These are the key contradictions discussed in Nuwellis' latest 2024 Q4 earnings call, specifically including: Timing of Reverse-HF trial completion and Vivian clinical trial start, Aquadex unit placements, and R&D spending expectations:
Revenue Decline and Consumables Increase:
- Nuwellis generated
$2.3 million in revenue for the fourth quarter of 2024, a
9% decrease year-over-year.
- The decline was due to a drop in U.S. console sales and international sales, which was offset by a
21% increase in consumables utilization.
Outpatient Market Expansion:
- Effective January 1, 2025, Nuwellis received a notice from CMS that the Aquadex Ultrafiltration code will be reassigned to the outpatient reimbursement level.
- This fourfold increase in daily facility reimbursement opened a new market for outpatient services, which is expected to drive top-line growth as Nuwellis penetrates new accounts and markets.
Clinical Data and Market Adoption:
- A recent peer-reviewed publication in JACC: Heart Failure showed that patients who received Aquadex therapy had a
60% reduction in heart failure events at 30 days compared to those receiving traditional IV diuretics.
- This data supports the adoption of Aquadex Ultrafiltration therapy as a standard of care and its inclusion in medical society guidelines.
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