Nuwellis, Inc. · NASDAQ:NUWE
Nuwellis — Sunshine Heart — Investor Presentation (October 2015)
28 slides from Nuwellis's investor presentation, Oct 13, 2015
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 st
Slide 2: Coronary Deaths vs Heart Failure
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
Slide 3: Heart Failure Facts
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
Slide 4: Heart Failure Facts
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
Slide 5: Mortality by Gender with Heart Failure
MORTALITY BY GENDER WITH HEART FAILURE * Heidenreich Circ HF 2013-AHA Forecast
Slide 6: Heart Failure Estimated Prevalence by Age & Gender
HEART FAILURE Estimated Prevalence by Age & Gender 10.6 Total > 7million % of Population 9 AHA Ht and Stroke Facts 2006
Slide 7: Current Estimate of Advanced HF Patients
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 200-300,00
Slide 8: Heart Failure Facts: Mortality, Hospitalizations, Cost
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 ef
Slide 9: Projected Increase in Total Cost of HF Care
PROJECTED INCREASE IN TOTAL COST OF HF CARE
Slide 10: Outcomes in Patients Hospitalized with Heart Failure
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 M
Slide 11: Median Survival Decreases Progressively after Each Hospitalization
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
Slide 12: Median Survival and Impact of Chronic Kidney Disease
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 C
Slide 13: Hospital Visits for Congestive Heart Failure
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.
Slide 14: Failed In-Hospital Trials-ADHF
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 2
Slide 15: Failed New Therapies for Heart Failure
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 (T
Slide 16: New Drugs 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
Slide 17: Current Management of Advanced/End Stage HF
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
Slide 18: Why Sunshine Heart COUNTER-HF
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-Q
Slide 19: OPTIONS HF Improvement in Ejection Fraction
OPTIONS HF Improvement in Ejection Fraction © 2015 Sunshine Heart, Inc. Baseline Ejection Fraction (%) 0 10 20 30 40 6M * * p<0.01
Slide 20: C-Pulse OPTIONS-HF Structural Remodeling
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
Slide 21: LVESV is Correlated with Mortality
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)
Slide 22: C-Pulse Target Population
23 Modified from Bristow M, in Braunwald, ed: Heart Disease, chap 24, 2005 Exclude “Futile” Implants C-PULSE Target Population
Slide 23: Current LVAD Problems
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
Slide 24: Recovery
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
Slide 25: C-Pulse Target Population
26 Modified from Bristow M, in Braunwald, ed: Heart Disease, chap 24, 2005 Exclude “Futile” Implants C-PULSE Target Population
Slide 26: Summary
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
Slide 27: Standardized Consent
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
Slide 28: Standardized Consent
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
Sunshine Heart — Investor Presentation (October 2015) on 6ix