Vivacelle Bio Announces Submission of an IND Application with U.S. FDA for VBI-S, an Injectable Fluid for the Treatment of Patients with Severe Septic Shock

• VBI-S is designed to elevate blood pressure of patients in severe
  septic shock in spite of the failure of current measures such as
  albumin, crystalloid, plasma, blood or vasopressor drugs.
• Phase IIa study expected to be initiated shortly after FDA review and
  clearance

CHICAGO–(BUSINESS WIRE)–Vivacelle Bio, Inc. today announced that it supported an investigational
new drug (IND) application to the U.S. Food & Drug Administration for a
phase IIa clinical trial of VBI-S, a phospholipid-based nanoparticle
fluid that has the potential to elevate the blood pressure of patients
who are suffering severe septic shock. Current therapy for these
patients is either minimally effective or totally ineffective. By
elevating blood pressure, the possibility of survival would be
significantly improved. This announcement follows the FDA clearance in
February 2019 of the company’s first patented and proprietary product,
VBI-1, for a phase IIa clinical trial of its safety and efficacy after
blood loss. See https://www.businesswire.com/news/home/20190215005521/en/Vivacelle-Bio-Receives-FDA-Clearance-Enroll-Patients.

Harven DeShield JD, PhD CEO of Vivacelle Bio commented, “It is widely
known and acknowledged that current fluid therapies deployed to elevate
blood pressure in septic shock patients are markedly inadequate. It is
our expectation that the availability of VBI-S upon FDA approval will
address the inadequacy of fluid therapy in raising blood pressure in
septic shock patients. This IND demonstrates our company’s efforts to
promote lipid emulsion-based therapies for life-threatening diseases.”

Cuthbert Simpkins MD, FACS the inventor of VBI-S stated, “I have been
heartbroken by the loss of my patients who died as a result of severe
septic shock since my surgical residency. I was committed and have been
researching since my stint at the Naval Medical Research Institute.
VBI-S is the solution I had been looking for which would offer hope to
patients and their families.”

About Vivacelle Bio, Inc.

Vivacelle Bio, Inc. is a clinical stage biotechnology company that is
focused on the discovery of new knowledge in the field of critical care
and trauma. Currently, the company’s strategy is to develop and
commercialize its discoveries that have led to a pipeline of products
that are based on the biophysical properties of phospholipid
nanoparticles and coupled with components of the aqueous phase. Various
formulations are designed to counteract the adverse aspects of a broad
spectrum of disease.

Forward looking statement

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assumptions, all statements other than statements of historical fact
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statements. Except as required by law, the Company assumes no obligation
to update these forward-looking statements publicly, or to update the
reasons actual results could differ materially from those anticipated in
the forward-looking statements, even if new information becomes
available in the future.

Contacts

Harven DeShield, JD, PhD
[email protected]
716-830-8932
Company
website: vivacellebio.com