JACC: Heart Failure Paper Reports Promising Findings of Aquadex Therapy in Updated AVOID-HF Study Analysis
Nuwellis (NUWE) announced promising findings from an updated analysis of the AVOID-HF study, published in JACC: Heart Failure. The study, led by Dr. Sean P. Pinney and Dr. Maria V. DeVita, revealed that patients treated with Aquadex SmartFlow ultrafiltration therapy showed a 60% reduction in heart failure events at 30 days compared to traditional IV diuretics.
The reanalysis of the AVOID-HF study included a broader dataset and demonstrated trends toward fewer hospitalizations and improved quality of life for patients using Aquadex therapy. Nuwellis plans to continue research through its REVERSE-HF trial to further establish the clinical and economic benefits of ultrafiltration therapy versus conventional treatments.
Nuwellis (NUWE) ha annunciato risultati promettenti da un'analisi aggiornata dello studio AVOID-HF, pubblicata su JACC: Heart Failure. Lo studio, condotto dal Dr. Sean P. Pinney e dalla Dr.ssa Maria V. DeVita, ha rivelato che i pazienti trattati con la terapia di ultrafiltrazione Aquadex SmartFlow hanno mostrato una riduzione del 60% degli eventi di insufficienza cardiaca a 30 giorni rispetto ai diuretici endovenosi tradizionali.
La rianalisi dello studio AVOID-HF ha incluso un dataset più ampio e ha dimostrato tendenze verso un minor numero di ospedalizzazioni e un miglioramento della qualità della vita per i pazienti che utilizzano la terapia Aquadex. Nuwellis prevede di continuare la ricerca attraverso il suo trial REVERSE-HF per stabilire ulteriormente i benefici clinici ed economici della terapia di ultrafiltrazione rispetto ai trattamenti convenzionali.
Nuwellis (NUWE) anunció hallazgos prometedores de un análisis actualizado del estudio AVOID-HF, publicado en JACC: Heart Failure. El estudio, dirigido por el Dr. Sean P. Pinney y la Dra. Maria V. DeVita, reveló que los pacientes tratados con terapia de ultrafiltración Aquadex SmartFlow mostraron una reducción del 60% en eventos de insuficiencia cardíaca a 30 días en comparación con los diuréticos intravenosos tradicionales.
La reanálisis del estudio AVOID-HF incluyó un conjunto de datos más amplio y demostró tendencias hacia menos hospitalizaciones y una mejor calidad de vida para los pacientes que utilizan la terapia Aquadex. Nuwellis planea continuar la investigación a través de su ensayo REVERSE-HF para establecer más a fondo los beneficios clínicos y económicos de la terapia de ultrafiltración frente a tratamientos convencionales.
Nuwellis (NUWE)는 JACC: Heart Failure에 발표된 AVOID-HF 연구의 업데이트된 분석에서 유망한 결과를 발표했습니다. Sean P. Pinney 박사와 Maria V. DeVita 박사가 이끄는 이 연구는 Aquadex SmartFlow 초여과 치료를 받은 환자들이 전통적인 IV 이뇨제에 비해 심부전 사건이 30일 동안 60% 감소했음을 밝혔습니다.
AVOID-HF 연구의 재분석은 더 넓은 데이터 세트를 포함했으며 Aquadex 치료를 사용하는 환자들의 병원 입원이 줄어들고 삶의 질이 개선되는 경향을 보여주었습니다. Nuwellis는 기존 치료법과 비교하여 초여과 치료의 임상적 및 경제적 이점을 더욱 확립하기 위해 REVERSE-HF 시험을 통해 연구를 계속할 계획입니다.
Nuwellis (NUWE) a annoncé des résultats prometteurs d'une analyse mise à jour de l'étude AVOID-HF, publiée dans JACC: Heart Failure. L'étude, dirigée par le Dr Sean P. Pinney et la Dr Maria V. DeVita, a révélé que les patients traités avec la thérapie d'ultrafiltration Aquadex SmartFlow ont montré une réduction de 60 % des événements d'insuffisance cardiaque à 30 jours par rapport aux diurétiques intraveineux traditionnels.
La réanalyse de l'étude AVOID-HF a inclus un ensemble de données plus large et a démontré des tendances vers moins d'hospitalisations et une amélioration de la qualité de vie pour les patients utilisant la thérapie Aquadex. Nuwellis prévoit de poursuivre ses recherches à travers son essai REVERSE-HF pour établir davantage les avantages cliniques et économiques de la thérapie d'ultrafiltration par rapport aux traitements conventionnels.
Nuwellis (NUWE) hat vielversprechende Ergebnisse aus einer aktualisierten Analyse der AVOID-HF-Studie veröffentlicht, die in JACC: Heart Failure veröffentlicht wurde. Die Studie, geleitet von Dr. Sean P. Pinney und Dr. Maria V. DeVita, zeigte, dass Patienten, die mit Aquadex SmartFlow Ultrafiltrations-Therapie behandelt wurden, im Vergleich zu traditionellen IV-Diuretika eine 60%ige Reduzierung der Herzinsuffizienz-Ereignisse innerhalb von 30 Tagen aufwiesen.
Die Neuanalyse der AVOID-HF-Studie umfasste einen breiteren Datensatz und zeigte Tendenzen zu weniger Krankenhausaufenthalten und einer verbesserten Lebensqualität für Patienten, die die Aquadex-Therapie nutzen. Nuwellis plant, die Forschung durch die REVERSE-HF-Studie fortzusetzen, um die klinischen und wirtschaftlichen Vorteile der Ultrafiltrationstherapie im Vergleich zu herkömmlichen Behandlungen weiter zu belegen.
- 60% reduction in heart failure events at 30 days with Aquadex therapy vs. traditional IV diuretics
- Demonstrated trends toward fewer hospitalizations
- Publication in prestigious JACC: Heart Failure journal validates clinical significance
- None.
Insights
The publication of updated AVOID-HF study results in JACC: Heart Failure represents a pivotal development for Nuwellis's commercial prospects. The demonstrated 60% reduction in heart failure events at 30 days is particularly noteworthy as it addresses a critical unmet need in heart failure management. This level of efficacy could significantly influence treatment protocols and payer decisions.
The study's publication in JACC: Heart Failure, one of the most prestigious cardiology journals, provides strong validation of Aquadex therapy's clinical utility. The involvement of leading cardiologists from major institutions adds substantial credibility and could accelerate adoption among key opinion leaders in the field.
Several factors make this development particularly significant for investors:
- The data strengthens Nuwellis's position in negotiations with healthcare payers, potentially supporting broader reimbursement coverage
- The ongoing REVERSE-HF trial indicates a strategic commitment to building a comprehensive clinical evidence base
- The focus on reducing hospitalizations aligns with healthcare systems' priorities for cost reduction and improved patient outcomes
The market opportunity is substantial, considering that heart failure affects approximately 6.2 million adults in the U.S. alone. With hospitalization costs averaging
| WHO | WHAT | WHERE | WHEN | WHY |
| Nuwellis, Inc., and Dr. Sean P. Pinney and Dr. Maria V. DeVita | Updated analysis of the AVOID-HF study data shows that Aquadex® SmartFlow ultrafiltration therapy led to a | Journal of the American College of Cardiology | Findings were recently updated and analyzed as of 2/19/25 | These promising results support further research into ultrafiltration's role in heart failure management and highlight its potential to improve treatment outcomes, supporting the current Nuwellis REVERSE-HF trial. |
MINNEAPOLIS, Feb. 20, 2025 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a commercial-stage medical device company focused on transforming the lives of people with fluid overload, today highlighted promising findings from an updated analysis of the AVOID-HF study, recently published in the Journal of the American College of Cardiology: Heart Failure. The analysis, led by Dr. Sean P. Pinney, Chief of Cardiology at Mount Sinai Morningside and Chief of Nephrology at Lenox Hill Hospital, Dr. Maria V. DeVita, provides new insights suggesting the potential benefits of Aquadex® SmartFlow ultrafiltration therapy in managing heart failure. The analysis found that patients treated with Aquadex therapy demonstrated a
The AVOID-HF study, initially designed to evaluate the effectiveness of ultrafiltration in managing heart failure, was updated to include a broader dataset, allowing a more comprehensive analysis of patient outcomes. The results indicate a promising trend in the reduction of heart failure events and suggest potential improvements in patient management strategies.
Dr. Sean P. Pinney commented on the findings, "The re-evaluated data from the AVOID-HF study offer compelling evidence supporting the use of ultrafiltration over conventional diuretics. These findings underscore the need for further investigation to fully validate the benefits of this therapy, particularly in reducing hospitalization rates and improving overall quality of life for heart failure patients."
Megan Cotts, the Vice President of Clinical Research and Reimbursement at Nuwellis, stated, "The updated AVOID-HF results contribute valuable insights into the Aquadex SmartFlow system's role in heart failure therapy. We are deeply grateful to Dr. Sean Pinney and Dr. Maria DeVita for their expertise and leadership in this comprehensive review. Our commitment to advancing patient care through innovative solutions is reinforced by these findings, which we believe will inspire further clinical exploration."
The reanalysis demonstrated not only a significant reduction in heart failure events but also suggested trends towards fewer hospitalizations and improved quality of life for those treated with Aquadex therapy over traditional methods. These findings advocate for its continued use in modern heart failure treatment regimens and set the stage for more rigorous trials. Nuwellis plans to continue its research efforts under its current REVERSE-HF trial, led by Dr. Pinney and Dr DeVita, to further establish the clinical and economic benefits of ultrafiltration therapy compared to conventional IV diuretic treatments. The company remains committed to improving outcomes for heart failure patients and reducing the overall burden of hospitalizations. The complete analysis will be available in the February 2025 issue of JACC: Heart Failure.
About the AVOID-HF Trial The AVOID-HF trial, a prospective, multicenter, randomized controlled study, explored whether treating heart failure patients with ultrafiltration could extend the period without heart failure events post-discharge compared to those receiving IV loop diuretics. Utilizing advanced statistical techniques, reanalysis of the AVOID-HF data demonstrated marked clinical advantages, supporting broader clinical adoption of the Aquadex system.
About Nuwellis Nuwellis, Inc. (Nasdaq: NUWE) is a medical device company focused on transforming the lives of patients with fluid overload through science, collaboration, and innovation. The company is focused on commercializing the Aquadex SmartFlow® system for ultrafiltration therapy. Nuwellis is headquartered in Minneapolis, with a wholly owned subsidiary in Ireland. For more information visit www.nuwellis.com or visit us on LinkedIn or X.
About the Aquadex SmartFlow® System The Aquadex SmartFlow system delivers clinically proven therapy using a simple, flexible and smart method of removing excess fluid from patients suffering from hypervolemia (fluid overload). The Aquadex SmartFlow system is indicated for temporary (up to 8 hours) or extended (longer than 8 hours in patients who require hospitalization) use in adult and pediatric patients weighing 20 kg or more whose fluid overload is unresponsive to medical management, including diuretics. All treatments must be administered by a health care provider, within an outpatient or inpatient clinical setting, under physician prescription, both having received training in extracorporeal therapies.
Forward-Looking Statements Certain statements in this release may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including without limitation, statements regarding the new market opportunities and anticipated growth in 2025 and beyond. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this release, including, without limitation, those risks associated with our ability to execute on our commercialization strategy, the possibility that we may be unable to raise sufficient funds necessary for our anticipated operations, our post-market clinical data collection activities, benefits of our products to patients, our expectations with respect to product development and commercialization efforts, our ability to increase market and physician acceptance of our products, potentially competitive product offerings, intellectual property protection, our ability to integrate acquired businesses, our expectations regarding anticipated synergies with and benefits from acquired businesses, and other risks and uncertainties described in our filings with the SEC. Forward-looking statements speak only as of the date when made. Nuwellis does not assume any obligation to publicly update or revise any forward-looking statements, whether due to new information, future events or otherwise.
For further information, please contact:
Investor Relations:
Vivian Cervantes
Gilmartin Group
ir@nuwellis.com
Media Contact:
Leah McMullen
Director of Communications
Leah.mcmullen@nuwellis.com
Source:
Nuwellis Inc.
FAQ
What were the key findings of the AVOID-HF study for NUWE's Aquadex therapy in February 2025?
How does NUWE's Aquadex SmartFlow therapy compare to traditional IV diuretics?
What is the significance of the JACC: Heart Failure publication for NUWE?
What are NUWE's future research plans following the AVOID-HF study results?
