11.19.20

Vivacelle Bio Receives $5.3 Million Award from the U.S. Navy for a Clinical Trial

Cuthbert Simpkins, MD, FACS, President & Chief Innovation Officer, Vivacelle Bio, Inc.

NEWS RELEASE

Fort Wayne, Indiana — Vivacelle Bio, Inc. today announces the Department of Defense awarded $5.3 million (USD) dollar 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 U.S. and 10 million people worldwide die of septic shock annually. 70% 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.”

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 stated, ” 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.”

Harven DeShield J.D., Ph.D. and CEO of Vivacelle Bio commented, “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.”

About Vivacelle Bio, Inc.
Vivacelle Bio, Inc. is a biopharmaceutical company focused on the discovery of life-saving interventions in critical illnesses due to a broad range of causes such as injuries resulting from warfare, major motor vehicle collisions or septic shock. Vivacelle Bio has a pipeline of products based upon its transformational phospholipid nanotechnology.

For more information on VBI-S or Vivacelle Bio, please contact Harven DeShield, J.D., Ph.D. at 716-830-8932 or via email, harven@vivacellebio.com. Company website: vivacellebio.com

About Medical Technology Enterprise Consortium
MTEC is a biomedical technology consortium collaborating with multiple government agencies under a 10-year renewable Other Transactional Agreement with the U.S. Army Medical Research and Development Command. To find out more about MTEC, visit www.mtec-sc.org.

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