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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, Inc. To Report Fourth Quarter and Full Year 2023 Financial Results on March 5, 2024

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Nuwellis, Inc. (NUWE) will release financial results for Q4 and full year 2023 on March 5, 2024. The company focuses on fluid overload solutions. A conference call and webcast will discuss financials and business updates.
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Nuwellis’ Distribution Partner, SeaStar Medical, Receives FDA Humanitarian Device Exemption for Pediatric Selective Cytopheretic Device Quelimmune™

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Nuwellis, Inc. announces FDA approval for SeaStar Medical's pediatric Selective Cytopheretic Device, Quelimmune, to treat acute kidney injury and sepsis in children, showing a 50% mortality rate reduction. Nuwellis plans targeted commercial launch activities in 2024.
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Nuwellis, Inc. Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

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Nuwellis, Inc. (NUWE) announced equity awards under its 2021 Inducement Plan for new employees. The awards include options to purchase 764 shares at $0.70 each, vesting over four years.
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Nuwellis to Announce Late-Breaking Clinical Data and Host Satellite Symposium at Technology and Heart Failure Therapeutics Conference

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Nuwellis, Inc. (NUWE) to showcase its Aquadex SmartFlow system at THT 2024 conference, featuring presentations by key experts on new developments in aquapheresis and AI-assisted identification of super responders for heart failure management.
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New Case Series Demonstrates Potential of Aquadex Therapy for End-Stage Liver Disease Patients with Fluid Overload

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Nuwellis, Inc. announces promising findings for Aquadex SmartFlow® system in treating fluid overload in end-stage liver disease patients. The new data demonstrates the potential value of aquapheresis therapy in removing excess fluid for patients who don't respond to diuretics, offering a new market opportunity for the company. The study shows positive results in treating patients with end-stage liver disease, including improved mobility, reduced frailty, and the potential to enhance their ability to receive a life-saving liver transplant.
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Nuwellis Receives FDA Clearance for an Additional Dual Lumen Extended Length Peripheral Catheter

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Nuwellis, Inc. (Nasdaq: NUWE) has received FDA clearance for its specialty peripheral dual lumen extended length catheter (dELC), providing an alternative peripheral access for ultrafiltration therapy across a broad range of patient physiologies. The new 12 cm dELC offers the same features as the longer 16 cm option but eliminates the need for trimming when a shorter catheter is needed. The Aquadex system is proven to remove excess fluid from patients suffering from fluid overload who have not responded to conventional medical management, including diuretics. It is cleared by the FDA for use in adults and pediatric patients weighing 20 kg (44 lbs.) or more.
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New Real-World Data Highlight the Clinical Benefits of Ultrafiltration Therapy with Hematocrit Monitoring for Pediatric Patients

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Nuwellis, Inc. (NUWE) announces new real-world data demonstrating the effectiveness of Aquadex® ultrafiltration therapy with continuous hematocrit monitoring for pediatric patients with fluid overload. The data, featured in Pediatric Nephrology, show successful treatment of small patients without complications, validating Aquadex as an effective treatment option for fluid overload.
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Nuwellis, Inc. Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

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Nuwellis, Inc. (NUWE) Approves Equity Awards Under 2021 Inducement Plan for New Hires. The company's independent directors approved equity awards as material inducements to five individuals entering into employment with the company. The options to purchase a total of 1,943 shares of the company's common stock were granted at an exercise price of $0.60 per share, with a ten-year term and vesting over a period of four years.
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Nuwellis, Inc. Announces Third Quarter 2023 Financial Results

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Nuwellis, Inc. reported a 17% revenue growth for the third quarter of 2023, driven by a 26% increase in circuit sales. The company also achieved a 26% increase in therapy utilization and continued revenue growth across all customer categories. Despite a decrease in gross margin and a net loss of $3.4 million, Nuwellis closed a public offering with gross proceeds of $2.25 million.
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Nuwellis Announces Board of Directors Transition

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Nuwellis, Inc. has appointed Dave McDonald and Dr. Archelle Georgiou, MD, to its board of directors. McDonald has extensive experience in finance and strategy, while Dr. Georgiou brings expertise in healthcare policy and patient education. The company aims to drive market penetration of its Aquadex® ultrafiltration therapy for patients with fluid overload.
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FAQ

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

The current stock price of Nuwellis (NUWE) is $1 as of December 20, 2024.

What is the market cap of Nuwellis (NUWE)?

The market cap of Nuwellis (NUWE) is approximately 4.4M.

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.

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4.37M
4.34M
1.6%
1.46%
17.27%
Medical Devices
Electromedical & Electrotherapeutic Apparatus
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United States of America
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