Following encouraging clinical-study results, NUWE stock closed the last session at $0.4889, an increase of 7.24% or $0.03 in after-hours trading. NUWE stock closed the last session at $0.46 increasing 8.52% or $0.04.
What has NUWE shared about clinical studies?
At the 2022 Annual Scientific Meeting of the Heart Failure Society of America (HFSA), Nuwellis (NUWE) announced the results of the AVOID-HF clinical study analysis. According to the Finkelstein-Schoenfeld method of Win-Ratios (WR), ultrafiltration was statistically superior to diuretics when treating fluid-overloaded heart failure patients.
According to the Win-Ratios calculation, adjustable ultrafiltration is safer and more effective than adjustable IV diuretics in reducing heart failure events for hospitalized heart failure patients. Compared to diuretics, ultrafiltration reduced heart failure events and cardiovascular mortality within 30 days more effectively in the NUEW study. In light of these results, NUEW is confident in the ongoing prospective, multicenter, randomized controlled trial REVERSE-HF.
- As a composite endpoint for AVOID-HF, cardiovascular (CV) mortality within 90 days, heart failure events within 30 days, and time to first HF event were evaluated. With 81% more wins, Adjustable Ultrafiltration (AUF) outperformed Adjustable IV Loop Diuretics (ALD).
- Using a composite endpoint of CV mortality within 30 days, HF events within 30 days, and time to first HF event within 90 days, a secondary WR analysis also found that AUF won by 109% more than ALD.
- According to multiple systematic reviews, adjustable ultrafiltration is more effective than diuretics in removing fluid, reducing weight, and reducing hospital readmissions3 compared to diuretics.
- Based on the results of this study, ultrafiltration with the Aquadex System reduces readmissions and rehospitalizations in heart failure patients with fluid overload.
- As a result of the Aquadex System, hospitals and the health care system will save significant money, but more importantly, patients will experience an improved quality of life.
- It was tested whether patients hospitalized for heart failure (HF) treated with ultrafiltration would have a longer wait before experiencing their first heart failure event within 90 days after discharge compared to those receiving IV loop diuretics in the AVOID-HF prospective, multicenter, randomized controlled trial.
What impact will this have on NUWE?
As the Nuwellis (NUEW) study was approaching full enrollment, it was terminated by the study sponsor for reasons unrelated to patient safety or clinical futility before it reached full enrollment. Due to smaller sample size than planned, NUWE’s AVOID-HF trial data were inconclusive at the time. Although a smaller study sample size is required when using the Finkelstein-Schoenfeld method of hierarchical Win Ratios in order to demonstrate significant differences in clinical outcomes between treatment arms, the method provides more statistical precision when demonstrating significant differences in clinical outcomes.