BARDA and Velico Medical are continuing a partnership to develop the FrontlineODP spray-dry plasma system for producing a point of care plasma product for transfusion.
Following the U.S. Food and Drug Administration (FDA) approval of Velico Medical’s Investigational Device Exemption application in June 2021, the company can move into a Phase 1 clinical study.
Velico’s spray-dry plasma system is designed to leverage the existing plasma volunteer donor base to produce an easily rehydrated plasma product with improved utility and availability over currently available plasma products.
The follow-on contract will support completion of clinical studies to request FDA Premarket Application Approval (PMA), clinical indication expansion as well as market readiness preparation activities including system and disposable cost reduction and manufacturing scale up.
If successful, the FrontlineODP system could help address the traumatic blood loss associated with a radiological/nuclear emergency, a critical component of national preparedness.
This award is one component of the BARDA’s CBRN Division medical countermeasure portfolio; visit the CBRN Portfolio to learn more.
About Velico Medical:
The following information is provided by the company and does not indicate endorsement by the federal government of the company or its products.
Velico Medical, Inc. is a private US medical technology company, committed to the mission of eliminating preventable death from bleeding. Headquartered in Beverly, Massachusetts, USA, Velico has been in business since 1992 (originally doing business as ZymeQuest). Velico personnel have substantial expertise and experience in transfusion medicine and medical device development. Velico will equip regional blood centers around the world to respond to the urgent clinicians need for a locally produced, consistently available, point of care, dry plasma product for transfusion. Velico is developing partnerships with civilian, government and military blood center staff, trauma surgeons, emergency medical physicians, military medics and first responders worldwide.