Nuwellis, Inc. · NASDAQ:NUWE
Nuwellis — Investor Presentation (July 2024)
38 slides from Nuwellis's investor presentation, Jul 17, 2024
Slide 1: July 2024 Investor Presentation
July 2024 Investor Presentation
Slide 2: Safe Harbor Statement
Aquadex FlexFlow® and Aquadex SmartFlow® are registered trademarks of Nuwellis, Inc. Aquadex ® is a trademark of Nuwellis, Inc. Safe Harbor Statement Financial and Statistical DataThis presentation also contains estimates and other statistical data made by independent parties and by us relating to m
Slide 3: Overview
Overview The Problem: Fluid Overload The Market Opportunity Nuwellis Solutions Market Validation Growth Strategy Financial Snapshot Team
Slide 4: Our Mission
4 Our Mission Nuwellis is dedicated to transforming the lives of patients suffering from Fluid Overload through science, collaboration, and innovation.
Slide 5: The Problem: Fluid Overload
The ProblemFluid Overload presents a significant public health challenge that impacts both patient outcomes and hospital resources.
Slide 6: What is Hypervolemia (Fluid Overload)?
What is Hypervolemia (Fluid Overload)? Hypervolemia is an excess of fluid in the bloodstream, vital organs and interstitial space that results in an array of patient symptoms Tiredness Shortness of breath Pulmonary edema (excess fluid in lungs) Swelling in ankles and legs Coughing Pleural effusion (
Slide 7: The Healthcare Burden of Heart Failure/Fluid Overload
6.7 million US adults with Heart Failure and ~50% will die within five years of their diagnosis5,6 8 Days Average HF Length of Stay2 $24,027 Total True Inpatient Cost per Encounter2 Long Lengths of Stay & High Costs of Care 90% of Heart Failure (HF) hospitalizations are due to signs and symptoms of
Slide 8: Three patient categories grapple with the impact of Fluid Overload
The market faces an urgent challenge as three patient categories grapple with the debilitating impact of Fluid Overload across multiple hospital specialty units Fluid Overload is a leading cause of hospital readmission post 30 days following cardiac surgery2 1. Costanzo MR, et al. JACC. 2017 May 16;
Slide 9: Diuretics have significant limitations leaving a gap in clinical care
Diuretics, the current standard of care, have significant limitations leaving a gap in clinical care Diuretics provide insufficient symptom relief and are associated with in hospital worsening heart failure and increased mortality after discharge1 1. Costanzo MR, et al. JACC. 2017;69(19)2428-2445. 2
Slide 10: Market Opportunity
Market OpportunityAcross our three strategic patient categories, we have an enormous opportunity to improve outcomes for Fluid Overload patients across multiple hospital specialty units.
Slide 11: Large and expanding addressable market
1. See Appendix. 2. Approved for use in pediatric patients weighing 20 kg or more. With a large and expanding addressable market, Nuwellis stands at the forefront of a transformative healthcare opportunity Outpatient market opportunity adds $0.5B+ to addressable market (heart failure and advanced li
Slide 12: Differentiated Solutions
Differentiated SolutionsNuwellis is a different company today
Slide 13: Aquadex foundation, collaborations and patent portfolio
Aquadex represent our foundation, positioning the company to effectively address significant market opportunities Collaborations Patent Portfolio Products Console Circuit Peripheral Access Accuracy & Safety Guided Therapy Robust clinical foundation reinforces strategic technology expansion and colla
Slide 14: Our hero therapy: Aquadex
Our hero therapy: Aquadex®A clinically superior solution for Fluid Overload The only device of its kind in the market
Slide 15: How the Aquadex system works
Filtered blood returns to the patient via the infusion line 5 Blood is taken from the patient via the withdrawal line using proprietary catheters technology 1 The blood is pushed through the filter by the blood pump (0-40 ml per minute) 2 The ultrafiltration pump withdraws fluid across filter membra
Slide 16: Late-breaking trial: reduction in HF events and hospitalization
At a Recent Late Breaking Clinical Trials, Significant Reduction in HF Events and HF Hospitalization at 30 Days Presented at THT 2024 in early March, a re-appraisal of a 224-patients randomized controlled trial (AVOID-HF) demonstrated statistically significance reductions at 30 days. THT Boston 20
Slide 17: Aquadex product strategy and differentiation
Aquadex Reintroduced in 2016 An estimated 25,700 patients treated across all three of our customer categories9 From proprietary technology to unmatched advantages in Fluid Overload therapy, Aquadex has the potential to be the standard of care for diuretic resistant patients Product Strategy & Differ
Slide 18: Coming soon: Vivian, our pediatric solution
Coming soon: Vivian™Our pediatric solution On track for H1 2027 launch
Slide 19: Pediatric business and improved survival
Received 510(k) and launched commerciallyin Q1 2020. We’ve seen a steady increase in our pediatric business, providing patients with high mortality an opportunity at life1 1. Source: Menon S, et al. CJSN, 2019; 14: 1432-40. Aquadex is currently cleared for use in pediatric patients weighing 20 kg or
Slide 20: Introducing Vivian
1. Sutherland SM, et al. American Journal of Kidney Diseases, vol. 55, no. 2, pp. 316-325, February 2010, 2. Gillespie RS, et al. Pediatric Nephrology, vol. 19, no. 12, pp. 1394-1399, December 2004., 3. Menon S, et al. CJSAN, vol 14, October 2019. Introducing Vivian™ Launch best-in-class pediatric C
Slide 21: Novel technology with strong IP portfolio
External Pump Detection Hemolysis/Blood Leak Detector Accounting for Density Auto Clamp Transport Mode Self-loading/Self-emptying Bags Open vs. Closed Loop Filter Clotting Prevention Source LineConnection Peripheral Flow Improvements Dual LumenCatheter Plasma and Blood Volume Measurement Physiologic
Slide 22: Strategic Collaborations
Strategic CollaborationsOur collaborations with DaVita and SeaStar are expanding market access, bolstering technology offerings, and accelerating Nuwellis growth trajectory.
Slide 23: DaVita supply and collaboration agreement
In June of 2023, we launched a supply and collaboration agreement with DaVita to expand the access of Aquadex therapy for heart failure 790+ hospital partnerships1 2,500+ clinic1 11.6B in revenue in 20221 65,000+ employees1 1. Used with permission from DaVita 77% survival rate1 At day 60 At day 60 N
Slide 24: Financial Snapshot, Key Milestones, Team, Investment Highlights
Financial Snapshot Key Milestones Executive TeamInvestment Highlights
Slide 25: Track record of revenue growth
With a track record of revenue growth, we believe our strategy will lead to continued revenue growth Annual Revenue ($000) Cash $1.4 million as of Mar 31, 2024 NO Debt Capitalization Table as of June 30th, 2024
Slide 26: Key milestones
Enroll 80th patient in REVERSE-HF clinical trial Execute DaVita Supply & Collaboration agreement FDA 510(k) clearance of 12cm dual-lumen length catheter (dELC) Completion of DaVita pilot program Commercial launch of SeaStar’s SCD for pediatric AKI Branded Quelimmune* IDE Anticipated approval for Viv
Slide 27: Our diverse leadership team
Our diverse leadership team boasts extensive industry experience and a successful history of commercialization Seasoned Leadership: Over 200 years’ ofcollective experience in clinical practice and the medical device industry, with significant tenures at industry leaders such as Medtronic, Boston Sci
Slide 28: Investment Highlights
Investment Highlights $2B+ TAM Positive ROI Clinical Evidence Scalable Consumables Commercial Infrastructure Product Pipeline Leadership Team $2B+ and growing addressable market in critical need Attractive clinical + economic benefits to hospitals and healthcare system Robust body of clinical eviden
Slide 29: Thank you!
Thank you! ws Nuwellis
Slide 30: Appendix
Appendix ws Nuwellis
Slide 31: DaVita pilot to commercialization
DaVita pilot to commercialization In June of 2023, we launched a supply and collaboration agreement with DaVita to expand the access of Aquadex therapy for Fluid Overload patients 790+ hospital partnerships1 2,500+ clinic1 11.6B in revenue in 20221 65,000+ employees1 Collaboration Strategy Pilot
Slide 32: SeaStar Distribution and Licensing Agreement
SeaStar Distribution and Licensing Agreement Collaboration Strategy Launch market-first SCD-PED device (2024) Offer new product to existing Nuwellis pediatric customers Develop relationships at new pediatric accounts to support Vivian launch in 2027 Explore Nuwellis manufacturing viability for S
Slide 33: Market Validation
Market ValidationReal-world testimonials and clinical studies provide meaningful validation for Nuwellis' products.
Slide 34: Ultrafiltration: Positive ROI, clinical and economic benefits
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 adjustable-rate UF using Aquadex Weight loss due to fluid removal Unchanged k
Slide 35: Extracorporeal ultrafiltration as an option to overcome shortcomings of diuretics
“Extracorporeal ultrafiltration has emerged as an option to overcome shortcomings of diuretics” Predictable, adjustable, and more efficient fluid removal with ultrafiltration compared to diuretics Applicability in other clinical settings, such as cardiac surgery, burn and other specialty units Poten
Slide 36: REVERSE-HF Clinical Study with Aquadex
With 15 sites and 125 patients enrolled, we are in the midst of executing our REVERSE-HF Clinical Study with Aquadex Planning + Enrollment Execution Analysis + Publication Protocol design based on AVOID-HF trial Target 20 sites Goal; enroll 372 patients by end of 2024 16 sites activated 80 patients
Slide 37: Growth Strategy
Growth StrategyWe aim to achieve sustainable expansion and market leadership through strategic growth plans and tactics.
Slide 38: Strategic growth plan: four key efforts
Our strategic growth plan emphasizes four key efforts 1 2 3 4 We’ve structured our sales and marketing team to ensure seamless execution