Nuwellis Inc Stock Price, News & Analysis

Nuwellis (NUWE) reported preliminary Q3 2024 results with revenue of approximately $2.4 million. The company achieved 28% revenue growth in the Pediatric category year-over-year and improved gross margin to 70%, up 12.7% from 57.3% in Q3 2023. Operating costs were reduced by approximately 30% compared to the same period. The company ended the quarter with $1.9 million in cash, with quarterly cash burn of $2.5 million. Nuwellis acquired five new accounts and received a $900,000 settlement from SeaStar Medical, with $500,000 already paid.

Nuwellis announces that University of Iowa Health Care Stead Family Children's Hospital has adopted the Aquadex SmartFlow® system for treating pediatric patients with fluid overload due to heart and kidney disease. The system provides adjustable ultrafiltration therapy for critically ill children experiencing excess fluid buildup. Dr. Kyle Merrill, Associate Medical Director of Pediatric Dialysis, highlights that fluid overload increases ICU time, ventilator dependency, and mortality rates. The hospital previously relied on diuretics and conventional dialysis methods. The Aquadex therapy offers a new solution for managing fluid overload in their most critical pediatric patients, aiming to improve outcomes and quality of life.

Nuwellis (Nasdaq: NUWE), a medical technology company specializing in fluid overload solutions, has announced it will release its third quarter 2024 financial results on November 11, 2024. The company will host a conference call and webcast at 9:00 AM ET to discuss financial results and provide a business update. Investors can access the webcast through the company's investor relations website or join via telephone using the provided dial-in numbers.

Nuwellis (Nasdaq: NUWE), a medical technology company focused on treating fluid overload, has announced its participation in the Third Annual ROTH Healthcare Opportunities Conference. The event is scheduled for Wednesday, October 9, 2024.

President and CEO Nestor Jaramillo will represent Nuwellis at the conference. Investor presentations and related materials will be accessible on the company's website in the investor relations section.

Interested parties can attend the conference and meet with Nuwellis representatives by contacting their ROTH representative, submitting an online registration request, or reaching out to Vivian Cervantes at Gilmartin Group via ir@nuwellis.com.

Nuwellis, Inc. (Nasdaq: NUWE) announced the publication of a new study in Current Problems in Cardiology demonstrating the effectiveness of Aquadex® ultrafiltration therapy in reducing 60-day hospital readmission rates for patients with acutely decompensated heart failure (ADHF). The study, conducted in a community hospital setting, analyzed data from 30 patients and found:

• Significant volume loss and weight reduction without adverse renal effects
• Statistically significant reduction in rehospitalization rates at 60 days (16.7% vs. 26.7%, p=0.013)
• 40% decrease in ADHF readmissions in 30 days and 59% in 60 days following therapy
• Stable renal function post-ultrafiltration

These results highlight the potential of Aquadex therapy to improve patient outcomes and reduce healthcare costs associated with heart failure management.

Nuwellis (NUWE) has announced a $916,000 registered direct offering priced at-the-market under Nasdaq rules. The company will sell 496,901 shares of common stock at $1.8450 per share. Additionally, in a concurrent private placement, Nuwellis will issue warrants to purchase up to 496,901 shares with an exercise price of $1.72 per share. The warrants will be immediately exercisable and have a 5-year term. The offering is expected to close around August 26, 2024. Ladenburg Thalmann & Co. Inc. is acting as the exclusive placement agent. Nuwellis plans to use the net proceeds for working capital and general corporate purposes.

Nuwellis Inc (Nasdaq: NUWE) reported Q2 2024 financial results, showing revenue growth and improved margins. Key highlights include:

- Revenue of $2.2 million, up 6% year-over-year
- Critical Care revenue growth of 28%
- Heart Failure consumables utilization growth of 35%
- Gross margin improved to 67.2% from 55.3%
- Total operating cost reduction of 38%

The company expanded its Aquadex® therapy to pediatric patients in Florida and secured a purchase agreement with a 50-hospital network in Texas. Nuwellis also introduced QUELIMMUNE™ for pediatric acute kidney injury and sepsis treatment. Despite revenue growth, the company reported a net loss of $7.7 million or $18.85 per share. Post-quarter, Nuwellis raised $2.0 million through a registered direct offering and private placement.

Nuwellis, Inc. (Nasdaq: NUWE) has been granted continued listing on the Nasdaq Stock Market by the Nasdaq Hearings Panel, subject to specific conditions. The decision follows a hearing on July 23, 2024. The company must meet the following requirements by November 19, 2024:

• File a Form 10-Q for Q3 2024, detailing transactions to achieve compliance with the minimum stockholder Equity Rule
• Provide 12-month income projections with clear assumptions
• Demonstrate compliance with the minimum Bid Price Rule

Nuwellis must promptly notify Nasdaq of any significant events affecting compliance during the exception period. The Panel reserves the right to reconsider the terms of the exception based on any developments that may make continued listing inadvisable or unwarranted.

Nuwellis, Inc. (Nasdaq: NUWE) announced the first commercial use of QUELIMMUNE™ therapy at Cincinnati Children's hospital. QUELIMMUNE, manufactured by SeaStar Medical (Nasdaq: ICU) and exclusively distributed by Nuwellis in U.S. pediatric hospitals, is designed to treat pediatric patients with acute kidney injury (AKI) and sepsis requiring kidney replacement therapy. Dr. Stuart Goldstein, who led the multi-center studies for FDA clearance, oversaw the treatment.

The therapy aims to mitigate cytokine storms caused by AKI and sepsis, potentially improving outcomes for critically ill children. Approximately 4,000 pediatric patients are hospitalized with AKI annually in the U.S. This milestone aligns with Nuwellis' pediatric business development strategy and their partnership with SeaStar Medical to bring innovative treatments to healthcare providers.