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DATE
Tuesday, May 12, 2026 at 9 a.m. ET
CALL PARTICIPANTS
- Chairman of the Board — John L. Erb
- Chief Executive Officer — Leah McMullen
- Chief Financial Officer — Carisa Schultz
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TAKEAWAYS
- Revenue -- $2.4 million for the first quarter of 2026, reflecting a 26% increase year over year, driven by higher console and circuit sales.
- Unit Sales -- 15 Aquadex consoles sold, including placements with pediatric and adult accounts, as well as upgrades from the FlexFlow to SmartFlow systems.
- Circuit Sales Growth -- Circuit sales rose 15%, indicating broader Aquadex utilization among treated patients.
- Gross Margin -- 70.1%, an improvement of 14 percentage points compared to the same quarter last year, attributed to enhanced pricing, shift in product mix, and completion of contract manufacturing transition.
- Operating Expenses -- Approximately $6 million, up from $4.1 million in the prior-year quarter, mainly due to increased sales headcount and compensation.
- Net Loss -- $4.3 million attributable to common shareholders, as reported for the quarter.
- Cash Position -- $2.2 million in cash and restricted cash equivalents at quarter-end, with no outstanding debt.
- Pediatrics Revenue Mix -- Pediatrics contributed approximately 50% of total U.S. revenue, expanding the company’s pediatric footprint to 47 centers, including 6 top-ranked children’s hospitals.
- Capital Raise -- An approximately $5 million private placement and warrant inducement transaction was completed during the quarter, directly supporting ongoing operations.
- Strategic Acquisition -- RendiaTech was acquired in March, adding automated kidney function monitoring to Nuwellis’s development pipeline, with U.S. market introduction targeted for 2027.
- Patent Issuance -- A new U.S. patent was secured for pediatric extracorporeal therapy safety, reinforcing intellectual property for the in-development Vivien pediatric CRRT system.
- Board and Leadership Changes -- Martin Emerson and David McDonald joined or rejoined the board, and Carisa Schultz was appointed CFO, all bringing significant healthcare and capital markets experience.
- Planned Cash Burn Reduction -- A reduction strategy aims to cut monthly cash burn by approximately 50% by the fourth quarter of this year, as stated by management.
SUMMARY
Nuwellis (NUWE 0.96%) accelerated its transition from strategic restructuring to operational execution, highlighted by robust revenue growth and meaningful margin expansion. The acquisition of RendiaTech marked a strategic entry into automated kidney function monitoring technology, aligning with the company’s push to broaden its cardiorenal platform. The mix shift toward pediatrics, now constituting half of U.S. revenue, underscores pediatrics as a key near- and long-term growth engine. Along with board and leadership enhancements and a recently completed capital raise, these developments indicate tighter operational discipline and enhanced strategic focus.
- Management outlined a clear commercialization timeline for RendiaTech’s bedside kidney monitoring system, targeting a 2027 U.S. launch.
- The newly issued U.S. patent for pediatric extracorporeal therapy safety directly strengthens the company's pediatric innovation pipeline.
- Leadership emphasized that future pediatric initiatives are being built around a category where the company already enjoys significant adoption and credibility.
- The management team conveyed plans for ongoing financial discipline, including an explicit goal to align resources behind highest-traction segments to support sustainable growth.
INDUSTRY GLOSSARY
- Aquadex: Nuwellis’s proprietary ultrafiltration therapy platform for fluid management in patients with fluid overload.
- CRRT (Continuous Renal Replacement Therapy): A continuous, extracorporeal blood purification process used in critical care to support kidney function.
- Extracorporeal Therapy: Medical treatments performed outside a patient’s body, often involving blood purification or fluid removal systems.
Full Conference Call Transcript
Leah McMullen: Thank you, operator. Thank you for joining today's conference call to discuss Nuwellis' corporate developments and financial results for the first quarter ended 03/31/2026. In addition to myself, with us today are John L. Erb, Nuwellis' Chairman of the Board and our CFO, Carisa Schultz. At 08:00AM eastern time today, Novelis released financial results for the first quarter 26. If you have not received Nuwellis' 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 2000.
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 any 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-Ks. With that, I would now like to turn the call over to John.
John L. Erb: Thank you, Leah, and good morning, everyone. I would like to begin by framing the quarter in the context of the work we completed over the past year. As we discussed on our last calls, 2025 was a year of structural change and deliberate repositioning for Newellis. We made important decisions to simplify the business, improve operational discipline, concentrate resources, and clarify our long term strategy around the cardiorenal care continuum. The 2026 represents the next step in that progression. Q1 was the quarter Nuwellis began moving from strategic reset to strategic execution. During the quarter, we strengthened our leadership and capital foundation.
Delivered stronger financial results and completed a meaningful strategic acquisition, and continued to validate pediatrics as a key growth category for the company. The important point is that these are not separate events. Together, they reflect a company moving with greater focus and discipline around the clinical and commercial opportunities where we believe Novelis can create the greatest value. First, we continue to strengthen the foundation for execution. During the quarter, we appointed Carisa Schultz as Chief Financial Officer. Carisa brings deep public company health care finance experience and her leadership is already supporting greater rigor around forecasting, capital allocation, and financial visibility.
We also completed approximately a $5 million private placement and warrant inducement transaction, adding capital to support our operation as we continue executing against our strategy. In addition, we strengthened the board with the appointment of Martin Emerson and the reappointment of David McDonald. Their experience in medical technology, commercial scaling, and capital markets adds important perspective as we move into the next phase. We also sharpened our market coverage and field leadership, including expansion into a new South Texas territory and the return of 3 highly experienced sales leaders. These additions bring deep Aquadex knowledge, established customer relationships, and field experience that will support utilization growth in high priority accounts.
These actions strengthen the leadership, governance, and position the company for more consistent execution across our highest priority growth areas. Second, we saw the stronger foundation begin to show up in our financial performance. Revenue for the first quarter increased 26% year over year, supported by a significant increase in console sales and continued growth in circuit sales. Gross margin improved to 70.1% reflecting the benefits of improved pricing, product mix, and our transition contract manufacturing at KDI. For us, the meaning behind this result is important. They demonstrate that the operating we the operating work we have been doing is beginning to translate into measurable commercial progress.
We are seeing stronger execution, improved economics, and continued increases in the number of patients treated with Aquadex therapy. At the same time, we are continuing to take action to improve operating efficiency and extend our financial runway. We are developing a cash burn reduction plan designed to reduce monthly cash burn by approximately 50% by the fourth quarter of this year while keeping resources aligned behind the areas of the business with the strongest commercial traction and strategic value While we remain focused on disciplined capital allocation and careful expense management, Q1 results reinforce that our strategy is gaining traction where clinical adoption and utilization is strongest.
Third, Q1 marked a meaningful step forward in our broader cardiorenal platform strategy. In March, we completed the acquisition of RendiaTech, adding automated kidney function monitoring capabilities to our product development portfolio. This is an important strategic expansion because it complements our existing focus on precision fluid removal. Aquadex helps clinicians remove excess fluid with precision. RendiaTech's technology adds potential for earlier insight into kidney function and fluid balance changes. Together, they support a broader vision of helping clinicians, identify risk earlier, intervene more precisely, and manage complex cardiorenal patients with better information. We also appointed doctor Stuart Goldstein as director of clinical strategy.
Doctor Goldstein is internationally recognized as an adult critical care nephrologist and a pioneer in pediatric nephrology with work that has helped define the modern understanding of acute kidney injury fluid overload, and continuous renal replacement therapy in critically ill patients. This expertise strengthens our clinical road map across pediatric and adult critical care where fluid overload, kidney function, and timing of intervention are deeply connected. Finally, pediatrics continues to validate itself as 1 of the clearest growth strategies for Newellis. Pediatrics now represents approximately 50% of total US revenue, and our pediatric footprint expanded to 47 centers nationwide including 6 of the top children's hospitals as ranked by US News and World Report.
This growth reflects increasing Aquadex utilization in leading pediatric centers and reinforces the clinical relevance of physician precision fluid removal in a high acuity patient population. Importantly, our future pediatric innovation is being built into a category where we already have meaningful adoption, established relationships, and clinical credibility. During the quarter, we announced the issuance of a new U. S. Patent supporting advanced safety design for pediatric extracorporeal therapy. This patent strengthens the intellectual property foundation behind Vivien our pediatric CRRT system in development and supports our longer term strategy to expand within a category where Nuwellis has already demonstrated market need. Pediatrics is both a commercial growth area today and a long term strategic opportunity for the company.
It gives Noelis a clear area of differentiation, a strong clinical foothold, and a focused path for future innovation. Taken together, the first quarter demonstrates meaningful progress against the strategy we outlined coming into 2026. We have strengthened the company's leadership, board of directors, and capital foundation. We delivered stronger financial performance. We completed the RendiaTech acquisition and expanded our cardiorenal platform. And we continue to build on a pediatric momentum both commercially and through future innovation. We are still early in this execution phase, and there is more work ahead But we believe Q1 reflects a more focused, more disciplined, and more strategically aligned Novelis.
With that, I will turn the call over to Carisa for a detailed review of our financial results.
Carisa Schultz: Thank you, John, and good morning. I will review our first quarter financial performance and balance sheet position. Revenue for the 2026 was $2.4 million compared with $1.9 million in the prior year quarter, representing a 26% increase year over year. The increase in sales was driven by stronger console and circuit performance. performance. During the quarter, the company sold 15 consoles, including upgrades from the former FlexFlow to the current SmartFlow systems. New consoles placed with pediatric accounts, and new consoles placed with adult accounts. Circuit sales also increased 15% reflecting continued growth in the number of patients treated with Aquadex therapy. Gross margin for the 2026 was 70.1%. A 14% increase compared to the prior year quarter.
The gross margin improvement reflects improved pricing, product mix, and the transition to contract manufacturing. Operating expenses for the 2026 were approximately $6 million compared to approximately $4.1 million in the prior year quarter. The increase was driven by higher sales headcount and compensation associated with increased sales activity. Net loss attributable to common shareholders for the 2026 was approximately $4.3 million As of 03/31/2026, the company had no debt and cash and restricted cash equivalents of approximately $2.2 million As we move forward, our financial priorities remain focused on disciplined capital deployment, gross margin consistency, commercial execution, and enhanced visibility into the drivers of utilization and account growth.
That concludes my prepared remarks, and I would like to turn the call back over to John for any remaining comments.
John L. Erb: Thank you, Carisa. Before opening the call to questions, I want to reinforce the central message for the quarter. Q1 was an important step in translating the work of 2025 into 2026 execution. We are operating with a clearer strategy, a stronger leadership and governance foundation, improved commercial focus, and a broader view of the cardiorenal opportunity ahead of us. Aquadex remains the foundation of the company. Our strategy is to grow from that foundation by deepening utilization in high need customer categories expanding our clinical relevance in pediatrics and critical care, and building a broader platform around the management of complex cardiorenal patients.
We appreciate the continued support of our Shell shareholders, the focus of our team, and the commitment of the clinicians and institutions using our technologies to support patients with fluid overload. Operator, we would now like to open the call to questions.
Operator: Thank you. To leave the queue at any time, press 2. Once again, that is *1 to ask. We will take our first question from Nicholas Sherwood with Maxim Group. Please go ahead. Your line is open.
Analyst: My first question is looking at the new, commercial coverage with the South Texas territory. Can you kind of talk about how your sales team is building out relationships in that territory? And outside of that territory, what the what other regions are you kind of targeting for expansion?
John L. Erb: Sure. Well, we are excited about that new primarily because we have had a former top sales rep rejoin the company. Libby is the rep. She built the New York territory to be 1 of our largest territories. She and her family moved south a while ago, left the company, went to another company, and saw what we were building at Nuwellis and wanted to come back. Which, of course, we accepted with open arms. So in doing that, we had a rep in larger Oklahoma area that we were able to split the territory keep the rep that had built the northern part of Texas, and allowed Libby, who operates out of Houston, take the southern part.
So it is a really positive from the standpoint that it was not just a new territory. It was bringing back a very experienced sales territory. Beyond that, you know, I think our growth area in the Northeast has consistently been the highest. If we look at New York, and the Washington, Philadelphia area, where we have added some new large pediatric accounts like, Children's Hospital of Philadelphia. it is it is been a focus and an important growth area for us. So the Northeast continues to be the strongest area. Also, last year, we opened the Western Territory with a new sales rep that has gotten off to a really good start.
Again, particularly, in pediatrics in the Seattle area, where Seattle Children's is a large account for us. So those are kind of our focused areas. Okay. Perfect. I really appreciate that detail then. Can you kind of just give me any more details you have on the integration with RendiaTech and how you have been able to present some of those offerings to your current customer base. Actually, have not, introduced Rendia Tech to The US market yet. RendiaTech had 2 products, 1 which they have marketed before they went bankrupt, both international in The US and internationally. That was a urine collection used in critical care.
They had a product in development that took just from the critical care urine collection to actually monitoring kidney output. And that was really the target product that we saw great value in acquiring RendiaTech. So we have just completed that acquisition. Brought the inventory that they had back into The US from Israel. It was an Israeli company. And, we are now in development on developing that more valuable product that was really the target of the acquisition. And that will not only in critical care, it is really important that they measure fluids in and fluids out. 1 thing we do with Aquadex is obviously take fluid out but they are also measuring urine output.
They take urine samples, send it to the lab, and get a lab report back that gives them the identifies the health of the kidney, tells them what oxygen levels, calcium levels, potassium levels, things like that. What this new product that we will be developing from RendiaTech does is that at the bedside so they get an immediate reading of those analytes or electrolyte balances in the urine. So it is going to be highly differentiated from anything that is on the market today. And we will introduce that product to The US market in 2027. Okay. And how many, Aquadex units were you able to sell in the first quarter? 15.
Analyst: Okay. Alright. Well, those are all my questions, and thank you for providing all that detail, I will return to the queue.
Operator: Thank you. We have no further questions in the queue at this time. I will turn the program back to John for some closing remarks.
John L. Erb: Thank you. We are encouraged by the progress made in the first quarter and remain focused on the disciplined execution throughout 2026. Our priorities are clear, We will continue supporting Aquadex utilization in the areas where clinical adoption is strongest, advancing the integration of in RendiaTech strengthening our pediatric strategy, and maintaining financial discipline as we build the company. We believe Nuwellis is better positioned today than it was a year ago and we look forward to updating you on our progress in the quarters ahead. Thank you again for joining us today. Goodbye.
Operator: That brings us to the end of today's meeting. We appreciate your time and participation. You may now disconnect. Thank you.
