Nuwellis, Inc. · NASDAQ:NUWE
Nuwellis — CHF Solutions — IPO Roadshow (November 2017)
27 slides from Nuwellis's IPO roadshow presentation, Nov 6, 2017
Slide 1: Corporate Presentation November 2017
11/6/2017 ©2017 CHF Solutions, Inc. Corporate Presentation (NASDAQ: CHFS)November 2017 17-1022-A
Slide 2: Forward Looking Statement
©2017 CHF Solutions, Inc. 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 diffe
Slide 3: Statement about Free Writing Prospectus
| ©2017 CHF Solutions, Inc. Statement about Free Writing Prospectus This presentation highlights basic information about us and the offering. Because it is a summary that has been prepared solely for informational purposes, it does not contain all of the information that you should consider before i
Slide 4: Aquadex Business Overview
©2017 CHF Solutions, Inc. Aquadex Business Overview 4 Business and Market OverviewAquadex and its Aquapheresis therapy, a form of ultrafiltration to reduce fluid overload in patients, when diuretics failAcquired from Baxter in August 2016FDA 510(k) market cleared and CE markedInstalled base of 500+
Slide 5: Aquadex Product Overview
©2017 CHF Solutions, Inc. Aquadex Product Overview 5 Aquadex Console Venous Catheter Blood Circuit Set
Slide 6: Our Vision
Our Vision To be the global market leader in the prediction, control, and prevention of hypervolemia.
Slide 7: Fluid Management Today vs Tomorrow
©2017 CHF Solutions, Inc. Fluid Management Today vs Tomorrow 7 Symptomatic Managing symptoms mostly in In-Patient settings. Used after diuretic failure in very sick patients. Pharmacologic Therapy Device-based Therapy Preventative Standard of care therapy to prevent fluid overload. Used both in In-P
Slide 8: Heart Failure: A Significant Burden on our Healthcare System
©2017 CHF Solutions, Inc. Heart FailureA weakening of the heart’s pumping ability causing fluid retention in the body. A Significant Burden on our Healthcare System 1 million people in the US are admitted annually to the hospital for heart failure¹90% of these admissions are because of fluid overloa
Slide 9: Recurrent Fluid Overload: An Alarming Problem
©2017 CHF Solutions, Inc. Recurrent fluid overload in heart failure has uniformly been associated with worse outcomes independent of age and renal function Recurrent Fluid Overload An Alarming Problem 9 24%Readmission Rate 50%Readmission Rate 30 Days 6 months 24% within 30 days50% within 6 months 24
Slide 10: Diuretics: The Current First-line Standard of Care
©2017 CHF Solutions, Inc. DiureticsThe Current First-line Standard of Care Symptomsof Fluid Overload Treatment 10 Limitations Difficulty in breathing and shortness of breathSwelling in legs, arms, abdomen, and fluid in lungsLimitations in daily life, decrease in patient’s quality of lifeLasix and Fu
Slide 11: Diuretics: The Current First-line Standard of Care
©2017 CHF Solutions, Inc. DiureticsThe Current First-line Standard of Care 11 In a large subset of patients, Diuretics fail to provide optimal patient outcomes due to:Diuretic resistance, which leads to ineffective removal of fluid from patientsResidual fluid excess at the time of discharge accounts
Slide 12: Indications for Use
Indications for Use ©2017 CHF Solutions, Inc. 12 Despite advances in HF-related medical care, frequent readmission leading to reduced patient quality of life and significant health care cost, remains today’s challenge. The Aquadex FlexFlow® System is indicated for:Temporary (up to 8 hours) ultrafilt
Slide 13: Aquadex Ultrafiltration System: How it Works
Aquadex Ultrafiltration System How it Works The device is connected to a catheter to withdraw blood containing excess fluid from the interstitial spaceThe blood then passes through a special filter in the deviceThe filter separates excess salt and water from the bloodThe blood is returned to the pat
Slide 14: Aquadex FlexFlow System: Controlling Fluid Reduction
©2017 CHF Solutions, Inc. 14 Aquadex FlexFlow® System Controlling Fluid Reduction. Restoring Balance. Clinical and Economic Advantages of the Aquadex System:Simple to use, highly automated, and provides precise control of rate and amount of fluid removedExtracts more sodium than diuretic therapy whi
Slide 15: Recent Clinical Evidence
©2017 CHF Solutions, Inc. 15 Recent Clinical EvidenceJournal of American College of Cardiology (JACC); May 16, 2017 Extracorporeal Ultrafiltration for Fluid Overload in Heart FailureUnmet Clinical Need:The foremost goal in managing acutely decompensated heart failure is to effectively resolve fluid
Slide 16: Significant Clinical Evidence
©2017 CHF Solutions, Inc. 16 Aquadex FlexFlow® Ultrafiltration SystemSignificant Clinical Evidence Study Name Study Design # of Patients Study Patient / Patients Group Date Key Findings SAFE Multi-center, prospective, single-arm 21 IDE for 510k 2003JCF Extracellular and intravascular fluid volume ex
Slide 17: Clinical Guidelines Support Aquapheresis Use
©2017 CHF Solutions, Inc. 17 Clinical Guidelines Support Aquapheresis Use HFSA 2010 Comprehensive Heart Failure Practice Guidelines: Lindenfeld J, et al. J Card Fail. 2010 Jun; 16(6): 475 – 539.ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure 2012: McMurray JJ, et al
Slide 18: 80% of Hospital Readmissions Due to Heart Failure
©2017 CHF Solutions, Inc. 18 80% of Hospital Readmissions Due to Heart Failure In response, on October 1, 2012 the Affordable Care Act instituted the Hospital Readmission Reduction Program (HRRP) Requirement: CMS to reduce payments to hospitals with excess readmissionsPenalty: hospitals can lose ≤ 3
Slide 19: Ultrafiltration vs. Intravenous Diuretics (UNLOAD Study)
Multicenter, prospective, randomized clinical study 100 patients UF vs. 100 patients standard of care (diuretics) Ultrafiltration vs. Intravenous Diuretics for Patients Hospitalized for Acute Decompensated CHF (UNLOAD Study)¹ ©2017 CHF Solutions, Inc. 19 63% reduction in re-hospitalized days (1.4 vs
Slide 20: Aquapheresis in a Clinical Setting: Good Samaritan Hospital
©2017 CHF Solutions, Inc. 20 Today’s Healthcare Environment Aquapheresis in a Clinical SettingGood Samaritan Hospital: A Single Center Experience Independent study on 67 heart failure patients who received Aquapheresis:No 30-day readmits for volume overloadLength of Stay when started within 24 hours
Slide 21: Recent Developments
©2017 CHF Solutions, Inc. Recent Developments 21 Revenue increased 21% compared to the same period in 2016 on a pro forma basis Expanded sales footprint to 10 territories by adding 6 additional sales professionalsDistribution commenced in United KingdomCompleted Scientific Advisory Board (SAB) meeti
Slide 22: Performance Metrics
©2017 CHF Solutions, Inc. Performance Metrics 22 (*) (*) Represents revenue since acquisition date, August 6, 2016 (**) Calculated on a pro forma basis (**)
Slide 23: Capitalization Table
Instrument Shares Common Shares (Nasdaq: CHFS) 625,791 Warrants (WAEP $26.10; Exp 2021-2025) 496,468 Options (WAEP: $90.70) 36,868 RSUs 297 Total 1,159,424 ©2017 CHF Solutions, Inc. 23 Capitalization Table
Slide 24: Growth Opportunities
©2017 CHF Solutions, Inc. Growth Opportunities 24 1 Established Customer BaseOpportunity to expand utilization in current base of over 300 US hospital customers who currently own over 500 consoles Untapped Outpatient MarketMedicare penalties for early readmissions is driving a growing outpatient mar
Slide 25: Executive Leadership Team
| ©2017 CHF Solutions, Inc. Executive Leadership Team 15 year finance career with Medtronic in United States and Europe20+ years finance/accounting experienceCPA, MBA Finance and Strategy University of Minnesota Claudia Napal DraytonChief Financial Officer 25+ years of medical device development exp
Slide 26: Board of Directors
| ©2017 CHF Solutions, Inc. Board of Directors John ErbChief Executive Officer, Chairman 40+ years of financial management experienceCurrent and past Board member for multiple medical device companies30 years experience as CFOMBA in Accounting from California State University at Fullerton Greg Walle
Slide 27: For More Information
Claudia Napal DraytonChief Financial OfficerCHF Solutions Inc. 952-345-4205 -or- Bret ShapiroManaging PartnerCORE IR516 222 2560brets@coreir.com For More Information Investor Relations:CHF Solutions, Inc.ir@chf-solutions.com