Nuwellis, Inc.

Later, you will have an opportunity to ask questions during the question and answer session. You may register to ask a question at any time by pressing the star and 1 on your telephone keypad. Please note this call is being recorded and I will be standing by should you need any assistance. It is now my pleasure to turn today's program over to Louisa Smith with Investor Relations.

Thank you, operator, and thank you for joining today's conference call to discuss New Ellis' corporate developments and financial results for the first quarter ended March 31st, 2025. In addition to myself, with us today on the call are John Erb, New Ellis' chairman of the board and interim CEO, and Rob Scott, chief financial officer. At 8 a.m. Eastern time today, New Ellis released financial results for the first quarter 2025. If you have not received New Ellis' 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 our estimated results or performance, are forward-looking statements. All forward looking statements are based on 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 with the Securities and Exchange Commission, including the latest 10-K. With that, I would now like to turn the call over to John.

Thank you, Louisa, and good morning, everyone. Welcome to New Ellis' first quarter 2025 earnings conference call. Today, I'll walk through our first quarter results, highlight key areas of growth and operational progress, and share how we are building a strong foundation for long-term success. Next, our Chief Financial Officer, Rob Scott, will provide a detailed commentary on our financial results before opening up the call for questions. We'll begin with an overview of the quarter. New Ellis generated $1.9 million in revenue for the first quarter of 2025, representing a 3% increase year-over-year supported by a 4% increase in consumables utilization and an increase in U.S. console sales. partially offset by a decrease in international sales. By customer category, we have had a strong quarter within pediatrics and heart failure, which saw 38% and 28% growth over prior year, respectively, driven by an increase in consumable utilization. Within pediatrics, we opened two new accounts during the quarter. Each of these additions underscores our strategic focus on the pediatrics category, where clinicians increasingly use Aquadex as a general alternative in cases where continuous renal replacement therapy or CRRT is not feasible due to the lower blood volumes and delicate hemodynamic balances required in pediatric patients. Sales in the critical care category decreased by 25% compared to the prior year. This decrease can be attributed primarily to one of our largest customers, that acquired excess inventory at the end of 24. This is a one-time impact, and we expect critical care to stabilize in the coming quarter. We continue to see positive trends in account penetration. Increasing clinical adoption, expanding reimbursement coverage, and enhanced physician advocacy continue to support a long-term growth and strategy. We continue to strengthen the clinical foundation supporting Aquadex therapy. Toward that end, the Journal of the American College of Cardiology Heart Failure, published in February of this year, included a reanalysis of data from the AVOID-HF trial, a randomized clinical trial evaluating ultrafiltration versus intravenous diuretics in patients with heart failure. This study demonstrated a 60% reduction in heart failure events with ultrafiltration at 30 days compared to standard intravenous diuretic therapy and significantly fewer heart failure hospitalizations. In addition to these clinical trial findings, real-world data are also building. An observational analysis titled Outcomes in Community Hospitals study led by Dr. John Jeffries evaluated the use of Aquadex across two regional hospitals. The study showed a statistically significant reduction in 60-day heart failure readmission rates volume loss and weight reduction among patients treated with ultrafiltration, along with stable renal function and meaningful clinical benefit. These results reinforce the value of Aquadex in community-based care settings, where effective fluid management can have a substantial impact on patient outcomes and hospital resources. Together, these findings strengthen the clinical case for Aquadex across a range of hospital environments. As I outlined on our fourth quarter call, we have also seen important progress in reimbursement coverage that strengthens our commercial opportunities. Effective January 1st, OxfordX was reassigned to a new outpatient reimburse level by CMS, increasing the facility reimbursement fee for the therapy by nearly four times to $1,639 per day. This adjustment increases the accessibility and financial viability of Aquadex in hospital-based outpatient settings, thereby enabling hospitals to provide improved fluid management outcomes relative to diuretics. The combination of improved reimbursement and our expanding clinical evidence base is paving the way to advance our outpatient strategy. These enhancements allow us to expand our reach and use cases while leveraging the same call point as our core inpatient business. Already, we see encouraging momentum in the outpatient setting, and expanded coverage makes Aquadex therapy more economically viable and accessible. We have built a growing pipeline of target outpatient facilities, representing an addressable market opportunity of approximately $773 million that we anticipate will help drive significant future top-line growth. Finally, before I turn the call over to Rob, I'd like to detail New Ellis' current exposure to tariffs. At this point, we manufacture our products in-house at our facilities in Minnesota with only a very small portion of our raw materials being sourced internationally. Our limited exposure to international components leaves us confident We will not materially be affected by current tariff policies. I'd now like to turn it over to Rob to detail our Q1 financial results.