Slide 1: March 2023 Investor Presentation
March 2023 Investor Presentation ©2023 Nuwellis, Inc
Slide 2: Safe Harbor Statement
Safe Harbor Statement Forward Looking Statement This presentation contains forward‐looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities and Exchange Act, as amended regarding our plans, expectations, beliefs, estimates, goal
Slide 3: Our Mission
is dedicated to transforming the lives of patients suffering from fluid overload through science, collaboration, and innovation. 3 Our Mission ©2023 Nuwellis, Inc
Slide 4: Investment Highlights
$2B+ and growing addressable market Outpatient market opportunity adds $0.5B+ to addressable market (heart failure and advanced liver disease) Positive ROI and attractive clinical + economic benefits to hospitals and healthcare system Robust body of clinical evidence Scalable consumables driven grow
Slide 5: Executive Leadership Team
Over 200 years’ collective experience in clinical practice and the medical device industry, working with companies including Medtronic, Boston Scientific and Abbott/St. Jude Medical Management team with proven success commercializing many therapies John Jefferies, M.D., joined as Chief Medical Offic
Slide 6: Fluid Overload is Associated with Greater Mortality
Survival (days) 90-day mortality by intravenous fluid median 1.000 0.975 0.950 0.925 0.900 0 10 20 30 40 50 60 70 80 90 Survival rates with No Excess Fluid Survival rates with Excess Fluid IVF > Median IVF ≤ Median Fluid overload is the leading cause of death for critically ill patients in the ICU w
Slide 7: Diuretics: Significant Limitations as Current Standard of Care
Diuretics: Significant Limitations as Current Standard of Care High risk of rehospitalization1 Long-term use of diuretics is associated with kidney damage1-4 Diuretics provide insufficient symptom relief and are associated with worsening heart failure and increased mortality after discharge1 >40% of
Slide 8: Clinically Superior Solution for Fluid Overload
SIMPLE FLEXIBLE SMART Reduces hospitalization by 81%1 compared to diuretics Rehospitalizations with Aquadex were 48% lower than the national average at 30 days1 Reduces length of hospital stay when initiated early, resulting in average savings of $3,975 (14%)6-7 No significant changes to kidney func
Slide 9: Multiple Growth Opportunities
$1B Market1 ~30% of sales Heart Failure $130M Market1 ~30% of sales PEDIATRIC $900M Market1 ~40% of sales CRITICAL CARE TREATING THE MOST VULNERABLE From children2 to the elderly, our therapy is critical to improving care and outcomes $2B+ TAM 1. See Appendix. 2. Approved for use in pediatric patien
Slide 10: Expanding Use of Ultrafiltration Across Hospital Specialty Units
Cardiac Surgery Liver Transplants Sepsis Advanced Liver Disease 550,000 patients/year1 12,000 patients/year2 VAD 6,000 patients/year3 1.8M patients/year4 700,000 patients/year5 Adult ECMO 15,000 patients/year6 NEAR-TERM OPPORTUNITIES (In the U.S.) MID to LONG-TERM OPPORTUNITIES (In the U.S.) Expandi
Slide 11: HF Case Study: Diuretic Limitations Create Significant Burden
HF Case Study: National data suggests the current standard of care for managing fluid overload in HF patients is challenging and costly for patients and hospitals Sources: 1. Costanzo MR, et al. J Am Coll Cardiol. 2017 May 16;69(19):2428-2445. 2. From Premier Applied Sciences database. 3. Reimbursem
Slide 12: AVOID-HF Trial Win Ratios Analysis
Aquapheresis Versus Intravenous Diuretics and Hospitalizations for Heart Failure (AVOID-HF) Trial Finkelstein-Schoenfeld Method of Win Ratios Analysis Provides New Insights Into Clinical Data Favors Adjustable Ultrafiltration (AUF) over Adjustable Loop Diuretics (ALD) in Treating Fluid Overloaded He
Slide 13: 10-Year, Real-World Experience with Ultrafiltration
HF HOSPITALIZATIONS 10-Year, Real-World Experience with Ultrafiltration1 ABINGTON HOSPITAL JEFFERSON HEALTH Retrospective, single center analysis 334 consecutive acutely decompensated heart failure patients Cohort of patients in study were sicker than those in other clinical trials Treated with adju
Slide 14: Outpatient Aquadex – Potential Savings for a Hospital
Outpatient Aquadex – Potential Savings for a Hospital Account With inpatient therapy only: 23% HF patient readmission rate $41.7M non reimbursable loss With outpatient Aquadex: 12% HF patient readmission rate 35% cost savings over inpatient therapy only HOSPITAL NAME Actual Hospital Account INPATIEN
Slide 15: Driving Use of Ultrafiltration in the Outpatient Setting
Heart Failure Advanced Liver Disease 400,000 patients/year1 700,000 patients/year2 NEAR-TERM OPPORTUNITY (U.S.) Driving Use of Ultrafiltration in the Outpatient SettingPrevents hospitalization and lowers readmission rates MID-TERM OPPORTUNITY (U.S.) 1. Derived from: https://www.grandviewresearch.com
Slide 16: Making Aquadex the Standard of Care in Fluid Overload
Making Aquadex the Standard of Care in Fluid Overload Growing body of clinical evidence; Advocating for medical society guidelines and improved provider reimbursement 1. Pinney S et al Poster presented HFSA Annual Meeting 2022. 2. Haas D et al. Ten year real world experience with ultrafiltration for
Slide 17: Aquadex in Hospital Specialty Units
Target Outpatient Accounts Driving Penetration and Increased Utilization Across Territories Scaling up field sales organization, education programs and social platforms Aquadex in Hospital Specialty Units ©2023 Nuwellis, Inc
Slide 18: Growing Pediatric Business
Pediatric revenue has outpaced total growth over past two years 18 FOR INVESTOR PURPOSES ONLY: NOT FOR PRODUCT PROMOTION ©2021 Nuwellis, Inc. Received 510(k) and launched commerciallyin Q1 2020. Growing Pediatric Business Development of novel pediatric pipeline product on track. Growing patent portf
Slide 19: Market-Driven Demand to Improve Pediatric Therapy
Market-Driven Demand to Improve Pediatric Therapy 19 1% With every 1% increase in fluid overload… 3% A 3% increase in pediatric mortality was observed 1,2 → Fluid overload drives pediatric morbidity and mortality risk in critically ill patients 8.5x mortality Children with >20% fluid overload had an
Slide 20: The Nuwellis Solution – Introducing Vivian
The Nuwellis Solution – Introducing Vivian™ 20 Business Objectives Launch best-in-class pediatric Continuous Renal Replacement Therapy (CRRT) system in 1H 2025 IDE approval anticipated in 1Q 2024 Continuously expand pediatric therapy value proposition with planned roadmap of product enhancements Pro
Slide 21: Novel Technology with Strong IP Portfolio
©2023 Nuwellis, Inc Novel Technology with Strong IP Portfolio 17 novel patents with protection to 2043+ Console Circuit Peripheral Access Accuracy & Safety Guided Therapy Interactive Screen Transport Mode Self-loading/Self-emptying Bags Open vs. Closed Loop Filter Clotting Prevention Source Line Con
Slide 22: Key Near-Term Milestones
2024 KEY MILESTONES 2023 2022 Q4 2022 Completed system integration and test for pediatric CRRT device Q2 2023 Enroll 50th patient in REVERSE-HF clinical trial Q4 2023 Treat 50th heart failure patient in outpatient setting Q4 2022 Acceptance by peer-reviewed journal: Ten-Year Real-World Experience wi
Slide 23: Financial Snapshot
Financial Snapshot Annual Revenue ($000) Growth Agenda Increase utilization of Aquadex therapy Focused sales strategy and expansion of field organization Expanding utilization of Aquadex therapy in the outpatient setting Grow body of clinical evidence to change practice guidelines and make Aquadex t
Slide 24: Investment Highlights
$2B+ and growing addressable market Outpatient market opportunity adds $0.5B+ to addressable market (heart failure and advanced liver disease) Positive ROI and attractive clinical + economic benefits to hospitals and healthcare system Robust body of clinical evidence Scalable consumables driven grow
Slide 25: Our Mission
25 dedicated to transforming the lives of patients suffering from fluid overload through science, collaboration, and innovation ©2023 Nuwellis, Inc
Slide 26: Market Size Sources
MARKET SIZE SOURCES Heart Failure – Inpatient ($1B+) Incidence of HF: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5494150/ Annual HF Hospitalizations: Costanzo MR, et al. J Am Coll Cardiol. 2017 May 16;69(19):2428-2445 Insufficient diuretic response: https://www.ahajournals.org/doi/10.1161/CIRCHEAR