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: Executive Summary
Executive Summary Focused on providing meaningful solutions for the $95 billion Heart Failure market in two distinct ways: Developing a fully implantable disruptive solution for Class III Heart Failure: Based on learnings from original C-Pulse device Proprietary neuro based approach Targets easy to
Slide 3: Executive Leadership Team
Executive Leadership Team ©2016 Sunshine Heart, Inc. 8/24/2016 3 40+ years experience in medical devices CE0 of 4 med-tech start-up companies Chairman of 3 public boards BA in Business Administration from California State University, Fullerton John Erb Chief Executive Officer, Chairman 15 year finan
Slide 4: Discussion Outline
Discussion Outline HF Market Opportunity Neuromodular Strategy Aquadex FlexFlow Product Line Financial Priorities ©2016 Sunshine Heart, Inc. 8/24/2016 4
Slide 5: Heart Failure is a Significant Economic Burden
Heart Failure is a Significant Economic Burden Incidence: 800,000+ new cases per year One of every 9 deaths HF linked to other major diseases: Obesity, Diabetes, Hypertension Mortality: 60%+ at 5 years, worse by NYHA class > 1 million hospitalizations per year More hospital days for HF than any othe
Slide 6: Current US Estimate of Heart Failure patients
Current US Estimate of Heart Failure patients 8/24/2016 ©2016 Sunshine Heart, Inc. 6 *Source: Circulation 2014 US Market Opportunity: > $30B* EU Market Opportunity: > $65B† † Source: Framingham Study, Windover 2007 Report, AHA 2010 Stroke Update, HRI 2010
Slide 7: Discussion Outline
Discussion Outline HF Market Opportunity Neuromodular Strategy Aquadex FlexFlow Product Line Financial Priorities ©2016 Sunshine Heart, Inc. 8/24/2016 7
Slide 8: Mechanical Counterpulsation: Our Original Focus
Mechanical Counterpulsation: Our Original Focus Increase diastolic pressure: Coronary Blood Flow Unloading of the left ventricle Maintenance of mean aortic pressure Optimize left ventricular coupling ©2016 Sunshine Heart, Inc. 8/24/2016 8 Extra-aortic cuff ECG Sensing leads Interface Lead Driver
Slide 9: Clinically Significant Results: Reduction in Heart Failure Readmissions
Clinically Significant Results: Reduction in Heart Failure Readmissions Meaningful readmission reductions at 3, 6, and 12 months Significant financial upside for Hospitals & Payers ©2016 Sunshine Heart, Inc. 8/24/2016 9 Readmission Rates 3-mo 6-mo 12-mo Class III Average 25% 36% 59% C-Pulse Feasibil
Slide 10: Clinically Significant Results: Improvement in Cardiac Structure
Clinically Significant Results: Improvement in Cardiac Structure 15 patients implanted in Europe Mean increase of 10 EF units (%), implying improved patient outcomes; CRT increases 2.7 units* Four patients weaned from therapy due to HF stabilization Significant improvements in 6 minute walk, NYHA cl
Slide 11: Hemodynamic Improvement Greater than Expected from Mechanical Counterpulsation
Hemodynamic Improvement Greater than Expected from Mechanical Counterpulsation ©2016 Sunshine Heart, Inc. 8/24/2016 11 Original Hypothesis: C-Pulse results driven by bio-mechanical flow improvement Clinical Benefit: More positive than predicted by mechanical action alone Observation: C-Pulse cuff pl
Slide 12: Compelling Evidence of Neuromodulatory Impact
Compelling Evidence of Neuromodulatory Impact ©2016 Sunshine Heart, Inc. 8/24/2016 12 In-vivo Simulation 89% 6% 102% 55% 52% 21% Independent Assessment by Professor Patrick Segers who is a leader in the study of arterial hemodynamics in Ghent, Belgium Assessment using a validated computer model of t
Slide 13: Positive Initial Neuro Assessment
Positive Initial Neuro Assessment Positive patient outcomes from Dallas VA with investigator Dr. Phi Wiegn led to a physician initiated study with Dr. William Cornwell and Dr. Ben Levine of University of Texas Southwestern Conducted an acute neuro and hemodynamic assessment of a patient who had been
Slide 14: Neuromodulation: A Better Clinical Solution
Neuromodulation: A Better Clinical Solution ©2016 Sunshine Heart, Inc. 8/24/2016 14 Counterpulsation: Challenges of a Mechanical Approach Driveline limited inclusion criteria and enrollment rate Limited market in advanced HF patients Current C-Pulse system challenging for patients to manage long ter
Slide 15: Innovative Neuromodulation Approach
Innovative Neuromodulation Approach Minimally Invasive: 2 small incisions IPG Pocket 1-2 inch neck exposure Easy: Nerve Cuff Placement on one of only two distinct & complementary afferent baroreceptor sites (Aortic Depressor Nerve) Fast: 45 - 60 min procedure Value: Procedural LOS < 1 day in hospita
Slide 16: Clinical Study Pathway
Clinical Study Pathway ©2016 Sunshine Heart, Inc. 8/24/2016 16 Near-Term Purpose: Publication revealing that neuromodulation is the mechanism driving clinical improvements n=5 with original CP-1 device; sympathetic nerve activity with C-Pulse ON vs. OFF Enrollment underway; complete follow-up in 201
Slide 17: Our Approach is Well Positioned for Clinical Success
Our Approach is Well Positioned for Clinical Success ©2016 Sunshine Heart, Inc. 8/24/2016 17 Easily Identifiable Target: Confirmed in Cadaver Studies Aortic Depressor Nerve identified in neck by Prof. John Karemaker Easily Separable Target Nerves are anatomically distinct from other structures Clear
Slide 18: Our Approach Seeks to Benefit Multiple Stakeholders
Our Approach Seeks to Benefit Multiple Stakeholders ©2016 Sunshine Heart, Inc. 8/24/2016 18 Patient Benefits Improved duration and Quality of Life Reduced readmissions and time in hospital Implant to discharge within 24 hours Significantly delay the need for later stage, more invasive therapies Phys
Slide 19: Discussion Outline
Discussion Outline HF Market Opportunity Neuromodular Strategy Aquadex FlexFlow Product Line Financial Priorities ©2016 Sunshine Heart, Inc. 8/24/2016 19
Slide 20: Aquadex FlexFlow Overview
Aquadex FlexFlow Overview Acquired from Baxter International (8/5/16) This is the former CHF Solutions Inc. business * Installed base of over 500 Aquadex consoles 300+ hospitals have purchased Aquadex Operationally Ready: 7 fully-trained Therapy Development Specialists Historical Revenue: $13M in 20
Slide 21: Aquadex FlexFlow Product Line
Aquadex FlexFlow Product Line 8/24/2016 © 2016 Sunshine Heart, Inc. 21 Aquadex Console Disposable peripheral Catheter Disposable, single-use Blood Set
Slide 22: Aquadex FlexFlow
Aquadex FlexFlow A simplified form of ultrafiltration (UF) Safe method to achieve dry weight Ease of Use Highly automated setup and operation Diverse physician prescription Inpatient or outpatient settings Peripheral or central venous access Used often with 4:1 RN ratios in Stepdown Ambulatory capab
Slide 23: The Aquadex FlexFlow System is indicated for
The Aquadex FlexFlow® System is indicated for: Temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload who have failed diuretic therapy Extended (longer than 8 hours) ultrafiltration treatment of patients with fluid overload who have failed diuretic therapy and require ho
Slide 24: Fluid Overload Drives Increased Heart Failure Costs
Fluid Overload Drives Increased Heart Failure Costs Congestive heart failure is the leading cause of hospitalizations1 Annual incidence of HF is 10 per 1,000 (pts over 65 years of age)2 90% of HF patients present with symptoms of fluid overload3 Almost 1 million hospitalizations annually in US for a
Slide 25: Discussion Outline
Discussion Outline HF Market Opportunity Neuromodular Strategy Aquadex FlexFlow Product Line Financial Priorities ©2016 Sunshine Heart, Inc. 8/24/2016 25
Slide 26: Financial Results and Key Balance Sheet Information
Financial Results and Key Balance Sheet Information ©2016 Sunshine Heart, Inc. 8/24/2016 26 Summary Balance Sheet Dec. 31, 2015 Q2 2016 Cash & Cash Equivalents: $23.1M $12.0M Long-term Debt $8.0M $6.1M Total Stockholders’ Equity: $12.2M $3.7M Operations Summary Year ended Dec 31, 2014 Year ended Dec
Slide 27: Key Financial Priorities
Key Financial Priorities ©2016 Sunshine Heart, Inc. 8/24/2016 27 Reduce cash burn Operations streamlined to extend cash runway Resources prioritized for development of fully implantable Raise capital to finance the development of the fully implantable system $3.5 million in convertible preferred sha
Slide 28: Thank you
Thank you FRM-04558-D ©2016 Sunshine Heart, Inc.
Slide 29: Sunshine Heart - Thank you
C SUNSHINE HEART Thank you