Nuwellis, Inc.

Please stand by. Your program is about to begin. If you need audio assistance during today's program, please press star zero. Good morning and welcome to New Wellness Earnings Conference Call for the second quarter ended June 30, 2024. All participants will be in a listen-only mode. Should you need any 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 your telephone keypad. To withdraw your question, please press star, then two. Participants of this call are advised that the audio of this conference call is being broadcast live over the Internet and is also being recorded for playback purposes. A replay of the call will be available approximately one hour after the end of the call. I would now like to turn the conference over to Vivian Cervantes, Investor Relations for Gilmartin Group. Please go ahead, ma'am.

Thank you, Operator. Good morning, everyone. Thank you for joining us in today's conference call to discuss Newellis' corporate developments and financial results for the second quarter end of June 30, 2024. In addition to myself, with us today are Nestor Jaramillo, Newellis' president and CEO, as well as Rob Scott, CFO. We are also joined today by our chief medical officer, Dr. John Jeffries, who is available to take your questions. At 8 a.m. Eastern time today, Newellis released financial results for the second quarter of 2024. If you have not received Newellis' earnings release, please visit the investors page on the company's 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 your estimated results or performance of 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 on 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' second quarter 2024 earnings conference call. On today's call, I will provide an overview of our second quarter performance and give an update on our strategic initiatives. Our Chief Financial Officer, Rob Scott, will then provide detailed commentaries on our financial results before opening up the call for questions, followed by my closing remarks. New Orleans generated $2.2 million in revenue for the second quarter of 2024, a 6% increase year-over-year, driven by a 30% increase in heart failure and critical care consumables utilizations. which translates to an increase in the number of patients being treated with Aquadex. This growth in consumables is a strong indication of the broader use of the Aquadex therapy in patients with fluid overload and not necessarily only in heart failure patients. Pediatrics saw a 10% revenue decline in the quarter with an increase in console cells offset by a decrease in consumables utilization. As a reminder, the utilization in consumables in the pediatric customer category is driven primarily by census, or the number of children born with kidney disease, which was soft this year, this quarter. However, our pediatric business continues to be strong with solid momentum as we expand Aquadex to pediatric patients at one of the largest hospital networks in Florida in mid-May. Fueling the growth in consumables is the new data supporting the clinical and economic benefits of using Aquadex that were presented at the Technology and Heart Failure Therapeutics Conference early this year. Now turning to our recent commercial developments and new product introductions. We were pleased to announce the first commercial sale of Qualimmune to Cincinnati Children's Hospital last month. This is a significant milestone as it allows us to further penetrate the pediatric market and significantly advance the standard of care in pediatric critical care. Qualimmune, or the selective thyrophoretic device for pediatrics, represent a transformative solution for pediatric patients suffering from acute kidney injury due to sepsis or a septic condition on antibiotic therapy and who require kidney replacement therapy. Early clinical data suggests a 77% survival rate for patients treated with this new therapy. As a reminder, New Welles have an exclusive U.S. license and distribution agreement for pediatric hospitals with C-STAR Medical. This therapy is now accessible under the humanitarian device exemption from the FDA to medical institutions like Cincinnati Children's, giving nephrologists and intensive care physicians a novel option to address the needs of these critically ill pediatric patients. We believe this product will have a positive impact on the patient population it serves, and we look forward to providing continued updates as we continue to roll out more devices around the country. We continue to be excited about our pediatric continuous kidney replacement therapy device, branded Vivian, which we are developing currently. 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 limited or no kidney function, kidney issues, or those born without kidneys. This device is complementary to the 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. I'd like to now turn to Rob to discuss our second quarter financial results.