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Nuwellis, Inc. - NUWE STOCK NEWS

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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.

Rhea-AI Summary

Nuwellis, a medical tech firm, announced on May 14, 2024, the expansion of its pediatric ultrafiltration program using the Aquadex SmartFlow System at a major hospital network in Florida. This initiative expands their current service, which caters to adult heart failure and critical care patients, to include pediatric patients.

Currently, seven hospitals within this network use Nuwellis' technology. This expansion enhances fluid management strategies across the healthcare system for all age groups.

The Aquadex system, FDA-cleared for both adults and pediatric patients over 20 kg, safely removes excess fluid from patients unresponsive to conventional diuretics. The device features customizable fluid removal rates and real-time hematocrit monitoring, important for pediatric care.

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Nuwellis, Inc. (Nasdaq: NUWE) has announced a purchase agreement with a top 25 integrated delivery network in the U.S., involving 50 hospitals, to provide Aquadex Ultrafiltration Therapy. This agreement aims to expand access to advanced ultrafiltration technology for heart failure, critical care, and pediatric patients, demonstrating a commitment to innovative treatment options.

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Nuwellis, Inc. reported financial results for Q1 2024 with revenue of $1.9 million, a 2% increase over the prior year. Consumables sales grew by 11%, pediatric revenue increased by 40%, and gross margin improved to 64.1%. The company received FDA clearance for a new catheter and launched Aquadex ultrafiltration therapy. Expense reductions of nearly 50% are expected for the rest of the year.

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Nuwellis, Inc. (Nasdaq: NUWE) has received a Notice of Allowance from the USPTO for a patent related to its innovative pediatric Continuous Renal Replacement Therapy (CRRT) device Vivian™. This patent enhances Nuwellis' IP portfolio, enabling healthcare providers to seamlessly switch between stationary and transport modes for improved patient care. The company is also developing a new pediatric CRRT device with NIH funding, in collaboration with Koronis Biomedical Technologies , to better care for children with kidney issues.

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Nuwellis, Inc. announced the closing of a $2.7 million public offering, issuing 11,250,000 shares of common stock and warrants. The gross proceeds will be used for working capital and general corporate purposes, including investments in commercialization efforts.

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Nuwellis, Inc. (NUWE) will report its first quarter 2024 financial results on May 7, 2024. The medical technology company will host a conference call and webcast to discuss the results and provide a business update.

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Nuwellis, Inc. (NUWE) announced the pricing of a $2.7 million public offering, including 11,250,000 shares of common stock and warrants to purchase up to 16,875,000 shares at $0.24 per share. Each share comes with a warrant to purchase 1.5 additional shares at an exercise price of $0.40 per share.

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Nuwellis, Inc. (NUWE) collaborates with Henry Ford Health to offer ultrafiltration therapy to heart failure patients as part of the REVERSE-HF study. The Aquadex SmartFlow system aims to improve clinical outcomes for patients resistant to diuretics, potentially revolutionizing heart failure treatment. Nuwellis focuses on addressing the therapy needs of the expanding heart failure patient population while reducing overall healthcare costs.
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Nuwellis, Inc. (NUWE) presents positive clinical data analysis from the AVOID-HF trial at the THT conference. Results show Aquadex System's superiority in reducing heart failure readmissions and predicting patient response. Ultrafiltration therapy outperformed intravenous diuretics, with fewer heart failure events and hospitalizations. AI and ML models identified top predictors for 90-day heart failure events, aiding in personalized treatment plans.
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Nuwellis, Inc. (NUWE) reported strong financial results for Q4 and full year 2023, with record revenue, expanding margins, and growth in pediatric sales. The company achieved a 9% increase in Q4 revenue, reaching $2.6 million, and a 4% increase in full-year revenue, totaling $8.9 million. Fourth quarter pediatric revenue grew by 35% year over year, with a 28% increase in utilization and a 49% increase in console sales. Nuwellis added new products, including a 12 cm dELC catheter and the Quelimmune SCD pediatric device. The company also received FDA approval for Quelimmune, enhancing its pediatric portfolio. Nuwellis showcased new clinical data and hosted a symposium at the THT conference to present Aquadex system trials. Despite challenges in the first half of 2023, the company achieved 27% revenue growth in the second half. Nuwellis aims to build on its momentum in 2024 with new clinical applications and product introductions.
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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.

Nuwellis, Inc.

Nasdaq:NUWE

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