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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) announced on August 19, 2022, that independent directors approved equity awards under the 2021 Inducement Plan for six new employees. These awards, complying with NASDAQ Listing Rule 5635(c)(4), consist of options to purchase a total of 22,334 shares at an exercise price of $0.66 each, the closing price on the grant date. The options have a ten-year term, vesting over four years. Nuwellis specializes in ultrafiltration therapy and is focused on enhancing treatment for patients suffering from fluid overload.
Nuwellis, Inc. (Nasdaq: NUWE) announced its participation in the Inaugural Gilmartin Group Emerging Growth Company Showcase, set to occur virtually on August 31, 2022, at 10:00 am ET. Management will present details about their innovative medical device, the Aquadex SmartFlow® system, which is essential for treating fluid overload conditions. Interested parties can access the live webcast and find archived materials on the Nuwellis website post-event. This highlights Nuwellis's commitment to improving patient outcomes through cutting-edge technology.
Nuwellis, Inc. (Nasdaq: NUWE) reported a total revenue of $2.2 million for Q2 2022, marking a 15% sequential increase from Q1 2022, although 12% lower year-over-year. The company enrolled its first patient in the pivotal REVERSE-HF clinical trial for Aquadex therapy and reduced operating expenses by 14% from Q2 2021, reinforcing cash management. CEO Nestor Jaramillo expressed optimism about the momentum gained, crediting strategic initiatives that position the company favorably for the remainder of 2022.
Nuwellis (Nasdaq: NUWE) announced the submission of the AVOID-HF clinical study analysis at the HFSA 2022 Annual Scientific Meeting, focusing on the superiority of ultrafiltration over diuretics in treating fluid overload in heart failure patients. The analysis utilized the Finkelstein-Schoenfeld method to enhance statistical precision, although the study was terminated early due to enrollment issues unrelated to patient safety. The company aims to establish Aquadex therapy as the standard care for diuretic-resistant heart failure patients and recently started its REVERSE-HF study.
Nuwellis, Inc. (NASDAQ: NUWE) will release its Q2 2022 financial results on August 9, 2022, followed by a conference call and webcast at 9:00 AM ET. The call aims to discuss the financial outcomes and provide a general business overview. Nuwellis focuses on developing the Aquadex SmartFlow® system for ultrafiltration therapy to assist patients with fluid overload. For additional details, visit the Investors page on their website.
Nuwellis, Inc. (Nasdaq: NUWE) recently hosted a webinar featuring leading clinicians discussing the effectiveness of Aquadex® ultrafiltration (UF) therapy for managing fluid overload in heart failure patients in outpatient settings. The panel emphasized the economic challenges of current care standards, highlighting that 24% of patients are readmitted within 30 days. Outpatient Aquadex therapy showed potential in reducing readmissions by up to 79% while improving patient satisfaction. The company aims to capitalize on this opportunity to enhance patient outcomes and reduce healthcare costs.
Nuwellis, Inc. (Nasdaq: NUWE) announced the enrollment of the first patient in its pivotal REVERSE-HF study, which will evaluate the efficacy of its Aquadex ultrafiltration therapy versus traditional IV diuretics for treating fluid overload in heart failure patients. Conducted across multiple sites in the U.S., the study aims to demonstrate improved patient outcomes and economic benefits, addressing the high readmission rates associated with heart failure. Key endpoints include mortality and heart failure events within 30 and 90 days, using innovative statistical methods to analyze results.
Nuwellis, Inc. (Nasdaq: NUWE) announced the expansion of its Aquadex SmartFlow® system to two new pediatric hospitals in Florida and Arkansas, highlighting a 36% CAGR in its pediatric segment. The device is specifically designed for gentle fluid removal in children suffering from fluid overload and is FDA-cleared for patients weighing over 20 kg. Additionally, Nuwellis is developing a new pediatric continuous renal replacement therapy device, supported by a $1.7 million NIH grant, aimed at improving care for small children with kidney issues.
Nuwellis, Inc. (NASDAQ: NUWE) announced the adjournment of its 2022 Annual Meeting of Stockholders, held on May 17, 2022, due to a lack of quorum. With only 49.23% of outstanding shares represented, the meeting will reconvene on May 25, 2022, at 2:00 p.m. Central Time to allow stockholders more time to vote on proposals outlined in the proxy statement filed on April 11, 2022. Stockholders of record as of March 30, 2022, are urged to vote before May 24, 2022, at 11:59 p.m. Eastern Time.
Nuwellis, Inc. (NUWE) reported a total revenue of $1.9 million for Q1 2022, marking a 17% increase from Q4 2021. This growth was driven by higher sales of consumables, despite capital equipment sales being lower than the previous year. The company received a Category III CPT Code effective January 1, 2022, enhancing reimbursement for therapeutic ultrafiltration and advancing Aquadex. Gross margin improved to 57.2%, while net loss decreased to $4.5 million. Cash reserves stood at approximately $19.3 million as of March 31, 2022.
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