Nuwellis, Inc.

Stand by, your program is about to begin. Good day, everyone, and welcome to today's New Ellis Second Quarter 2025 Earnings Conference Call. At this time, all participants are in a listen-only mode. Later, you may have the opportunity to ask questions during the question-and-answer session. Please note, today's call will be recorded. and I will be standing by should you need any assistance. It is now my pleasure to turn the conference over to Leah McMullen, Director of Communications. Please go ahead.

Thank you, Operator, and good morning, everyone. Thank you for joining today's conference call to discuss New Ellis' financial results for the second quarter, ended June 30, 2025. With me on the call are John Erb, our Chairman of the Board and Chief Executive Officer, and Rob Scott, our Chief Financial Officer. Earlier today, we issued a press release that outlines our financial results for the quarter. If you haven't had the chance to review it, you can find it on the investor page of our website. Before we begin, I'd like to remind everyone that we'll be making forward-looking statements on today's call. These statements are protected under the Private Securities Litigation Reform Act of 1995 and are based on current assumptions and estimates. Actual results could differ materially from those described, and we encourage you to review the risk factors included in our filings with the Securities and Exchange Commission. The company assumes no obligation to update any forward-looking statements. Please do not place any undue reliance on these statements. With that, I'll turn the call over to John Irvin.

Thank you, Leah, and good morning, everyone. We entered the second quarter focused on strengthening the fundamentals of our business, operational discipline, commercial execution, and strategic investments in areas where we see the greatest opportunity for impact and growth, all of which we believe position Newell as for growth and the opportunity to drive shareholder value. Revenue for the second quarter was $1.7 million, a year-over-year decline of 21%. While the top line reflects some difficult headwinds, I want to address the context behind these numbers. Due to an industry-wide issue with our sterilization vendor, we experienced a temporary backorder of approximately $400,000 in revenue. During this time, our team acted quickly and decisively to prioritize our pediatric patients, ensuring that our most vulnerable patients received access to our life-saving therapy. I believe we successfully navigated this temporary setback and importantly, in the first week of July, we fully reconciled this backorder and are no longer in backorder. This gives us a strong footing in entering Q3. I'll now break things down further by customer category. Our pediatrics business remains a cornerstone of the company. We continue to see strong demand for our established hospital customers and ongoing interest from new centers looking for a safe and effective therapy for patients who cannot tolerate traditional renal replacement modalities. Aquadex remains one of the only two FDA-cleared devices in the U.S. that enables fluid removal in patients weighing as little as 20 kilograms, and that differentiation continues to translate into clinical interest and sustained utilization. Within critical care, we saw increasing adoption as many of our accounts moved from initial trialing into consistent practice. Our strategy shifted to deeper support for clinical teams and alignment with protocol-based fluid management, particularly post-cardiac surgery where acute kidney injury poses serious risk. In heart failure, our efforts are increasingly centered on the outpatient opportunity. As hospitals prepare to launch dedicated outpatient clinics or expanding existing heart failure programs, Aquadex is showing its value as a cost-efficient alternative. There are clear and logical challenges to scaling, staffing, and space, to name a few. But we continue to engage directly with hospitals working through these questions. Based on these early learnings, we're refining our support tools and enhancing our site engagement program for the back half of the year. We also implemented several important strategic decisions this quarter. We continue to plan for an orderly and efficient transition from our manufacturing to KDI precision manufacturing with Go Live planned for October. We expect this move to result in meaningful operational efficiencies and cost savings over the next 12 months. Additionally, we recently terminated the reverse HF clinical trial. While the study was designed to build additional evidence for inpatient heart failure, we believe this indication does not align with our investment focus or other sufficient near-term commercial opportunities. By ending the trial, we can reallocate approximately $4 million previously budgeted to support reverse HF toward higher impact growth areas. It is important to note that our decision to terminate this post-market clinical study was not related to device performance or patient safety concerns. Looking ahead, our growth strategy is centered on the key areas of cardiac surgery within critical care, pediatrics, and outpatient heart failure. In cardiac surgery, Aquadex offers unique ability to manage post-operative fluid overload and protect renal function. In pediatrics, Aquadex remains a viable fluid management option for many children with little to no kidney function. And in outpatient heart failure, we believe that the expanded reimbursement and clinical need are paving the way for broader access to safe, effective ultrafiltration. With that, I'll turn the call over to Rob Scott to walk through our financial results in more detail.