Velico Medical achieves milestones in developing spray-dried plasma for point-of-care transfusions

Receives US FDA approval to proceed with a Phase-I (human) clinical study for its proprietary FrontlineODP system for spray drying plasma

Velico Medical announced that the US Food and Drug Administration (FDA) has approved for the company to proceed with a Phase-I (human) clinical study for its proprietary FrontlineODP (On Demand Plasma) system for spray drying plasma. As a result of FDA’s green light, the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the US Department of Health and Human Services, executed a new contract (#75A50121C00059) with the company that will provide $20 million, with potential follow-on options up to a total of $74.3 million, in non-dilutive funding to support the continued research and development, scale-up manufacturing and preparation for commercial launch. 

“This is a major step forward for Velico Medical. Our entire team and a broad range of external advisors have worked tremendously hard for several years to get us to this point. I thank the people at BARDA for their continued support. We are looking forward to a successful clinical study while at the same time expanding the company’s production and commercial capabilities,” said Richard Meehan, CEO, Velico Medical.

The work associated with the clinical study, further product development, manufacturing scale-up, building commercial readiness and PMA submission is being funded by the new contract. 

FrontlineODP is expected to be easy to produce, easy to use, point-of-care plasma product for transfusion in settings where current plasma products (most often frozen) are unavailable or inconvenient to use because of challenging cold chain logistics and short dating. Velico Medical’s proprietary spray drying process results in a powdered plasma product that can be stored in a refrigerator or at ambient temperature and then reconstituted on-scene in minutes. With FrontlineODP, plasma could become more readily available to first responders such as ground or air ambulances, in rural hospitals where plasma is typically not stocked, for the military and during mass casualty events. 

Using Velico Medical’s spray drying technology and associated products, FrontlineODP will be produced by blood centres around the world. These centres have the infrastructure and expertise to provide a sustainable source of dried plasma to service local and regional needs while also supporting national disaster preparedness initiatives.