What is FrontlineODP™?
Preventable death from hemorrhage following trauma is a global concern which has been targeted by trauma surgeons, emergency medical providers, mass casualty planners, the military and national governments as a top priority. Velico® is proud to be developing the Frontline ODP™ technology in support of this call to action.
A FrontlineODP™ Unit is spray dried plasma unit ready for rehydration. The intended use is for the management of traumatic hemorrhage where conventional plasma is unavailable or impractical for use such as pre-hospital transfusions, rural/austere hospitals or military applications.
Frontline ODP™ Spray Dried Plasma is being designed for easy integration in blood center component laboratories. Decentralized production by blood centers will take advantage of deep blood component manufacturing expertise and product supply chains, from established volunteer blood donor bases to end user distribution including emergency logistics channels.
Decentralized production has the potential to enable local dry plasma self-sufficiency and access to spray dried plasma for national emergency preparedness including civilian, government and military collaboration for strategic stockpiles and readiness for mass casualty events.
A FrontlineODP™ Unit is spray dried plasma unit ready for rehydration. The intended use is for the management of traumatic hemorrhage where conventional plasma is unavailable or impractical for use such as pre-hospital transfusions, rural/austere hospitals or military applications.
Frontline ODP™ Spray Dried Plasma is being designed for easy integration in blood center component laboratories. Decentralized production by blood centers will take advantage of deep blood component manufacturing expertise and product supply chains, from established volunteer blood donor bases to end user distribution including emergency logistics channels.
Decentralized production has the potential to enable local dry plasma self-sufficiency and access to spray dried plasma for national emergency preparedness including civilian, government and military collaboration for strategic stockpiles and readiness for mass casualty events.
Why is it needed?
30-40 percent of deaths from bleeding are considered preventable. In the United States alone preventable death from bleeding takes over 30,000 lives per year.
A spray dried plasma solution will potentially allow for new methods of blood product distribution throughout the EMT community. The potential for longer storage of Spray Dried Plasma means that emergency vehicles may be able to carry this product for longer than whole blood or other alternatives without replenishing as often.
In addition, as Spray Dried Plasma is being designed to be stored in ambient conditions, it has the potential to save more lives, especially where emergency vehicles do not have appropriate refrigerated facilities but could provide ambient controlled temperature storage conditions.
A spray dried plasma solution will potentially allow for new methods of blood product distribution throughout the EMT community. The potential for longer storage of Spray Dried Plasma means that emergency vehicles may be able to carry this product for longer than whole blood or other alternatives without replenishing as often.
In addition, as Spray Dried Plasma is being designed to be stored in ambient conditions, it has the potential to save more lives, especially where emergency vehicles do not have appropriate refrigerated facilities but could provide ambient controlled temperature storage conditions.
Who It Will Support
Velico's® FODP 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 component manufacturing 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
Velico® is developing a novel, platform technology for manufacturing spray dried human plasma. The FrontlineODP™ system is intended to be deployed at regional blood centers that who 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.
Reconstitution
FrontlineODP™ is easily reconstituted with 200 ml of sterile water for injection (SWFI), and potentially available to be used within minutes, making it practical in the prehospital settings where thawed plasma is unavailable.
Transfusion
Plasma transfusions are lifesaving in critical care for the treatment of many types of trauma that result in blood loss and uncontrolled hemorrhage. Uncontrolled bleeding 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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