Who We Support
Hospitals
Introduction to FrontlineODP™
FrontlineODP™ Spray Dried Plasma is designed for easy integration in blood center component laboratories. Decentralized production by blood centers would leverage deep blood component manufacturing expertise and product supply chains, from established volunteer blood donor bases to end user distribution including emergency logistic channels.
Decentralized production would establish local dry plasma self-sufficiency and availability for national emergency preparedness including civilian, government and military collaboration for strategic stockpiles and readiness for mass casualty events.
Applications in Industry
The FrontlineODP™ system is intended to be deployed at blood centers who will produce dry plasma for use by hospitals, emergency first responders and the military.
The use of thawed plasma in the emergency department, allowing plasma to be used as a primary in-hospital resuscitation fluid, was associated with improved survival.
FrontlineODP™ requires less cold chain management, and offers a more rapid reconstitution process, which has the potential to improve inventory management and surge capability while also reducing logistical constraints of conventional plasma.
Stable and dry substance which has the potential shelf life of 2 years.
Value & Potential Benefits of FrontlineODP™
Pivotal studies show that early transfusion of plasma improves patient outcomes and prevents unnecessary death from bleeding in military and civilian situations.
Stable and dry substance which has the potential shelf life of 2 years
Reconstitution process takes minutes using sterile water for injection
FrontlineODP™ has the potential to allow for rapid treatment of coagulopathies due to hemorrhage
In situations where traditional plasma products are not available or inconvenient to use, dried plasma offers a potential alternative for early plasma transfusion for patients suffering from hemorrhagic shock.
Why is it needed?
The leading cause of avoidable death in trauma patients is hemorrhage.† In contrast to the conventional wisdom on the "golden hour", peak mortality in patients with acute truncal bleeding happens at 30 min.† The median time to bleeding fatality for patients who make it to a hospital is 90–150 minutes after admission.† It is well recognized that a common path to fatal and irreversible shock is through the lethal triad of hypothermia, acidosis, and acute coagulopathy following trauma.
The optimum method for treating traumatic hemorrhage is damage control resuscitation (DCR) with blood components that mimic whole blood in the presence of permissive hypotension, avoiding crystalloid and colloid solutions. The best approach to avoid traumatic hemorrhagic death and prevent trauma induced coagulopathy (TIC) is rapid bleeding control followed by hemorrhage management. This strategy requires plasma transfusion. Dried plasma is a shelf-stable plasma product that is easy to transport and administer.
† Holcomb J. Transport time and preoperating room hemostatic interventions are important. Crit Care Med. 2018;46(3):447–53.
† Alarhayem A, Myers J, Dent D, Liao L, Muir M, Mueller D, et al. Time is the enemy: mortality in trauma patients with hemorrhage from torso injury occurs long before the “golden hour”. Am J Surg. 2016;212(6):1101–5.
† Holcomb J, del Junco D, Fox E, Wade C, Cohen M, Schreiber M, et al. The prospective, observational, multicenter, major trauma transfusion [PROMMTT] study. JAMA Surg. 2013;148(2):127.
Velico's® FrontlineODP™ Business Model
Velico's® business model will be based on partnerships with regional blood centers which collect, test and manufacture lifesaving blood components every day. Velico's® FrontlineODP™ system is being designed for straight-forward integration into existing blood centers.
The FrontlineODP™ development program is funded by the Biomedical Advanced Research and Development Authority (BARDA), within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services under contract No. 75A50121C00059.
Resulting Plasma
Resulting Plasma
Velico® is developing FrontlineODP™, a novel, platform technology for manufacturing spray dried human plasma. The FrontlineODP™ system is intended to be deployed at regional blood centers that will produce dry plasma for use by hospitals, emergency first responders and the military. Dry plasma overcomes the logistics of conventional frozen plasma and potentially extends the availability of plasma closer to the point of injury, including rural and austere settings. The resulting plasma units are compact and can be stored either refrigerated or at room temperature.
Reconstitution
FrontlineODP™ is easily reconstituted with 200 ml of sterile water for injection (SWFI), and ready for use within minutes, making it practical in prehospital settings where conventional plasma is unavailable.
Transfusion
Uncontrolled hemorrhage is recognized as the leading cause of potentially preventable death among victims of trauma.† The early administration of plasma has been shown to be lifesaving for many of these patients.
† Sperry JL, et al. Prehospital Plasma during Air Medical Transport in Trauma Patients at Risk for Hemorrhagic Shock. N Engl J Med. 2018 Jul 26;379(4):315-326
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