Preliminary results from the C-Pulse OPTIONS HF European Multicenter Post-Market Study Holger Hotz, CardioCentrum Berlin, Berlin, Germany; Antonia Schulz, Cardiocentrum Berlin, Berlin, Germany; Jan Schmitto, Hannover Medical Sch, Hannover, Germany; Mirko Seidel, Unfallkrankenhaus Berlin, Berlin, Germany; Thomas Krabatsch, Deutsches Herzzentrum Berlin, Berlin, Germany American Heart Association Meeting American Heart Association meeting - November 20141

Disclosures H. Hotz: None A.Schulz: None J. Schmitto: None M. Seidel: None T. Krabatsch: None American Heart Association meeting - November 20142

Sunshine Heart, Inc. is sponsoring the OPTIONS HF Clinical Trial. It is a post market, multi-center surveillance study with up to 15 centers participating throughout Europe. Up to 50 patients will be implanted in the study and be followed up to 5 years. OPTIONS HF Clinical Study X Ascending aortic calcification or CABG X Mitral Valve Incompetence, Grade 4+ X Aortic Valve Incompetence, Grade X Patient has systolic blood pressure less than 90 or greater than 140 mm Hg √NYHA Class III and Ambulatory Class IV √ On optimal medical therapy and remains symptomatic √ Had been evaluated for or have CRT or CRT-D therapy and remain symptomatic or ICD therapy (narrow QRS) √ 6MHW m √ At least one hospitalization for decompensated HF, while on HF medications, OR BNP level > 300 or NTproBNP > 1500 within 12 months prior to randomization √ Both ischemic and non-ischemic Key Study Qualifications: Study Objective: The study is designed to observe the clinical outcomes of heart failure patients treated with the C-Pulse® System in the usual manner and according to the approved indications and contraindications. American Heart Association meeting - November 20143

A minimally invasive, non-blood contacting, counter- pulsation heart assist therapy for the treatment of moderate to severe heart failure. Reduce LV work, increase flow Balloon inflates – increases coronary perfusion (addresses hemodynamics - primary pathophysiology of heart failure) Balloon deflates – decrease afterload Minimally invasive procedure can be performed in 90 minutes No blood contact – lower likelihood of clot or stroke Ability to disconnect – patient comfort and convenience The C-Pulse® System Extra-Aortic Cuff ECG Sensing Lead Driver Percutaneous Interface Lead American Heart Association meeting - November 20144

All Patients (N=8) Mean ±SD (range) Age (in years)60.8 ± 10.5 (51, 79) Gender Male87.5% (7/8) Female12.5% (1/8) Co-morbidities Arrhythmia50% (4/8) Diabetes Mellitus62.5% (5/8) Smoking history87.5% (7/8) Cardiomyopathy100% (8/8) - Ischemic50% (4/8) - Non-Ischemic50% (4/8) INTERMACS Profile 4: Resting symptoms37.5% (3/8) 5: Exertion Intolerant37.5% (3/8) 6: Exertion Limited25% (2/8) NYHA Class III87.5% (7/8) IV12.5% (1/8) CRT62.5% (5/8) ICD Therapy75.0% (6/8) Methods American Heart Association meeting - November 20145

8/8 (100%) of patients successfully implanted No procedural device-related complications CPB used in 1 patient with concomitant CABG No stroke, myocardial infarction, major bleeding or major infection were reported due to the device through 6 months One patient was weaned off the device after 6 months of support and showed an increase in EF from 20% at baseline to 44% at 6-months One patient developed non-device related refractory tachycardia with worsening heart failure 12 hours after surgery which prevented C-Pulse from supporting the heart properly resulting in subsequent VAD implant 5 days after the index procedure Results American Heart Association meeting - November 20146

Baseline N=4 6 months N=4 Results: NYHA – 6 Months American Heart Association meeting - November 20147

Baseline N=4 6 months N= ± 77 Results: 6MWT – 6 Months ± 25 American Heart Association meeting - November 20148

Results: LVEF (%) – 6 Months American Heart Association meeting - November 20149

Conclusion Preliminary results from this small cohort in the European Option HF post-market study demonstrate safety of implantation of the C-Pulse System 6 month results show improvements in functional capacity and physician assessed functional status Efficacy also demonstrated in cardiac remodeling C-Pulse Heart Assist System is a promising therapeutic option for patients with moderate to severe heart failure American Heart Association meeting - November