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Clinical Lab
OCTOBER 8, 2019
Vivacelle Bio, discovery of interventions in emergency life-threatening illness or trauma
Via: PetaCrunch
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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
Vivacelle Bio CEO
July 8, 2019
Shreveport Physician Granted FDA Permission to Test a New Fluid for Shock Due to Blood infection.
Cuthbert O. Simpkins II MD, son of civil rights icon Dr. C.O Simpkins, has invented a new injectable fluid, VBI-S, that is designed to save the lives of patients who die of infection of the bloodstream, known as sepsis. See https://www.businesswire.com/news/home/20190708005192/en/Vivacelle-Bio-Announces-FDA-Clearance-Enroll-Patients
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.
Previous attempts to treat sepsis have been based on blocking the effects of harmful molecules. But because these molecules that take life must also be present to maintain life previous therapies have failed. Too little or too much of these molecules can lead to death. The balance must be just right. The infusion of VBI-S shifts the body’s molecular balance from non-survival to survival. This is a new approach for which Dr. Simpkins has received numerous patents nationally and internationally.
US patents are listed here, https://patents.justia.com/inventor/cuthbert-o-simpkins.
Dr. Simpkins commented, "Over the last 40 years there has been a tremendous increase in our understanding of sepsis. But a solution has eluded us time and time again. VBI-S is a different approach. I am very excited about the possibility that VBI-S could be what the world’s medical community has been seeking for many decades.”
The development of VBI-S is being conducted by Vivacelle Bio, Inc., company founded by Dr. Simpkins and his wife Diane Simpkins in 2013. The CEO of the company is Harven DeShield, PhD, JD, an intellectual property attorney with a PhD in Biochemistry who stated,
“The clearance of this IND will further accelerate our company’s efforts to promote phospholipid nanoparticle therapies for life-threatening diseases. 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. The combination of VBI-S and VBI-1 promises to be transformative with respect to providing critical technologies to address unmet medical need and save numerous lives both in the US and globally. ”
Vivacelle Bio, Inc. Is a biopharmaceutical company focused on the discovery of life saving interventions in critical illness. For more information on VBI-S Contact Harven DeShield, PhD, JD, (harven@vivacellebio.com, 716-830-8932. The company website is vivacellebio.com
The development of VBI-S is being conducted by Vivacelle Bio, Inc., company founded by Dr. Simpkins and his wife Diane Simpkins in 2013. The CEO of the company is Harven DeShield, PhD, JD, an intellectual property attorney with a PhD in Biochemistry who stated,
“The clearance of this IND will further accelerate our company’s efforts to promote phospholipid nanoparticle therapies for life-threatening diseases. 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. The combination of VBI-S and VBI-1 promises to be transformative with respect to providing critical technologies to address unmet medical need and save numerous lives both in the US and globally. ”
Vivacelle Bio, Inc. Is a biopharmaceutical company focused on the discovery of life saving interventions in critical illness. For more information on VBI-S Contact Harven DeShield, PhD, JD, (harven@vivacellebio.com) 716-830-8932. The company website is www.vivacellebio.com
June 7, 2019
(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
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
Harven DeShield PhD, JD, 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. Vivacelle Bio More News
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.
February 21, 2019
Shreveport Sun Magazine
The influence of a father on a son.
C.O. Simpkins & Cuthbert Simpkins II
November, 2020
Grab interest
Cuthbert Simpkins, MD, Founder, President and Chief Innovation Officer, Vivacelle Bio, was featured at the GIANT Global Innovation and New Technology Health Event in London, November 16, 2016
Cuthbert Simpkins, MD, Founder, President, and Chief Innovation Officer of Vivacelle® Bio, Inc., delivered a presentation “Nanoparticles and all that Jazz” on November 16, 2016 during The Global Innovation and New Technology Health Event in London.
Sponsored by GIANT Health, this event combines a conference, trade show and consumer fair showcasing leading technologies and is the most informative and network bridging event within #HealthTechWeek. Using a dynamic, interdisciplinary forum it will create, shape and celebrate new thinking in health innovation that will translate to helping people live better lives. The Event was held November 16-19, 2016.
Vivacelle Bio is a US-based life sciences company established in 2013 to develop and commercialize as its first product VBI-1, a novel nanoparticle, lipid-based intravenous resuscitation fluid to reverse the consequences of hypovolemia and hypovolemic shock. The company has completed preclinical development of VBI-1 and is preparing to enter clinical trials in 2017.
During this presentation, Dr. Simpkins discussed the critical need for improved therapeutics to treat shock caused by acute blood loss from trauma, surgical procedures and other conditions and his efforts to develop VBI-1.
He also shared his personal journey of growing up during the height of the US civil rights movement through being a student at Harvard Medical School, writing the definitive biography of John Coltrane, working as a trauma surgeon, founding Vivacelle Bio and identifying a nanoparticle technology to better treat the underlying pathophysiology of shock. He identified parallels between life science product development and jazz, citing the influence and innovation of John Coltrane on his efforts.
The_GIANT_Health_Event.pdf
1.8 MB
Cuthbert Simpkins talks about how he drew inspiration from music to start is own biotech company
Cuthbert Simpkins, MD, President and Chief Innovation Officer at Vivacelle Bio, Inc. talks to us about his intriguing presentation on ‘Nanoparticles and all that jazz’ at the Giant Health Event in London. Cuthbert explains how he drew inspiration from music, particularly John Coltrane, and highlights the way that science and music are developed using similar patterns. The inspiration that he gained from Coltrane and his jazz enabled him to start his own biotech company, Vivacelle, where they have developed a nanoparticle technology to solve problems in the pathophysiology shock in critical care. A company focussed on innovation, Cuthbert emphasizes that there will be many more products in the pipeline.
THE NEW ORLEANS CONFERENCE
Dr. Cuthbert Simpkins will be a featured speaker during The New Orleans Conference in Las Vegas, Nevada, June 28-July 1, 2017. He will present "A New Organ Protective Volume Expanding Perfusion (VB-1) Fluid Based on Phospholipid Nanoparticles".
The conference is organized by perfusionists and cardiothoracic surgeons who specialize in heart and lung operations and transplantation. The New Orleans Conference - Las Vegas Edition offers unique learning opportunities with lectures on diagnosing and treating coagulopathy, beating heart organ donation, tissue engineering, regenerative medicine, brain protection, Trans-Cranial Doppler, ECMO/VAD therapies, Medical Law and many more topics.
Pre-register at http://www.theneworleansconference.com
43NORTH SEMIFNALIST
Vivacelle Bio, Incorporated is thrilled to be a @forty3north semifinalist and to move on to the next round of the $5M startup competition!
This year, over 500 startups from across North America submitted applications to 43North to complete for $5 million in cash awards! Vivacelle Bio, Incorporated is proud to be among the 134 semifinalists chosen.
We're IN it to WIN it!
www.43north.org/2017-semifinalists/
www.43north.org/governor-cuomo-announces-2017-semifinalists/
www.43north.org/presenting-our-2017-semifinalists/