Hemodynamicsof C-Pulse:Aortic Counterpulsation and Beyond? www.sunshineheart.com Dimitrios Georgakopoulos, PhD CSO, Sunshine Heart Inc. FRM-04558-B

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 on Form 10-K for the fiscal year ended December 31, 2014. 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 • • •

Counterpulsation Mechanism Based On Physiologic Hemodynamics of Wave Travel in Arteries McDonald’s Blood Flow In Arteries. 6th Ed. 2

c, SUNSHINE HEART C Pulse Counterpulsation: 30 CT Clinical Example Courtesy 01'. Danie/Bujnoch; Department of CardiacSurguy,Univusity of &lmgen, 6effnmy D 3

C-Pulse Design: Uni–que Placement on Ascending Aorta Proximal Aorta 70% of compliance in • Arterial System 2 Arndt et al. Circ. Res. 28:1971 4

Counterpulsation and Myocardial Oxygen Consumption The heart is especially vulnerable to ischemia, because its O2 extraction ratio is 65% (vs. average • of 25% for rest of body) Because the heart is near maximal O2 extraction during increased demand, primarily accomplished by increasing blood flow • 5

C-Pulse Effect on Coronary Hemodynamics in Normal Swine Backward waves from descending less efficiently propagated to aortic root OFF 250 200 150 100 50 0 -50 -100 -150 Mynard et al. J. Hypten. 33:2015 0 100 200 300 400 500 600 700 800 900 Time “If you wanted to design a perfect sound absorber, you could hardly do better than a set of tapering and branching tubes …such as the arterial tree. (DA McDonald 1960).” 42 6 Coronary Flow (mL/min) C-Pulse

Boost Diastolic Pressure: Reservoir for Coronaries to Fill OFF OFF ON ON 43 7

Counterpulsation and Coronary Perfusion and Oxygen Utilization at Rest and Exertion 8

What About Other Concept of Counterpulsation: Reduce Cardiac Afterload? 9

Wave Travel and Reflection Animation Play Video Courtesy AtCor Medical (www.atcormedical.com) 10

LVOT CCA 11

Ultrasound data – Ascending Aorta and Carotid Artery Device OFF 1.2 1 0.8 0.6 0.4 0.2 0 -0.2 0 0.5 1 1.5 2 2.5 3 3.5 4 0.4 0.3 0.2 0.1 0 -0.1 0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 Device ON 1.2 1 0.8 0.6 0.4 0.2 0 -0.2 0 0.5 1 1.5 2 2.5 3 3.5 4 • • • Marked increase in carotid net flow (+57%) Increased flow in diastole Avg 30% increase in carotid flow 0.6 0.5 0.4 0.3 0.2 0.1 0 -0.1 0 0.2 0.4 0.6 0.8 1 12

Forward and Backward Waves in Patients with C-Pulse: Ascending Aorta 13

Wall Stress Peaks Late Systole in HF Noordergraaf, A. Circulatory System Dynamics. Lea and Febiger (1976). 12 14

C-Pulse Reduces Wall Stress and Increases Shortening Velocity Leggett et al. Circ. 112:I-26. 2005 15

C-Pulse: (N=3) Wave Intensity Analysis in Carotid and Aorta Carotid Artery Ascending Aorta • Average Increase in Forward Compression Wave (Energy generated by LV): 65% Similar to positive inotrope with improved energetics profile • 16

lnotrope C, SUNSHINE HEART C-Pulse Hemodynamically Similar to Positive p III.S 1.0 i p lmmllal ! : u . J.J\.Aa! 110 v :0.6 l · 0 l 0.6 ! \Y1 \Y2 . I I (\ A .. 0 R Rl 0..6 0 c:; R R 1lm•l<l o.6 11n><l>l Dobuta mine Propranolol Control 17

HEM 002 – Pressure and Flow – carotid artery Carotid input impedance modulus • • • Marked decrease in carotid bed resistance Marked decrease in impedance Impedance ~ reduced reflections 10 0 0 5 10 15 harmonic nr OFF ON Carotid input impedance phase 50 0 0 2 4 6 8 10 12 -50 -100 OhFaFrmonic nOrN 18 phase (degrees) modulus (AU) Avg. Reduction in DC resistance: 30%

Clinical Importance of Wave Reflections and Late Systolic Load Hypertension 2014; 64: 958-964 19

Hemodynamic Effects of Unloading with C-Pulse On Central Pressure and Wave Reflections Mean±SD. Paired t-test. † p<0.01; * p=0.01; ‡ p<0.05 31 To be presented AHA 2015! 20 (N=6) OFF ON Max Aortic BP (mmHg) 114.4±4.4114.3±4.9 68±13.465.7±14.7 106.5±6.0109.3±4.9† 182±20.8161±29.5* 1.70±0.451.99±0.53† 1.23±0.131.04±0.06† Diastolic BP (mmHg) P1 (mmHg) Time to P2 (ms) SEVR Aix (P2/P1)

Wave Reflections Primarily Arise from Periphery: How Does C-Pulse Affect Peripheral Arteries? 21

HOW DOES A CUFF IN ASCENDING AORTA INFLUENCE PERIPHERAL VESSELS?

Large Unloading Effects Partly Due to Neural Reflexes? Direct and reflex vascular effects of intra-aortic balloon counterpulsation in dogs Am. J. Physiol. 221(3); 1971 C-Pulse balloon placement even more optimal location to activate reflexes Mitchell GAG. Anatomy Autonomic Nervous System. 1953 23

Systemic Effects of Neural Reflex Modulation of Sympathetic Nervous System F ↑ Afterload Black, HR. Braunwald’s Hypertension; 2012. 24

C-Pulse Central Aortic Pressure Arterial Baroreceptor Activity Bronk and Stella. J Cell. Comp. Physiol. (1): 1932 Peterson, LH. Circ. 21:1960 Counterpulsation Timed to Most Sensitive Phases of Cardiac Cycle for Baroreceptor Stimulation 25

C-Pulse Effects on Renal Blood Flow: Normal Swine 250 200 150 ON OFF 100 50 0 -50 0 500 1000 1500 2000 2500 3000 3500 Time 47 26 Renal Artery Flow (mL/min) Diastolic Augmentation

C-Pulse and Volume Management Patient with C-Pulse Therapy and Cardiomems C-Pulse OFF Submitted to HFSA 2015

C-Pulse and Heart Rate Variability: Clinical Case PIL Replacement

Pulsatility and Sympathetic Nervous System: Insights from LVAD Patients Individual and mean muscle sympathetic nerve activity (MSNA) burst frequencies in healthy controls and patients with pulsatile and non-pulsatile left ventricular assist devices in the supine position and during upright tilt. Markham D W et al. Circ Heart Fail. 2013;6:293-299 Copyright © American Heart Association, Inc. All rights reserved. 29

C, C-Pul.se n Multi-DISCI tudies to Assess roach Neuromodulation Effects: hna A SUNSHINE HEART HEMODYNAMIC IMPACT OF THE C-PULSE CARDIAC SUPPORT DEVICE: A 1D ARTERIAL MODEL STUDY D. Campos Arias1• T. Rodriguez.N. Stergiopulos2, P.Segers3 1Cujae, Research Group of Biomechanics and Biomaterlals, Cuba, 2 LHTC, EPFL, Lausanne, Switzerland; 3 IBiTech-bioMMeda, iMinds Medical IT, Ghent University., Belgium

Animal Studies: Pulmonary Artery Counterpulsation • Pulmonary HTN • RV Failure Secondary LVAD to • Congenital Defects (Tetralogy of Falot) 31

C-Pulse Counterpulsation on Pulmonary Artery OFF PA Flow OFF PA Pressure 32

Pulmonary Pressure and Flow in PA HTN: C Pulse Acutely Reverses Elevated PA Pressure 33

C-Pulse Unloads RV during Right Reduces LV Dilation Heart Failure and Simultaneously • C-Pulse restores RV function in setting of pulmonary hypertension and acute RV failure C-Pulse OFF LV Volume (conductance catheter) • Reduces dilation of LV during right heart failure RV Pressure 34

Counterpulsation on PA Improves RV Function In Acute Right Heart Failure due to Embolism 1200 1000 800 600 400 200 0 -200 -400 -600 -800 0.0 0.2 0.4 0.6 0.81.0 1.2 1.4 Time (seconds) 35 Right Ventricle dp/dt (mmHg/s)

Summary • C pulse provides based on traditional concepts of counterpulsation: increase coronary perfusion and afterload reduction. • Advanced hemodynamic analysis from patients indicates afterload reduction in late systole not onset of ejection related to balloon deflation. • Late systolic reduction associated with marked vasodilation in carotid artery and distal arterioles. What is mechanism???? • Hypothesis of mechanical stimulation of aortic and carotid baroreceptors. Stimulation due to nature of counterpulsation timed during cardiac cycle mimics physiologic stimulation pattern • Chronic neuromodulation and enhanced coronary perfusion may provide substrate for chronic remodeling and myocardial recovery. EU – CE marked / US - Caution: Investigational device, limited by Federal (or United States) Law to Investigational use. 36

Thank You! www.sunshineheart.com FRM-04558-B

MANAGEMENT OF ADVANCED HEART FAILURE TODAY Leslie W. Miller, MD Director of Heart Failure Morgan Heart Institute

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 on Form 10-K for the fiscal year ended December 31, 2014. 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.

3 Coronary Deaths Coronary deaths are down by half But heart failure has almost tripled Heart Failure Source: National Hospital Discharge Survey, CDC/NCHS and NHLBI. Consequence of our Success Need new technologies for chronic disease management Heart Failure versus Coronary Deaths

Heart Failure Facts Only form of CV disease increasing in Mortality > 7 million patients in U.S.; > 50% Systolic HF > 800,000 New cases/year*; One every 9 deaths* Increase is due to advances-AMI*, PCI, ICDs Epidemic of Obesity, Diabetes, HTN Prevalence: 7-10% people > 65 yrs of age (M=F) Population > 65 yr-double the incidence by 2030 NUMBER Patients increase by 2025 to > 10 M

5 CIRC HF 2013

MORTALITY BY GENDER WITH HEART FAILURE * Heidenreich Circ HF 2013-AHA Forecast

HEART FAILURE Estimated Prevalence by Age & Gender 10.6 Total > 7million % of Population 9 AHA Ht and Stroke Facts 2006

Current Estimate of Advanced HF Pts 309 Million Population HF= 2.6 % Population* or 7.4 Million Total 45-50 % Preserved Systolic Function 3.0-3.5M 50-55 % Systolic HF 3.0-3.5 Million 35% Class I 35% Class II 25% Class III (10% IIIB) 5 % Class IV Class IV 150-200,000 Class IIIB+IV < 75 yrs 200-300,000 Pts Theoretical Candidates for Advanced Therapy Class III B 300-350,000 *Circulation 2014

Heart Failure Facts Mortality > 60% at 5 yrs, worse by Class > 1 Million Hospitalizations/Yr (3 M as #2,3 Dx) More Hosp days care HF than any other Dx # 1 cause of readmission 30 days: 20-30% Loss of work impact > $8 Billion COST NOW: $31 B ; COST 2030: $ 70 Billion* Mandate to find new more cost effective therapies * Heidenreich Circ HF 2013-AHA Forecast

PROJECTED INCREASE IN TOTAL COST OF HF CARE

Outcomes in Patients Hospitalized with Heart Failure References: Aghababian RV. Rev Cardiovasc Med. 2002;3(suppl 4):S3-S9. Jong P et al. Arch Intern Med. 2002;162:1689-1694. 0 25 50 75 100 20% 50% 30 Days 6 Months Hospital Readmissions 0 25 50 75 100 12% 60% 30 Days 12 Months Mortality 33% 5 Years Median length of hospital stay: 6 days N = 38,702 N = 38,702

Median Survival Decreases Progressively after Each Hospitalization 1st hospitalization (n=14,374) 2nd hospitalization (n=3,358) 3rd hospitalization (n=1,123) 4th hospitalization (n=417) 0.0 1.0 2.0 3.0 Medial Survival (years) Setoguchi et al. AHJ 07 Average age of HF hosp In community = 74-77 years

Median Survival Decreases Progressively after Each Hospitalization Impact of Chronic Kidney Disease (CKD) 1st hospitalization (n=14,374) 2nd hospitalization (n=3,358) 3rd hospitalization (n=1,123) 4th hospitalization (n=417) 0.0 1.0 2.0 3.0 Medial Survival (years) Setoguchi et al. AHJ 2007 CKD CKD CKD CKD Average age of HF hosp In community = 74-77 years

Hospital Visits for Congestive Heart Failure Initial Episode = 21% Repeat Visit = 79% Emergency Department Presentations Aghababian RV. Rev Cardiovasc Med. 2008;3(suppl 4):S3–S9.

Failed In-Hospital Trials-ADHF DOSE-Diuretic dosing: IV infusion vs Bolus ASCEND- BNP vs Std Care DAD-HF: low dose Dopamine, high/low lasix PROTECT: Rolofyline vs std care CARRESS: Ultrafiltration RELAX: Seralaxin vs placebo ASTRONAUT: Aliskerin SMAC-HF: Hypertonic saline Givertz et al J Card Fail 2013

Intravenous Inotropes-Milrinone (OPTIME) Calcium Sensitizer Inotrope-Levosimendan (LIDO) Endothelin Receptor Antagonists (RITZ) BNP metabolism Neprolysin inhibitor (OVERTURE) Calcium Channel Blockers (PRAISE) TNF antibodies (RENAISSANCE) Brain Natriuretic Peptide (FUSION 3) Vasopressin Antagonist (Tolvaptan) Adenosine Receptor Antagonist (PROTECT) Angiotensin Receptor Block (Irbesartan) (I-PRESERVE) Failed New Therapies for Heart Failure

Entresto : New combined ARB and BNP inhibitor VS ACEI PARADIGM Study*: 8,000 patients Reduced Mortality by 20% Reduced Hospitalization by 20% Only 1 % were Class IV Corlanor: Designed to slow HF; only blocks ion channel No effect on Mortality Reduced Hospitalization by 23% Add on drug, Beta Blocker intolerant Only 1 % Class IV; 1% African Am *NEJM Sept 2014 New Drugs for Heart Failure

Current Management of Advanced/End Stage HF Optimized Oral HF Drug Rx Tx High Risk CV Surgery BiV Pacer DT Investigational Drugs VADs HUGE GAP IN THERAPEUTIC OPTIONS C-PULSE

WHY SUNSHINE HEART COUNTER-HF™ Huge Gap in Therapeutic Options between optimized Medical Therapy/CRT Ht Tx or large LVAD Implant is much less invasive compared to Tx/LVAD Multiple Mechanisms of benefit Device can be safely stopped-Relieve Anxiety of Risk Patient can SHOWER with drive line detached-QOL Modular design allows easy repair of drive line Moving to eliminating drive line Caution: C-Pulse ® is an investigational device. The device is limited by federal (United States) law to investigational use only.

OPTIONS HF Improvement in Ejection Fraction © 2015 Sunshine Heart, Inc. Baseline Ejection Fraction (%) 0 10 20 30 40 6M * * p<0.01

C- Pulse OPTIONS-HF Structural Remodeling End Systolic Volume N=11 Baseline End Systolic Volume (mL) 0 30 60 90 120 150 180 N=8 Month 6 Sunshine Heart data on file Confidential

LVESV is Correlated with Mortality Meta Analysis of 30 trials* Studies indicate that a 30 mL LVESV change correlates with~80% improvement in mortality. 30 mL volume change demonstrated in STOP-HF Reduced LVESV (mL) % Mortality Benefit *Kramer DG. JACC 2010; 56(5)

23 Modified from Bristow M, in Braunwald, ed: Heart Disease, chap 24, 2005 Exclude “Futile” Implants C-PULSE Target Population

CURRENT LVAD PROBLEMS Significant advances in technology Cost is >$150,000 just for index hospitalization READMISSION rate: Avg 2.6 admits first year GI Bleeding-main cause of readmission Stroke: 8-10% Device Thrombosis/Replacement Infection

RECOVERY Holy Grail of any form of mechanical support Sufficient improvement to remove the device Limited success with today’s chronic LVADs- 5-10% Explant and failure requires large Reoperation procedure If improvements seen in the short follow up with C-Pulse Persist or improve more, could lead to increased Recovery Goal is significant sustained improvement If HF returns, limited procedure to reinitiate therapy

26 Modified from Bristow M, in Braunwald, ed: Heart Disease, chap 24, 2005 Exclude “Futile” Implants C-PULSE Target Population

SUMMARY Growth in Heart Failure is “At a Tipping Point” Rapid increase in those still symptomatic on Optimal MM Once hospitalized for HF, dramatic decline in Survival Cost of this expansion (hospitalizations) is not sustainable Clear need for effective new alternative to current Rx Pilot data from C-Pulse is very encouraging Sustainable Recovery would have enormous impact Design makes it much more attractive to patient COUNTER trial should enroll well

STANDARDIZED CONSENT C-PULSE Trial enrollment is a critical component of success Enrollment varies between sites Significant Variability Consent Presentation New Approach: Create Scripted, Video-Taped Presentation of study and details- Allows uniform and “ideal” presentation as many times as patient needs and subsequent questions addressed FDA, Sponsor, PI, and Patient ALL Advantaged Caution: C-Pulse ® is an investigational device. The device is limited by federal (United States) law to investigational use only.

This image Progressof theFully ImplantableSystem TCT Conference, Oct 13, 2015 San www.sunshineheart.com Francisco cannot currently be display ed.

TThhiiss iimmaaggee 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 on Form 10-K for the fiscal year ended December 31, 2014. 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 1 • • • ccaannnnoott ccuurrrreennttllyy bbee ddiissppllaayy eedd..

This image C-Pulse II Overview: C-Pulse II - Fully Implantable System Internal electro-hydraulic converter and TETS eliminate the percutaneous drive line and associated infection risks. 1.Non-blood contacting 2.Non-obligatory cannot currently be display ed.

This image C-Pulse II Overview: C-Pulse II - Fully Implantable System Internal electro-hydraulic converter and TETS eliminate the percutaneous drive line and associated infection risks. 1. 2. 3. Non-blood contacting Non-obligatory No percutaneous drive line cannot currently be display ed.

This image C-Pulse II Overview: C-Pulse II - Fully Implantable System Internal electro-hydraulic converter and TETS eliminate the percutaneous drive line and associated infection risks. 1. 2. 3. 4. Non-blood contacting Non-obligatory No percutaneous drive No implanted battery line cannot currently be display ed.

. ESI/100 pt-Months > .Entire Cohort . 9. 22 ::J 0-3 rno 3-6 rno 6-12 mo E . ::J 8.18 u . 5.38 . 120 150 80 (days) Pramod Bonde eta/. Yale University 5 m e S u rvrv al 450 420 390 3 6 0 330 300 270 240 210 T1 1 90 60 30 0 0 0 259 N = 1 0 2 0 3 0 I 4 0 .... D.. C1l lc

:00 300 e To Ffrst Exrt Site Infection Pramod Bonde eta/. Yale University 6

G not Eliminating the driveline is a new idea... SUNSHINE HEART Heartrnate ® Blood Pump \ Rechargeable Internal Battety and Controls 1985 Circa 7

Arrow LionHeart LVAD 8

Arrow LionHeart LVAD 9

Arrow LionHeart LVAD 10

TThhiiss iimmaaggee PennState Arrow Lionheart summary Nov 9, 2003 • • • • • • • 23 male patients enrolled between Oct 1999 and 10/23 discharged home with device 8/23 alive at 2 years 1/23 alive at 3 years Mean duration 347 days (17-1259) Dec 2002 5/23 serious infections (.17/patient year vs. year REMATCH… no deaths due to infections) No serious TETs complications .60/patient 11 ccaannnnoott ccuurrrreennttllyy bbee ddiissppllaayy eedd..

TThhiiss iimmaaggee PennState Arrow Lionheart summary Nov 9, 2003 • • • • • • • 23 male patients enrolled between Oct 1999 and 10/23 discharged home with device 8/23 alive at 2 years 1/23 alive at 3 years Mean duration 347 days (17-1259) Dec 2002 5/23 serious infections (.17/patient year vs. year REMATCH… no deaths due to infections) No serious TETs complications .60/patient 12 ccaannnnoott ccuurrrreennttllyy bbee ddiissppllaayy eedd..

TThhiiss iimmaaggee Where will clinical implementation of TETS technology first find traction? 13 ccaannnnoott ccuurrrreennttllyy bbee ddiissppllaayy eedd..

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TThhiiss iimmaaggee SUNSHINE HEART C-pulse extra-aortic balloon cuff 16 ccaannnnoott ccuurrrreennttllyy bbee ddiissppllaayy eedd..

TThhiiss iimmaaggee SUNSHINE HEART C-pulse extra-aortic balloon cuff Non-obligatory 17 No blood contact … ccaannnnoott ccuurrrreennttllyy bbee ddiissppllaayy eedd..

TThhiiss iimmaaggee SUNSHINE HEART C-pulse II 18 ccaannnnoott ccuurrrreennttllyy bbee ddiissppllaayy eedd..

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TThhiiss iimmaaggee C-Pulse II – Leveraging powerful synergies Minnetronix Cirtec Medical Systems 21 TEXAS HEART INSTITUTE at St. Luke’s Episcopal Hospital ccaannnnoott ccuurrrreennttllyy bbee ddiissppllaayy eedd..

TThhiiss iimmaaggee Cirtec Medical Systems Electrohydraulic pump-•Rapidly inflates and deflates extra-aortic balloon cuff (reproduces C-I physiology) •EKG synchronized to provide counter-pulsation •Balloon passively empties in the event of pump or power failure •Leverages the incompressibility of silicone oil (essential) •Compliance reservoir incorporated into the base of the pump 22 ccaannnnoott ccuurrrreennttllyy bbee ddiissppllaayy eedd..

TThhiiss iimmaaggee Cirtec Medical Systems Electrohydraulic pump-•Rapidly inflates and deflates extra-aortic balloon cuff (reproduces C-I physiology) •EKG synchronized to provide counter-pulsation •Balloon passively empties in the event of pump or power failure •Leverages the incompressibility of silicone oil (essential) •Compliance reservoir incorporated into the base of the pump 23 ccaannnnoott ccuurrrreennttllyy bbee ddiissppllaayy eedd..

G II-Important IP progress C-Pulse SUNSHINE HEART METHODS,SYSTEMS, AND DEVICES RELATING TO A FAIL-SAFE PUMP FOR A HEART ASSIST DEVICE Detailed Description [001] The various embodiments disclosed herein relate to pumps for use in various medical device systems, including, for example, mechanical heart assist device systems. 24

TThhiiss iimmaaggee C-Pulse II – Important IP progress So no need for an implantable battery 25 ccaannnnoott ccuurrrreennttllyy bbee ddiissppllaayy eedd..

going to power it? SUNSHINE NSHINE HEART 26 G HEART How are we

TThhiiss iimmaaggee Trans-cutaneous Energy Transfer System (TETS) • • • DC DC AC battery current current pack outside the body is put through an oscillator to make AC energizes external coil (1o) to generate an oscillating magnetic field Oscillating magnetic field Oscillating magnetic field internal coil (2o) resulting • • goes through the skin is picked up by a tuned in induction of AC current • AC current rectified into DC used to run the internal device 27 ccaannnnoott ccuurrrreennttllyy bbee ddiissppllaayy eedd..

Standard transformer G SUNSHINE HEART 28

Inductive coupling through an air-gap G SUNSHINE HEART - 29

TThhiiss iimmaaggee Nikola Tesla July 10, 1856 – January 7, 1943 30 ccaannnnoott ccuurrrreennttllyy bbee ddiissppllaayy eedd..

TThhiiss iimmaaggee Minnetronix Leaders in Transcutaneous (TETS) Energy Transfer Systems Newest systems are: • • • • Smaller size so easier to implant More energy efficient so improved battery life More tolerant of geometric misalignment Newer iterations avoid previous challenges associated with thermal injury to the skin 31 ccaannnnoott ccuurrrreennttllyy bbee ddiissppllaayy eedd..

TThhiiss iimmaaggee Minnetronix Leaders (TETS) in Transcutaneous Energy Transfer Systems 32 ccaannnnoott ccuurrrreennttllyy bbee ddiissppllaayy eedd..

TThhiiss iimmaaggee Minnetronix Improvement in TETS component geometry and function 33 ccaannnnoott ccuurrrreennttllyy bbee ddiissppllaayy eedd..

TThhiiss iimmaaggee How are we going to power it? Where are we going to test it? 34 ccaannnnoott ccuurrrreennttllyy bbee ddiissppllaayy eedd..

TThhiiss iimmaaggee Hospital 35 TEXAS HEART INSTITUTE at St. Luke’s Episcopal ccaannnnoott ccuurrrreennttllyy bbee ddiissppllaayy eedd..

TThhiiss iimmaaggee THI Cardiovascular Research Lab ICU nonclinical and preclinical safety testing are required the global regulations prior to human trials by ccaannnnoott ccuurrrreennttllyy bbee ddiissppllaayy eedd..

TThhiiss iimmaaggee Surgical Implant and system integration • • • THI’s Cardiovascular Research Lab One of the premiere large animal cardiovascular research lab in the world Domain dominance in development and implementation technology of heart failure • Successful acute system implantation (first generation) 37 ccaannnnoott ccuurrrreennttllyy bbee ddiissppllaayy eedd..

TThhiiss iimmaaggee Minimally Invasive Implantation Small incision Sternal-sparing No cardiopulmonary bypass 38 ccaannnnoott ccuurrrreennttllyy bbee ddiissppllaayy eedd..

TThhiiss iimmaaggee Recent Progress -Bench-Top Tests, CPII versus CPI Typical Average power ≈ 3Watts Peak Instantaneous ≈ 20W 39 ccaannnnoott ccuurrrreennttllyy bbee ddiissppllaayy eedd..

G Recent Acute animals (x2) SUNSHINE HEART 0 E ' 20 n and subsequent reduction in end diastolic pressure (t.) of >15mmHg 40 80 I :X: ..§.60 \ Time Figure 11. Hemodynamic performance of the CP2-Gen1 assembly operating in 1:2 mode during an acute bovine trial. Trace shows clear diastolic augmentation com ared to the ad·acent non-counter ulsated c cle.

TThhiiss iimmaaggee 41 ccaannnnoott ccuurrrreennttllyy bbee ddiissppllaayy eedd..

NE 42

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TThhiiss iimmaaggee In summary… • 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 Early preclinical testing suggests the design is performing as intended and within established safety parameters 50 • • • • ccaannnnoott ccuurrrreennttllyy bbee ddiissppllaayy eedd..