Annuncio • 12h
Nuwellis, Inc. has filed a Follow-on Equity Offering. Nuwellis, Inc. has filed a Follow-on Equity Offering.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 4,854,369
Price\Range: $1.03
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant
Securities Offered: 4,854,369
Security Name: Series C Common Warrants
Security Type: Equity Warrant
Securities Offered: 4,854,369
Security Name: Series D Common Warrants
Security Type: Equity Warrant
Securities Offered: 4,854,369 Annuncio • May 16
Nuwellis Inc Announces Successful Completion of Fda Pre-Submission 510(K) Meeting to Expand Aquadex Label Nuwellis, Inc. announced the successful completion of a recent pre-submission meeting with the U.S. Food and Drug Administration (FDA) regarding the proposed label expansion of the Aquadex SmartFlow System to support pediatric patients weighing 5 kg and above. The currently cleared indication is for patients weighing 20 kg and above. Over the past 10 years, multiple publications from pediatric centers have demonstrated the safe and effective use of Aquadex in patients weighing less than the currently indicated 20 kg. The repeated utilization in the 5-20 kg population and evidence has demonstrated the need for expanding the labeling to reflect its consistent use for these patients. The pre-submission meeting provided constructive feedback on the Company’s proposed regulatory strategy, including a pathway toward a 510(k) submission supported by targeted bench testing, toxicological assessments, and pediatric clinical evidence. The feedback provides important clarity as Nuwellis advances its regulatory and clinical plans in this high-need patient population. The Company anticipates submitting to the FDA by the end of 2026. The proposed label update is intended to address a significant unmet need in low-weight pediatric patients with fluid overload who require controlled ultrafiltration without the complexity of full renal replacement therapy. Annuncio • May 05
Nuwellis, Inc. to Report Q1, 2026 Results on May 12, 2026 Nuwellis, Inc. announced that they will report Q1, 2026 results Pre-Market on May 12, 2026 Annuncio • Apr 30
Nuwellis, Inc. Announces Receipt Of Notice Of Allowance For Dual Lumen Midline Catheter Technology Nuwellis, Inc. announced that the U.S. Patent and Trademark Office (USPTO) has issued a Notice of Allowance for a new patent covering its novel dual lumen midline catheter technology designed for use in ultrafiltration therapies. This next-generation catheter incorporates advanced design elements to optimize blood flow dynamics during therapy. The technology includes separate withdrawal and infusion lumens with pressure-balancing features that help maintain stable flow and reduce complications associated with fluid removal procedures. The catheter design is further enhanced by a segmented reinforcement structure that allows clinicians to customize catheter length at the bedside while preserving kink resistance and consistent flow performance. This improves ease of use across a wide range of patient anatomies and may reduce interruptions during therapy. Once the patent issues, the patented catheter technology is expected to complement Nuwellis’ existing product portfolio and support the company’s strategy to expand access to ultrafiltration therapy in both hospital and outpatient settings. Annuncio • Apr 23
Nuwellis, Inc. Announces Aquadex Software Update Nuwellis, Inc. announced a software update to its Aquadex SmartFlow ultrafiltration platform. The update is designed to improve usability, streamline clinical workflow, and enhance overall user experience. A key feature of the release is a more precise ultrafiltration adjustment capability, reducing the step size to 5 mL/hr from 10 mL/hr. This advancement is particularly important in pediatric care, where small-volume fluid shifts can have a significant clinical impact. The update also includes enhancements aimed at improving ease-of-use of the device and therapy visibility, particularly for nursing staff managing day-to-day treatment. Key updates include: Refined blood flow algorithm designed to reduce nuisance alarms and improve flow stability; Enhanced blood flow resistance graph to provide earlier indication of potential filter clotting; and Expanded hourly data log with additional therapy parameters to support clinical monitoring and documentation. The software update is available to existing customers at no cost and can be deployed through standard update processes with support from Nuwellis’ field and service teams. Annuncio • Apr 03
Nuwellis, Inc., Annual General Meeting, Apr 28, 2026 Nuwellis, Inc., Annual General Meeting, Apr 28, 2026. Annuncio • Mar 28
Nuwellis, Inc. Announces Board of Directors Changes, Effective March 26, 2026 On March 26, 2026, each of Mika Grasso (independent director) and Katharyn Field (independent director) resigned, effective immediately, from the Board of Directors of Nuwellis, Inc. Mr. Grasso resigned due to the matters set forth in his resignation letter, which details various disagreements with the Company, including the Company’s and its advisors’ alleged failure to timely provide him with certain information, such that he believes that he is no longer able to effectively fulfill his duties as a director. Ms. Field resigned due to the matters set forth in her resignation letter, which details various disagreements with the Company, including the Company’s and its advisors’ alleged failure to timely provide her with certain information, such that she believes that she is no longer able to effectively fulfill her duties as a director. As a result of these resignations, on March 27, 2026, the Board determined to decrease the size of the Board from seven (7) to five (5) members, effective immediately. Katharyn Field was appointed to the Nuwellis Board on January 21, 2026. Annuncio • Mar 17
Nuwellis, Inc. (NasdaqCM:NUWE) completed the acquisition of Rendiatech Ltd. Nuwellis, Inc. (NasdaqCM:NUWE) signed a non-binding letter of intent to acquire Rendiatech Ltd. on August 19, 2025. Nuwellis, Inc. entered into an Securities Purchase Agreement Rendiatech, Ltd to acquire Rendiatech Ltd. for $3.75 million on January 29, 2026. As consideration for the acquisition, the Nuwellis will pay $125,000 in cash at closing, issue 150,000 shares of Common Stock, and grant stock options for 30,000 additional shares. The Nuwellis will also pay $125,000 to the Sellers’ Representative by December 31, 2026, and $250,000 upon the earlier of the Commercial Regulatory Clearance Date or December 31, 2027. Additionally, the sellers will receive a 9% earn-out royalty on gross sales of “Clarity RMS” and “Clarity Prime” products, up to $2,000,000. As part of the proposed transaction, Nuwellis would add to its product portfolio Rendiatech’s Clarity RMS. The transaction is subject to final Board approval, consummation of due diligence investigation and certain closing conditions. The transaction has been approved by the boards of directors of both companies. The transaction is expected to be completed in the fourth quarter of 2025.
Phillip D. Torrence of Honigman LLP acted as legal advisor for NUWELLIS, INC. Einat Katzenell of Katzenell Dimant, Law Offices acted as legal advisor for sellers.
Nuwellis, Inc. (NasdaqCM:NUWE) completed the acquisition of Rendiatech Ltd. on March 17, 2026. Annuncio • Mar 06
Nuwellis, Inc. Appoints Stuart L. Goldstein as Director of Clinical Strategy Nuwellis, Inc. announced the appointment of Stuart L. Goldstein, MD, FASN as Director of Clinical Strategy. Dr. Goldstein is internationally recognized as a pioneer in pediatric nephrology and critical care medicine. He serves as Director of the Center for Acute Care Nephrology, holds the Clark D. West Endowed Chair in Pediatric Nephrology at Cincinnati Children's Hospital Medical Center, and is Professor of Pediatrics at the University of Cincinnati College of Medicine. His work has helped define the modern understanding of acute kidney injury (AKI), fluid overload, and the use of continuous renal replacement therapies in critically ill children. Dr. Goldstein’s research has been foundational in demonstrating the relationship between fluid overload and mortality in critically ill pediatric patients, including landmark studies through the Prospective Pediatric Continuous Renal Replacement Therapy Registry. His work has significantly shaped global standards for early identification and management of AKI and fluid balance in critically ill populations. As Director of Clinical Strategy, Dr. Goldstein will consult with and advise Nuwellis on clinical feedback, product development, pediatric innovation, evidence generation, and educational initiatives aligned with the company’s evolving cardiorenal focus. His expertise will directly support Nuwellis’ commitment to advancing precision fluid management solutions that address the critical interplay between the heart and kidneys across the continuum of care. Annuncio • Feb 27
Nuwellis Appoints David A. Mcdonald and Martin J. Emerson to Board of Directors, Effective February 24, 2026 Nuwellis, Inc. announced the appointment of David A. McDonald and Martin J. Emerson to its Board of Directors, effective February 24, 2026. The appointments strengthen the Company’s board with complementary expertise in public company leadership, capital markets, and medical device commercialization. Mr. Emerson currently serves as President and Chief Executive Officer of Monteris Medical. He previously served as President and Chief Executive Officer of Galil Medical, where he led the company to a successful acquisition by BTG plc. Prior to Galil, he served as President and Chief Executive Officer of American Medical Systems, a global urology and gynecology device company with over $500 million in annual revenue. Earlier in
his career, he held senior management roles at Boston Scientific Corporation and Baxter International. Mr. Emerson currently serves on the boards of Contraline and SubioMed and has previously served on several public and private company boards, including Wright Medical, Vascular Solutions, Tepha Medical and AdvaMed. He holds a Bachelor of Science in Accounting from Marquette University. Mr. McDonald serves as Vice Chairman Healthcare Investment Banking at Lake Street Capital Markets and brings more than 25 years of experience in healthcare capital markets and corporate development. He has held senior financial and business development leadership roles at SillaJen Biotherapeutics, Delcath Systems and AngioDynamics, where he raised nearly $200 million in capital and executed global partnerships and transactions. Earlier in his career, Mr. McDonald served as a Healthcare Investment Banker, Equity Research Analyst and Investor with RBC Capital Markets, Craig-Hallum, Canaccord Genuity and American Express. He holds a Bachelor of Arts in Economics from St. Olaf College. Annuncio • Feb 24
Nuwellis, Inc. to Report Q4, 2025 Results on Mar 10, 2026 Nuwellis, Inc. announced that they will report Q4, 2025 results on Mar 10, 2026 Annuncio • Jan 31
Nuwellis, Inc. Announces the Appointment of Carisa Schultz as the Principal Financial Officer, and Principal Accounting Officer, Effective from February 2, 2026 On January 29, 2026,Nuwellis, Inc. announced the appointment of Carisa Schultz as the Principal Financial Officer, and Principal Accounting Officer of the Company, effective February 2, 2026. Ms. Schultz, age 48, most recently served as Vice President, Finance for NeueHealth (formerly Bright Health Group), a health care company that was publicly traded on NYSE, from April 2024 to November 2025, where she led all enterprise finance, treasury and corporate development activities. Prior to that role, she served as Associate Vice President, Enterprise Finance from April 2022 to April 2024, and as Director, Finance from September 2020 to April 2022. She previously served as Senior Business Intelligence Analyst for Starkey Hearing Technologies from October 2019 until July 2020, where she led all Business Intelligence activities supporting the US Retail Sales organization, as Director of Analytics and Interim Controller at Highline Labs from February 2015 until September 2019, where she led the Analytics and Revenue Cycle Management team, and as Lead Financial Consultant and President at The Wavelength Group, a consulting firm providing strategic FP&A and sales operations expertise to clients across multiple industries from July 2012 to February 2015. Earlier in her career, she worked in Big 4 public accounting before moving into corporate finance at Boston Scientific and also advanced to Finance Manager at Cardiovascular Systems Inc. before founding The Wavelength Group. Ms. Schultz received her Bachelor of Science of Business, Accounting degree from the University of Minnesota, Curtis L. Carlson School of Management. Annuncio • Jan 30
Nuwellis, Inc. Appoints Carisa Schultz as Chief Financial Officer, Effective February 2, 2026 Nuwellis, Inc. announced the appointment of Carisa Schultz as Chief Financial Officer, effective February 2, 2026. Ms. Schultz, age 48, most recently served as Vice President, Finance for NeueHealth (formerly Bright Health Group), a health care company that was publicly traded on NYSE, from April 2024 to November 2025, where she led all enterprise finance, treasury and corporate development activities. Prior to that role, she served as Associate Vice President, Enterprise Finance from April 2022 to April 2024, and as Director, Finance from September 2020 to April 2022. She previously served as Senior Business Intelligence Analyst for Starkey Hearing Technologies from October 2019 until July 2020, where she led all Business Intelligence activities supporting the US Retail Sales organization, as Director of Analytics and Interim Controller at Highline Labs from February 2015 until September 2019, where she led the Analytics and Revenue Cycle Management team, and as Lead Financial Consultant and President at The Wavelength Group, a consulting firm providing strategic FP&A and sales operations expertise to clients across multiple industries from July 2012 to February 2015. Earlier in her career, she worked in Big 4 public accounting before moving into corporate finance at Boston Scientific and also advanced to Finance Manager at Cardiovascular Systems Inc. before founding The Wavelength Group. Ms. Schultz received her Bachelor of Science of Business, Accounting degree from the University of Minnesota, Curtis L. Carlson School of Management. Annuncio • Jan 24
Nuwellis, Inc. Announces Changes to Board of Directors, Effective January 21, 2026 Nuwellis, Inc. announced the appointment of Katharyn Field and Mika Grasso to its board of directors, effective January 21, 2026. Katharyn Field, Age 32, is the Chief Executive Officer of ISpecimen Inc., where she oversees performance improvement and the redevelopment of the proprietary software platform. Prior to serving as Chief Executive Officer she served as President, Chairman, and as an independent director. She has served as a director of LogProstyle since September 2024, as an Executive Director of Akanda Corporation since June 2022, and previously served as a director of Virpax Pharmaceuticals Inc. and Aerwins Technologies Inc. Ms. Field previously served in various roles at Halo Collective, including as Chief Executive Officer and Chairman from 2022 to 2025, as President from 2020 to 2022, and as Chief Strategy Officer from 2019 to 2020, and also served as Executive Vice President, Corporate Development for Marimed Inc. from 2018 to 2019. She received her MBA with a concentration in Strategy and Economics from Columbia Business School and a BA in Public Policy, with a Minor in Art History, from Stanford University. Mika Grasso, Age 28, is an Investment Manager at a private family office, where he is responsible for evaluating investment opportunities across public and private markets. Prior to serving as an Investment Manager, he served as a Finance Associate for Zions Capital Markets from November 2023 until March 2025, Investment Banking Associate at Paulson Investment Company from February 2022 until November 2023, Analyst at Goldman Sachs from August 2021 to February 2022, and as an Analyst on the Real Assets Team at Power Systems Management from May 2020 to August 2021. Mr. Grasso received his MS in Finance with a concentration in Investment Management and BS in Business Administration from the University of Colorado Boulder, Leeds School of Business. Also, effective January 21, 2026, Dave McDonald, Mike McCormick, and Dr. Maria Costanzo each resigned from the Company’s Board of Directors and the respective committees on which they served. Annuncio • Dec 10
Nuwellis, Inc. Announces the Presentation of New Real-World Data from New York City's Lenox Hill Hospital at the 2025 American Society of Nephrology (ASN) Kidney Week Nuwellis, Inc. announced the presentation of new real-world data from New York City's Lenox Hill Hospital at the 2025 American Society of Nephrology (ASN) Kidney Week, reinforcing the versatility of Aquadex®? ultrafiltration therapy in patients with acute kidney injury (AKI) and complex fluid management needs. The retrospective analysis, titled "Diversifying Aquapheresis Applications in Critical Care: Nephrology-Led Institutional Experience" (Presentation #FR-PO0590), reviewed 69 cases treated with Aquadex between 2018 and 2024. The study demonstrated effective and predictable fluid removal in patients with multiple underlying conditions--ranging from oliguric AKI and post-cardiac-surgery volume overload to pre-operative optimization in end-stage renal disease. The analysis found that patients had an average of 6.4 liters of ultrafiltrate removed over a mean duration of 78 hours, with stable hemodynamics even among those on vasopressor support. The study was conducted in collaboration with Maria V. DeVita, MD, Chief of Nephrology at Lenox Hill Hospital, and Andrew A. Moses, MD, MD, Nephrologist at Lenox Hill Hospital--both of whom play key roles in advancing innovative approaches to fluid management and renal care across the institution. The findings build on growing evidence supporting precision ultrafiltration as a complement to traditional kidney replacement therapy. As outlined in Cardiorenal Medicine (Kazory et al., 2022), moderate and individualized ultrafiltration rates are associated with improved outcomes in critically ill patients with AKI and fluid overload. The 2023 POQI/ERAS Cardiac consensus similarly highlights goal-directed, patient-specific volume management as essential to preventing AKI and improving recovery following cardiac surgery. By extending its application beyond traditional heart-failure cases, aquapheresis demonstrates increasing increase in nephrology and critical care--where early, controlled fluid removal can stabilize hemodynamics, support renal recovery, and reduce downstream complications. Annuncio • Nov 11
Nuwellis, Inc. Receives Notice of Allowance of A New U.S. Patent Strengthening Vivian™? Pediatric System with Advanced Clamp Safety Technology Nuwellis, Inc. announced that the United States Patent and Trademark Office has issued Nuwellis a notice of allowance for a new patent covering advanced safety mechanisms for blood return line clamps used in extracorporeal blood filtration systems, including the company's Vivian™? Pediatric Continuous Renal Replacement Therapy (CRRT) System currently in development. Many extracorporeal blood filtration systems rely on automated clamps as part of their safety design to prevent air embolism or pressure imbalances. The newly patented technology enhances this core function by dynamically adjusting clamping force based on environmental factors, automatically reconditioning the tubing under defined thermal conditions, and adding thermal insulation for improved material stability. Together, these innovations strengthen one of the most critical safety components in pediatric extracorporeal therapy--ensuring consistent, reliable protection for the smallest patients. This patent adds to a growing portfolio of intellectual property supporting the Vivian system and Nuwellis' pediatric technology roadmap, following the September 2025 patent issuance for hemolysis sensing in extracorporeal circuits. Together, these advancements reflect meaningful progress toward safer, smarter, and more responsive pediatric fluid management. The company's innovation in this space is further supported by National Institute of Health (NIH) grant-funded research and the use of the Aquadex®? system in pediatric patients weighing 20 kg or more, helping to inform design decisions and guide future clinical applications for Vivian. With each patent, Nuwellis continues to strengthen its leadership in precision fluid management and its mission to deliver safer, smarter solutions for patients across the cardio-renal continuum. Annuncio • Oct 23
Nuwellis, Inc. to Report Q3, 2025 Results on Nov 12, 2025 Nuwellis, Inc. announced that they will report Q3, 2025 results Pre-Market on Nov 12, 2025 Annuncio • Oct 02
Nuwellis, Inc. Announces 92% Survival in Children with Acute Kidney Injury, Fluid Overload or Congenital Kidney Failure Following Treatment with Aquadex® Nuwellis, Inc. announced findings from the ULTRA-Peds registry, a multi-center observational study examining the real-world use of the Aquadex System in children with acute kidney injury (AKI), fluid overload, or congenital kidney failure. The ULTRA-Peds Registry enrolled 91 pediatric patients across eight U.S. centers, representing a comprehensive real-world dataset to date in this vulnerable population. Diagnoses included congenital heart disease (30%), end-stage renal disease (25%), and malignancy (14%). Results demonstrated strong survival and procedural success: 92% of patients survived their Aquadex treatment course; 66% survived to hospital discharge; 86% of circuits completed their intended treatment course without interruption; Heparin anticoagulation was associated with longer circuit duration compared to bivalirudin. These findings show that Aquadex therapy is both feasible and well tolerated in critically ill children, a population with extremely limited treatment alternatives. The Aquadex System is FDA-cleared for adult patients with fluid overload who have failed diuretic therapy, as well as for pediatric patients weighing 20kg or more. The U LTRA-Peds registry included two distinct arms, one of which was a retrospective review of prior use cases already completed, so included some patients under this weight threshold and the other, which was exclusively prospective and on -label. The ULTRA- Peds registry is more than a dataset - it highlights a critical gap in care and provides a foundation for Nuwellis' pediatric and cardio-renal strategy. Building on these findings, Nuwellis is advancing development of Vivian, a dedicated pediatric continuous renal replacement therapy (CRRT) system designed specifically for neonates and small children weighing between 2.5kg and 20kg. Unlike existing technologies adapted from adult use, Vivian is purpose-built to address the delicate physiology of infants and provide clinicians with a safer, more precise tool for kidney support. The program recently received a $3 millionNIH development grant and is protected by newly issued patents, underscoring both the clinical importance and innovation behind this technology. Together, ULTRA-Peds and Vivian represent a deliberate, staged approach to transforming pediatric kidney support and advancing Nuwellis' broader leadership in cardio-renal care. The company's roadmap is designed to move from evidence to innovation to leadership: Support evidence generation through registries like ULTRA-Peds to better understand real-world care; Advance Vivian to better understand real- world care; Advance Vivian to transform pediatric kidney support. Annuncio • Sep 06
Nuwellis Introduces New 24-Hour Aquadex™? Circuit to Support Hospital-Based Outpatient and Short-Term Fluid Management Nuwellis, Inc. announced plans to introduce a new 24-hour circuit for Aquadex therapy in the United States this fall. The new circuit is designed for single-day outpatient sessions and complements the company's existing 72-hour option that is commonly used for multi-day therapy or inpatient care. Together, these options help hospitals match supply to setting while maintaining a consistent therapy experience. Hospitals are building outpatient Aquadex programs to deliver predictable, scheduled care for patients who need fluid removal without a hospital admission. The 24-hour circuit supports that model by aligning with single-visit workflows, easing scheduling, and program planning. For patients, the goal is a straightforward same-day visit. For providers and administrators, the aim is a reliable pathway to run more efficient clinics and scale capacity. Annuncio • Sep 03
Nuwellis, Inc. has filed a Follow-on Equity Offering in the amount of $4.65 million. Nuwellis, Inc. has filed a Follow-on Equity Offering in the amount of $4.65 million.
Security Name: Common Stock
Security Type: Common Stock
Transaction Features: At the Market Offering Annuncio • Aug 22
Nuwellis, Inc. Receives FDA 510(k) Clearance for New Dual Lumen Extended Length Catheter Nuwellis, Inc. announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for a new size of its Dual Lumen Extended Length Catheter (dELC). Advancing a broader fluid management platform: This clearance supports Nuwellis' multi-year plan to build a comprehensive fluid management platform--combining therapy delivery, dedicated venous access, and practical implementation support--so hospitals and clinics can standardize how they identify patients, begin ultrafiltration therapy earlier, and sustain programs from the ICU to step-down and hospital-based outpatient settings. The company's strategy centers on three growth drivers: critical care, cardiac surgery recovery, and hospital-based outpatient heart failure programs. Annuncio • Jul 22
Nuwellis, Inc. to Report Q2, 2025 Results on Aug 12, 2025 Nuwellis, Inc. announced that they will report Q2, 2025 results on Aug 12, 2025 Annuncio • Jul 17
Nuwellis Announces Termination of REVERSE-HF Clinical Trial to Focus on Strategic Growth in Outpatient Heart Failure Care Nuwellis, Inc. announced the termination of its REVERSE-HF clinical trial, a randomized post-market trial evaluating ultrafiltration vs. IV loop diuretic therapy for fluid management in hospitalized heart failure patients. This decision reflects the company's strategic commitment to prioritize resources in areas demonstrating the greatest potential for patient impact and business growth--namely, outpatient heart failure, pediatric, and critical care. Nuwellis is seeing increasing demand and interest of its ultrafiltration therapy in hospital-based outpatient heart failure programs. Redirecting investment from REVERSE-HF allows the com
pany to accelerate progress in this high-potential area, while continuing to support ongoing strong growth in its pediatric and critical care customer categories. The company anticipates it will save approximately $4.0M over the next 2.5 years by ending the REVERSE-HF trial. The REVERSE-HF Trial collected valuable data that may be helpful in informing clinical practice. The trial began enrolling patients in 2022, and at the time of its termination, it had enrolled 167 patients. The company intends to work with the steering committee, investigators, and biostatisticians to identify what statistical value can be derived from the existing data to support potential future clinical publications or podium presentations. The decision to terminate the post-market clinical study was not related to device performance or patient safety concerns. The Nuwellis SmartFlow remains on the market as an FDA cleared treatment for patients suffering from fluid overload. Annuncio • Jun 24
Nuwellis Receives Non-Compliance Letter from Nasdaq Regarding Minimum Bid Price Requirement On June 18, 2025, Nuwellis, Inc. (the Company") received a letter (the Deficiency Notice") from the Listing Qualifications Department (the Staff") of the Nasdaq Stock Market (Nasdaq") informing the Company that because the closing bid price for the Company's common stock listed on Nasdaq was below $1.00 for 30 consecutive trading days, the Company is not in compliance with the minimum bid price requirement for continued listing on the Nasdaq Capital Market, as set in Nasdaq Marketplace Rule 5550(a)(2) (the Minimum Bid Price Requirement"). The Deficiency Notice also indicated that the Company is not eligible for any compliance period specified in Nasdaq Listing Rule 5810(c)(3)(A) because the Company effected a reverse stock split over the prior one-year period or has effected one or more reverse stock splits over the prior two-year period with a cumulative ratio of 250 shares or more to one; accordingly, the Company was informed that its securities were subject to delisting from Nasdaq unless the Company timely requested a hearing before the Nasdaq Hearings Panel (the Panel"). As previously disclosed, the Company effected a reverse stock split of its Common Stock on June 27, 2024. At its annual meeting held on May 20, 2025, the Company's stockholders approved a proposal allowing the board of directors of the Company to effect a reverse split in the range of 1-for-5 to 1-for-70. The Company's board of directors intends to effect a reverse stock split in the near term in order to regain compliance with the Minimum Bid Price Requirement. The Company intends to timely submit a request for a hearing and the Company's securities will then remain listed and eligible for trading on the Nasdaq Capital Market at least pending the ultimate conclusion of any hearing process. There can be no assurance that the Panel will grant the Company's request for continued listing or that the Company will be able to regain compliance and thereafter maintain its listing on Nasdaq. Annuncio • Jun 10
Nuwellis, Inc. has completed a Follow-on Equity Offering in the amount of $4.346418 million. Nuwellis, Inc. has completed a Follow-on Equity Offering in the amount of $4.346418 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 406,755
Price\Range: $0.3
Discount Per Security: $0.027
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant
Securities Offered: 14,085,998
Price\Range: $0.2999
Discount Per Security: $0.027
Security Name: Series A Warrants
Security Type: Equity Warrant
Securities Offered: 43,478,259
Security Name: Series B Warrants
Security Type: Equity Warrant
Securities Offered: 14,492,753 Annuncio • May 30
Nuwellis, Inc. has filed a Follow-on Equity Offering in the amount of $9.999461 million. Nuwellis, Inc. has filed a Follow-on Equity Offering in the amount of $9.999461 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 5,387,931
Price\Range: $0.928
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant
Securities Offered: 5,387,931
Price\Range: $0.9279
Security Name: Series A Warrants
Security Type: Equity Warrant
Securities Offered: 10,775,862
Security Name: Series B Warrants
Security Type: Equity Warrant
Securities Offered: 5,387,931
Security Name: Representative Warrants
Security Type: Equity Warrant
Securities Offered: 161,637 Annuncio • Apr 23
Nuwellis, Inc. to Report Q1, 2025 Results on May 13, 2025 Nuwellis, Inc. announced that they will report Q1, 2025 results on May 13, 2025 Annuncio • Apr 04
Nuwellis, Inc., Annual General Meeting, May 20, 2025 Nuwellis, Inc., Annual General Meeting, May 20, 2025. Annuncio • Feb 21
Nuwellis, Inc Highlights Promising Findings from Updated Analysis of the AVOID-HF Study Nuwellis, Inc. highlighted promising findings from an updated analysis of the AVOID-HF study, recently published in the Journal of the American College of Cardiology: Heart Failure. The analysis, led by Dr. Sean P. Pinney, Chief of Cardiology at Mount Sinai Morningside and Chief of Nephrology at Lenox Hill Hospital, Dr. Maria V. DeVita, provides new insights suggesting the potential benefits of Aquadex® SmartFlow ultrafiltration therapy in managing heart failure. The analysis found that patients treated with Aquadex therapy demonstrated a 60% reduction in heart failure events at 30 days compared to those receiving traditional IV diuretics. The AVOID-HF study, initially designed to evaluate the effectiveness of ultrafiltration in managing heart failure, was updated to include a broader dataset, allowing a more comprehensive analysis of patient outcomes. The results indicate a promising trend in the reduction of heart failure events and suggest potential improvements in patient management strategies. The reanalysis demonstrated not only a significant reduction in heart failure events but also suggested trends towards fewer hospitalizations and improved quality of life for those treated with Aquadex therapy over traditional methods. These findings advocate for its continued use in modern heart failure treatment regimens and set the stage for more rigorous trials. Nuwellis plans to continue its research efforts under its current REVERSE-HF trial, led by Dr. Pinney and Dr. DeVita, to further establish the clinical and economic benefits of ultrafiltration therapy compared to conventional IV diuretic treatments. The company remains committed to improving outcomes for heart failure patients and reducing the overall burden of hospitalizations. The complete analysis will be available in the February 2025 issue of JACC: Heart Failure.About the AVOID-HF Trial The AVOID-HF trial, a prospective, multicenter, randomized controlled study, explored whether treating heart failure patients with ultrafiltration could extend the period without heart failure events post-discharge compared to those receiving IV loop diuretics. Utilizing advanced statistical techniques, reanalysis of the AVOID-HF data demonstrated marked clinical advantages, supporting broader clinical adoption of the Aquadex system. Annuncio • Feb 19
Nuwellis, Inc. to Report Q4, 2024 Results on Mar 11, 2025 Nuwellis, Inc. announced that they will report Q4, 2024 results on Mar 11, 2025 Annuncio • Nov 02
Nuwellis Provides Revenue Guidance for Third Quarter Ended September 30, 2024 Nuwellis, Inc. announced that based on preliminary, unaudited results, management expects the Company to report the following in respect of its quarterly period ended September 30, 2024, Revenue of approximately $2.4 million. Annuncio • Oct 24
Nuwellis, Inc. to Report Q3, 2024 Results on Nov 11, 2024 Nuwellis, Inc. announced that they will report Q3, 2024 results on Nov 11, 2024 Annuncio • Oct 22
Seastar Medical Holding Corporation Enters into Confidential Settlement Agreement and Release with Nuwellis SeaStar Medical Holding Corporation announced that In December 2022 the Company entered into a license and distribution agreement with Nuwellis Inc., pursuant to which the Company appointed Nuwellis as its exclusive distributor for the sale and distribution of its pediatric SCD product throughout the United States. In May 2024, the Company provided notice to Nuwellis that Nuwellis had breached the Distribution Agreement and that the Distribution Agreement would terminate effective August 18, 2024. Nuwellis disputed the validity of the termination and on October 20, 2024, the Company entered into a confidential settlement agreement and release with Nuwellis, pursuant to which the Company agreed to pay Nuwellis an aggregate of $900,000 payable in three installments through December 31, 2024. Annuncio • Aug 27
Nuwellis, Inc. has completed a Follow-on Equity Offering in the amount of $0.891783 million. Nuwellis, Inc. has completed a Follow-on Equity Offering in the amount of $0.891783 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 483,351
Price\Range: $1.845
Discount Per Security: $0.1476
Transaction Features: Registered Direct Offering Annuncio • Aug 24
Nuwellis, Inc. has filed a Follow-on Equity Offering in the amount of $0.916782 million. Nuwellis, Inc. has filed a Follow-on Equity Offering in the amount of $0.916782 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 496,901
Price\Range: $1.845
Transaction Features: Registered Direct Offering Annuncio • Aug 09
Nasdaq Panel Grants Nuwellis Continued Listing on the Nasdaq Stock Market, Subject to Conditions Nuwellis, Inc. announced The Nasdaq Hearings Panel (Panel) granted its request to continue its listing on the Nasdaq Stock Market, subject to certain conditions. The decision was based on information the Company presented to the Panel during a hearing on July 23, 2024. The letter received from the Panel stated that the continued listing was subject to the following: 1) on or before November 19, 2024, the Company shall file a Form 10-Q for the period ending September 30, 2024, describing the transactions undertaken by the Company to achieve compliance and demonstrate long-term compliance with the minimum stockholder Equity Rule and provide an indication of its equity following those transactions, 2) on or before November 19, 2024, the Company must provide the Panel with income projections for the next 12 months, with all underlying assumptions clearly stated, and 3) on or before November 19, 2024, the Company shall demonstrate compliance with the minimum Bid Price Rule. The letter also stated that it is a requirement during the exception period that the Company provide prompt notification of any significant events that occur during this time that may affect the Company's compliance with Nasdaq requirements. This includes, but is not limited to, any event that may call into question the Company's ability to meet the terms of the exception granted. The Panel reserves the right to reconsider the terms of this exception based on any event, condition or circumstance that exists or develops that would, in the opinion of the Panel, make continued listing of the Company's securities on the Exchange inadvisable or unwarranted. Annuncio • Jul 26
Nuwellis Announces First Pediatric Patient Treated in A Commercial Setting with Seastar Medical's Quelimune Therapy At Cincinnati Children's Nuwellis, Inc. announced that the first patient has been treated with the newly launched QUELIMMUNE™? therapy in a commercial setting at Cincinnati Children's. QUELIMMUNE, manufactured for SeaStar Medical and exclusively licensed and distributed in U.S. pediatric hospitals by Nuwellis, is a novel therapy designed to treat pediatric patients (weighing 10 kg or more) suffering from acute kidney injury (AKI) with sepsis or a septic condition and requiring kidney replacement therapy (KRT). Dr. Stuart Goldstein, Director of the Center for Acute Care Nephrology at Cincinnati Children's, and Principal Investigator of the multi-center studies that led to FDA clearance of QUELIMMUNE, oversaw the administration of QUELIMMUNE to the first patient. Approximately 4,000 pediatric patients are hospitalized with AKI each year in the U.S.1 QUELIMMUNE is designed to address the underlying immune dysregulation in pediatric patients, aiming to reduce the incidence and several of cytokine storms. This therapy represents a significant advancement in the management of AKI and sepsis, offering a novel approach to improving patient outcomes. About QUELIMMUNE is a patented cell-directed extracorporeal device that employs immunomodulating technology to selectively target proinflammatory neutrophils and monocytes during KRT and reduces the hyperinflammatory milieu including the cytokine storm that causes inflammation, organ failure and possible death in critically ill patients. Unlike pathogen removal and other blood-purification tools, the device is integrated with KRThemofiltration systems to selectively target and transition proinflammatory monocytes to a reparative state and promote activated neutrophils to be less inflammatory. QUELIMMUNE selectively targets the most highly activated proinflammatory neutrophils and Monocytes. These cells are then returned back into the body through the blood, and the body is signaled to lower its inflammatory environment and focus on repair. This unique immunomodulation approach may promote long-term organ recovery and eliminate the need for future KRT, including dialysis. Annuncio • Jul 25
Nuwellis, Inc. has filed a Follow-on Equity Offering in the amount of $1.990002 million. Nuwellis, Inc. has filed a Follow-on Equity Offering in the amount of $1.990002 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 469,340
Price\Range: $4.24
Transaction Features: Registered Direct Offering Annuncio • Jul 24
Nuwellis, Inc. to Report Q2, 2024 Results on Aug 13, 2024 Nuwellis, Inc. announced that they will report Q2, 2024 results on Aug 13, 2024 Annuncio • Jul 18
Nuwellis Marks First Commercial Sale of Quelimune Therapy to Cincinnati Children's Nuwellis, Inc. announced its first commercial sale of QUELIMMUNE™?, a novel therapy developed by SeaStar Medical Holding Corporation for pediatric patients suffering from an uncontrolled inflammatory response triggered by their immune systems, to Cincinnati Children's. The company believe this milestone marks a significant advancement in pediatric critical care and underscores Nuwellis' commitment to revolutionizing pediatric patient outcomes. QUELIMMUNE, or Selective Cytopheretic Device for pediatrics, represents a transformative solution for pediatric patients suffering from acute kidney injury (AKI) due to sepsis or a septic condition on antibiotic therapy and requiring kidney replacement therapy (KRT). Early clinical data suggest a 77% survival rate for patients treated with this new therapy1. Through Nuwellis' exclusive U.S. license and distribution agreement with SeaStar Medical, the developer of QUELIMMUNE, this therapy is now accessible under a Humanitarian Device Exemption (HDE) from the Food and Drug Administration (FDA) to medical institutions like Cincinnati Children's, giving nephrologists and intensive care physicians a novel option to address the needs of these critically ill pediatric patients. Annuncio • Jul 10
Nuwellis, Inc. Announces New Clinical Evidence Demonstrating the Efficacy of its Aquadex® System to be Presented at HFSA 2024 Conference Nuwellis, Inc. announced that new clinical evidence demonstrating the efficacy of its Aquadex® system will be presented at the Heart Failure Society of America (HFSA) Annual Scientific Meeting, taking place September 27-30, 2024, in Atlanta, Georgia. The study, conducted by Dr. Wayne Old, MD, an advanced heart failure cardiologist at Sentara Health, based out of Sentara Norfolk General Hospital in Norfolk, Va., highlights the benefits of Aquadex ultrafiltration therapy for heart failure patients experiencing fluid overload who have not responded to traditional diuretic treatments. The research underscores Aquadex's ability to effectively manage fluid levels, providing a critical therapeutic alternative for this challenging patient population. Sentara Health is also actively participating in REVERSE-HF, a pivotal clinical study on ultrafiltration using Aquadex. REVERSE-HF (Ultrafiltration Versus IV Diuretics in Worsening Heart Failure) is evaluating the clinical outcomes and economic value of Aquadex ultraf filtiltration therapy in comparison to intravenous (IV) diuretics for the treatment of fluid overload in patients with worsening heart failure. Annuncio • May 30
Nuwellis Receives Non-Compliance Letter from Nasdaq Regarding Minimum Stockholders' Equity Requirement On May 23, 2024, Nuwellis, Inc. (the Company") received a letter (the Notice") from the Listing Qualifications Department (the Staff") of the Nasdaq Stock Market (Nasdaq") informing the Company that it was not in compliance with the minimum stockholders' equity requirement for continued listing on The Nasdaq Capital Market, under Listing Rule 5550(b)(1), because the Company's stockholders' equity of $885,000, as reported in the Company's Quarterly Report on Form 10-Q for the period ended March 31, 2024, was below the required minimum of $2.5 million, and because, as of May 23, 2024, the Company did not meet the alternative compliance standards, relating to the market value of listed securities of $35 million or net income from continuing operations of $500,000 in the most recently completed fiscal year or in two of the last three most recently completed fiscal years. The Notice has no immediate impact on the listing of the Company's common stock, which will continue to be listed and traded on The Nasdaq Capital Market, subject to the Company's compliance with the other continued listing requirements. The Company has 45 calendar days from May 23, 2024, or through July 8, 2024, to submit to Nasdaq a plan to regain compliance with Listing Rule 5550(b)(1). If Nasdaq accepts the Company's plan, Nasdaq may grant an extension of up to 180 calendar days from May 23, 2024, or through Tuesday, November 19, 2024, to regain compliance. If Nasdaq does not accept the Company's plan, the Company will have the right to appeal such decision to a Nasdaq hearings panel. The Company intends to submit to Nasdaq, within the requisite time period, a plan to regain compliance with Listing Rule 5550(b)(1). There can be no assurance that Nasdaq will accept the Company's plan or that the Company will be able to regain compliance with Listing Rule 5550(b)(1) or maintain compliance with any other Nasdaq requirement in the future. Reported Earnings • May 08
First quarter 2024 earnings: EPS exceeds analyst expectations while revenues lag behind First quarter 2024 results: US$0.78 loss per share (improved from US$5.76 loss in 1Q 2023). Revenue: US$1.86m (up 1.7% from 1Q 2023). Net loss: US$4.87m (loss narrowed 25% from 1Q 2023). Revenue missed analyst estimates by 7.2%. Earnings per share (EPS) exceeded analyst estimates by 43%. Revenue is forecast to grow 16% p.a. on average during the next 2 years, compared to a 8.1% growth forecast for the Medical Equipment industry in the US. Annuncio • Apr 10
Nuwellis, Inc. Announces Launch of Ultrafiltration Therapy Using Aquadex Smartflow® System at Henry Ford Health Nuwellis, Inc. announced that Henry Ford Health has begun offering ultrafiltration therapy to heart failure patients suffering from fluid overload using the company's Aquadex SmartFlow system as part of Nuwellis' pivotal REVERSE-HF clinical study. Major Estimate Revision • Mar 18
Consensus EPS estimates upgraded to US$2.69 loss The consensus outlook for fiscal year 2024 has been updated. 2024 losses forecast to reduce from -US$3.89 to -US$2.69 per share. Revenue forecast unchanged from US$10.4m at last update. Medical Equipment industry in the US expected to see average net income growth of 16% next year. Consensus price target down from US$6.00 to US$5.25. Share price fell 13% to US$0.41 over the past week. Annuncio • Mar 08
Nuwellis, Inc. Announces Results from Two New Clinical Data Analyses from the AVOID-HF Trial, Which Demonstrate the Benefits of its Aquadex System in Reducing Heart Failure Readmissions at 30 Days Nuwellis, Inc. announced results from two new clinical data analyses from the AVOID-HF trial, which demonstrate the benefits of its Aquadex System in reducing heart failure readmissions at 30 days. Results from the analyses were presented in a late-breaking session at the Technology and Heart Failure Therapeutics (THT) conference in Boston. The data was presented by Dr. Sean P. Pinney, M.D., Professor of Medicine and director of the Heart Failure and Transplantation Program at the Mount Sinai Health System, and evaluated the clinical benefit of adjustable ultrafiltration (AUF) therapy with Nuwellis’ Aquadex System compared to adjustable loop diuretics (ALD) by re-analyzing data from the AVOID-HF (Aquapheresis vs. Intravenous Diuretics and Hospitalizations for Heart Failure) clinical trial1 using the Finkelstein-Schoenfeld method of Win-Ratios. In the trial, 221 study participants were randomized to AUF (n=110) or ALD (n=111), and 213 (AUF=105, AUD= 108) patients who completed index treatment and discharge were included in the analysis. Data were independently adjudicated by a blinded clinical events committee, which evaluated AUF compared to ALD within the three-factor composite endpoint of cardiovascular mortality, heart failure events and quality of life. Key findings demonstrating the benefits of AUF include: Fewer heart failure events and heart failure hospitalizations: AUF patients had significantly fewer heart failure events within 30 days compared to ALD (90% vs 77.3% p=0.0138) and fewer heart failure hospitalizations for the AUF patients compared to the ALD patients (90.0% vs. 79.2% p=0.0321) within 30 days. Results of the Hierarchical Win-Ratio: In the primary composite outcome, 72.6% resulted in either a “win” or “loss” and the remaining 27.4% resulted in a “tie”. AUF won in 71.0% of the heart failure event related paired comparisons (versus 29.0% for ALD) and in 53.4% of the quality-of-life comparisons (versus 46.6% for ALD) resulting in a WR=1.43 (p=0.056) favoring ultrafiltration. Other statistically significant results presented from the original AVOID-HF trial1 included: Fewer patients re-hospitalized for heart failure (p=0.034) Fewer days in the hospital due to heart failure readmissions (p=0.029) Lower rehospitalization rates due to a cardiovascular event (p=0.037) Fewer rehospitalization days due to a cardiovascular event (p=0.018) Fewer patients re-hospitalized for a cardiovascular event (p=0.042) This study, presented by Deya Alkhatib, M.D., Section of Cardiovascular Medicine, Yale School of Medicine, aimed to develop a model for pretreatment and identification of risk for 90-day heart failure events among heart failure patients who have undergone AUF therapy. Using artificial intelligence (AI) and machine learning (ML), a predictive model was developed based on data from the AVOID-HF trial. The model was designed to be used before initiating AUF to anticipate which patients will respond well to the therapy and which will be at high risk for future heart failure events. Key findings from the analysis include: Top predictors for 90-day heart failure events: Using ML, the study identified the top 10 predictors for 90-day heart failure events. Notably, “intimate relationships with loved ones” was a strong predictor of response to AUF therapy. Other predictors included valvular heart disease, history of arrhythmia, poor adherence to medical therapy, history of diabetes mellitus, suboptimal diuretic therapy response, chronic obstructive lung disease, ALD use during acute decompensated heart failure hospitalization, history of cerebrovascular disease, and intravenous bumetanide use. Successful prediction of outcomes: The ML model used in the study was more successful in predicting the outcome for heart failure patients treated with AUF. The predictive model anticipated 90-day heart failure events with better statistical accuracy than existing classic models. Strong results for super-responders: 90% of patients categorized as super-responders to AUF therapy within this model did not experience any 90-day heart failure events. Accurate predictions for high-risk patients: The model assigned 41% of patients in the study to the high-risk category. Among these patients, 57% experienced a 90-day heart failure event. Reported Earnings • Mar 07
Full year 2023 earnings: EPS exceeds analyst expectations Full year 2023 results: US$11.52 loss per share. Revenue: US$8.86m (up 3.8% from FY 2022). Net loss: US$22.6m (loss widened 56% from FY 2022). Revenue was in line with analyst estimates. Earnings per share (EPS) surpassed analyst estimates by 5.5%. Revenue is forecast to grow 24% p.a. on average during the next 2 years, compared to a 7.8% growth forecast for the Medical Equipment industry in the US. Annuncio • Feb 28
Nuwellis, Inc. to Report Q4, 2023 Results on Mar 05, 2024 Nuwellis, Inc. announced that they will report Q4, 2023 results on Mar 05, 2024 New Risk • Feb 20
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 17% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$19m free cash flow). Share price has been highly volatile over the past 3 months (17% average weekly change). Shareholders have been substantially diluted in the past year (over 9x increase in shares outstanding). Market cap is less than US$10m (US$3.42m market cap). Minor Risk Currently unprofitable and not forecast to become profitable over next 2 years (US$13m net loss in 2 years). Annuncio • Jan 05
Nuwellis, Inc. Receives FDA Clearance for an Additional Dual Lumen Extended Length Peripheral Catheter Nuwellis, Inc. announced it has received U.S. Food and Drug Administration (FDA) clearance for its specialty peripheral dual lumen extended length catheter (dELC). The addition of a new 12 cm catheter provides clinicians who treat patients with fluid overload with an additional venous access option to use the company's Aquadex ultrafiltration system. Nuwellis' dELC specialty catheter is available in two lengths and provides alternative peripheral access for ultrafiltration therapy across a broad range of patient physiologies. The new 12 cm dELC has the same features as the longer 16 cm option offered by the company but eliminates the need for trimming when a shorter catheter is needed. The dELC offers the performance capabilities of a central catheter from the periphery, and its unique inner coil design ensures consistent blood flow and prevents kinking. Aquadex is proven to simply, safely, and precisely remove excess fluid from patients suffering from fluid overload who have not responded to conventional medical management, including diuretics. Providers can specify and adjust the rate of fluid removed for each individual patient, resulting in a gradual reduction of excess fluid. The device's built-in, customizable hematocrit monitoring technology provides real-time measurement of% blood volume changes that can be tailored to individual patients' needs. A customizable fluid removal rate is particularly important for pediatric patients, who have a small amount of blood in their bodies. The Aquadex system is cleared by the FDA for use in adults and pediatric patients weighing 20 kg (44 lbs.) or more. Annuncio • Dec 14
Nuwellis Receives Non-Compliance Notice from Nasdaq On December 7, 2023, Nuwellis, Inc. (the “Company”) received a letter (the “Notice”) from the Listing Qualifications Department (the “Staff”) of the Nasdaq Stock Market (“Nasdaq”) informing the Company that because the closing bid price for the Company’s common stock listed on Nasdaq was below $1.00 for 30 consecutive trading days, the Company is not in compliance with the minimum bid price requirement for continued listing on the Nasdaq Capital Market, as set in Nasdaq Marketplace Rule 5550(a)(2) (the “Minimum Bid Price Requirement”). In accordance with Nasdaq Marketplace Rule 5810(c)(3)(A), the Company has a period of 180 calendar days from December 7, 2023, or until June 4, 2024, to regain compliance with the Minimum Bid Price Requirement. If at any time before June 4, 2024, the closing bid price of the Company’s common stock closes at or above $1.00 per share for a minimum of 10 consecutive trading days (which number days may be extended by Nasdaq), Nasdaq will provide written notification that the Company has achieved compliance with the Minimum Bid Price Requirement, and the matter would be resolved. The Notice also disclosed that in the event the Company does not regain compliance by June 4, 2024, the Company may be eligible for additional time. To qualify for additional time, the Company would be required to meet the continued listing requirement for market value of publicly held shares and all other initial listing standards for The Nasdaq Capital Market, with the exception of the bid price requirement, and would need to provide written notice of its intention to cure the deficiency during the second compliance period, by effecting a reverse stock split, if necessary. If the Company meets these requirements, Nasdaq will inform the Company that it has been granted an additional 180 calendar days. However, if it appears to the Staff that the Company will not be able to cure the deficiency, or if the Company is otherwise not eligible, Nasdaq will provide notice that the Company’s securities will be subject to delisting. The Company intends to continue actively monitoring the closing bid price for the Company’s common stock between now and June 4, 2024, and will consider available options to resolve the deficiency and regain compliance with the Minimum Bid Price Requirement. If the Company does not regain compliance within the allotted compliance period, including any extensions that may be granted by Nasdaq, Nasdaq will provide notice that the Company’s common stock will be subject to delisting. The Company would then be entitled to appeal that determination to a Nasdaq hearings panel. There can be no assurance that the Company will regain compliance with the Minimum Bid Price Requirement during the 180 day compliance period, secure a second period of 180 calendar days to regain compliance, or maintain compliance with the other Nasdaq listing requirements. Annuncio • Nov 29
Nuwellis, Inc. Announces New Real-World Data Highlight the Clinical Benefits of Ultrafiltration Therapy with Hematocrit Monitoring Foriatric Patients Nuwellis, Inc. announced Nuwellis, Inc. The publication, " Using Aquapheresis with Continuous Hematocrit Monitoring to Guide Ultrafiltration," was featured in Pediatric Nephrology. The publication is a single-center case study review of pediatric patients with hypo albuminemia and severe fluid overload. Patients were treated with Nuwellis' Aquadex®? ultrafiltration therapy with continuous hematocrit monitoring to guide isotonic fluid removal. The study concluded that the therapy successfully treated small patients without hemodynamic instability or other complications, demonstrating that Aquadex is an effective treatment option for fluid overload. Effectively managing fluid overload for pediatric patients is critical. Fluid overload is associated with significant increases in mortality in pediatric patients. Research has shown that a 3% increase in mortality is observed for every 1% increase in fluid overload among these patients. Aquadex is proven to simply, safely, and precisely remove excess fluid from patients suffering from fluid overload who have not responded to conventional medical management, including diuretics. Providers can specify and adjust the rate of fluid removed for each individual patient, resulting in a gradual reduction of excess fluid. The device's built-in, customizable hematocrit monitoring technology provides real-time measurement of% blood volume changes that can be tailored to individual patients' needs. A customizable fluid removal rate is particularly important for pediatric patients, who have a small amount of blood in their bodies. The Aquadex system is cleared by the FDA for use in adults and pediatric patients weighing 20 kg (44 lbs.) or more. Price Target Changed • Nov 12
Price target decreased by 36% to US$6.00 Down from US$9.40, the current price target is an average from 2 analysts. New target price is 884% above last closing price of US$0.61. Stock is down 97% over the past year. The company is forecast to post a net loss per share of US$12.20 next year compared to a net loss per share of US$83.48 last year. Reported Earnings • Nov 09
Third quarter 2023 earnings: EPS and revenues exceed analyst expectations Third quarter 2023 results: US$1.81 loss per share (improved from US$36.72 loss in 3Q 2022). Revenue: US$2.41m (up 17% from 3Q 2022). Net loss: US$3.37m (loss narrowed 13% from 3Q 2022). Revenue exceeded analyst estimates by 5.6%. Earnings per share (EPS) also surpassed analyst estimates by 42%. Revenue is forecast to grow 24% p.a. on average during the next 3 years, compared to a 7.7% growth forecast for the Medical Equipment industry in the US. New Risk • Nov 08
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 2.0% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$18m free cash flow). Share price has been highly volatile over the past 3 months (16% average weekly change). Earnings are forecast to decline by an average of 2.0% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (491% increase in shares outstanding). Market cap is less than US$10m (US$1.31m market cap). Minor Risk Currently unprofitable and not forecast to become profitable over next 2 years (US$11m net loss in 2 years). Board Change • Nov 05
Less than half of directors are independent Following the recent departure of a director, there are only 3 independent directors on the board. The company's board is composed of: 3 independent directors. 4 non-independent directors. Lead Independent Director Mike McCormick was the last independent director to join the board, commencing their role in 2023. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model. Annuncio • Nov 02
Nuwellis, Inc. Announces Board of Directors Transition Nuwellis, Inc. announced the appointment of Dave McDonald and Archelle Georgiou, MD, to its board of directors, effective November 1, 2023. Mr. McDonald serves as Head of Life Science Investment Banking at Lake Street Capital Markets, raising $6 billion in financing for clients since joining the firm. His extensive industry and Capital Markets experience provide a unique perspective to Lake Street clients. Immediately prior to joining Lake Street, Mr. McDonald spent seven years in the oncology industry, serving as a Senior Financial and Business Development Executive for SillaJen Biotherapeutics, Delcath Systems, and AngioDynamics. In addition, he has more than 35 years of Capital Markets experience serving the needs of emerging growth companies as a Healthcare Investment Banker, Equity Research Analyst, and Investor with RBC Capital Markets, Craig-Hallum, Canaccord Genuity, and American Express. Mr. McDonald received his BA in Economics from St. Olaf College. Dr. Georgiou is a physician with over 16 years of experience in leadership positions in managed care, investment banking, and medical device companies, including serving as Chief Medical Officer and Senior Executive at UnitedHealth Group, and currently serves as the Chair of the Board of Directors at Children’s Hospital and Clinics of Minnesota and Executive in Residence at the University of Minnesota's Carlson School of Management. In addition to her business leadership experience, Dr. Georgiou has produced and aired more than 2,000 news segments that simplify complex healthcare information for viewers. As a nationally recognized consumer advocate, Dr. Georgiou is passionate about helping people make data-driven decisions. Dr. Georgiou has been featured on CNN and Good Morning America, and has shared her thought leadership at events hosted by the World Bank, Mayo Clinic, Gallup, and AARP. Dr. Georgiou holds a degree from the Johns Hopkins School of Medicine and was board-certified in Internal Medicine. In addition, Nuwellis announced that Jon Salveson is stepping down from the Board after 10 years of outstanding service. Annuncio • Oct 19
Nuwellis, Inc. to Report Q3, 2023 Results on Nov 07, 2023 Nuwellis, Inc. announced that they will report Q3, 2023 results on Nov 07, 2023 Annuncio • Oct 18
Nuwellis, Inc. has completed a Composite Units Offering in the amount of $2.25 million. Nuwellis, Inc. has completed a Composite Units Offering in the amount of $2.25 million.
Security Name: Units
Security Type: Equity/Preferred Unit
Securities Offered: 150,000
Price\Range: $15
Discount Per Security: $1.2 Annuncio • Oct 11
Nuwellis Provides Regulatory Update on Seastar Medical's Selective Cytopheretic Device Use in Pediatric Acute Kidney Injury Under A Humanitarian Device Exemption Nuwellis, Inc. announced that its distribution partner, SeaStar Medical (SeaStar), received correspondence from the U.S. Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) indicating that the Agency considers SeaStar's Selective Cytopheretic Device (SCD) Pediatric (SCD-PED) to be approvable under a Humanitarian Device Exemption (HDE) for use in children weighing 10 kilograms or more with acute kidney injury (AKI) and sepsis or a septic condition requiring continuous kidney replacement therapy (CKRT) in the hospital intensive care unit (ICU). The correspondence indicates that an Approvable Letter is expected to be issued within a month. The Approvable Letter will outline conditions, including language for safety, probable benefit and labeling for intended use, which will be required for formal marketing approval. In December of 2022, Nuwellis and SeaStar entered into a U.S. license and distribution agreement for SeaStar Medical's SCD for pediatric AKI. Under this agreement, Nuwellis will market and distribute the SCD through its direct salesforce to nephologists and intensive care physicians who are trained in pediatric extracorporeal therapy. Each year in the U.S. approximately 4,000 children with AKI require CKRT and those patient profiles are associated with high mortality. The mortality rate in children with AKI requiring CKRT is approximately 50 percent. Children who survive an AKI episode are at risk for long-term conditions, including chronic kidney disease (CKD). New Risk • Oct 11
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 15% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$18m free cash flow). Share price has been highly volatile over the past 3 months (15% average weekly change). Shareholders have been substantially diluted in the past year (over 16x increase in shares outstanding). Market cap is less than US$10m (US$1.92m market cap). Minor Risk Currently unprofitable and not forecast to become profitable over next 2 years (US$12m net loss in 2 years). Annuncio • Aug 19
Nuwellis, Inc. Appoints Robert B. Scott as Chief Financial Officer, Effective September 2, 2023 Effective September 2, 2023 the (“ Effective Date ”), Robert B. Scott will be appointed as Chief Financial Officer of Nuwellis, Inc. (the “ Company ”). Mr. Scott, age 43, currently serves as the Company’s Senior Finance Director. Mr. Scott has held various positions of increasing responsibility with the Company in finance, strategic planning and financial reporting. Mr. Scott joined the Company in 2013. Prior to joining the Company, Mr. Scott served as the Finance Director from 2011 to 2013 at Entrepreneurial Advantage, a digital marketing start-up company, and from 2006 to 2011, Mr. Scott served in various finance roles at UnitedHealth Group. He is a graduate of the University of Minnesota, Carlson School of Management, where he earned a Bachelor of Science in Finance and Entrepreneurial Studies. Reported Earnings • Aug 08
Second quarter 2023 earnings released: US$3.65 loss per share (vs US$40.67 loss in 2Q 2022) Second quarter 2023 results: US$3.65 loss per share. Revenue: US$2.08m (down 6.2% from 2Q 2022). Net loss: US$4.85m (loss widened 13% from 2Q 2022). Revenue is forecast to grow 39% p.a. on average during the next 3 years, compared to a 7.8% growth forecast for the Medical Equipment industry in the US. Annuncio • Jul 21
Nuwellis, Inc. to Report Q2, 2023 Results on Aug 08, 2023 Nuwellis, Inc. announced that they will report Q2, 2023 results on Aug 08, 2023 New Risk • Jul 13
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 16% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$17m free cash flow). Earnings are forecast to decline by an average of 16% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (over 10x increase in shares outstanding). Market cap is less than US$10m (US$2.90m market cap). Minor Risks Currently unprofitable and not forecast to become profitable next year (US$21m net loss next year). Share price has been volatile over the past 3 months (14% average weekly change). Annuncio • Jun 06
Nuwellis, Inc. Announces the Appointment of Mike Mccormick to its Board of Directors Nuwellis, Inc. announced that Mike McCormick has been appointed to the company’s Board of Directors. Mr. McCormick’s vast experience includes more than 25 years of service in the medical device industry through varying leadership roles for several private and publicly traded companies. Mr. McCormick will also serve as Lead Independent Director and serve as a member of the Audit Committee and as Chair of the Nominating and Corporate Governance Committee of the Board. From 2010 to 2023, Mr. McCormick served as the Chief Executive officer of Osprey Medical, a publicly traded, commercial-stage interventional cardiology company focused on technologies to reduce contrast-induced acute kidney injury. Prior to Osprey Medical, from 2003 to 2008, Mr. McCormick served as the Chief Executive Officer of Anulex Technologies, Inc., a private company focused on developing proprietary technologies to support the healing of spinal soft tissues. During his tenure, Anulex Technologies was successfully sold to Boston Scientific. Prior to Anulex Technologies, Mr. McCormick was President of Centerpulse Spine-Tech, a publicly traded company that was sold to Zimmer in 2003. Earlier in his career, Mr. McCormick held various sales and sales management positions with Boston Scientific and Baxter. Mr. McCormick received his Bachelor of Business Administration, Business Management degree from the University of Texas at Austin. Mr. McCormick is currently a member of the board of directors at Osprey Medical, Inc., and Formae, Inc. He also previously served on the board of directors at OrthoCor Medical, as a director for the Cardio Renal Society of America and on the board of directors at Anulex Technologies. Major Estimate Revision • May 16
Consensus revenue estimates fall by 19% The consensus outlook for revenues in fiscal year 2023 has deteriorated. 2023 revenue forecast decreased from US$10.9m to US$8.80m. Forecast losses increased from -US$13.08 to -US$17.08 per share. Medical Equipment industry in the US expected to see average net income growth of 18% next year. Consensus price target down from US$21.33 to US$16.00. Share price fell 38% to US$2.74 over the past week. Price Target Changed • May 12
Price target decreased by 27% to US$16.00 Down from US$22.00, the current price target is an average from 3 analysts. New target price is 414% above last closing price of US$3.11. Stock is down 95% over the past year. The company is forecast to post a net loss per share of US$17.08 next year compared to a net loss per share of US$83.48 last year. Reported Earnings • May 10
First quarter 2023 earnings: EPS and revenues miss analyst expectations First quarter 2023 results: US$5.76 loss per share. Revenue: US$1.83m (down 5.2% from 1Q 2022). Net loss: US$6.49m (loss widened 45% from 1Q 2022). Revenue missed analyst estimates by 22%. Earnings per share (EPS) also missed analyst estimates by 52%. Revenue is forecast to grow 46% p.a. on average during the next 3 years, compared to a 8.3% growth forecast for the Medical Equipment industry in the US. Major Estimate Revision • Mar 29
Consensus EPS estimates upgraded to US$13.08 loss The consensus outlook for fiscal year 2023 has been updated. 2023 losses forecast to reduce from -US$16.58 to -US$13.08 per share. Revenue forecast unchanged from US$10.9m at last update. Medical Equipment industry in the US expected to see average net income growth of 14% next year. Consensus price target down from US$22.00 to US$21.33. Share price was steady at US$4.92 over the past week. Reported Earnings • Mar 02
Full year 2022 earnings: EPS and revenues exceed analyst expectations Full year 2022 results: US$83.48 loss per share (improved from US$287 loss in FY 2021). Revenue: US$8.54m (up 7.9% from FY 2021). Net loss: US$14.5m (loss narrowed 26% from FY 2021). Revenue exceeded analyst estimates by 1.6%. Earnings per share (EPS) also surpassed analyst estimates by 42%. Revenue is forecast to grow 37% p.a. on average during the next 3 years, compared to a 7.5% growth forecast for the Medical Equipment industry in the US. Annuncio • Feb 08
Nuwellis, Inc. to Report Q4, 2022 Results on Feb 28, 2023 Nuwellis, Inc. announced that they will report Q4, 2022 results on Feb 28, 2023 Annuncio • Jan 19
Nuwellis, Inc. Announces Board Changes On January 16, 2023, Mr. Steve Brandt provided notice of his resignation from the Board of Directors (the Board") of Nuwellis, Inc. (the Company), effective immediately. Mr. Brandt's resignation was not the result of any disagreement with the Company regarding the Company's operations, policies or practices. Jon W. Salveson, a current director of the Company, was appointed to the Audit Committee of the Board. As a result, the Audit Committee of the Board currently consists of Gregory D. Waller, Warren S. Watson, and Jon W. Salveson. Annuncio • Jan 10
Nuwellis, Inc. Provides Preliminary Revenue Guidance for the Fourth Quarter and Full Year Ended December 31, 2022 Nuwellis, Inc. provided preliminary revenue guidance for the fourth quarter and full year ended December 31, 2022. Preliminary unaudited revenue for the fourth quarter and full year 2022 is anticipated to be approximately $2.3 million and $8.5 million, respectively, representing an increase of 42% and 8% over the same periods last year. Annuncio • Jan 06
Nuwellis Appoints John Jefferies as Chief Medical Officer On January 5, 2023, Nuwellis, Inc. announced the appointment of John Jefferies, MD, MPH, FACC, FHFSA as Chief Medical Officer (CMO). In this new role, Dr. Jefferies will provide Nuwellis with strategic guidance on clinical and medical affairs issues, act as a liaison between the Company and the medical community and serve as a key advisor on corporate development matters. Dr. Jefferies currently serves as the Jay M. Sullivan Endowed Chair in Cardiovascular Medicine and Chief of Cardiology at the University of Tennessee Health Science Center. He will continue in this role while serving as CMO for Nuwellis. Dr. Jefferies began his medical career with a combined residency in internal medicine and pediatrics at the University of Kentucky. Dr. Jefferies then completed a fellowship in general internal medicine and earned a master’s degree in public health from the University of Kentucky before completing an additional combined fellowship in adult cardiovascular diseases and pediatric cardiology at the Baylor College of Medicine. Dr. Jefferies has served on the Nuwellis medical advisory board since 2019. Price Target Changed • Nov 16
Price target decreased to US$2.17 Down from US$3.25, the current price target is an average from 3 analysts. New target price is 1,817% above last closing price of US$0.11. Stock is down 93% over the past year. The company is forecast to post a net loss per share of US$1.31 next year compared to a net loss per share of US$2.87 last year. Board Change • Nov 16
Insufficient new directors There is 1 new director who has joined the board in the last 3 years. The company's board is composed of: 1 new director. 7 experienced directors. 4 highly experienced directors. President, CEO & Director Nestor Jaramillo was the last director to join the board, commencing their role in 2021. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Reported Earnings • Nov 09
Third quarter 2022 earnings: EPS and revenues miss analyst expectations Third quarter 2022 results: US$0.37 loss per share (improved from US$0.74 loss in 3Q 2021). Revenue: US$2.07m (up 11% from 3Q 2021). Net loss: US$3.87m (loss narrowed 27% from 3Q 2021). Revenue missed analyst estimates by 9.5%. Earnings per share (EPS) also missed analyst estimates by 16%. Revenue is forecast to grow 43% p.a. on average during the next 3 years, compared to a 7.5% growth forecast for the Medical Equipment industry in the US. Board Change • Nov 01
Insufficient new directors There is 1 new director who has joined the board in the last 3 years. The company's board is composed of: 1 new director. 7 experienced directors. 4 highly experienced directors. President, CEO & Director Nestor Jaramillo was the last director to join the board, commencing their role in 2021. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Major Estimate Revision • Oct 22
Consensus forecasts updated The consensus outlook for 2022 has been updated. 2022 revenue forecast fell from US$9.16m to US$8.86m. 2022 losses expected to reduce from -US$1.64 to -US$1.39 per share. Medical Equipment industry in the US expected to see average net income growth of 9.7% next year. Consensus price target down from US$3.83 to US$3.25. Share price fell 5.1% to US$0.25 over the past week. Board Change • Oct 02
Insufficient new directors There is 1 new director who has joined the board in the last 3 years. The company's board is composed of: 1 new director. 7 experienced directors. 4 highly experienced directors. President, CEO, Interim CFO, & Director Nestor Jaramillo was the last director to join the board, commencing their role in 2021. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Reported Earnings • Aug 10
Second quarter 2022 earnings: EPS and revenues exceed analyst expectations Second quarter 2022 results: US$0.41 loss per share (up from US$0.72 loss in 2Q 2021). Revenue: US$2.21m (down 12% from 2Q 2021). Net loss: US$4.29m (loss narrowed 9.4% from 2Q 2021). Revenue exceeded analyst estimates by 4.5%. Earnings per share (EPS) also surpassed analyst estimates by 3.9%. Over the next year, revenue is forecast to grow 38%, compared to a 6.2% growth forecast for the industry in the US. Reported Earnings • May 11
First quarter 2022 earnings: EPS and revenues exceed analyst expectations First quarter 2022 results: US$0.42 loss per share (up from US$1.25 loss in 1Q 2021). Revenue: US$1.93m (flat on 1Q 2021). Net loss: US$4.47m (loss narrowed 15% from 1Q 2021). Revenue exceeded analyst estimates by 7.7%. Earnings per share (EPS) also surpassed analyst estimates by 3.1%. Over the next year, revenue is forecast to grow 22%, compared to a 9.0% growth forecast for the industry in the US. Price Target Changed • Apr 27
Price target decreased to US$5.00 Down from US$8.67, the current price target is an average from 3 analysts. New target price is 525% above last closing price of US$0.80. Stock is down 85% over the past year. The company is forecast to post a net loss per share of US$1.66 next year compared to a net loss per share of US$2.87 last year. Reported Earnings • Mar 03
Full year 2021 earnings: EPS and revenues miss analyst expectations Full year 2021 results: US$2.86 loss per share (up from US$10.67 loss in FY 2020). Revenue: US$7.92m (up 6.5% from FY 2020). Net loss: US$19.6m (loss widened 11% from FY 2020). Revenue missed analyst estimates by 5.7%. Earnings per share (EPS) also missed analyst estimates by 2.5%. Over the next year, revenue is forecast to grow 11%, compared to a 11% growth forecast for the industry in the US. Price Target Changed • Dec 20
Price target decreased to US$8.67 Down from US$13.42, the current price target is an average from 3 analysts. New target price is 599% above last closing price of US$1.24. Stock is down 85% over the past year. The company is forecast to post a net loss per share of US$2.94 next year compared to a net loss per share of US$10.67 last year.