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26 items found for ""

  • Vivacelle Bio's President and Chief Innovation Officer to Present Data Highlighting the Company's Late-Stage Clinical Programs at the BIO International Convention 2024

    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

  • Vivacelle Bio and University of Missouri-Kansas City School of Medicine Announce Groundbreaking Results from Phase 2a Clinical Trial of VBI-S for Refractory Hypotension in Severe Septic Shock Patients

    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

  • Vivacelle Bio Integrates Sub-Saharan Africa Strategy into Series B Financing Round

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

  • Feds hope to cut sepsis deaths by hitching Medicare payments to treatment stats

    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.

  • Vivacelle Bio’s VBI-S Phase IIa Clinical Trial Meets Primary and Secondary Endpoints for Treating Hypovolemia in Septic Shock Patients

    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.

  • Septic Shock Market is Expected to Expand at a Healthy Growth Rate by (2022-2032), States DelveInsight | Key Companies – Adrenomed AG, Vivacelle Bio, Inotrem

    By GetNews Published September 19, 2022 DelveInsight’s “Septic Shock Market Insights, Epidemiology, and Market Forecast-2032″ report offers an in-depth understanding of the Septic Shock, historical and forecasted epidemiology as well as the Septic Shock market trends in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom) and Japan. The Septic Shock market is expected to surge due to the disease’s increasing prevalence and awareness during the forecast period. Furthermore, launching various multiple-stage Septic Shock pipeline products will significantly revolutionize the Septic Shock market dynamics. Septic Shock Overview According to the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis3), septic shock is defined by persisting hypotension that requires vasopressors to maintain amean arterial pressure of 65 mm Hg or higher and a serum lactate level greater than 2 mm ol/L(18 mg/dL) despite adequate volume resuscitation. The symptoms of septic shock include hypotension, confusion or disorientation, diarrhea, nausea and vomiting, cold, clammy, and pale skin. Some of the key facts of the Septic Shock Market Report: The Septic Shock market size is anticipated to grow with a significant CAGR during the study period (2019-2032) Sepsis-2 septic shock accounted for three-quarters of the severe sepsis population, and the extrapolated population incidence increased from 69–79 per 100,000 person-years Key Septic Shock Companies: Adrenomed AG, Vivacelle Bio, Inotrem, and others Key Septic Shock Therapies: Adrecizumab, VBI-S, Nangibotide, and others The Septic shock epidemiology based on gender analyzed that the percentage of females who stayed in ICU due to septic shock was 36.7% Get a Free sample for the Septic Shock Market Report Key benefits of the Septic Shock Market report: Septic Shock market report covers a descriptive overview and comprehensive insight of the Septic Shock Epidemiology and Septic Shock market in the 7MM (the United States, EU5 (Germany, Spain, France, Italy, UK) & Japan.) The Septic Shock market report provides insights on the current and emerging therapies. Septic Shock market report provides a global historical and forecasted market covering drug outreach in 7MM. The Septic Shock market report offers an edge that will help develop business strategies by understanding trends shaping and driving the Septic Shock market. Discover more about therapies set to grab major Septic Shock market share @ Septic Shock market forecast Septic Shock Epidemiology Segmentation: The Septic Shock market report proffers epidemiological analysis for the study period 2019–2032 in the 7MM segmented into: Total Prevalence of Septic Shock Prevalent Cases of Septic Shock by severity Gender-specific Prevalence of Septic Shock Diagnosed Cases of Episodic and Chronic Septic Shock Septic Shock Market The dynamics of the Septic Shock market are anticipated to change in the coming years owing to the expected launch of emerging therapies such as Adrecizumab, VBI-S, Nangibotide, and others during the forecasted period 2019-2032. Download the report to understand which factors are driving Septic Shock epidemiology trends @ Septic Shock Epidemiological Insights Septic Shock Therapies and Key Companies Adrecizumab: Adrenomed AG VBI-S: Vivacelle Bio Nangibotide: Inotrem Scope of the Septic Shock Market Report Study Period: 2019–2032 Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan] Key Septic Shock Companies: Adrenomed AG, Vivacelle Bio, Inotrem, and others Key Septic Shock Therapies: Adrecizumab, VBI-S, Nangibotide, and others Septic Shock Therapeutic Assessment: Septic Shock current marketed and Septic Shock emerging therapies Septic Shock Market Dynamics:  Septic Shock market drivers and barriers Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter’s five forces, BCG Matrix, Market entry strategies Unmet Needs, KOL’s views, Analyst’s views, Septic Shock  Market Access and Reimbursement Table of Contents 1. Septic Shock Market Report Introduction 2. Executive Summary for Septic Shock 3. SWOT analysis of Septic Shock 4. Septic Shock Patient Share (%) Overview at a Glance 5. Septic Shock Market Overview at a Glance 6. Septic Shock Disease Background and Overview 7. Septic Shock Epidemiology and Patient Population 8. Country-Specific Patient Population of Septic Shock 9. Septic Shock Current Treatment and Medical Practices 10. Septic Shock Unmet Needs 11. Septic Shock Emerging Therapies 12. Septic Shock Market Outlook 13. Country-Wise Septic Shock Market Analysis (2019–2032) 14. Septic Shock Market Access and Reimbursement of Therapies 15. Septic Shock Market drivers 16. Septic Shock Market barriers 17.  Septic Shock Appendix 18. Septic Shock Report Methodology 19. DelveInsight Capabilities 20. Disclaimer 21. About DelveInsight To know more about Septic Shock treatment, visit @ Septic Shock Medications Media ContactCompany Name: DelveInsight Business Research LLPContact Person: Gaurav BoraEmail: Send EmailPhone: 9193216187Address:304 S. Jones Blvd #2432City: Las VegasState: NevadaCountry: United StatesWebsite: https://www.delveinsight.com/

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