DENVER - SeaStar Medical Holding Corporation (NASDAQ:ICU), a medical device company, announced it has received a Category B Coverage Letter from the U.S. Centers for Medicare & Medicaid Services (CMS) for its NEUTRALIZE-AKI trial, which is evaluating the company's Selective Cytopheretic Device (SCD) in adults with acute kidney injury (AKI).
The CMS reimbursement will cover certain expenses for trial patients covered by Medicare or Medicaid, potentially accelerating site activations and patient enrollment.
The NEUTRALIZE-AKI trial aims to enroll up to 200 adult patients with AKI at up to 30 clinical sites. Since the first patient was enrolled in June 2023, 10 medical centers have been cleared, and 38 patients have been enrolled. The CMS Category B coverage includes the SCD, along with related routine items and services.
Eric Schlorff, CEO of SeaStar Medical, expressed optimism about the impact of CMS reimbursement on the trial's cost savings and the acceleration of patient enrollment. The company plans to conduct an interim analysis after reaching a 90-day primary endpoint with 100 enrolled subjects.
SeaStar Medical's SCD has received FDA Breakthrough Device Designation for the adult AKI indication, signaling its potential to offer substantial improvement over existing therapies. The NEUTRALIZE-AKI trial's primary endpoint is to evaluate the effectiveness of the SCD in reducing 90-day mortality or dialysis dependency in AKI patients.
The SCD operates alongside continuous kidney replacement therapy (CKRT) and targets proinflammatory neutrophils and monocytes, aiming to reduce hyperinflammation and promote organ recovery. This immunomodulation approach could potentially eliminate the need for future CKRT, including dialysis.
This development is based on a press release statement from SeaStar Medical and may present a significant opportunity for the company within the AKI treatment market. The trial's success and the device's efficacy could have implications for the care of critically ill patients with AKI, a condition that affects a significantly larger patient population in adults compared to children.
In other recent news, SeaStar Medical is facing a shareholder class action lawsuit alleging material misstatements and omitted information about its business operations and regulatory approvals. The lawsuit is linked to a restatement of the company's consolidated financial statements.
Concurrently, SeaStar Medical has received FDA approval for the final labeling of its QUELIMMUNE device for pediatric patients. The company has also finalized a warrant redemption agreement with an investor and regained compliance with Nasdaq's minimum bid price requirement.
SeaStar Medical has also seen significant changes in its board of directors, with the appointment of Jennifer A. Baird, Bernadette N. Vincent, and John Neuman. The company is progressing with its adult acute kidney injury study and NEUTRALIZE-AKI pivotal trial.
Following FDA approval, SeaStar plans to treat the first critically ill child with AKI and sepsis using its Quelimmune™ pediatric therapeutic device. These are some of the recent developments at SeaStar Medical.
InvestingPro Insights
SeaStar Medical Holding Corporation (NASDAQ:ICU) has recently achieved a promising milestone with the CMS coverage for its NEUTRALIZE-AKI trial, potentially enhancing its financial outlook and clinical trial progression. However, an analysis of real-time data and InvestingPro Tips reveals some challenges and opportunities facing the company.
InvestingPro data indicates a relatively small market capitalization of 30.43 million USD for SeaStar Medical, which may reflect investor caution given the company's financial metrics. The negative P/E ratio of -0.32 and an adjusted P/E ratio over the last twelve months as of Q1 2024 at -1.11 suggest that the company is not currently profitable.
Moreover, a significant one-week price total return of -43.85% contrasts with a strong one-month price total return of 89.61%, highlighting the stock's high volatility, as noted in one of the InvestingPro Tips.
Despite these challenges, SeaStar Medical has shown some resilience with a noteworthy 89.61% price increase over the past month. This surge in stock price could be an indicator of investor confidence in the company's long-term prospects, particularly following the recent positive development with the CMS coverage. The company's stock also tends to move inversely to market trends, which could be advantageous in times of broader market downturns.
For investors seeking a more in-depth analysis, there are additional InvestingPro Tips available that delve into the company's financial health, including concerns such as weak gross profit margins and the fact that short-term obligations exceed liquid assets. With these insights, investors can make more informed decisions about the potential risks and rewards associated with SeaStar Medical's stock.
To explore these tips further and to access a wealth of financial analysis tools, interested readers can visit InvestingPro and use the coupon code PRONEWS24 to get up to 10% off a yearly Pro and a yearly or biyearly Pro+ subscription. In total, there are 10 additional InvestingPro Tips available for SeaStar Medical, providing a comprehensive understanding of the company's financial and market position.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.