Nuwellis, Inc. · NASDAQ:NUWE

Nuwellis — Sunshine Heart — Technical Presentation (October 2015)

38 slides from Nuwellis's technical presentation, Oct 13, 2015

  1. Slide 1: Forward Looking Statement

    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

  2. Slide 2: Counterpulsation Mechanism Based On Physiologic Hemodynamics of Wave Travel in Arteries

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

  3. Slide 3: C-Pulse Counterpulsation: CT Clinical Example

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

  4. Slide 4: C-Pulse Design: Unique Placement on Ascending Aorta

    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

  5. Slide 5: Counterpulsation and Myocardial Oxygen Consumption

    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 •

  6. Slide 6: C-Pulse Effect on Coronary Hemodynamics in Normal Swine

    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

  7. Slide 7: Boost Diastolic Pressure: Reservoir for Coronaries to Fill

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

  8. Slide 8: Counterpulsation and Coronary Perfusion and Oxygen Utilization at Rest and Exertion

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

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

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

  10. Slide 10: Wave Travel and Reflection Animation

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

  11. Slide 11: Wave Travel and Reflection Animation

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

  12. Slide 12: Ultrasound data – Ascending Aorta and Carotid Artery

    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%) Increa

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

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

  14. Slide 14: Wall Stress Peaks Late Systole in HF

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

  15. Slide 15: C-Pulse Reduces Wall Stress and Increases Shortening Velocity

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

  16. Slide 16: Wave Intensity Analysis in Carotid and Aorta

    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

  17. Slide 17: C-Pulse Hemodynamically Similar to Positive Inotrope

    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

  18. Slide 18: HEM – Pressure and Flow – carotid artery

    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

  19. Slide 19: Clinical Importance of Wave Reflections and Late Systolic Load

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

  20. Slide 20: Hemodynamic Effects of Unloading with C-Pulse On Central Pressure and Wave Reflections

    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†

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

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

  22. Slide 22: How Does a Cuff in Ascending Aorta Influence Peripheral Vessels?

    HOW DOES A CUFF IN ASCENDING AORTA INFLUENCE PERIPHERAL VESSELS?

  23. Slide 23: Large Unloading Effects Partly Due to Neural Reflexes?

    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

  24. Slide 24: Systemic Effects of Neural Reflex Modulation of Sympathetic Nervous System

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

  25. Slide 25: Counterpulsation Timed to Most Sensitive Phases of Cardiac Cycle for Baroreceptor Stimulation

    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

  26. Slide 26: C-Pulse Effects on Renal Blood Flow: Normal Swine

    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

  27. Slide 27: C-Pulse and Volume Management

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

  28. Slide 28: C-Pulse and Heart Rate Variability: Clinical Case

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

  29. Slide 29: Pulsatility and Sympathetic Nervous System: Insights from LVAD Patients

    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. Mar

  30. Slide 30: Multi-Disciplinary Approach to Assess Neuromodulation Effects

    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,

  31. Slide 31: Animal Studies: Pulmonary Artery Counterpulsation

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

  32. Slide 32: C-Pulse Counterpulsation on Pulmonary Artery

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

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

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

  34. Slide 34: C-Pulse Unloads RV during Right Heart Failure and Reduces LV Dilation

    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

  35. Slide 35: Counterpulsation on PA Improves RV Function In Acute Right Heart Failure due to Embolism

    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)

  36. Slide 36: Summary

    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

  37. Slide 37: Thank You!

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

  38. Slide 38: Thank You!

    C SUNSHINE HEART Thank You! www.sunshineheart.com FRM-04558-8

Sunshine Heart — Technical Presentation (October 2015) on 6ix