See Trial Information here: https://clinicaltrials.gov/study/NCT04257136?tab=table

April 22, 2020 Vivacelle Biosciences said it will make its experimental sepsis treatment VBI-S available for compassionate use in COVID-19 patients. VBI-S is being investigated for treatment of decreased blood circulation due to sepsis and septic shock. In early studies, the drug improved blood pressure and oxygenation in patients when other measures failed. The Chicago-based drugmaker is currently evaluating the drug in a phase 2a trial for hypotension in septic shock patients. https://www.fdanews.com/articles/196749-vivacelle-bio-provides-its-sepsis-treatment-for-covid-19-via-compassionate-use

Most COVID patients die of septic shock. In early studies VBI-S improved blood pressure and oxygenation of septic shock patients when all other measures had failed. NEWS PROVIDED BY Vivacelle Bio, Inc. 21 Apr, 2020, 05:01 ET CHICAGO, April 21, 2020 /PRNewswire/ -- Vivacelle Bio, Inc., a U.S. biotechnology firm that develops products for critically ill patients, will make VBI-S, available for use in COVID-19 patients.  Seventy percent of deaths of COVID-19 patients are due to septic shock.  While intravenous infusion of VBI-S has demonstrated encouraging preliminary results in a phase IIa clinical study, VBI-S remains an experimental drug. See a listing of our VBI-S IIa clinical trial at  the link: https://clinicaltrials.gov/ct2/show/record/NCT04257136?cond=septic+shock&cntry=US&state=US%3AIN&draw=2&rank=1 VBI-S could rescue lives of COVID patients even when standard treatment has failed by shifting the balance of complex nitric oxide effects toward survival. Vivacelle Bio CEO Harven DeShield, JD, PhD, commented, "VBI-S holds the promise of being a compelling and novel technology to address COVID-19 induced sepsis and septic shock and thus the potential to save numerous lives both in the US and globally." Cuthbert Simpkins MD inventor of VBI-S and Vivacelle Bio Chief Innovation Officer commented, "It is fulfilling to serve both as a critical care physician providing direct care to COVID patients and as a scientist whose invention could rescue people who are dying of this  disease." Mallory Williams MD, MPH Chief of Trauma and Critical Care and Director of the Surgical Intensive Care Unit at Howard University Hospital stated, "I am greatly encouraged that Vivacelle Bio through its innovative discoveries has proposed therapeutic solutions for the most critically ill patients.  Severe sepsis claims the lives of over 250,000 Americans and 10 million globally each year and now there is a reason to believe that we are closer to significantly decreasing this number." Mukesh Kumar, PhD, Vivacelle's Senior VP of Regulatory Affairs stated, "We look to partner with physicians and hospitals to make VBI-S rapidly available to treat COVID-19 patients in dire life-threatening condition." Jim J. Huang, Ph.D., CEO of Ascendia Pharmaceuticals, a specialty CDMO company, engaged in nanoparticle formulation, is pleased to support Vivacelle Bio in meeting this international crisis. 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. About Vivacelle Bio, Inc. Vivacelle Bio, Inc. is a clinical stage life science company focused on a new paradigm of nitric oxide redistribution that utilizes biophysical properties of phospholipid nanoparticles. The Company's first product, VBI-S is designed to treat septic shock caused by COVID-19, other viruses, bacteria, parasites or fungi. Press Contact: Harven DeShield716-830-8932harven@vivacellebio.com,Website: https://vivacellebio.com SOURCE Vivacelle Bio, Inc. Related Links https://vivacellebio.com/

February 15, 2019 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. “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.” 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.