Free Radical Biology and Medicine Volume 227 , 1 February 2025, Pages 276-281 https://www.sciencedirect.com/science/article/abs/pii/S0891584924011262?dgcid=author Abstract Nitric oxide plays a critical role in regulating vascular tone, but excessive nitric oxide release during septic shock results in hypotension due to excessive vasodilation and the formation of toxic free radicals. VBI-S is a phospholipid nanoparticle based fluid composed of lipid bilayers formed primarily by phosphatidylcholine and micelles of soybean oil encapsulated by a monolayer of phosphatidylcholine. These nanoparticles offer a novel solution by absorbing and redistributing nitric oxide and nitrite, potentially mitigating the harmful effects of excessive nitric oxide in sepsis. This paper proposes a mechanism in which VBI-S not only redistributes nitric oxide but also reduces ischemia-reperfusion injury by limiting the production and availability of reactive species. VBI-S captures nitric oxide and nitrite in areas of high concentration and redistributes them in low-nitric oxide environments, primarily within oxygen-deprived tissues. Nitrite then contributes to nitric oxide regeneration in hypoxic microvasculature via various reduction pathways, thereby improving tissue perfusion and minimizing oxidative stress. Preliminary studies suggest that nitrite may also decrease reactive species production, primarily superoxide, through the inhibition of mitochondrial complex I. Additionally, the lipid composition of VBI-S is rich in poly and monounsaturated fatty acids which allows VBI-S to act as a substrate for peroxidation via peroxynitrite. Therefore, VBI-S acts as a decoy target thereby protecting cellular membranes from oxidative damage caused by reactive species. These findings position VBI-S as a promising therapeutic agent, offering both nitric oxide regulation and protection against hypotension and toxic free radicals in septic shock patients. Further research is necessary to fully elucidate the molecular pathways and optimize its clinical application.

KANSAS CITY, Mo., Sept. 24, 2024 /PRNewswire/ --  Vivacelle Bio , a late-stage biopharma company developing life-saving treatments for shock and trauma, today announced its support of the Sepsis Alliance in its mission to raise awareness and understanding around sepsis. Sepsis, which is an overwhelming or impaired whole-body  immune response  to an infection or other insult, is the leading cause of death in U.S. hospitals, the cause of approximately 6% of all U.S. hospitalizations and 35% of all in-hospital deaths.1, https://www.prnewswire.com/news-releases/vivacelle-bio-commemorates-sepsis-awareness-month-recognizing-the-leading-cause-of-death-in-us-hospitals-302255761.html?tc=eml_cleartime

https://empoweredpatientradio.com/

KANSAS CITY, Mo., Sept. 3, 2024 /PRNewswire/ -- Vivacelle Bio , a late-stage biopharma company developing life-saving treatments for shock and trauma, today announced that it has enrolled the first patient in a Phase 3 trial for its lead therapeutic candidate, phospholipid nanoparticle-based VBI-S, to treat both absolute and relative hypovolemia due to septic shock and has initiated six trial sites. VBI-S is the first successful treatment for the overproduction of nitric oxide and to address both absolute and relative hypovolemia. https://www.prnewswire.com/news-releases/vivacelle-bio-enrolls-first-patient-in-phase-3-trial-of-hypovolemia-due-to-septic-shock-for-phospholipid-nanoparticle-based-vbi-s-302235487.html?tc=eml_cleartime

https://www.clinicaltrialvanguard.com/executiveinterviews/surge-in-septic-shock-care-vivacelles-innovative-approach/

https://www.prnewswire.com/news-releases/vivacelle-bio-initiates-phase-3-trial-for-lead-asset-vbi-s-to-treat-patients-with-hypovolemia-due-to-septic-shock-302203465.html?tc=eml_cleartime

https://www.prnewswire.com/news-releases/vivacelle-bio-integrates-sub-saharan-africa-strategy-into-series-b-financing-round-302067989.html

Vivacelle is advancing a robust pipeline of therapies for shock and trauma-induced conditions Vivacelle's pipeline is led by VBI-S, a Phase 3-ready asset designated for the treatment of hypotension and hypovolemia in septic shock patients, and VBI-1, a Phase 2-ready candidate for hemorrhagic shock. KANSAS CITY, Mo., May 31, 2024 /PRNewswire/ -- Vivacelle Bio, a late-stage biopharma company developing life-saving treatments for shock and trauma, today announced that Cuthbert Simpkins MD, FACS, President and Chief Innovation Officer, has been invited by the National Institutes of Health (NIH) to present data highlighting the company's late-stage clinical programs at the 2024 BIO International Convention taking place in San Diego, CA from June 3 – 6, 2024. Details of Dr. Simpkins' presentations are as follows: Presentation Title: Multiple Clinical Problems Solved Using Phospholipid Nanoparticles Date/Time: June 3, 2024, 2:45pm PDT Track/Location: Company Presentations - Theater 3 Date/Time: June 4, 2024, 11:30am PDT Track/Location: NIH Booth "After a year of significant clinical milestone achievements, including the remarkable 100% efficacy results from our VBI-S Phase 2 trial, and a groundbreaking study published in The Lancet eClinicalMedicine, we are excited to engage with potential pharmaceutical and commercial partners, as well as investors, at BIO to discuss our product portfolio and plans to soon initiate a multicenter Phase 3 study of VBI-S," commented Harven DeShield, PhD, JD, MSc, CEO of Vivacelle. Vivacelle's pipeline is led by VBI-S, a Phase 3-ready product built on the company's pioneering and patented phospholipid nanoparticle technology, which leverages the redistribution of nitric oxide to elevate blood pressure in hypovolemic septic shock, a leading cause of death that impacts millions around the world. A recently completed Phase 2 trial of VBI-S demonstrated 100% efficacy, with the treatment resulting in elevated blood pressure in hypovolemic septic shock patients who are refractory to therapy. "Dr. Simpkins' presentation at BIO, along with substantial scientific and clinical evidence generated over the past decade, will highlight the innovative and effective nature of our phospholipid nanoparticle technology platform, initially targeting hypovolemia resulting from septic shock. Nearly 2 million people in the US develop sepsis annually, a condition that current standard-of-care treatments fail to adequately address. Our extensive clinical data indicates that VBI-S is not only safe but also significantly improves blood pressure and reverses organ failure—a critical factor in sepsis-related mortality. The promising and disruptive therapeutic impact of this product candidate for patients has been recognized by ongoing support from the US Department of Defense and the NIH. We are confident that our advancements and strategic market approach will be well received by the BIO community, paving the way for tangible next steps that will propel our mission forward," added Dr. DeShield. Vivacelle Bio's Phase 2a clinical trial and ensuing multicenter Phase 3 study of VBI-S is funded by the Naval Medical Research Command (NMRC) – Naval Advanced Medical Development (NAMD) program via the Medical Technology Enterprise Consortium (MTEC). About MTEC The Medical Technology Enterprise Consortium (MTEC) is a 501(c)(3) biomedical technology consortium collaborating under an Other Transaction Agreement (OTA) with the U.S. Army Medical Research and Development Command (USAMRDC) that serves those who serve our nation. For more information about MTEC, visit mtec-sc.org. The views and conclusions contained herein are those of the authors and should not be interpreted as necessarily representing the official policies or endorsements, either expressed or implied, of the U.S. Government. About Vivacelle Bio Vivacelle Bio is a late-stage biopharma company developing life-saving treatments for shock and trauma. The company's lead product, Phase 3-ready VBI-S, is built on its pioneering and patented phospholipid nanoparticle technology, which leverages the redistribution of nitric oxide to elevate blood pressure in hypovolemic septic shock, a leading cause of death that impacts millions around the world. A Phase 2 trial of VBI-S demonstrated 100% efficacy, with the treatment resulting in elevated blood pressure in hypovolemic septic shock patients who are refractory to therapy. In addition to venture capital, Vivacelle has garnered backing and financial support from the US Department of Defense and the National Institutes of Health. Vivacelle Bio is headquartered in Kansas City, MO. Learn more at https://www.vivacellebio.com. Contact Investor Relations Tiberend Strategic Advisors, Inc. Daniel Kontoh-Boateng (862) 213-1398 dboateng@tiberend.com Media Relations Tiberend Strategic Advisors, Inc. Casey McDonald (646) 577-8520 cmcdonald@tiberend.com

KANSAS CITY, Mo., Feb. 29, 2024 /PRNewswire/ -- Today, researchers at Vivacelle Bio, Inc., a pioneering biotechnology company revealed the compelling outcomes of their phase 2a clinical trial of the investigational cardiovascular support fluid, VBI-S, in patients with severe septic shock. This landmark study now published in the Lancet's eClinicalMedicine , showcases the potential of VBI-S in transforming the treatment landscape for refractory hypotension in these critically ill patients. Unlike previous septic shock trials, this study, conducted in collaboration with the University of Missouri- Kansas City School of Medicine, there were no restrictions on the severity or duration of the illness or the cardiorespiratory stability of the enrolled patients. Some patients were unstable when given VBI-S. Yet the primary endpoint was achieved in each case. Twenty patients with high doses of vasopressors, multiple organ system failure, and a severely dysregulated response to infection were enrolled in the study. Patients, after failing standard fluids, received intravenous VBI-S, a revolutionary composition of phospholipid nanoparticles that reversibly absorb nitric oxide. The results were astonishing, with VBI-S proving 100% effective in elevating mean blood pressure by 10 mmHg or more. Within just 48 hours of the infusion, there were statistically significant improvements across multiple parameters, including oxygenation, renal function, inflammation, lactic acid levels, prothrombin time, and international normalized ratio. Furthermore, the sequential organ failure assessment (SOFA) score, a key indicator of illness severity, showed a notable decrease, signifying improved patient conditions. Remarkably, no serious adverse events were attributed to VBI-S. Sepsis, affecting 49 million people worldwide and claiming eleven million lives annually, poses a significant global health challenge. In the United States alone, 357,000 people succumb to sepsis each year. The efficacy and safety demonstrated by VBI-S in reversing hypotension, inflammation, and organ failure in septic shock patients suggest a potential paradigm shift in treating sepsis with its associated high mortality and morbidity. Dr. Cuthbert Simpkins, MD, the Sosland Missouri Endowed Chair in Trauma Services at the University of Missouri Kansas City School of Medicine and Chief Innovation Officer of Vivacelle Bio, Inc. stated, "This study was initially intended as a pilot to determine the variability of VBI-S effects. We did not expect the convincing results that we obtained. These results fuel our optimism that at last we may have an effective and safe intervention for these very sick patients." Harven DeShield, J.D., Ph. D., CEO of Vivacelle Bio, added, "Ultimately, the availability, affordability, and accessibility of VBI-S would represent a paradigm shift, substantially transforming how septic shock is treated both in the US and globally upon FDA's clearance of VBI-S to be marketed to the public." In a statement, Rod Cotton, 2Flo Ventures Advisory Board Member said, "The publication of  these clinical trial results in such a highly regarded peer reviewed journal is evidence of the importance of Vivacelle Bio's technology. This article is the introduction of a new concept of medical intervention that will revolutionize the treatment of sepsis and a broad-spectrum of medical conditions bringing hope to patients and their families." 2Flo Ventures is a startup studio and venture capital firm, and investor in Vivacelle Bio. This groundbreaking research opens new possibilities for the treatment of septic shock, offering hope and potential survival for millions of patients worldwide. The implications of VBI-S in reshaping the landscape of septic shock treatment are promising, marking a significant step forward in the fight against this life-threatening condition. This work was supported by the Naval Medical Research Command (NMRC) - Naval Advanced Medical Development (NAMD) Program under MTEC award 20-02-NavyMultiTopic-002. About MTEC The Medical Technology Enterprise Consortium (MTEC) is a 501(c)(3) biomedical technology consortium collaborating under an Other Transaction Agreement (OTA) with the U.S. Army Medical Research and Development Command (USAMRDC) that serves those who serve our nation. For more information about MTEC, visit mtec-sc.org. About 2Flo Ventures 2Flo Ventures is a startup studio and venture capital firm dedicated to accelerating equitable innovation in healthcare. They invest in diverse healthcare entrepreneurs and companies built to close gaps in health outcomes for underserved communities. About Vivacelle BioVivacelle Bio (www.vivacellebio.com) is a life sciences company that utilizes patented phospholipid nanoparticle technology to design products that increase the survivability of critically-ill patients. In addition to VBI-S and VBI-1, Vivacelle Bio has a pipeline of products at various stages of development applicable to a range of health areas including reperfusion injury, organ preservation and transplantation, multiple organ dysfunction syndrome and hyperprocalcitonemia.  Vivacelle Bio has raised approximately $10.9M in seed and Series A1-A3 funding, including from the US Department of Defense, the US National Institutes of Health, and 2Flo Ventures. Forward looking statements 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. SOURCE Vivacelle Bio

https://21ninety.com/krystal-anderson-sepsis-death-stillbirth

KANSAS CITY, Mo., Feb. 10, 2023 /PRNewswire/ -- Vivacelle Bio, Inc., a privately held life science company focused on the development of treatments for hypovolemia in shock including septic shock and hemorrhagic shock, announced the successful completion of its Phase IIa clinical trial of VBI-S in septic shock patients with severe hypovolemia. Severe septic shock patients experience a drastic drop in blood pressure that is associated with multiple organ failure causing patient death. While conventional fluids are effective for treating absolute hypovolemia, they are ineffective for treating relative hypovolemia, which is caused by excessive production of nitric oxide (NO) in septic shock. VBI-S, which is administered intravenously, reversibly absorbs NO, reducing the bioavailability of NO. This first of its kind approach reduces the bioavailability of NO without interfering with its production or essential cellular interactions. In the VBI-S Phase IIa trial, reversal of relative hypovolemia led to an increase in blood pressure and improvement of organ function. All 20 patients enrolled in the trial met the primary endpoint of elevating mean arterial blood pressure by at least 10 mmHg within an average of 1.5 hours. The secondary endpoint which was to reduce the dose of vasopressors was also met. Significant improvements in tissue perfusion, inflammation, kidney and lung function were also observed within 48 hours, with no drug-related adverse effects reported. The mortality rate of patients with septic shock is approximately forty percent (40%) with 270,000 deaths per year in the United States and eleven (11) million deaths per year worldwide. Reversal of the drop in blood pressure and improvement of organ function by targeting relative hypovolemia with VBI-S infusion in septic shock patients could be significantly important for improving the chance of survival of these patients. Cuthbert Simpkins MD, the Sosland Missouri Endowed Chair in Trauma Services at the UMKC School of Medicine in Kansas City and the Chief Innovation Officer of Vivacelle Bio, Inc. stated, "We could not have imagined a better outcome for our clinical trial. We believe VBI-S is what physicians have been seeking for decades. We are very excited to have created a novel treatment for hypovolemia due to septic shock much different from the multiple treatment approaches for this life-threatening disease that do not work." Harven DeShield JD, Ph.D., the CEO of Vivacelle Bio, Inc. commented, "contingent upon Food and Drug Administration (FDA) clearance, VBI-S represents a paradigm shift in the treatment of hypovolemia due to septic shock because it is very likely to markedly reduce the probability of a patient being placed on Extracorporeal Membrane Oxygenation (ECMO) after the failure of fluid therapy and vasopressors and potentially improve survival of patients." The clinical trial is funded by the Naval Medical Research Center (NMRC) – Naval Advanced Medical Development (NAMD) program via the Medical Technology Enterprise Consortium (MTEC). About MTEC The Medical Technology Enterprise Consortium (MTEC) is a 501(c)(3) biomedical technology consortium collaborating under an Other Transaction Agreement (OTA) with the U.S. Army Medical Research and Development Command (USAMRDC) that serves those who serve our nation. For more information about MTEC, visit mtec-sc.org. For more information on VBI-S or Vivacelle Bio, Inc., please contact Harven DeShield, J.D., Ph.D., CEO, at 716-830-8932 or via email, harven@vivacellebio.com. Forward looking statements 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. Contacts Harven DeShield, J.D., Ph.D., CEO716-830-8932harven@vivacellebio.com.

Feds hope to cut sepsis deaths by hitching Medicare payments to treatment stats. https://www.fiercehealthcare.com/providers/feds-hope-cut-sepsis-deaths-hitching-medicare-payments-treatment-stats The rule emphasizes the following measures: Quick Blood Tests: Hospitals must perform blood tests promptly to identify markers indicating sepsis.Timely Antibiotics: Antibiotics must be administered within three hours of identifying a possible sepsis case.Other Measures: The Severe Sepsis/Septic Shock Early Management Bundle also includes additional tests and intravenous fluids to maintain safe blood pressure levels.