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Nuwellis, Inc. - NUWE STOCK NEWS

Welcome to our dedicated page for Nuwellis news (Ticker: NUWE), a resource for investors and traders seeking the latest updates and insights on Nuwellis stock.

Nuwellis, Inc. (Nasdaq: NUWE) is a medical technology company dedicated to transforming the lives of patients suffering from fluid overload through innovative solutions. The company's flagship products include the Aquadex SmartFlow System and the RenalSense Clarity RMS. The Aquadex SmartFlow System is designed for patients who have not responded to diuretics, offering a clinically proven method to remove excess fluid safely. The RenalSense Clarity RMS is a continuous kidney monitoring system that provides real-time data to medical staff, enhancing patient care.

Recently, Nuwellis announced promising results from new clinical data analyses from the AVOID-HF trial. These studies highlight the effectiveness of the Aquadex System in reducing heart failure readmissions within 30 days, presenting a potential superior therapy compared to traditional diuretics. The re-analysis of the AVOID-HF data demonstrates significant benefits in managing heart failure events and hospitalizations.

Nuwellis is also advancing in pediatric care with a new, fully integrated pediatric continuous renal replacement therapy (CRRT) device. This initiative is partly funded by a $1.7 million grant from the National Institutes of Health (NIH), indicating the company's commitment to addressing the needs of young patients with limited kidney function.

The company has a robust intellectual property portfolio, including a recent patent that allows for seamless transitions between stationary and mobile operation modes, enhancing patient flexibility and care. This technology, along with ongoing clinical trials and collaborations, positions Nuwellis as a leader in fluid management and ultrafiltration therapy.

Nuwellis is headquartered in Minneapolis, with a subsidiary in Ireland, and continues to push the boundaries of medical technology to improve patient outcomes worldwide. For more information, visit www.nuwellis.com.

News

Nuwellis’ Strategic Partner, SeaStar Medical, Receives FDA Approvable Letter for Its Pediatric Selective Cytopheretic Device

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Nuwellis, Inc. announces that its strategic partner, SeaStar Medical Holding Corporation, has received an Approvable Letter from the FDA for its pediatric Selective Cytopheretic Device (SCD-PED). The SCD-PED will provide a new therapy option for children with acute kidney injury and sepsis. The Approvable Letter indicates that SeaStar Medical's HDE application meets the requirements for an Approval Order, with minor administrative steps remaining. Clinical data showed a 77% reduction in mortality rate and no dialysis dependency at Day 601,2.
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Nuwellis, Inc. To Announce Third Quarter 2023 Financial Results on November 7, 2023

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Nuwellis, Inc. to release Q3 2023 financial results on November 7, 2023
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Nuwellis Announces Closing of $2.25 Million Public Offering of Series J Convertible Redeemable Preferred Stock and Warrants

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Nuwellis, Inc. has closed its public offering of 150,000 units, consisting of Series J Convertible Redeemable Preferred Stock and warrants. The purchase price for one unit was $15. The Series J Convertible Preferred Stock has a term of three years and is convertible at the option of the holder. Dividends on the Series J Convertible Preferred Stock will be paid in-kind in additional shares. The gross proceeds from the offering were approximately $2.25 million.
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Nuwellis Announces Pricing of $2.25 Million Public Offering of Series J Convertible Redeemable Preferred Stock and Warrants

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Nuwellis, Inc. announces pricing of public offering of 150,000 units
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Nuwellis Provides Regulatory Update on SeaStar Medical’s Selective Cytopheretic Device Use in Pediatric Acute Kidney Injury Under a Humanitarian Device Exemption

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Nuwellis announces FDA approval progress for pediatric kidney therapy device
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Nuwellis to Present at the Gilmartin Group Emerging Growth Showcase

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Nuwellis, Inc. to participate in fireside chat at Gilmartin Group Emerging Growth Showcase
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Nuwellis, Inc. Announces Second Quarter 2023 Financial Results

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Nuwellis reports Q2 2023 financial results with revenue of $2.1 million, a 14% increase over the prior quarter. Gross margin rate improves to 55.3%. The company enters a Supply and Collaboration Agreement with DaVita Inc. Cash and cash equivalents are approximately $9 million with no debt.
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Nuwellis Announces Plan for CFO Transition

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Nuwellis, Inc. (NUWE) announces the transition of CFO Lynn Blake and the appointment of Rob Scott as her successor. Ms. Blake will remain in her role through September 1, 2023, and consult with the Company through March 31, 2024. Mr. Scott, a 10-year veteran of Nuwellis, is set to be appointed as CFO at the next Board of Directors meeting. The company expresses gratitude to Ms. Blake for her contributions and excitement for Rob's promotion.
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Nuwellis, Inc. To Announce Second Quarter 2023 Financial Results on August 8, 2023

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Nuwellis, Inc. will release its second quarter 2023 financial results on August 8, 2023. The company will host a conference call and webcast to discuss the results and provide a general business overview.
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Nuwellis Inc. Announces Pilot Agreement With DaVita Inc.

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Nuwellis, Inc. has entered into a Supply and Collaboration Agreement with DaVita Inc. to pilot Aquadex ultrafiltration therapy in select U.S. markets. The agreement aims to expand access to ultrafiltration therapy for heart failure patients and reduce healthcare costs. The pilot program is expected to launch by the end of Q3 2023.
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FAQ

What is the current stock price of Nuwellis (NUWE)?

The current stock price of Nuwellis (NUWE) is $1.06 as of December 23, 2024.

What is the market cap of Nuwellis (NUWE)?

The market cap of Nuwellis (NUWE) is approximately 4.3M.

What does Nuwellis, Inc. specialize in?

Nuwellis, Inc. specializes in medical technology focused on ultrafiltration therapy and fluid management solutions, primarily for heart failure and critical care patients.

What is the Aquadex SmartFlow System?

The Aquadex SmartFlow System is a medical device that removes excess fluid from patients who have not responded to diuretics, providing an effective treatment for fluid overload.

What recent clinical trials have Nuwellis conducted?

Nuwellis recently announced results from the AVOID-HF trial, which demonstrated the benefits of their Aquadex System in reducing heart failure readmissions and hospitalizations.

What is the RenalSense Clarity RMS?

The RenalSense Clarity RMS is a kidney monitoring system that provides real-time, continuous measurement of urine output and flow, aiding medical staff in patient care.

What innovations has Nuwellis introduced for pediatric patients?

Nuwellis is developing a pediatric continuous renal replacement therapy (CRRT) device, funded in part by a $1.7 million NIH grant, to better support young patients with kidney issues.

Where is Nuwellis headquartered?

Nuwellis, Inc. is headquartered in Minneapolis, Minnesota, with a wholly owned subsidiary in Ireland.

How does the Aquadex SmartFlow System benefit patients?

The Aquadex SmartFlow System offers a safe and effective method of fluid removal for patients unresponsive to diuretics, improving patient outcomes and reducing hospital readmissions.

Does Nuwellis have any recent patents?

Yes, Nuwellis recently received a patent for a feature that allows seamless switching between stationary and mobile operation modes, enhancing patient mobility and care.

What partnerships does Nuwellis have?

Nuwellis collaborates with various institutions, including a partnership with Koronis Biomedical Technologies Corporation for developing pediatric renal replacement therapy devices.

What is the focus of Nuwellis' business strategy?

Nuwellis focuses on developing innovative fluid management technologies, expanding their clinical and economic evidence base, and building a strong intellectual property portfolio.

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Nuwellis, Inc.

Nasdaq:NUWE

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NUWE Stock Data

4.33M
4.34M
1.6%
1.46%
17.27%
Medical Devices
Electromedical & Electrotherapeutic Apparatus
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United States of America
EDEN PRAIRIE