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About our Phase 3 Trial
Vivacelle Bio Recently Initiated a Phase 3 Trial for its Lead Asset - VBI-S - to Treat Patients with Hypovolemia Due to Septic Shock
The open-label, randomized, controlled Phase 3 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 3 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.
[CM1]Need to update this stating that the trial has been initiated.
Millions of Lives
Substantial Medical Need & Market Opportunity
Sepsis is a leading cause of death killing 11M globally including 3.4M children
Innovative Platform
Phospholipid Nanoparticles – VBI-S and VBI-1 – are designed to restore intravascular volume and redistribute overproduced nitric oxide to treat relative and absolute hypovolemia resulting in reversal of hypotension and organ failure in patients who are septic or have had severe blood loss.
A New Paradigm
For the treatment of absolute and relative hypovolemia for life-saving intervention in septic shock and severe blood loss
Our team is composed of dedicated doctors and business leaders focusing on advancing the field of shock treatments to save the lives of millions.
CIO, Founder & President
CEO, Co-Founder
CMO, Co-Founder
SVP, Regulatory Affairs