MINNEAPOLIS - Nuwellis, Inc. (NASDAQ:NUWE), a medical device company specializing in fluid overload treatment, announced a significant reimbursement rate increase for its Aquadex ultrafiltration therapy. The Centers for Medicare and Medicaid Services (CMS) will raise the outpatient reimbursement rate by 397%, from $413 to $1,639 per day, starting January 1, 2025.
The reclassification of the Aquadex ultrafiltration code aligns with the clinical administration and treatment costs of ultrafiltration therapy. This move by CMS is expected to encourage the adoption of ultrafiltration therapy in outpatient settings, potentially reducing hospitalizations and managing disease more effectively.
Nestor Jaramillo, President and CEO of Nuwellis, welcomed the CMS decision, highlighting the clinical significance and cost-effectiveness of the Aquadex SmartFlow therapy. He emphasized the expected expansion of patient access to this essential therapy and acknowledged the guidance of medical professionals in achieving this reimbursement milestone.
The CMS has reassigned the therapeutic ultrafiltration CPT code 0692T from APC 5241 to APC 5242, reflecting the value and effectiveness of the Aquadex SmartFlow system for heart failure patients with fluid overload. The change provides a clearer reimbursement pathway for ultrafiltration therapy delivered outside of hospital settings, which could increase the number of patients receiving this treatment as part of a chronic disease management program.
Nuwellis is dedicated to commercializing the Aquadex SmartFlow system, which offers a method for removing excess fluid in patients suffering from hypervolemia. The system is indicated for use in both adult and pediatric patients over 20 kg who do not respond to medical management, including diuretics.
The information in this article is based on a press release statement from Nuwellis, Inc.
In other recent news, Nuwellis, Inc. reported a 6% rise in revenue for Q2 2024, totaling $2.2 million, largely due to a 30% increase in heart failure and critical care consumables utilization. The company also marked its first commercial sale of QUELIMMUNE to Cincinnati Children's Hospital and expanded its pediatric market reach with the addition of a new account, bringing the total to 41 pediatric accounts.
Nuwellis secured funding through a registered direct offering and concurrent private placement, selling 496,901 shares of common stock to certain institutional investors, with Ladenburg Thalmann & Co. Inc. serving as the exclusive placement agent. However, the company mutually agreed to terminate its Supply and Collaboration Agreement with DaVita (NYSE:DVA) Inc., leading to the cessation of a Common Stock Purchase Warrant and a Registration Rights Agreement.
Roth/MKM analysts maintain a Buy rating on Nuwellis, despite lowering the price target to $16.00 from $17.00 due to the impact of a recent equity raise. The company is currently conducting the REVERSE-HF trial, evaluating the clinical outcomes and economic value of Aquadex compared to intravenous loop diuretics in treating fluid overload in patients with worsening heart failure.
Nuwellis also terminated its exclusive distribution and supply agreements with SeaStar Medical Holding Corporation, marking a significant shift in its business operations. Under the terms of the settlement, SeaStar has agreed to pay Nuwellis $900,000 in three payments, with the final installment due by December 31, 2024. These developments highlight the company's recent activities and strategic changes.
InvestingPro Insights
As Nuwellis (NASDAQ:NUWE) prepares for the significant reimbursement rate increase for its Aquadex ultrafiltration therapy, investors should consider some key financial metrics and trends. According to InvestingPro data, Nuwellis has a market capitalization of $2.54 million, reflecting its current small-cap status in the medical device sector.
Despite the positive news on reimbursement, InvestingPro Tips highlight that Nuwellis is "quickly burning through cash" and is "not profitable over the last twelve months." This context is crucial as the company aims to expand the adoption of its Aquadex SmartFlow system. The revenue for the last twelve months as of Q2 2024 stood at $9.01 million, with a revenue growth of 8.54% over the same period.
The stock's recent performance has been challenging, with InvestingPro data showing a 34.62% decline in the past week and a significant 93.31% drop year-to-date. This volatility is consistent with the InvestingPro Tip noting that the "stock generally trades with high price volatility."
While the increased reimbursement rate could potentially improve Nuwellis's financial outlook, it's worth noting that analysts, according to another InvestingPro Tip, "do not anticipate the company will be profitable this year." This underscores the importance of the upcoming reimbursement change in potentially altering the company's financial trajectory.
For investors seeking a more comprehensive analysis, InvestingPro offers 13 additional tips for Nuwellis, providing a deeper understanding of the company's financial health and market position.
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