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Each year, at least 1.7 million adults in U.S. develop sepsis, with >350,000 dying as a result, often from complications of septic shock and is a major financial burden for the medical system.

VBI-S, Vivacelle's Phase 3 therapeutic candidate is a phospholipid nanoparticle-based treatment designed to treat both absolute and relative hypovolemia due to septic shock.

KANSAS CITY, Mo., Sept. 24, 2024 /PRNewswire/ -- Vivacelle Bio, a late-stage biopharma company developing life-saving treatments for shock and trauma, today announced its support of the Sepsis Alliance in its mission to raise awareness and understanding around sepsis. Sepsis, which is an overwhelming or impaired whole-body immune response to an infection or other insult, is the leading cause of death in U.S. hospitals, the cause of approximately 6% of all U.S. hospitalizations and 35% of all in-hospital deaths.^1,2

"Sepsis Awareness Month plays a vital role in advancing the discussion around sepsis and septic shock in an effort to build awareness among patients, healthcare professionals, and industry to this global challenge and the need to improve treatments for this often-deadly condition," said Harven DeShield, PhD, JD, MSc, CEO of Vivacelle Bio. "Sepsis is an equal-opportunity killer, which can strike people of all ages and backgrounds, though it takes an especially devastating toll on those with weakened immune systems, racial and ethnic minorities, and lower income individuals and families. The Vivacelle team and our research partners are proud to be aligned with Sepsis Alliance in its mission to save lives and reduce suffering by educating the public and improving diagnosis and treatment."

Vivacelle is developing Phase 3 VBI-S, a therapeutic built on the company's pioneering and patented phospholipid nanoparticle technology, which expands intravascular volume and redistributes nitric oxide to elevate blood pressure and reverse multisystem organ failure in patients with absolute and/or relative hypovolemia due to septic shock. Growing evidence suggests hypovolemia is a critical link to mortality among sepsis patients.

Decades of research into the role of endogenously produced nitric oxide in the pathogenesis of septic shock resulted in the design of VBI-S.³ Vivacelle's Phase 3-technology has the potential to be the first treatment of septic shock that utilizes phospholipid nanoparticles with hydrophobic cores that both expand intravascular volume and reversibly absorb nitric oxide in the blood vessel, preventing excessive and damaging vasodilation, and redistributing nitric oxide to increase the probability of survival.

Vivacelle Bio's Phase 3 study is funded by the Naval Medical Research Command (NMRC) – Naval Advanced Medical Development (NAMD) program via the Medical Technology Enterprise Consortium (MTEC).

About MTEC
The Medical Technology Enterprise Consortium (MTEC) is a 501(c)(3) biomedical technology consortium collaborating under an Other Transaction Agreement (OTA) with the U.S. Army Medical Research and Development Command (USAMRDC) that serves those who serve our nation. For more information about MTEC, visit mtec-sc.org.

About Vivacelle Bio
Vivacelle Bio is a late-stage biopharma company developing life-saving treatments for shock and trauma. The company's lead, Phase 3 product, VBI-S, is built on its pioneering and patented phospholipid nanoparticle technology, which leverages the redistribution of nitric oxide to elevate blood pressure in hypovolemic septic shock, a leading cause of death that impacts millions around the world. A Phase 2 trial of VBI-S demonstrated 100% efficacy, with the treatment resulting in elevated blood pressure in hypovolemic septic shock patients who are refractory to therapy. In addition to venture capital, Vivacelle has garnered backing and financial support from the US Department of Defense and the National Institutes of Health. Vivacelle Bio is headquartered in Kansas City, MO. Learn more at https://www.vivacellebio.com.

Contact
Investor Relations
Tiberend Strategic Advisors, Inc.
David Irish
(231) 632-0002
dirish@tiberend.com

Media Relations
Tiberend Strategic Advisors, Inc.
Casey McDonald
(646) 577-8520
cmcdonald@tiberend.com

References:
1. Liu V, et al. "Hospital Deaths in Patients With Sepsis From 2 Independent Cohorts." JAMA. 2014;312(1):90-92. https://jamanetwork.com/journals/jama/fullarticle/1873131
2. Rhee C, et al. "Incidence and Trends of Sepsis in US Hospitals Using Clinical vs Claims Data, 2009-2014." JAMA. 2017;318(13):1241-1249. http://jamanetwork.com/journals/jama/fullarticle/2654187
3. Vallance P, Moncada S. Role of endogenous nitric oxide in septic shock. New Horiz. 1993 Feb;1(1):77-86. PMID: 7922396. https://pubmed.ncbi.nlm.nih.gov/7922396/

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SOURCE Vivacelle Bio