Nuwellis, Inc. (NUWE) PT Lowered to $16 at Roth/MKM

Roth/MKM analyst Jon Aschoff lowered the price target on Nuwellis, Inc. (NASDAQ: NUWE) to $16.00 (from $17.00) while maintaining a Buy rating.

THe analyst comments "Yesterday morning, NUWE announced a publication in Current Problems in Cardiology demonstrating that Aquadex ultrafiltration therapy statistically significantly reduced hospital readmission rates at 60 days for diureticresistant patients with acutely decompensated heart failure (ADHF). Our PT has been trimmed to $16 from $17 owing to recent equity raise dilution. ■ Yesterday morning, NUWE announced a publication in Current Problems in Cardiology demonstrating that Aquadex ultrafiltration therapy reduced hospital readmission rates at 60 days for diuretic-resistant patients with acutely decompensated heart failure (ADHF). The 30-patient study titled “Outcomes of Ultrafiltration in community-based hospitals” was conducted in a community hospital setting, and showed that ultrafiltration with Aquadex reduced the typically high readmission rates seen in refractory ADHF patients. The study demonstrated a statistically significant reduction in rehospitalization rates for refractory ADHF at 60 days from the start of ultrafiltration therapy, using the pre-ultrafiltration period as a control (16.7% versus 26.7%, p=0.013). The total number of refractory ADHF readmissions in the 30 days following ultrafiltration therapy decreased by 40%, and by 59% in the subsequent 60 days. Also, serum creatinine levels at 72 hours post-ultrafiltration did not change significantly (-0.01 mg/dL, 95% CI -0.26, 0.23), and there was a significant reduction in volume and weight without adverse renal effects. ■ NUWE is conducting the REVERSE-HF trial, which most importantly, and by contrast to all other Aquadex trials, is only enrolling diuretic refractory patients (i.e., those who are on diuretics but whose heart failure continues to worsen). REVERSE-HF is a randomized, open-label, controlled, multicenter, adaptive design U.S. trial to evaluate clinical outcomes and economic value for Aquadex versus intravenous loop diuretics when treating fluid overload in patients with worsening heart failure. Ultrafiltration is viewed as a viable alternative to diuretics, especially in patients who do not adequately respond, or respond at all, to diuretics, and thus have worsening heart failure despite receiving standard treatment. Given the mixed results with prior Aquadex trials, enrolling only patients with worsening disease despite taking diuretics should result in the most positive trial outcome for Aquadex, and thus an outcome that should substantially drive Aquadex use in diuretic refractory patients. The trial’s primary efficacy endpoints are mortality and heart failure events within 30 and 90 days, with heart failure event defined as any heart failure rehospitalization or unplanned use of intravenous loop diuretics, vasoactive medications or Aquadex therapy in any outpatient setting. Key safety parameters include specific cardiovascular and renal adverse events. We expect REVERSE-HF to be fully enrolled in late 2025, with top-line results estimated to be reported in mid-2026."

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