- Commitment to make life-saving products to treat life-threatening hypovolemia due to sepsis and blood loss available in Sub-Saharan Africa where there is outsized demand.
- Targeted $20M Series B Round to include Sub-Saharan Africa in product development.
- Partnering with Propelevate to drive Sub-Saharan Africa strategy.
KANSAS CITY, Mo., Feb. 22, 2024 — Life sciences company Vivacelle Bio today announced Sub-Saharan Africa as a priority region for its life-saving alternative to fluid resuscitation to treat hypovolemia caused by severe sepsis, septic shock, or blood loss. Vivacelle Bio’s lifesaving cardiovascular support fluids (VBI-S and VBI-1), both comprised of phospholipid nanoparticles, can be used to treat the refractory hypovolemia and hypotension that occur in severe sepsis and septic shock, and used instead of blood to correct hypovolemia from blood loss such as after major vehicle collisions and postpartum hemorrhage. Vivacelle Bio is partnering with Propelevate to drive the Sub-Saharan Africa strategy, which is fully integrated into its Series B financing round.
Globally, sepsis kills ~11M people each year. Young children in Sub-Saharan Africa have outsized rates of sepsis death from neonatal sepsis, and sepsis caused by respiratory infection, diarrheal disease, and malaria. A child born in sub-Saharan Africa is nearly 8 times more likely to die in the first month of life than a child born in the US. Likewise, seventy percent of pregnancy-related deaths globally occur in Sub-Saharan Africa. Annually more than 75,000 women in the region die from postpartum hemorrhage or maternal sepsis.
Vivacelle Bio’s use of phospholipid nanoparticles to raise the blood pressure in patients with life-threatening hypovolemia due to blood loss, sepsis and septic shock is unprecedented. A successful phase 2a clinical trial of VBI-S, the formulation designed for treating hypovolemia due to septic shock, was recently completed. The fluid restores intravascular volume and absorbs nitric oxide, a gas made by the body that is largely responsible for the drop in blood pressure that is not responsive to current therapy. The evidence from the clinical trial showed that VBI-S is safe for patients while it increases blood pressure and reverses organ failure even when standard therapy has failed. This is the first-time in 20 years that a phase 2 or phase 3 trial in septic shock has succeeded in meeting all of its efficacy endpoints.
VBI-1, designed for blood loss, also absorbs nitric oxide, and protects vital organs from reperfusion injury. Pre-clinical studies show that VBI-1 has greater efficacy than blood or standard of care fluids in raising blood pressure after severe hemorrhagic shock. Blood and other fluids promote reperfusion injury to vital organs while VBI-1 prevents this organ damage.
The current $20M Series B round includes funding for a Global Pediatric Phase III trial for VBI-S, and two Phase IIA trials for VBI-1, which will integrate sites in Sub-Saharan Africa to ensure the efficacy of both products in diverse contexts.
Vivacelle Bio Co-Founder Dr. Cuthbert Simpkins, MD, Chief Innovation Officer of Vivacelle Bio and Sosland Missouri Endowed Chair in Trauma Services at the University of Missouri, Kansas City (UMKC) School of Medicine, says “VBI-S and VBI-1 can be used in any context where there is a health worker able to administer IV fluids. VBI-S has shown to be more effective than vasopressors at addressing septic shock, without the side effects such as gangrene of fingers and toes. Moreover, VBI-S carries oxygen and is shown to improve lung oxygenation, and reverse elevated creatinine in septic patients. Both VBI-S and VBI-1 are shelf stable for at least a year at room temperature with VBI-S currently having more than 2 years stability at room temperature. VBI-1 circumvents many of the challenges of blood transfusions: the challenges of securing blood donors, the need to type, to maintain cold chain, the short shelf-life, and the risk of disease transmission.”
Harven DeShield, JD, PhD, the CEO of Vivacelle Bio commented, “Being born in Liberia, and raised in Liberia, Côte d’Ivoire and Tanzania, the critical value proposition of VBI-S and VBI-1 being readily affordable and available in Africa is not only of immense personal importance, but also provides a holistic, strategic vehicle to address persistent health inequities in Africa related to treatment of shock and trauma.”
Dr. Angela James, Senior Advisor for 2Flo Ventures, a Chicago-based startup studio and venture capital firm, and investor in Vivacelle Bio, echoed the importance of the impact of addressing the global unmet need for people with sepsis and septic shock having equitable access to safe and effective treatments. “Vivacelle Bio is poised to bring life-changing drugs to patients and their families in a region which has not been given equitable access to effective therapies is a great opportunity from both a healthcare and business perspective.”
Through partnership with Propelevate, Vivacelle Bio will engage global health funders and stakeholders during final stages of product development, and Propelevate will drive Vivacelle Bio’s go-to-market strategy for African markets upon regulatory approval. “We are excited to partner with Vivacelle Bio because of their commitment to Sub-Saharan Africa. Life sciences companies typically think about the region as an afterthought. Vivacelle Bio is already taking specific needs in the region into account in product development and laying the groundwork for eventual local manufacturing to ensure wide availability of its life-saving products,” said Propelevate’s Managing Director Krisila Benson.
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 Vivacelle Bio: Vivacelle 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.
About Propelevate: Propelevate (www.propelevate.global) is a consulting firm working at the intersection of the private sector and social impact. Propelevate has experience bringing new health products to market in Africa and Asia, raising tens of millions of dollars in global health financing, and brokering successful partnerships between commercial and development actors.
SOURCE Vivacelle Bio
