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 trial.
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.