronchoalveolar cell CA LUL s/p resection .No adjuvant therapy

Patient #3 .5/10 worsening HF .90 degree orthopnea .Worsened renal function with diuresis .Milrinone begun – immediate improvement .2 weaning attempts failed within hours – recurrent 90 degree orthopnea, oliguria, elevated creatinine .Home inotropes begun with stability .Patient is clearly INTERMACS profile 3

Patient #3 .Insurance would not pay for LVAD .Right heart cath on milrinone – RA 8, PA 39/21/26, PCWP, CO/CI 4.3/2.2 .8/10 C-Pulse® placement after 3 months of inotropic dependence .Milrinone weaned off 2-3 hours postop after extubation .6 month RHC – RA 7, PA 47/25/31, PCWP 10, CO/CI 4.2/2.2

Patient #3 .Currently NYHA II .Has not required inotropes .Several admissions for COPD only .Long smoking history .Lung resection .Patient felt well enough to “self-wean” soon after 30 day time point

Patient #3 C-Pulse® Usage 0 20 40 60 80 1 3 6 12 18 24 30 36 Months % Use

Patient #3 LVEF 0 10 20 30 40 0 3 12 30 36 Months LVEF (%)

Patient #3 - Lessons .Patient was clearly INTERMACS level 3 .C-Pulse® placement had same sustained hemodynamic effect as milrinone in this case .Decrease in C-Pulse® usage suggests improvement in cardiac function .C-Pulse® placement has helped him maintain HF stability for 3+ years

Conclusion .C-Pulse® implantation feasible via minimally invasive right thoracotomy .Weaning of C-Pulse® support feasible after varying duration of hemodynamic support, with the potential for PIL explantation .Further investigation will be necessary to confirm these single center observations

Patient Video

© 2013 Sunshine Heart, Inc. Progress of the Fully Implantable System TCT – October 2013 www.sunshineheart.com

Forward Looking Statement This presentation contains forward-looking statements. All forward-looking statements are management’s present expectations of future events and are subject to a number of risks and uncertainties. Various factors could cause actual results to differ materially from these statements including timing, clinical enrollment, clinical results, financing availability, product sales and marketing or efficacy of products, and the other risks set forth under the caption “Risk Factors” and elsewhere in our periodic and other reports filed with the U.S. Securities and Exchange Commission, including our Annual Report or Form 10-K for the fiscal year ended December 31, 2012. Although the Company believes that the forward-looking statements are reasonable and based on information currently available, 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. Caution: C-Pulse ® is an investigational device. The device is limited by federal (United States) law to investigational use only. C-Pulse is a registered trademark of Sunshine Heart Inc. 1 © 2013 Sunshine Heart, Inc. | Slide

C-Pulse II - Fully Implantable System Internal electro-hydraulic converter eliminates the percutaneous drive line and associated infection risks. Non-blood contacting Non-obligatory CAUTION: Investigational device, limited by Federal (or United States) Law to Investigational Use C-Pulse II Overview

C-Pulse II - Fully Implantable System Internal electro-hydraulic converter eliminates the percutaneous drive line and associated infection risks. Non-blood contacting Non-obligatory No percutaneous drive line CAUTION: Investigational device, limited by Federal (or United States) Law to Investigational Use C-Pulse II Overview:

 CAUTION: Investigational device, limited by Federal (or United States) Law to Investigational Use C-Pulse II Overview: C-Pulse II - Fully Implantable System Internal electro-hydraulic converter eliminates the percutaneous drive line and associated infection risks. Non-blood contacting Non-obligatory No percutaneous drive line No implanted battery

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Eliminating the driveline is not a new idea... © 2012 Sunshine Heart, Inc. Circa 1985

Arrow LionHeart LVAD First clinical TETS system

Arrow LionHeart LVAD First clinical TETS system

Arrow LionHeart LVAD First clinical TETS system

© 2013 Sunshine Heart, Inc. Where will clinical implementation of TETS technology first find traction?

© 2013 Sunshine Heart, Inc. SUNSHINE HEART C-pulse juxta-aortic balloon

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© 2013 Sunshine Heart, Inc. SUNSHINE HEART C-pulse juxta-aortic balloon Non-obligatory No blood contact so...

© 2013 Sunshine Heart, Inc. SUNSHINE HEART C-pulse juxta-aortic balloon

SUNSHINE HEART C-pulse II © 2013 Sunshine Heart, Inc.

SUNSHINE HEART C-pulse II

Electrohydraulic pump...

C-Pulse II – Leveraging powerful synergies Minnetronix Cirtec Medical Systems TEXAS HEART INSTITUTE at St. Luke’s Episcopal Hospital

Electrohydraulic pump- Rapidly inflates and deflates the juxta-aortic balloon (reproduces C-I physiology) EKG synchronized to provide counter-pulsation Balloon passively empties in the event of pump or power failure (essential) Leverages the incompressibility of silicone oil Compliance reservoir incorporated into the base of the pump Cirtec Medical Systems

C-Pulse II – Important IP progress

Cirtec Medical Systems Electrohydraulic pump-

How are we going to power it?

Trans-cutaneous Energy Transfer System (TETS) DC battery pack outside the body DC current is put through an oscillator to make AC AC current is put through a large electro-magnetic coil (1o) to generate an oscillating magnetic field Oscillating magnetic field goes through the skin Oscillating magnetic field is picked up by a tuned internal coil (2o) resulting in induction of AC current AC current rectified into DC used to charge internal battery and run the LVAD

Standard transformer

Inductive coupling through an air-gap

 July 10, 1856 – January 7, 1943 Nikola Tesla

Newest systems are: Smaller size so easier to implant More energy efficient so improved battery life More tolerant of geometric misalignment © 2013 Sunshine Heart, Inc. Minnetronix Leaders in Transcutaneous Energy Transfer Systems (TETS)

Minnetronix Leaders in Transcutaneous Energy Transfer Systems (TETS)

Improvement in TETS component geometry and function Minnetronix

Improvement in TETS component geometry and function Minnetronix

Where are we going to test it?

TEXAS HEART INSTITUTE at St. Luke’s Episcopal Hospital

THI Cardio Vascular Research Lab ICU

THI Cardio Vascular Research Lab ICU

Surgical Implant and System Integration THI’s Cardio Vascular Research Lab The premiere large animal cardiovascular research lab in the world Domain dominance in development and implementation of heart failure technology Successful acute system implantation (first generation) 36 © 2013 Sunshine Heart, Inc. | Slide

Minimally Invasive Implantation Small incision Sternal-sparing No cardiopulmonary bypass

The SUNSHINE HEART C-Pulse II has the potential to be the first completely self-contained therapy for heart failure since the bi-ventricular pacer Lack of blood contact and non-obligatory feature make it the most likely candidate to leverage TETS in a mechanical circulatory assist device Pump innovation has facilitated development of a novel technology, avoiding the safety and regulatory risks of an implantable battery The system is well suited for implantation off-pump through a small sternal sparing incision, making it well suited for patients earlier in the course of heart failure © 2013 Sunshine Heart, Inc. In summary