Full Press Release Details
July 2024 Investor Presentation
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Overview The Problem: Fluid Overload The Market Opportunity Nuwellis
Solutions Market Validation Growth Strategy Financial Snapshot Team
4 Our Mission Nuwellis is dedicated to transforming the lives of patients
suffering from Fluid Overload through science, collaboration, and innovation.
The ProblemFluid Overload presents a significant public health challenge that
impacts both patient outcomes and hospital resources.
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 (excess fluid
around lungs) Swelling in abdomen (ascites) Pumping action of the heart grows weaker
6.7 million US adults with Heart Failure and ~50% will die within five years of
their diagnosis 5,6 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 Fluid
Overload1 Unresolved congestion Poor clinical outcomes1 High Readmission Rates Related Costs/Penalties $24,027 Non-reimbursable cost estimate for readmission encounter2 Opportunity Cost of occupied bed of ALL Medicare
reimbursements4 Up to 3% 24% 30-Day Readmission rate1 50% 90-Day Readmission rate1 Low Reimbursement $8,2833 $15,744 Loss per visit DRG 291 DRG 292 $5,7083 $18,319 Loss per visit DRG 293 $3,9013 $20,126 Loss per visit High
Loss per HF Hospitalization The Healthcare Burden of Heart Failure/Fluid Overload With Fluid Overload as a leading cause of HF readmissions, it also presents a considerable economic burden on hospitals PATIENT HOSPITAL Over 1 million
HF hospitalizations occur annually in the US1 Efficacy of diuretic use in HF & CV surgery patients 10-40%5 are refractory 68%5 show sub-optimal response Decompensated HF admission drives economic loss per admission High readmission
rates lead to Medicare penalties4 1. Costanzo MR, et al. J Am Coll Cardiol. 2017 May 16;69(19):2428-2445. 2. From Premier Applied Sciences database. 3. 2021 DRG National Average Payment Table Update 4.
https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/Readmissions-Reduction-Program 5. Testani, Circ Heart Failure, 2016;9:e002370. 6. Kazory A, Sgarabotto L, Ronco C: Extracorporeal Ultrafiltration for Acute Heart
Failure. Cardiorenal Med 2023;13:1-8. doi: 10.1159/000527204
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;69(19):2428-2445.
2. Iribarne A, et al. Ann Thorac Surg. 2014; 98(4): 1274-80. 3. Vaara ST et al. Crit Care.2012; 16: 1-11. 4. Sutherland SM, et al. Am J Kidney Disease. 2010; 5(2): 316-25. 5. Gillespie RS, et al. Ped Nephro. 2004; 19(12): 1394-99. For
critically ill patients in the ICU, Fluid Overload was associated with a markedly increased risk for 90-day mortality3 In pediatric patients, Fluid Overload is associated with significant increases in mortality4-5 90% of all heart failure
hospitalizations are due to symptoms of Fluid Overload 1 Heart Failure Critical Care Pediatric
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. Felker MG &
Mentz RJ. JACC. 2012;59(24):2145-53. 3. Al Naher et al. Br J Clin Pharmacol. 2018 Jan; 84(1): 5-17. 4. Butler J et al. Am Heart J. 2004 Feb;147(2):331-8. 5. Testani JM, et al. Circ Heart Fail. 2016;9(1):e002370. 6. Kazory et al. Cardiorenal
Med 2023;13:1-8. doi: 10.1159/000527204. High risk of readmissions 1 Long-term use of diuretics is associated with kidney damage1-4 Efficacy of diuretic use in HF & CV surgery patients 10-40%5 have poor diuretic response 68%5 show
sub-optimal response "Diuretic resistance has been a well-known challenge in the care of these patients, and not surprisingly is tied to worse prognosis."6 "Extracorporeal Ultrafiltration for Acute Heart Failure" Cardiorenal Medicine
Market OpportunityAcross our three strategic patient categories, we have an
enormous opportunity to improve outcomes for Fluid Overload patients across multiple hospital specialty units.
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 liver disease) $1B
Market1 ~30% of current Nuwellis sales Heart Failure $900M Market1 ~40% of current Nuwellis sales Critical Care $130M Market1 ~30% of current Nuwellis sales Pediatric $2B+ TAM
Differentiated SolutionsNuwellis is a different company today
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 collaboration
Our hero therapy: Aquadex A clinically superior solution for Fluid
Overload The only device of its kind in the market
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 membrane using
negative pressure Hematocrit sensor monitors preset hematocrit limits 3 Ultrafiltration pump can pull 0-500 ml of fluid per hour 4 How the Aquadex system works Predictable and precise fluid removal
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 2024 - Featured
Late-Breaking Clinical Science Abstract III - Aquapheresis for Management of Decompensated Heart Failure: A Re-appraisal of AVOID-HF
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 &
Differentiation More effective in decongesting resulting in stabilized or improved cardiac hemodynamics2-5 Easier to set-up than CRRT; built-in Hematocrit sensor allows real-time measurement of blood volume changes Designed for multiple
settings: ICU, Stepdown Unit, Telemetry Unit, HF Floor, and Outpatient - versus ICU only for CRRT Predictably removes excess isotonic fluid (water and sodium)8 No significant changes to kidney function1 A proven and predictable solution
for Fluid Overload. 1.74 fewer hospitalizations1 At one year after Aquadex therapy treatment, compared to 2.14 before treatment Compared to the 24% national average at 30 days1 12.4% readmission rate Over $2B addressable market 1.
Watson R et al. J Cardiac Fail. 2020; 26(10): s56. 2. Kiziltepe, U, et al. Ann Thorac Surg. 2001;71(2): 684-93. 3. Sahoo, TK, et al. Indian J Thorac Cardiovas Surg. 2007;23(2): 116-24. 4. Boga et al. Perfusion. 2000;15:143-50. 5. Onoe et al.
Perfusion. 2001;16:37-42.65. 6. Costanzo MR et al. JACC. 2005; 46(11); 2457-51. 7. Costanzo, et. al., ISPOR 23rd Annual Int'l Mtg., May 19-23, 2018, Baltimore, MD, USA. 8. Kazory A, Sgarabotto L, Ronco C: Extracorporeal Ultrafiltration for
Acute Heart Failure. Cardiorenal Med 2023;13:1-8. doi: 10.1159/000527204. 9. Utilization figures are based upon Company estimates, including certain good faith assumptions of the number of blood circuits used per adult and per pediatric
procedures, such that patients served equals total number of units sold divided by a per procedure estimate of circuit used per adult and pediatric patients. Reduces length of hospital stay when initiated early, resulting in average savings
of $3,975 (14%)6-7 $3,975 in average savings
Coming soon: Vivian Our pediatric solution On track for H1 2027 launch
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
more. Attributes Group 1: <10kg Group 2: 10-20kg Group 3: >20kg # of Patients N = 72 N = 13 N = 34 Primary disease 43% kidney 29% cardiac 54% kidney 31%other 38% kidney 28% cardiac Survival at end of treatment
(Aquadex) 43 (60%) 13 (100%) 33 (97%) Group 1 patients traditionally do not receive any kind of therapy "For our babies born with diseased or absent kidneys, Aquadex has given them a chance at life because in the past, there were
no options to treat these patients." Kara Short MSN, CRNP, NICU nurse practitioner at Alabama Children's Hospital Improved patient survival at end of treatment 4-10 circuits/pts 3-6 consoles per hospital Pediatrics represents a $130M
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 CRRT system, H1
2027 Early feedback from pediatric nephrologists: "This will be a game-changer for us." Nuwellis Pediatric Advisory Board member Product Strategy & Differentiation Integrates Ultrafiltration with Hemofiltration and Hemodialysis
capabilities Expected broadest weight indication: 2.5 kg + Safety features: lowest extracorporeal blood volume; built-in hematocrit sensor Clinician-driven UX design Product name: "Viv" Latin root means life; Vivian - Lady of the Lake in
King Arthur, allusion to Land of 10,000 Lakes Therapy to fill crucial gaps, offering a lifeline to critically ill neonates and children Ultrafiltration Hemofiltration Hemodialysis 8.5x mortality Fluid Overload drives pediatric morbidity
and mortality risk in critically ill patients Children with >20% fluid overload had an odds ratio for mortality of 8.5 compared to children with <20% FO 1,2 Providing renal support and hemodynamic stability can be life-saving 60%
survival to end therapy In patients <20 kg who primarily received Slow Continuous Ultrafiltration (SCUF)3 $130m addressable pediatric market
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 Physiological Parameters Guidance Console Circuit Peripheral Access Accuracy & Safety Guided Therapy We are keenly focused on developing novel technology with a strong IP portfolio Robust and evolving portfolio of
patents circling the technology 16 Nuwellis patent applications (US & EU) in addition to licensed IP from Baxter Wide technology scope coverage 13 issued patents with protection to 2043
Strategic CollaborationsOur collaborations with DaVita and SeaStar are expanding
market access, bolstering technology offerings, and accelerating Nuwellis growth trajectory.
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 NO dialysis
dependency2 2x length of stay in ICU for patients with AKI (8 days vs. 4 days) as ICU patients without AKI3 SeaStar distribution and licensing agreement to offers a new Selective Cytopheretic Device (SCD-PED) for pediatric patients
with AKI 1) Use of the Selective Cytopheretic Device to Support Critically Ill Children Requiring Continuous Renal Replacement Therapy: A Probable Benefit-Risk Assessment Stuart L. Goldstein, Nicholas J. Ollberding, David
J. Askenazi, Rajit K. Basu, David T. Selewski, Kelli . Krallman, Lenar Yessayan, H. David HumesmedRxiv 2023.08.22.23294378; doi: https://doi.org/10.1101/2023.08.22.23294378 2) SL Goldstein et al.: The Selective Cytopheretic Device in
Children; Kidney International Reports (2021) 3) De Zan F, Amigoni A, Pozzato R, Pettenazzo A, Murer L, Vidal E. Acute Kidney Injury in Critically Ill Children: A Retrospective Analysis of Risk Factors. Blood Purif. 2020;49(1-2):1-7. doi:
10.1159/000502081. Epub 2019 Aug 5. PMID: 31382259.