Nuwellis, Inc.

Good day and welcome to the NUELIS first quarter 2024 earnings conference call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star, then one, on a touch-tone phone. To withdraw your question, please press star, then two. Please note this event is being recorded. I would now like to turn the conference over to Vivian Cervantes, Investor Relations with Gilmartin Group. Please go ahead.

Thank you, Cindy. Good morning, everyone. Thank you for joining us in today's conference call to discuss Noellis' corporate development and financial results for the first quarter ended March 31st, 2024. In addition to myself, with us today are Nestor Jaramillo, New Orleans' president and CEO, as well as Rob Scott, CFO. At 8 a.m. Eastern today, New Orleans released financial results for the first quarter ended March 31st, 2024. If you have not received New Orleans' earnings release, please visit the company's investor page on its website. During this conference call, the company will be making forward-looking statements. All forward-looking statements made during today's call will be protected under the Private Securities Litigation Reform Act of 1995. Any statements that relate to expectations or predictions of future events and market trends, as well as our estimated results or performance, are forward-looking statements. All forward-looking statements are based upon our current estimates and various assumptions. These statements involve material risks and uncertainties that could cause actual results or events to materially differ from those anticipated or implied by these forward-looking statements. All forward-looking statements are based upon current available information, and the company assumes no obligation to update these statements. Accordingly, you should not place undue reliance in these statements. Please refer to the cautionary statements and discussion of risk in the company's filings for the SEC, including the latest 10-K. With that, I'd like to now turn the call over to Nestor.

Thank you, Vivian, and good morning, everyone. Welcome to New Orleans' first quarter 2024 earnings conference call. On today's call, I will provide an overview of our first quarter performance and give an update on our strategic initiatives. Our Chief Financial Officer, Rob Scott, will then provide detailed commentary on the financial results before opening of the call for questions, followed by my closing remarks. New Well has generated $1.9 million in revenue for the first quarter of 2024, a 2% increase year-over-year, driven by our 11% increase in consumable utilization. Our pediatric customer category once again led the way with 40% revenue growth which was driven by 54% increase in consumable utilization. We continue to grow our pediatric customer category, acquiring five new accounts over the past 12 months for a total of 40 accounts compared to 10 accounts in 2019 prior to FDA clearance. Revenue in our critical care customer category was flat, however, Consumable utilization grew by 9%, and heart failure revenue decreased by 38%, which was driven by lower utilization and consult sales. We are pleased to continue to see a healthy consumable utilization trend signaling strong therapy adoption. Consumable sales in Q1 represented 82% of the total revenue, which grew 11% compared to last year. we continue to balance the strong sales of consumables with the unpredictable capital sales cycle in our hospital's accounts. Our capital rental program provides an alternative to our customers experiencing capital budget constraints with a solution to treat patients with Aquadex. Similar to last year, first quarter capital sales were lower than expected. However, as in the second half of 2023, we expect capital sales to increase throughout the year, as our pipeline of new target accounts is robust. We are confident of our growth momentum in 2024 because of the increased awareness of the efficacy of Aquadex, including recent clinical data reported at the Technology and Heart Failure Therapeutics Conference also known as the THG Conference, in early March. At the late-breaking clinical trial session, the use of the Aquadex demonstrated a clinically and a statistical significant reduction in heart failure hospitalizations and heart failure events at 30 days. This new clinical data is the result of our key priority to continue developing strong clinical and economic evidence for using the Aquadex system to treat patients with fluid overload and who are unresponsive to diuretics. In addition to the steady organic growth in our based business, we look forward to new product sales in our fast-growing pediatric category. In addition to expanding the utilization of Aquadex as we progress our Davida pilot program, which I will provide more details next. Now turning to our recent commercial developments and expected new product introduction. In February, Seastar Medical received Humanitarian Device Exemption, or HDE, from the FDA for its Selective Cypheretic Device, or SCD, branded Qualimune, for use in pediatric patients with acute kidney injury due to sepsis or a septic condition. New Welles has exclusive US license and distribution rights, and we have begun commercializing Qualimmune in targeted medical centers by pursuing IRB approvals in five accounts while simultaneously engaging in preliminary dialogue with other key pediatric institutions. The unique technology behind Qualimmune has demonstrated a 77% ICU survival rate in children with potentially deadly hyperinflammation. We believe this product will have a positive impact on the patient population for which it serves, and we look forward to providing continued updates as this collaboration progresses. We also continue the development of our pediatric continuous kidney replacement therapy device branded Vivian. We, along with many pediatric nephrologists, believe this product will have a positive impact on survival and improve the quality of life of neonates and small children with kidney malfunction, kidney issues, or those born without kidneys. This device is complementary to C-Star Medical's Qualimmune device, and we believe these two products together will add meaningful value to our growing portfolio of products for pediatric patients with fluid overload and renal disease. We continue to advance the pilot phase of our supply and collaboration agreement with DaVita. As a reminder, this collaboration allows DaVita and New Welles to pilot Aquadex therapy for adults, heart failure patients in selected U.S. markets. Pairing Aquadex with DaVita's clinical infrastructure could potentially help accelerate the clinical adoption of ultrafiltration when diuretic therapies are ineffective. We have made introduction in nine hospitals with very positive results. We look forward to providing more specific information during the quarter. In early April, we announced the launch of ultrafiltration therapy for heart failure patients using the Aquadex at Henry Ford Health as part of our pivotal reverse heart failure clinical study. Based in Michigan, Henry Ford Health is one of the nation's leading academic heart failure centers recognized for clinical excellence in heart failure, heart transplant, and left ventricular assist devices. We are honored to be working with them as their heart failure program is one of the largest in Michigan. Dr. Jennifer Cogler, head of the heart failure program, will lead the efforts, and I look forward to hearing her findings as the study progresses. We currently have 123 patients enrolled in the randomized multicenter trial, and Henry IV is the only site in Michigan offering this study intervention. I'd like to now turn it to Rob to discuss our first quarter financial results.