Vivacelle Bio, Inc. Receives FDA Clearance to Enroll Patients into its Phase IIa Clinical Trial of VBI-1 for Severe Blood Loss and/or Raising Blood Pressure in Hypovolemic Subjects

CHICAGO–(BUSINESS WIRE)–Vivacelle Bio, Inc. today announces that the US. Food and Drug
Administration (FDA) has granted it an Investigational New Drug (IND)
clearance to proceed with its phase IIa clinical trial of the safety and
efficacy of VBI-1. VBI-1 is a paradigm-changing cardiovascular support
fluid that is designed for the treatment of patients with emergently
life-threatening conditions due to blood loss and other causes of severe
hypovolemia (low blood volume). The treatment of hypovolemia and raising
blood pressure are essential to survival of a broad range of critical
conditions such as blood loss, burns, gastrointestinal losses, septic
shock, acute radiation syndrome, or attacks utilizing biological or
chemical weapons.

Harven DeShield J.D., PhD and CEO of Vivacelle Bio commented, “This
is the most transformational milestone achieved to date by our company.
It is our expectation that the achievement of this milestone will serve
as a launching pad to eventually providing critical technologies to
address unmet medical need and save lives.”

Commitments have been obtained from key physicians at leading medical
centers for participation in the study. Vivacelle Bio is currently
seeking funding opportunities to support its performance of the clinical

Cuthbert Simpkins, M.D., Chief Innovation Officer and inventor of the
Vivacelle Bio technology stated, “As a Trauma Surgeon I am grateful that
my invention will save many lives which was my motivation for developing
it in the first place.”

Vivacelle Bio, Inc. is a biopharmaceutical company focused on the
discovery of life-saving interventions in critical illnesses that
rapidly cause death such as injuries encountered in warfare, major motor
vehicle collisions and septic shock.

Forward looking statement

This press release may contain certain forward-looking statements.
Although the Company believes its expectations are based on reasonable
assumptions, all statements other than statements of historical fact
included in this press release about future events are subject to (I)
change without notice, (ii) factors beyond the Company’s control and
(iii) the financial capabilities of the Company. These statements may
include, without limitation, any statements preceded by, followed by or
including words such as “target,” “believe,” “expect,” “aim,” “intend,”
“may,” “anticipate,” “estimate,” “plan,” “project,” “will,” “can have,”
“likely,” “should,” “would,” “could” and other words and terms of
similar meaning or the negative thereof. Forward looking statements are
subject to inherent risks and uncertainties beyond the Company’s control
that could cause the Company’s actual results, performance or
achievements to be materially different from the expected results,
performance or achievements expressed or implied by such forward-looking
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.


Harven DeShield

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