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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.
Nuwellis (NUWE) reported Q3 2024 financial results with revenue of $2.4 million, showing a 2% decrease from the prior year. Notable highlights include a 297% CMS reimbursement increase to $1,639 for Aquadex facility fee effective January 2025, 28% growth in pediatrics revenue, and improved gross margin of 70% compared to 57.3% last year. The company achieved a 30% reduction in operating costs and reported net income of $2.4 million. A new study showed significant reduction in Heart Failure readmissions using Aquadex. The company added three new pediatric and two new adult accounts, while receiving $5.1 million through warrant exercises.
Nuwellis announced the exercise of warrants generating $5.1 million in gross proceeds. This includes $3.8 million from the immediate exercise of warrants issued on April 30, 2024, at $2.10 per share, plus $1.3 million from warrant exercises over the last week. In exchange for the immediate exercise, the company will issue new Series I and Series II warrants to purchase up to 3,665,034 shares. The new warrants will have an exercise price of $1.94, with Series I having a 5-year term and Series II a 2-year term, both exercisable after 6 months. Ladenburg Thalmann & Co. Inc. served as the exclusive warrant inducement agent.
Nuwellis (Nasdaq: NUWE) announces a significant reimbursement rate increase for its Aquadex SmartFlow therapy from the Centers for Medicare and Medicaid Services (CMS). Effective January 1, 2025, the payment rate will increase by 397% from $413 to $1,639 per day. This change involves reassigning the therapeutic ultrafiltration CPT code 0692T from APC 5241 to APC 5242, creating a better reimbursement pathway for outpatient treatment. The decision aims to expand patient access to ultrafiltration therapy and improve fluid management care in outpatient settings.
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.
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