Nuwellis, Inc., a medical device company, focuses on developing, manufacturing, and commercializing medical devices used in ultrafiltration therapy. The company's products are the Aquadex FlexFlow and Aquadex SmartFlow systems, which are indicated for the treatment of patients suffering from fluid overload who have failed diuretics. Its Aquadex FlexFlow system includes a console, disposable blood set, and catheter. The company sells its products to hospitals and clinics through its direct salesforce in the United States; and through independent specialty distributors primarily in Austria, Brazil, Brunei, Germany, Greece, Hong Kong, India, Israel, Italy, Palestine, Singapore, Spain, Switzerland, Thailand, and the United Kingdom. The company was formerly known as CHF Solutions, Inc. and changed its name to Nuwellis, Inc. in April 2021. Nuwellis, Inc. was founded in 1999 and is headquartered in Eden Prairie, Minnesota.
IPO Year:
Exchange: NASDAQ
Website: nuwellis.com
| Date | Price Target | Rating | Analyst |
|---|---|---|---|
| 7/29/2024 | $17.00 | Buy | ROTH MKM |
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ROTH MKM initiated coverage of Nuwellis with a rating of Buy and set a new price target of $17.00
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4 - Nuwellis, Inc. (0001506492) (Issuer)
4 - Nuwellis, Inc. (0001506492) (Issuer)
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8-K - Nuwellis, Inc. (0001506492) (Filer)
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ULTRA-Peds Registry, the largest multi-center dataset of its kind, shows Aquadex therapy was well-tolerated in critically ill children, a population with extremely limited treatment options Results highlight life-threatening gaps in pediatric care and underscore Nuwellis' commitment to pediatric innovation and integrated cardio-renal care MINNEAPOLIS, Sept. 30, 2025 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (NASDAQ:NUWE), a medical technology company committed to delivering solutions for patients with cardio-renal conditions, addressing the critical interplay between the heart and kidneys, today announced findings from the ULTRA-Peds registry, a multi-center observational study examining the re
EDEN PRAIRIE, Minn., Sept. 18, 2025 (GLOBE NEWSWIRE) -- Nuwellis, Inc., a fluid management company, today announced that the United States Patent and Trademark Office has issued U.S. Patent No. 12,415,021 on September 16, 2025, based on Application No. 18/298,860. The patent relates to the use of one or more hemolysis sensors with extracorporeal blood filtration systems—such as ultrafiltration therapy and continuous renal replacement therapy (CRRT)—to help detect and localize red blood cell destruction occurring within or around the circuit. The intellectual property supports Nuwellis' pediatric device, Vivian, in development and future platform innovation. Why hemolysis matters Hemolys
Watch the "What This Means" segment here MINNEAPOLIS, Sept. 17, 2025 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (NASDAQ:NUWE), a medical technology company delivering fluid management solutions for critically ill patients, today announced that it participated in a Virtual Investor "What This Means" segment. For the segment, Ryan Marthaler, Vice President of Product Marketing & Business Development of Nuwellis, discussed the Company's recent news release announcing that the National Institutes of Health (NIH) has awarded an approximately $3 million multi-year grant to its development partner, Koronis Biomedical Technologies Corporation (KBT). The NIH-supported program will accelerate Vivian™, Nu
Awarded grant supports dedicated pediatric continuous renal replacement therapy (CRRT) device in development for patients between 2.5 and 20 kg where therapeutic options are scarce Company working to advance Vivian™ towards an investigational device study to support the path to US regulatory clearance MINNEAPOLIS, Sept. 09, 2025 (GLOBE NEWSWIRE) -- Nuwellis Inc. (NASDAQ:NUWE), announced today that the National Institutes of Health (NIH) has awarded an approximately $3 million multi-year grant to its development partner, Koronis Biomedical Technologies Corporation (KBT). The NIH-supported program will accelerate Vivian™, Nuwellis' dedicated pediatric continuous renal replacement thera
MINNEAPOLIS, Sept. 04, 2025 (GLOBE NEWSWIRE) -- Nuwellis, Inc., a fluid management company, 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 alignin
MINNEAPOLIS, Aug. 21, 2025 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (NASDAQ:NUWE), a medical technology company focused on fluid management, today 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 hospi
Proposed acquisition supports strategy to drive technology expansion of fluid management offering to include continuous renal health monitoring technologies supporting the full patient journey, from early risk assessment to targeted fluid removal MINNEAPOLIS, Aug. 19, 2025 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (NASDAQ:NUWE), a medical technology company focused on improving patient outcomes through advanced fluid management, today announced it has signed a non-binding letter of intent (LOI) to acquire Rendiatech, Ltd., an Israeli-based medical device company specializing in real-time urine flow and acute kidney injury monitoring technologies. The proposed acquisition is expected to support N
MINNEAPOLIS, Aug. 15, 2025 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (NASDAQ:NUWE), a medical technology company delivering fluid management solutions for critically ill patients, today announced that it will present at the Webull Financial Corporate Connect Webinar Series: Biotech/MedTech being held virtually August 19-21, 2025. Details for the presentation are as follows: Date/Time: Thursday, August 21, 2025 at 2:40 PM ET Presenter: John Erb, President and Chief Executive OfficerRegistration Link: HERE About Webull Financial Webull Financial is a leading online brokerage platform committed to empowering self-directed investors with innovative tools and cutting-edge technology. With
MINNEAPOLIS, Aug. 14, 2025 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (NASDAQ:NUWE), a commercial-stage medical technology company dedicated to transforming care for fluid overload patients, today announced financial results for the second quarter ended June 30, 2025, and provided a business update. Second Quarter 2025 and Recent Business Highlights Nuwellis continued to advance its strategic realignment during the second quarter, sharpening focus on high-impact growth areas in pediatric and cardiac surgery care while laying the foundation for expansion in outpatient heart failure. Despite temporary r
MINNEAPOLIS, Aug. 07, 2025 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (NASDAQ:NUWE), a medical technology company delivering fluid management solutions for critically ill patients, today announced its decision to exit international operations in order to focus exclusively on the U.S. market—where the company is seeing the strongest growth and clinical demand. This strategic realignment supports Nuwellis' core business strategy: investing in the markets driving revenue growth. With expanding traction in U.S. cardiac surgery and pediatric programs, and a rising opportunity in the hospital-based outpatient space, the company is streamlining to prioritize investment in markets where it can have t
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WHOWHATWHEREWHENHOWJohn ErbAppointed as Chief Executive Officer (no longer serving in an interim capacity)Nuwellis HeadquartersEffective June 27, 2025Appointment confirmed by the Board of Directors following his interim leadership MINNEAPOLIS, July 02, 2025 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (NASDAQ:NUWE), a medical technology company dedicated to advancing solutions in fluid management, today announced the appointment of John Erb as its Chief Executive Officer. Erb, who has served as interim CEO since February 2025, will continue to lead the company with a focus on strategic clarity, operational discipline, and sustainable growth. This marks Erb's return to the CEO role at Nuwellis, havi
MINNEAPOLIS, Feb. 24, 2025 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (NASDAQ:NUWE), a medical technology company focused on transforming the lives of people with fluid overload, announced today that Nestor Jaramillo, Jr. retired as President and Chief Executive Officer and as a director of the company, effective February 18, 2025. John Erb, who currently serves as Chairman of the company's Board of Directors, assumed the role of Interim President and Chief Executive Officer and assumed all of the duties formerly performed by Mr. Jaramillo. Nuwellis intends to retain an executive search firm to assist in identifying a permanent CEO. Mr. Erb, stated, "Nestor has been with the company for nearly si
MINNEAPOLIS, Nov. 01, 2023 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (NASDAQ:NUWE), a medical technology company focused on transforming the lives of people with fluid overload, today announced the appointment of Dave McDonald and Archelle Georgiou, MD, to its board of directors, effective November 1, 2023. "With decades of experience and leadership in their respective fields, we welcome Dave and Archelle to our board. Dave's significant experience in finance and strategy will provide key insights to our board as we advance our growth and expansion initiatives. In turn, our board will benefit from perspectives gained from Archelle's healthcare policy, clinical, and patient education experience
MINNEAPOLIS, June 05, 2023 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (NASDAQ:NUWE), a medical technology company focused on transforming the lives of patients suffering from fluid overload, today 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. "We are delighted to welcome Mike to Nuwellis' Board
MINNEAPOLIS, Jan. 05, 2023 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (NASDAQ:NUWE), a medical technology company focused on transforming the lives of people with fluid overload, today 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. "I am thrilled to welcome Dr. Jefferies in this new role of CMO," said Nestor Jaramillo, Jr., President and CEO of Nuwellis. "Dr. Jefferies' pediatric training and expertise in car
EDEN PRAIRIE, Minn., June 22, 2021 (GLOBE NEWSWIRE) -- Continuing its dynamic growth in support of its commitment to expanding access to life-saving ultrafiltration therapies for adult and pediatric patients suffering from fluid overload, Nuwellis, Inc. (NASDAQ:NUWE), formerly CHF Solutions, Inc., today announced the appointment of George Montague as Chief Financial Officer, effective June 28, 2021. Neil P. Ayotte, Esq. also joined the Company as Senior Vice President, General Counsel, Secretary and Chief Compliance Officer on June 7, 2021. "Nuwellis is entering an energizing new phase with significant opportunities in heart failure, pediatrics and critical care. The deep knowledge and ex
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MINNEAPOLIS, Aug. 06, 2025 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (NASDAQ:NUWE), a medical technology company focused on fluid management, today announced that it will postpone its 2025 second quarter earnings release and conference call, originally scheduled for August 12, 2025. The Company requires additional time to complete its valuations and for its audit firm to complete its related audit procedures. There are no current disagreements with Baker Tilly US, LLP, the Company's auditor. The Company expects to host a conference call and webcast at 9:00 AM ET on August 14, 2025 to discuss its financial results and provide a general business update. To access the live webcast, please visit the
MINNEAPOLIS, July 22, 2025 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (NASDAQ:NUWE), a commercial-stage medical technology company focused on transforming the lives of people with fluid overload, today announced that it will release financial results for the second quarter 2025 on August 12, 2025. Nuwellis will host a conference call and webcast at 9:00 AM ET to discuss its financial results and provide a general business update. To access the live webcast, please visit the Investors page of the Nuwellis website at https://ir.nuwellis.com. Alternatively, you may access the live conference call by dialing 1-800-245-3047 (U.S) or 1-203-518-9765 (international) and using the conference ID: NUWEQ2. A
MINNEAPOLIS, May 13, 2025 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (NASDAQ:NUWE), a commercial-stage medical device company dedicated to transforming care for fluid overload patients, today announced financial results for the first quarter ended March 31, 2025, and provided a business update. First Quarter 2025 and Recent Business Highlights Nuwellis continued to advance its strategic priorities during the first quarter, delivering growth in customer categories and strengthening the foundation for broader adoption of Aquadex therapy. Higher CMS reimbursement, strong pediatric performance, and disciplined expense management position the company to capitalize on both inpatient growth and em
MINNEAPOLIS, April 22, 2025 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (NASDAQ:NUWE), a commercial-stage medical technology company focused on transforming the lives of people with fluid overload, today announced that it will release financial results for the first quarter 2025 on May 13, 2025. Nuwellis will host a conference call and webcast at 9:00 AM ET to discuss its financial results and provide a general business update. To access the live webcast, please visit the Investors page of the Nuwellis website at https://ir.nuwellis.com. Alternatively, you may access the live conference call by dialing 1-800-579-2543 (U.S) or 1-785-424-1789 (international) and using the conference ID: NUWEQ1. An a
MINNEAPOLIS, March 11, 2025 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (NASDAQ:NUWE), a commercial-stage medical device company focused on transforming the lives of people with fluid overload, today reported financial results for the fourth quarter and full year ended December 31, 2024. Recent Highlights: CMS four-fold payment increase to $1,639 for Aquadex Ultrafiltration Therapy in the outpatient setting effective January 1, 2025.New data published in JACC: Heart Failure showed Aquadex ultrafiltration reduced heart failure events by 60% compared to IV diuretics.Full year operating cost reduction of $5.9 million, or 26%, compared to the pr
MINNEAPOLIS, Feb. 18, 2025 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (NASDAQ:NUWE), a commercial-stage medical technology company focused on transforming the lives of people with fluid overload, today announced that it will release financial results for the fourth quarter and full year 2024 on March 11, 2025. Nuwellis will host a conference call and webcast at 9:00 AM ET to discuss its financial results and provide a general business update. To access the live webcast, please visit the Investors page of the Nuwellis website at https://ir.nuwellis.com. Alternatively, you may access the live conference call by dialing 1-800-245-3047 (U.S) or 1-203-518-9765 (international) and using the conference
MINNEAPOLIS, Nov. 11, 2024 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (NASDAQ:NUWE), a medical device company focused on transforming the lives of people with fluid overload, today reported financial results for the third quarter ended September 30, 2024. Recent Highlights: Received a 297% CMS reimbursement increase to $1,639 for Aquadex facility fee, effective January 1, 2025.Revenue of $2.4 million.Pediatrics revenue growth of 28% compared to the prior year quarter.Gross margin of 70%, compared to 57.3% in the prior-year quarter.Total operating cost reduction of 30% compared to the prior-year quarter.New study published in Current Problems in Cardiology highlighted statistically significan
MINNEAPOLIS, Nov. 01, 2024 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (NASDAQ:NUWE), a medical device company dedicated to transforming the lives of patients suffering from fluid overload, today announced certain preliminary, unaudited results for the quarter ended September 30, 2024. The company plans to report its complete results and host its earnings conference call for the third quarter of 2024 on November 11, 2024. 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.Revenue growth of 28% in the Pediatric customer category compared to the same period
MINNEAPOLIS, Oct. 23, 2024 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (NASDAQ:NUWE), a medical technology company focused on transforming the lives of people with fluid overload, today announced that it will release financial results for the third quarter of 2024 on Monday, November 11, 2024. Nuwellis will host a conference call and webcast at 9:00 AM ET to discuss its financial results and provide a general business update. To access the live webcast, please visit the Investors page of the Nuwellis website at https://ir.nuwellis.com. Alternatively, you may access the live conference call by dialing 1-800-445-7795 (U.S) or 1-785-424-1789 (international) and using the conference ID: NUWEQ3. An aud
MINNEAPOLIS, July 23, 2024 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (NASDAQ:NUWE), a medical technology company focused on transforming the lives of people with fluid overload, today announced that it will release financial results for the second quarter of 2024 on Tuesday, August 13, 2024. Nuwellis will host a conference call and webcast at 9:00 AM ET to discuss its financial results and provide a general business update. To access the live webcast, please visit the Investors page of the Nuwellis website at https://ir.nuwellis.com. Alternatively, you may access the live conference call by dialing 1-800-267-6316 (U.S) or 1-203-518-9783 (international) and using the conference ID: NUWEQ2. An aud
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