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

BEVERLY, Mass., Aug. 24, 2021 /PRNewswire/ -- Velico Medical, an organization that is pioneering lifesaving innovation in transfusion medicine, today announced that the US Food and Drug Administration (FDA) has granted approval 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 U.S. 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 a number of 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 Velico Medical's CEO Richard Meehan.

The work associated with the clinical study, further product development, manufacturing scaleup, building commercial readiness and PMA submission is being funded by the new contract. "BARDA support has allowed us to advance this product to the exciting point where it is today. We are grateful for the significant funding commitment and the collaborative nature of our relationship with BARDA," said Bill Merritt Velico's Chief Program Officer.

FrontlineODP is expected to be an 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. 

"Spray-dried plasma would truly be a game-changer for Boston MedFlight, and likely for all Helicopter and Ground EMS providers. The product's long shelf-stability and minimal form factor are critical for allowing us to bring the treatment to the point of injury and begin reversing coagulopathy as soon as possible. Hemorrhagic resuscitation should start with plasma transfusion, but the challenge of safe and effective storage in the back of a helicopter, often precludes our ability to utilize it. Additionally, plasma's short shelf-life results in the potential waste of precious blood products and un-recouped expenses. We are a non-profit organization and the loss of every unit of blood product takes away directly from our life-saving mission," said Dr. Jason Cohen DO, FACEP, FCCM, Chief Medical Officer at Boston MedFlight.

Using Velico Medical's spray drying technology and associated products, FrontlineODP will be produced by blood centers around the world. These centers 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. 

"Our clinical partners and study sites, renowned in their own right, are very excited about working with us to contribute to the advancement of FrontlineODP, while also helping us develop regulatory compliant protocols and processes. Working together we hope to aid in saving thousands of lives all over the world," said Velico Medical's Chief Medical Officer Mark Popovsky M.D. 

About Velico Medical
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 ZymeQuest). Velico personnel have substantial expertise and experience in transfusion medicine and medical device development. Velico intends to equip regional blood centers around the world to respond to the urgent clinical need for a locally produced, consistently available, point of care, dry plasma product for transfusion. In support of its mission, Velico is developing partnerships with civilian, government and military blood center leadership, trauma surgeons, emergency medical physicians, military medics and first responders worldwide.

SOURCE Velico Medical, Inc.