Full Press Release Details
March 2023 Investor Presentation 2023 Nuwellis, Inc
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, goals and outlook
for the future that are intended to be covered by the Private Securities Litigation Reform Act of 1995. Except for statements of historical fact, all forward looking statements are management's present expectations and are not guarantees of
future events and are subject to a number of known and unknown risks and uncertainties and other factors that may cause actual results to differ materially from those expressed in, or implied by, such forward-looking statements. In some
cases, you can identify forward-looking statements by terminology such as "may," "will," "could," "would," "should," "plan," "predict," "potential," "project," "promising," "expect," "estimate," "anticipate," "intend," "goal," "strategy,"
"milestone," and similar expressions and variations thereof. Various factors could cause actual results to differ materially from these statements including our ability to execute on our commercial strategy and to grow our Aquadex
business, the possibility that we may be unable to raise sufficient funds necessary for our anticipated operations, our post-market clinical data collection activities, benefits of our products to patients, our expectations with respect to
product development and commercialization efforts, our ability to increase market and physician acceptance of our products, potentially competitive product offerings, intellectual property protection, our expectations regarding anticipated
synergies with and benefits of the Aquadex business, our business strategy, market size, potential growth opportunities and the other risks set forth under the caption "Risk Factors" and elsewhere in our periodic and other reports filed
with the U.S. Securities and Exchange Commission ("SEC"), including our Annual Report on Form 10 K for the fiscal year ended December 31, 2022 and subsequent reports. We are providing this information as of the date of this presentation,
and we undertake no obligation to update any forward-looking statements contained in this presentation as a result of new information, future events or otherwise. Although the Company believes that the forward looking statements are
reasonable and based on information currently available, it can give no assurances that the Company's expectations are correct. All forward-looking statements are expressly qualified in their entirety by this cautionary
statement. Financial and Statistical Data This presentation also contains estimates and other statistical data made by independent parties and by us relating to market shares and other data about our industry. These data involve a number
of assumptions and limitations and have not been reviewed or audited by our independent registered accounting firm. You are cautioned not to give undue weight to such estimates. In addition, projections, assumptions and estimates of our
future performance and future performance of the markets in which we operate are necessarily subject to a high degree of uncertainty and risk. Neither we nor our advisors or representatives makes any representations as to the accuracy or
completeness of that data or undertake to update such data after the date of this presentation. Trademarks The trademarks included herein are the property of the owners thereof and are used for reference purposes only. Such use should
not be construed as an endorsement of such products. Additional Information You should read the documents that we have filed with the SEC for more complete information about us. We encourage you to read such documents in full for more
detailed information, statistics, reports and clinical trials referenced in this presentation. You may access these documents for free by visiting EDGAR on the SEC website at http://www.sec.gov. Aquadex FlexFlow and Aquadex SmartFlow
are registered trademarks of Nuwellis, Inc. Aquadex is a trademark of Nuwellis, Inc. 2023 Nuwellis, Inc
is dedicated to transforming the lives of patients suffering from fluid
overload through science, collaboration, and innovation. 3 Our Mission 2023 Nuwellis, Inc
$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 growth Commercial
infrastructure leverage Novel product pipeline Experienced leadership FOR INVESTOR PURPOSES ONLY: NOT FOR PRODUCT PROMOTION 2022 Nuwellis, Inc. Investment Highlights 2023 Nuwellis, Inc
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 Officer Nestor
Jaramillo, Jr. President & Chief Executive Officer Lynn Blake Chief Financial Officer Neil P. Ayotte General Counsel, SVP & Chief Compliance Officer Sandra Eayrs Chief Human Resources Officer John Kowalczyk Senior Vice
President of Sales & Marketing Laurent Duhoux Vice President of International Business Development Vitaliy Epshteyn Senior Vice President of Operations & Engineering Al Saalabi Vice President of Quality and Regulatory Megan
Cease Vice President of Clinical Research and Reimbursement Executive Leadership Team John Jefferies, M.D. Chief Medical Officer 2023 Nuwellis, Inc
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 within 90 days1 Excess fluid following cardiac surgery leads to three-fold increase in mortality at 90 days2 90% of heart failure hospitalizations are due to signs and symptoms of fluid overload3 Vaara ST et al. Crit
Care.2012; 16: 1-11. Pradeep, A. et al. HSR Proc IC and Car An. 2010 Mar; 2(4): 287-296. Costanzo MR, et al. J Am Coll Cardiol. 2017 May 16;69(19):2428-2445. Fluid Overload is Associated with Greater Mortality 2023 Nuwellis, Inc
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 heart
failure patients have poor diuretic response5 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. 2023 Nuwellis, Inc
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
function1 Stabilizes or improves cardiac hemodynamics2-5 Predictably removes excess fluid Safe, easy to use and flexible in application Clinically Superior Solution for Fluid Overload 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. The only device of its kind in the market: Saving lives, time & money 2023 Nuwellis, Inc
$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
patients weighing 20 kg or more. Multiple Growth Opportunities Moving Aquadex to standard of care in fluid overload 2023 Nuwellis, Inc
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.)
Expanding Use of Ultrafiltration Across Hospital Specialty UnitsImproves outcomes for fluid overloaded patients 1. Derived from: https://www.grandviewresearch.com/industry-analysis/coronary-artery-bypass-graft-cabg-market and growth rate
from: https://www.hcup-us.ahrq.gov/reports/statbriefs/sb171-Operating-Room-Procedure-Trends.pdf. 2. Derived from: https://www.healthline.com/health/liver-transplant-survival and this for growth rate:
https://www.grandviewresearch.com/industry-analysis/ventricular-assist-devices-market ($600m estimated market in 2018 / Avg cost per procedure of $200k = 3k procedures) and growth rate from same source. 4. Derived from:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6557150/. 5. Derived from: https://www.ncbi.nlm.nih.gov/pubmed/25291348. 6. Derived from: https://www.uclahealth.org/medical-services/heart/ecmo/research/statistics and growth rate from same
source. 2023 Nuwellis, Inc
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. Reimbursement
estimates from MCRA. 4. https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/Readmissions-Reduction-Program 5. Testani, Circ Heart Failure, 2016;9:e002370. 30-40%5 68%5 Efficacy of Diuretic Use in HF & CV
Surgery Patients are refractory show sub-optimal response BACKGROUND Over 1 million HF hospitalizations occur annually in the US1 Diuretic Limitations Create Significant Burden to Hospitals & Healthcare Systems High patient
readmission rates and related costs/penalties 2023 Nuwellis, Inc
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 Heart Failure
Patients *Sean Pinney1, Maria DeVita2, Maria Rosa Costanzo3 1. University of Chicago Medicine, Division of Cardiology, Chicago, IL (through February 2023). Mount Sinai Morningside, Division of Cardiology, New York, NY (March 2023 to
present); 2. Lenox Hill Hospital, Division of Nephrology, New York, NY. 3. Midwest Cardiovascular Institute, Division of Cardiology, Naperville, IL. Aquadex Ultrafiltration: A Safe and More Effective Therapy Than Diuretics 2023 Nuwellis,
Inc Adjustable Ultrafiltration "won" more times than Adjustable IV Loop Diuretics, resulting in Win Ratios that all favored Ultrafiltration over diuretics in reducing CV mortality and HF events in congested HF patients
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 adjustable-rate UF using Aquadex Weight loss due to fluid removal Unchanged kidney function Average 2.14 hospitalizations Year before Aquadex Ultrafiltration 1 Year After Aquadex ultrafiltration Average 0.4
hospitalizations 12.4% at 30 days 14.9% at 90 days 27.3% at 1 year NATIONAL AVERAGE 24% at 30 days2 50% at 6 months HOSPITAL READMISSIONS Watson R et al. J Cardiac Fail. 2020; 26(10): s56. 2. Costanzo MR, et al. JACC. 2017 May
16;69(19):2428-2445. Significant quality of life improvement for the patients and savings to the healthcare system and to the individual hospitals Ultrafiltration: Positive ROI, Clinical and Economic Benefits 81% reduction in heart
failure hospitalizations per year Newly published 2023 Nuwellis, Inc
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 INPATIENT
TREATMENT WITH DIURETICS ONLY ESTIMATED HEART FAILURE (HF) 30-DAY READMISSION COSTS Est Annual HF Admissions1 7,537 30-Day Readmission Rate1 23% Est Annual HF Readmissions 1,734 Est Cost Per HF Patient Readmission
(Inpatient)2 $24,027 Est Reimbursement Per HF Readmission (Inpatient) $0 Est Loss Per HF Patient (Inpatient) $24,027 EST LOSS FOR ALL 30-DAY READMISSIONS ($41,662,818) ESTIMATED PER PATIENT REIMBURSEMENT FOR OUTPATIENT
AQUADEX Outpatient Facility Payment $1,216 Venous Access Payment $1,436 Physician Payment $366 TOTAL ESTIMATED REIMBURSEMENT (PER PATIENT) $3,018 NET OUPATIENT AQUADEX COSTS (PER PATIENT) ($3,490) ESTIMATED COSTS FOR
OUTPATIENT AQUADEX Total Costs (All Patients) ($11,284,433) Total Reimbursement (All Patients) $5,233,472 NET OUPATIENT AQUADEX COSTS (ALL PATIENTS) ($6,050,961) 30-DAY READMISSIONS (AQUADEX TREATED PATIENTS) %
Readmission Reduction 50% Readmission Reduction (Number of Patients) 867 READMISSION REDUCTION COST ($20,831,409) 30-DAY READMISSIONS (NON-AQUADEX TREATED PATIENTS) % Readmission Reduction 0% Readmission Reduction (Number
of Patients) 0 READMISSION REDUCTION SAVINGS $0 ADJUSTED REAMISSIONS AND COSTS ADJUSTED READMISSIONS (NUMBER OF PATIENTS) 867 ADJUSTED COSTS FOR READMISSIONS ($20,831,409) NET COSTS FOR ADMINISTRATION OF OUTPATIENT
AQUADEX ($6,050,961) TOTAL COSTS FOR OUTPATIENT AQUADEX ($26,882,370) NET SAVINGS OVER INPATIENT THERAPY ONLY $14,780,448 % COST SAVINGS 35% ADJUSTED READMISSION RATE 12% 1. Definitive Health Database for year 2019. 2. Premier
Applied Sciences database. 2023 Nuwellis, Inc *Figures above are not guaranteed, are used for illustrative purposes only and actual results can and will vary by location
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.ncbi.nlm.nih.gov/pubmed/25291348. 2023 Nuwellis, Inc
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 the
management of acute decompensated heart failure. American Heart Journal, 2022. 3. Beckles DL et al. The Use of Simple Ultrafiltration Technology as a Fluid Management Strategy for High Risk Coronary Artery Bypass Grafting Surgery. J Cardiac
Surg, 2022. DOI: 10.1111/jocs.16867 4. Sutherland SM, Davis AS, Powell D, Tanaka J, Woo M, Josephs S, Wong CJ. Kidney Replacement Therapy in Low Birth Weight Preterm Newborns. Pediatrics. 2022 Sep 1;150(3):e2022056570. doi:
10.1542/peds.2022-056570. PMID: 35945293. 5. Engelman DT, Shaw AD. A Turnkey Order Set for Prevention of Cardiac Surgery-Associated Acute Kidney Injury. 2023 Jan 1. The Annals of Thoracic Surgery. doi.org/10.1016/j.athoracsur.2022.10.022.
Change practice guidelines to Ultrafiltration Reimbursement expansion into outpatient setting New clinical evidence in Heart Failure: Finkelstein-Schoenfeld Win Ratio (WR) analysis favored ultrafiltration in reducing cardiovascular
mortality and heart failure rehospitalization as compared to intravenous diuretics at 30 days and 90 days1 New peer-reviewed publication: Data from ten-year, real-world experience demonstrated 81% reduction in heart failure
hospitalizations per year and 48% decrease in 30-day hospital readmission rates, as well as improvements in renal function response, with ultrafiltration2 New clinical evidence in Critical Care: 100% survival at 30 days following use of
ultrafiltration in high-risk postoperative coronary artery bypass grafting (CABG) patients3 Recent peer-reviewed publication of promising clinical data demonstrating 71% survival with kidney replacement therapy with ultrafiltration to
treat, low weight preterm neonates with end-stage kidney disease4 2023 peer-reviewed publication of a turnkey order set for cardiac-surgery associated acute kidney injury, viewed as a template to guide clinicians in creating
institution-specific, evidence-based protocols for patient care, that provides a recommendation to consider ultrafiltration if unresponsive to diuretics5 Ongoing REVERSE-HF randomized controlled trial to support driving ultrafiltration to
standard of care 2023 Nuwellis, Inc
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
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 portfolio