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Investor releaseQuarter not tagged2026-08-13Nuwellis Reports Second Quarter 2026 Financial Results and Business Highlights Focused on Double Digit Revenue Growth and Expanded Gross Margin
GlobeNewswire
Nuwellis Reports Second Quarter 2026 Financial Results and Business Highlights Focused on Double Digit Revenue Growth and Expanded Gross Margin
Recent capital raise and warrant exercises extend cash runway through second quarter of 2027 Conference call begins at 9:00 a.m. Eastern time today MINNEAPOLIS, Aug. 13, 2026 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company committed to delivering solutions for patients with cardiorenal conditions, today reported financial results for the three and six months ended June 30, 2026. Second Quarter Results and Recent Highlights: Net sales were $2.0 million in the second quarter, a 14% increase compared with the prior-year period; U.S. revenue increased 17% Net sales for the first six months of 2026 were $4.4 million, a 20% increase compared with the prior-year period; U.S. revenue increased 24% Gross margin in the second quarter improved to 76%, compared with 56% in the prior-year quarter, reflecting improved pricing, product mix, and the transition to contract manufacturing Sold nine consoles during the second quarter and 24 during the first half of 2026, compared with five during the first half of 2025, expanding the installed base for future circuit utilization First-half revenue increased across all core customer categories compared with the prior-year period, led by a 29% increase in pediatrics, 28% in critical care, and 27% in heart failure. U.S. revenue growth outpaced the total Company average, which included lower international, service, and rental revenue. Raised $6.0 million in gross proceeds through a June registered direct offering Subsequent to June 30, 2026, raised approximately $6.7 million in gross proceeds from a July financing and warrant exercises, strengthening the Company’s cash position and simplifying its capitalization structure Advanced the proposed Aquadex label expansion to patients weighing 5 kilograms or more, from patients weighing 20 kilograms or more, following a successful U.S. Food and Drug Administration pre-submission meeting Appointed Mike McCormick as President and Chief Executive Officer, effective June 30, 2026 The second quarter demonstrated continued year-over-year growth, meaningful gross-margin improvement and progress across Nuwellis’ commercial and strategic priorities. The Company enters its next phase focused on increasing the installed based and utilization of Aquadex, building recurring circuit revenue, expanding its position in pediatrics and critical care, and selectively advanci…Read full documentShow less
Recent capital raise and warrant exercises extend cash runway through second quarter of 2027 Conference call begins at 9:00 a.m. Eastern time today MINNEAPOLIS, Aug. 13, 2026 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company committed to delivering solutions for patients with cardiorenal conditions, today reported financial results for the three and six months ended June 30, 2026. Second Quarter Results and Recent Highlights: Net sales were $2.0 million in the second quarter, a 14% increase compared with the prior-year period; U.S. revenue increased 17% Net sales for the first six months of 2026 were $4.4 million, a 20% increase compared with the prior-year period; U.S. revenue increased 24% Gross margin in the second quarter improved to 76%, compared with 56% in the prior-year quarter, reflecting improved pricing, product mix, and the transition to contract manufacturing Sold nine consoles during the second quarter and 24 during the first half of 2026, compared with five during the first half of 2025, expanding the installed base for future circuit utilization First-half revenue increased across all core customer categories compared with the prior-year period, led by a 29% increase in pediatrics, 28% in critical care, and 27% in heart failure. U.S. revenue growth outpaced the total Company average, which included lower international, service, and rental revenue. Raised $6.0 million in gross proceeds through a June registered direct offering Subsequent to June 30, 2026, raised approximately $6.7 million in gross proceeds from a July financing and warrant exercises, strengthening the Company’s cash position and simplifying its capitalization structure Advanced the proposed Aquadex label expansion to patients weighing 5 kilograms or more, from patients weighing 20 kilograms or more, following a successful U.S. Food and Drug Administration pre-submission meeting Appointed Mike McCormick as President and Chief Executive Officer, effective June 30, 2026 The second quarter demonstrated continued year-over-year growth, meaningful gross-margin improvement and progress across Nuwellis’ commercial and strategic priorities. The Company enters its next phase focused on increasing the installed based and utilization of Aquadex, building recurring circuit revenue, expanding its position in pediatrics and critical care, and selectively advancing technologies that strengthen its broader cardiorenal platform. “Nuwellis has an established commercial foundation with differentiated strength in pediatrics and momentum in critical care. Our straightforward objective is to grow recurring revenue, improve operating leverage, and position Nuwellis as the leading precision fluid management company across the cardiorenal continuum,” said Mike McCormick, Nuwellis President and Chief Executive Officer. “The recent infusion of capital strengthens our balance sheet and extends our cash runway, which provides financial flexibility to execute on our strategic priorities. We intend to concentrate our investments where we have clear clinical differentiation, attractive commercial opportunities, and the ability to generate sustainable shareholder value. As part of our strategic plan, we are evaluating opportunities to leverage our commercial infrastructure through complementary products and collaborations that deepen relationships within our existing hospital customers.” Second Quarter 2026 Financial Results Revenue for the second quarter of 2026 was $2.0 million, compared with approximately $1.7 million in the prior-year quarter, representing a 14% increase. The increase was driven by higher U.S. circuit and console sales, partially offset by lower technical services, catheter, and international sales. The Company sold nine consoles during the second quarter, compared with three during the second quarter of 2025. The expanding installed base is expected to bolster growth in recurring circuit revenue, which remains the Company's primary driver of long-term growth. U.S. circuit and console average selling prices increased approximately 5% and 3%, respectively, compared with the prior-year quarter, reflecting pricing adjustments implemented during the third quarter of 2025. Gross margin for the second quarter of 2026 was 76%, compared with 56% in the prior-year quarter. The improvement reflected pricing adjustments implemented in 2025, favorable product mix, and our successful transition to contract manufacturing. Operating expenses were approximately $4.7 million for the second quarter of 2026, compared with $3.9 million in the prior-year period, reflecting planned investments in commercial expansion and product development. Net loss was approximately $4.8 million, including approximately $1.7 million of non-cash warrant valuation expense associated with the June 2026 financing, compared with a net loss of $12.6 million in the prior-year quarter. Following the effective date of the Company’s most recent reverse stock split on July 2, 2026, the related warrants were reclassified from liability to equity in early July. As of June 30, 2026, the Company had cash and cash equivalents of approximately $3.9 million. Through second-quarter financing activity and subsequent financing events, Nuwellis raised approximately $12.7 million in gross proceeds, strengthening its cash position and simplifying its capitalization structure. This activity included $6.0 million raised in June and, subsequent to June 30, an additional $3.4 million from a July financing and $3.3 million from warrant exercise proceeds. Webcast and Conference Call Information The Company will host a conference call and webcast at 9:00 a.m. Eastern time today to discuss its financial results and provide an update on the Company’s performance. To access the live webcast, please visit the Investors page of the Nuwellis website at https://ir.nuwellis.com/. Alternatively, the live conference call may be accessed by dialing (833) 316-1983 or (785) 838-9310 and using conference ID NUWEQ2. An audio archive of the webcast will be available following the call on the Investors page. About Aquadex The Aquadex SmartFlow System is indicated for the continuous ultrafiltration therapy for temporary (up to 8 hours) or extended (longer than 8 hours in patients who require hospitalization) use in adult and pediatric patients weighing 20 kilograms or more whose fluid overload is unresponsive to medical management, including diuretics. All treatments must be administered by a healthcare provider, within an outpatient or inpatient clinical setting, under physician prescription, both of whom having received training in extracorporeal therapies. About Nuwellis Nuwellis, Inc. (Nasdaq: NUWE) is a medical technology company committed to delivering solutions for patients with cardiorenal conditions. The Company develops solutions designed to support patient care through monitoring, therapy, and data-informed clinical decision-making across acute and chronic care settings. Nuwellis’ portfolio includes commercially available and development-stage technologies addressing complex cardiorenal conditions, with a focus on safety, precision, and scalability across patient populations. For more information, visit www.nuwellis.com. Forward-Looking Statements Certain statements in this release may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including without limitation, statements regarding the new market opportunities and anticipated growth in 2026 and beyond. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this release, including, without limitation, those risks associated with our ability to execute on our commercialization strategy, the possibility that we may be unable to raise sufficient funds necessary for our anticipated operations, our post-market clinical data collection activities, benefits of our products to patients, our expectations with respect to product development and commercialization efforts, our ability to increase market and physician acceptance of our products, potentially competitive product offerings, intellectual property protection, our ability to integrate acquired businesses, our expectations regarding anticipated synergies with and benefits from acquired businesses, and other risks and uncertainties described in our filings with the SEC. Forward-looking statements speak only as of the date when made. Nuwellis does not assume any obligation to publicly update or revise any forward-looking statements, whether due to new information, future events or otherwise. For further information, please contact: Investor Relations: CORE [email protected] Media Contact: CORE [email protected]
Investor releaseQuarter not tagged2026-08-13Nuwellis Inc (NUWE) (Q2 2026) Earnings Call Highlights: Revenue Surges 14% and Installed Base ...
GuruFocus.com
Nuwellis Inc (NUWE) (Q2 2026) Earnings Call Highlights: Revenue Surges 14% and Installed Base ...
This article first appeared on GuruFocus. Release Date: August 13, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Nuwellis Inc (NASDAQ:NUWE) reported a 14% increase in Q2 2026 revenue to $1.97 million, with U.S. revenue up 17%. The company sold 24 consoles in the first half of 2026, compared to only 5 in the same period of 2025, expanding its installed base. Gross margin improved significantly to 76% in Q2 2026, up from 56% in the prior-year quarter, driven by higher pricing and contract manufacturing benefits. Nuwellis Inc (NASDAQ:NUWE) is advancing its pediatric label expansion to include patients weighing 5 kg and above, with a planned FDA submission in Q4 2026. The company raised approximately $12.7 million in gross proceeds through financing activities, strengthening its cash position and simplifying its capital structure. Nuwellis Inc (NASDAQ:NUWE) received a notice of allowance for its dual-lumen midline catheter technology, which could support less invasive peripheral access for extracorporeal therapies. Nuwellis Inc (NASDAQ:NUWE) reported a net loss of approximately $4.8 million in Q2 2026, though improved from a $12.6 million loss in the prior-year quarter. Operating expenses increased to $4.7 million in Q2 2026, up from $3.9 million in the prior-year quarter, reflecting higher investment costs. The company's cash position remains low at $3.9 million as of June 30, 2026, despite subsequent financing efforts. Lower OUS service and rental revenue moderated overall revenue growth, indicating weakness in international markets. Nuwellis Inc (NASDAQ:NUWE) continues to rely on external financing to support operations, as evidenced by multiple capital raises in 2026. The company faces regulatory and development risks with its proposed pediatric label expansion and Clarity Prime product, which is not expected to launch until 2027. Warning! GuruFocus has detected 4 Warning Signs with NUWE. Is NUWE fairly valued? Test your thesis with our free DCF calculator. Q: What are the company's three essential objectives under the new CEO's mandate to drive growth and value?A: Mike McCormick, President and CEO, outlined three priorities: first, increase Aquadex utilization and recurrent circuit revenue by focusing on accounts and clinical pathways with sustained use; second, build the company's position in pedi…Read full documentShow less
This article first appeared on GuruFocus. Release Date: August 13, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Nuwellis Inc (NASDAQ:NUWE) reported a 14% increase in Q2 2026 revenue to $1.97 million, with U.S. revenue up 17%. The company sold 24 consoles in the first half of 2026, compared to only 5 in the same period of 2025, expanding its installed base. Gross margin improved significantly to 76% in Q2 2026, up from 56% in the prior-year quarter, driven by higher pricing and contract manufacturing benefits. Nuwellis Inc (NASDAQ:NUWE) is advancing its pediatric label expansion to include patients weighing 5 kg and above, with a planned FDA submission in Q4 2026. The company raised approximately $12.7 million in gross proceeds through financing activities, strengthening its cash position and simplifying its capital structure. Nuwellis Inc (NASDAQ:NUWE) received a notice of allowance for its dual-lumen midline catheter technology, which could support less invasive peripheral access for extracorporeal therapies. Nuwellis Inc (NASDAQ:NUWE) reported a net loss of approximately $4.8 million in Q2 2026, though improved from a $12.6 million loss in the prior-year quarter. Operating expenses increased to $4.7 million in Q2 2026, up from $3.9 million in the prior-year quarter, reflecting higher investment costs. The company's cash position remains low at $3.9 million as of June 30, 2026, despite subsequent financing efforts. Lower OUS service and rental revenue moderated overall revenue growth, indicating weakness in international markets. Nuwellis Inc (NASDAQ:NUWE) continues to rely on external financing to support operations, as evidenced by multiple capital raises in 2026. The company faces regulatory and development risks with its proposed pediatric label expansion and Clarity Prime product, which is not expected to launch until 2027. Warning! GuruFocus has detected 4 Warning Signs with NUWE. Is NUWE fairly valued? Test your thesis with our free DCF calculator. Q: What are the company's three essential objectives under the new CEO's mandate to drive growth and value?A: Mike McCormick, President and CEO, outlined three priorities: first, increase Aquadex utilization and recurrent circuit revenue by focusing on accounts and clinical pathways with sustained use; second, build the company's position in pediatrics and expand into adult critical care, areas with strong clinical relevance and commercial traction; and third, strategically broaden the cardiorenal platform through complementary technologies and collaborations that strengthen customer relationships and have a clear path to commercial value. Q: What is the status of the proposed FDA label expansion for Aquadex, and what is the timeline?A: Mike McCormick, President and CEO, stated that the company completed a pre-submission meeting with the FDA regarding expanding the Aquadex indication from patients 20 kilograms and above to those weighing five kilograms and above. The meeting provided clarity on the regulatory pathway, including bench testing, toxicology assessments, and pediatric clinical evidence. The company plans to submit the proposed label expansion to the FDA in the fourth quarter of 2026. Q: How did the company's financial performance in Q2 2026 compare to the prior year, and what drove the improvements?A: Carisa Schultz, CFO, reported that Q2 2026 revenue was $1.97 million, a 14% increase year-over-year, with U.S. revenue up 17%. Gross profit was approximately $1.5 million, resulting in a gross margin of 76%, a significant improvement from 56% in the prior-year quarter. This was driven by higher circuit and console average selling prices, favorable product mix, and the benefits of the transition to contract manufacturing. Q: What progress has been made in expanding the installed base of Aquadex consoles?A: Mike McCormick, President and CEO, highlighted that the company sold nine consoles in Q2 2026, bringing the first-half total to 24, compared to only five in the first half of 2025. Each placement expands the opportunity for recurrent circuit utilization. The focus is now on helping these accounts translate placements into sustained clinical use through training, protocol development, and early identification of appropriate patients. Q: What are the key developments in the pediatric segment, and how is the company expanding its footprint?A: Mike McCormick, President and CEO, noted that during the quarter, the company expanded its presence in a major South Carolina healthcare system and entered two new states, Michigan and Wisconsin, with their first pediatric programs. The company also celebrated five years of support for the Pediatric Cardiac Critical Care Consortium (PC4) and highlighted a case presented at the ISHLT meeting from the University of Iowa on using Aquadex for complex pediatric patients. Q: What is the company's strategy for adult critical care, and what initiatives are underway?A: Mike McCormick, President and CEO, discussed a strategic development initiative to expand Aquadex capabilities into broader extracorporeal therapy platforms, including higher flow capabilities for new filtration technologies and high-pressure environments. The company is also developing an enhanced user interface called Smart View to improve clinical workflows. During the quarter, over 280 physicians attended a critical care cardiac education summit with hands-on Aquadex training, one of the largest training initiatives in company history. Q: What is the status of the Clarity Prime product acquired with Renditech, and what is the expected launch timeline?A: Mike McCormick, President and CEO, stated that Clarity Prime, an automated kidney function monitoring system, is in the product development and technology integration phase. It has the potential to provide earlier and more continuous insights into kidney function changes. The company expects to launch Clarity Prime in 2027, which will complement Aquadex in providing stronger cardiorenal care solutions. Q: How is the company managing its cash position and capital allocation?A: Carisa Schultz, CFO, reported that as of June 30, 2026, the company had no debt and cash and cash equivalents of approximately $3.9 million. Subsequent to quarter end, the company raised an additional $3.4 million from a registered direct offering and $3.3 million from warrant exercises, strengthening the balance sheet. Mike McCormick emphasized capital discipline, focusing resources on Aquadex utilization, the pediatric label expansion, Clarity Prime development, and selected strategic opportunities. Q: What is the company's approach to evaluating complementary technologies for its cardiorenal platform?A: Mike McCormick, President and CEO, explained that the company is evaluating complementary pediatric technologies, including pediatric urine output monitoring and non-invasive cardiac monitoring. The approach will be selective and capital-efficient, only pursuing technologies that strengthen the company's position in pediatrics and critical care, complement existing customer relationships, and create a clear clinical and commercial benefit. Q: What recent intellectual property developments support the company's technology foundation?A: Mike McCormick, President and CEO, mentioned that the company received a notice of allowance from the U.S. Patent and Trademark Office for its dual-lumen midline catheter technology, which was issued in mid-July. This IP could support less invasive peripheral access for extracorporeal therapies and strengthens the technology foundation surrounding the fluid management platform. For the complete transcript of the earnings call, please refer to the full earnings call transcript.
TranscriptFY2026 Q22026-08-13FY2026 Q2 earnings call transcript
Earnings source - 21 paragraphs
FY2026 Q2 earnings call transcript
Good morning, and welcome to Nuwellis earnings conference call for the second quarter ended June 30, 2026. All participants are in listen-only mode. Should you need assistance, please signal a conferencing 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 on this call are advised that the audio of this conference call is being broadcast live over the internet and is 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 Leah McMullen, Director of Communications. Please go ahead.
Thank you, operator. Thank you for joining today's conference call to discuss Nuwellis' Corporate Developments and Financial Results for the Second Quarter ended June 30, 2026. Joining me today are Mike McCormick, Nuwellis' newly appointed President and Chief Executive Officer, and Carisa Schultz, Chief Financial Officer. Earlier today, Nuwellis released its financial results for the second quarter of 2026. If you have not received the earnings release, please visit the investor 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 our expectations or predictions of future events and marketing 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 currently 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 Mike.
Thank you, Leah, and good morning, everyone. I am pleased to be joining you for my first earnings call as CEO of Nuwellis. I would like to begin by thanking John Erb for his leadership and for the work he has done to position the company for its next phase. John has transitioned his executive role. However, he still remains as Chairman of our board. Personally, having served on the board since 2023 and closely working with the company on its commercial strategy, I enter this role with a clear understanding of Nuwellis' strengths and where greater focus can create meaningful value. We have established a commercial therapy addressing an important clinical need, a growing installed base, strong relationships with leading institutions, and a differentiated position in precision fluid management. My mandate is to turn those strengths into a growing, scalable, and financially disciplined business.
We will do that by prioritizing three essential objectives. First, we intend to increase Aquadex utilization and recurrent circuit revenue by concentrating on accounts and clinical pathways where we can establish sustained use. Second, we intend to build our position in pediatrics and expand our presence in adult critical care, two areas where we see the strongest combination of clinical relevance and commercial traction as well as long-term growth opportunities. Third, we will endeavor to strategically broaden our cardiorenal platform through technologies and collaborations that complement the Aquadex, strengthen our existing customer relationships, and have a clear path toward commercial value. We believe the second quarter results showed progress across all of these priorities. An important commercial indicator of our continued expansion is the installed base.
During the second quarter, we sold nine consoles, bringing the first half total to 24, compared with only five in the first half of 2025. Each of those placements expands the opportunity for recurrent circuit utilization. Our focus is now on helping all of those accounts translate the placements into sustained clinical use through training, protocol development, and early identification of appropriate patients. We will measure progress not only by the consoles placed but by the number of accounts achieving consistent utilization, the number of patients treated, and recurring circuit revenue generated from the installed base. Pediatrics remained the clearest example of this strategy in action. During the quarter, we expanded our presence in a major South Carolina healthcare system, and we expanded into two new states with the first pediatric programs in their history. We opened in Michigan and also in Wisconsin.
We continue to strengthen the educational foundation supporting pediatric adoption. At the International Society for Heart and Lung Transplantation 46th Annual Meeting and Scientific Sessions, clinicians from the University of Iowa presented a case that highlighted the Aquadex use in managing recurrent fluid overload in a very complex pediatric cardiac patient. We also marked five years of support for the Pediatric Cardiac Critical Care Consortium, or PC4, a collaborative network focused on improving outcomes for critically ill pediatric cardiac patients. From a product standpoint, we continue to enhance the Aquadex platform with software updates designed to improve workflow efficiency, support treatment precision, and reduce barriers to therapy use. We also completed a pre-submission meeting with the FDA regarding a proposed expansion of the Aquadex indication for patients from 20 kg and above, which it is today, to patients weighing 5 kg and above.
This meeting provided greater clarity regarding the proposed regulatory pathway. That includes bench testing, toxicology assessments, and supporting pediatric clinical evidence. We plan to submit the proposed label expansion to the FDA in the fourth quarter of this year. Together, these developments create a focused pediatric growth strategy, expand our commercial footprint, increase utilization within existing programs, improve products for smaller patients, and pursue a regulatory pathway that can meaningfully broaden the population that we serve. Critical care represents another significant opportunity for us. We recently announced the strategic development initiative to expand the capabilities of the Aquadex into broader extracorporeal therapy platform. These initiatives include higher flow capabilities designed to support new filtration technologies and expand the potential use of Aquadex in more complex critical care, high-pressure extracorporeal environments.
We are also developing an enhanced user interface called SmartView that will make the Aquadex easier to use, improve clinical workflows, and support greater utilization. Together, these development programs are intended to broaden the capabilities of Aquadex and to strengthen our position in critical care. During the quarter, more than 280 physicians attended a critical care cardiac education summit that included hands-on training with the Aquadex. That created one of the largest concentrated physician training initiatives in the company's history. Our next step is to connect that growing clinical awareness with focused account development. We see an opportunity with our broader cardiorenal strategy to build from the same customer relationships and area of clinical expertise. The acquisition of Rendiatech in the first quarter of 2026 added ClarityPRIME, an automated kidney function monitoring system to our development portfolio.
During the second quarter, our focus was on product development and technology integration and commercial planning. Aquadex gives clinicians the ability to remove excess fluid with precision. ClarityPRIME has the potential to provide earlier and more continuous insights, allowing early detection of changes in kidney function. We expect this important ClarityPRIME product to launch in 2027. Together, these technologies support stronger solutions to cardiorenal care in which clinicians can make better-informed decisions about fluid balance and kidney function. To further broaden our product offering and leverage our commercial infrastructure, we are evaluating complementary pediatric technologies, including pediatric urine output monitoring and pediatric non-invasive cardiac monitoring. Our approach will remain selective and capital efficient. We expect to only pursue technologies and collaborations that strengthen our position in pediatrics and critical care, complement the customer relationships we already have, and create a clear clinical and commercial benefit.
During the quarter, we also received a notice of allowance from the United States Patent and Trademark Office for our dual lumen midline catheter technology. This intellectual property could support less invasive peripheral access for extracorporeal therapies, and it strengthens the technology foundation surrounding our fluid management platform. That patent, in fact, issued in mid-July. Excuse me. Capital discipline will remain central to the way that we operate. We intend to concentrate resources around Aquadex utilization, the proposed pediatric label expansion, focused development of ClarityPRIME, and selected strategic opportunities that directly support our strategy. Nuwellis has an established commercial foundation, differentiated strength in pediatrics, a growing traction in critical care, and a focused strategy to expand our role in cardiorenal care. While we do not provide formal financial guidance, our objectives remain clear.
Deliver consistent double-digit revenue growth, maintain strong gross margins, increase our installed base and recurring circuit utilization, and advance our highest priority development programs to reduce and reduce cash utilization over time. In addition, through June financing and subsequent to the end-of-the-quarter financing events, we raised approximately $12.7 million in gross proceeds. That included $6 million in June. That was a private placement, and subsequent to the end of the quarter, we raised an additional $3.4 million from a registered direct offering and $3.3 million from warrant exercises. These actions strengthened our cash position, and it simplified our capitalization structure. With that, I am pleased to turn the call over to Carisa Schultz, who is our Chief Financial Officer, for a detailed review of our financial results. Carisa?
Thank you, Mike, and good morning. I will review our second quarter and year-to-date financial performance and balance sheet position. Revenue for the second quarter of 2026 was $1.97 million, compared with approximately $1.7 million in the prior year quarter, representing an increase of 14%, while U.S. revenue increased 17%. Revenue for the first six months of 2026 was $4.37 million, an increase of 20% from the prior year, while U.S. revenue increased 24%. Lower OUS service and rental revenue moderated reported growth, while U.S. revenue growth outpaced total company growth. During the quarter, the company sold nine U.S. consoles, compared with three in the second quarter of 2025. The new console placements, including within pediatric programs, expanded the installed base and created additional opportunities for sustained Aquadex utilization.
U.S. circuit average selling prices increased approximately 5% compared with the prior year quarter, and console average selling prices increased approximately 3%. These increases primarily reflect pricing adjustments implemented during the third quarter of 2025. Gross profit for the second quarter was approximately $1.5 million, resulting in a gross margin of 76%, compared with 56% in the prior year quarter. The 20 percentage point improvement was driven by higher circuit and console average selling prices, favorable product mix, and the benefits of our transition to contract manufacturing. Operating expenses for the second quarter were approximately $4.7 million, compared with approximately $3.9 million in the prior year quarter and approximately $6.3 million in the first quarter of 2026. The year-over-year increase primarily reflects investments supporting commercial expansion and product development initiatives. The sequential decrease reflects our continued effort to align expenses with the company's highest priority commercial and strategic programs.
Reported net loss for the second quarter was approximately $4.8 million, compared with approximately $12.6 million in the prior year quarter. The second quarter result included approximately $1.7 million of warrant valuation expense associated with the June 2026 financing. Following the effective date of the company's most recent reverse stock split on July 2nd, 2026, the related warrants were reclassified from liability to equity in early July. During June, the company completed a $6 million registered public offering. As of June 30th, 2026, the company had no debt, and cash and cash equivalents were approximately $3.9 million. As Mike previously mentioned, subsequent to quarter end, we further strengthened our balance sheet. In July, we raised an additional $3.4 million in gross proceeds through a registered direct offering and received $3.3 million from the cash exercise of warrants in connection with the June 2026 financing.
As we move through the second half of the year, our financial priorities remain focused on increasing recurring circuit revenue, maintaining gross margin discipline, reducing cash utilization, and directing capital toward the commercial and development programs with the greatest potential to create value. That concludes my prepared remarks. I will now turn the call back to Mike.
Thank you, Carisa Schultz. Before opening the call to questions, I want to reinforce the strategic direction we have outlined today. Nuwellis has an established commercial foundation with a clear pathway to growth. Our focus is to increase the Aquadex installed base, utilization, and recurrent circuit revenue within the accounts and clinical categories where we can establish sustained use. We intend to continue building differentiated position in pediatrics through commercial expansion, product improvements, clinical evidence, and proposed label expansion. We intend to grow our presence in adult critical care by connecting clinical education with focused account development and stronger pathways for Aquadex use. We are expected to selectively advance ClarityPRIME, our complementary technology that will broaden the relevance across fluid management and kidney function monitoring.
These priorities are designed to create a stronger recurring revenue base, expand the patients and clinicians that we serve, as well as build more value in our cardiorenal platform. We will pursue them with a disciplined capital allocation and clear expectation of measurable progress. Operator, we would now like to open the call to any questions.
Thank you. If you would like to ask a question, press star one on your keypad. To leave the queue at any time, press star two. Once again, that is star one to ask a question. We will pause for just a moment to allow everyone a chance to join the queue. At this time, we have no questions in the queue. I will now turn the call back to Mike McCormick for concluding remarks.
Thank you very much. We look forward to updating everyone on our progress and discussing our third quarter financial results on our next conference call that will be scheduled in November. Thank you again for joining us today.
Thank you. This brings us to the end of today's meeting. We appreciate your time and participation. You may now disconnect.
Investor releaseQuarter not tagged2026-07-27Nuwellis Announces Preliminary Revenue Results for the Second Quarter 2026 Showing Double Digit Growth
GlobeNewswire
Nuwellis Announces Preliminary Revenue Results for the Second Quarter 2026 Showing Double Digit Growth
Company expects preliminary revenue year-over-year growth of 14% for second quarter 2026 and 20% for the first half of 2026 as Aquadex Ultrafiltration platform drives continued commercial momentum Nuwellis to report second quarter 2026 financial results on August 13 MINNEAPOLIS, July 27, 2026 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company committed to delivering solutions for patients with cardiorenal conditions, today announced unaudited preliminary results for its second quarter ended June 30, 2026, with revenue year-over-year growth of 14% for the second quarter of 2026 and 20% for the first six months of 2026. Management expects to report its financial results for the three and six months ended June 30, 2026, before the open of the U.S. financial markets on August 13th and will host a conference call and webcast beginning at 9:00 a.m. Eastern time. "Our second quarter preliminary revenue results reflect continued commercial momentum and the outstanding execution of our entire Nuwellis team," said Mike McCormick, Nuwellis Chief Executive Officer. "Revenue growth of 20% during the first half of 2026 demonstrates the increasing adoption of Aquadex and the progress we are making in executing our long-term growth strategy. During our earnings call, we look forward to reviewing our financial performance, and discussing our commercial initiatives, product development programs, and strategic partnerships. Additionally, we will highlight opportunities we believe position us for continued growth through the remainder of 2026 and into next year." The financial information in this release is unaudited and subject to adjustment and confirmation as the Company completes its quarterly review and finalizes its financial statements to be filed with the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2026, and discussed in greater detail during its financial results conference call. Conference Call & Webcast Information Date: August 13, 2026Time: 9:00 a.m. Eastern TimeDial-in: 1-833-316-1983 or 1-785-838-9310Conference ID: NUWEQ2 To access the live webcast, please visit the Investors page of the Nuwellis website at https://ir.nuwellis.com or access here. An audio archive of the webcast will be available following the call on the Investors page. About AquadexThe Aquadex SmartFlow System is indicated for the continuous…Read full documentShow less
Company expects preliminary revenue year-over-year growth of 14% for second quarter 2026 and 20% for the first half of 2026 as Aquadex Ultrafiltration platform drives continued commercial momentum Nuwellis to report second quarter 2026 financial results on August 13 MINNEAPOLIS, July 27, 2026 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company committed to delivering solutions for patients with cardiorenal conditions, today announced unaudited preliminary results for its second quarter ended June 30, 2026, with revenue year-over-year growth of 14% for the second quarter of 2026 and 20% for the first six months of 2026. Management expects to report its financial results for the three and six months ended June 30, 2026, before the open of the U.S. financial markets on August 13th and will host a conference call and webcast beginning at 9:00 a.m. Eastern time. "Our second quarter preliminary revenue results reflect continued commercial momentum and the outstanding execution of our entire Nuwellis team," said Mike McCormick, Nuwellis Chief Executive Officer. "Revenue growth of 20% during the first half of 2026 demonstrates the increasing adoption of Aquadex and the progress we are making in executing our long-term growth strategy. During our earnings call, we look forward to reviewing our financial performance, and discussing our commercial initiatives, product development programs, and strategic partnerships. Additionally, we will highlight opportunities we believe position us for continued growth through the remainder of 2026 and into next year." The financial information in this release is unaudited and subject to adjustment and confirmation as the Company completes its quarterly review and finalizes its financial statements to be filed with the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2026, and discussed in greater detail during its financial results conference call. Conference Call & Webcast Information Date: August 13, 2026Time: 9:00 a.m. Eastern TimeDial-in: 1-833-316-1983 or 1-785-838-9310Conference ID: NUWEQ2 To access the live webcast, please visit the Investors page of the Nuwellis website at https://ir.nuwellis.com or access here. An audio archive of the webcast will be available following the call on the Investors page. About AquadexThe Aquadex SmartFlow System is indicated for the continuous ultrafiltration therapy for temporary (up to 8 hours) or extended (longer than 8 hours in patients who require hospitalization) use in adult and pediatric patients weighing 20 kilograms or more whose fluid overload is unresponsive to medical management, including diuretics. All treatments must be administered by a healthcare provider, within an outpatient or inpatient clinical setting, under physician prescription, both of whom having received training in extracorporeal therapies. About NuwellisNuwellis, Inc. (Nasdaq: NUWE) is a medical technology company committed to delivering solutions for patients with cardiorenal conditions. The Company develops solutions designed to support patient care through monitoring, therapy, and data-informed clinical decision-making across acute and chronic care settings. Nuwellis’ portfolio includes commercially available and development-stage technologies addressing complex cardiorenal conditions, with a focus on safety, precision, and scalability across patient populations. For more information, visit www.nuwellis.com. Forward-Looking StatementsCertain statements in this release may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including without limitation, statements regarding the new market opportunities and anticipated growth in 2026 and beyond. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this release, including, without limitation, those risks associated with our ability to execute on our commercialization strategy, the possibility that we may be unable to raise sufficient funds necessary for our anticipated operations, our post-market clinical data collection activities, benefits of our products to patients, our expectations with respect to product development and commercialization efforts, our ability to increase market and physician acceptance of our products, potentially competitive product offerings, intellectual property protection, our ability to integrate acquired businesses, our expectations regarding anticipated synergies with and benefits from acquired businesses, and other risks and uncertainties described in our filings with the SEC. Forward-looking statements speak only as of the date when made. Nuwellis does not assume any obligation to publicly update or revise any forward-looking statements, whether due to new information, future events or otherwise. For further information, please contact: Investor Relations: CORE [email protected] Media Contact: CORE [email protected]
Investor releaseQuarter not tagged2026-05-13Nuwellis, Inc. Q1 2026 Earnings Call Summary
Moby
Nuwellis, Inc. Q1 2026 Earnings Call Summary
Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Management characterized Q1 2026 as the transition from a 2025 structural reset to active strategic execution, focusing on the cardiorenal care continuum. Revenue growth of 26% was attributed to a significant increase in console sales and continued expansion of circuit sales, indicating higher patient treatment volumes. Gross margin expansion to 70.1% was driven by a combination of improved pricing strategies, favorable product mix, and the operational transition to contract manufacturing at KDI. The pediatric segment has become a primary growth engine, now representing approximately 50% of total U.S. revenue with a footprint in 47 centers nationwide. Strategic leadership changes, including a new CFO and board appointments, were implemented to instill greater rigor in forecasting and capital allocation. The acquisition of RendiaTech is intended to evolve the company from a fluid removal specialist to a broader provider of automated kidney function monitoring. Management is developing a cash burn reduction plan aimed at reducing monthly cash burn by approximately 50% by the fourth quarter of 2026. Future pediatric innovation is centered on the 'Vivien' CRRT system, supported by a new U.S. patent for advanced safety design in extracorporeal therapy. The company plans to develop a highly differentiated bedside kidney monitoring product from the RendiaTech acquisition for a projected U.S. market introduction in 2027. Sales strategy involves deepening utilization in high-priority accounts by leveraging experienced sales leaders returned to the company in key territories like South Texas. Completed an approximately $5 million private placement and warrant inducement transaction to bolster the capital foundation for ongoing operations. Operating expenses increased to approximately $6 million, primarily due to higher sales headcount and compensation tied to increased commercial activity. The company reported having no debt as of March 31, 2026, with approximately $2.2 million in cash and restricted cash equivalents. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management highlighted the return of a top-performing sales representative to lead the new South Tex…Read full documentShow less
Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Management characterized Q1 2026 as the transition from a 2025 structural reset to active strategic execution, focusing on the cardiorenal care continuum. Revenue growth of 26% was attributed to a significant increase in console sales and continued expansion of circuit sales, indicating higher patient treatment volumes. Gross margin expansion to 70.1% was driven by a combination of improved pricing strategies, favorable product mix, and the operational transition to contract manufacturing at KDI. The pediatric segment has become a primary growth engine, now representing approximately 50% of total U.S. revenue with a footprint in 47 centers nationwide. Strategic leadership changes, including a new CFO and board appointments, were implemented to instill greater rigor in forecasting and capital allocation. The acquisition of RendiaTech is intended to evolve the company from a fluid removal specialist to a broader provider of automated kidney function monitoring. Management is developing a cash burn reduction plan aimed at reducing monthly cash burn by approximately 50% by the fourth quarter of 2026. Future pediatric innovation is centered on the 'Vivien' CRRT system, supported by a new U.S. patent for advanced safety design in extracorporeal therapy. The company plans to develop a highly differentiated bedside kidney monitoring product from the RendiaTech acquisition for a projected U.S. market introduction in 2027. Sales strategy involves deepening utilization in high-priority accounts by leveraging experienced sales leaders returned to the company in key territories like South Texas. Completed an approximately $5 million private placement and warrant inducement transaction to bolster the capital foundation for ongoing operations. Operating expenses increased to approximately $6 million, primarily due to higher sales headcount and compensation tied to increased commercial activity. The company reported having no debt as of March 31, 2026, with approximately $2.2 million in cash and restricted cash equivalents. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management highlighted the return of a top-performing sales representative to lead the new South Texas territory, specifically targeting the Houston area. The Northeast remains the strongest regional performer, while the Western territory is seeing early traction particularly in pediatric accounts like Seattle Children's. The acquisition was driven by a product in development that monitors kidney output and analytes at the bedside, providing immediate data compared to traditional lab reports. Management clarified that RendiaTech products have not yet been introduced to the U.S. market by Nuwellis; the target product is currently in development for a 2027 launch. Management confirmed the company sold 15 Aquadex units during the first quarter, which included upgrades to SmartFlow systems and new placements in both pediatric and adult accounts.
Investor releaseQuarter not tagged2026-05-13Nuwellis Inc (NUWE) Q1 2026 Earnings Call Highlights: Strong Revenue Growth and Strategic ...
GuruFocus.com
Nuwellis Inc (NUWE) Q1 2026 Earnings Call Highlights: Strong Revenue Growth and Strategic ...
This article first appeared on GuruFocus. Release Date: May 12, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Revenue for the first quarter increased by 26% year-over-year, driven by stronger console and circuit sales. Gross margin improved to 70.1%, reflecting better pricing, product mix, and transition to contract manufacturing. The company completed a strategic acquisition of RendiaTek, enhancing its product development portfolio with automated kidney function monitoring capabilities. Pediatrics now represents approximately 50% of total U.S. revenue, with an expanded footprint in 47 centers nationwide. The appointment of experienced leaders, including a new CFO and board members, strengthens the company's leadership and governance. Operating expenses increased to approximately $6 million, up from $4.1 million in the prior-year quarter, due to higher sales headcount and compensation. Net loss attributable to common shareholders was approximately $4.3 million for the first quarter. The company had cash and restricted cash equivalents of only $2.2 million as of March 31, 2026, indicating limited liquidity. The integration of RendiaTek's technology is still in development, with no immediate introduction to the U.S. market until 2027. Despite revenue growth, the company is still in the early stages of executing its strategic plan, with more work ahead to achieve consistent execution. Warning! GuruFocus has detected 3 Warning Signs with NUWE. Is NUWE fairly valued? Test your thesis with our free DCF calculator. Q: Can you discuss the new commercial coverage in the South Texas territory and any other regions targeted for expansion? A: John Erb, CEO, explained that the South Texas territory is promising due to the return of a top sales rep, Libby, who previously built the New York territory. The territory was split to allow Libby to focus on the southern part, while another rep covers the northern part. The Northeast, particularly New York and the Washington-Philadelphia area, remains a strong growth area, with new pediatric accounts like Children's Hospital of Philadelphia. The western territory, especially in Seattle, is also a focus area. Q: Can you provide details on the integration with RendiaTek and how you are presenting these offerings to your current customer base? A: John Erb, CEO, stated that…Read full documentShow less
This article first appeared on GuruFocus. Release Date: May 12, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Revenue for the first quarter increased by 26% year-over-year, driven by stronger console and circuit sales. Gross margin improved to 70.1%, reflecting better pricing, product mix, and transition to contract manufacturing. The company completed a strategic acquisition of RendiaTek, enhancing its product development portfolio with automated kidney function monitoring capabilities. Pediatrics now represents approximately 50% of total U.S. revenue, with an expanded footprint in 47 centers nationwide. The appointment of experienced leaders, including a new CFO and board members, strengthens the company's leadership and governance. Operating expenses increased to approximately $6 million, up from $4.1 million in the prior-year quarter, due to higher sales headcount and compensation. Net loss attributable to common shareholders was approximately $4.3 million for the first quarter. The company had cash and restricted cash equivalents of only $2.2 million as of March 31, 2026, indicating limited liquidity. The integration of RendiaTek's technology is still in development, with no immediate introduction to the U.S. market until 2027. Despite revenue growth, the company is still in the early stages of executing its strategic plan, with more work ahead to achieve consistent execution. Warning! GuruFocus has detected 3 Warning Signs with NUWE. Is NUWE fairly valued? Test your thesis with our free DCF calculator. Q: Can you discuss the new commercial coverage in the South Texas territory and any other regions targeted for expansion? A: John Erb, CEO, explained that the South Texas territory is promising due to the return of a top sales rep, Libby, who previously built the New York territory. The territory was split to allow Libby to focus on the southern part, while another rep covers the northern part. The Northeast, particularly New York and the Washington-Philadelphia area, remains a strong growth area, with new pediatric accounts like Children's Hospital of Philadelphia. The western territory, especially in Seattle, is also a focus area. Q: Can you provide details on the integration with RendiaTek and how you are presenting these offerings to your current customer base? A: John Erb, CEO, stated that RendiaTek has not been introduced to the U.S. market yet. The acquisition was primarily for a product in development that monitors kidney output, which will be developed further. This product will provide immediate readings of electrolyte balances at the bedside, differentiating it from current market offerings. The product is expected to be introduced in the U.S. market in 2027. Q: How many Aquadex units were sold in the first quarter? A: John Erb, CEO, confirmed that 15 Aquadex units were sold in the first quarter. Q: What are the financial priorities moving forward? A: Carissa Schultz, CFO, emphasized that the financial priorities include disciplined capital deployment, maintaining gross margin consistency, commercial execution, and enhancing visibility into utilization and account growth drivers. Q: What are the main strategic focuses for Nuwellis in 2026? A: John Erb, CEO, highlighted that the focus is on supporting Aquadex utilization in areas with strong clinical adoption, advancing the integration of RendiaTek, strengthening the pediatric strategy, and maintaining financial discipline. The company aims to build on its cardiorenal platform and expand its clinical relevance in pediatrics and critical care. For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Investor releaseQuarter not tagged2026-05-12Nuwellis, Inc. Announces First Quarter 2026 Financial Results
GlobeNewswire
Nuwellis, Inc. Announces First Quarter 2026 Financial Results
MINNEAPOLIS, May 12, 2026 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company committed to delivering solutions for patients with cardiorenal conditions, today reported financial results for the first quarter ended March 31, 2026. First Quarter and Recent Highlights: Net sales were $2.4 million, a 26% increase compared to the prior-year period Gross margin improved to 70.1%, reflecting improved pricing, product mix, and the transition to contract manufacturing Completed the acquisition of Rendiatech, adding automated kidney-function monitoring capabilities to the Company’s product development portfolio Appointed Carisa Schultz as Chief Financial Officer and Dr. Stuart L. Goldstein as Director of Clinical Strategy Appointed Martin J. Emerson and reappointed David A. McDonald to the Board of Directors Expanded commercial coverage with a new South Texas territory and the return of experienced sales leaders with deep Aquadex expertise Received issuance of a new U.S. patent supporting advanced safety design for pediatric extracorporeal therapy Received a Notice of Allowance from the U.S. Patent and Trademark Office for a new patent covering the Company’s novel dual-lumen midline catheter technology designed for use in ultrafiltration therapies The first quarter marked an important step in Nuwellis’ transition from strategic reset to execution. The quarter demonstrated progress across the Company’s commercial, financial, and platform priorities, with stronger Aquadex performance, continued pediatric momentum, and further expansion of its broader cardiorenal strategy. “Q1 showed that the strategic reset we made in 2025 is beginning to translate into a more focused and commercially disciplined company,” said John Erb, Chairman and Chief Executive Officer of Nuwellis. “We are concentrating our resources around the areas where Nuwellis has clear clinical relevance, existing customer traction, and a differentiated path to growth, while maintaining the financial discipline required to execute. Aquadex gives us the foundation, pediatrics gives us a distinct growth category, and Rendiatech expands our ability to think more broadly across the cardiorenal continuum.” First Quarter 2026 Financial Results Revenue for the first quarter of 2026 was $2.4 million, compared to $1.9 million in the prior-year quarter, a 26% increase over the prior year pe…Read full documentShow less
MINNEAPOLIS, May 12, 2026 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company committed to delivering solutions for patients with cardiorenal conditions, today reported financial results for the first quarter ended March 31, 2026. First Quarter and Recent Highlights: Net sales were $2.4 million, a 26% increase compared to the prior-year period Gross margin improved to 70.1%, reflecting improved pricing, product mix, and the transition to contract manufacturing Completed the acquisition of Rendiatech, adding automated kidney-function monitoring capabilities to the Company’s product development portfolio Appointed Carisa Schultz as Chief Financial Officer and Dr. Stuart L. Goldstein as Director of Clinical Strategy Appointed Martin J. Emerson and reappointed David A. McDonald to the Board of Directors Expanded commercial coverage with a new South Texas territory and the return of experienced sales leaders with deep Aquadex expertise Received issuance of a new U.S. patent supporting advanced safety design for pediatric extracorporeal therapy Received a Notice of Allowance from the U.S. Patent and Trademark Office for a new patent covering the Company’s novel dual-lumen midline catheter technology designed for use in ultrafiltration therapies The first quarter marked an important step in Nuwellis’ transition from strategic reset to execution. The quarter demonstrated progress across the Company’s commercial, financial, and platform priorities, with stronger Aquadex performance, continued pediatric momentum, and further expansion of its broader cardiorenal strategy. “Q1 showed that the strategic reset we made in 2025 is beginning to translate into a more focused and commercially disciplined company,” said John Erb, Chairman and Chief Executive Officer of Nuwellis. “We are concentrating our resources around the areas where Nuwellis has clear clinical relevance, existing customer traction, and a differentiated path to growth, while maintaining the financial discipline required to execute. Aquadex gives us the foundation, pediatrics gives us a distinct growth category, and Rendiatech expands our ability to think more broadly across the cardiorenal continuum.” First Quarter 2026 Financial Results Revenue for the first quarter of 2026 was $2.4 million, compared to $1.9 million in the prior-year quarter, a 26% increase over the prior year period. Revenue growth in the first quarter was driven by continued expansion across all core categories, including Pediatric, Adult Heart Failure, and Critical Care, along with growth in both system placements and utilization of Aquadex therapy. Gross margin for the first quarter of 2026 was 70.1%, a 14% increase to the prior-year quarter. The gross margin improvement reflects improved pricing and product mix and switching to contract manufacturing. Operating expenses for the first quarter of 2026 were approximately $6.0 million, compared to approximately $4.1 million in the prior-year quarter. The increase is driven by increased sales headcount and compensation associated with increased sales. Net loss attributable to common shareholders for the first quarter of 2026 was approximately $4.3 million. On March 31, 2026, the Company had no debt and cash, cash equivalents, and restricted cash of approximately $2.2 million. Webcast and Conference Call Information The Company will host a conference call and webcast at 9:00 AM ET today to discuss its financial results and provide an update on the Company's performance. To access the live webcast, please visit the Investors page of the Nuwellis website at https://ir.nuwellis.com. Alternatively, you may access the live conference call by dialing 1-800-274-8461 (U.S.) or 1-203-518-9814 (international) and using the conference ID: NUWEQ1. An audio archive of the webcast will be available following the call on the Investors page. For more information, visit www.nuwellis.com. About Nuwellis Nuwellis, Inc. (Nasdaq: NUWE) is a medical technology company committed to delivering solutions for patients with cardiorenal conditions. The Company develops solutions designed to support patient care through monitoring, therapy, and data-informed clinical decision-making across acute and chronic care settings. Nuwellis’ portfolio includes commercially available and development-stage technologies addressing complex cardiorenal conditions, with a focus on safety, precision, and scalability across patient populations. For more information, visit www.nuwellis.com. Forward-Looking Statements Certain statements in this release may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including without limitation, statements regarding the new market opportunities and anticipated growth in 2026 and beyond. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this release, including, without limitation, those risks associated with our ability to execute on our commercialization strategy, the possibility that we may be unable to raise sufficient funds necessary for our anticipated operations, our post-market clinical data collection activities, benefits of our products to patients, our expectations with respect to product development and commercialization efforts, our ability to increase market and physician acceptance of our products, potentially competitive product offerings, intellectual property protection, our ability to integrate acquired businesses, our expectations regarding anticipated synergies with and benefits from acquired businesses, and other risks and uncertainties described in our filings with the SEC. Forward-looking statements speak only as of the date when made. Nuwellis does not assume any obligation to publicly update or revise any forward-looking statements, whether due to new information, future events or otherwise. For further information, please contact: Investor Relations: [email protected] Media Contact: CORE PR [email protected] Supplemental cash flow information
Investor releaseQuarter not tagged2026-05-12Nuwellis (NUWE) Q1 2026 Earnings Transcript
Motley Fool
Nuwellis (NUWE) Q1 2026 Earnings Transcript
Image source: The Motley Fool. Tuesday, May 12, 2026 at 9 a.m. ET Chairman of the Board — John L. Erb Chief Executive Officer — Leah McMullen Chief Financial Officer — Carisa Schultz Need a quote from a Motley Fool analyst? Email [email protected] 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 Nu…Read full documentShow less
Image source: The Motley Fool. Tuesday, May 12, 2026 at 9 a.m. ET Chairman of the Board — John L. Erb Chief Executive Officer — Leah McMullen Chief Financial Officer — Carisa Schultz Need a quote from a Motley Fool analyst? Email [email protected] 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. 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This article is a transcript of this conference call produced for The Motley Fool. While we strive for our Foolish Best, there may be errors, omissions, or inaccuracies in this transcript. As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. Nuwellis (NUWE) Q1 2026 Earnings Transcript was originally published by The Motley Fool
TranscriptFY2026 Q12026-05-12FY2026 Q1 earnings call transcript
Earnings source - 27 paragraphs
FY2026 Q1 earnings call transcript
I would now like to turn the conference over to Leah McMullen, Director of Communications. Please go ahead.
Thank you, operator. Thank you for joining today's conference call to discuss Nuwellis' corporate developments and financial results for the Q1 ended March 31, 2026. In addition to myself, with us today are John Erb, Nuwellis' Chairman of the Board and CEO, and our CFO, John Erb. At 8:00 A.M. Eastern Time today, Nuwellis released financial results for the Q1, 2026. If you have not received Nuwellis' earnings release, please visit the investor's 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 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-K. With that, I would now like to turn the call over to John.
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 call, 2025 was a year of structural change and deliberate repositioning for Nuwellis. 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 Q1 of 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 Nuwellis can create the greatest value. First, we continued to strengthen the foundation for execution. During the quarter, we appointed Carisa Schultz as Chief Financial Officer. Carisa brings deep public company healthcare 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. We strengthened the board with the appointment of Martin Emerson and the reappointment of David A. 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 Q1 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 to contract manufacturing at KDI. For us, the meaning behind this result is important.
They demonstrate that 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 Q4 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 Dr. Stuart Goldstein as Director of Clinical Strategy. Dr. 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 critical ill patients.
This expertise strengthens our clinical roadmap 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 one of the clearest growth strategies for Nuwellis. Pediatrics now represents approximately 50% of total U.S. revenue, and our pediatric footprint expanded to 47 centers nationwide, including six of the top children's hospitals as ranked by U.S. News & World Report. This growth reflects increasing Aquadex utilization in leading pediatric centers and reinforces the clinical relevance of precision fluid removal in a high acuity patient population. Importantly, our future pediatric innovation is being built into a category. 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 Vivian, 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 Nuwellis a clear area of differentiation, a strong clinical foothold, and a focused path for future innovation. Taken together, the Q1 demonstrates meaningful progress against the strategy we outlined coming into 2026. We 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 Nuwellis. With that, I will turn the call over to Carisa for a detailed review of our financial results.
Thank you, John, and good morning. I will review our Q1 financial performance and balance sheet position. Revenue for the Q1 of 2026 was $2.4 million compared to $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. 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 Q1 of 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 Q1 of 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 Q1 of 2026 was approximately $4.3 million. As of March 31st, 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 enhance 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.
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 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.
Thank you. If you'd like to ask a question, press star one on your keypad. To leave the queue at any time, press star two. Once again, that is star and one to ask a question. We'll take our first question from Nicholas Sherwood with Maxim Group. Please go ahead. Your line is open.
Hi. Thank you for taking my questions. You know, my first question is looking at the new, you know, commercial coverage with the South Texas territory. Can you kinda talk about how, you know, your sales team is building out relationships in that territory and, you know, outside of that territory, you know, what other regions are you kinda targeting for expansion?
Sure. Well, we're excited about that new territory 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 one 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. In doing that, we had a rep in the larger Texas-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. It really positive from the standpoint that it wasn't 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've added some new large pediatric accounts like Children's Hospital of Philadelphia, it's been a focus and an important growth area for us. 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. Those are kind of our focused areas.
Okay, perfect. I really appreciate that detail. Can you kinda just give me any more details you have on the integration with Rendiatech and, you know, how you've been able to present, you know, some of those offerings to your current customer base?
Actually have not introduced Rendiatech to the U.S. market yet. Rendiatech had 2 products. One, which they have marketed, before they went bankrupt, in the U.S. 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. That was really the target product that we saw great value in acquiring Rendiatech. We have just completed that acquisition, brought the inventory that they had back into the U.S. from Israel. It was an Israel company. We are now in development on developing that more valuable product that was really the target of the acquisition. That will not only in critical care, it's really important that they measure fluids in and fluids out.
One thing we do with Aquadex is obviously take fluid out, they're also measuring urine output. They take urine sample, send it to the lab, get a lab report back that gives them 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 that at the bedside, they get an immediate reading of those analytes or electrolyte balances in the urine. It's gonna be highly differentiated from anything that's on the market today, we will introduce that product to the U.S. market in 2027.
Okay. How many Aquadex units were you able to sell in the Q1?
15.
Okay. All right. Well, those are all my questions. Thank you for providing all that detail. I'll return to the queue.
Thank you. We have no further questions in the queue at this time. I'll turn the program back to John for some closing remarks.
Thank you. We are encouraged by the progress made in the Q1 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 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. We look forward to updating you on our progress in the quarters ahead. Thank you again for joining us today. Goodbye.
That brings us to the end of today's meeting. We appreciate your time and participation. You may now disconnect. Thank you.
Investor releaseQuarter not tagged2026-05-05Nuwellis, Inc. To Announce First Quarter 2026 Financial Results on May 12, 2026
GlobeNewswire
Nuwellis, Inc. To Announce First Quarter 2026 Financial Results on May 12, 2026
MINNEAPOLIS, May 05, 2026 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company committed to delivering solutions for patients with cardiorenal conditions, announces it will report its financial results for the first quarter ended March 31, 2026 premarket on Tuesday, May 12, 2026. The Company will subsequently host a conference call and webcast at 9:00 AM ET on May 12, 2026 to discuss its financial results and provide an update on the Company's performance. To access the live webcast, please visit the Investors page of the Nuwellis website at https://ir.nuwellis.com or access here. Alternatively, you may listen to the live conference call by dialing 1-800-274-8461 (U.S.) or 1-203-518-9814 (international) and using the conference ID: NUWEQ1. An audio archive of the webcast will be available following the call on the Investors page. For more information, visit www.nuwellis.com. About Nuwellis Nuwellis, Inc. (Nasdaq: NUWE) is a medical technology company committed to delivering solutions for patients with cardiorenal conditions. The Company develops solutions designed to support patient care through monitoring, therapy, and data-informed clinical decision-making across acute and chronic care settings. Nuwellis’ portfolio includes commercially available and development-stage technologies addressing complex cardiorenal conditions, with a focus on safety, precision, and scalability across patient populations. For more information, visit www.nuwellis.com. Forward-Looking Statements Certain statements in this release may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including without limitation, statements regarding the new market opportunities and anticipated growth in 2026 and beyond. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this release, including, without limitation, those risks associated with our ability to execute on our commercialization strategy, the possibility that we may be unable to raise sufficient funds necessary for our anticipated operations, our post-market clinical data collection a…Read full documentShow less
MINNEAPOLIS, May 05, 2026 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company committed to delivering solutions for patients with cardiorenal conditions, announces it will report its financial results for the first quarter ended March 31, 2026 premarket on Tuesday, May 12, 2026. The Company will subsequently host a conference call and webcast at 9:00 AM ET on May 12, 2026 to discuss its financial results and provide an update on the Company's performance. To access the live webcast, please visit the Investors page of the Nuwellis website at https://ir.nuwellis.com or access here. Alternatively, you may listen to the live conference call by dialing 1-800-274-8461 (U.S.) or 1-203-518-9814 (international) and using the conference ID: NUWEQ1. An audio archive of the webcast will be available following the call on the Investors page. For more information, visit www.nuwellis.com. About Nuwellis Nuwellis, Inc. (Nasdaq: NUWE) is a medical technology company committed to delivering solutions for patients with cardiorenal conditions. The Company develops solutions designed to support patient care through monitoring, therapy, and data-informed clinical decision-making across acute and chronic care settings. Nuwellis’ portfolio includes commercially available and development-stage technologies addressing complex cardiorenal conditions, with a focus on safety, precision, and scalability across patient populations. For more information, visit www.nuwellis.com. Forward-Looking Statements Certain statements in this release may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including without limitation, statements regarding the new market opportunities and anticipated growth in 2026 and beyond. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this release, including, without limitation, those risks associated with our ability to execute on our commercialization strategy, the possibility that we may be unable to raise sufficient funds necessary for our anticipated operations, our post-market clinical data collection activities, benefits of our products to patients, our expectations with respect to product development and commercialization efforts, our ability to increase market and physician acceptance of our products, potentially competitive product offerings, intellectual property protection, our ability to integrate acquired businesses, our expectations regarding anticipated synergies with and benefits from acquired businesses, and other risks and uncertainties described in our filings with the SEC. Forward-looking statements speak only as of the date when made. Nuwellis does not assume any obligation to publicly update or revise any forward-looking statements, whether due to new information, future events or otherwise. For further information, please contact: Investor Relations: [email protected] Media Contact: CORE PR [email protected]
Investor releaseQuarter not tagged2026-03-10Nuwellis, Inc. Announces Fourth Quarter and Full Year 2025 Financial Results
GlobeNewswire
Nuwellis, Inc. Announces Fourth Quarter and Full Year 2025 Financial Results
MINNEAPOLIS, March 10, 2026 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company committed to delivering solutions for patients with cardiorenal conditions, today reported financial results for the fourth quarter and full year ended December 31, 2025. Fourth Quarter and Recent Highlights: Fourth quarter revenue of $2.4 million, a 4% increase compared to the prior-year quarter and 9% increase sequentially. 208% increase in U.S. console sales in Q4 versus prior year quarter. Heart Failure revenue increased 48% and Pediatrics increased 16% year-over-year in Q4. Gross margin of 68.2% in Q4, compared to 58.4% in the prior-year quarter. Closed a $5.0 million private placement and warrant inducement transaction in January 2026, strengthening the Company's capital position. Appointed Carisa Schultz as Chief Financial Officer, effective February 2, 2026. Executed a definitive stock purchase agreement to acquire Rendiatech, expanding the Company's cardiorenal portfolio. “2025 was a year of structural change and strategic re-focus for Nuwellis,” said John Erb, Chief Executive Officer of Nuwellis. “While full year revenue declined compared to 2024, fourth quarter results reflected stronger utilization trends and meaningful gross margin expansion. Throughout the year, we prioritized operational discipline, refined our commercial focus around the cardiorenal continuum, and strengthened the underlying foundation of the business.” “Additionally, we are entering 2026 with new momentum,” Mr. Erb added, “including the execution of our agreement to acquire Rendiatech and the pending expansion of our portfolio, the appointment of a new Chief Financial Officer, and additional capital to support operations. As we look ahead, we remain focused on integrating the Rendiatech acquisition, progressing development of Vivian, our novel pediatric solution supported by NIH grant funding, and driving more consistent commercial execution and deeper utilization within targeted accounts.” Fourth Quarter 2025 Financial Results Revenue for the fourth quarter of 2025 was $2.4 million, a 4% increase compared to the prior-year quarter and a 9% increase sequentially. The year-over-year increase was attributable to a 208% increase in U.S. console sales (8 units vs. 3), an 11% circuit average selling price increase, and a non-recurring 59% increase in international sales, re…Read full documentShow less
MINNEAPOLIS, March 10, 2026 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company committed to delivering solutions for patients with cardiorenal conditions, today reported financial results for the fourth quarter and full year ended December 31, 2025. Fourth Quarter and Recent Highlights: Fourth quarter revenue of $2.4 million, a 4% increase compared to the prior-year quarter and 9% increase sequentially. 208% increase in U.S. console sales in Q4 versus prior year quarter. Heart Failure revenue increased 48% and Pediatrics increased 16% year-over-year in Q4. Gross margin of 68.2% in Q4, compared to 58.4% in the prior-year quarter. Closed a $5.0 million private placement and warrant inducement transaction in January 2026, strengthening the Company's capital position. Appointed Carisa Schultz as Chief Financial Officer, effective February 2, 2026. Executed a definitive stock purchase agreement to acquire Rendiatech, expanding the Company's cardiorenal portfolio. “2025 was a year of structural change and strategic re-focus for Nuwellis,” said John Erb, Chief Executive Officer of Nuwellis. “While full year revenue declined compared to 2024, fourth quarter results reflected stronger utilization trends and meaningful gross margin expansion. Throughout the year, we prioritized operational discipline, refined our commercial focus around the cardiorenal continuum, and strengthened the underlying foundation of the business.” “Additionally, we are entering 2026 with new momentum,” Mr. Erb added, “including the execution of our agreement to acquire Rendiatech and the pending expansion of our portfolio, the appointment of a new Chief Financial Officer, and additional capital to support operations. As we look ahead, we remain focused on integrating the Rendiatech acquisition, progressing development of Vivian, our novel pediatric solution supported by NIH grant funding, and driving more consistent commercial execution and deeper utilization within targeted accounts.” Fourth Quarter 2025 Financial Results Revenue for the fourth quarter of 2025 was $2.4 million, a 4% increase compared to the prior-year quarter and a 9% increase sequentially. The year-over-year increase was attributable to a 208% increase in U.S. console sales (8 units vs. 3), an 11% circuit average selling price increase, and a non-recurring 59% increase in international sales, reflecting customer last-time buys. Growth in Heart Failure and Pediatrics was partially offset by lower Critical Care revenue compared to the prior-year quarter. Gross margin for the fourth quarter of 2025 was 68.2%, compared to 58.4% in the prior-year quarter. The gross margin improvement reflects improved pricing and product mix, partially offset by unfavorable manufacturing variances. Operating expenses for the fourth quarter of 2025 were approximately $4.1 million, compared to approximately $3.7 million in the prior-year quarter. Operating loss for the fourth quarter of 2025 was approximately $2.4 million, flat with the prior-year quarter. Net loss attributable to common shareholders for the fourth quarter of 2025 was approximately $2.4 million. Full Year 2025 Financial Results Revenue for the full year ended December 31, 2025, was $8.3 million, a 5% decrease compared to the prior year. Heart Failure revenue increased 8% year-over-year, and Pediatrics increased 14%, while Critical Care declined 19%. Gross margin as a percent of revenue for the full year was 62.0%, compared to 64.9% in the prior year. Operating expenses for the full year were $16.2 million, $0.4 million lower than the prior year. Net loss attributable to common shareholders for the full year was $17.5 million, which includes a $6.4 million non-cash warrant valuation expense and approximately $0.3 million in executive severance expense. On December 31, 2025, the Company had no debt and cash, cash equivalents and restricted cash of approximately $1.2 million. Webcast and Conference Call Information The Company will host a conference call and webcast at 9:00 AM ET today to discuss its financial results and provide an update on the Company's performance. To access the live webcast, please visit the Investors page of the Nuwellis website at https://ir.nuwellis.com. Alternatively, you may access the live conference call by dialing 1-800-343-4885 (U.S.) or 1-203-518-9851 (international) and using the conference ID: NUWEQ4. An audio archive of the webcast will be available following the call on the Investors page. For more information, visit www.nuwellis.com. About Nuwellis Nuwellis, Inc. (Nasdaq: NUWE) is a medical technology company advancing precision fluid management technologies across the cardiorenal continuum. The Company develops solutions designed to support patient care through monitoring, therapy, and data-informed clinical decision-making across acute and chronic care settings. Nuwellis’ portfolio includes commercially available and development-stage technologies addressing complex cardiorenal conditions, with a focus on safety, precision, and scalability across patient populations. About the Aquadex SmartFlow® System The Aquadex SmartFlow system delivers clinically proven therapy using a simple, flexible and smart method of removing excess fluid from patients suffering from hypervolemia (fluid overload). The Aquadex SmartFlow system is indicated for temporary (up to 8 hours) or extended (longer than 8 hours in patients who require hospitalization) use in adult and pediatric patients weighing 20 kg or more whose fluid overload is unresponsive to medical management, including diuretics. All treatments must be administered by a health care provider, within an outpatient or inpatient clinical setting, under physician prescription, both having received training in extracorporeal therapies. Forward-Looking Statements Certain statements in this release may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including without limitation, statements regarding the new market opportunities and anticipated growth in 2026 and beyond. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this release, including, without limitation, those risks associated with our ability to execute on our commercialization strategy, the possibility that we may be unable to raise sufficient funds necessary for our anticipated operations, our post-market clinical data collection activities, benefits of our products to patients, our expectations with respect to product development and commercialization efforts, our ability to increase market and physician acceptance of our products, potentially competitive product offerings, intellectual property protection, our ability to integrate acquired businesses, our expectations regarding anticipated synergies with and benefits from acquired businesses, and other risks and uncertainties described in our filings with the SEC. Forward-looking statements speak only as of the date when made. Nuwellis does not assume any obligation to publicly update or revise any forward-looking statements, whether due to new information, future events or otherwise. For further information, please contact: Investor Relations: [email protected] Media Contact: Leah McMullen Director of Communications [email protected]
TranscriptFY2025 Q42026-03-10FY2025 Q4 earnings call transcript
Earnings source - 13 paragraphs
FY2025 Q4 earnings call transcript
Thank you for your continued patience. Your meeting will begin shortly. If you need assistance at any time, please press 0, and a member of our team will be happy to help you. Hello, and welcome, everyone, to Nuwellis, Inc.'s fourth quarter 2025 earnings conference call. At this time, all participants are in a listen-only mode. Later, you will have the opportunity to ask questions during the question-and-answer session. To register to ask a question at any time, please press. Please note this call is being recorded. We are standing by if you should need any assistance. It is now my pleasure to turn the meeting over to Leah McMullen, Director of Communications. Please go ahead.
Thank you, Operator. And thank you all for joining today's conference call to discuss Nuwellis, Inc.'s corporate developments and financial results for the fourth quarter and full year as of December 31, 2025. In addition to myself, with us today are John L. Erb, Nuwellis, Inc.'s Chairman of the Board and CEO, and our newly appointed CFO, Carissa Schultz. At 8:00 a.m. Eastern Time today, Nuwellis, Inc. released financial results for the fourth quarter and full year 2025. If you have not received Nuwellis, Inc.'s earnings, please visit the investor page on the company's website. During the 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 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.
Thank you, Leah, and good morning, everyone. I would like to begin by stepping back from the quarter and reflecting on the year as a whole. 2025 was not a continuation year for Nuwellis, Inc. It was a year of structural change and deliberate repositioning. While full-year revenue declined 5% compared to 2024, the defining characteristic of 2025 was not top-line variability. It was the strengthening of the company's operating foundation and the clarification of our long-term strategy. Throughout the year, we made intentional decisions to simplify the business, improve operational discipline, and concentrate resources in areas where clinical adoption and economic value are most aligned. A central initiative was the transition of manufacturing to KDI Precision Manufacturing. This was a significant operational undertaking requiring coordination across supply chain, quality systems, and production leadership. The objective was not short-term cost reduction. It was long-term reliability, scalable manufacturing alignment, and improved structural margin performance. As we move forward, this transition enhances operational predictability and strengthens our supply chain foundation. We also evaluated and refined our international commercial strategy. Portions of that business generated inconsistent returns and required disproportionate resources. During the year, we reduced exposure in certain markets and redirected focus towards geographies where clinical demand and commercial conversion are more predictable. That decision reflects discipline and prioritization. Over the course of the year, we also maintained access to capital through financing transactions that support operational continuity during a period of transition. We ended the year with approximately $1.2 million in cash and no outstanding debt. Liquidity management and disciplined capital allocation remain central priorities as we execute our strategy. Beyond operational and financial refinements, 2025 marked a critical clarification of strategic positioning. Historically, Nuwellis, Inc. has been described as a fluid management company. Over the course of the year, we sharpened our focus around the cardiorenal continuum. Our technology serves patients whose cardiac and renal conditions are tightly interrelated and where precision volume management directly influences outcomes across both organ systems. This alignment reflects where we see the strongest clinical traction and the most durable long-term opportunity. Growth in heart failure and pediatrics reinforces that our value proposition is most compelling within complex cardiorenal populations. Within this strategy, our pediatric program represents a meaningful extension of our platform. During the year, we expanded intellectual property supporting our pediatric device development and were the beneficiary of a National Institutes of Health grant to advance this program. The combination of strengthened IP protection and nondilutive NIH funding provides external validation of the clinical importance of this work and reinforces the long-term defensibility of our innovation within the cardiorenal continuum. Turning to the fourth quarter. Revenue was $2.4 million, an increase of 4% compared to the prior-year quarter and 9% sequentially. U.S. console sales increased 208%, reflecting stronger activity within targeted accounts. Gross margin expanded to 68.2% in the quarter compared to 58.4% in the prior-year period. Full-year operating expenses were $400,000 lower than the prior year, reflecting tighter expense management, improved forecasting discipline, and more select commercial deployment. These results reinforce a core operating principle. Where clinical adoption is established, utilization expands. Our strategy is not broad-based expansion across all possible customer opportunities. It is disciplined concentration in accounts and patient populations where clinical pull and economic value are demonstrable. Taken together, 2025 was a year of operational strengthening, portfolio alignment, disciplined capital management, and strategic clarity. The organization enters 2026 more focused, more disciplined, and structurally stronger than it was a year ago. As we begin 2026, we have further strengthened our financial leadership. Earlier this year, we welcomed Carissa Schultz as Chief Financial Officer. Carissa brings deep experience in medical technology, finance, and operational leadership. Her focus on forecasting precision, capital allocation discipline, and financial transparency supports the operating model we have refined over the past year. With that, I will turn the call over to Carissa for a detailed review of our results.
Thank you, John, and good morning. I will begin with fourth quarter performance before turning to full-year results and our balance sheet position. Revenue for the fourth quarter was $2.4 million, representing a 4% increase compared to the prior-year quarter and a 9% increase sequentially. The year-over-year improvement was driven by a 208% increase in U.S. console sales, with eight units sold compared to three in the prior-year period, and an 11% circuit average selling price increase. International sales increased 59% year over year, largely as a result of last-time buys from distributors whose territories we were exiting. These gains were partially offset by a 24% decline in critical care revenue. Sequentially, revenue growth was driven primarily by increased cath utilization, partially offset by lower console sales compared to the third quarter. Gross margin for the fourth quarter was 68.2%, an improvement of 9.9 percentage points compared to the prior-year quarter. Operating expenses for the quarter were $4.1 million, representing a $400,000 increase compared to the prior-year quarter. The year-over-year increase reflects higher professional services, recruiting activity, and targeted development initiatives. Operating loss for the fourth quarter was $2.4 million, flat with the prior-year quarter. Net loss attributable to common shareholders for the quarter was $2.4 million. Turning to full-year results. Revenue for 2025 was $8.3 million, a 5% decrease compared to the prior year. The year-over-year decline reflects lower consumables utilization, lower U.S. console average selling prices, reduced international contribution following strategic rationalization, and prior-year SeaStar sales prior to that agreement's termination. Heart failure and pediatrics grew 814% year over year, respectively, partially offset by a 19% decline in critical care. Full-year gross margin was 62%, three percentage points higher than the prior year. Operating expenses for the full year were $16.2 million, slightly lower than the prior year, reflecting improved expense discipline and forecasting rigor. Net loss attributable to common shareholders for the full year was $17.5 million, which includes a $6.4 million noncash warrant valuation expense and approximately $300,000 in executive severance expense. From a liquidity standpoint, full-year cash utilization was approximately $10.9 million. We ended the year with approximately $1.2 million in cash and no outstanding debt. During 2025, we raised approximately $7 million in net proceeds through financing activities, supporting operations during a period of structural transition. As we move into 2026, our financial priorities focus on gross margin consistency, disciplined expense management, enhanced visibility into commercial conversion, and prudent capital deployment. This concludes our prepared remarks. Operator, we would now like to open the call to questions.
Thank you. And if you would like to ask a question, please press 1 on your keypad. To leave the queue at any time, press 2. Once again, that is star and 1 to ask a question. And once again, that is star and 1 if you would like to join the queue. We are showing one question comes from the line of Anthony V. Vendetti with Maxim Group. Please go ahead. Your line is open.
Thank you. Yeah. So I wanted to, John, just talk about, you know, you said you had some operational changes this year and refocus of the business. Can you talk a little bit about, you know, where the salesforce and where your main focus is now versus where it was maybe a couple years ago? And then also, second part of the question is going to be on the Rendytek—if I am pronouncing it correctly—the acquisition, how those products are going to be incorporated into your current product portfolio.
Thanks. Sure, Anthony. Well, let me start off and say that in 2025, we reinforced our direct sales team. We had declined at the beginning of the year by several account territories, and we brought some folks on board, both account managers and clinical specialists, to bring us back up to the budgeted amount, which we saw that impact in the second half of the year. We are really beginning to see much greater growth in 2026. You know, at the beginning of the year this year, we were recovering from a product recall and from some quality issues that we really needed to redirect the business, and that was the primary reason we ended up going to contract manufacturing with KDI Precision Manufacturing. That has really brought stability to our supply and product quality that we are very pleased with. We also looked hard at expenses, looking at our cash burn and how we could reduce it. Internationally, particularly in the European Union, we have lost money, continuing year after year. We made the decision that we would exit the EU and basically successfully pulled out of that and reduced our cash burn. We also looked hard at an expensive clinical trial that was in place with the REVERSE-HF clinical trial. It was budgeted to spend an additional $3 million to complete the trial, take a couple of years, and the benefit of a very successful trial was still going to be two or three years down the road. So, again, looking at cash management, we made the decision to terminate that trial. We are actively now working with the principal investigators with the data that was completed to put together a publication with some positive results. So a lot of activity around refocusing the business. You know, the NIH grant that we received for pediatrics development of the renal replacement therapy devices is very positive for us. And we continue to grow in the pediatrics area. So I would say a bit of a refocus, not so much away from heart failure, but in addition to heart failure, really focusing on the pediatric nephrologist and the benefit that the Aquadex product was bringing to the pediatric marketplace. Let me see what else. I think that covered your main question. The second part of your question regarding Aurinia Tech, the value there is in critical care. You know, as we remove fluid after a patient has come off of the heart-lung machine, very gently and very carefully, which is what the heart needs, what the kidneys need, you know, after extubation from the heart-lung machine, they also measure all the fluid off, and renal output or urine output is another critical measure. What Rendiatek has is a technology basically that helps measure that renal or urine output in the ICU. What is exciting about that product is the opportunity that we are already working on to enhance the capability of not just measuring flow and measuring quantity, but also measuring the analytes or electrolytes that are in the urine. That is a key biomarker for kidney health, acute kidney injury. About 60% of patients in critical care that come off of the heart-lung machine do experience acute kidney injury. Rather than that urine being sent to the lab and waiting for lab results to come back to look at the potassium, sodium, oxygen level in the urine, they can get this bedside. So that was really the primary reason we were interested in the Rendiatek acquisition, that very differentiated capability that it will bring to the ICU.
Okay, John. That is helpful. Maybe since it looked like fourth quarter sales were driven more by utilization within existing accounts versus new accounts, so RendiA Tech—is the focus going to be to try to get more utilization out of the current accounts as we begin this year and try to get Rendia Tech into all those accounts? And then where is your salesforce or territory manager number currently, and is that expected to be constant for this year, or do you expect to add as you move through the year?
Thanks. Sure. Well, let me start with the second part of that question. Right now, our total sales team is 24 individuals between account managers and clinical specialists. And that really brings it up to what was budgeted for a headcount in 2025, and I anticipate keeping it at that number through 2026. We have a lot of opportunity in existing accounts, and this is the first part of your question. We will focus on increased utilization. The sales team is primarily focused on critical care. We see critical care ICU—the cardiorenal issue in these patients that have gone through cardiac surgery—as a really big opportunity for the company. So that is a primary focus. Of course, we will continue to support our heart failure customers and patients and work closely in nephrology in the pediatric area as the product sees. But I would say that the majority of the focus is to grow the critical care business in existing accounts. A lot of these accounts are already heart failure accounts that we are expanding into critical care, and we see the Rendiatek acquisition as an opportunity to enhance utilization within those accounts.
Okay. Thanks so much. That is very helpful. I will jump back in the queue.
Thank you. And once again, if you would like to ask a question, please press 1 on your keypad now. We will pause for another moment. And once more, that is star and 1 if you would like to join the queue. Thank you. And at this time, there are no further questions in queue. I will now turn the meeting back to management for closing remarks.
Thank you. 2025 marked a necessary inflection point for the company. We made decisive adjustments to strengthen the operating model and clarify our strategic focus. As we enter 2026, we are doing so with renewed momentum, including the execution of our agreement to acquire Rendiatek and the planned expansion of our portfolio, the appointment of Ms. Schultz as our Chief Financial Officer, and additional capital to support operations. Entering this next phase, we are more disciplined, more deliberate, and aligned around the cardiorenal opportunity that will define our next phase of growth. The structural work completed in 2025 positions us to shift from refinement to execution in 2026. Our objective in 2026 is to translate strategic clarity into more predictable commercial performance. We will continue executing with discipline, concentrating resources in cardiorenal populations where clinical adoption and utilization are strongest, and driving deeper penetration within active accounts. We are actively integrating our recent acquisition of RoentDeck and plan to relaunch the Clarity product midyear. We also continue progressing development of Vivien, our novel pediatric solution supported by the NIH grant funding. We will maintain financial rigor, strengthen margin consistency, and prioritize capital efficiency as we scale. We appreciate the continued support of our shareholders, the drive and focus of our team, and look forward to updating you on progress throughout the year. Thank you, and goodbye.
Thank you. This brings us to the end of today's meeting. We appreciate your time and participation. You may now disconnect.

