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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, Inc. (Nasdaq: NUWE) reported record quarterly revenue of $2.5 million for Q2 2021, marking a 35% increase from the previous year. This is the sixth consecutive quarter of double-digit growth, fueled by strong demand for capital equipment and consumables. Notable leadership additions include George Montague as CFO and Neil Ayotte as Senior VP. The company received a Category III CPT code for therapeutic ultrafiltration, effective January 1, 2022. Despite a net loss of $4.7 million, cash reserves remain strong at $24 million with no debt.
Nuwellis (Nasdaq: NUWE) announced plans to develop a pediatric continuous renal replacement therapy (CRRT) device aimed at critically ill children with kidney failure. Supported by a $1.7 million NIH grant, this partnership with Koronis Biomedical Technologies will enhance treatment options for small patients. The device will address limitations in current therapies by improving functionality and reducing complications. The Aquadex SmartFlow® system is already recognized for its benefits in pediatric care, setting the stage for this innovative product to meet urgent medical needs.
Nuwellis, Inc. (NASDAQ: NUWE) will announce its second quarter 2021 financial results on August 10, 2021, at 9:00 AM ET. Following the release, management will host a conference call and webcast to discuss the company's performance and provide a business overview. Interested parties can access the live discussion via the Nuwellis Investors page or by phone. The company specializes in developing the Aquadex SmartFlow® system for ultrafiltration therapy, aimed at helping patients with fluid overload.
Nuwellis announces the issuance of a new Category III CPT code (0692T) for Therapeutic Ultrafiltration, effective January 1, 2022. This code aims to enhance reimbursement for providers using the Aquadex system to treat fluid overload in patients. The code's approval, following validation by the American Medical Association, supports the accessibility of this life-saving therapy. Nuwellis' CEO emphasizes the importance of this milestone for patient access and provider adoption, potentially improving treatment outcomes across the healthcare system.
Nuwellis, Inc. (NASDAQ: NUWE) announced participation in the 2021 Ladenburg Thalmann Healthcare Conference, scheduled for July 14, 2021, at 4:00 pm ET. The event will include a presentation and a fireside chat featuring CEO Nestor Jaramillo and CFO George Montague. An audio webcast will be accessible through Nuwellis’ investor relations website, with a replay available for 90 days post-event. Nuwellis focuses on treating fluid overload through its Aquadex SmartFlow system, which is designed for both adult and pediatric patients when diuretics are ineffective.
Nuwellis, Inc. (NASDAQ: NUWE) announced the approval of an equity award for George Montague as a material inducement for his role as Chief Financial Officer and Treasurer, effective June 30, 2021. Montague received an option to purchase 62,535 shares at an exercise price of $4.20, the closing stock price on the grant date. The options vest over four years, contingent on his continued employment. Nuwellis develops the Aquadex SmartFlow system for ultrafiltration therapy to aid patients with fluid overload, showcasing its commitment to innovative medical solutions.
Nuwellis, Inc. (NASDAQ: NUWE) announced on June 22, 2021, that independent directors approved four equity awards as an inducement for new hires. The awards consist of options to purchase a total of 46,737 shares at an exercise price of $3.98 per share, aligned with the market close on the grant date. The options carry a ten-year term and will vest over four years, with 25% vesting after one year. This decision adheres to NASDAQ Listing Rule 5635(c)(4), necessitating public disclosure of such equity awards.
Nuwellis, Inc. announced the appointments of George Montague as Chief Financial Officer and Neil P. Ayotte as General Counsel and Chief Compliance Officer. Montague, effective June 28, 2021, brings over 20 years of healthcare finance experience, including prior roles at Smiths Medical and Medtronic. Ayotte, who joined on June 7, 2021, has extensive legal experience from his tenure at Bluestem Group and Medtronic. Their expertise is aimed at expanding access to Nuwellis's Aquadex SmartFlow® technology for fluid overload therapies.
Nuwellis, Inc. (Nasdaq: NUWE) has secured a three-year national contract with Premier, Inc. to promote its Aquadex SmartFlow® System for fluid management. This agreement allows Premier members to access special pricing for the therapy, which is the first in its newly defined Aquapheresis category. This collaboration aims to enhance the availability of ultrafiltration technology in hospitals across the U.S. Nuwellis focuses on innovative solutions for patients experiencing fluid overload, benefiting pediatric and critical care demographics.
Nuwellis, Inc. (NASDAQ: NUWE) announced on May 19, 2021, that its independent directors approved eight equity awards as an inducement for new employment, aligning with NASDAQ Listing Rule 5635(c)(4). The awards consist of options to purchase 6,227 shares at an exercise price of $3.63, which equals the stock's closing price on the grant date. These options will vest over four years and have a ten-year term. Nuwellis is focused on innovating medical devices for fluid overload treatment through its Aquadex SmartFlow system.
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