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FDA grants breakthrough status to SeaStar Medical's SCD

Published 06/11/2024, 14:06
ICU
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DENVER - SeaStar Medical (TASE:PMCN) Holding Corporation (NASDAQ:ICU), a medical device company, announced it has received a Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its Selective Cytopheretic Device (SCD). The device is intended for use in treating chronic systemic inflammation in patients with end-stage renal disease (ESRD) who require chronic hemodialysis.

The SCD, a first-in-class cell-directed therapy, is designed to target dysregulated immune responses in these patients, aiming to improve their survival rates and quality of life. Chronic hemodialysis patients, who number over 480,000 in the U.S., often suffer from high disease burden, including chronic fatigue and frequent hospitalizations, with a five-year survival rate of 42%.

The Breakthrough Device Designation is expected to expedite the development and review process for the SCD, granting the company priority review by the FDA, early patient access, and potential for differentiated market positioning. This marks the fourth such designation for SeaStar Medical's SCD, expanding its addressable patient population in the U.S. to at least 745,000 annually.

Kevin Chung, MD, Chief Medical Officer at SeaStar Medical, highlighted the potential of the SCD to safely and effectively address chronic systemic inflammation, which is a major contributor to poor outcomes in ESRD patients. The company aims to demonstrate that concurrent SCD therapy can improve survival and clinical outcomes for patients undergoing chronic dialysis.

The SCD works by targeting proinflammatory neutrophils and monocytes during continuous renal replacement therapy (CRRT), transitioning them to a reparative state and reducing inflammation. This approach differs from other blood-purification tools by focusing on immunomodulation, potentially promoting long-term organ recovery and reducing the need for future renal replacement therapies.

SeaStar Medical's broader portfolio includes applications of the SCD for a variety of conditions associated with excessive inflammatory responses, such as sepsis and acute kidney injury. The company, which focuses on cell-directed extracorporeal therapies, aims to redefine the impact of extracorporeal treatments on vital organs affected by inflammation.

This news article is based on a press release statement from SeaStar Medical.

In other recent news, SeaStar Medical successfully settled a dispute with Nuwellis over a distribution agreement for its pediatric SCD product, agreeing to pay Nuwellis $900,000 by December 31, 2024. The dispute, which had centered around a breach of the agreement, has now been resolved, allowing both companies to proceed with their operations. Additionally, SeaStar Medical has reached a significant milestone in its NEUTRALIZE-AKI trial, with 51 participants enrolled, surpassing the halfway mark of its 100-subject interim analysis goal.

Further developments include the expansion of trial sites to include Brooke Army Medical Center and the United States Army Institute of Surgical Research, bringing the total number of clinical sites to 11. SeaStar Medical has also reported the full retirement of its long-term debt, previously over $9 million, marking a crucial financial milestone.

Additionally, the company has announced a $10 million stock and warrant sale, expected to generate funds for general corporate purposes. However, SeaStar Medical is also facing a shareholder class action lawsuit alleging material misstatements and omitted information about its business operations and regulatory approvals. Lastly, the company has seen significant board changes with the appointment of Jennifer A. Baird, Bernadette N. Vincent, and John Neuman. These are among the recent developments at SeaStar Medical.

InvestingPro Insights

While SeaStar Medical Holding Corporation (NASDAQ:ICU) has made significant strides with its Breakthrough Device Designation from the FDA, recent financial data from InvestingPro paints a challenging picture for the company. The stock's market capitalization stands at a modest $11.69 million, reflecting the early-stage nature of the company's medical device development.

InvestingPro data reveals that ICU's stock has experienced significant downward pressure, with a one-year price total return of -85.84% as of the most recent data. This decline is further emphasized by the stock trading at just 6.24% of its 52-week high, suggesting investor skepticism about the company's near-term prospects despite the recent FDA designation.

Two relevant InvestingPro Tips highlight the company's current financial situation:

1. ICU is not profitable over the last twelve months, which is not uncommon for early-stage medical device companies but does underscore the financial risks involved.

2. The company's short-term obligations exceed its liquid assets, indicating potential liquidity challenges as it works towards commercializing its SCD technology.

These insights suggest that while SeaStar Medical's technological advancements are promising, the company faces significant financial hurdles. Investors considering ICU should weigh the potential of its breakthrough device against its current financial position.

For a more comprehensive analysis, InvestingPro offers 9 additional tips that could provide valuable context for understanding SeaStar Medical's market position and future prospects.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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