Vivacelle Bio Receives Award from Navy for VBI-S Trial for Hypovolemia of Septic Shock Due to COVID

Vivacelle Bio announces the Department of Defense awarded $5.3 million dollars for the clinical trial of VBI-S, an intravenously injected fluid based upon Vivacelle Bio's phospholipid nanoparticle technology for the treatment of septic shock due to various pathogens including COVID-19, other viruses and/or bacteria. Approximately 270,000 people in the US and 10 million people worldwide die of septic shock annually. Seventy percent of COVID deaths are due to septic shock. Vivacelle's VBI-S is likely to be effective in elevating blood pressure to survivable levels and improving oxygenation at early and even late stages of septic shock when current therapy, consisting of fluids and vasopressor medications, have failed. A phase IIa trial will be performed followed by a phase IIb/III trial of VBI-S.

The award was issued on behalf of the Naval Medical Research Center (NMRC) under Medical Technology Enterprise Consortium (MTEC) a biomedical technology consortium that collaborates under a transaction agreement (OTA) with the US Army Medical Research and Development Command (USAMRDC). The award issued is entitled "Phospholipid Nanoparticles in The Treatment of Septic Shock."

"VBI-S is a game changer. Many years ago, I received the training that enabled me to make this discovery while I served as a Naval Officer at the Naval Medical Research Institute. I have been doing research on septic shock for nearly 40 years. Finally, we have what I and others have been seeking for all of this time, a way to save lives and to reduce suffering of patients and their loved ones. I am very grateful to the Navy for providing the opportunity to move this life saving technology forward," Harvard Medical-school graduate and trauma surgeon, Cuthbert Simpkins, M.D., Founder of Vivacelle Bio, Chief Innovation Office and inventor of the phospholipid nanoparticle technology said.

"This milestone clearly establishes both the clinical importance of VBI-S and the commercial trajectory of Vivacelle Bio. We are well poised to leverage our nanotechnology to rapidly address unmet clinical needs and save lives,” Harven DeShield J.D., Ph.D. and CEO of Vivacelle Bio said.