 Nuwellis

Nuwellis, Inc. operates as a medical device company. It engages in the provision of products for the treatment of fluid overload. The firm's products include Aquadex FlexFlow System, which provides an ultrafiltration for the removal of salt and water in patients with hypervolemia, or fluid overload. It operates through Cardiac and Coronary Disease Products segment. The company was founded by Crispin Marsh and William S. Peters in November 1999 and is headquartered in Eden Prairie, MN.

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Nuwellis reports revenue growth and margin improvement in Q1 2024

Nuwellis' Q1 2024 performance showed revenue growth driven by consumable utilization, improved margins, and reduced operating losses. Challenges in critical care revenue persist, but expense reductions and growth opportunities in pediatrics signal a positive outlook.

Nuwellis reports revenue growth and operational improvements in Q2 2024

Nuwellis (NUWE) showed improved financial performance in Q2 2024 with revenue growth and reduced operating loss, despite challenges in the pediatric segment.
The company's strengths lie in successful product launches, financial stability, and increasing market presence, while facing challenges in pediatric revenue and R&D expenses.
Opportunities for Nuwellis include leveraging positive momentum, expanding product adoption, and capitalizing on its strong financial position for future growth.

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MINNEAPOLIS, Nov. 05, 2024 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE) (“Nuwellis” or the “Company”), a commercial-stage medical device company committed to transforming the lives of people with fluid overload, today announced the entry into definitive agreements for the immediate exercise of certain outstanding warrants issued by the Company on April 30, 2024 (collectively, the “Existing Warrants”) to purchase up to an aggregate of 1,832,517 shares of the Company's common stock at their current exercise price of $2.10 per share for total gross proceeds of approximately $3.8 million, prior to deducting inducement agent fees and estimated offering expenses. An additional $1.3 million of gross proceeds was received through the exercise of warrants over the last week in accordance with their original terms.

Nuwellis Announces Exercise of Warrants for $5.1 Million of Gross Proceeds

Reimbursement rate to increase 397% per day effective January 1, 2025 New rate expected to encourage adoption of ultrafiltration therapy in the outpatient setting MINNEAPOLIS, Nov. 04, 2024 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a commercial-stage medical device company committed to transforming the lives of people with fluid overload, is pleased to announce that the Centers for Medicare and Medicaid Services (CMS) will reassign the Aquadex ultrafiltration code to the outpatient reimbursement level most consistent with administration of ultrafiltration therapy and cost of treatment. Effective January 1, 2025, the payment rate will increase 397% from $413 to $1,639 per day.

Nuwellis Receives Increased Reimbursement Rate for Aquadex SmartFlow® Therapy from the Centers for Medicare and Medicaid

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.

Nuwellis Announces Preliminary Results for Third Quarter of 2024

MINNEAPOLIS, Oct. 31, 2024 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company dedicated to transforming the lives of patients with fluid overload, is pleased to announce that University of Iowa Health Care Stead Family Children's Hospital in Iowa City, Iowa, has adopted the Aquadex SmartFlow® system to treat pediatric patients suffering from fluid overload due to heart and kidney disease.

Nuwellis Welcomes University of Iowa Health Care Stead Family Children's Hospital as Newest Pediatric Customer

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.

Nuwellis, Inc. To Report Third Quarter 2024 Financial Results on November 11, 2024

MINNEAPOLIS, Sept. 25, 2024 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company dedicated to transforming the lives of patients with fluid overload, is pleased to announce that President and Chief Executive Officer Nestor Jaramillo will participate in ROTH Capital Partners' third annual ROTH Healthcare Opportunities Conference on Wednesday, October 9, 2024.

Nuwellis to Present at the Third Annual ROTH Healthcare Opportunities Conference

MINNEAPOLIS, Aug. 23, 2024 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE) (“Nuwellis” or the “Company”), a medical technology company focused on transforming the lives of people with fluid overload, today announced that it has entered into a definitive securities purchase agreement with certain institutional investors for the purchase and sale of 496,901 shares of the Company's common stock at a price of $1.8450 per share of common stock in a registered direct offering priced at-the-market under Nasdaq rules.

Nuwellis Announces Pricing of $916,000 Registered Direct Offering Priced At-The-Market Under Nasdaq Rules

Nuwellis, Inc. (NASDAQ:NUWE ) Q2 2024 Earnings Conference Call August 13, 2024 9:00 AM ET Company Participants Vivian Cervantes - Gilmartin Group, Investor Relations Nestor Jaramillo - President, CEO & Director Rob Scott - Chief Financial Officer Conference Call Participants Jonathan Aschoff - Roth Anthony Vendetti - Maxim Group Operator Good morning. And welcome to the Nuwellis Earnings Conference Call for the Second Quarter ended June 30th, 2024.

Nuwellis, Inc. (NUWE) Q2 2024 Earnings Call Transcript

MINNEAPOLIS, Aug. 13, 2024 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company focused on transforming the lives of people with fluid overload, today reported financial results for the second quarter ended June 30, 2024.

Nuwellis, Inc. Announces Second Quarter 2024 Financial Results

MINNEAPOLIS, July 26, 2024 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company dedicated to transforming the lives of patients suffering from fluid overload, today announced that the first patient has been treated with the newly launched QUELIMMUNE™ therapy in a commercial setting at Cincinnati Children's. QUELIMMUNE, manufactured for SeaStar Medical (Nasdaq: ICU) and exclusively licensed and distributed in U.S. pediatric hospitals by Nuwellis, is a novel therapy designed to treat pediatric patients (weighing 10 kg or more) suffering from acute kidney injury (AKI) with sepsis or a septic condition and requiring kidney replacement therapy (KRT).

Nuwellis Announces First Pediatric Patient Treated in a Commercial Setting with SeaStar Medical's QUELIMMUNE™ Therapy at Cincinnati Children's

MINNEAPOLIS, July 24, 2024 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE) (“Nuwellis” or the “Company”), a medical technology company focused on transforming the lives of people with fluid overload, today announced that it has entered into a definitive securities purchase agreement with certain institutional investors for the purchase and sale of 469,340 shares of the Company's common stock at a price of $4.24 per share of common stock in a registered direct offering priced at-the-market under Nasdaq rules.

Nuwellis Announces Pricing of $2.0 Million Offering Priced At-The-Market Under Nasdaq Rules

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.

Nuwellis, Inc. To Report Second Quarter 2024 Financial Results on August 13, 2024

MINNEAPOLIS, July 17, 2024 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company dedicated to transforming the lives of patients suffering from fluid overload, is proud to announce its first commercial sale of QUELIMMUNE™, a novel therapy developed by SeaStar Medical Holding Corporation for pediatric patients suffering from an uncontrolled inflammatory response triggered by their immune systems, to Cincinnati Children's. We believe this milestone marks a significant advancement in pediatric critical care and underscores Nuwellis' commitment to revolutionizing pediatric patient outcomes.

Nuwellis Marks First Commercial Sale of QUELIMMUNE™ Therapy to Cincinnati Children's

MINNEAPOLIS, June 26, 2024 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE) (“Nuwellis” or the “Company”), a medical technology company focused on transforming the lives of people with fluid overload, announced today a 1-for-35 reverse split (the “Reverse Stock Split”) of its common stock, par value $0.0001 (the “Common Stock”), effective at 5:00 pm Eastern Time June 27, 2024. Beginning on June 28, 2024, the Company's Common Stock will trade on The Nasdaq Capital Market on a split-adjusted basis.

Nuwellis Announces Reverse Stock Split

MINNEAPOLIS, June 25, 2024 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company focused on transforming the lives of people with fluid overload, today announced the recent grant of a new patent from the United States Patent and Trademark Office (USPTO) related to its groundbreaking pediatric continuous renal replacement therapy (CRRT), Vivian™. This patent covers critical advancements that will significantly improve the performance and user experience of Vivian. This is the second of several forthcoming patents for Vivian, underscoring Nuwellis' commitment to development of novel technology designed to improve treatment options for critically ill children.

Nuwellis Secures New Patent for Innovative Pediatric Continuous Renal Replacement Therapy, Vivian™

DaVita

DaVita DVA recently extended the pilot phase of a previously announced supply and collaboration agreement with Nuwellis NUWE until Aug 31, 2024.At the conclusion of the pilot phase, DaVita may extend the supply agreement with Nuwellis for continued provision of both inpatient and outpatient ultrafiltration services for up to 10 years.

DaVita, Nuwellis Extend Pilot Collaboration for Aquadex

Pilot Collaboration for Aquadex® Ultrafiltration Therapy for Adult Patients with Congestive Heart Failure is extended to August 31, 2024 Pilot Collaboration for Aquadex® Ultrafiltration Therapy for Adult Patients with Congestive Heart Failure is extended to August 31, 2024

Nuwellis and DaVita Extend Supply and Collaboration Agreement Pilot Phase

MINNEAPOLIS, May 14, 2024 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company focused on transforming the lives of people with fluid overload, today announced the launch of a new pediatric ultrafiltration program utilizing Nuwellis' Aquadex SmartFlow System® at one of the largest health integrated delivery networks (IDN) in Florida. This program marks an expansion by this network to offer ultrafiltration to its pediatric patients, in addition to its current heart failure and critical care patients.

Nuwellis Announces Expansion of Ultrafiltration Program to Pediatric Patients at One of the Largest Hospital Networks in Florida

MINNEAPOLIS, May 09, 2024 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company focused on transforming the lives of people with fluid overload, today announced a new purchase agreement with one of the top 25 largest integrated delivery networks (IDN) in the U.S.

Nuwellis Announces Purchase Agreement with a 50 Hospital Network for Aquadex Ultrafiltration Therapy

Nuwellis, Inc. (NASDAQ:NUWE ) Q1 2024 Earnings Conference Call May 7, 2024 9:00 AM ET Company Participants Vivian Cervantes - Investor Relations Nestor Jaramillo - President and Chief Executive Officer Rob Scott - Chief Financial Officer Conference Call Participants Anthony Vendetti - Maxim Group Operator Good day and welcome to the Nuwellis First Quarter 2024 Earnings Conference Call. All participants will be in a listen-only mode.

Nuwellis, Inc. (NUWE) Q1 2024 Earnings Call Transcript

MINNEAPOLIS, May 07, 2024 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company focused on transforming the lives of people with fluid overload, today reported financial results for the first quarter ended March 31, 2024.

Nuwellis, Inc. Announces First Quarter 2024 Financial Results

MINNEAPOLIS, April 30, 2024 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE) (“Nuwellis” or the “Company”), a medical technology company focused on transforming the lives of people with fluid overload, today announced the closing of its previously announced public offering of 11,250,000 shares of its common stock (or pre-funded warrants in lieu thereof) and warrants to purchase up to an aggregate of 16,875,000 shares of its common stock at a combined public offering price of $0.24 per share (or pre-funded warrant in lieu thereof) and associated warrant. Each share of common stock (or prefunded warrant in lieu thereof) was sold together with one warrant to purchase one and a half shares of common stock. The warrants have an exercise price of $0.40 per share, are exercisable immediately upon issuance, and will expire five years following the date of issuance.

Nuwellis Announces Closing of $2.7 Million Public Offering

MINNEAPOLIS, April 30, 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 first quarter of 2024 on Tuesday, May 7, 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.

Nuwellis, Inc. To Report First Quarter 2024 Financial Results on May 7, 2024

MINNEAPOLIS, April 26, 2024 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE) (“Nuwellis” or the “Company”), a medical technology company focused on transforming the lives of people with fluid overload, today announced the pricing of a public offering of 11,250,000 shares of its common stock (or pre-funded warrants in lieu thereof) and warrants to purchase up to an aggregate of 16,875,000 shares of its common stock at a combined public offering price $0.24 per share (or pre-funded warrant in lieu thereof) and associated warrant. Each share of common stock (or prefunded warrant in lieu thereof) is being sold together with one warrant to purchase one and a half shares of common stock. The warrants will have an exercise price of $0.40 per share, are exercisable immediately upon issuance, and will expire five years following the date of issuance.

Nuwellis Announces Pricing of $2.7 Million Public Offering

- Analysis demonstrates the statistically superior benefits of ultrafiltration therapy in heart failure events and heart failure hospitalizations compared to intravenous loop diuretics-  Artificial intelligence and machine learning-based model show that lifestyle and clinical factors can be strong predictors of heart failure events

Late-Breaking Data Highlighting Benefits of Ultrafiltration Therapy Using the Aquadex System for Heart Failure Patients was Presented at the Technology and Heart Failure Therapeutics Conference

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