AN URGENT GLOBAL CRISIS
Millions of Lives
Sepsis is a leading cause of death worldwide, claiming 11 million lives each year—including 3.4 million children. This urgent crisis presents a profound unmet medical need and a significant opportunity for transformative treatments.
Innovative Platform
Phospholipid nanoparticles (VBI-S and VBI-1) restore intravascular volume and redirect excess nitric oxide to treat relative and absolute hypovolemia, helping reverse hypotension and prevent organ failure in patients who are septic or have severe blood loss.
A New Paradigm
We are pioneering a groundbreaking approach to critical care—one that offers life-saving intervention for septic shock and acute hemorrhage. Our mission is to transform treatment outcomes, protect vital organs, and ultimately save millions of lives worldwide.
MECHANISM OF ACTION: HOW OUR NANOPARTICLE THERAPY (VBI-S) WORKS
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Learn About Vivacelle Bio’s Potentially Revolutionary Treatment for Hypovolemia
Absolute hypovolemia occurs when fluid or blood is lost from the vessels and is typically treated with blood and intravenous fluids, although large volumes can lead to severe complications.
In relative hypovolemia, excessive nitric oxide dilates blood vessels, causing persistent low blood pressure even when fluid levels are normal or high. Vasopressors are the only available treatment but carry life-threatening risks and are often ineffective, leaving patients with few options and a high risk of death.
A NEW PARADIGM IN FLUID RESUSCITATION
Enrolling Our Phase III Trial
Vivacelle Bio Recently Initiated a Phase III Trial for its Lead Asset – VBI-S – to Treat Patients with Hypovolemia Due to Septic Shock.
The open-label, randomized, controlled Phase III trial is enrolling 40 septic shock patients across seven planned sites in the U.S., including some of the largest septic shock treatment centers in the country. The study is designed to compare VBI-S and standard of care (SOC) to SOC alone in a 1:1 ratio.
The primary endpoint for the trial is an increase in the mean arterial blood pressure (MAP) by at least 10 mmHg with a target of 60-65 mmHg. Patients in the Phase III trial will have failed attempts to raise blood pressure to a survivable level using standard fluids and will be on vasopressors which may produce severe life-threatening complications.