Latest news with #Nuwellis
Yahoo
4 days ago
- Business
- Yahoo
Nuwellis Inc (NUWE) Q2 2025 Earnings Call Highlights: Strategic Shifts Amid Revenue Challenges
Release Date: August 14, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Positive Points Nuwellis Inc (NASDAQ:NUWE) successfully resolved a temporary backorder issue with their sterilization vendor, which had impacted revenue. The pediatrics business segment showed strong performance with a 23% increase in revenue compared to the previous year. The company is transitioning its manufacturing to KDI precision manufacturing, expected to result in operational efficiencies and cost savings. Nuwellis Inc (NASDAQ:NUWE) has increased reimbursement rates for outpatient heart failure treatment, which is expected to drive growth in this segment. The company remains debt-free and recently raised $5 million in capital, strengthening its financial position. Negative Points Total revenue for the second quarter was $1.7 million, a 21% decline year-over-year. Heart failure and critical care revenue declined by 53% and 35% respectively, due to the temporary backorder. Gross margin decreased to 55.5% from 67.2% in the previous year, impacted by lower production volumes. Operating loss increased to $2.9 million compared to $2.3 million in the same quarter last year. Net loss attributable to common shareholders was $12.6 million, significantly higher than the $7.7 million loss in the previous year. Q & A Highlights Warning! GuruFocus has detected 2 Warning Signs with NUWE. Q: You mentioned the issue with the vendor regarding sterilization, which accounts for around $400,000 in revenue. When was it resolved, and will there be any impact in the current third quarter? A: It was resolved in the first week of July, and we are no longer in backorder. We are now building finished goods inventory rapidly to prepare for the transfer to KDI manufacturing. The issue is behind us, and the sterilization provider is fully operational. The impact was primarily in heart failure and cardiac surgery, as we prioritized inventory for pediatrics. (John Herb, CEO) Q: As the business evolves, where do you see the largest opportunity: pediatrics, critical care, or heart failure? A: We see growth opportunities in all three areas. Pediatrics continues to grow as more children's hospitals adopt Aquadex. In cardiac surgery, clinicians are using Aquadex to efficiently manage fluid post-surgery. The fastest-growing area is likely heart failure due to the outpatient opportunity, supported by increased reimbursement from $413 to $1639 per day for treatments in hospital outpatient clinics. (John Herb, CEO) Q: Can you elaborate on the strategic decisions made this quarter, such as the termination of the reverse HF clinical trial? A: We terminated the reverse HF clinical trial to reallocate approximately $4 million towards higher-impact growth areas. This decision was not related to device performance or patient safety concerns. We are focusing on cardiac surgery, pediatrics, and outpatient heart failure, where we see significant growth potential. (John Herb, CEO) Q: How did the temporary product backorder affect financial results for the quarter? A: The backorder primarily impacted heart failure and critical care revenues, which declined by 53% and 35%, respectively. However, pediatric revenues increased by 23% compared to the second quarter of 2024. The gross margin was affected, dropping to 55.5% from 67.2% due to lower production volumes. (Rob Scott, CFO) Q: What are the company's priorities moving forward? A: Our priorities include progressing towards being cash flow positive, achieving commercial targets in pediatrics and cardiac surgery, enhancing outpatient engagement with heart failure programs, completing our manufacturing transition, and increasing clinical awareness of Aquadex's role in fluid management. We aim to expand access to Aquadex and build a portfolio for fluid management across various care settings. (John Herb, CEO) For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Globe and Mail
05-08-2025
- Business
- Globe and Mail
Nuwellis Announces the First Successful Outpatient Application of the Aquadex Smartflow® System Under New CMS Code
MINNEAPOLIS, Aug. 05, 2025 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company dedicated to transforming fluid management, today announced that the first patients have been successfully treated with Aquadex ® ultrafiltration therapy in a hospital-based outpatient setting. This milestone reflects a major advancement in the company's mission to improve access to fluid management and support better care across the continuum. The treatments were performed at a leading healthcare institution in the southeastern United States using the same Aquadex SmartFlow ® system and clinical protocols trusted in inpatient environments. By enabling therapy in a hospital-based outpatient setting, Nuwellis is helping to reimagine how and where patients with fluid overload can be supported—offering a potential new model for earlier, more proactive care. 'For patients struggling with fluid overload, access to consistent, effective therapy can make a life-changing difference,' said John Erb, CEO of Nuwellis. 'This milestone represents more than just a shift in setting—it reflects our vision for expanding how care is delivered and making fluid management more flexible, scalable, and patient-centered.' In addition to the clinical benefits, hospitals may also realize significant economic advantages by transitioning appropriate therapies to outpatient care. With outpatient reimbursement increasing from approximately $413 to $1,639 per treatment day, this model offers a more sustainable path forward for health systems facing pressure to reduce readmissions while managing complex patients more effectively. The hospital-based outpatient setting provides an opportunity to treat patients using existing venous access and care teams, without requiring hospitalization. This approach may offer significant advantages to patients who are repeatedly admitted due to volume challenges, while also helping healthcare systems manage resources more efficiently. Nuwellis continues to work closely with providers to support hospital-based outpatient program development, including training, protocols, and workflow integration. The company sees this as a foundational step in building sustainable access to ultrafiltration therapy—and a key part of its long-term strategy to expand the impact of Aquadex. For more information, please visit and to learn more about the Company's reimbursement for outpatient, please visit the reimbursement page. About Nuwellis Nuwellis, Inc. (Nasdaq: NUWE) is a medical device company dedicated to transforming the lives of patients suffering from fluid overload through science, collaboration, and innovation. The company is focused on commercializing the Aquadex SmartFlow ® system for ultrafiltration therapy. Nuwellis is headquartered in Minneapolis, with a wholly owned subsidiary in Ireland. For more information visit or visit us on LinkedIn or X, formerly Twitter. 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 2025 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:
Yahoo
16-07-2025
- Business
- Yahoo
Nuwellis Secures New U.S. Patent, Strengthening Its Position as a Leader in Fluid Management Innovation
WHO WHAT WHERE WHEN WHY Nuwellis, Inc. Issuance of U.S. Patent No. 12,357,734 United States Patent and Trademark Office July 15, 2025 To protect innovations in blood filtering system design and methods that support safe and precise fluid removal during ultrafiltration July 15, 2025 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company focused on fluid management solutions, today announced the issuance by the U.S Patent and Trademark Office of U.S. Patent No. 12,357,734, titled 'Extracorporeal Blood Filtering Machine and Methods.' The patent was officially granted on July 15, 2025, further strengthening the company's growing intellectual property portfolio. The patent covers methods for improving the accuracy of fluid balance calculations by incorporating the density of replacement fluids and effluent—a known source of error in continuous renal replacement therapy (CRRT) systems that use weight-based measurements. While most systems assume a default fluid density of 1 g/mL, actual fluid densities vary. This discrepancy, if uncorrected, can lead to clinically relevant fluid balance errors. The patented approach enables CRRT systems to account for density—via user input, machine measurement, or derived data—resulting in more accurate volumetric flow tracking. The patent joins Nuwellis' robust and growing portfolio, of pending U.S. patents related to its proprietary system and methods. 'Expanding our intellectual property portfolio is a key part of our strategy,' said John Erb, Chief Executive Officer of Nuwellis. 'Each new patent reinforces our commitment to building long-term value through innovation that supports patients, clinicians, and our future growth.' This addition reflects Nuwellis' investment in protecting advancements in extracorporeal fluid management and reinforces its position in the evolving field of fluid management therapies. For more information, visit About Nuwellis Nuwellis, Inc. (Nasdaq: NUWE) is a medical device company dedicated to transforming the lives of patients suffering from fluid overload through science, collaboration, and innovation. The company is focused on commercializing the Aquadex SmartFlow® system for ultrafiltration therapy. Nuwellis is headquartered in Minneapolis, with a wholly owned subsidiary in Ireland. For more information visit or visit us on LinkedIn or X, formerly known as Twitter. 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 2025 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: Robert ScottChief Financial Officerir@ Media Contact: Leah McMullenDirector of in to access your portfolio
Yahoo
10-06-2025
- Business
- Yahoo
Nuwellis announces pricing of $4.3M underwritten public offering
Nuwellis (NUWE) announced the pricing of a public offering of 406,755 shares of its common stock, pre-funded warrants to purchase 14,085,998 shares of Common Stock, in each case with accompanying Series A Warrants to purchase up to 43,478,259 shares of Common Stock and Series B Warrants to purchase up to 14,492,753 shares of Common Stock. The public offering price per share of Common Stock and accompanying warrants is $0.30 per share and accompanying warrants, and the public offering price per pre-funded warrant and accompanying warrants is $0.2999 per pre-funded warrant and accompanying warrants. Nuwellis expects to use the net proceeds from the offering for working capital and general corporate purposes, including possible acquisition activity. Each pre-funded warrant has an exercise price of $0.0001 per pre-funded warrant, and is immediately exercisable until such pre-funded warrant is exercised in full. Each of the Series A Warrants and Series B Warrants has an exercise price of $0.30, and will be exercisable for a period of five years following the receipt of stockholder approval, as required by the applicable rules and regulations of Nasdaq. The Series A Warrants will contain a one-time reset of the exercise price in the event that the Company implements a reverse stock split to the greater of: 20% of the combined public offering price per share of Common Stock and accompanying warrants in this offering and the lowest daily volume weighted average price for the five trading days immediately following the date of the implementation of a reverse stock split. The Series B Warrants will include a zero cash exercise option allowing holders of a Series B Warrant the right to receive, without payment of any additional cash to the Company, an aggregate number of shares equal to the number of shares of Common Stock that would be issuable upon a cash exercise of such Series B Warrant. Ladenburg Thalmann & Co. Inc. is acting as sole book-running manager in connection with the offering. The offering is expected to close on or about June 10, 2025, subject to customary closing conditions. Easily unpack a company's performance with TipRanks' new KPI Data for smart investment decisions Receive undervalued, market resilient stocks right to your inbox with TipRanks' Smart Value Newsletter Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>> See the top stocks recommended by analysts >> Read More on NUWE: Disclaimer & DisclosureReport an Issue Nuwellis files to sell 5.39M shares of common stock, warrants Nuwellis Approves Reverse Stock Split at Meeting Nuwellis, Inc. Earnings Call: Balancing Growth and Challenges Nuwellis, Inc. Reports Modest Growth and Strategic Expansion Nuwellis price target lowered to $11 from $13 at Roth Capital
Associated Press
09-06-2025
- Business
- Associated Press
Nuwellis Announces Pricing of $4.3 Million Underwritten Public Offering
MINNEAPOLIS, June 09, 2025 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE) ('Nuwellis' or the 'Company'), a commercial-stage medical device company dedicated to transforming care for fluid overload patients, today announced the pricing of a public offering of 406,755 shares of its common stock ('Common Stock'), pre-funded warrants to purchase 14,085,998 shares of Common Stock, in each case with accompanying Series A Warrants to purchase up to 43,478,259 shares of Common Stock and Series B Warrants to purchase up to 14,492,753 shares of Common Stock. The public offering price per share of Common Stock and accompanying warrants is $0.30 per share and accompanying warrants, and the public offering price per pre-funded warrant and accompanying warrants is $0.2999 per pre-funded warrant and accompanying warrants. Nuwellis expects to use the net proceeds from the offering for working capital and general corporate purposes, including possible acquisition activity. Each pre-funded warrant has an exercise price of $0.0001 per pre-funded warrant, and is immediately exercisable until such pre-funded warrant is exercised in full. Each of the Series A Warrants and Series B Warrants has an exercise price of $0.30, and will be exercisable for a period of five years following the receipt of stockholder approval, as required by the applicable rules and regulations of Nasdaq. The Series A Warrants will contain a one-time reset of the exercise price in the event that the Company implements a reverse stock split to the greater of: (i) 20% of the combined public offering price per share of Common Stock and accompanying warrants in this offering and (ii) the lowest daily volume weighted average price for the five trading days immediately following the date of the implementation of a reverse stock split. The Series B Warrants will include a zero cash exercise option allowing holders of a Series B Warrant the right to receive, without payment of any additional cash to the Company, an aggregate number of shares equal to the number of shares of Common Stock that would be issuable upon a cash exercise of such Series B Warrant. Ladenburg Thalmann & Co. Inc. is acting as sole book-running manager in connection with the offering. The offering is expected to close on or about June 10, 2025, subject to customary closing conditions. The securities described above are being offered pursuant to a registration statement on Form S-1 (File No. 333-287663) that was declared effective by the U.S. Securities and Exchange Commission ('SEC'), on June 9, 2025. Electronic copies of the final prospectus supplement may be obtained, when available, on the SEC's website at or by contacting Ladenburg Thalmann & Co. Inc., Prospectus Department, 640 Fifth Avenue, 4th Floor, New York, New York 10019 or by email at [email protected]. This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor will there be any sales of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction. The offering is being made solely by means of a prospectus. A final prospectus relating to this offering will be filed by Nuwellis with the SEC. About Nuwellis Nuwellis, Inc. (Nasdaq: NUWE) is a commercial-stage medical device company focused on transforming the lives of patients with fluid overload through science, collaboration, and innovation. The company is focused on commercializing the Aquadex SmartFlow® system for ultrafiltration therapy. Nuwellis is headquartered in Minneapolis, with a wholly owned subsidiary in Ireland. For more information visit or visit us on LinkedIn or X. 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 receipt of stockholder approval to permit the exercise of the Series A Warrants and Series B Warrants, the satisfaction of customary closing conditions related to the offering, the expected closing date of the offering and the amount and expected use of the net proceeds from the offering. 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. Forward-looking statements are often identified by terms such as 'believe,' 'continue,' 'intends to,' 'expect,' 'will,' 'goal,' 'aim to' and similar expressions. Such forward-looking statements include, among others, statements regarding the Company's anticipated closing of the public offering. 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: INVESTORS: Robert Scott Chief Financial Officer, Nuwellis [email protected] MEDIA CONTACT: Leah McMullen Director of Communications, Nuwellis [email protected] Source: Nuwellis Inc.
