1-877 BLACKPR (252-2577)
For Immediate Release
June 07, 2019
Contact Information

Harven DeShield, JD, PhD
harven@vivacellebio.com
716-830-8932
Company website: vivacellebio.com

(BPRW) 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

(Black PR Wire) Chicago, Ill. 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

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.