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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.

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Nuwellis, Inc. (NASDAQ: NUWE) was recognized at the 2021 R&D 100 Awards for its Aquadex SmartFlow® system, winning in the Analytical/Test category. This award highlights products with significant technological contributions. The Aquadex system effectively removes excess fluid from patients unresponsive to diuretics, with a removal rate of up to 500 mL per hour. Since its FDA clearance in February 2020 for pediatric use, it has been implemented in various leading hospitals. Nuwellis aims to expand treatment options in this vital area.

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Nuwellis has been awarded the 2021 Governor's International Trade Award by Minnesota Governor Tim Walz, recognizing the company for its growth in foreign markets. This honor highlights Nuwellis' commitment to sustaining jobs in Minnesota while promoting its Aquadex SmartFlow® System, an ultrafiltration therapy for fluid-overloaded patients. The firm has expanded its operations internationally, including recent market entries in Austria, Israel, and the UAE, and holds distribution agreements covering 18 countries. In September 2021, Nuwellis received CE Mark certification for its 24-Hour Blood Circuit Set, further broadening its market reach.

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Nuwellis, Inc. (NASDAQ: NUWE) announced the release date for its third quarter 2021 financial results, set for November 9, 2021. The company will also hold a conference call at 9:00 AM ET to discuss these results along with a general business overview. Investors can access the call via the company’s website or by dialing in. As a medical device company, Nuwellis focuses on innovative solutions for patients suffering from fluid overload, primarily through its Aquadex SmartFlow® system.

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Nuwellis has received CE Mark Certification for its 24-Hour Blood Circuit Set (UF 500-24 Hour), enabling marketing in the EU and other recognized countries. This device, used with the Aquadex SmartFlow® system, enhances outpatient ultrafiltration treatment accessibility for patients not responding to diuretics. The certification supports Nuwellis' strategy to meet clinical and economic needs in Europe, particularly in outpatient settings, and addresses hospital capacity pressures exacerbated by the pandemic.

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Nuwellis, Inc. (NASDAQ:NUWE) has successfully closed an underwritten public offering of 4,005,588 shares at $2.50 each, raising approximately $10 million, including the full exercise of an over-allotment option. The funds will be used for general corporate purposes, particularly enhancing commercialization efforts. The offering was executed under a shelf registration statement filed with the SEC. Ladenburg Thalmann & Co. served as the sole book-running manager for this transaction.

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Nuwellis, Inc. (NASDAQ:NUWE) announced the pricing of an underwritten public offering of 3,483,120 shares at $2.50 each, generating approximately $8.7 million before expenses. An additional 522,468 shares may be purchased by underwriters within 45 days. The proceeds will support general corporate purposes, particularly commercialization efforts. The offering is part of a shelf registration statement filed with the SEC. Closing is expected on or about September 17, 2021, subject to customary conditions.

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Nuwellis, Inc. (NASDAQ:NUWE) announced plans for an underwritten public offering of its common stock, with the possibility for underwriters to purchase an additional 15% of shares. Proceeds from the offering will be used for general corporate purposes, enhancing commercialization efforts. The offering is subject to market conditions, and no assurance can be made regarding completion or terms. Ladenburg Thalmann & Co. Inc. is the sole book-running manager for the offering, which follows the company’s effective shelf registration statement.

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Nuwellis, Inc. (NASDAQ: NUWE) announced the approval of an equity award under its 2021 Inducement Plan for a new employee, effective September 13, 2021. The award includes an option to purchase 5,965 shares at an exercise price of $4.02, reflecting the stock's closing price on the grant date. The option vests over four years, with 25% vesting after the first year. Nuwellis specializes in medical devices, focusing on the Aquadex SmartFlow® system for treating fluid overload in patients. This award complies with NASDAQ Listing Rule 5635(c)(4), necessitating public notice of non-stockholder approved equity awards.

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Nuwellis, Inc. (NASDAQ: NUWE) announced its participation in two upcoming investor conferences. Nestor Jaramillo Jr. and George Montague will represent the company at the H.C. Wainwright 23rd Annual Global Investment Conference on September 13, 2021, at 7:00 AM ET, and at the Lake Street Capital Markets 5th Annual Best Ideas Growth Conference on September 14, 2021, at 11:00 AM ET. The webcasts will be accessible on Nuwellis’ Investor Relations website, with a replay available for 90 days post-event.

Nuwellis focuses on solutions for patients with fluid overload, featuring the Aquadex SmartFlow system.

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Nuwellis, Inc. (NASDAQ: NUWE) announced on August 24, 2021, that independent directors approved equity awards for four new hires under the 2021 Inducement Plan. These awards, as per NASDAQ Listing Rule 5635(c)(4), consisted of options to purchase a total of 42,345 shares of common stock at an exercise price of $4.57 per share, equal to the closing price on the grant date. The options have a ten-year term, vesting over four years, contingent on continued employment. Nuwellis focuses on the Aquadex SmartFlow system for treating fluid overload in patients.

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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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