What Vivacelle Bio does

Vivacelle Bio is a privately held, clinical-stage biopharmaceutical company developing phospholipid nanoparticle-based resuscitation fluids for critical care, with a primary focus on septic shock and hemorrhagic shock. The company's lead asset, VBI-S, is an intravenously administered fluid composed of lipid bilayer nanoparticles and soybean oil micelles that selectively absorb and redistribute nitric oxide in the microcirculation, addressing both absolute hypovolemia (fluid/blood loss) and relative hypovolemia (excess nitric oxide–driven vasodilation) without blocking nitric oxide production. The platform is protected by 57 patents covering VBI-S, VBI-1 (hemorrhagic shock, Phase II-ready), VBI-R (reperfusion injury), VBI-M (multiple organ dysfunction syndrome), VBI-3 (hyperprocalcitonemia), and VBI-7 (intracavity infection). The company is currently running a 40-patient, open-label, randomized Phase III trial across seven US sites in patients with refractory hypotension from septic shock, with a primary endpoint of increasing mean arterial pressure by at least 10 mmHg; Phase IIa results published in The Lancet eClinicalMedicine reported 100% primary endpoint achievement and no drug-related adverse events.

Vivacelle Bio serves hospital critical care units, ICUs, emergency departments, and Level I trauma centers, with secondary focus on US military and defense health systems (supported by US Navy and Department of Defense funding) and, more recently, Sub-Saharan African healthcare systems (supported by a partnership with Propelevate). The company has raised approximately $10.9M in seed and Series A1-A3 funding from the US Department of Defense, the US National Institutes of Health, and 2Flo Ventures, plus a $5.3M US Navy award under MTEC, and is targeting a $20M Series B integrated with its Sub-Saharan Africa strategy. Leadership includes founder and President/CIO Dr. Cuthbert Simpkins (trauma surgeon, UMKC), CEO and co-founder Harven DeShield (pharma BD and IP law background), Chief Business Officer Paul Burton (founder of 2Flo Ventures), and CMO Dr. Krishna Talluri.

The business model is a standard biopharmaceutical commercialization plan: upon FDA approval, VBI-S and future products will be sold to hospitals, healthcare systems, and government health programs through conventional pharmaceutical distribution channels. Vivacelle Bio is pre-revenue and pre-commercial, with no products approved, no disclosed pricing, and no disclosed licensing revenue. The company has 1-10 employees and is headquartered in Kansas City, Missouri, with clinical development operations in collaboration with the University of Missouri-Kansas City School of Medicine.

Name

Vivacelle Bio

Legal name

Vivacelle Bio, Inc.

Website

https://vivacellebio.com

Company type

Private

Founded year

2017

Operating status

Operating

Headcount range

1–10 employees

Short description

Vivacelle Bio is a clinical-stage biopharma company developing phospholipid nanoparticle resuscitation fluids that selectively redistribute nitric oxide to treat hypovolemia in septic shock and hemorrhagic shock, serving hospital ICUs, trauma centers, and military health systems, with its lead asset VBI-S in Phase III trials.

Ownership category

akta.pro rank

Product category

Critical Care Pharmaceuticals

NAICS

Biological Product (except Diagnostic) Manufacturing (325414)

SIC

Pharmaceutical Preparations (2834)

akta.pro primary industry

Cardiology & Vascular Specialty Pharmaceuticals (HLAIACAG)

Keywords

• Septic shock treatment
• Resuscitation fluid therapy
• Phospholipid nanoparticle drugs
• Hemorrhagic shock therapy
• Critical care biopharma

Headquarters

HQ city

Chicago

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales, Supply Chain

Revenue model

1. Pharmaceutical Product Sales: As a late-stage biopharma company, Vivacelle Bio's primary revenue model will be through the sale of FDA-approved pharmaceutical products (VBI-S, VBI-1, and future pipeline products). The company is currently in Phase III clinical trials and has not yet commercialized any products. Revenue will be generated from selling its nanoparticle-based therapies to hospitals, healthcare systems, and potentially government healthcare programs.

Go-to-market motion1 record

Distribution channels2 records

Marketing channels7 records

Core offering

Vivacelle Bio develops intravenously administered phospholipid nanoparticle-based resuscitation fluids for critical care. Its lead product VBI-S is in Phase III clinical trials for treating hypovolemia and hypotension in septic shock, while VBI-1 is ready to begin Phase II for hemorrhagic shock and reperfusion injury. The products work by reversibly absorbing and redistributing nitric oxide within the microcirculation to restore blood pressure and organ function in patients who fail standard fluids and vasopressors.

Product overview

Vivacelle Bio is a late-stage biopharma company developing a portfolio of phospholipid nanoparticle-based cardiovascular support fluids for critical care applications. The company's lead product is VBI-S (Phase III), which treats hypovolemia and hypotension in septic shock patients by redistributing nitric oxide. VBI-1 (Phase II-ready) addresses hemorrhagic shock and reperfusion injury. The pipeline also includes VBI-R (reperfusion injury), VBI-M (multiple organ dysfunction syndrome), VBI-3 (hyperprocalcitonemia), and VBI-7 (intracavity infection). All products are based on the company's proprietary phospholipid nanoparticle technology platform, which leverages the lipophilic properties of nanoparticles to absorb and redistribute nitric oxide, restoring blood pressure without interfering with its essential biological functions.

Differentiator

Problem solved

Functional benefit

Products and services

• VBI-S Phospholipid nanoparticle-based cardiovascular support fluid for treating hypovolemia and hypotension in septic shock patients. VBI-S is administered intravenously and works by reversibly absorbing and redistributing nitric oxide to elevate blood pressure in patients who are refractory to standard fluids and vasopressors. Currently in Phase III clinical trial (NCT06072430) with 100% efficacy demonstrated in Phase IIa (20/20 patients met the primary endpoint of increasing mean arterial pressure by at least 10 mmHg).
• VBI-1 Organ-protective, volume-expanding perfusion fluid based on phospholipid nanoparticles as the colloid, designed for treatment of hemorrhagic shock and reperfusion injury in patients with emergently life-threatening conditions due to blood loss. Has FDA IND clearance and is ready to start Phase II clinical trials, building on the same nitric-oxide-redistribution platform as VBI-S.

Quantifiable outcome

• 100% of patients (20/20) met primary endpoint of elevating mean arterial blood pressure by at least 10 mmHg within average 1.5 hours in Phase IIa trial
• +4 more outcomes

Named customers2 records

Segments3 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

Three partnerships are on record, tiered minor, core and major.

• Sepsis AllianceminorGTM or Marketing Partner · 24 September 2024Vivacelle Bio announced its support of the Sepsis Alliance in its mission to raise awareness and understanding around sepsis. Sepsis is the leading cause of death in U.S. hospitals, causing approximately 6% of all U.S. hospitalizations and 35% of all in-hospital deaths.
• University of Missouri-Kansas City School of MedicinecoreStrategic or Co-development Partner · 29 February 2024Collaboration partner for Phase 2a clinical trial of VBI-S for refractory hypotension in severe septic shock patients. The landmark study, published in The Lancet's eClinicalMedicine journal, demonstrated 100% efficacy with statistically significant improvements across multiple parameters including oxygenation, renal function, inflammation, and organ failure assessment scores.
• PropelevatemajorStrategic or Co-development Partner · 22 February 2024Partnership with Propelevate to drive Sub-Saharan Africa strategy, which is fully integrated into the company's Series B financing round. Focuses on making life-saving products to treat hypovolemia due to sepsis and blood loss available in Sub-Saharan Africa where there is outsized demand.

Scale indicators9 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• La Jolla Pharmaceutical Company: Developed Giapreza (angiotensin II), the first FDA-approved vasopressor for septic shock patients with refractory hypotension. Most directly comparable as a critical-care biopharma targeting the same septic shock population that Vivacelle's VBI-S addresses.
• Adrenomed AG: Develops adrecizumab, a monoclonal antibody targeting adrenomedullin for septic shock. Directly comparable as a late-stage European biotech targeting septic shock biomarker modulation with a non-vasopressor mechanism.
• Inotrem S.A. Clinical-stage biotech developing nangibotide, a TREM-1 inhibitor for septic shock. Comparable as a peer-stage company targeting the immune/inflammatory axis of septic shock rather than vasopressor pathways.
• AM-Pharma B.V. Develops recombinant human alkaline phosphatase for sepsis-associated acute kidney injury. Comparable as a late-stage European biotech developing an enzyme/biologic therapeutic for critically ill sepsis patients.
• Spectral Medical Inc. Develops PMX (polymyxin B hemoperfusion) for endotoxin removal in septic shock, currently in Phase III (EUPHRATES trial). Comparable as a clinical-stage company with a non-vasopressor intervention targeting septic shock patients.

Broad incumbents

• Baxter International: Global manufacturer of IV solutions, resuscitation fluids, and critical-care pharmaceuticals. Relevant as the established incumbent that dominates the hospital fluid resuscitation market Vivacelle would enter.
• B. Braun Melsungen AG: One of the world's largest manufacturers of infusion solutions, IV fluids, and clinical nutrition products used in critical care. Comparable as an incumbent supplier of standard resuscitation fluids to hospitals.
• Fresenius Kabi: Major manufacturer of IV generics, infusion solutions, and clinical nutrition products for critically ill patients. Comparable as an incumbent in the hospital fluid resuscitation and critical care pharmaceutical markets.
• Eagle Pharmaceuticals: Specialty pharmaceutical company developing and commercializing injectable therapeutics for critical care and hospital use. Comparable as a US-focused specialty pharma addressing hospital-administered therapies.
• Chiesi Farmaceutici S.p.A. Privately held global specialty pharmaceutical company with a critical care portfolio including respiratory and cardiovascular hospital therapies. Comparable as a privately held, science-driven specialty pharma with hospital channel focus.

Market position

Strengths5 records

Weaknesses4 records

Competitive moat4 records

Key risks5 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/vivacelle-bio
• Facebookfacebook.com/Vivacellebio

Revenue estimate

Valuation estimate

Number of profiles

Profiles5 records

Funding overview

Funding rounds2 records

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Vivacelle Bio