SeaStar Medical Expands AKI Clinical Trial with New Hospital

SeaStar Medical Expands Its Pivotal Trial for Acute Kidney Injury

SeaStar Medical Holding Corporation (Nasdaq: ICU), a medical device innovator, is thrilled to announce the activation of Sentara Norfolk General Hospital as its thirteenth active site for the crucial NEUTRALIZE-AKI pivotal trial. This announcement comes alongside an enrollment update for the trial, designed to evaluate a novel treatment for adult acute kidney injury (AKI).

Enrollment Progress in the NEUTRALIZE-AKI Trial

In November, the trial recorded the enrollment of nine critically ill adult patients suffering from AKI, bringing the total number of participants to 65. The NEUTRALIZE-AKI trial aims to assess the safety and effectiveness of SeaStar Medical's Selective Cytopheretic Device (SCD) among 200 subjects in intensive care units who are receiving continuous renal replacement therapy (CRRT).

Significant Growth in Enrollment Rates

Kevin Chung, MD, the Chief Medical Officer of SeaStar Medical, expressed gratitude for the swift activation of new sites and the impressive rate of enrollment. He pointed out that enrollment has surged, with nearly double the number of subjects enrolled in the first two months of this fourth quarter compared to the previous three quarters. Efforts are ongoing to activate additional sites in December to expedite reaching enrollment targets.

Insights From Pilot Studies

Eric Schlorff, CEO of SeaStar Medical, conveyed optimism about the SCD’s capabilities, based on previous pilot studies showing its potential to save lives and alleviate dialysis dependency in critically ill patients. With approximately 210,000 adults suffering from AKI annually in the U.S., the company anticipates peak annual sales of around $1 billion for the SCD related to this condition. The SCD is also expected to aid in treating various other severe illnesses exacerbated by hyperinflammation, with future clinical endeavors geared towards tackling cardiorenal syndrome.

Understanding Acute Kidney Injury

AKI is notable for its rapid onset and temporary hindrance of kidney function, typically resulting from conditions such as severe trauma, COVID-19, or surgeries. It often incites hyperinflammation—an overproduction of inflammatory cells and agents that can cause extensive damage not just to the kidneys, but potentially to the heart and liver, leading to multi-organ dysfunction. The consequences can include an enhanced risk of mortality and a long-term struggle with chronic kidney disease or the necessity for dialysis.

The Role of the Selective Cytopheretic Device

The SCD represents a groundbreaking advancement in medical technology, designed to selectively engage and modulate proinflammatory cells during CRRT. This revolutionary approach aims not only to minimize excessive inflammatory responses but also to promote recovery of organ function, potentially averting the need for future renal replacement therapies. Its unique capacity to integrate with existing CRRT systems makes it a valuable asset in critical care.

Expansion of Clinical Trials and Regulatory Designations

SeaStar Medical has received FDA Breakthrough Device Designation for the SCD in the context of treating adults with AKI. This designation is a recognition of therapies with promising early evidence indicating substantial improvement over existing treatment options. Furthermore, the Centers for Medicare & Medicaid Services have recently approved Category B coverage for specific expenses associated with hospitals treating Medicare and Medicaid enrollees involved in the NEUTRALIZE-AKI trial.

A Bright Future in Pediatric Treatment

In addition to its adult AKI initiatives, SeaStar Medical has developed QUELIMMUNE™, a version of the SCD tailored for pediatric patients. Approved under a Humanitarian Device Exemption, it provides a crucial lifeline for critically ill children suffering from AKI and related conditions, ensuring a continuum of innovative care across age groups.

About SeaStar Medical

SeaStar Medical is committed to revolutionizing extracorporeal therapies aimed at alleviating severe inflammation's detrimental effects on vital organs. By nurturing scientific innovation, the company strives to deliver effective solutions for critically ill patients globally.

Frequently Asked Questions

What is the NEUTRALIZE-AKI trial's main goal?

The NEUTRALIZE-AKI trial aims to evaluate the safety and efficacy of the Selective Cytopheretic Device in treating adult patients with acute kidney injury.

How many patients are expected to be enrolled in the NEUTRALIZE-AKI trial?

The trial is set to enroll up to 200 adult patients diagnosed with AKI.

What advantages does the Selective Cytopheretic Device offer?

The SCD is designed to target proinflammatory cells, potentially improving patient outcomes and reducing the need for dialysis.

How does SeaStar Medical support pediatric patients?

SeaStar Medical has developed QUELIMMUNE™, a device specifically for critically ill children with AKI, approved under a Humanitarian Device Exemption.

What role does the FDA play in the development of the SCD?

The FDA awarded the SCD Breakthrough Device Designation, recognizing its promising potential in treating serious and life-threatening conditions.

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