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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 (Nasdaq: NUWE) presented three Aquadex-related abstracts at the Pediatric Academic Societies meeting, held from April 21-25, 2022, in Denver. The research, partially funded by Nuwellis and the Ultrafiltration Therapy Registry, emphasizes the negative effects of fluid overload and the benefits of ultrafiltration therapy for pediatric patients. The Aquadex SmartFlow® system allows for precise fluid removal, critical for patients weighing 20 kg or more. CEO Nestor Jaramillo Jr. highlighted the research's importance in improving outcomes for those suffering from pediatric kidney disease.
Nuwellis, Inc. (NASDAQ: NUWE) announced that its Q1 2022 financial results will be released on May 10, 2022. The company will host a conference call at 9:00 AM ET to discuss the results and provide a business overview. Investors can access the live webcast through the Nuwellis website or dial in using the provided numbers. Nuwellis focuses on developing the Aquadex SmartFlow® system for ultrafiltration therapy, aimed at patients with fluid overload.
Nuwellis (Nasdaq: NUWE) has obtained IRB approval for its REVERSE-HF study, aimed at evaluating its Aquadex® ultrafiltration therapy against IV diuretics for heart failure patients with fluid overload. Over 1 million heart failure hospitalizations occur annually in the U.S., with 40% of these patients resistant to current treatments. The multicenter trial, beginning enrollment in 2022, will be led by prominent medical experts and seeks to affirm the therapeutic benefits of Aquadex, potentially transforming patient care.
Nuwellis, Inc. (Nasdaq: NUWE) reported a 4Q 2021 revenue of $1.6 million, down 19.6% year-over-year but up 20% compared to 4Q 2019.
The full-year revenue reached $7.9 million, marking a 6.5% increase from 2020 and a 44% growth from 2019. Gross margin for 4Q 2021 was 54.4%, down from 56.1% in 2020, while full-year gross margin improved to 56.7%. The net loss for 4Q was $4.4 million. The company ended 2021 with $24.2 million in cash and no debt, signaling financial stability.
Nuwellis, Inc. (NASDAQ: NUWE) announced on February 22, 2022, that its independent directors approved equity awards for five new employees as part of the 2021 Inducement Plan. The awards include options for a total of 7,694 shares, with an exercise price of $1.10 per share, matching the stock's closing price on the grant date. These options have a ten-year term and vest over four years. Nuwellis focuses on treating fluid overload through its Aquadex SmartFlow system, providing innovative ultrafiltration therapy to patients unresponsive to traditional medical management.
Nuwellis (Nasdaq: NUWE) announced a new clinical trial, REVERSE-HF, evaluating the effectiveness of its Aquadex therapy against traditional intravenous diuretics for treating fluid overload in heart failure patients. Led by Dr. Sean Pinney and Dr. Maria V. DeVita, this multicenter, randomized controlled trial will assess mortality and heart failure events within 30 and 90 days. With over 1 million heart failure hospitalizations yearly in the U.S., addressing fluid overload is critical to reducing readmissions, which occur in nearly 25% of patients within 30 days.
Nuwellis, Inc. (NASDAQ: NUWE) will release its fourth quarter 2022 financial results on March 1, 2022, followed by a conference call at 9:00 AM ET. The company focuses on innovative solutions for patients with fluid overload and markets the Aquadex SmartFlow® system for ultrafiltration therapy. Investors can access the live webcast on the company's website or join the conference call via specified phone numbers. Nuwellis is headquartered in Minneapolis, MN, and operates a subsidiary in Ireland.
Nuwellis, Inc. (Nasdaq: NUWE) announced the implementation of a new CPT code (0692T) for Therapeutic Ultrafiltration, effective immediately. This code, granted by the American Medical Association, enhances reimbursement access for healthcare providers using the Aquadex system to treat fluid overload in patients. CEO Nestor Jaramillo emphasized that this advancement is crucial for patient access to this effective treatment, which offers significant potential for improved quality of life and cost savings. The code will remain in effect for at least five years.
Nuwellis, Inc. (NASDAQ: NUWE) announced an equity award as an inducement for a new employee, effective November 17, 2021. The independent directors approved an option for 24,560 shares at an exercise price of $1.76 per share. This option vests over four years, with 25% vesting after one year and the remainder in monthly increments, subject to certain conditions. Nuwellis aims to improve the lives of patients with fluid overload through its Aquadex SmartFlow system, which is designed for ultrafiltration therapy in both adult and pediatric patients.
Nuwellis, Inc. (Nasdaq: NUWE) reported third-quarter results ending September 30, 2021, with total revenue of $1.9 million, a 3% decline year-over-year. Year-to-date revenue reached $6.3 million, showing a 16% increase compared to 2020 and a 52% increase versus pre-pandemic 2019. The company opened three new pediatric accounts, the largest addition in 2021, and announced an R&D partnership with Koronis Biomedical Technologies, backed by a $1.7 million NIH grant. Despite COVID-related challenges, Nuwellis ended Q3 with $28.4 million in cash and no debt.
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