"Vivacelle Bio Announces Compassionate Use for COVID-19 Patients with our Sepsis Treatment, VBI-S, for the elevation of blood pressure (treating persistently low hypotension) in Covid-19 induced Septic Shock.  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.  See Press Release immediately below."

https://www.prnewswire.com/news-releases/vivacelle-bio-announces-compassionate-use-for-covid-19-patients-with-its-sepsis-treatment-vbi-s-301044045.html

Via: PetaCrunch

AI-powered media company

Vivacelle Bio has raised $2.6M in total. We talked with Harven V. DeShield, its CEO.

How would you describe Vivacelle Bio in a single tweet?

Vivacelle Bio  is focused on the discovery of  interventions in emergency life-threatening illness or trauma that shift the balance from non-survival to survival. 

How did it all start and why?

Vivacelle Bio was founded by Dr. Cuthbert Simpkins, a trauma surgeon, who was driven to find ways to save severely ill or injured patients whose survival is beyond  current technology.

What have you achieved so far?

Vivacelle Bio has developed an innovative and disruptive cardiovascular support fluid that treats shock due to sepsis and severe blood loss. Three fundamental characteristics of shock are (1) hypovolemia due to insufficient circulating volume (2) overproduction of nitric oxide and (3) organ damage due to ischemia-reperfusion injury.  Preclinical studies have shown that our patented and proprietary formulations are able to correct the volume deficit, acutely elevate blood pressure as well as blood, favorably adsorbs and release/redistribute nitric oxide and/or also prevent the tissue destruction caused by shock.

Vivacelle Bio now owns nine US patents and 33 patents in international jurisdictions and has additional patent applications pending.  In preclinical studies, our methods and fluid have been shown to restore life after exsanguination (severe blood loss which leads to a loss of pulse). Our cardiovascular support fluid has also been shown to elevate blood pressure in human patients with shock due to sepsis after all other measures have failed. This would greatly improve the chance of survival. Vivacelle Bio has put together a highly qualified and experienced management team. This team has not only assisted with securing and managing our strong intellectual property portfolio but has also achieved a key regulatory milestone in being granted clearance by the FDA to do phase II clinical trials of VBI-S designed for shock due to sepsis and VBI-1 which is designed for shock due to severe blood loss. This year we expect to move forward with our clinical trial of VBI-S in patients with sepsis. 

What do you plan to achieve in the next 2-3 years?

In 3 years, it is anticipated that Vivacelle Bio could possibly be 

(1) a 500-million-dollar company primarily known for providing solutions to address unmet medical needs in emergency and trauma care

(2) developing additional products now in our pipeline

(3) making products based on new discoveries that will save many lives

https://petacrunch.com/2019/10/08/vivacelle-bio-discovery-of-interventions-in-emergency-life-threatening-illness-or-trauma/ 

I(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. know.

https://blackprwire.com/press-releases/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

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